CFR 2023 Title21 Vol2

Title 21
Food and Drugs

Parts 100 to 169
Revised as of April 1, 2023
Containing a codification of documents

of general applicability and future effect
As of April 1, 2023
Published by the Office of the Federal Register

National Archives and Records Administration
as a Special Edition of the Federal Register
sfrattini on LAPCK6H6L3 with DISTILLER
VerDate Sep<11>2014 09:03 May 08, 2023 Jkt 259072 PO 00000 Frm 00001 Fmt 8091 Sfmt 8091 Q:\21\21V2.TXT PC31
U.S. GOVERNMENT OFFICIAL EDITION NOTICE
Legal Status and Use of Seals and Logos

The seal of the National Archives and Records Administration
(NARA) authenticates the Code of Federal Regulations (CFR) as
the official codification of Federal regulations established under
the Federal Register Act. Under the provisions of 44 U.S.C. 1507, the
contents of the CFR, a special edition of the Federal Register, shall
be judicially noticed. The CFR is prima facie evidence of the origi-
nal documents published in the Federal Register (44 U.S.C. 1510).
It is prohibited to use NARA’s official seal and the stylized Code
of Federal Regulations logo on any republication of this material
without the express, written permission of the Archivist of the
United States or the Archivist’s designee. Any person using
NARA’s official seals and logos in a manner inconsistent with the
provisions of 36 CFR part 1200 is subject to the penalties specified
in 18 U.S.C. 506, 701, and 1017.
Use of ISBN Prefix

This is the Official U.S. Government edition of this publication
and is herein identified to certify its authenticity. Use of the 0–16
ISBN prefix is for U.S. Government Publishing Office Official Edi-
tions only. The Superintendent of Documents of the U.S. Govern-
ment Publishing Office requests that any reprinted edition clearly
be labeled as a copy of the authentic work with a new ISBN.
U.S. GOVERNMENT PUBLISHING OFFICE
U.S. Superintendent of Documents • Washington, DC 20402–0001

http://bookstore.gpo.gov
gpologo2.eps</GPH>
Phone: toll-free (866) 512-1800; DC area (202) 512-1800

archives.ai</GPH>
Table of Contents
Page
Explanation ................................................................................................ v
Title 21:
Chapter I—Food and Drug Administration, Department of Health

and Human Services (Continued) ................................................. 3
Finding Aids:
Table of CFR Titles and Chapters ....................................................... 735
Alphabetical List of Agencies Appearing in the CFR ......................... 755
List of CFR Sections Affected ............................................................. 765

iii
Cite this Code: CFR
To cite the regulations in

this volume use title,
part and section num-
ber. Thus, 21 CFR 100.1
refers to title 21, part
100, section 1.
iv
Explanation
The Code of Federal Regulations is a codification of the general and permanent
rules published in the Federal Register by the Executive departments and agen-
cies of the Federal Government. The Code is divided into 50 titles which represent
broad areas subject to Federal regulation. Each title is divided into chapters
which usually bear the name of the issuing agency. Each chapter is further sub-
divided into parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year and issued
on a quarterly basis approximately as follows:
Title 1 through Title 16..............................................................as of January 1
Title 17 through Title 27 .................................................................as of April 1
Title 28 through Title 41 ..................................................................as of July 1
Title 42 through Title 50 .............................................................as of October 1
The appropriate revision date is printed on the cover of each volume.
LEGAL STATUS
The contents of the Federal Register are required to be judicially noticed (44
U.S.C. 1507). The Code of Federal Regulations is prima facie evidence of the text
of the original documents (44 U.S.C. 1510).
HOW TO USE THE CODE OF FEDERAL REGULATIONS
The Code of Federal Regulations is kept up to date by the individual issues
of the Federal Register. These two publications must be used together to deter-
mine the latest version of any given rule.
To determine whether a Code volume has been amended since its revision date
(in this case, April 1, 2023), consult the ‘‘List of CFR Sections Affected (LSA),’’
which is issued monthly, and the ‘‘Cumulative List of Parts Affected,’’ which
appears in the Reader Aids section of the daily Federal Register. These two lists
will identify the Federal Register page number of the latest amendment of any
given rule.
EFFECTIVE AND EXPIRATION DATES
Each volume of the Code contains amendments published in the Federal Reg-
ister since the last revision of that volume of the Code. Source citations for
the regulations are referred to by volume number and page number of the Federal
Register and date of publication. Publication dates and effective dates are usu-
ally not the same and care must be exercised by the user in determining the
actual effective date. In instances where the effective date is beyond the cut-
off date for the Code a note has been inserted to reflect the future effective
date. In those instances where a regulation published in the Federal Register
states a date certain for expiration, an appropriate note will be inserted following
the text.
OMB CONTROL NUMBERS
The Paperwork Reduction Act of 1980 (Pub. L. 96–511) requires Federal agencies
to display an OMB control number with their information collection request.
Many agencies have begun publishing numerous OMB control numbers as amend-
ments to existing regulations in the CFR. These OMB numbers are placed as
close as possible to the applicable recordkeeping or reporting requirements.
PAST PROVISIONS OF THE CODE
Provisions of the Code that are no longer in force and effect as of the revision
date stated on the cover of each volume are not carried. Code users may find
the text of provisions in effect on any given date in the past by using the appro-
priate List of CFR Sections Affected (LSA). For the convenience of the reader,
a ‘‘List of CFR Sections Affected’’ is published at the end of each CFR volume.
For changes to the Code prior to the LSA listings at the end of the volume,
consult previous annual editions of the LSA. For changes to the Code prior to
2001, consult the List of CFR Sections Affected compilations, published for 1949-
1963, 1964-1972, 1973-1985, and 1986-2000.
‘‘[RESERVED]’’ TERMINOLOGY
The term ‘‘[Reserved]’’ is used as a place holder within the Code of Federal
Regulations. An agency may add regulatory information at a ‘‘[Reserved]’’ loca-
tion at any time. Occasionally ‘‘[Reserved]’’ is used editorially to indicate that
a portion of the CFR was left vacant and not dropped in error.
INCORPORATION BY REFERENCE
What is incorporation by reference? Incorporation by reference was established
by statute and allows Federal agencies to meet the requirement to publish regu-
lations in the Federal Register by referring to materials already published else-
where. For an incorporation to be valid, the Director of the Federal Register
must approve it. The legal effect of incorporation by reference is that the mate-
rial is treated as if it were published in full in the Federal Register (5 U.S.C.
552(a)). This material, like any other properly issued regulation, has the force
of law.
What is a proper incorporation by reference? The Director of the Federal Register
will approve an incorporation by reference only when the requirements of 1 CFR
part 51 are met. Some of the elements on which approval is based are:
(a) The incorporation will substantially reduce the volume of material pub-
lished in the Federal Register.
(b) The matter incorporated is in fact available to the extent necessary to
afford fairness and uniformity in the administrative process.
(c) The incorporating document is drafted and submitted for publication in
accordance with 1 CFR part 51.
What if the material incorporated by reference cannot be found? If you have any
problem locating or obtaining a copy of material listed as an approved incorpora-
tion by reference, please contact the agency that issued the regulation containing
that incorporation. If, after contacting the agency, you find the material is not
available, please notify the Director of the Federal Register, National Archives
and Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001, or
call 202-741-6010.
CFR INDEXES AND TABULAR GUIDES
A subject index to the Code of Federal Regulations is contained in a separate
volume, revised annually as of January 1, entitled CFR INDEX AND FINDING AIDS.
This volume contains the Parallel Table of Authorities and Rules. A list of CFR
titles, chapters, subchapters, and parts and an alphabetical list of agencies pub-
lishing in the CFR are also included in this volume.

An index to the text of ‘‘Title 3—The President’’ is carried within that volume.
vi
The Federal Register Index is issued monthly in cumulative form. This index
is based on a consolidation of the ‘‘Contents’’ entries in the daily Federal Reg-
ister.
A List of CFR Sections Affected (LSA) is published monthly, keyed to the
revision dates of the 50 CFR titles.
REPUBLICATION OF MATERIAL
There are no restrictions on the republication of material appearing in the
Code of Federal Regulations.
INQUIRIES
For a legal interpretation or explanation of any regulation in this volume,
contact the issuing agency. The issuing agency’s name appears at the top of
odd-numbered pages.
For inquiries concerning CFR reference assistance, call 202–741–6000 or write
to the Director, Office of the Federal Register, National Archives and Records
Administration, 8601 Adelphi Road, College Park, MD 20740-6001 or e-mail
fedreg.info@nara.gov.
SALES
The Government Publishing Office (GPO) processes all sales and distribution
of the CFR. For payment by credit card, call toll-free, 866-512-1800, or DC area,
202-512-1800, M-F 8 a.m. to 4 p.m. e.s.t. or fax your order to 202-512-2104, 24 hours
a day. For payment by check, write to: US Government Publishing Office – New
Orders, P.O. Box 979050, St. Louis, MO 63197-9000.
ELECTRONIC SERVICES
The full text of the Code of Federal Regulations, the LSA (List of CFR Sections
Affected), The United States Government Manual, the Federal Register, Public
Laws, Public Papers of the Presidents of the United States, Compilation of Presi-
dential Documents and the Privacy Act Compilation are available in electronic
format via www.govinfo.gov. For more information, contact the GPO Customer
Contact Center, U.S. Government Publishing Office. Phone 202-512-1800, or 866-
512-1800 (toll-free). E-mail, ContactCenter@gpo.gov.
The Office of the Federal Register also offers a free service on the National
Archives and Records Administration’s (NARA) website for public law numbers,
Federal Register finding aids, and related information. Connect to NARA’s
website at www.archives.gov/federal-register.
The eCFR is a regularly updated, unofficial editorial compilation of CFR mate-
rial and Federal Register amendments, produced by the Office of the Federal
Register and the Government Publishing Office. It is available at www.ecfr.gov.
OLIVER A. POTTS,
Director,
Office of the Federal Register
April 1, 2023
vii
THIS TITLE
Title 21—FOOD AND DRUGS is composed of nine volumes. The parts in these
volumes are arranged in the following order: Parts 1–99, 100–169, 170–199, 200–299,
300–499, 500–599, 600–799, 800–1299, and 1300 to end. The first eight volumes, con-
taining parts 1–1299, comprise Chapter I—Food and Drug Administration, Depart-
ment of Health and Human Services. The ninth volume, containing part 1300 to
end, includes Chapter II—Drug Enforcement Administration, Department of Jus-
tice, and Chapter III—Office of National Drug Control Policy. The contents of
these volumes represent all current regulations codified under this title of the
CFR as of April 1, 2023.
For this volume, Gabrielle E. Burns was Chief Editor. The Code of Federal
Regulations publication program is under the direction of John Hyrum Martinez,
assisted by Stephen J. Frattini.
ix
Title 21—Food and
Drugs
(This book contains parts 100 to 169)
Part
CHAPTER I—Food and Drug Administration, Department of

Health and Human Services (Continued) ........................... 100
CHAPTER I—FOOD AND DRUG
ADMINISTRATION, DEPARTMENT OF HEALTH
AND HUMAN SERVICES (CONTINUED)
(Parts 100 to 169)
EDITORIAL NOTE: Nomenclature changes to chapter I appear at 59 FR 14366, Mar. 28, 1994,
59 FR 24879, May 9, 1994, 68 FR 13717, Mar. 24, 2004, 69 FR 18803, Apr. 9, 2004, 70 FR 40880, July
15, 2005, and 70 FR 67650, Nov. 8, 2005.
SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION
Part Page
100 General .................................................................... 5
101 Food labeling ........................................................... 10
102 Common or usual name for nonstandardized foods 198
104 Nutritional quality guidelines for foods ................. 205
105 Foods for special dietary use ................................... 209
106 Infant formula requirements pertaining to current
good manufacturing practice, quality control
procedures, quality factors, records and reports,
and notifications .................................................. 211
107 Infant formula ......................................................... 238
108 Emergency permit control ...................................... 248
109 Unavoidable contaminants in food for human con-
sumption and food-packaging material ................ 258
110 Current good manufacturing practice in manufac-
turing, packing, or holding human food ............... 264
111 Current good manufacturing practice in manufac-
turing, packaging, labeling, or holding oper-
ations for dietary supplements ............................ 274
112 Standards for the growing, harvesting, packing,
and holding of produce for human consumption .. 304
113 Thermally processed low-acid foods packaged in
hermetically sealed containers ............................ 342
114 Acidified foods ......................................................... 376
115 Shell eggs ................................................................ 382
21 CFR Ch. I (4–1–23 Edition)
Part Page
117 Current good manufacturing practice, hazard anal-
ysis, and risk-based preventive controls for
human food ........................................................... 385
118 Production, storage, and transportation of shell
eggs ...................................................................... 425
119 Dietary supplements that present a significant or
unreasonable risk ................................................. 436
120 Hazard Analysis and Critical Control Point
(HACCP) systems ................................................. 436
121 Mitigation strategies to protect food against in-
tentional adulteration ......................................... 445
123 Fish and fishery products ........................................ 453
129 Processing and bottling of bottled drinking water 461
130 Food standards: General ......................................... 466
131 Milk and cream ....................................................... 474
133 Cheeses and related cheese products ....................... 490
135 Frozen desserts ........................................................ 542
136 Bakery products ...................................................... 549
137 Cereal flours and related products .......................... 553
139 Macaroni and noodle products ................................ 568
145 Canned fruits ........................................................... 578
146 Canned fruit juices .................................................. 619
150 Fruit butters, jellies, preserves, and related prod-
ucts ...................................................................... 633
152 Fruit pies ................................................................ 638
155 Canned vegetables ................................................... 640
156 Vegetable juices ...................................................... 662
158 Frozen vegetables .................................................... 665
160 Eggs and egg products ............................................. 668
161 Fish and shellfish .................................................... 673
163 Cacao products ........................................................ 690
164 Tree nut and peanut products ................................. 698
165 Beverages ................................................................ 701
166 Margarine ................................................................ 721
168 Sweeteners and table sirups .................................... 723
169 Food dressings and flavorings ................................. 728
SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION
PART 100—GENERAL ticular need for information that is not

met by the preemptive Federal require-
Subpart A—State and Local Requirements ment.
(b) Definitions. (1) Act means the Fed-
Sec. eral Food, Drug, and Cosmetic Act (21
100.1 Petitions requesting exemption from U.S.C. 321 et seq.).
preemption for State or local require- (2) Agency means the Food and Drug
ments.
Administration.
100.2 State enforcement of Federal regula-
tions.
(3) Commissioner means the Commis-
sioner of Food and Drugs.
Subparts B–E [Reserved] (4) State means a State as defined in
section 201(a)(1) of the act (which in-
Subpart F—Misbranding for Reasons Other cludes a territory of the United States,
Than Labeling the District of Columbia, and Puerto
Rico) or any political subdivision of a
100.100 Misleading containers. State having authority to issue food
Subpart G—Specific Administrative Rulings standards and food labeling regulations
and Decisions having force of law.
(5) State requirement means any stat-
100.155 Salt and iodized salt. ute, standard, regulation, or other re-
AUTHORITY: 21 U.S.C. 321, 331, 337, 342, 343, quirement that is issued by a State.
348, 371. (c) Prerequisites for petitions for exemp-
tion from preemption. The Food and
SOURCE: 42 FR 14306, Mar. 15, 1977, unless
Drug Administration will consider a
otherwise noted.
petition for exemption from preemp-
EDITORIAL NOTE: Nomenclature changes to tion on its merits only if the petition
part 100 appear at 81 FR 49895, July 29, 2016. demonstrates that:
(1) The State requirement was en-
Subpart A—State and Local acted or was issued as a final rule by
Requirements an authorized official of the State and
is in effect or would be in effect but for
§ 100.1 Petitions requesting exemption the provisions of section 403A of the
from preemption for State or local act.
requirements. (2) The State requirement is subject
(a) Scope and purpose. (1) This subpart to preemption under section 403A(a) of
applies to the submission and consider- the act because of a statutory provi-
ation of petitions under section 403A(b) sion listed in that section or because of
of the Federal Food, Drug, and Cos- a Federal standard or other Federal
metic Act (the act), by a State or a po- regulation that is in effect, or that has
litical subdivision of a State, request- been published as a final rule with a
ing exemption of a State requirement designated effective date, and that was
from preemption under section 403A(a) issued under the authority of a statu-
of the act. tory provision listed in that section.
(2) Section 403A(b) of the act provides For the purposes of this subpart, all pe-
that where a State requirement has titions seeking exemption from pre-
been preempted under section 403A(a) emption under section 403A(a)(3)
of the act, the State may petition the through (a)(5) of the act submitted be-
agency for an exemption. The agency fore May 8, 1992, will be considered
may grant the exemption, under such timely even though the applicable stat-
conditions as it may prescribe by regu- utory provisions or regulations are not
lation, if the agency finds that the yet in effect.
State requirement will not cause any (3) The petitioner is an official of a
food to be in violation of any applica- State having authority to act for, or on
ble requirement under Federal law, behalf of, the Government in applying
will not unduly burden interstate com- for an exemption of State requirements
merce, and is designed to address a par- from preemption.
§ 100.1 21 CFR Ch. I (4–1–23 Edition)
(4) The State requirement is subject A. Action Requested

to preemption under section 403A(a) of 1. Identify and give the exact wording of
the act because it is not identical to the State requirement and give date it was
the requirement of the preemptive Fed- enacted or issued in final form.
eral statutory provision or regulation 2. Identify the specific standard or regula-
including a standard of identity, qual- tion that is believed to preempt the State re-
ity, and fill. ‘‘Not identical to’’ does quirement and the section and paragraph of
not refer to the specific words in the the act that the standard or regulation im-
requirement but instead means that plements.
the State requirement directly or indi-
B. Documentation of State Requirement
rectly imposes obligations or contains
provisions concerning the composition Provide a copy of the State requirement
or labeling of food, or concerning a that is the subject of the application. Where
food container, that: available, the application should also include
(i) Are not imposed by or contained copies of any legislative history or back-
ground materials used in issuing the require-
in the applicable provision (including
ment, including hearing reports or studies
any implementing regulation) of sec- concerning the development or consideration
tion 401 or 403 of the act; or of the requirement.
(ii) Differ from those specifically im-
posed by or contained in the applicable C. Statement of Grounds
provision (including any implementing A petition for an exemption from preemp-
regulation) of section 401 or 403 of the tion should contain the following:
act. 1. An explanation of the State requirement
(d) Form of petition. (1) All informa- and its rationale, and a comparison of State
tion included in the petition should and Federal requirements to show dif-
meet the general requirements of ferences.
§ 10.20(c) of this chapter. 2. An explanation of why compliance with
(2) An original and one copy of the the State requirement would not cause a
petition shall be submitted, or the peti- food to be in violation of any applicable re-
quirement under Federal law.
tioner may submit an original and a
3. Information on the effect that granting
computer readable disk containing the
the State petition will have on interstate
petition. Contents of the disk should be commerce. The petition should contain in-
in a standard format, such as ASCII formation on economic feasibility, i.e.,
format. (Petitioners interested in sub- whether the State and Federal requirements
mitting a disk should contact the Cen- have significantly different effects on the
ter for Food Safety and Applied Nutri- production and distribution of the food prod-
tion for details.) uct; comparison of the costs of compliance as
(3) Petitions for exemption from pre- shown by data or information on the actual
emption for a State requirement shall or anticipated effect of the State and Fed-
be submitted to the Division of Dock- eral requirements on the sale and price of
the food product in interstate commerce; and
ets Management in the following form:
the effect of the State requirement on the
(Date) ________________ availability of the food product to con-
Division of Dockets Management, sumers. To the extent possible, the petition
Food and Drug Administration, should include information showing that it
Department of Health and Human Services, is practical and feasible for producers of food
5630 Fishers Lane, rm. 1061, products to comply with the State require-
Rockville, MD 20852. ment. Such information may be submitted in
the form of statements from affected persons
PETITION REQUESTING EXEMPTION FROM indicating their ability to comply.
PREEMPTION FOR STATE REQUIREMENT 4. Identification of a particular need for in-
The undersigned submits this petition formation that the State requirement is de-
under section 403A(b)of the Federal Food, signed to meet, which need is not met by
Drug, and Cosmetic Act to request that the Federal law. The petition should describe the
Food and Drug Administration exempt a conditions that require the State to petition
State requirement from preemption. for an exemption, the information need that
The undersigned has authority to act for, the State requirement fulfills, the inad-
or on behalf of, the (identify State or political equacy of the Federal requirement in ad-
subdivision of the State) because (document pe- dressing this need, and the geographical area
titioner’s authority to submit petition on behalf or political subdivision in which such need
of the State). exists.
Food and Drug Administration, HHS § 100.2
D. Environmental Impact writing of the filing and docket number
The petition shall contain a claim for cat- of a petition.
egorical exclusion under 21 CFR 25.24 or an (4) Any interested person may submit
environmental assessment under 21 CFR written comments to the Division of
25.31. Dockets Management on a filed peti-
E. Notification tion as provided in § 10.30(d) of this
chapter.
Provide name and address of person,
(5) Within 90 days of the date of filing
branch, department, or other instrumen-
tality of the State government that should the agency will furnish a response to
be notified of the Commissioner’s action con- the petitioner. The response will ei-
cerning the petition. ther:
(i) State that the agency has ten-
F. Certification
tatively determined that the petition
The undersigned certifies, that, to the best merits the granting of an exemption,
knowledge and belief of the undersigned, this and that it intends to publish in the
petition includes all information and views FEDERAL REGISTER a proposal to grant
on which the petition relies.
(Signature) ________________________
the exemption through rulemaking;
(Name of petitioner) ________________ (ii) Deny the petition and state the
(Mailing address) __________________ reasons for such denial; or
(Telephone number) ________________ (iii) Provide a tentative response in-
(Information collection requirements in dicating why the agency has been un-
this section were approved by the Office of able to reach a decision on the peti-
Management and Budget (OMB) and assigned
OMB number 0910–0277)
tion, e.g., because of other agency pri-
orities or a need for additional infor-
(e) Submission of petition for exemption; mation.
public disclosure. The availability for (g) If a State submitted a petition for
public disclosure of a petition for ex- exemption of a State requirement from
emption will be governed by the rules preemption under section 403A(a)(3)
specified in § 10.20(j) of this chapter. through (a)(5) of the act before May 8,
(f) Agency consideration of petitions. (1) 1992, that State requirement will not
Unless otherwise specified in this sec- be subject to preemption until:
tion, all relevant provisions and re- (1) November 8, 1992; or
quirements of subpart B of part 10 of (2) Action on the petition, whichever
this chapter, are applicable to State occurs later.
petitions requesting exemption from
Federal preemption under section [58 FR 2468, Jan. 6, 1993]
403A(b) of the act.
(2) If a petition does not meet the § 100.2 State enforcement of Federal
regulations.
prerequisite requirements of paragraph
(c) of this section, the agency will issue (a) Under section 307 of the Federal
a letter to the petitioner denying the Food, Drug, and Cosmetic Act (the
petition and stating in what respect act), a State may bring, in its own
the petition does not meet these re- name and within its own jurisdiction,
quirements. proceedings for the civil enforcement,
(3) If a petition appears to meet the or to restrain violations, of sections
prerequisite requirements in paragraph 401, 403(b), 403(c), 403(d), 403(e), 403(f),
(c) of this section, it will be filed by the 403(g), 403(h), 403(i), 403(k), 403(q), or
Division of Dockets Management, 403(r) of the act if the food that is the
stamped with the date of filing, and as- subject of the proceedings is located in
signed a docket number. The docket the State.
number identifies the file established (b) No proceeding may be commenced
by the Division of Dockets Manage- by a State under paragraph (a) of this
ment for all submissions relating to section:
the petition, as provided in this part. (1) Before 30 days after the State has
Subsequent submissions relating to the given notice to the Food and Drug Ad-
matter must refer to the docket num- ministration (FDA) that the State in-
ber and will be filed in the docket file. tends to bring such proceeding.
The Division of Dockets Management (2) Before 90 days after the State has
will promptly notify the petitioner in given notice to FDA of such intent if
§ 100.2 21 CFR Ch. I (4–1–23 Edition)
FDA has, within such 30 days, com- H. Name of firm against which action is
menced an informal or formal enforce- anticipated (if applicable).
ment action pertaining to the food I. Type of enforcement action.
which would be the subject of such pro- Yours very truly,
ceeding. Reporting Agency
(3) If FDA is diligently prosecuting a By ____________
proceeding in court pertaining to such (Indicate authority)
food, has settled such proceeding, or (e) The letter of notification should
has settled the informal or formal en- be signed by a State official authorized
forcement action pertaining to such by the State to institute the con-
food. templated enforcement actions.
(c) A State may intervene as a mat- (f) The letter of notification should
ter of right, in any court proceeding be sent to the Division of Enforcement
described in paragraph (b)(3) of this (HFS–605), Center for Food Safety and
section. Applied Nutrition, Food and Drug Ad-
(d) The notification that a State sub-
ministration, 5001 Campus Dr., College
mits in accordance with paragraph (b)
Park, MD 20740, FAX number 202–205–
of this section should include the fol-
4642.
lowing information and be submitted
(g) FDA will notify the State of the
in the following recommended format:
date in which its letter of notification
(Date) ________________ was received by FDA, Center for Food
Name of State agency ____________ Safety and Applied Nutrition, Division
Post office address ____________
of Enforcement (HFS–605) (within 2
Street address ____________
City, State, and ZIP code ____________ working days after date of receipt).
Name of product(s) covered by the notifica- This date will be the date of notifica-
tion ____________ tion for the purposes of paragraph (b)
Reporting official, title, and telephone no. of this section.
____________ (h) The Director, Division of Enforce-
FAX No. ____________ ment, Office of Field Programs, Center
Agency contact (if different from reporting
official), title, and telephone no. for Food Safety and Applied Nutrition,
____________ FDA, will respond to the State’s notifi-
cation within 30 days of the date of no-
Director,
tification by advising:
Division of Enforcement (HFS–605),
Center for Food Safety and Applied Nutri- (1) Whether FDA has commenced an
tion, informal or formal enforcement action
Food and Drug Administration, pertaining to the food that is the sub-
5001 Campus Dr., ject of the notification; or
College Park, MD 20740. (2) Whether FDA is prosecuting a
To Whom It May Concern: proceeding in court pertaining to such
The undersigned, ______, submits this letter food, has settled such proceeding, or
of notification pursuant to section 307(b)(1) has settled informal or formal enforce-
of the Federal Food, Drug, and Cosmetic Act
ment action pertaining to such food.
(21 U.S.C. 337(b)(1)) with respect to ________.
(name of products covered by the notifica- (i) Information contained in State
tion and the enforcement action that is to be notification letters shall be exempt
initiated) from public disclosure to the same ex-
Attached hereto, and constituting a part of tent to which such information would
this letter of notification are the following: be so exempt pursuant to §§ 20.61, 20.64,
A. The name of the product. and 20.88 of this chapter.
B. The type and size of each product con-
tainer. (j) Definitions. (1) Informal enforcement
C. Copy of the label and labeling of the actions include warning letters, recalls,
product. detentions, or other administrative en-
D. Manufacturing code (if applicable). forcement actions that pertain to the
E. Name and address of firm believed to be food in question.
responsible for violations.
(2) Formal enforcement actions include
F. Name and address of parent firm (if
known). seizures, injunctions, or other civil ju-
G. Reason for the anticipated State en- dicial enforcement actions that pertain
forcement action (list specific violations, in- to the food in question. (Information
cluding sections of the law violated). collection requirements in this section
were approved by the Office of Manage- date required food labeling (excluding
ment and Budget (OMB) and assigned any vignettes or other nonmandatory
OMB control number 0910–0275.) designs or label information), discour-
age pilfering, facilitate handling, or ac-
[58 FR 2460, Jan. 6, 1993; 58 FR 17097, Apr. 1,
1993, as amended at 66 FR 56035, Nov. 6, 2001] commodate tamper-resistant devices).
(b) [Reserved]
Subparts B–E [Reserved] [59 FR 537, Jan. 5, 1994]
Subpart F—Misbranding for Subpart G—Specific Administra-

Reasons Other Than Labeling tive Rulings and Decisions
§ 100.100 Misleading containers. § 100.155 Salt and iodized salt.
In accordance with section 403(d) of (a) For the purposes of this section,
the act, a food shall be deemed to be the term iodized salt or iodized table salt
misbranded if its container is so made, is designated as the name of salt for
formed, or filled as to be misleading. human food use to which iodide has
(a) A container that does not allow been added in the form of cuprous io-
the consumer to fully view its contents dide or potassium iodide permitted by
shall be considered to be filled as to be §§ 184.1265 and 184.1634 of this chapter.
misleading if it contains nonfunctional In the labeling of such products, all
slack-fill. Slack-fill is the difference words in the name shall be equal in
between the actual capacity of a con- prominence and type size. The state-
tainer and the volume of product con- ment ‘‘This salt supplies iodide, a nec-
tained therein. Nonfunctional slack-fill essary nutrient’’ shall appear on the
is the empty space in a package that is label immediately following the name
filled to less than its capacity for rea- and shall be in letters which are not
sons other than: less in height than those required for
(1) Protection of the contents of the the declaration of the net quantity of
package; contents as specified in § 101.7 of this
(2) The requirements of the machines chapter.
used for enclosing the contents in such (b) Salt or table salt for human food
package; use to which iodide has not been added
(3) Unavoidable product settling dur- shall bear the statement, ‘‘This salt
ing shipping and handling; does not supply iodide, a necessary nu-
(4) The need for the package to per- trient.’’ This statement shall appear
form a specific function (e.g., where immediately following the name of the
packaging plays a role in the prepara- food and shall be in letters which are
tion or consumption of a food), where not less in height than those required
such function is inherent to the nature for the declaration of the net quantity
of the food and is clearly commu- of contents as specified in § 101.7 of this
nicated to consumers; chapter.
(5) The fact that the product consists (c) Salt, table salt, iodized salt, or io-
of a food packaged in a reusable con- dized table salt to which anticaking
tainer where the container is part of agents have been added may bear in ad-
the presentation of the food and has dition to the ingredient statement des-
value which is both significant in pro- ignating the anticaking agent(s), a
portion to the value of the product and label statement describing the charac-
independent of its function to hold the teristics imparted by such agent(s) (for
food, e.g., a gift product consisting of a example, ‘‘free flowing’’), providing
food or foods combined with a con- such statement does not appear with
tainer that is intended for further use greater prominence or in type size larg-
after the food is consumed; or durable er than the statements which imme-
commemorative or promotional pack- diately follow the name of the food as
ages; or required by paragraphs (a) and (b) of
(6) Inability to increase level of fill this section.
or to further reduce the size of the (d) Individual serving-sized packages

package (e.g., where some minimum containing less than 1⁄2 ounce and pack-
package size is necessary to accommo- ages containing more than 21⁄2 pounds
Pt. 101 21 CFR Ch. I (4–1–23 Edition)
of a food described in this section shall 101.30 Percentage juice declaration for foods
be exempt from declaration of the purporting to be beverages that contain
statements which paragraphs (a) and fruit or vegetable juice.
(b) of this section require immediately Subpart C—Specific Nutrition Labeling
following the name of the food. Such Requirements and Guidelines
exemption shall not apply to the outer
container or wrapper of a multiunit re- 101.36 Nutrition labeling of dietary supple-
tail package. ments.
(e) All salt, table salt, iodized salt, or 101.42 Nutrition labeling of raw fruit, vege-
iodized table salt in packages intended tables, and fish.
101.43 Substantial compliance of food retail-
for retail sale shipped in interstate ers with the guidelines for the voluntary
commerce 18 months after the date of nutrition labeling of raw fruit, vegeta-
publication of this statement of policy bles, and fish.
in the FEDERAL REGISTER, shall be la- 101.44 Identification of the 20 most fre-
beled as prescribed by this section; and quently consumed raw fruit, vegetables,
if not so labeled, the Food and Drug and fish in the United States.
Administration will regard them as 101.45 Guidelines for the voluntary nutri-
misbranded within the meaning of section labeling of raw fruit, vegetables, and
fish.
tions 403 (a) and (f) of the Federal
Food, Drug, and Cosmetic Act. Subpart D—Specific Requirements for
[42 FR 14306, Mar. 15, 1977, as amended at 48 Nutrient Content Claims
FR 10811, Mar. 15, 1983; 49 FR 24119, June 12,
101.54 Nutrient content claims for ‘‘good
1984; 81 FR 59131, Aug. 29, 2016]
source,’’ ‘‘high,’’ ‘‘more,’’ and ‘‘high po-
tency.’’
PART 101—FOOD LABELING 101.56 Nutrient content claims for ‘‘light’’
or ‘‘lite.’’
Subpart A—General Provisions 101.60 Nutrient content claims for the cal-
orie content of foods.
Sec. 101.61 Nutrient content claims for the so-
101.1 Principal display panel of package dium content of foods.
form food. 101.62 Nutrient content claims for fat, fatty
101.2 Information panel of package form acid, and cholesterol content of foods.
food. 101.65 Implied nutrient content claims and
101.3 Identity labeling of food in packaged related label statements.
form. 101.67 Use of nutrient content claims for
101.4 Food; designation of ingredients. butter.
101.5 Food; name and place of business of 101.69 Petitions for nutrient content claims.
manufacturer, packer, or distributor.
101.7 Declaration of net quantity of con- Subpart E—Specific Requirements for
tents. Health Claims
101.8 Vending machines.
101.9 Nutrition labeling of food. 101.70 Petitions for health claims.
101.10 Nutrition labeling of restaurant foods 101.71 Health claims: claims not authorized.
whose labels or labeling bear nutrient 101.72 Health claims: calcium, vitamin D,
content claims or health claims. and osteoporosis.
101.11 Nutrition labeling of standard menu 101.73 Health claims: dietary lipids and can-
items in covered establishments. cer.
101.12 Reference amounts customarily con- 101.74 Health claims: sodium and hyper-
sumed per eating occasion. tension.
101.13 Nutrient content claims—general 101.75 Health claims: dietary saturated fat
principles. and cholesterol and risk of coronary
101.14 Health claims: general requirements. heart disease.
101.15 Food; prominence of required state- 101.76 Health claims: fiber-containing grain
ments. products, fruits, and vegetables and can-
101.17 Food labeling warning, notice, and cer.
safe handling statements. 101.77 Health claims: fruits, vegetables, and
101.18 Misbranding of food. grain products that contain fiber, par-
ticularly soluble fiber, and risk of coro-
Subpart B—Specific Food Labeling nary heart disease.
Requirements 101.78 Health claims: fruits and vegetables
and cancer.
101.22 Foods; labeling of spices, flavorings, 101.79 Health claims: Folate and neural tube
colorings and chemical preservatives. defects.
10
101.80 Health claims: dietary noncariogenic bear alternate principal display panels,
carbohydrate sweeteners and dental car- information required to be placed on
ies. the principal display panel shall be du-
101.81 Health claims: Soluble fiber from cer-
tain foods and risk of coronary heart dis-
plicated on each principal display
ease (CHD). panel. For the purpose of obtaining
101.82 Health claims: Soy protein and risk uniform type size in declaring the
of coronary heart disease (CHD). quantity of contents for all packages of
101.83 Health claims: plant sterol/stanol substantially the same size, the term
esters and risk of coronary heart disease area of the principal display panel means
(CHD). the area of the side or surface that
Subpart F—Specific Requirements for De- bears the principal display panel,
scriptive Claims That Are Neither Nutri- which area shall be:
ent Content Claims nor Health Claims (a) In the case of a rectangular pack-
age where one entire side properly can
101.91 Gluten-free labeling of food. be considered to be the principal dis-
101.93 Certain types of statements for die- play panel side, the product of the
tary supplements. height times the width of that side;
101.95 ‘‘Fresh,’’ ‘‘freshly frozen,’’ ‘‘fresh fro-
zen,’’ ‘‘frozen fresh.’’
(b) In the case of a cylindrical or
nearly cylindrical container, 40 percent
Subpart G—Exemptions From Food of the product of the height of the con-
Labeling Requirements tainer times the circumference;
(c) In the case of any otherwise
101.100 Food; exemptions from labeling. shaped container, 40 percent of the
101.108 Temporary exemptions for purposes
total surface of the container: Provided,
of conducting authorized food labeling
experiments. however, That where such container
APPENDIX A TO PART 101 [RESERVED]
presents an obvious ‘‘principal display
APPENDIX B TO PART 101—GRAPHIC ENHANCE- panel’’ such as the top of a triangular
MENTS USED BY THE FDA or circular package of cheese, the area
APPENDIX C TO PART 101—NUTRITION FACTS shall consist of the entire top surface.
FOR RAW FRUITS AND VEGETABLES In determining the area of the prin-
APPENDIX D TO PART 101—NUTRITION FACTS cipal display panel, exclude tops, bot-
FOR COOKED FISH
toms, flanges at tops and bottoms of
AUTHORITY: 15 U.S.C. 1453, 1454, 1455; 21 cans, and shoulders and necks of bot-
U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C. 243, tles or jars. In the case of cylindrical
264, 271. or nearly cylindrical containers, infor-
SOURCE: 42 FR 14308, Mar. 15, 1977, unless mation required by this part to appear
otherwise noted. on the principal display panel shall ap-
EDITORIAL NOTE: Nomenclature changes to pear within that 40 percent of the cir-
part 101 appear at 63 FR 14035, Mar. 24, 1998, cumference which is most likely to be
66 FR 17358, Mar. 30, 2001, 66 FR 56035, Nov. 6, displayed, presented, shown, or exam-
2001, and 81 FR 49895, July 29, 2016. ined under customary conditions of dis-
play for retail sale.
Subpart A—General Provisions
§ 101.2 Information panel of package
§ 101.1 Principal display panel of pack- form food.
age form food. (a) The term information panel as it
The term principal display panel as it applies to packaged food means that
applies to food in package form and as part of the label immediately contig-
used in this part, means the part of a uous and to the right of the principal
label that is most likely to be dis- display panel as observed by an indi-
played, presented, shown, or examined vidual facing the principal display
under customary conditions of display panel with the following exceptions:
for retail sale. The principal display (1) If the part of the label imme-
panel shall be large enough to accom- diately contiguous and to the right of
modate all the mandatory label infor- the principal display panel is too small
mation required to be placed thereon to accommodate the necessary infor-
by this part with clarity and conspicu- mation or is otherwise unusable label
ousness and without obscuring design, space, e.g., folded flaps or can ends, the
vignettes, or crowding. Where packages panel immediately contiguous and to
11
§ 101.2 21 CFR Ch. I (4–1–23 Edition)
the right of this part of the label may the specified minimum type size, ex-
be used. cept the label will not be required to
(2) If the package has one or more al- bear the information required by § 101.5
ternate principal display panels, the in- if this information appears on the bot-
formation panel is immediately contig- tle closure or on the lid of the can in a
uous and to the right of any principal type size not less than one-sixteenth
display panel. inch in height, or if embossed on the
(3) If the top of the container is the lid of the can in a type size not less
principal display panel and the pack- than one-eighth inch in height.
age has no alternate principal display (B) If the soft drink is packaged in a
panel, the information panel is any bottle which does not bear a paper,
panel adjacent to the principal display plastic foam jacket or foil label, or is
panel.
packaged in a reusable bottle bearing a
(b) All information required to ap-
label lithographed onto the surface of
pear on the label of any package of
the bottle:
food under §§ 101.4, 101.5, 101.8, 101.9,
101.13, 101.17, 101.36, subpart D of part (1) Neither the bottle nor the closure
101, and part 105 of this chapter shall is required to bear nutrition labeling in
appear either on the principal display compliance with § 101.9, except that any
panel or on the information panel, un- multiunit retail package in which it is
less otherwise specified by regulations contained shall bear nutrition labeling
in this chapter. if required by § 101.9; and any vending
(c) All information appearing on the machine in which it is contained shall
principal display panel or the informa- bear nutrition labeling if nutrition la-
tion panel pursuant to this section beling is not present on the bottle or
shall appear prominently and conspicu- closure, if required by § 101.9.
ously, but in no case may the letters (2) All other information pursuant to
and/or numbers be less than one-six- this section shall appear on the top of
teenth inch in height unless an exemp- the bottle closure prominently and
tion pursuant to paragraph (f) of this conspicuously in letters and/or num-
section is established. The require- bers no less than one thirty-second
ments for conspicuousness and leg- inch in height, except that if the infor-
ibility shall include the specifications mation required by § 101.5 is placed on
of §§ 101.7(h)(1) and (2) and 101.15. the side of the closure in accordance
(1)(i) Soft drinks packaged in bottles with § 1.24(a)(5)(ii) of this chapter, such
manufactured before October 31, 1975 information shall appear in letters and/
shall be exempt from the requirements or numbers no less than one-sixteenth
prescribed by this section to the extent inch in height.
that information which is blown, (3) Upon the petition of any inter-
lithographed, or formed onto the sur- ested person demonstrating that the
face of the bottle is exempt from the bottle closure is too small to accom-
size and placement requirements of modate this information, the Commis-
this section. sioner may by regulation establish an
(ii) Soft drinks packaged in bottles alternative method of disseminating
shall be exempt from the size and such information. Information appear-
placement requirements prescribed by
ing on the closure shall appear in the
this section if all of the following con-
following priority:
ditions are met:
(A) If the soft drink is packaged in a (i) The statement of ingredients.
bottle bearing a paper, plastic foam (ii) The name and address of the man-
jacket, or foil label, or is packaged in ufacturer, packer, or distributor.
a nonreusable bottle bearing a label (iii) The statement of identity.
lithographed onto the surface of the (2) Individual serving-size packages
bottle or is packaged in metal cans, the of food served with meals in res-
product shall not be exempt from any taurants, institutions, and on board
requirement of this section other than passenger carriers, and not intended
the exemptions created by § 1.24(a)(5) for sale at retail, are exempt from
(ii) and (v) of this chapter and the label type-size requirements of this para-
shall bear all required information in graph, provided:
12
(i) The package has a total area of 3 on the lid if this information appears
square inches or less available to bear on the container body in accordance
labeling; with this section. Further, the state-
(ii) There is insufficient area on the ment of ingredients is not required on
package available to print all required the container body if this information
information in a type size of 1⁄16 inch in appears on the lid in accordance with
height; this section.
(iii) The information required by (e) All information appearing on the
paragraph (b) of this section appears on information panel pursuant to this sec-
the label in accordance with the provi- tion shall appear in one place without
sions of this paragraph, except that the other intervening material.
type size is not less than 1⁄32 inch in (f) If the label of any package of food
height. is too small to accommodate all of the
(d)(1) Except as provided by information required by §§ 101.4, 101.5,
§§ 101.9(j)(13) and (j)(17) and 101.36(i)(2) 101.8, 101.9, 101.13, 101.17, 101.36, subpart
and (i)(5), all information required to D of part 101, and part 105 of this chap-
appear on the principal display panel ter, the Commissioner may establish
or on the information panel under this by regulation an acceptable alternative
section shall appear on the same panel method of disseminating such informa-
unless there is insufficient space. In de- tion to the public, e.g., a type size
termining the sufficiency of the avail- smaller than one-sixteenth inch in
able space, except as provided by height, or labeling attached to or in-
§§ 101.9(j)(17) and 101.36(i)(5), any vi- serted in the package or available at
gnettes, designs, and other nonmanda- the point of purchase. A petition re-
tory label information shall not be con- questing such a regulation, as an
sidered. If there is insufficient space amendment to this paragraph, shall be
for all of this information to appear on submitted under part 10 of this chap-
a single panel, it may be divided be- ter.
tween these two panels, except that the [42 FR 14308, Mar. 15, 1977, as amended at 42
information required under any given FR 15673, Mar. 22, 1977; 42 FR 45905, Sept. 13,
section or part shall all appear on the 1977; 42 FR 47191, Sept. 20, 1977; 44 FR 16006,
same panel. A food whose label is re- Mar. 16, 1979; 49 FR 13339, Apr. 4, 1984; 53 FR
quired to bear the ingredient state- 16068, May 5, 1988; 58 FR 44030, Aug. 18, 1993;
60 FR 17205, Apr. 5, 1995; 62 FR 43074, Aug. 12,
ment on the principal display panel 1997; 62 FR 49847, Sept. 23, 1997; 63 FR 14817,
may bear all other information speci- Mar. 27, 1998; 81 FR 59131, Aug. 29, 2016]
fied in paragraph (b) of this section on
the information panel. § 101.3 Identity labeling of food in
(2) Any food, not otherwise exempted packaged form.
in this section, if packaged in a con- (a) The principal display panel of a
tainer consisting of a separate lid and food in package form shall bear as one
body, and bearing nutrition labeling of its principal features a statement of
pursuant to § 101.9, and if the lid quali- the identity of the commodity.
fies for and is designed to serve as a (b) Such statement of identity shall
principal display panel, shall be ex- be in terms of:
empt from the placement requirements (1) The name now or hereafter speci-
of this section in the following re- fied in or required by any applicable
spects: Federal law or regulation; or, in the
(i) The name and place of business in- absence thereof,
formation required by § 101.5 shall not (2) The common or usual name of the
be required on the body of the con- food; or, in the absence thereof,
tainer if this information appears on (3) An appropriately descriptive
the lid in accordance with this section. term, or when the nature of the food is
(ii) The nutrition information re- obvious, a fanciful name commonly
quired by § 101.9 shall not be required used by the public for such food.
on the lid if this information appears (c) Where a food is marketed in var-
on the container body in accordance ious optional forms (whole, slices,
with this section. diced, etc.), the particular form shall

(iii) The statement of ingredients re- be considered to be a necessary part of
quired by § 101.4 shall not be required the statement of identity and shall be
13
§ 101.3 21 CFR Ch. I (4–1–23 Edition)
declared in letters of a type size bear- tion establishing a nutritional quality

ing a reasonable relation to the size of guideline pursuant to part 104 of this
the letters forming the other compo- chapter), and which complies with all
nents of the statement of identity; ex- of the applicable requirements of such
cept that if the optional form is visible regulation(s), shall not be deemed to be
through the container or is depicted by an imitation.
an appropriate vignette, the particular (4) Nutritional inferiority includes:
form need not be included in the state- (i) Any reduction in the content of an
ment. This specification does not affect essential nutrient that is present in a
the required declarations of identity measurable amount, but does not in-
under definitions and standards for clude a reduction in the caloric or fat
foods promulgated pursuant to section content provided the food is labeled
401 of the act. pursuant to the provisions of § 101.9,
(d) This statement of identity shall and provided the labeling with respect
be presented in bold type on the prin- to any reduction in caloric content
cipal display panel, shall be in a size complies with the provisions applicable
reasonably related to the most promi- to caloric content in part 105 of this
nent printed matter on such panel, and chapter.
shall be in lines generally parallel to (ii) For the purpose of this section, a
the base on which the package rests as measurable amount of an essential nu-
it is designed to be displayed.
trient in a food shall be considered to
(e) Under the provisions of section
be 2 percent or more of the Daily Ref-
403(c) of the Federal Food, Drug, and
erence Value (DRV) of protein listed
Cosmetic Act, a food shall be deemed
under § 101.9(c)(7)(iii) and of potassium
to be misbranded if it is an imitation of
listed under § 101.9(c)(9) per reference
another food unless its label bears, in
amount customarily consumed and 2
type of uniform size and prominence,
percent or more of the Reference Daily
the word ‘‘imitation’’ and, immediately
Intake (RDI) of any vitamin or mineral
thereafter, the name of the food imi-
listed under § 101.9(c)(8)(iv) per ref-
tated.
erence amount customarily consumed,
(1) A food shall be deemed to be an
imitation and thus subject to the re- except that selenium, molybdenum,
quirements of section 403(c) of the act chromium, and chloride need not be
if it is a substitute for and resembles considered.
another food but is nutritionally infe- (iii) If the Commissioner concludes
rior to that food. that a food is a substitute for and re-
(2) A food that is a substitute for and sembles another food but is inferior to
resembles another food shall not be the food imitated for reasons other
deemed to be an imitation provided it than those set forth in this paragraph,
meets each of the following require- he may propose appropriate revisions
ments: to this regulation or he may propose a
(i) It is not nutritionally inferior to separate regulation governing the par-
the food for which it substitutes and ticular food.
which it resembles. (f) A label may be required to bear
(ii) Its label bears a common or usual the percentage(s) of a characterizing
name that complies with the provisions ingredient(s) or information con-
of § 102.5 of this chapter and that is not cerning the presence or absence of an
false or misleading, or in the absence ingredient(s) or the need to add an in-
of an existing common or usual name, gredient(s) as part of the common or
an appropriately descriptive term that usual name of the food pursuant to
is not false or misleading. The label subpart B of part 102 of this chapter.
may, in addition, bear a fanciful name (g) Dietary supplements shall be
which is not false or misleading. identified by the term ‘‘dietary supple-
(3) A food for which a common or ment’’ as a part of the statement of
usual name is established by regulation identity, except that the word ‘‘die-
(e.g., in a standard of identity pursuant tary’’ may be deleted and replaced by
to section 401 of the act, in a common the name of the dietary ingredients in
or usual name regulation pursuant to the product (e.g., calcium supplement)
part 102 of this chapter, or in a regula- or an appropriately descriptive term
14
indicating the type of dietary ingredi- culture, or conforms to a definition and

ents that are in the product (e.g., herb- standard of identity established pursu-
al supplement with vitamins). ant to section 401 of the Federal Food,
[42 FR 14308, Mar. 15, 1977, as amended at 48
Drug, and Cosmetic Act, shall be des-
FR 10811, Mar. 15, 1983; 58 FR 2227, Jan. 6, ignated in the statement of ingredients
1993; 60 FR 67174, Dec. 28, 1995; 62 FR 49847, on the label of such food by either of
Sept. 23, 1997] the following alternatives:
(i) By declaring the established com-
§ 101.4 Food; designation of ingredi- mon or usual name of the ingredient
ents. followed by a parenthetical listing of
(a)(1) Ingredients required to be de- all ingredients contained therein in de-
clared on the label or labeling of a scending order of predominance except
food, including foods that comply with that, if the ingredient is a food subject
standards of identity, except those in- to a definition and standard of identity
gredients exempted by § 101.100, shall be established in subchapter B of this
listed by common or usual name in de- chapter that has specific labeling pro-
scending order of predominance by visions for optional ingredients, op-
weight on either the principal display tional ingredients may be declared
panel or the information panel in ac- within the parenthetical listing in ac-
cordance with the provisions of § 101.2, cordance with those provisions.
except that ingredients in dietary sup- (ii) By incorporating into the state-
plements that are listed in the nutri- ment of ingredients in descending order
tion label in accordance with § 101.36 of predominance in the finished food,
need not be repeated in the ingredient the common or usual name of every
list. Paragraph (g) of this section de- component of the ingredient without
scribes the ingredient list on dietary listing the ingredient itself.
supplement products. (3) Skim milk, concentrated skim
(2) The descending order of predomi- milk, reconstituted skim milk, and
nance requirements of paragraph (a)(1) nonfat dry milk may be declared as
of this section do not apply to ingredi- ‘‘skim milk’’ or ‘‘nonfat milk’’.
ents present in amounts of 2 percent or (4) Milk, concentrated milk, reconsti-
less by weight when a listing of these tuted milk, and dry whole milk may be
ingredients is placed at the end of the declared as ‘‘milk’’.
ingredient statement following an ap- (5) Bacterial cultures may be de-
propriate quantifying statement, e.g., clared by the word ‘‘cultured’’ followed
‘‘Contains __ percent or less of ______’’ by the name of the substrate, e.g.,
or ‘‘Less than __ percent of ______.’’ The ‘‘made from cultured skim milk or cul-
blank percentage within the quanti- tured buttermilk’’.
fying statement shall be filled in with
(6) Sweetcream buttermilk, con-
a threshold level of 2 percent, or, if de-
centrated sweetcream buttermilk, re-
sired, 1.5 percent, 1.0 percent, or 0.5
constituted sweetcream buttermilk,
percent, as appropriate. No ingredient
and dried sweetcream buttermilk may
to which the quantifying phrase applies
be declared as ‘‘buttermilk’’.
may be present in an amount greater
than the stated threshold. (7) Whey, concentrated whey, recon-
(b) The name of an ingredient shall stituted whey, and dried whey may be
be a specific name and not a collective declared as ‘‘whey’’.
(generic) name, except that: (8) Cream, reconstituted cream, dried
(1) Spices, flavorings, colorings and cream, and plastic cream (sometimes
chemical preservatives shall be de- known as concentrated milk fat) may
clared according to the provisions of be declared as ‘‘cream’’.
§ 101.22. (9) Butteroil and anhydrous butterfat
(2) An ingredient which itself con- may be declared as ‘‘butterfat’’.
tains two or more ingredients and (10) Dried whole eggs, frozen whole
which has an established common or eggs, and liquid whole eggs may be de-
usual name, conforms to a standard es- clared as ‘‘eggs’’.
tablished pursuant to the Meat Inspec- (11) Dried egg whites, frozen egg
tion or Poultry Products Inspection whites, and liquid egg whites may be
Acts by the U.S. Department of Agri- declared as ‘‘egg whites’’.
15
§ 101.4 21 CFR Ch. I (4–1–23 Edition)
(12) Dried egg yolks, frozen egg yolks, oil ingredients not present in the prod-
and liquid egg yolks may be declared as uct may be listed if they may some-
‘‘egg yolks’’. times be used in the product. Such in-
(13) [Reserved] gredients shall be identified by words
(14) Each individual fat and/or oil in- indicating that they may not be
gredient of a food intended for human present, such as ‘‘or’’, ‘‘and/or’’, ‘‘con-
consumption shall be declared by its tains one or more of the following:’’,
specific common or usual name (e.g., e.g., ‘‘vegetable oil shortening (con-
‘‘beef fat’’, ‘‘cottonseed oil’’) in its tains one or more of the following: cot-
order of predominance in the food ex- tonseed oil, palm oil, soybean oil)’’. No
cept that blends of fats and/or oils may fat or oil ingredient shall be listed un-
be designated in their order of pre- less actually present if the fats and/or
dominance in the foods as ‘‘______ oils constitute the predominant ingre-
shortening’’ or ‘‘blend of ______ oils’’, dient of the product, as defined in this
the blank to be filled in with the word paragraph (b)(14).
‘‘vegetable’’, ‘‘animal’’, ‘‘marine’’, with (15) When all the ingredients of a
or without the terms ‘‘fat’’ or ‘‘oils’’, wheat flour are declared in an ingre-
or combination of these, whichever is dient statement, the principal ingre-
applicable if, immediately following dient of the flour shall be declared by
the term, the common or usual name of the name(s) specified in §§ 137.105,
each individual vegetable, animal, or 137.200, 137.220 and 137.225 of this chap-
marine fat or oil is given in paren- ter, i.e., the first ingredient designated
theses, e.g., ‘‘vegetable oil shortening in the ingredient list of flour, or
(soybean and cottonseed oil)’’. For bromated flour, or enriched flour, or
products that are blends of fats and/or self-rising flour is ‘‘flour’’, ‘‘white
oils and for foods in which fats and/or flour’’, ‘‘wheat flour’’, or ‘‘plain flour’’;
oils constitute the predominant ingre- the first ingredient designated in the
dient, i.e., in which the combined ingredient list of durum flour is
weight of all fat and/or oil ingredients ‘‘durum flour’’; the first ingredient des-
equals or exceeds the weight of the ignated in the ingredient list of whole
most predominant ingredient that is wheat flour, or bromated whole wheat
not a fat or oil, the listing of the com- flour is ‘‘whole wheat flour’’, ‘‘graham
mon or usual names of such fats and/or flour’’, or ‘‘entire wheat flour’’; and the
oils in parentheses shall be in descend- first ingredient designated in the ingre-
ing order of predominance. In all other dient list of whole durum wheat flour
foods in which a blend of fats and/or is ‘‘whole durum wheat flour’’.
oils is used as an ingredient, the listing (16) Ingredients that act as leavening
of the common or usual names in pa- agents in food may be declared in the
rentheses need not be in descending ingredient statement by stating the
order of predominance if the manufac- specific common or usual name of each
turer, because of the use of varying individual leavening agent in paren-
mixtures, is unable to adhere to a con- theses following the collective name
stant pattern of fats and/or oils in the ‘‘leavening’’, e.g., ‘‘leavening (baking
product. If the fat or oil is completely soda, monocalcium phosphate, and cal-
hydrogenated, the name shall include cium carbonate)’’. The listing of the
the term hydrogenated, or if partially common or usual name of each indi-
hydrogenated, the name shall include vidual leavening agent in parentheses
the term partially hydrogenated. If each shall be in descending order of pre-
fat and/or oil in a blend or the blend is dominance: Except, That if the manu-
completely hydrogenated, the term facturer is unable to adhere to a con-
‘‘hydrogenated’’ may precede the stant pattern of leavening agents in
term(s) describing the blend, e.g., ‘‘hy- the product, the listing of individual
drogenated vegetable oil (soybean, cot- leavening agents need not be in de-
tonseed, and palm oils)’’, rather than scending order of predominance. Leav-
preceding the name of each individual ening agents not present in the product
fat and/or oil; if the blend of fats and/ may be listed if they are sometimes
or oils is partially hydrogenated, the used in the product. Such ingredients

term ‘‘partially hydrogenated’’ may be shall be identified by words indicating
used in the same manner. Fat and/or that they may not be present, such as
16
‘‘or’’, ‘‘and/or’’, ‘‘contains one or more stating the specific common or usual
of the following:’’. name of each individual firming agent
(17) Ingredients that act as yeast nu- in descending order of predominance in
trients in foods may be declared in the parentheses following the collective
ingredient statement by stating the name ‘‘firming agents’’. If the manu-
specific common or usual name of each facturer is unable to adhere to a con-
individual yeast nutrient in paren- stant pattern of firming agents in the
theses following the collective name food, the listing of the individual firm-
‘‘yeast nutrients’’, e.g., ‘‘yeast nutri- ing agents need not be in descending
ents (calcium sulfate and ammonium order of predominance. Firming agents
phosphate)’’. The listing of the com- not present in the product may be list-
mon or usual name of each individual ed if they are sometimes used in the
yeast nutrient in parentheses shall be product. Such ingredients shall be
in descending order of predominance: identified by words indicating that
Except, That if the manufacturer is un- they may not be present, such as ‘‘or’’,
able to adhere to a constant pattern of ‘‘and/or’’, ‘‘contains one or more of the
yeast nutrients in the product, the list- following:’’.
ing of the common or usual names of (20) For purposes of ingredient label-
individual yeast nutrients need not be ing, the term sugar shall refer to su-
in descending order of predominance. crose, which is obtained from sugar
Yeast nutrients not present in the cane or sugar beets in accordance with
product may be listed if they are some- the provisions of § 184.1854 of this chap-
times used in the product. Such ingre- ter.
dients shall be identified by words indi- (21) [Reserved]
cating that they may not be present, (22) Wax and resin ingredients on
such as ‘‘or’’, ‘‘and/or’’, or ‘‘contains fresh produce when such produce is
one or more of the following:’’. held for retail sale, or when held for
(18) Ingredients that act as dough other than retail sale by packers or re-
conditioners may be declared in the in- packers shall be declared collectively
gredient statement by stating the spe- by the phrase ‘‘coated with food-grade
cific common or usual name of each in- animal-based wax, to maintain
dividual dough conditioner in paren- freshness’’ or the phrase ‘‘coated with
theses following the collective name food-grade vegetable-, petroleum-,
‘‘dough conditioner’’, e.g., ‘‘dough con- beeswax-, and/or shellac-based wax or
ditioners (L-cysteine, ammonium sul- resin, to maintain freshness’’ as appro-
fate)’’. The listing of the common or priate. The terms ‘‘food-grade’’ and ‘‘to
usual name of each dough conditioner maintain freshness’’ are optional. The
in parentheses shall be in descending term lac-resin may be substituted for
order of predominance: Except, That if the term shellac.
the manufacturer is unable to adhere (23) When processed seafood products
to a constant pattern of dough condi- contain fish protein ingredients con-
tioners in the product, the listing of sisting primarily of the myofibrillar
the common or usual names of indi- protein fraction from one or more fish
vidual dough conditioners need not be species and the manufacturer is unable
in descending order of predominance. to adhere to a constant pattern of fish
Dough conditioners not present in the species in the fish protein ingredient,
product may be listed if they are some- because of seasonal or other limita-
times used in the product. Such ingre- tions of species availability, the com-
dients shall be identified by words indi- mon or usual name of each individual
cating that they may not be present, fish species need not be listed in de-
such as ‘‘or’’, ‘‘and/or’’, or ‘‘contains scending order of predominance. Fish
one or more of the following:’’. species not present in the fish protein
(19) Ingredients that act as firming ingredient may be listed if they are
agents in food (e.g., salts of calcium sometimes used in the product. Such
and other safe and suitable salts in ingredients must be identified by words
canned vegetables) may be declared in indicating that they may not be
the ingredient statement, in order of present, such as ‘‘or’’, ‘‘and/or’’, or

predominance appropriate for the total ‘‘contains one or more of the fol-
of all firming agents in the food, by lowing:’’ Fish protein ingredients may
17
§ 101.4 21 CFR Ch. I (4–1–23 Edition)
be declared in the ingredient statement (g) When present, the ingredient list
by stating the specific common or on dietary supplement products shall
usual name of each fish species that be located immediately below the nu-
may be present in parentheses fol- trition label, or, if there is insufficient
lowing the collective name ‘‘fish pro- space below the nutrition label, imme-
tein’’, e.g., ‘‘fish protein (contains one diately contiguous and to the right of
or more of the following: Pollock, cod, the nutrition label and shall be pre-
and/or pacific whiting)’’. ceded by the word ‘‘Ingredients,’’ un-
(c) When water is added to reconsti- less some ingredients (i.e., sources) are
tute, completely or partially, an ingre- identified within the nutrition label in
dient permitted by paragraph (b) of accordance with § 101.36(d), in which
this section to be declared by a class case the ingredients listed outside the
name, the position of the ingredient nutrition label shall be in a list pre-
class name in the ingredient statement ceded by the words ‘‘Other ingredi-
shall be determined by the weight of ents.’’ Ingredients in dietary supple-
the unreconstituted ingredient plus the ments that are not dietary ingredients
weight of the quantity of water added or that do not contain dietary ingredi-
to reconstitute that ingredient, up to ents, such as excipients, fillers, artifi-
the amount of water needed to recon- cial colors, artificial sweeteners, fla-
stitute the ingredient to single vors, or binders, shall be included in
strength. Any water added in excess of the ingredient list.
the amount of water needed to recon- (h) The common or usual name of in-
stitute the ingredient to single gredients of dietary supplements that
strength shall be declared as ‘‘water’’ are botanicals (including fungi and
in the ingredient statement. algae) shall be consistent with the
names standardized in Herbs of Com-
(d) When foods characterized on the
merce, 1992 edition, which is incor-
label as ‘‘nondairy’’ contain a casein-
porated by reference in accordance
ate ingredient, the caseinate ingre-
with 5 U.S.C. 552(a) and 1 CFR part 51.
dient shall be followed by a parenthet-
Copies may be obtained from the Amer-
ical statement identifying its source.
ican Herbal Products Association, 8484
For example, if the manufacturer uses
Georgia Ave., suite 370, Silver Spring,
the term ‘‘nondairy’’ on a creamer that
MD 20910, 301-588-1171, FAX 301-588-1174,
contains sodium caseinate, it shall in- e-mail: ahpa@ahpa.org, or may be ex-
clude a parenthetical term such as ‘‘a amined at the Dockets Management
milk derivative’’ after the listing of so- Staff (HFA–305), Food and Drug Admin-
dium caseinate in the ingredient list. istration, 5630 Fishers Lane, Rm. 1061,
(e) If the percentage of an ingredient Rockville, MD 20852, 240–402–7500, be-
is included in the statement of ingredi- tween 9 a.m. and 4 p.m., Monday
ents, it shall be shown in parentheses through Friday, or at the National Ar-
following the name of the ingredient chives and Records Administration
and expressed in terms of percent by (NARA). For information on the avail-
weight. Percentage declarations shall ability of this material at NARA, call
be expressed to the nearest 1 percent, 202–741–6030, or go to: http://
except that where ingredients are www.archives.gov/federal_register/
present at levels of 2 percent or less, code_of_federal_regulations/
they may be grouped together and ex- ibr_locations.html. The listing of these
pressed in accordance with the quanti- names on the label shall be followed by
fying guidance set forth in paragraph statements of:
(a)(2) of this section. (1) The part of the plant (e.g., root,
(f) Except as provided in § 101.100, in- leaves) from which the dietary ingre-
gredients that must be declared on la- dient is derived (e.g., ‘‘Garlic bulb’’ or
beling because there is no label for the ‘‘Garlic (bulb)’’), except that this des-
food, including foods that comply with ignation is not required for algae. The
standards of identity, shall be listed name of the part of the plant shall be
prominently and conspicuously by expressed in English (e.g., ‘‘flower’’
common or usual name in the manner rather than ‘‘flos’’);

prescribed by paragraph (b) of this sec- (2) The Latin binomial name of the
tion. plant, in parentheses, except that this
18
name is not required when it is avail- § 101.5 Food; name and place of busi-
able in the reference entitled: Herbs of ness of manufacturer, packer, or
Commerce for the common or usual distributor.
name listed on the label, and, when re- (a) The label of a food in packaged
quired, the Latin binomial name may form shall specify conspicuously the
be listed before the part of the plant. name and place of business of the man-
Any name in Latin form shall be in ac- ufacturer, packer, or distributor.
cordance with internationally accepted (b) The requirement for declaration
rules on nomenclature, such as those of the name of the manufacturer, pack-
found in the International Code of Bo- er, or distributor shall be deemed to be
tanical Nomenclature and shall include satisfied, in the case of a corporation,
the designation of the author or au- only by the actual corporate name,
thors who published the Latin name, which may be preceded or followed by
the name of the particular division of
when a positive identification cannot
the corporation. In the case of an indi-
be made in its absence. The Inter-
vidual, partnership, or association, the
national Code of Botanical Nomenclature name under which the business is con-
(Tokyo Code), 1994 edition, a publica- ducted shall be used.
tion of the International Association (c) Where the food is not manufac-
for Plant Taxonomy, is incorporated by tured by the person whose name ap-
reference in accordance with 5 U.S.C. pears on the label, the name shall be
552(a) and 1 CFR part 51. Copies of the qualified by a phrase that reveals the
International Code of Botanical Nomen- connection such person has with such
clature may be obtained from Koeltz food; such as ‘‘Manufactured for
Scientific Books, D–61453 Konigstein, ______’’, ‘‘Distributed by ______’’, or any
Germany, and University Bookstore, other wording that expresses the facts.
Southern Illinois University, (d) The statement of the place of
Carbondale, IL 62901–4422, 618–536–3321, business shall include the street ad-
FAX 618–453–5207, or may be examined dress, city, State, and ZIP code; how-
at the Dockets Management Staff ever, the street address may be omitted
(HFA–305), Food and Drug Administra- if it is shown in a current city direc-
tion, 5630 Fishers Lane, Rm. 1061, Rock- tory or telephone directory. The re-
ville, MD 20852, 240–402–7500, between 9 quirement for inclusion of the ZIP code
a.m. and 4 p.m., Monday through Fri- shall apply only to consumer com-
day, or at the National Archives and modity labels developed or revised
Records Administration (NARA). For after the effective date of this section.
In the case of nonconsumer packages,
information on the availability of this
the ZIP code shall appear either on the
material at NARA, call 202–741–6030, or
label or the labeling (including in-
go to: http://www.archives.gov/fed- voice).
eral_register/code_of_federal_regulations/ (e) If a person manufactures, packs,
ibr_locations.html. or distributes a food at a place other
(3) On labels of single-ingredient die- than his principal place of business, the
tary supplements that do not include label may state the principal place of
an ingredient list, the identification of business in lieu of the actual place
the Latin binomial name, when needed, where such food was manufactured or
and the part of the plant may be packed or is to be distributed, unless
prominently placed on the principal such statement would be misleading.
display panel or information panel, or
included in the nutrition label. § 101.7 Declaration of net quantity of
contents.
[42 FR 14308, Mar. 15, 1977, as amended at 43 (a) The principal display panel of a
FR 12858, Mar. 28, 1978; 43 FR 24519, June 6,
food in package form shall bear a dec-
1978; 48 FR 8054, Feb. 25, 1983; 55 FR 17433,
Apr. 25, 1990; 58 FR 2875, Jan. 6, 1993; 62 FR laration of the net quantity of con-
49847, Sept. 23, 1997; 62 FR 64634, Dec. 8, 1997; tents. This shall be expressed in the
64 FR 50448, Sept. 17, 1999; 66 FR 17358, Mar. terms of weight, measure, numerical
30, 2001; 66 FR 66742, Dec. 27, 2001; 68 FR 15355, count, or a combination of numerical
Mar. 31, 2003; 81 FR 5590, Feb. 3, 2016; 88 FR count and weight or measure. The
17716, Mar. 24, 2023] statement shall be in terms of fluid
19
§ 101.7 21 CFR Ch. I (4–1–23 Edition)
measure if the food is liquid, or in sumer usage and trade custom of em-
terms of weight if the food is solid, ploying different common fractions in
semisolid, or viscous, or a mixture of the net quantity declaration of a par-
solid and liquid; except that such state- ticular commodity, they may be em-
ment may be in terms of dry measure ployed. A common fraction shall be re-
if the food is a fresh fruit, fresh vege- duced to its lowest terms; a decimal
table, or other dry commodity that is fraction shall not be carried out to
customarily sold by dry measure. If more than two places. A statement
there is a firmly established general that includes small fractions of an
consumer usage and trade custom of ounce shall be deemed to permit small-
declaring the contents of a liquid by er variations than one which does not
weight, or a solid, semisolid, or viscous include such fractions.
product by fluid measure, it may be (e) The declaration shall be located
used. Whenever the Commissioner de- on the principal display panel of the
termines that an existing practice of label, and with respect to packages
declaring net quantity of contents by bearing alternate principal panels it
weight, measure, numerical count, or a shall be duplicated on each principal
combination in the case of a specific display panel.
packaged food does not facilitate value (f) The declaration shall appear as a
comparisons by consumers and offers distinct item on the principal display
opportunity for consumer confusion, he panel, shall be separated (by at least a
will by regulation designate the appro- space equal to the height of the let-
priate term or terms to be used for tering used in the declaration) from
such commodity. other printed label information appear-
(b)(1) Statements of weight shall be ing above or below the declaration and
in terms of avoirdupois pound and (by at least a space equal to twice the
ounce. width of the letter ‘‘N’’ of the style of
(2) Statements of fluid measure shall type used in the quantity of contents
be in terms of the U.S. gallon of 231 statement) from other printed label in-
cubic inches and quart, pint, and fluid formation appearing to the left or right
ounce subdivisions thereof, and shall: of the declaration. It shall not include
(i) In the case of frozen food that is any term qualifying a unit of weight,
sold and consumed in a frozen state, measure, or count (such as ‘‘jumbo
express the volume at the frozen tem- quart’’ and ‘‘full gallon’’) that tends to
perature. exaggerate the amount of the food in
(ii) In the case of refrigerated food the container. It shall be placed on the
that is sold in the refrigerated state, principal display panel within the bot-
express the volume at 40 °F (4 °C). tom 30 percent of the area of the label
(iii) In the case of other foods, ex- panel in lines generally parallel to the
press the volume at 68 °F (20 °C). base on which the package rests as it is
(3) Statements of dry measure shall designed to be displayed: Provided,
be in terms of the U.S. bushel of That on packages having a principal
2,150.42 cubic inches and peck, dry display panel of 5 square inches or less,
quart, and dry pint subdivisions there- the requirement for placement within
of. the bottom 30 percent of the area of the
(c) When the declaration of quantity label panel shall not apply when the
of contents by numerical count does declaration of net quantity of contents
not give adequate information as to meets the other requirements of this
the quantity of food in the package, it part.
shall be combined with such statement (g) The declaration shall accurately
of weight, measure, or size of the indi- reveal the quantity of food in the pack-
vidual units of the foods as will provide age exclusive of wrappers and other
such information. material packed therewith: Provided,
(d) The declaration may contain That in the case of foods packed in con-
common or decimal fractions. A com- tainers designed to deliver the food
mon fraction shall be in terms of under pressure, the declaration shall
halves, quarters, eighths, sixteenths, or state the net quantity of the contents
thirty-seconds; except that if there ex- that will be expelled when the instruc-
ists a firmly established general con- tions for use as shown on the container
20
are followed. The propellant is included specified in paragraphs (h)(1) through

in the net quantity declaration. (4) of this section shall be increased by
(h) The declaration shall appear in one-sixteenth of an inch.
conspicuous and easily legible boldface (j) On packages containing less than
print or type in distinct contrast (by 4 pounds or 1 gallon and labeled in
typography, layout, color, embossing, terms of weight or fluid measure:
or molding) to other matter on the (1) The declaration shall be expressed
package; except that a declaration of both in ounces, with identification by
net quantity blown, embossed, or mold- weight or by liquid measure and, if ap-
ed on a glass or plastic surface is per- plicable (1 pound or 1 pint or more) fol-
missible when all label information is lowed in parentheses by a declaration
so formed on the surface. Requirements in pounds for weight units, with any re-
of conspicuousness and legibility shall mainder in terms of ounces or common
include the specifications that: or decimal fractions of the pound (see
(1) The ratio of height to width (of examples set forth in paragraphs (m)
the letter) shall not exceed a differen- (1) and (2) of this section), or in the
tial of 3 units to 1 unit (no more than case of liquid measure, in the largest
3 times as high as it is wide). whole units (quarts, quarts and pints,
(2) Letter heights pertain to upper or pints, as appropriate) with any re-
case or capital letters. When upper and mainder in terms of fluid ounces or
lower case or all lower case letters are common or decimal fractions of the
used, it is the lower case letter ‘‘o’’ or pint or quart (see examples in para-
its equivalent that shall meet the min- graphs (m) (3) and (4) of this section).
imum standards. (2) If the net quantity of contents
(3) When fractions are used, each declaration appears on a random pack-
component numeral shall meet one- age, that is a package which is one of
half the minimum height standards. a lot, shipment, or delivery of packages
(i) The declaration shall be in letters of the same consumer commodity with
and numerals in a type size established varying weights and with no fixed
in relationship to the area of the prin- weight pattern, it may, when the net
cipal display panel of the package and weight exceeds 1 pound, be expressed in
shall be uniform for all packages of terms of pounds and decimal fractions
substantially the same size by com- of the pound carried out to not more
plying with the following type speci- than two decimal places. When the net
fications: weight does not exceed 1 pound, the
(1) Not less than one-sixteenth inch declaration on the random package
in height on packages the principal dis- may be in decimal fractions of the
play panel of which has an area of 5 pound in lieu of ounces (see example in
square inches or less. paragraph (m)(5) of this section).
(2) Not less than one-eighth inch in (3) The declaration may appear in
height on packages the principal dis- more than one line. The term ‘‘net
play panel of which has an area of more weight’’ shall be used when stating the
than 5 but not more than 25 square net quantity of contents in terms of
inches. weight. Use of the terms ‘‘net’’ or ‘‘net
(3) Not less than three-sixteenths contents’’ in terms of fluid measure or
inch in height on packages the prin- numerical count is optional. It is suffi-
cipal display panel of which has an cient to distinguish avoirdupois ounce
area of more than 25 but not more than from fluid ounce through association of
100 square inches. terms; for example, ‘‘Net wt. 6 oz’’ or
(4) Not less than one-fourth inch in ‘‘6 oz Net wt.’’ and ‘‘6 fl oz’’ or ‘‘Net
height on packages the principal dis- contents 6 fl oz’’.
play panel of which has an area of more (k) On packages containing 4 pounds
than 100 square inches, except not less or 1 gallon or more and labeled in
than 1⁄2 inch in height if the area is terms of weight or fluid measure, the
more than 400 square inches. declaration shall be expressed in
Where the declaration is blown, em- pounds for weight units with any re-
bossed, or molded on a glass or plastic mainder in terms of ounces or common

surface rather than by printing, typ- or decimal fraction of the pound, or in
ing, or coloring, the lettering sizes the case of fluid measure, it shall be
21
§ 101.7 21 CFR Ch. I (4–1–23 Edition)
expressed in the largest whole unit weight plus numerical count, net con-
(gallons followed by common or dec- tents plus dilution directions of a con-
imal fraction of a gallon or by the next centrate, etc.) are not regarded as sup-
smaller whole unit or units (quarts, or plemental net quantity statements and
quarts and pints)) with any remainder may be located on the principal display
in terms of fluid ounces or common or panel.
decimal fractions of the pint or quart (p) A separate statement of the net
(see paragraph (m)(6) of this section). quantity of contents in terms of the
(l) [Reserved] metric system is not regarded as a sup-
(m) Examples: plemental statement and an accurate
(1) A declaration of 11⁄2 pounds weight statement of the net quantity of con-
shall be expressed as ‘‘Net Wt. 24 oz (1 tents in terms of the metric system of
lb 8 oz),’’ ‘‘Net Wt. 24 oz (11⁄2 lb),’’ or weight or measure may also appear on
‘‘Net Wt. 24 oz (1.5 lb)’’. the principal display panel or on other
(2) A declaration of three-fourths panels.
pound avoirdupois weight shall be ex- (q) The declaration of net quantity of
pressed as ‘‘Net Wt. 12 oz’’. contents shall express an accurate
(3) A declaration of 1 quart liquid statement of the quantity of contents
measure shall be expressed as ‘‘Net 32 fl of the package. Reasonable variations
oz (1 qt)’’. caused by loss or gain of moisture dur-
(4) A declaration of 13⁄4 quarts liquid ing the course of good distribution
measure shall be expressed as ‘‘Net practice or by unavoidable deviations
contents 56 fluid ounces (1 quart 11⁄2 in good manufacturing practice will be
pints)’’ or as ‘‘Net 56 fluid oz (1 qt 1 pt recognized. Variations from stated
8 oz)’’, but not in terms of quart and quantity of contents shall not be un-
ounce such as ‘‘Net 56 fluid oz (1 quart reasonably large.
24 ounces)’’. (r) The declaration of net quantity of
(5) On a random package, declaration contents on pickles and pickle prod-
of three-fourths pound avoirdupois may ucts, including relishes but excluding
be expressed as ‘‘Net Wt. .75 lb’’. one or two whole pickles in clear plas-
(6) A declaration of 21⁄2 gallons liquid tic bags which may be declared by
measure shall be expressed as ‘‘Net count, shall be expressed in terms of
contents 21⁄2 gallons,’’ ‘‘Net contents 2.5 the U.S. gallon of 231 cubic inches and
gallons,’’ or ‘‘Net contents 2 gallons 2
quart, pint, and fluid ounce subdivi-
quarts’’ and not as ‘‘2 gallons 4 pints’’.
sions thereof.
(n) For quantities, the following ab-
(s) On a multiunit retail package, a
breviations and none other may be em-
statement of the quantity of contents
ployed (periods and plural forms are
shall appear on the outside of the pack-
optional):
age and shall include the number of in-
weight wt pint pt dividual units, the quantity of each in-
ounce oz quart qt dividual unit, and, in parentheses, the
pound lb fluid fl total quantity of contents of the multi-
gallon gal
unit package in terms of avoirdupois or
(o) Nothing in this section shall pro- fluid ounces, except that such declara-
hibit supplemental statements at location of total quantity need not be fol-
tions other than the principal display lowed by an additional parenthetical
panel(s) describing in nondeceptive declaration in terms of the largest
terms the net quantity of contents; whole units and subdivisions thereof,
Provided, that such supplemental state- as required by paragraph (j)(1) of this
ments of net quantity of contents shall section. A multiunit retail package
not include any term qualifying a unit may thus be properly labeled: ‘‘6–16 oz
of weight, measure, or count that tends bottles—(96 fl oz)’’ or ‘‘3–16 oz cans—
to exaggerate the amount of the food (net wt. 48 oz)’’. For the purposes of
contained in the package; for example, this section, ‘‘multiunit retail pack-
‘‘jumbo quart’’ and ‘‘full gallon’’. Dual age’’ means a package containing two
or combination declarations of net or more individually packaged units of
quantity of contents as provided for in the identical commodity and in the

paragraphs (a), (c), and (j) of this sec- same quantity, intended to be sold as
tion (for example, a combination of net part of the multiunit retail package
22
but capable of being individually sold (2) The product shall be labeled on
in full compliance with all require- the outside of its shipping container
ments of the regulations in this part. with the statement(s):
Open multiunit retail packages that do (i) When the variation concerns net
not obscure the number of units or pre- weight and/or drained weight or vol-
vent examination of the labeling on ume, ‘‘Product Mislabeled. Actual net
each of the individual units are not weight (drained weight or volume
subject to this paragraph if the label- where appropriate) may be as low as
ing of each individual unit complies __% below labeled quantity. This Prod-
with the requirements of paragraphs (f) uct Not for Retail Distribution’’, the
blank to be filled in with the maximum
and (i) of this section. The provisions
percentage variance between the la-
of this section do not apply to that
beled and actual weight or volume of
butter or margarine covered by the ex- contents of the individual packages in
emptions in § 1.24(a) (10) and (11) of this the shipping container, and
chapter. (ii) When the variation is in regard to
(t) Where the declaration of net a fill of container standard, ‘‘Product
quantity of contents is in terms of net Mislabeled. Actual fill may be as low
weight and/or drained weight or vol- as __% below standard of fill. This
ume and does not accurately reflect Product Not for Retail Distribution’’.
the actual quantity of the contents or (3) The statements required by para-
the product falls below the applicable graphs (t)(2) (i) and (ii) of this section,
standard of fill of container because of which may be consolidated where ap-
equipment malfunction or otherwise propriate, shall appear prominently
unintentional product variation, and and conspicuously as compared to
the label conforms in all other respects other printed matter on the shipping
to the requirements of this chapter (ex- container and in boldface print or type
cept the requirement that food falling on a clear, contrasting background in
below the applicable standard of fill of order to render them likely to be read
container shall bear the general state- and understood by the purchaser under
ment of substandard fill specified in ordinary conditions of purchase.
§ 130.14(b) of this chapter), the mis- [42 FR 14308, Mar. 15, 1977, as amended at 42
labeled food product, including any FR 15673, Mar. 22, 1977. Redesignated at 81 FR
food product that fails to bear the gen- 59131, Aug. 29, 2016]
eral statement of substandard fill spec-
§ 101.8 Vending machines.
ified in § 130.14(b) of this chapter, may
be sold by the manufacturer or proc- (a) Definitions. The definitions of
essor directly to institutions operated terms in section 201 of the Federal
by Federal, State or local governments Food, Drug, and Cosmetic Act apply to
(schools, prisons, hospitals, etc.): Pro- such terms when used in this section.
vided, That: In addition, for the purposes of this
(1) The purchaser shall sign a state- section:
Authorized official of a vending ma-
ment at the time of sale stating that
chine operator means an owner, oper-
he is aware that the product is mis-
ator, agent in charge, or any other per-
labeled to include acknowledgment of
son authorized by a vending machine
the nature and extent of the operator who is not otherwise subject
mislabeling, (e.g., ‘‘Actual net weight to section 403(q)(5)(H)(viii) of the Fed-
may be as low as __% below labeled eral Food, Drug, and Cosmetic Act (21
quantity’’) and that any subsequent U.S.C. 343(q)(5)(H)(viii)), to register the
distribution by him of said product ex- vending machine operator with the
cept for his own institutional use is un- Food and Drug Administration
lawful. This statement shall be kept on (‘‘FDA’’) for purposes of paragraph (d)
file at the principal place of business of of this section.
the manufacturer or processor for 2 Vending machine means a self-service
years subsequent to the date of ship- machine that, upon insertion of a coin,
ment of the product and shall be avail- paper currency, token, card, or key, or
able to the Food and Drug Administra- by optional manual operation, dis-
tion upon request. penses servings of food in bulk or in
23
§ 101.8 21 CFR Ch. I (4–1–23 Edition)
packages, or prepared by the machine, The visible nutrition information must

without the necessity of replenishing be clear and conspicuous and able to be
the machine between each vending op- easily read on the article of food while
eration. in the vending machine, in a type size
Vending machine operator means a at least 150 percent of the size required
person(s) or entity that controls or di- by § 101.7(i) for the net quantity of con-
rects the function of the vending ma- tents declaration on the front of the
chine, including deciding which arti- package, and with sufficient color and
cles of food are sold from the machine contrasting background to other print
or the placement of the articles of food on the label to permit the prospective
within the vending machine, and is purchaser to clearly distinguish the in-
compensated for the control or direc- formation.
tion of the function of the vending ma-
(c) Requirements for calorie labeling for
chine.
certain food sold from vending machines—
(b) Articles of food not covered. Arti-
(1) Applicability; covered vending ma-
cles of food sold from a vending ma-
chine food. For the purposes of this sec-
chine are not covered vending machine
food if: tion, the term ‘‘covered vending ma-
(1) The prospective purchaser can chine food’’ means an article of food
view: that is:
(i) The calories, serving size, and (i) Sold from a vending machine that
servings per container listed in the Nu- does not permit the prospective pur-
trition Facts label on the vending ma- chaser to examine the Nutrition Facts
chine food without any obstruction. label prior to purchase as provided in
The Nutrition Facts label must be in paragraph (b)(1) of this section or oth-
the format required in § 101.9(c) and (d). erwise provide visible nutrition infor-
The Nutrition Facts label must be in a mation at the point of purchase as pro-
size that permits the prospective pur- vided in paragraph (b)(2) of this sec-
chaser to be able to easily read the nu- tion; and
trition information contained in the (ii) Sold from a vending machine
Nutrition Facts label on the article of that:
food in the vending machine. Smaller (A) Is operated by a person engaged
formats allowed for Nutrition Facts for in the business of owning or operating
certain food labeling under FDA regu- 20 or more vending machines; or
lation at § 101.9 are not considered to be (B) Is operated by a vending machine
a size that a prospective purchaser is operator that has voluntarily elected
able to easily read; or to be subject to the requirements of
(ii) The calories, serving size, and this section by registering with FDA
servings per container listed in a repro- under paragraph (d) of this section.
duction of the Nutrition Facts label on (2) Calorie declaration. (i) The number
the vending machine food, provided of calories for a covered vending ma-
that the reproduction is a reproduction chine food must be declared in the fol-
of an actual Nutrition Facts label that
lowing manner:
complies with § 101.9 for a vending ma-
(A) To the nearest 5-calorie incre-
chine food, is presented in a size that
permits the prospective purchaser to be ment up to and including 50 calories
able to easily read the nutrition infor- and 10-calorie increment above 50 cal-
mation, and the calories, serving size, ories, except that amounts less than 5
and servings per container are dis- calories may be expressed as zero.
played by the vending machine before (B) The term ‘‘Calories’’ or ‘‘Cal’’
the prospective purchaser makes his or must appear adjacent to the caloric
her purchase; or content value for each food in the
(2) The prospective purchaser can vending machine.
otherwise view visible nutrition infor- (C) The calorie declaration for a
mation, including, at a minimum, the packaged food must include the total
total number of calories for the article calories present in the packaged food,
of food as sold at the point of purchase. regardless of whether the packaged

This visible nutrition information food contains a single serving or mul-
must appear on the food label itself. tiple servings. The vending machine
24
operator may voluntarily disclose cal- tion or name of the food item, the cal-
ories per serving in addition to the orie declaration must be in close prox-
total calories for the food. imity to the picture or other represen-
(D) If a covered vending machine food tation or name, or in close proximity
is one where the prospective purchaser to the selection button.
selects among options to produce a (E) For electronic vending machines
final vended product (e.g., vended cof- (e.g., machines with digital or elec-
fee, hot chocolate or tea with options tronic or liquid crystal display (LCD)
for added sugar, sugar substitute, milk, displays), the calorie declaration must
and cream), calories must be declared be displayed before the prospective
per option or for the final vended prod- purchaser makes his or her purchase.
ucts. (F) For vending machines with few
(ii) Calorie declarations for covered choices, e.g., popcorn, the calorie dec-
vending machine food must be clear laration may appear on the face of the
and conspicuous and placed promi- machine so long as the declaration is
nently in the following manner: prominent, not crowded by other label-
(A) The calorie declarations may be ing on the machine, and the type size is
placed on a sign in close proximity to no smaller than the name of the food
the article of food or selection button, on the machine (not the label), selec-
i.e., in, on, or adjacent to the vending tion number, or price of the food as dis-
machine, but not necessarily attached played on the vending machine, which-
to the vending machine, so long as the ever is smallest.
calorie declaration is visible at the
(d) Voluntary provision of calorie label-
same time as the food, its name, price,
ing for foods sold from vending ma-
selection button, or selection number
chines—(1) Applicability. A vending ma-
is visible. The sign must give calorie
chine operator that is not subject to
declarations for those articles of food
the requirements of section
that are sold from that particular
403(q)(5)(H)(viii) of the Federal Food,
vending machine.
Drug, and Cosmetic Act may, through
(B) When the calorie declaration is in
its authorized official, voluntarily reg-
or on the vending machine, the calorie
declaration must be in a type size no ister with FDA to be subject to the re-
smaller than the name of the food on quirements established in paragraph
the machine (not the label), selection (c)(2) of this section. An authorized of-
number, or price of the food as dis- ficial of a vending machine operator
played on the vending machine, which- that voluntarily registers cannot be
ever is smallest, with the same promi- subject to any State or local nutrition
nence, i.e., the same color, or in a color labeling requirements that are not
at least as conspicuous, as the color of identical to the requirements in
the name, if applicable, or price of the 403(q)(5)(H) of the Federal Food, Drug,
food or selection number, and the same and Cosmetic Act.
contrasting background, or a back- (2) Who may register? A vending ma-
ground at least as contrasting as the chine operator that is not otherwise
background used for the item it is in subject to the requirements of section
closest proximity to, i.e., name, selec- 403(q)(5)(H) of the Federal Food, Drug,
tion number, or price of the food item and Cosmetic Act may register with
as displayed on the machine. FDA.
(C) When the calorie declaration is (3) What information is required? The
on a sign adjacent to the vending ma- vending machine operator must pro-
chine, the calorie declaration must be vide FDA with the following informa-
in a type size large enough to render it tion:
likely to be read and understood by the (i) The contact information (includ-
prospective purchaser under customary ing name, address, phone number,
conditions of purchase and use, and in email address), for the vending ma-
a type that is all black or one color on chine operator;
a white or other neutral background (ii) The address of the location of
that contrasts with the type color. each vending machine owned or oper-
(D) Where the vending machine only ated by the vending machine operator
displays a picture or other representa- that is being registered;
25
§ 101.9 21 CFR Ch. I (4–1–23 Edition)
(iii) Preferred mailing address (if dif- for vending machines selling covered
ferent from the vending machine oper- vending machine food. The contact in-
ator address), for purposes of receiving formation must list the vending ma-
correspondence; and chine operator’s name, telephone num-
(iv) Certification that the informa- ber, and mailing address or email ad-
tion submitted is true and accurate, dress.
that the person or firm submitting it is (2) The contact information must be
authorized to do so, and that each reg- readable and may be placed on the face
istered vending machine will be subject of the vending machine, or otherwise
to the requirements of this section. must be placed with the calorie dec-
(v) Information should be submitted larations as described in paragraph
by email by typing complete informa- (c)(2)(ii) of this section (i.e., on the sign
tion into the portable document format in, on, or adjacent to the vending ma-
(PDF) form, saving it on the reg- chine).
istrant’s computer, and sending it by (f) Signatures. Signatures obtained
email to under paragraph (d) of this section that
menulawregistration@fda.hhs.gov. If meet the definition of electronic signa-
email is not available, the registrant tures in § 11.3(b)(7) of this chapter are
can either fill in the PDF form and exempt from the requirements of part
print it out (or print out the blank 11 of this chapter.
PDF and fill in the information by
hand or typewriter), and either fax the [79 FR 71291, Dec. 1, 2014, as amended at 84
FR 57610, Oct. 28, 2019]
completed form to 301–436–2804 or mail
it to FDA, CFSAN Menu and Vending § 101.9 Nutrition labeling of food.
Machine Labeling Registration, White
Oak Building 22, rm. 0209, 10903 New (a) Nutrition information relating to
Hampshire Ave., Silver Spring, MD food shall be provided for all products
20993. intended for human consumption and
(vi) Authorized officials of a vending offered for sale unless an exemption is
machine operator who elect to be sub- provided for the product in paragraph
ject to the Federal requirements can (j) of this section.
register by visiting http://www.fda.gov/ (1) When food is in package form, the
food/ingredientspackaginglabeling/ required nutrition labeling information
labelingnutrition/ucm217762.htm. FDA shall appear on the label in the format
has created a form that contains fields specified in this section.
requesting the information in para- (2) When food is not in package form,
graph (d) of this section and made the the required nutrition labeling infor-
form available at this Web site. Reg- mation shall be displayed clearly at
istrants must use this form to ensure the point of purchase (e.g., on a
that complete information is sub- counter card, sign, tag affixed to the
mitted. product, or some other appropriate de-
(vii) To keep the establishment’s reg- vice). Alternatively, the required infor-
istration active, the authorized official mation may be placed in a booklet,
of the vending machine operator must looseleaf binder, or other appropriate
register every other year within 60 format that is available at the point of
days prior to the expiration of the purchase.
vending machine operator’s current (3) Solicitation of requests for nutri-
registration with FDA. Registration tion information by a statement ‘‘For
will automatically expire if not re- nutrition information write to
newed. ______________________ ’’ on the label or
(e) Vending machine operator contact in the labeling or advertising for a
information. (1) A vending machine op- food, or providing such information in
erator that is subject to section a direct written reply to a solicited or
403(q)(5)(H)(viii) of the Federal Food, unsolicited request, does not subject
Drug, and Cosmetic Act or a vending the label or the labeling of a food ex-
machine operator that voluntarily reg- empted under paragraph (j) of this sec-
isters to be subject to the requirements tion to the requirements of this section

under paragraph (d) of this section if the reply to the request conforms to
must provide its contact information the requirements of this section.
26
(4) If any vitamin or mineral is added of evaluating whether weight-control

to a food so that a single serving pro- products that are available only
vides 50 percent or more of the Ref- through a weight-control program
erence Daily Intake (RDI) for the age qualify for nutrient content claims or
group for which the product is in- health claims.
tended, as specified in paragraph (i) For products in discrete units
(c)(8)(iv) of this section, of any one of (e.g., muffins, sliced products, such as
the added vitamins or minerals, unless sliced bread, or individually packaged
such addition is permitted or required products within a multiserving pack-
in other regulations, e.g., a standard of age) and for products which consist of
identity or nutritional quality guide- two or more foods packaged and pre-
line, or is otherwise exempted by the sented to be consumed together where
Commissioner, the food shall be consid- the ingredient represented as the main
ered a food for special dietary use with- ingredient is in discrete units (e.g.,
in the meaning of § 105.3(a)(1)(iii) of pancakes and syrup), the serving size
this chapter. shall be declared as follows:
(b) Except as provided in § 101.9(h)(3), (A) If a unit weighs 50 percent or less
all nutrient and food component quan- of the reference amount, the serving
tities shall be declared in relation to a size shall be the number of whole units
serving as defined in this section. that most closely approximates the ref-
(1) The term serving or serving size erence amount for the product cat-
means an amount of food customarily egory;
consumed per eating occasion by per- (B) If a unit weighs more than 50 per-
sons 4 years of age or older which is ex- cent, but less than 67 percent of the
pressed in a common household meas- reference amount, the manufacturer
ure that is appropriate to the food. may declare one unit or two units as
When the food is specially formulated the serving size;
or processed for use by infants or by (C) If a unit weighs 67 percent or
toddlers, a serving or serving size more, but less than 200 percent of the
means an amount of food customarily reference amount, the serving size
consumed per eating occasion by in- shall be one unit;
fants up to 12 months of age or by chil- (D) If a unit weighs at least 200 per-
dren 1 through 3 years of age, respec- cent and up to and including 300 per-
tively. cent of the applicable reference
(2) Except as provided in paragraphs amount, the serving size shall be the
(b)(3), (b)(4), and (b)(6) of this section amount that approximates the ref-
and for products that are intended for erence amount. In addition to pro-
weight control and are available only viding a column within the Nutrition
through a weight-control or weight- Facts label that lists the quantitative
maintenance program, serving size de- amounts and percent Daily Values per
clared on a product label shall be deter- serving size, the manufacturer shall
mined from the ‘‘Reference Amounts provide a column within the Nutrition
Customarily Consumed Per Eating Oc- Facts label that lists the quantitative
casion * * * *’’ (reference amounts) amounts and percent Daily Values per
that appear in § 101.12(b) using the pro- individual unit. The first column would
cedures described below. For products be based on the serving size for the
that are both intended for weight con- product and the second column would
trol and available only through a be based on the individual unit. The ex-
weight-control program, a manufac- emptions in paragraphs (b)(12)(i)(A),
turer may determine the serving size (B), and (C) of this section apply to this
that is consistent with the meal plan of provision.
the program. Such products must bear (E) The serving size for maraschino
a statement, ‘‘for sale only through the cherries shall be expressed as 1 cherry
______ program’’ (fill in the blank with with the parenthetical metric measure
the name of the appropriate weight- equal to the average weight of a me-
control program, e.g., Smith’s Weight dium size cherry.
Control), on the principal display (F) The serving size for products that
panel. However, the reference amounts naturally vary in size (e.g., pickles,
in § 101.12(b) shall be used for purposes shellfish, whole fish, and fillet of fish)
27
§ 101.9 21 CFR Ch. I (4–1–23 Edition)
may be the amount in ounces that 1⁄5, 1⁄6, or smaller fractions that can be
most closely approximates the ref- generated by further division by 2 or 3.

erence amount for the product cat- (iii) For nondiscrete bulk products
egory. Manufacturers shall adhere to (e.g., breakfast cereal, flour, sugar, dry
the requirements in paragraph mixes, concentrates, pancake mixes,
(b)(5)(vi) of this section for expressing macaroni and cheese kits), and for
the serving size in ounces. products which consist of two or more
(G) For products which consist of two foods packaged and presented to be
or more foods packaged and presented consumed together where the ingre-
to be consumed together where the in- dient represented as the main ingre-
gredient represented as the main ingredient is a bulk product (e.g., peanut
dient is in discrete units (e.g., pan- butter and jelly), the serving size shall
cakes and syrup), the serving size may be the amount in household measure
be the number of discrete units rep- that most closely approximates the ref-
resented as the main ingredient plus erence amount for the product cat-
proportioned minor ingredients used to egory and may be the amount of the
make the reference amount for the bulk product represented as the main
combined product determined in ingredient plus proportioned minor in-
§ 101.12(f). gredients used to make the reference
amount for the combined product de-
(H) For packages containing several
termined in § 101.12(f).
individual single-serving containers,
(3) The serving size for meal products
each of which is labeled with all re-
and main dish products as defined in
quired information including nutrition
§ 101.13 (l) and (m) that comes in single-
labeling as specified in § 101.9 (that is,
serving containers as defined in para-
are labeled appropriately for individual graph (b)(6) of this section shall be the
sale as single-serving containers), the entire content (edible portion only) of
serving size shall be 1 unit. the package. Serving size for meal
(ii) For products in large discrete products and main dish products in
units that are usually divided for con- multiserving containers shall be based
sumption (e.g., cake, pie, pizza, melon, on the reference amount applicable to
cabbage), for unprepared products the product in § 101.12(b) if the product
where the entire contents of the pack- is listed in § 101.12(b). Serving size for
age is used to prepare large discrete meal products and main dish products
units that are usually divided for con- in multiserving containers that are not
sumption (e.g., cake mix, pizza kit), listed in § 101.12(b) shall be based on the
and for products which consist of two reference amount according to
or more foods packaged and presented § 101.12(f).
to be consumed together where the in- (4) A variety pack, such as a package
gredient represented as the main ingre- containing several varieties of single-
dient is a large discrete unit usually di- serving units as defined in paragraph
vided for consumption (e.g., prepared (b)(2)(i) of this section, and a product
cake packaged with a can of frosting), having two or more compartments
the serving size shall be the fractional with each compartment containing a
slice of the ready-to-eat product (e.g., different food, shall provide nutrition
1⁄12 cake, 1⁄8 pie, 1⁄4 pizza, 1⁄4 melon, 1⁄6
information for each variety or food
cabbage) that most closely approxi- per serving size that is derived from
mates the reference amount for the the reference amount in § 101.12(b) ap-
product category, and may be the frac- plicable for each variety or food and
tion of the package used to make the the procedures to convert the reference
reference amount for the unprepared amount to serving size in paragraph
product determined in § 101.12(c) or the (b)(2) of this section.
fraction of the large discrete unit rep- (5) For labeling purposes, the term
resented as the main ingredient plus common household measure or common
proportioned minor ingredients used to household unit means cup, tablespoon,
make the reference amount for the teaspoon, piece, slice, fraction (e.g., 1⁄4
combined product determined in pizza), ounce (oz), fluid ounce (fl oz), or
§ 101.12(f). In expressing the fractional other common household equipment
slice, manufacturers shall use 1⁄2, 1⁄3, 1⁄4, used to package food products (e.g., jar,
28
tray). In expressing serving size in ponent or as a composite. The serving

household measures, except as speci- size may be provided in accordance
fied in paragraphs (b)(5)(iv), (b)(5)(v), with the provisions of paragraphs
(b)(5)(vi), and (b)(5)(vii) of this section, (b)(2)(i), (b)(2)(ii), and (b)(2)(iii) of this
the following rules shall be used: section, or alternatively in ounces with
(i) Cups, tablespoons, or teaspoons an appropriate visual unit of measure,
shall be used wherever possible and ap- as described in paragraph (b)(5)(iii) of
propriate except for beverages. For this section (e.g., declared as separate
beverages, a manufacturer may use components: ‘‘3 oz dry macaroni (84 g/
fluid ounces. Cups shall be expressed in about 2⁄3 cup)’’ and ‘‘1 oz dry cheese mix
1/4- or 1/3-cup increments. Tablespoons (28 g/about 2 tbsp);’’ declared as a com-
shall be expressed as 1, 1 1/3, 1 1/2, 1 2/ posite value: ‘‘4 oz (112 g/about 2⁄3 cup
3, 2, or 3 tablespoons. Teaspoons shall macaroni and 2 tbsp dry cheese mix)’’).
be expressed as 1/8, 1/4, 1/2, 3/4, 1, or 2 (viii) For nutrition labeling purposes,
teaspoons. a teaspoon means 5 milliliters (mL), a
(ii) If cups, tablespoons or teaspoons tablespoon means 15 mL, a cup means
are not applicable, units such as piece, 240 mL, 1 fl oz means 30 mL, and 1 oz in
slice, tray, jar, and fraction shall be weight means 28 g.
used. (ix) When a serving size, determined
(iii) If paragraphs (b)(5)(i) and from the reference amount in § 101.12(b)
(b)(5)(ii) of this section are not applica- and the procedures described in this
ble, ounces may be used with an appro- section, falls exactly half way between
priate visual unit of measure such as a two serving sizes, e.g., 2.5 tbsp, manu-
dimension of a piece, e.g., 1 oz (28 g/ facturers shall round the serving size
about 1⁄2 pickle). Ounce measurements up to the next incremental size.
shall be expressed in 0.5 oz increments (6) A product that is packaged and
most closely approximating the ref- sold individually that contains less
erence amount. than 200 percent of the applicable ref-
(iv) A description of the individual erence amount must be considered to
container or package shall be used for be a single-serving container, and the
single serving containers and for indi- entire content of the product must be
vidually packaged products within labeled as one serving. In addition to
multiserving containers (e.g., can, box, providing a column within the Nutri-
package). A description of the indi- tion Facts label that lists the quan-
vidual unit shall be used for other titative amounts and percent Daily
products in discrete units (e.g., piece, Values per serving, for a product that
slice, cracker, bar). is packaged and sold individually that
(v) For unprepared products where contains more than 150 percent and less
the entire contents of the package is than 200 percent of the applicable ref-
used to prepare large discrete units erence amount, the Nutrition Facts
that are usually divided for consump- label may voluntarily provide, to the
tion (e.g., cake mix, pizza kit), the left of the column that provides nutri-
fraction or portion of the package may tion information per container (i.e., per
be used. serving), an additional column that
(vi) Ounces with an appropriate vis- lists the quantitative amounts and per-
ual unit of measure, as described in cent Daily Values per common house-
paragraph (b)(5)(iii) of this section, hold measure that most closely ap-
may be used for products that natu- proximates the reference amount.
rally vary in size as provided for in (7) A label statement regarding a
paragraph (b)(2)(i)(F) of this section. serving shall be the serving size ex-
(vii) As provided for in § 101.9(h)(1), pressed in common household measures
for products that consist of two or as set forth in paragraphs (b)(2)
more distinct ingredients or compo- through (b)(6) of this section and shall
nents packaged and presented to be be followed by the equivalent metric
consumed together (e.g. dry macaroni quantity in parenthesis (fluids in milli-
and cheese mix, cake and muffin mixes liters and all other foods in grams) ex-
with separate ingredient packages, cept for single-serving containers.

pancakes and syrup), nutrition infor- (i) For a single-serving container, the
mation may be declared for each com- parenthetical metric quantity, which
29
§ 101.9 21 CFR Ch. I (4–1–23 Edition)
will be presented as part of the net obtained from the Office of Nutrition
weight statement on the principal dis- and Food Labeling (HFS–800), Center
play panel, is not required except for Food Safety and Applied Nutrition,
where nutrition information is re- Food and Drug Administration, 5001
quired on a drained weight basis ac- Campus Dr., College Park, MD 20740.
cording to § 101.9(b)(9). However, if a (8) Determination of the number of
manufacturer voluntarily provides the servings per container shall be based
metric quantity on products that can on the serving size of the product de-
be sold as single servings, then the nu- termined by following the procedures
merical value provided as part of the described in this section.
serving size declaration must be iden- (i) The number of servings shall be
tical to the metric quantity declara- rounded to the nearest whole number
tion provided as part of the net quan- except for the number of servings be-
tity of contents statement. tween 2 and 5 servings and random
(ii) The gram or milliliter quantity weight products. The number of
equivalent to the household measure servings between 2 and 5 servings shall
should be rounded to the nearest whole be rounded to the nearest 0.5 serving.
number except for quantities that are Rounding should be indicated by the
less than 5 g (mL). The gram (mL) use of the term about (e.g., about 2
quantity between 2 and 5 g (mL) should servings, about 3.5 servings).
be rounded to the nearest 0.5 g (mL) (ii) When the serving size is required
and the g (mL) quantity less than 2 g to be expressed on a drained solids
(mL) should be expressed in 0.1-g (mL) basis and the number of servings varies
increments. because of a natural variation in unit
(iii) In addition, serving size may be size (e.g., maraschino cherries, pick-
declared in ounce and fluid ounce, in les), the manufacturer may state the
parenthesis, following the metric typical number of servings per con-
measure separated by a slash where tainer (e.g., usually 5 servings).
other common household measures are (iii) For random weight products,
used as the primary unit for serving manufacturers may declare ‘‘varied’’
size, e.g., 1 slice (28 g/1 oz) for sliced for the number of servings per con-
bread. The ounce quantity equivalent tainer provided the nutrition informa-
to the metric quantity should be ex- tion is based on the reference amount
pressed in 0.1 oz increments. expressed in the appropriate household
(iv) If a manufacturer elects to use measure based on the hierarchy de-
abbreviations for units, the following scribed in paragraph (b)(5) of this sec-
abbreviations shall be used: tbsp for tation. Random weight products are
blespoon, tsp for teaspoon, g for gram, foods such as cheeses that are sold as
mL for milliliter, oz for ounce, and fl random weights that vary in size, such
oz for fluid ounce. that the net contents for different con-
(v) For products that only require tainers would vary. The manufacturer
the addition of water or another ingre- may provide the typical number of
dient that contains insignificant servings in parentheses following the
amounts of nutrients in the amount ‘‘varied’’ statement.
added and that are prepared in such a (iv) For packages containing several
way that there are no significant individual single-serving containers,
changes to the nutrient profile, the each of which is labeled with all re-
amount of the finished product may be quired information including nutrition
declared in parentheses at the end of labeling as specified in § 101.9 (that is,
the serving size declaration (e.g., 1⁄2 cup are labeled appropriately for individual
(120 mL) concentrated soup (makes 1 sale as single-serving containers), the
cup prepared)). number of servings shall be the number
(vi) To promote uniformity in label of individual packages within the total
serving sizes in household measures de- package.
clared by different manufacturers, FDA (v) For packages containing several
has provided a guidance document enti- individually packaged multiserving
tled, ‘‘Guidelines for Determining the units, the number of servings shall be
Gram Weight of the Household Meas- determined by multiplying the number
ure.’’ The guidance document can be of individual multiserving units in the
30
total package by the number of reference amount must provide an ad-

servings in each individual unit. ditional column within the Nutrition
(9) The declaration of nutrient and Facts label that lists the quantitative
food component content shall be on the amounts and percent Daily Values for
basis of food as packaged or purchased the entire package, as well as a column
with the exception of raw fish covered listing the quantitative amounts and
under § 101.42 (see 101.44), packaged sin- percent Daily Values for a serving that
gle-ingredient products that consist of is less than the entire package (i.e., the
fish or game meat as provided for in serving size derived from the reference
paragraph (j)(11) of this section, and of amount). The first column would be
foods that are packed or canned in based on the serving size for the prod-
water, brine, or oil but whose liquid uct and the second column would be
packing medium is not customarily based on the entire contents of the
consumed (e.g., canned fish, mara- package.
schino cherries, pickled fruits, and (A) This provision does not apply to
pickled vegetables). Declaration of nu- products that meet the requirements
trient and food component content of to use the tabular format in paragraph
raw fish shall follow the provisions in (j)(13)(ii)(A)(1) of this section or to
§ 101.45. Declaration of the nutrient and products that meet the requirements
food component content of foods that to use the linear format in paragraph
are packed in liquid which is not cus- (j)(13)(ii)(A)(2) of this section.
tomarily consumed shall be based on (B) This provision does not apply to
the drained solids. raw fruits, vegetables, and seafood for
(10) Another column of figures may which voluntary nutrition labeling is
be used to declare the nutrient and provided in the product labeling or ad-
food component information: vertising or when claims are made
(i) Per 100 g or 100 mL, or per 1 oz or about the product.
1 fl oz of the food as packaged or pur- (C) This provision does not apply to
chased; products that require further prepara-
(ii) Per one unit if the serving size of tion and provide an additional column
a product in discrete units is more of nutrition information under para-
than 1 unit. graph (e) of this section, to products
(iii) Per cup popped for popcorn in a that are commonly consumed in com-
multiserving container. bination with another food and provide
(11) If a product is promoted on the an additional column of nutrition in-
label, labeling, or advertising for a use formation under paragraph (e) of this
that differs in quantity by twofold or section, to products that provide an ad-
greater from the use upon which the ditional column of nutrition informa-
reference amount in § 101.12(b) was tion for two or more groups for which
based (e.g., liquid cream substitutes RDIs are established (e.g., both infants
promoted for use with breakfast cere- and children less than 4 years of age),
als), the manufacturer shall provide a to popcorn products that provide an ad-
second column of nutrition informa- ditional column of nutrition informa-
tion based on the amount customarily tion per 1 cup popped popcorn, or to
consumed in the promoted use, in addi- varied-weight products covered under
tion to the nutrition information per paragraph (b)(8)(iii) of this section.
serving derived from the reference (ii) When a nutrient content claim or
amount in § 101.12(b), except that nonhealth claim is made on the label of a
discrete bulk products that are used product that uses a dual column as re-
primarily as ingredients (e.g., flour, quired in paragraph (b)(2)(i)(D) or
sweeteners, shortenings, oils), or tradi- (b)(12)(i) of this section, the claim must
tionally used for multipurposes (e.g., be followed by a statement that sets
eggs, butter, margarine), and multipur- forth the basis on which the claim is
pose baking mixes are exempt from made, except that the statement is not
this requirement. required for products when the nutri-
(12)(i) Products that are packaged ent that is the subject of the claim
and sold individually and that contain meets the criteria for the claim based
at least 200 percent and up to and in- on the reference amount for the prod-
cluding 300 percent of the applicable uct and the entire container or the
31
§ 101.9 21 CFR Ch. I (4–1–23 Edition)
unit amount. When a nutrient content spectively, as described in USDA Hand-

claim is made, the statement must ex- book No. 74 (slightly revised, 1973) pp.
press that the claim refers to the 9–11;
amount of the nutrient per serving (C) Using the general factors of 4, 4,
(e.g., ‘‘good source of calcium per serv- and 9 calories per gram for protein,
ing’’ or ‘‘per X [insert unit]__serving’’) total carbohydrate (less the amount of
or per reference amount (e.g., ‘‘good non-digestible carbohydrates and sugar
source of calcium per [insert reference alcohols), and total fat, respectively, as
amount (e.g., per 8 ounces)]), as re- described in USDA Handbook No. 74
quired based on § 101.12(g). When a (slightly revised, 1973) pp. 9–11. A gen-
health claim is made, the statement eral factor of 2 calories per gram for
shall be ‘‘A serving of __ounces of this soluble non-digestible carbohydrates
product conforms to such a diet.’’ shall be used. The general factors for
(c) The declaration of nutrition infor- caloric value of sugar alcohols provided
mation on the label and in labeling of in paragraph (c)(1)(i)(F) of this section
a food shall contain information about shall be used;
the level of the following nutrients, ex- (D) Using data for specific food fac-
cept for those nutrients whose inclu- tors for particular foods or ingredients
sion, and the declaration of amounts, is approved by the Food and Drug Admin-
voluntary as set forth in this para- istration (FDA) and provided in parts
graph. No nutrients or food compo- 172 or 184 of this chapter, or by other
nents other than those listed in this means, as appropriate;
paragraph as either mandatory or vol- (E) Using bomb calorimetry data sub-
untary may be included within the nu- tracting 1.25 calories per gram protein
trition label. Except as provided for in to correct for incomplete digestibility,
paragraphs (f) or (j) of this section, nu- as described in USDA Handbook No. 74
trient information shall be presented (slightly revised, 1973) p. 10; or
using the nutrient names specified and (F) Using the following general fac-
in the following order in the formats tors for caloric value of sugar alcohols:
specified in paragraphs (d) or (e) of this Isomalt—2.0 calories per gram,
section. lactitol—2.0 calories per gram,
(1) ‘‘Calories, total,’’ ‘‘Total cal- xylitol—2.4 calories per gram,
ories,’’ or ‘‘Calories’’: A statement of maltitol—2.1 calories per gram, sor-
the caloric content per serving, ex- bitol—2.6 calories per gram, hydro-
pressed to the nearest 5-calorie incre- genated starch hydrolysates—3.0 cal-
ment up to and including 50 calories, ories per gram, mannitol—1.6 calories
and 10-calorie increment above 50 cal- per gram, and erythritol—0 calories per
ories, except that amounts less than 5 gram.
calories may be expressed as zero. En- (ii) ‘‘Calories from saturated fat’’ or
ergy content per serving may also be ‘‘Calories from saturated’’ (VOL-
expressed in kilojoule units, added in UNTARY): A statement of the caloric
parentheses immediately following the content derived from saturated fat as
statement of the caloric content. defined in paragraph (c)(2)(i) of this
(i) Caloric content may be calculated section in a serving may be declared
by the following methods. Where either voluntarily, expressed to the nearest 5-
specific or general food factors are calorie increment, up to and including
used, the factors shall be applied to the 50 calories, and the nearest 10-calorie
actual amount (i.e., before rounding) of increment above 50 calories, except
food components (e.g., fat, carbo- that amounts less than 5 calories may
hydrate, protein, or ingredients with be expressed as zero. This statement
specific food factors) present per serv- shall be indented under the statement
ing. of calories as provided in paragraph
(A) Using specific Atwater factors (d)(5) of this section.
(i.e., the Atwater method) given in (2) ‘‘Fat, total’’ or ‘‘Total fat’’: A
table 13, USDA Handbook No. 74 statement of the number of grams of
(slightly revised, 1973), total fat in a serving defined as total
(B) Using the general factors of 4, 4, lipid fatty acids and expressed as
and 9 calories per gram for protein, triglycerides where fatty acids are ali-
total carbohydrate, and total fat, re- phatic carboxylic acids consisting of a
32
chain of alkyl groups and characterized nificant source of trans fat’’ shall be
by a terminal carboxyl group. Amounts placed at the bottom of the table of nu-
shall be expressed to the nearest 0.5 (1⁄2) trient values.
gram increment below 5 grams and to (iii) ‘‘Polyunsaturated fat’’ or ‘‘Poly-
the nearest gram increment above 5 unsaturated’’ (VOLUNTARY): A state-
grams. If the serving contains less than ment of the number of grams of poly-
0.5 gram, the content shall be expressed unsaturated fat in a serving defined as
as zero. cis,cis-methylene-interrupted poly-
(i) ‘‘Saturated fat,’’ or ‘‘Saturated’’: unsaturated fatty acids may be de-
A statement of the number of grams of clared voluntarily, except that when
saturated fat in a serving defined as monounsaturated fat is declared, or
the sum of all fatty acids containing no when a claim about fatty acids or cho-
double bonds, except that label dec- lesterol is made on the label or in la-
laration of saturated fat content infor- beling of a food other than one that
mation is not required for products meets the criteria in § 101.62(b)(1) for a
that contain less than 0.5 gram of total claim for ‘‘fat free,’’ label declaration
fat in a serving if no claims are made of polyunsaturated fat is required.
about fat, fatty acid, or cholesterol Polyunsaturated fat content shall be
content, and if ‘‘calories from satu- indented and expressed as grams per
rated fat’’ is not declared. Except as serving to the nearest 0.5 (1⁄2) gram in-
provided for in paragraph (f) of this crement below 5 grams and to the near-
section, if a statement of the saturated est gram increment above 5 grams. If
fat content is not required and, as a re- the serving contains less than 0.5 gram,
sult, not declared, the statement ‘‘Not the content shall be expressed as zero.
a significant source of saturated fat’’ (iv) ‘‘Monounsaturated fat’’ or
shall be placed at the bottom of the ‘‘Monounsaturated’’ (VOLUNTARY): A
table of nutrient values. Saturated fat statement of the number of grams of
content shall be indented and expressed monounsaturated fat in a serving de-
as grams per serving to the nearest 0.5 fined as cis-monounsaturated fatty
gram (1⁄2) gram increment below 5 acids may be declared voluntarily ex-
grams and to the nearest gram incre- cept that when polyunsaturated fat is
ment above 5 grams. If the serving con- declared, or when a claim about fatty
tains less than 0.5 gram, the content acids or cholesterol is made on the
shall be expressed as zero. label or in labeling of a food other than
(ii) ‘‘Trans fat’’ or ‘‘Trans’’: A state- one that meets the criteria in
ment of the number of grams of trans § 101.62(b)(1) for a claim for ‘‘fat free,’’
fat in a serving, defined as the sum of label declaration of monounsaturated
all unsaturated fatty acids that con- fat is required. Monounsaturated fat
tain one or more isolated (i.e., noncon- content shall be indented and expressed
jugated) double bonds in a trans con- as grams per serving to the nearest 0.5
figuration, except that label declara- (1⁄2) gram increment below 5 grams and
tion of trans fat content information is to the nearest gram increment above 5
not required for products that contain grams. If the serving contains less than
less than 0.5 gram of total fat in a serv- 0.5 gram, the content shall be expressed
ing if no claims are made about fat, as zero.
fatty acid or cholesterol content. The (3) ‘‘Cholesterol’’: A statement of the
word ‘‘trans’’ may be italicized to indi- cholesterol content in a serving ex-
cate its Latin origin. Trans fat content pressed in milligrams to the nearest 5-
shall be indented and expressed as milligram increment, except that label
grams per serving to the nearest 0.5 declaration of cholesterol information
(1⁄2)-gram increment below 5 grams and is not required for products that con-
to the nearest gram increment above 5 tain less than 2 milligrams cholesterol
grams. If the serving contains less than in a serving and make no claim about
0.5 gram, the content, when declared, fat, fatty acids, or cholesterol content,
shall be expressed as zero. Except as or such products may state the choles-
provided for in paragraph (f) of this terol content as zero. Except as pro-
section, if a statement of the trans fat vided for in paragraph (f) of this sec-
content is not required and, as a result, tion, if cholesterol content is not re-
not declared, the statement ‘‘Not a sig- quired and, as a result, not declared,
33
§ 101.9 21 CFR Ch. I (4–1–23 Edition)
the statement ‘‘Not a significant part 51 (the availability of this incorpo-

source of cholesterol’’ shall be placed ration by reference is given in para-
at the bottom of the table of nutrient graph (c)(1)(i)(A) of this section).
values in the same type size. If the food (i) ‘‘Dietary fiber’’: A statement of
contains 2 to 5 milligrams of choles- the number of grams of total dietary
terol per serving, the content may be fiber in a serving, indented and ex-
stated as ‘‘less than 5 milligrams.’’ pressed to the nearest gram, except
(4) ‘‘Sodium’’: A statement of the that if a serving contains less than 1
number of milligrams of sodium in a gram, declaration of dietary fiber is
specified serving of food expressed as not required or, alternatively, the
zero when the serving contains less statement ‘‘Contains less than 1 gram’’
than 5 milligrams of sodium, to the or ‘‘less than 1 gram’’ may be used, and
nearest 5-milligram increment when if the serving contains less than 0.5
the serving contains 5 to 140 milligram, the content may be expressed as
grams of sodium, and to the nearest 10- zero. Dietary fiber is defined as non-di-
milligram increment when the serving gestible soluble and insoluble carbo-
contains greater than 140 milligrams. hydrates (with 3 or more monomeric
(5) ‘‘Fluoride’’ (VOLUNTARY): A units), and lignin that are intrinsic and
statement of the number of milligrams intact in plants; isolated or synthetic
of fluoride in a specified serving of food non-digestible carbohydrates (with 3 or
may be declared voluntarily, except more monomeric units) determined by
that when a claim is made about fluo- FDA to have physiological effects that
ride content, label declaration shall be are beneficial to human health. Except
required. Fluoride content shall be ex- as provided for in paragraph (f) of this
pressed as zero when the serving con- section, if dietary fiber content is not
tains less than 0.1 milligrams of fluo- required, and as a result not declared,
ride, to the nearest 0.1-milligram incre- the statement ‘‘Not a significant
ment when the serving contains less source of dietary fiber’’ shall be placed
than or equal to 0.8 milligrams of fluo- at the bottom of the table of nutrient
ride, and the nearest 0.2 milligram-in- values in the same type size. The fol-
crement when a serving contains more lowing isolated or synthetic nondigest-
than 0.8 milligrams of fluoride. Bottled ible carbohydrate(s) have been deter-
water that bears a statement about mined by FDA to have physiological ef-
added fluoride, as permitted by fects that are beneficial to human
§ 101.13(q)(8), must bear nutrition label- health and, therefore, shall be included
ing that complies with requirements in the calculation of the amount of die-
for the simplified format in paragraph tary fiber: [beta]-glucan soluble fiber
(f) of this section. (as described in § 101.81(c)(2)(ii)(A)),
(6) ‘‘Carbohydrate, total’’ or ‘‘Total psyllium husk (as described in
carbohydrate’’: A statement of the § 101.81(c)(2)(ii)(B)(1)), cellulose, guar
number of grams of total carbohydrate gum, pectin, locust bean gum, and
in a serving expressed to the nearest hydroxypropylmethylcellulose. The
gram, except that if a serving contains manufacturer must make and keep
less than 1 gram, the statement ‘‘Con- records in accordance with paragraphs
tains less than 1 gram’’ or ‘‘less than 1 (g)(10) and (11) of this section to verify
gram’’ may be used as an alternative, the declared amount of dietary fiber in
or if the serving contains less than 0.5 the label and labeling of food when a
gram, the content may be expressed as mixture of dietary fiber, and added
zero. Total carbohydrate content shall nondigestible carbohydrate(s) that does
be calculated by subtraction of the sum not meet the definition of dietary
of the crude protein, total fat, mois- fiber, is present in the food.
ture, and ash from the total weight of (A) ‘‘Soluble fiber’’ (VOLUNTARY):
the food. This calculation method is A statement of the number of grams of
described in A. L. Merrill and B. K. soluble dietary fiber in a serving may
Watt, ‘‘Energy Value of Foods—Basis be declared voluntarily except that
and Derivation,’’ USDA Handbook 74 when a claim is made on the label or in
(slightly revised 1973) pp. 2 and 3, which labeling about soluble fiber, label dec-
is incorporated by reference in accord- laration shall be required. Soluble fiber
ance with 5 U.S.C. 552(a) and 1 CFR must meet the definition of dietary
34
fiber in this paragraph (c)(6)(i). The be placed at the bottom of the table of
manufacturer must make and keep nutrient values in the same type size.
records in accordance with paragraphs Total sugars shall be defined as the
(g)(10) and (11) of this section to verify sum of all free mono- and disaccharides
the declared amount of soluble fiber in (such as glucose, fructose, lactose, and
the label and labeling of food when a sucrose). Total sugars content shall be
mixture of soluble fiber and added non- indented and expressed to the nearest
digestible carbohydrate(s) that does gram, except that if a serving contains
not meet the definition of dietary fiber less than 1 gram, the statement ‘‘Con-
is present in the food. Soluble fiber tains less than 1 gram’’ or ‘‘less than 1
content shall be indented under dietary gram’’ may be used as an alternative,
fiber and expressed to the nearest and if the serving contains less than 0.5
gram, except that if a serving contains gram, the content may be expressed as
less than 1 gram, the statement ‘‘Con- zero.
tains less than 1 gram’’ or ‘‘less than 1 (iii) ‘‘Added Sugars’’: A statement of
gram’’ may be used as an alternative, the number of grams of added sugars in
and if the serving contains less than 0.5 a serving, except that label declaration
gram, the content may be expressed as of added sugars content is not required
zero.’’ for products that contain less than 1
(B) ‘‘Insoluble fiber’’ (VOLUNTARY): gram of added sugars in a serving if no
A statement of the number of grams of claims are made about sweeteners, sug-
insoluble dietary fiber in a serving may ars, added sugars, or sugar alcohol con-
be declared voluntarily except that tent. Except as provided for in para-
when a claim is made on the label or in graph (f) of this section, if a statement
labeling about insoluble fiber, label of the added sugars content is not re-
declaration shall be required. Insoluble quired and, as a result, not declared,
fiber must meet the definition of die- the statement ‘‘Not a significant
tary fiber in this paragraph (c)(6)(i). source of added sugars’’ shall be placed
The manufacturer must make and keep at the bottom of the table of nutrient
records in accordance with paragraphs values in the same type size. Added
(g)(10) and (11) of this section to verify sugars are either added during the
the declared amount of insoluble fiber processing of foods, or are packaged as
in the label and labeling of food when a such, and include sugars (free, mono
mixture of insoluble and added non-di- and disaccharides), sugars from syrups
gestible carbohydrate(s) that does not and honey, and sugars from con-
meet the definition of dietary fiber is centrated fruit or vegetable juices that
present in the food. Insoluble fiber con- are in excess of what would be expected
tent shall be indented under dietary from the same volume of 100 percent
fiber and expressed to the nearest fruit or vegetable juice of the same
gram, except that if a serving contains type, except that fruit or vegetable
less than 1 gram, the statement ‘‘Con- juice concentrated from 100 percent
tains less than 1 gram’’ or ‘‘less than 1 juices sold to consumers, fruit or vege-
gram’’ may be used as an alternative, table juice concentrates used towards
and if the serving contains less than 0.5 the total juice percentage label dec-
gram, the content may be expressed as laration under § 101.30 or for Brix stand-
zero. ardization under § 102.33(g)(2) of this
(ii) ‘‘Total Sugars’’: A statement of chapter, fruit juice concentrates which
the number of grams of sugars in a are used to formulate the fruit compo-
serving, except that the label declara- nent of jellies, jams, or preserves in ac-
tion of sugars content is not required cordance with the standard of identi-
for products that contain less than 1 ties set forth in §§ 150.140 and 150.160 of
gram of sugars in a serving if no claims this chapter, or the fruit component of
are made about sweeteners, sugars, or fruit spreads shall not be labeled as
sugar alcohol content. Except as pro- added sugars. Added sugars content
vided for in paragraph (f) of this sec- shall be indented under Total Sugars
tion, if a statement of the total sugars and shall be prefaced with the word
content is not required and, as a result, ‘‘Includes’’ followed by the amount (in
not declared, the statement ‘‘Not a sig- grams) ‘‘Added Sugars’’ (‘‘Includes ‘X’
nificant source of total sugars’’ shall g Added Sugars’’). It shall be expressed
35
§ 101.9 21 CFR Ch. I (4–1–23 Edition)
to the nearest gram, except that if a resented or purported to be for adults

serving contains less than 1 gram, the and children 4 or more years of age has
statement ‘‘Contains less than 1 gram’’ a protein quality value that is a pro-
or ‘‘less than 1 gram’’ may be used as tein digestibility-corrected amino acid
an alternative, and if the serving con- score of less than 20 expressed as a per-
tains less than 0.5 gram, the content cent, or when the protein in a food rep-
may be expressed as zero. When a mix- resented or purported to be for children
ture of naturally occurring and added greater than 1 but less than 4 years of
sugars is present in the food, and for age has a protein quality value that is
specific foods containing added sugars, a protein digestibility-corrected amino
alone or in combination with naturally acid score of less than 40 expressed as a
occurring sugars, where the added sug- percent, either of the following shall be
ars are subject to fermentation and/or placed adjacent to the declaration of
non-enzymatic browning, the manufac- protein content by weight: The state-
turer must make and keep records in ment ‘‘not a significant source of pro-
accordance with paragraphs (g)(10) and tein,’’ or a listing aligned under the
(11) of this section to verify the de- column headed ‘‘Percent Daily Value’’
clared amount of added sugars in the of the corrected amount of protein per
label and labeling of food. serving, as determined in paragraph
(iv) ‘‘Sugar alcohol’’ (VOLUNTARY): (c)(7)(ii) of this section, calculated as a
A statement of the number of grams of percentage of the Daily Reference
sugar alcohols in a serving may be de- Value (DRV) or Reference Daily Intake
clared voluntarily on the label, except (RDI), as appropriate, for protein and
that when a claim is made on the label expressed as a Percent of Daily Value.
or in labeling about sugar alcohol or When the protein quality in a food as
total sugars, or added sugars when measured by the Protein Efficiency
sugar alcohols are present in the food, Ratio (PER) is less than 40 percent of
sugar alcohol content shall be declared. the reference standard (casein) for a
For nutrition labeling purposes, sugar food represented or purported to be
alcohols are defined as the sum of sac- specifically for infants through 12
charide derivatives in which a hydroxyl months, the statement ‘‘not a signifi-
group replaces a ketone or aldehyde cant source of protein’’ shall be placed
group and whose use in the food is list- adjacent to the declaration of protein
ed by FDA (e.g., mannitol or xylitol) or content. Protein content may be cal-
is generally recognized as safe (e.g., culated on the basis of the factor 6.25
sorbitol). In lieu of the term ‘‘sugar al- times the nitrogen content of the food
cohol,’’ the name of the specific sugar as determined by the appropriate
alcohol (e.g., ‘‘xylitol’’) present in the method of analysis as given in the ‘‘Of-
food may be used in the nutrition label ficial Methods of Analysis of the AOAC
provided that only one sugar alcohol is International,’’ except when official
present in the food. Sugar alcohol con- AOAC procedures described in this
tent shall be indented and expressed to paragraph (c)(7) require a specific fac-
the nearest gram, except that if a serv- tor other than 6.25, that specific factor
ing contains less than 1 gram, the shall be used.
statement ‘‘Contains less than 1 gram’’ (i) A statement of the corrected
or ‘‘less than 1 gram’’ may be used as amount of protein per serving, as de-
an alternative, and if the serving con- termined in paragraph (c)(7)(ii) of this
tains less than 0.5 gram, the content section, calculated as a percentage of
may be expressed as zero. the RDI or DRV for protein, as appro-
(7) ‘‘Protein’’: A statement of the priate, and expressed as Percent of
number of grams of protein in a serv- Daily Value, may be placed on the
ing, expressed to the nearest gram, ex- label, except that such a statement
cept that if a serving contains less shall be given if a protein claim is
than 1 gram, the statement ‘‘Contains made for the product, or if the product
less than 1 gram’’ or ‘‘less than 1 is represented or purported to be spe-
gram’’ may be used as an alternative, cifically for infants through 12 months
and if the serving contains less than 0.5 or children 1 through 3 years of age.
gram, the content may be expressed as When such a declaration is provided, it
zero. When the protein in foods rep- should be placed on the label adjacent
36
to the statement of grams of protein paragraphs (d), (e), and (f) of this sec-
and aligned under the column headed tion, foods represented or purported to
‘‘Percent Daily Value,’’ and expressed be specifically for infants through 12
to the nearest whole percent. However, months, children 1 through 3 years,
the percentage of the RDI for protein pregnant women, and lactating women
shall not be declared if the food is rep- shall use the RDIs that are specified
resented or purported to be specifically for the intended group. For foods rep-
for infants through 12 months and the resented or purported to be specifically
protein quality value is less than 40 for both infants through 12 months of
percent of the reference standard. age and children 1 through 3 years of
(ii) The ‘‘corrected amount of protein age, the percent of Daily Value shall be
(gram) per serving’’ for foods rep- presented by separate declarations ac-
resented or purported for adults and cording to paragraph (e) of this section
children 1 or more years of age is equal based on the RDI values for infants
to the actual amount of protein (gram) through 12 months of age and children
per serving multiplied by the amino 1 through 3 years of age. When such
acid score corrected for protein digest- dual declaration is used on any label, it
ibility. If the corrected score is above shall be included in all labeling, and
1.00, then it shall be set at 1.00. The equal prominence shall be given to
protein digestibility-corrected amino both values in all such labeling. The
acid score shall be determined by percent Daily Value based on the RDI
methods given in sections 5.4.1, 7.2.1, values for pregnant women and lac-
and 8.00 in ‘‘Report of the Joint FAO/ tating women shall be declared on food
WHO Expert Consultation on Protein represented or purported to be specifi-
Quality Evaluation,’’ except that when cally for pregnant women and lactating
official AOAC procedures described in women. All other foods shall use the
paragraph (c)(7) of this section require RDI for adults and children 4 or more
a specific factor other than 6.25, that years of age.
specific factor shall be used. For foods (ii) The declaration of vitamins and
represented or purported to be specifi- minerals as a quantitative amount by
cally for infants through 12 months, weight and percent of the RDI shall in-
the corrected amount of protein clude vitamin D, calcium, iron, and po-
(grams) per serving is equal to the ac- tassium in that order, for infants
tual amount of protein (grams) per through 12 months, children 1 through
serving multiplied by the relative pro- 3 years of age, pregnant women, lac-
tein quality value. The relative protein tating women, and adults and children
quality value shall be determined by 4 or more years of age, except quan-
dividing the subject food protein PER titative weights for these vitamins and
value by the PER value for casein. If minerals are not required for labels de-
the relative protein value is above 1.00, scribed in paragraph (j)(13) of this sec-
it shall be set at 1.00. tion. The declaration of folic acid shall
(iii) For the purpose of labeling with be included as a quantitative amount
a percent of the DRV or RDI, a value of by weight when added as a nutrient
50 grams of protein shall be the DRV supplement or a claim is made about
for adults and children 4 or more years the nutrient. The declaration of vita-
of age, a value of 11 grams of protein mins and minerals in a food, as a quan-
shall be the RDI for infants through 12 titative amount by weight and percent
months, a value of 13 grams shall be of the RDI, may include any of the
the DRV for children 1 through 3 years other vitamins and minerals listed in
of age, and a value of 71 grams of pro- paragraph (c)(8)(iv) of this section. The
tein shall be the RDI for pregnant declaration of vitamins and minerals
women and lactating women. shall include any of the other vitamins
(8) ‘‘Vitamins and minerals’’: The re- and minerals listed in paragraph
quirements related to including a (c)(8)(iv) of this section as a statement
statement of the amount per serving of of the amount per serving of the vita-
vitamins and minerals are described in mins and minerals as described in this
this paragraph (c)(8). paragraph (c)(8)(ii), calculated as a per-

(i) For purposes of declaration of percent of the RDI and expressed as a per-
cent of Daily Value as provided for in cent of the Daily Value, when they are
37
§ 101.9 21 CFR Ch. I (4–1–23 Edition)
added as a nutrient supplement, or (or other symbol) that refers to an-

when a claim is made about them, un- other asterisk (or symbol) that is
less otherwise stated as quantitative placed at the bottom of the table and
amount by weight and percent of the that is followed by the statement
Daily Value. Other vitamins and min- ‘‘Contains less than 2 percent of the
erals need not be declared if neither Daily Value of this (these) nutrient
the nutrient nor the component is oth- (nutrients)’’ or ‘‘Contains <2 percent of
erwise referred to on the label or the the Daily Value of this (these) nutrient
labeling or advertising and the vita- (nutrients).’’ Alternatively, except as
mins and minerals are: provided for in paragraph (f) of this
(A) Required or permitted in a stand- section, if vitamin D, calcium, iron, or
ardized food (e.g., thiamin, riboflavin, potassium is present in amounts less
and niacin in enriched flour) and that than 2 percent of the RDI, label dec-
standardized food is included as an in- laration of the nutrient(s) is not re-
gredient (i.e., component) in another quired if the statement ‘‘Not a signifi-
food; or cant source of—(listing the vitamins or
(B) Included in a food solely for tech- minerals omitted)’’ is placed at the
nological purposes and declared only in bottom of the table of nutrient values.
the ingredient statement. The declara- Either statement shall be in the same
tion may also include any of the other type size as nutrients that are in-
vitamins and minerals listed in para- dented. The quantitative amounts of
graph (c)(8)(iv) of this section when vitamins and minerals, excluding so-
they are naturally occurring in the dium, shall be the amount of the vita-
food. The additional vitamins and min- min or mineral included in one serving
erals shall be listed in the order estab- of the product, using the units of meas-
lished in paragraph (c)(8)(iv) of this urement and the levels of significance
section. given in paragraph (c)(8)(iv) of this sec-
(iii) The percentages for vitamins tion, except that zeros following dec-
and minerals shall be expressed to the imal points may be dropped, and addi-
nearest 2-percent increment up to and tional levels of significance may be
including the 10-percent level, the used when the number of decimal
nearest 5-percent increment above 10 places indicated is not sufficient to ex-
percent and up to and including the 50- press lower amounts (e.g., the RDI for
percent level, and the nearest 10-per- zinc is given in whole milligrams, but
cent increment above the 50-percent the quantitative amount may be de-
level. Quantitative amounts and per- clared in tenths of a milligram).
centages of vitamins and minerals (iv) The following RDIs, nomen-
present at less than 2 percent of the clature, and units of measure are es-
RDI are not required to be declared in tablished for the following vitamins
nutrition labeling but may be declared and minerals which are essential in
by a zero or by the use of an asterisk human nutrition:
RDI
Pregnant
Adults and Infants 1 Children 1 women and
Nutrient Unit of measure children ≥ 4 through 12 through 3 lactating
years months years women
Vitamin D ............. Micrograms (mcg) 2 ............................ 20 10 15 15

Calcium ................ Milligrams (mg) ................................... 1,300 260 700 1,300
Iron ....................... Milligrams (mg) ................................... 18 11 7 27
Potassium ............ Milligrams (mg) ................................... 4,700 700 3,000 5,100
Vitamin A .............. Micrograms RAE 3 (mcg) .................... 900 500 300 1,300
Vitamin C ............. Milligrams (mg) ................................... 90 50 15 120
Vitamin E .............. Milligrams (mg) 4 ................................. 15 5 6 19
Vitamin K .............. Micrograms (mcg) ............................... 120 2.5 30 90
Thiamin ................ Milligrams (mg) ................................... 1.2 0.3 0.5 1.4
Riboflavin ............. Milligrams (mg) ................................... 1.3 0.4 0.5 1.6
Niacin ................... Milligrams NE 5 (mg) ........................... 16 4 6 18
Vitamin B6 ............ Milligrams (mg) ................................... 1.7 0.3 0.5 2.0
Folate 6 ................. Micrograms DFE 7 (mcg) .................... 400 80 150 600
Vitamin B12 ........... Micrograms (mcg) ............................... 2.4 0.5 0.9 2.8
Biotin .................... Micrograms (mcg) ............................... 30 6 8 35
Pantothenic acid .. Milligrams (mg) ................................... 5 1.8 2 7
38
RDI
Pregnant
Adults and Infants 1 Children 1 women and
Nutrient Unit of measure children ≥ 4 through 12 through 3 lactating
years months years women
Phosphorus .......... Milligrams (mg) ................................... 1,250 275 460 1,250

Iodine ................... Micrograms (mcg) ............................... 150 130 90 290
Magnesium ........... Milligrams (mg) ................................... 420 75 80 400
Zinc ...................... Milligrams (mg) ................................... 11 3 3 13
Selenium .............. Micrograms (mcg) ............................... 55 20 20 70
Copper ................. Milligrams (mg) ................................... 0.9 0.2 0.3 1.3
Manganese .......... Milligrams (mg) ................................... 2.3 0.6 1.2 2.6
Chromium ............. Micrograms (mcg) ............................... 35 5.5 11 45
Molybdenum ......... Micrograms (mcg) ............................... 45 3 17 50
Chloride ................ Milligrams (mg) ................................... 2,300 570 1,500 2,300
Choline ................. Milligrams (mg) ................................... 550 150 200 550
Protein .................. Grams (g) ........................................... N/A 11 N/A 8 71
1 RDIs are based on dietary reference intake recommendations for infants through 12 months of age.
2 The amount of vitamin D may, but is not required to, be expressed in international units (IU), in addition to the mandatory
declaration in mcg. Any declaration of the amount of vitamin D in IU must appear in parentheses after the declaration of the
amount of vitamin D in mcg.
3 RAE = Retinol activity equivalents; 1 microgram RAE = 1 microgram retinol, 2 micrograms supplemental b-carotene, 12
micrograms dietary b-carotene, or 24 micrograms dietary a-carotene, or 24 micrograms dietary b-cryptoxanthin.
4 1 mg a-tocopherol (label claim) = 1 mg a-tocopherol = 1 mg RRR- a-tocopherol = 2 mg all rac-a-tocopherol.
5 NE = Niacin equivalents, 1 mg NE = 1 mg niacin = 60 milligrams tryptophan.
6 ‘‘Folate’’ and ‘‘Folic Acid’’ must be used for purposes of declaration in the labeling of conventional foods and dietary supple-
ments. The declaration for folate must be in mcg DFE (when expressed as a quantitative amount by weight in a conventional
food or a dietary supplement), and percent DV based on folate in mcg DFE. Folate may be expressed as a percent DV in con-
ventional foods. When folic acid is added or when a claim is made about the nutrient, folic acid must be declared in parentheses,
as mcg of folic acid.
7 DFE = Dietary Folate Equivalents; 1 DFE = 1 mcg naturally occurring folate = 0.6 mcg folic acid.
8 Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and for pregnant
women and lactating women.
(v) The following synonyms may be folate, and/or synthetic folate as a

added in parentheses immediately fol- component of dietary supplement, such
lowing the name of the nutrient or die- as calcium salt of L–5-MTHF), folic
tary component: acid, or a mixture of folate and folic
Calories—Energy acid. The name of the synthetic form of
Vitamin C—Ascorbic acid the nutrient ‘‘folic acid’’, when added
Thiamin—Vitamin B1 or a claim is made about the nutrient,
Riboflavin—Vitamin B2 shall be included in parentheses after
(vi) A statement of the percent of vi- this declaration with the amount of
tamin A that is present as beta-caro- folic acid. The declaration must be
tene may be declared voluntarily. folate in mcg DFE (when expressed as a
When the vitamins and minerals are quantitative amount by weight in a
listed in a single column, the state- conventional food or a dietary supple-
ment shall be indented under the infor- ment) and the percent DV based on
mation on vitamin A. When vitamins folate in mcg DFE, or for conventional
and minerals are arrayed horizontally, food, may be expressed as folate and
the statement of percent shall be pre- the percent DV based on folate in mcg
sented in parenthesis following the dec- DFE. When declared, folic acid must be
laration of vitamin A and the percent in parentheses, mcg of folic acid as
DV of vitamin A in the food (e.g., shown in paragraph (d)(12) of this sec-
‘‘Percent Daily Value: Vitamin A 50 (90 tion in the display that illustrates vol-
percent as beta-carotene)’’). When de- untary declaration of nutrition infor-
clared, the percentages shall be ex-
mation.
pressed in the same increments as are
provided for vitamins and minerals in (9) The following DRVs, nomen-
paragraph (c)(8)(iii) of this section. clature, and units of measure are es-
(vii) When the amount of folate is de- tablished for the following food compo-
clared in the labeling of a conventional nents:
food or a dietary supplement, the nu-

trient name ‘‘folate’’ shall be listed for
products containing folate (natural
39
§ 101.9 21 CFR Ch. I (4–1–23 Edition)
Pregnant
Adults and Children 1
Infants through women and
Food component Unit of measure children ≥4 through 3
12 months lactating
years years women
Fat ........................................ Grams (g) ............................ 1 78 30 2 39 1 78
Saturated fat ........................ Grams (g) ............................ 1 20 N/A 2 10 1 20
Cholesterol ........................... Milligrams (mg) ................... 300 N/A 300 300

Total carbohydrate ............... Grams (g) ............................ 1 275 95 2 150 1 275
Sodium ................................. Milligrams (mg) ................... 2,300 N/A 1,500 2,300

Dietary Fiber ........................ Grams (g) ............................ 1 28 N/A 2 14 1 28
Protein ................................. Grams (g) ............................ 1 50 N/A 2 13 N/A

Added Sugars ...................... Grams (g) ............................ 1 50 N/A 2 25 1 50
1 Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and for pregnant
women and lactating women
2 Based on the reference caloric intake of 1,000 calories for children 1 through 3 years of age.
(d)(1) Nutrient information specified (iii) Information required in para-

in paragraph (c) of this section shall be graphs (d)(7) and (8) of this section
presented on foods in the following for- shall be in type size no smaller than 8
mat, as shown in paragraph (d)(12) of point. Information required in para-
this section, except on foods where the graph (d)(5) of this section for the
tabular display is permitted as pro- ‘‘Calories’’ declaration shall be high-
vided for in paragraph (d)(11) of this lighted in bold or extra bold and shall
section, on which dual columns of nu- be in a type size no smaller than 16
trition information are declared as pro- point except the type size for this in-
vided for in paragraph (e) of this sec- formation required in the tabular dis-
tion, on those food products on which plays as shown in paragraphs (d)(11),
the simplified format is required to be (e)(6)(ii), and (j)(13)(ii)(A)(1) of this sec-
used as provided for in paragraph (f) of tion and the linear display for small
this section, on foods for infants packages as shown in paragraph
through 12 months of age and children (j)(13)(ii)(A)(2) of this section shall be
1 through 3 years of age as provided for in a type size no smaller than 10 point.
in paragraph (j)(5) of this section, and The numeric amount for the informa-
on foods in small or intermediate-sized tion required in paragraph (d)(5) of this
packages as provided for in paragraph section shall also be highlighted in
(j)(13) of this section. In the interest of bold or extra bold type and shall be in
uniformity of presentation, FDA a type size no smaller than 22 point, ex-
strongly recommends that the nutri- cept the type size for this information
tion information be presented using required for the tabular display for
the graphic specifications set forth in small packages as shown in paragraph
appendix B to part 101. (j)(13)(ii)(A)(1) of this section, and for
(i) The nutrition information shall be the linear display for small packages
set off in a box by use of hairlines and as shown in paragraph (j)(13)(ii)(A)(2) of
shall be all black or one color type, this section no smaller than 14 point.
printed on a white or other neutral The information required in para-
contrasting background whenever prac- graphs (d)(4), (6), and (9) of this section
tical. shall be in a type size no smaller than
(ii) All information within the nutri- 6 point. When provided, the informa-
tion label shall utilize: tion described in paragraph (d)(10) of
(A) Except as provided for in para- this section shall be in a type size no
graph (c)(2)(ii) of this section, a single smaller than 6 point.
easy-to-read type style, (iv) The headings required by para-
(B) Upper and lower case letters, graphs (d)(2), (d)(3)(ii), (d)(4), and (d)(6)
(C) At least one point leading (i.e., of this section (i.e., ‘‘Nutrition Facts,’’
space between two lines of text) except ‘‘Serving size,’’ ‘‘Amount per serving,’’
that at least four points leading shall and ‘‘% Daily Value*’’), the names of
be utilized for the information required all nutrients that are not indented ac-
by paragraphs (d)(7) and (d)(8) of this cording to requirements of paragraph
section as shown in paragraph (d)(12), (c) of this section (i.e., ‘‘Calories,’’

and ‘‘Total Fat,’’ ‘‘Cholesterol,’’ ‘‘Sodium,’’
(D) Letters should never touch. ‘‘Total Carbohydrate’’ and ‘‘Protein’’),
40
and the percentage amounts required small packages as shown in paragraph

by paragraph (d)(7)(ii) of this section (j)(13)(ii)(A)(2) of this section. For the
shall be highlighted in bold or extra linear display for small packages as
bold type or other highlighting (reverse shown in paragraph (j)(13)(ii)(A)(2) of
printing is not permitted as a form of this section, the actual number of
highlighting) that prominently distin- servings may be listed after the
guishes it from other information. No servings per container declaration.
other information shall be highlighted. (ii) ‘‘Serving size’’: A statement of
(v) A hairline rule that is centered the serving size as specified in para-
between the lines of text shall separate graph (b)(7) of this section which shall
‘‘Nutrition Facts’’ from the servings immediately follow the ‘‘____servings
per container statement required in per container’’ declaration. The infor-
paragraph (d)(3)(i) of this section and mation required in this paragraph shall
shall separate each nutrient and its be highlighted in bold or extra bold and
corresponding percent Daily Value re- be in a type size no smaller than 10
quired in paragraphs (d)(7)(i) and (ii) of point, except the type size shall be no
this section from the nutrient and per- smaller than 9 point for this informa-
cent Daily Value above and below it, as tion in the tabular displays as shown in
shown in paragraph (d)(12) of this sec- paragraphs (d)(11) and (e)(6)(ii) of this
tion and in Appendix B to Part 101. section, the tabular display for small
(2) The information shall be pre- packages as shown in paragraph
sented under the identifying heading of (j)(13)(ii)(A)(1) of this section, and the
‘‘Nutrition Facts’’ which shall be set in linear display for small packages as
a type size no smaller than all other shown in paragraph (j)(13)(ii)(A)(2) of
print size in the nutrition label except this section. The serving size amount
for the numerical information for must be right justified if adequate
‘‘Calories’’ required in paragraph (d)(5) space is available. If the ‘‘Serving size’’
of this section, and except for labels declaration does not fit in the allo-
presented according to the format pro- cated space a type size of no smaller
vided for in paragraphs (d)(11),
than 8 point may be used on packages
(d)(13)(ii), (e)(6)(ii), (j)(13)(ii)(A)(1), and
of any size.
(j)(13)(ii)(A)(2) of this section, unless
(4) A subheading ‘‘Amount per serv-
impractical, shall be set the full width
of the information provided under ing’’ shall be separated from the serv-
paragraph (d)(7) of this section, as ing size information by a bar as shown
shown in paragraph (d)(12) of this sec- in paragraph (d)(12) of this section, ex-
tion. cept this information is not required
(3) Information on servings per con- for the dual column formats shown in
tainer and serving size shall imme- paragraphs (e)(5), (e)(6)(i), and (e)(6)(ii)
diately follow the heading as shown in of this section.
paragraph (d)(12) of this section. Such (5) Information on calories shall im-
information shall include: mediately follow the subheading
(i) ‘‘____ servings per container’’: The ‘‘Amount per serving’’ and shall be de-
number of servings per container, ex- clared in one line. If ‘‘Calories from
cept that this statement is not re- saturated fat’’ is declared, it shall be
quired on single serving containers as indented under ‘‘Calories’’ and shall be
defined in paragraph (b)(6) of this sec- in a type size no smaller than 8 point.
tion or on other food containers when (6) The column heading ‘‘% Daily
this information is stated in the net Value,’’ followed by an asterisk (e.g.,
quantity of contents declaration. The ‘‘% Daily Value*’’), shall be separated
information required in this paragraph from information on calories by a bar
shall be located immediately after the as shown in paragraph (d)(12) of this
‘‘Nutrition Facts’’ heading and shall be section. The position of this column
in a type size no smaller than 10 point, heading shall allow for a list of nutri-
except the type size for this informa- ent names and amounts as described in
tion shall be no smaller than 9 point in paragraph (d)(7) of this section to be to
the tabular display for small packages the left of, and below, this column
as shown in paragraph (j)(13)(ii)(A)(1) of heading. The column headings ‘‘Per-
this section and the linear display for cent Daily Value,’’ ‘‘Percent DV,’’ or
41
§ 101.9 21 CFR Ch. I (4–1–23 Edition)
‘‘% DV’’ may be substituted for ‘‘% and calcium should be listed on the
Daily Value.’’ first line and iron and potassium
(7) Except as provided for in para- should be listed on the second line, as
graph (j)(13)(ii)(A)(2) of this section, shown in paragraph (d)(12) of this sec-
nutrient information for both manda- tion in the side-by-side display. When
tory and any voluntary nutrients listed more than four vitamins and minerals
in paragraph (c) of this section that are are declared voluntarily as shown in
to be declared in the nutrition label, paragraph (d)(12) of this section in the
except for folic acid in conventional label which illustrates the mandatory
food and voluntarily declared vitamins plus voluntary provisions of paragraph
and minerals expressed as a statement (d) of this section, they may be de-
of the amount per serving calculated as clared vertically with percentages list-
a percent of the RDI and expressed as a ed under the column headed ‘‘% Daily
percent Daily Value, shall be declared Value.’’
as follows: (9) A footnote, preceded by an aster-
(i) The name of each nutrient, as isk, shall be placed beneath the list of
specified in paragraph (c) of this sec- vitamins and minerals and shall be sep-
tion, shall be given in a column and arated from the list by a bar, except
followed immediately by the quan-
that the footnote may be omitted from
titative amount by weight for that nu-
foods that can use the terms ‘‘calorie
trient appended with a ‘‘g’’ for grams,
free,’’ ‘‘free of calories,’’ ‘‘without cal-
‘‘mg’’ for milligrams, or ‘‘mcg’’ for
ories,’’ ‘‘trivial source of calories,’’
micrograms as shown in paragraph
‘‘negligible source of calories,’’ or ‘‘di-
(d)(12) of this section. The symbol ‘‘<’’
etary insignificant source of calories’’
may be used in place of ‘‘less than.’’
on the label or in the labeling of foods
(ii) A listing of the percent of the
DRV as established in paragraphs as defined in § 101.60(b). The first sen-
(c)(7)(iii) and (c)(9) of this section shall tence of the footnote: ‘‘The % Daily
be given in a column aligned under the Value tells you how much a nutrient in
heading ‘‘% Daily Value’’ established a serving of food contributes to a daily
in paragraph (d)(6) of this section with diet’’ may be used on foods that can
the percent expressed to the nearest use the terms ‘‘calorie free,’’ ‘‘free of
whole percent for each nutrient de- calories,’’ ‘‘without calories,’’ ‘‘trivial
clared in the column described in para- source of calories,’’ ‘‘negligible source
graph (d)(7)(i) of this section for which of calories,’’ or ‘‘dietary insignificant
a DRV has been established, except source of calories’’ on the label or in
that the percent for protein may be the labeling of foods as defined in
omitted as provided in paragraph (c)(7) § 101.60(b). The footnote shall state:
of this section. The percent shall be ‘‘*The % Daily Value tells you how
calculated by dividing either the much a nutrient in a serving of food
amount declared on the label for each contributes to a daily diet. 2,000 cal-
nutrient or the actual amount of each ories a day is used for general nutrition
nutrient (i.e., before rounding) by the advice.’’ If the food product is rep-
DRV for the nutrient, except that the resented or purported to be for children
percent for protein shall be calculated 1 through 3 years of age, the second
as specified in paragraph (c)(7)(ii) of sentence of the footnote shall sub-
this section. The numerical value shall stitute ‘‘1,000 calories’’ for ‘‘2,000 cal-
be followed by the symbol for percent ories.’’
(i.e., %). (10) Caloric conversion information
(8) Nutrient information for vitamins on a per gram basis for fat, carbo-
and minerals (except sodium) shall be hydrate, and protein may be presented
separated from information on other beneath the information required in
nutrients by a bar and may be arrayed paragraph (d)(9) of this section, sepa-
vertically as shown in paragraph (d)(12) rated from that information by a hair-
of this section (e.g., Vitamin D 2 mcg line. This information may be pre-
10%, Calcium 260 mg 20%, Iron 8 mg sented horizontally as shown in para-
45%, Potassium 235 mg 6%) or may be graph (d)(12) of this section (i.e., ‘‘Cal-
listed horizontally. When listed hori- ories per gram: fat 9, carbohydrate 4,
zontally in two columns, vitamin D protein 4’’) or vertically in columns.
42
(11)(i) If the space beneath the infor- clared or the information required in
mation on vitamins and minerals is not paragraph (d)(9) of this section, the re-
adequate to accommodate the informa- maining information may be moved to
tion required in paragraph (d)(9) of this the right and set off by a line that dis-
section, the information required in tinguishes it and sets it apart from the
paragraph (d)(9) may be moved to the nutrients and the percent DV informa-
right of the column required in para- tion given to the left. The caloric con-
graph (d)(7)(ii) of this section and set version information provided for in
off by a line that distinguishes it and paragraph (d)(10) of this section may be
sets it apart from the percent Daily presented beneath either side or along
Value information. The caloric conver- the full length of the nutrition label.
sion information provided for in para- (iii) If there is not sufficient contin-
graph (d)(10) of this section may be pre- uous vertical space (i.e., approximately
sented beneath either side or along the 3 in) to accommodate the required
full length of the nutrition label. components of the nutrition label up to
(ii) If the space beneath the manda- and including the mandatory declara-
tory declaration of potassium is not tion of potassium, the nutrition label
adequate to accommodate any remain- may be presented in a tabular display
ing vitamins and minerals to be de- as shown in the following sample label.
(12) The following sample labels illus- paragraph (d) of this section and the
trate the mandatory provisions and side-by-side display.
mandatory plus voluntary provisions of
43
ER24MR23.011</GPH>
§ 101.9 21 CFR Ch. I (4–1–23 Edition)
44
ER27MY16.001</GPH>
45
ER27MY16.002</GPH>
§ 101.9 21 CFR Ch. I (4–1–23 Edition)
(13)(i) Nutrition labels on the outer imum extent possible, except that the
label of packages of products that con- identity of each food shall be specified
tain two or more separately packaged immediately to the right of the ‘‘Nu-
foods that are intended to be eaten in- trition Facts’’ heading, and both the
dividually (e.g., variety packs of cere- quantitative amount by weight (i.e., g/
als or snack foods) or of packages that mg/mcg amounts) and the percent
are used interchangeably for the same Daily Value for each nutrient shall be
type of food (e.g., round ice cream con- listed in separate columns under the
tainers) may use an aggregate display. name of each food. The following sam-
(ii) Aggregate displays shall comply
ple label illustrates an aggregate dis-
with the format requirements of para-
play.
graph (d) of this section to the max-
46
ER27MY16.003</GPH>
(14) In accordance with § 101.15(c)(2), provided, equal prominence shall be

when nutrition labeling must appear in given to both sets of values. Informa-
a second language, the nutrition infor- tion shall be presented in a format con-
mation may be presented in a separate sistent with paragraph (d) of this sec-
nutrition label for each language or in tion, except that:
one nutrition label with the informa- (1) Following the serving size infor-
tion in the second language following mation there shall be two or more col-
that in English. Numeric characters umn headings accurately describing
that are identical in both languages the amount per serving size of the form
need not be repeated (e.g., ‘‘Protein/ of the same food (e.g., ‘‘Per 1⁄4 cup mix’’
Proteinas 2 g’’). All required informa- and ‘‘Per prepared portion’’), the com-
tion must be included in both lan- binations of food, the units, or the RDI
guages. groups that are being declared as
(e) Nutrition information may be pre- shown in paragraph (e)(5) of this sec-
sented for two or more forms of the tion.
same food (e.g., both ‘‘as purchased’’ (2) The quantitative information by
and ‘‘as prepared’’) or for common com- weight as required in paragraph
binations of food as provided for in (d)(7)(i) and the information required
paragraph (h)(4) of this section, for dif- in paragraph (d)(7)(ii) of this section
ferent units (e.g., slices of bread or per shall be presented for the form of the
100 grams) as provided for in paragraph product as packaged and for any other
(b) of this section, or for two or more form of the product (e.g., ‘‘as prepared’’
groups for which RDIs are established or combined with another ingredient as
(e.g., both infants through 12 months of shown in paragraph (e)(5) of this sec-
age and children 1 through 3 years of tion).

age) as shown in paragraph (e)(5) of (3) When the dual labeling is pre-
this section. When such dual labeling is sented for two or more forms of the
47
ER27MY16.004</GPH>
§ 101.9 21 CFR Ch. I (4–1–23 Edition)
same food, for combinations of food, for separated from information on other
different units, or for two or more nutrients by a bar and shall be arrayed
groups for which RDIs are established, vertically in the following order: Vita-
the quantitative information by weight min D, calcium, iron, potassium as
and the percent Daily Value shall be shown in paragraph (e)(5) of this sec-
presented in two columns and the col- tion.
umns shall be separated by vertical (5) The following sample label illus-
lines as shown in paragraph (e)(5) of trates the provisions of paragraph (e)
this section. of this section:
(4) Nutrient information for vitamins
and minerals (except sodium) shall be
(6) When dual labeling is presented graph (b)(12)(i) of this section or on a

for a food on a per serving basis and per per serving basis and per unit basis as
container basis as required in para- required in paragraph (b)(2)(i)(D) of
48
ER21DE18.010</GPH>
this section, the quantitative informa- (i) Nutrient information for vitamins
tion by weight as required in paragraph and minerals shall be separated from
(d)(7)(i) and the percent Daily Value as information on other nutrients by a
required in paragraph (d)(7)(ii) shall be bar and shall be arrayed vertically in
presented in two columns, and the col- the following order: Vitamin D, cal-
umns shall be separated by vertical cium, iron, and potassium as shown in
lines as shown in the displays in para- the following sample labels.
graph (e)(6)(i) of this section.
49
ER21DE18.011</GPH>
§ 101.9 21 CFR Ch. I (4–1–23 Edition)
(ii) The following sample label illus- (b)(2)(i)(D) and (b)(12)(i) of this section
trates the provisions of paragraphs for labels that use the tabular display.
ER21DE18.013</GPH>
50
ER21DE18.012</GPH>
(f) The declaration of nutrition infor- (i) Total calories, total fat, total car-
mation may be presented in the sim- bohydrate, protein, and sodium;
plified format set forth herein when a (ii) Any other nutrients identified in
food product contains insignificant paragraph (f) of this section that are
amounts of eight or more of the fol- present in the food in more than insig-
lowing: Calories, total fat, saturated nificant amounts; and
fat, trans fat, cholesterol, sodium, total (iii) Any vitamins and minerals list-
carbohydrate, dietary fiber, total sug- ed in paragraph (c)(8)(iv) of this section
ars, added sugars, protein, vitamin D, when they are required to be added as
calcium, iron, and potassium; except a nutrient supplement to foods for
that for foods intended for infants which a standard of identity exists.
through 12 months of age and children (iv) Any vitamins or minerals listed
1 through 3 years of age to which para- in paragraph (c)(8)(iv) of this section
graph (j)(5)(i) of this section applies, voluntarily added to the food as nutri-
nutrition information may be pre- ent supplements.
sented in the simplified format when a (3) Other nutrients that are naturally
food product contains insignificant present in the food in more than insig-
amounts of six or more of the fol- nificant amounts may be voluntarily
lowing: Calories, total fat, sodium, declared as part of the simplified for-
total carbohydrate, dietary fiber, total mat.
sugars, added sugars, protein, vitamin (4) If any nutrients are declared as
D, calcium, iron, and potassium. provided in paragraphs (f)(2)(iii),
(1) An ‘‘insignificant amount’’ shall (f)(2)(iv), or (f)(3) of this section as part
be defined as that amount that allows of the simplified format or if any nutri-
a declaration of zero in nutrition label- tion claims are made on the label or in
ing, except that for total carbohydrate, labeling, the statement ‘‘Not a signifi-
dietary fiber, and protein, it shall be an cant source of ________’’ (with the blank
amount that allows a declaration of filled in with the name(s) of any nutri-
‘‘less than 1 gram.’’ ent(s) identified in paragraph (f) of this
(2) The simplified format shall in- section that are present in insignifi-
clude information on the following nu- cant amounts) shall be included at the
trients: bottom of the nutrition label.
51
ER27MY16.008</GPH>
§ 101.9 21 CFR Ch. I (4–1–23 Edition)
(5) Except as provided for in para- monounsaturated fat shall be deemed

graphs (j)(5) and (j)(13) of this section, to be misbranded under section 403(a)
nutrient information declared in the of the Federal Food, Drug, and Cos-
simplified format shall be presented in metic Act (the act) unless it meets the
the same manner as specified in para- following requirements:
graphs (d) or (e) of this section, except (i) When a vitamin, mineral, protein,
that the footnote required in paragraph or dietary fiber meets the definition of
(d)(9) of this section is not required, a Class I nutrient, the nutrient content
and an asterisk shall be placed at the of the composite must be formulated to
bottom of the label followed by the be at least equal to the value for that
statement ‘‘% DV = % Daily Value’’ nutrient declared on the label.
when ‘‘Daily Value’’ is not spelled out (ii) When a vitamin, mineral, protein,
in the heading, as shown in paragraph total carbohydrate, polyunsaturated or
(f)(4). monounsaturated fat, or dietary fiber
(g) Compliance with this section meets the definition of a Class II nutri-
shall be determined as follows: ent, the nutrient content of the com-
(1) A collection of primary containers posite must be at least equal to 80 per-
or units of the same size, type, and cent of the value for that nutrient de-
style produced under conditions as clared on the label. Provided, That no
nearly uniform as possible, designated regulatory action will be based on a de-
by a common container code or mark- termination of a nutrient value that
ing, or in the absence of any common falls below this level by a factor less
container code or marking, a day’s pro- than the variability generally recog-
duction, constitutes a ‘‘lot.’’ nized for the analytical method used in
(2) The sample for nutrient analysis that food at the level involved.
shall consist of a composite of 12 sub-
(5) A food with a label declaration of
samples (consumer units), taken 1 from
calories, total sugars, added sugars
each of 12 different randomly chosen
(when the only source of sugars in the
shipping cases, to be representative of
food is added sugars), total fat, satu-
a lot. Unless a particular method of
rated fat, trans fat, cholesterol, or so-
analysis is specified in paragraph (c) of
this section, composites shall be ana- dium shall be deemed to be misbranded
lyzed by appropriate methods as given under section 403(a) of the act if the
in the ‘‘Official Methods of Analysis of nutrient content of the composite is
the AOAC International,’’ or, if no greater than 20 percent in excess of the
AOAC method is available or appro- value for that nutrient declared on the
priate, by other reliable and appro- label. Provided, That no regulatory ac-
priate analytical procedures. tion will be based on a determination
(3) Two classes of nutrients are de- of a nutrient value that falls above this
fined for purposes of compliance: level by a factor less than the varia-
(i) Class I. Added nutrients in for- bility generally recognized for the ana-
tified or fabricated foods; and lytical method used in that food at the
(ii) Class II. Naturally occurring (in- level involved.
digenous) nutrients. When a nutrient is (6) Reasonable excesses of vitamins,
naturally occurring (indigenous) in a minerals, protein, total carbohydrate,
food or an ingredient that is added to a dietary fiber, soluble fiber, insoluble
food, the total amount of such nutrient fiber, sugar alcohols, polyunsaturated
in the final food product is subject to or monounsaturated fat over labeled
class II requirements, except that when amounts are acceptable within current
an exogenous source of the nutrient is good manufacturing practice. Reason-
also added to the final food product, able deficiencies of calories, total sug-
the total amount of the nutrient in the ars, added sugars, total fat, saturated
final food product (indigenous and ex- fat, trans fat, cholesterol, or sodium
ogenous) is subject to class I require- under labeled amounts are acceptable
ments. within current good manufacturing
(4) A food with a label declaration of practice.
a vitamin, mineral, protein, total car- (7) Compliance will be based on the
bohydrate, dietary fiber, soluble fiber, metric measure specified in the label
insoluble fiber, polyunsaturated or statement of serving size.
52
(8) Alternatively, compliance with nition of dietary fiber, is present in the

the provisions set forth in paragraphs food, a manufacturer must make and
(g)(1) through (6) of this section may be keep written records of the amount of
provided by use of an FDA approved non-digestible carbohydrate(s) added to
database that has been computed fol- the food that does not meet the defini-
lowing FDA guideline procedures and tion of dietary fiber.
where food samples have been handled (ii) When a mixture of soluble fiber
in accordance with current good manu- and added non-digestible carbo-
facturing practice to prevent nutrition hydrate(s) that does not meet the defi-
loss. FDA approval of a database shall nition of dietary fiber is present in the
not be considered granted until the food, a manufacturer must make and
Center for Food Safety and Applied Nu- keep written records necessary to
trition has agreed to all aspects of the verify the amount of the non-digestible
database in writing. The approval will carbohydrate(s) added to the food that
be granted where a clear need is pre- does not meet the definition of dietary
sented (e.g., raw produce and seafood). fiber.
Approvals will be in effect for a limited (iii) When a mixture of insoluble
time, e.g., 10 years, and will be eligible fiber and added non-digestible carbo-
for renewal in the absence of signifi- hydrate(s) that does not meet the defi-
cant changes in agricultural or indus- nition of dietary fiber is present in the
try practices. Approval requests shall food, a manufacturer must make and
be submitted in accordance with the keep written records necessary to
provisions of § 10.30 of this chapter. verify the amount of the non-digestible
Guidance in the use of databases may carbohydrate(s) added to the food that
be found in the ‘‘FDA Nutrition Label- does not meet the definition of dietary
ing Manual—A Guide for Developing fiber.
and Using Data Bases,’’ available from (iv) When a mixture of naturally oc-
the Office of Nutrition and Food Label- curring and added sugars is present in
ing (HFS–800), Center for Food Safety the food, a manufacturer must make
and Applied Nutrition, Food and Drug and keep written records of the amount
Administration, 5001 Campus Dr., Col- of added sugars added to the food dur-
lege Park, MD 20740 or by going to ing the processing of the food, and if
http://www.fda.gov. packaged as a separate ingredient, as
(9) When it is not technologically fea- packaged (whether as part of a package
sible, or some other circumstance containing one or more ingredients or
makes it impracticable, for firms to packaged as a single ingredient).
comply with the requirements of this (v) When the amount of sugars added
section (e.g., to develop adequate nutri- to food products is reduced through
ent profiles to comply with the require- non-enzymatic browning and/or fer-
ments of paragraph (c) of this section), mentation, manufacturers must:
FDA may permit alternative means of (A) Make and keep records of all rel-
compliance or additional exemptions evant scientific data and information
to deal with the situation. Firms in relied upon by the manufacturer that
need of such special allowances shall demonstrates the amount of added sug-
make their request in writing to the ars in the food after non-enzymatic
Center for Food Safety and Applied Nu- browning and/or fermentation and a
trition (HFS–800), Food and Drug Ad- narrative explaining why the data and
ministration, 5001 Campus Dr., College information are sufficient to dem-
Park, MD 20740. onstrate the amount of added sugars
(10) The manufacturer must make declared in the finished food, provided
and keep written records (e.g., analyses the data and information used is spe-
of databases, recipes, formulations, in- cific to the type of food that is subject
formation from recipes or formula- to non-enzymatic browning and/or fer-
tions, or batch records) to verify the mentation; or
declared amount of that nutrient on (B) Make and keep records of the
the Nutrition Facts label as follows: amount of added sugars added to the
(i) When a mixture of dietary fiber, food before and during the processing
and added non-digestible carbo- of the food, and if packaged as a sepa-
hydrate(s) that does not meet the defi- rate ingredient, as packaged (whether
53
§ 101.9 21 CFR Ch. I (4–1–23 Edition)
as part of a package containing one or either as original records, true copies

more ingredients or packaged as a sin- (such as photocopies, pictures, scanned
gle ingredient) and in no event shall copies, microfilm, microfiche, or other
the amount of added sugars declared accurate reproductions of the original
exceed the amount of total sugars on records), or electronic records which
the label; or must be kept in accordance with part
(C) Submit a petition, under 21 CFR 11 of this chapter. These records must
10.30, to request an alternative means be accurate, indelible, and legible.
of compliance. The petition must pro- Failure to make and keep the records
vide scientific data or other informa- or provide the records to appropriate
tion for why the amount of added sug- regulatory authorities, as required by
ars in a serving of the product is likely this paragraph (g)(11), would result in
to have a significant reduction in the food being misbranded under sec-
added sugars compared to the amount tion 403(a)(1) of the act.
added prior to non-enzymatic browning (h) Products with separately pack-
and/or fermentation. A significant re- aged ingredients or foods, with assort-
duction would be where reduction in ments of food, or to which other ingre-
added sugars after non-enzymatic dients are added by the user may be la-
browning and/or fermentation may be beled as follows:
significant enough to impact the label (1) If a product consists of two or
declaration for added sugars by an more separately packaged ingredients
amount that exceeds the reasonable de- enclosed in an outer container or of as-
ficiency acceptable within good manu- sortments of the same type of food
facturing practice under paragraph (e.g., assorted nuts or candy mixtures)
(g)(6) of this section. In addition, the in the same retail package, nutrition
scientific data or other information labeling shall be located on the outer
must include the reason that the man- container or retail package (as the case
ufacturer is unable to determine a rea- may be) to provide information for the
sonable approximation of the amount consumer at the point of purchase.
of added sugars in a serving of their However, when two or more food prod-
finished product and a description of ucts are simply combined together in
the process that they used to come to such a manner that no outer container
that conclusion. is used, or no outer label is available,
(vi) When a mixture of all rac-a-to- each product shall have its own nutri-
copherol and RRR-a-tocopherol is tion information, e.g., two boxes taped
present in a food, manufacturers must together or two cans combined in a
make and keep written records of the clear plastic overwrap. When sepa-
amount of all rac-a-tocopherol added to rately packaged ingredients or assort-
the food and RRR-a-tocopherol in the ments of the same type of food are in-
finished food. tended to be eaten at the same time,
(vii) When a mixture of folate and the nutrition information may be spec-
folic acid is present in a food, manufac- ified per serving for each component or
turers must make and keep written as a composite value.
records of the amount of synthetic (2) If a product consists of two or
folate and/or folic acid added to the more separately packaged foods that
food and the amount of naturally-oc- are intended to be eaten individually
curring folate in the finished food. and that are enclosed in an outer con-
(11) Records necessary to verify cer- tainer (e.g., variety packs of cereals or
tain nutrient declarations that are snack foods), the nutrition information
specified in paragraph (g)(10) of this shall:
section must be kept for a period of at (i) Be specified per serving for each
least 2 years after introduction or de- food in a location that is clearly visible
livery for introduction of the food into to the consumer at the point of pur-
interstate commerce. Such records chase; and
must be provided to FDA upon request, (ii) Be presented in separate nutri-
during an inspection, for official review tion labels or in one aggregate nutri-
and photocopying or other means of re- tion label with separate columns for
production. Records required to verify the quantitative amount by weight and
information on the label may be kept the percent Daily Value for each food.
54
(3) If a package contains a variety of mation under paragraph (h) of this sec-
foods, or an assortment of foods, and is tion if it is not specifically listed in a
in a form intended to be used as a gift, promotional catalogue as being present
the nutrition labeling shall be in the in the gift package, and:
form required by paragraphs (a) (A) It is used in small quantities pri-
through (f) of this section, but it may marily to enhance the appearance of
be modified as follows: the gift package; or
(i) Nutrition information may be pre- (B) It is included in the gift package
sented on the label of the outer pack- as a free gift or promotional item.
age or in labeling within or attached to (4) If a food is commonly combined
the outer package. with other ingredients or is cooked or
(ii) In the absence of a reference otherwise prepared before eating, and
amount customarily consumed in directions for such combination or
§ 101.12(b) that is appropriate for the preparations are provided, another col-
variety or assortment of foods in a gift umn of figures may be used to declare
package, the following may be used as nutrition information on the basis of
the standard serving size for purposes the food as consumed in the format re-
of nutrition labeling of foods subject to quired in paragraph (e) of this section;
this paragraph: 1 ounce for solid foods; e.g., a dry ready-to-eat cereal may be
2 fluid ounces for nonbeverage liquids described with the percent Daily Value
(e.g., syrups); 8 ounces for beverages
and the quantitative amounts for the
that consist of milk and fruit juices,
cereal as sold (e.g., per ounce), and the
nectars and fruit drinks; and 12 fluid
percent Daily Value and the quan-
ounces for other beverages. However,
titative amounts for the cereal and
the reference amounts customarily
milk as suggested in the label (e.g., per
consumed in § 101.12(b) shall be used for
ounce of cereal and 1⁄2cup of vitamin D
purposes of evaluating whether indi-
fortified skim milk); and a cake mix
vidual foods in a gift package qualify
may be labeled with the percent Daily
for nutrient content claims or health
Value and the quantitative amounts
claims.
for the dry mix (per serving) and the
(iii) The number of servings per con-
tainer may be stated as ‘‘varied.’’ percent Daily Value and the quan-
(iv) Nutrition information may be titative amounts for the serving of the
provided per serving for individual final cake when prepared, as shown in
foods in the package, or, alternatively, paragraph (e)(5) of this section: Pro-
as a composite per serving for reason- vided, that, the type and quantity of
able categories of foods in the package the other ingredients to be added to
having similar dietary uses and similar the product by the user and the specific
significant nutritional characteristics. method of cooking and other prepara-
Reasonable categories of foods may be tion shall be specified prominently on
used only if accepted by FDA. In deter- the label.
mining whether a proposed category is (i) Except as provided in paragraphs
reasonable, FDA will consider whether (j)(13) and (j)(17) of this section, the lo-
the values of the characterizing nutri- cation of nutrition information on a
ents in the foods proposed to be in the label shall be in compliance with
category meet the compliance criteria § 101.2.
set forth in paragraphs (g)(3) through (j) The following foods are exempt
(6) of this section. Proposals for such from this section or are subject to spe-
categories may be submitted in writing cial labeling requirements:
to the Office of Nutrition and Food La- (1)(i) Food offered for sale by a person
beling (HFS–800), Center for Food Safe- who makes direct sales to consumers
ty and Applied Nutrition, Food and (e.g., a retailer) who has annual gross
Drug Administration, 5001 Campus Dr., sales made or business done in sales to
College Park, MD 20740. consumers that is not more than
(v) If a food subject to paragraph $500,000 or has annual gross sales made
(j)(13) of this section because of its or business done in sales of food to con-
small size is contained in a gift pack- sumers of not more than $50,000, Pro-
age, the food need not be included in vided, That the food bears no nutrition
the determination of nutrition infor- claims or other nutrition information
55
§ 101.9 21 CFR Ch. I (4–1–23 Edition)
in any context on the label or in labeling or advertising. Claims or other nu-
ing or advertising. Claims or other nutrition information subject the food to
trition information subject the food to the provisions of this section;
the provisions of this section, § 101.10, (iv) Used only in such facilities and
or § 101.11, as applicable. not served to the consumer in the
(ii) For purposes of this paragraph, package in which they are received
calculation of the amount of sales shall (e.g., foods that are not packaged in in-
be based on the most recent 2-year av- dividual serving containers); or
erage of business activity. Where firms (v) Sold by a distributor who prin-
have been in business less than 2 years, cipally sells food to such facilities: Pro-
reasonable estimates must indicate vided, That:
that annual sales will not exceed the (A) This exemption shall not be
amounts specified. For foreign firms available for those foods that are man-
that ship foods into the United States, ufactured, processed, or repackaged by
the business activities to be included that distributor for sale to any persons
shall be the total amount of food sales, other than restaurants or other estab-
as well as other sales to consumers, by lishments that serve food for imme-
the firm in the United States. diate human consumption, and
(2) Except as provided in § 101.11, food (B) The manufacturer of such prod-
products that are: ucts is responsible for providing the
(i) Served in restaurants, Provided, nutrition information on the products
That the food bears no nutrition claims if there is a reasonable possibility that
or other nutrition information in any the product will be purchased directly
context on the label or in labeling or by consumers.
advertising. Claims or other nutrition (3) Except as provided in § 101.11, food
information subject the food to the products that are:
provisions of this section; (i) Of the type of food described in
(ii) Served in other establishments in paragraphs (j)(2)(i) and (j)(2)(ii) of this
which food is served for immediate section,
human consumption (e.g., institutional (ii) Ready for human consumption,
food service establishments, such as (iii) Offered for sale to consumers but
schools, hospitals, and cafeterias; not for immediate human consump-
transportation carriers, such as trains tion,
and airplanes; bakeries, delicatessens, (iv) Processed and prepared primarily
and retail confectionery stores where in a retail establishment, and
there are facilities for immediate con- (v) Not offered for sale outside of
sumption on the premises; food service that establishment (e.g., ready-to-eat
vendors, such as lunch wagons, ice foods that are processed and prepared
cream shops, mall cookie counters, on-site and sold by independent deli-
vending machines, and sidewalk carts catessens, bakeries, or retail confec-
where foods are generally consumed tionery stores where there are no fa-
immediately where purchased or while cilities for immediate human consump-
the consumer is walking away, includ- tion; by in-store delicatessen, bakery,
ing similar foods sold from convenience or candy departments; or at self-serv-
stores; and food delivery systems or es- ice food bars such as salad bars), Pro-
tablishments where ready-to-eat foods vided, That the food bears no nutrition
are delivered to homes or offices), Pro- claims or other nutrition information
vided, That the food bears no nutrition in any context on the label or in label-
claims or other nutrition information ing or advertising. Claims or other nu-
in any context on the label or in label- trition information subject the food to
ing or advertising, except as provided the provisions of this section.
in § 101.8(c). Claims or other nutrition (4) Except as provided in § 101.11,
information, except as provided in foods that contain insignificant
§ 101.8(c), subject the food to the provi- amounts of all of the nutrients and
sions of this section; food components required to be in-
(iii) Sold only in such facilities, Pro- cluded in the declaration of nutrition
vided, That the food bears no nutrition information under paragraph (c) of this
claims or other nutrition information section, Provided, That the food bears
in any context on the label or in label- no nutrition claims or other nutrition
56
information in any context on the label ing. The nutrients declared for infants
or in labeling or advertising. Claims or through 12 months of age and children
other nutrition information, except as 1 through 3 years of age shall include
provided in § 101.8(c), subject the food calories, total fat, saturated fat, trans
to the provisions of this section. An in- fat, cholesterol, sodium, total carbo-
significant amount of a nutrient or hydrates, dietary fiber, total sugars,
food component shall be that amount added sugars, protein, and the fol-
that allows a declaration of zero in nu- lowing vitamins and minerals: Vitamin
trition labeling, except that for total D, calcium, iron, and potassium.
carbohydrate, dietary fiber, and pro-
(ii) Foods, other than infant formula,
tein, it shall be an amount that allows
represented or purported to be specifi-
a declaration of ‘‘less than 1 gram.’’
Examples of foods that are exempt cally for infants through 12 months of
under this paragraph include coffee age shall bear nutrition labeling, ex-
beans (whole or ground), tea leaves, cept that:
plain unsweetened instant coffee and (A) Such labeling shall not declare a
tea, condiment-type dehydrated vege- percent Daily Value for saturated fat,
tables, flavor extracts, and food colors. trans fat, cholesterol, sodium, dietary
(5)(i) Foods, other than infant for- fiber, total sugars, or added sugars and
mula, represented or purported to be shall not include a footnote.
specifically for infants through 12 (B) The following sample label illus-
months of age and children 1 through 3 trates the provisions of paragraph
years of age shall bear nutrition label- (j)(5)(ii) of this section.
(C)–(E) [Reserved] years of age shall include a footnote

(iii) Foods, other than infant for- that states: ‘‘*The % Daily Value tells
mula, represented or purported to be you how much a nutrient in a serving
specifically for children 1 through 3 of food contributes to a daily diet. 1,000
57
ER24MR23.012</GPH>
§ 101.9 21 CFR Ch. I (4–1–23 Edition)
calories a day is used for general nutri- (A) The following sample label illus-
tion advice.’’ trates the provisions of paragraph
(j)(5)(iii) of this section.
(B) [Reserved] natural state) for the partial or exclu-

(6) Dietary supplements, except that sive feeding of a patient by means of
such foods shall be labeled in compli- oral intake or enteral feeding by tube;
ance with § 101.36. (ii) It is intended for the dietary
(7) Infant formula subject to section management of a patient who, because
412 of the act, as amended, except that of therapeutic or chronic medical
such foods shall be labeled in compli- needs, has limited or impaired capacity
ance with part 107 of this chapter. to ingest, digest, absorb, or metabolize
(8) Medical foods as defined in section ordinary foodstuffs or certain nutri-
5(b) of the Orphan Drug Act (21 U.S.C. ents, or who has other special medi-
360ee(b)(3)). A medical food is a food cally determined nutrient require-
which is formulated to be consumed or ments, the dietary management of
administered enterally under the su- which cannot be achieved by the modi-
pervision of a physician and which is fication of the normal diet alone;
intended for the specific dietary man- (iii) It provides nutritional support
agement of a disease or condition for specifically modified for the manage-
which distinctive nutritional requirement of the unique nutrient needs that
ments, based on recognized scientific result from the specific disease or con-
principles, are established by medical dition, as determined by medical eval-
evaluation. A food is subject to this ex- uation;
emption only if: (iv) It is intended to be used under
(i) It is a specially formulated and medical supervision; and

processed product (as opposed to a nat- (v) It is intended only for a patient
urally occurring foodstuff used in its receiving active and ongoing medical
58
ER27MY16.010</GPH>
supervision wherein the patient re- these foods bear no nutrition claims or
quires medical care on a recurring other nutrition information in any
basis for, among other things, instruc- context on the label or in labeling or
tions on the use of the medical food. advertising, except as provided in
(9) Food products shipped in bulk § 101.8(c). Claims or other nutrition in-
form that are not for distribution to formation, except as provided in
consumers in such form and that are § 101.8(c), subject the food to the provi-
for use solely in the manufacture of sions of this section. Foods in packages
other foods or that are to be processed, subject to requirements of paragraphs
labeled, or repacked at a site other (j)(13)(ii)(A)(1) and (2) of this section do
than where originally processed or not require the information in para-
packed. graphs (d)(9) and (f)(5) related to the
(10) Raw fruits, vegetables, and fish footnote, however the abbreviated foot-
subject to section 403(q)(4) of the act, note statement ‘‘% DV = % Daily
except that the labeling of such foods
Value’’ may be used.
should adhere to guidelines in § 101.45.
(A) The manufacturer, packer, or dis-
This exemption is contingent on the
food bearing no nutrition claims or tributor shall provide on the label of
other nutrition information in any packages that qualify for and use this
context on the label or in labeling or exemption an address or telephone
advertising. Claims or other nutrition number that a consumer can use to ob-
information subject the food to nutri- tain the required nutrition information
tion labeling in accordance with (e.g., ‘‘For nutrition information, call
§ 101.45. The term fish includes fresh- 1–800–123–4567’’).
water or marine fin fish, crustaceans, (B) When such products bear nutri-
and mollusks, including shellfish, am- tion labeling, either voluntarily or be-
phibians, and other forms of aquatic cause nutrition claims or other nutri-
animal life. tion information is provided, all re-
(11) Packaged single-ingredient prod- quired information shall be in type size
ucts that consist of fish or game meat no smaller than 6 point or all upper-
(i.e., animal products not covered case type of 1⁄16 inches minimum
under the Federal Meat Inspection Act height, except that individual serving-
or the Poultry Products Inspection size packages of food served with meals
Act, such as flesh products from deer, in restaurants, institutions, and on
bison, rabbit, quail, wild turkey, or os- board passenger carriers, and not in-
trich) subject to this section may pro- tended for sale at retail, may comply
vide required nutrition information for with § 101.2(c)(2).
a 3-ounce cooked edible portion (i.e., on (ii) Foods in packages that have a
an ‘‘as prepared’’ basis), except that: total surface area available to bear la-
(i) Such products that make claims beling of 40 or less square inches may
that are based on values as packaged
modify the requirements of paragraphs
must provide nutrition information on
(c) through (f) and (i) of this section by
an as packaged basis, and
one or more of the following means:
(ii) Nutrition information is not re-
quired for custom processed fish or (A) Presenting the required nutrition
game meats. information in a tabular or, as pro-
(12) Game meats (i.e., animal prod- vided below, linear (i.e., string) fashion
ucts not covered under the Federal rather than in vertical columns if the
Meat Inspection Act or the Poultry product has a total surface area avail-
Products Inspection Act, such as flesh able to bear labeling of less than 12
products from deer, bison, rabbit, square inches, or if the product has a
quail, wild turkey, or ostrich) may pro- total surface area available to bear la-
vide required nutrition information on beling of 40 or less square inches and
labeling in accordance with the provi- the package shape or size cannot ac-
sions of paragraph (a)(2) of this section. commodate a standard vertical column
(13)(i) Foods in small packages that or tabular display on any label panel.
have a total surface area available to Nutrition information may be given in

bear labeling of less than 12 square a linear fashion only if the label will
inches, Provided, That the labels for not accommodate a tabular display.
59
§ 101.9 21 CFR Ch. I (4–1–23 Edition)
(1) The following sample label illus-

trates the tabular display for small
packages.
(2) The following sample label illus-

trates the linear display.
(B) Using any of the following abbre- Vitamin—Vit. This abbreviation can
viations: also be used on the standard vertical
Serving size—Serv size side-by-side display as shown in para-
Servings per container—Servings graph (d)(12) of this section.
Calories from saturated fat—Sat fat cal Potassium—Pot. This abbreviation can
Saturated fat—Sat fat also be used on the standard vertical
Monounsaturated fat—Monounsat fat side-by-side display as shown in para-
Polyunsaturated fat—Polyunsat fat graph (d)(12) of this section.
Cholesterol—Cholest Includes—Incl. This abbreviation can
Total carbohydrate—Total carb. This also be used on dual-column displays
abbreviation can also be used on as shown in paragraphs (e)(5),
dual-column displays as shown in (e)(6)(i), and (e)(6)(ii) of this section.
paragraphs (e)(5), (e)(6)(i), and (C) Presenting the required nutrition
(e)(6)(ii) of this section. information on any label panel.
Dietary fiber—Fiber (14) Shell eggs packaged in a carton
Soluble fiber—Sol fiber that has a top lid designed to conform

ER24MR23.014</GPH>
Insoluble fiber—Insol fiber to the shape of the eggs are exempt

Sugar alcohol—Sugar alc from outer carton label requirements
60
ER24MR23.013</GPH>
where the required nutrition informa- (j)(18)(iv) of this section, are the sub-
tion is clearly presented immediately ject of a claim for an exemption that
beneath the carton lid or in an insert provides the information required
that can be clearly seen when the car- under paragraph (j)(18)(iv) of this sec-
ton is opened. tion, that is filed before the beginning
(15) The unit containers in a multi- of the time period for which the exemp-
unit retail food package where: tion is claimed, and that is filed by a
(i) The multiunit retail food package person, whether it is the manufacturer,
labeling contains all nutrition infor- packer, or distributor, that qualifies to
mation in accordance with the require- claim the exemption under the require-
ments of this section; ments for average full-time equivalent
(ii) The unit containers are securely employees in paragraphs (j)(18)(i) or
enclosed within and not intended to be (j)(18)(ii) of this section; and whose la-
separated from the retail package bels, labeling, and advertising do not
under conditions of retail sale; and provide nutrition information or make
(iii) Each unit container is labeled a nutrient content or health claim.
with the statement ‘‘This Unit Not La- (i) For food products first introduced
beled For Retail Sale’’ in type size not into interstate commerce before May 8,
less than 1/16-inch in height, except 1994, the product shall be exempt for
that this statement shall not be re- the period:
quired when the inner unit containers (A) Between May 8, 1995, and May 7,
bear no labeling at all. The word ‘‘in- 1996, if, for the period between May 8,
dividual’’ may be used in lieu of or im- 1994, and May 7, 1995, the person claim-
mediately preceding the word ‘‘Retail’’ ing the exemption employed fewer than
in the statement. an average of 300 full-time equivalent
(16) Food products sold from bulk employees and fewer than 400,000 units
containers: Provided, That nutrition in- of that product were sold in the United
formation required by this section be States; and
displayed to consumers either on the (B) Between May 8, 1996, and May 7,
labeling of the bulk container plainly 1997, if for the period between May 8,
in view or in accordance with the pro- 1995, and May 7, 1996, the person claim-
visions of paragraph (a)(2) of this sec- ing the exemption employed fewer than
tion. an average of 200 full-time equivalent
(17) Foods in packages that have a employees and fewer than 200,000 units
total surface area available to bear la- of that product were sold in the United
beling greater than 40 square inches States.
but whose principal display panel and (ii) For all other food products, the
information panel do not provide suffi- product shall be eligible for an exemp-
cient space to accommodate all re- tion for any 12-month period if, for the
quired information may use any alter- preceding 12 months, the person claim-
nate panel that can be readily seen by ing the exemption employed fewer than
consumers for the nutrition label. The an average of 100 full-time equivalent
space needed for vignettes, designs, and employees and fewer than 100,000 units
other nonmandatory label information of that product were sold in the United
on the principal display panel may be States, or in the case of a food product
considered in determining the suffi- that was not sold in the 12-month pe-
ciency of available space on the prin- riod preceding the period for which ex-
cipal display panel for the placement of emption is claimed, fewer than 100,000
the nutrition label. Nonmandatory units of such product are reasonably
label information on the information anticipated to be sold in the United
panel shall not be considered in deter- States during the period for which ex-
mining the sufficiency of available emption is claimed.
space for the placement of the nutri- (iii) If a person claims an exemption
tion label. under paragraphs (j)(18)(i) or (j)(18)(ii)
(18) Food products that are low-vol- of this section for a food product and
ume (that is, they meet the require- then, during the period of such exemp-
ments for units sold in paragraphs tion, the number of full-time equiva-
(j)(18)(i) or (j)(18)(ii) of this section); lent employees of such person exceeds
that, except as provided in paragraph the appropriate number, or the number
61
§ 101.9 21 CFR Ch. I (4–1–23 Edition)
of food products sold in the United which an exemption is claimed. For

States exceeds the appropriate number, products that have been in production
or, if at the end of the period of such for 1 year or more prior to the period
exemption, the food product no longer for which exemption is claimed, the 12-
qualifies for an exemption under the month period is the period imme-
provisions of paragraphs (j)(18)(i) or diately preceding the period for which
(j)(18)(ii) of this section, such person an exemption is claimed. For other
shall have 18 months from the date products, the 12-month period is the pe-
that the product was no longer quali- riod for which an exemption is claimed;
fied as a low-volume product of a small and
business to comply with this section. (F) The notice shall be signed by a re-
(iv) A notice shall be filed with the sponsible individual for the person who
Office of Nutrition and Food Labeling can certify the accuracy of the infor-
(HFS–800), Center for Food Safety and mation presented in the notice. The in-
Applied Nutrition, Food and Drug Ad- dividual shall certify that the informa-
ministration, 5001 Campus Dr., College tion contained in the notice is a com-
Park, MD 20740 and contain the fol- plete and accurate statement of the av-
lowing information, except that if the erage number of full-time equivalent
person is not an importer and has fewer employees of this person and its affili-
than 10 full-time equivalent employees, ates and of the number of units of the
that person does not have to file a no- product for which an exemption is
tice for any food product with annual claimed sold by the person. The indi-
sales of fewer than 10,000 total units: vidual shall also state that should the
(A) Name and address of person re- average number of full-time equivalent
questing exemption. This should in- employees or the number of units of
clude a telephone number or FAX num- food products sold in the United States
ber that can be used to contact the per- by the person exceed the applicable
son along with the name of a specific numbers for the time period for which
contact; exemption is claimed, the person will
(B) Names of the food products (in- notify FDA of that fact and the date on
cluding the various brand names) for which the number of employees or the
which exemption is claimed; number of products sold exceeded the
(C) Name and address of the manufac- standard.
turer, distributor, or importer of the (v) FDA may by regulation lower the
food product for which an exemption is employee or units of food products re-
claimed, if different than the person quirements of paragraph (j)(18)(ii) of
that is claiming the exemption; this section for any food product first
(D) The number of full-time equiva- introduced into interstate commerce
lent employees. Provide the average after May 8, 2002, if the agency deter-
number of full-time equivalent individ- mines that the cost of compliance with
uals employed by the person and its af- such lower requirement will not place
filiates for the 12 months preceding the an undue burden on persons subject to
period for which a small business ex- it.
emption is claimed for a product. The (vi) For the purposes of this para-
average number of full-time equivalent graph, the following definitions apply:
employees is to be determined by divid- (A) Unit means the packaging or, if
ing the total number of hours of salary there is no packaging, the form in
or wages paid to employees of the per- which a food product is offered for sale
son and its affiliates by the number of to consumers.
hours of work in a year, 2,080 hours (B) Food product means food in any
(i.e., 40 hours × 52 weeks); sized package which is manufactured
(E) Approximate total number of by a single manufacturer or which
units of the food product sold by the bears the same brand name, which
person in the United States in the 12- bears the same statement of identity,
month period preceding that for which and which has similar preparation
a small business exemption is claimed. methods.
Provide the approximate total number (C) Person means all domestic and
of units sold, or expected to be sold, in foreign affiliates, as defined in 13 CFR
a 12-month period for each product for 121.401, of the corporation, in the case
62
of a corporation, and all affiliates, as ability of this material at NARA, call

defined in 13 CFR 121.401, of a firm or 202–741–6030, or go to: http://
other entity, when referring to a firm www.archives.gov/federal_register/
or other entity that is not a corpora- code_of_federal_regulations/
tion. ibr_locations.html.
(D) Full-time equivalent employee (1) AOAC Reseller. Techstreet, 6300
means all individuals employed by the Interfirst Dr., Ann Arbor, MI 48108, Toll
person claiming the exemption. This free in United States: 1–800–699–9277,
number shall be determined by divid- Outside United States: 1–734–780–8000,
ing the total number of hours of salary Fax: 1–734–780–2046, www.techstreet.com,
or wages paid directly to employees of techstreet.service@thomsonreuters.com.
the person and of all of its affiliates by FDA does not endorse any particular
the number of hours of work in a year, reseller and notes that other resellers
2,080 hours (i.e., 40 hours × 52 weeks). also may have the reference for sale.
(k) A food labeled under the provi- Consult FDA at 240–402–2404 for more
sions of this section shall be deemed to information on additional resellers.
be misbranded under sections 201(n) (i) ‘‘Official Methods of Analysis of
and 403(a) of the act if its label or la- the AOAC INTERNATIONAL,’’ 19th
beling represents, suggests, or implies: Edition, Volumes 1 and 2, 2012.
(1) That the food, because of the pres- (ii) [Reserved]
ence or absence of certain dietary prop- (2) Food and Agriculture Organiza-
erties, is adequate or effective in the tion of the United Nations/World
prevention, cure, mitigation, or treat- Health Organization (FAO/WHO), Pub-
ment of any disease or symptom. Infor- lications Division, Viale delle Terme di
mation about the relationship of a die- Caracalla, 00100 Rome, Italy
tary property to a disease or health-re- (i) FAO Food and Nutrition Paper
lated condition may only be provided 51,’’Report of the Joint FAO/WHO Ex-
in conformance with the requirements pert Consultation on Protein Quality
of § 101.14 and part 101, subpart E. Evaluation,’’ Rome, 1991. http://
(2) That the lack of optimum nutri- apps.who.int/iris/bitstream/10665/38133/1/
tive quality of a food, by reason of the 9251030979_eng.pdf.
soil on which that food was grown, is or (ii) [Reserved]
may be responsible for an inadequacy (3) United States Department of Ag-
or deficiency in the quality of the daily riculture (USDA), Agricultural Re-
diet. search Service, Washington, DC, Nutri-
(3) That the storage, transportation, ent Data Laboratory, Bldg. 005 Room
processing, or cooking of a food is or 105 BARC-West, Beltsville, MD 20705,
may be responsible for an inadequacy 301–504–0630. http://www.ars.usda.gov/
or deficiency in the quality of the daily News/docs.htm?docid=9447.
diet. (i) USDA Handbook No. 74, Energy
(4) That a natural vitamin in a food Value of Foods—basis and derivation,
is superior to an added or synthetic vi- by A. L. Merrill and B. K. Watt, (slight-
tamin. ly revised, 1973) http://www.ars.usda.gov/
(l) The standards required in this sec- SP2UserFiles/Place/80400525/Data/Classics/
tion are incorporated by reference into ah74.pdf.
this section with the approval of the (ii) [Reserved]
Director of the Federal Register under [58 FR 2175, Jan. 6, 1993]
5 U.S.C. 552(a) and 1 CFR part 51. All
approved material is available for in- EDITORIAL NOTE: For FEDERAL REGISTER ci-
tations affecting § 101.9, see the List of CFR
spection at the Office of Nutrition and
Sections Affected, which appears in the
Food Labeling (HFS–800), Center for Finding Aids section of the printed volume
Food Safety and Applied Nutrition, and at www.govinfo.gov.
Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, § 101.10 Nutrition labeling of res-
240–402–2404 and is available from the taurant foods whose labels or label-
sources indicated below. It is also ing bear nutrient content claims or
health claims.
available for inspection at the National

Archives and Records Administration Nutrition labeling in accordance with
(NARA). For information on the avail- § 101.9 shall be provided upon request
63
§ 101.11 21 CFR Ch. I (4–1–23 Edition)
for any restaurant food or meal for owner, operator, or agent in charge to
which a nutrient content claim (as de- register the restaurant or similar re-
fined in § 101.13 or in subpart D of this tail food establishment, which is not
part) or a health claim (as defined in otherwise subject to section 403(q)(5)(H)
§ 101.14 and permitted by a regulation of the Federal Food, Drug, and Cos-
in subpart E of this part) is made, ex- metic Act, with FDA for the purposes
cept that information on the nutrient of paragraph (d) of this section.
amounts that are the basis for the Combination meal means a standard
claim (e.g., ‘‘low fat, this meal provides menu item that consists of more than
less than 10 grams of fat’’) may serve one food item, for example a meal that
as the functional equivalent of com- includes a sandwich, a side dish, and a
plete nutrition information as de- drink. A combination meal may be rep-
scribed in § 101.9. For the purposes of resented on the menu or menu board in
this section, restaurant food includes narrative form, numerically, or pic-
two categories of food. It includes food torially. Some combination meals may
which is served in restaurants or other include a variable menu item or be a
establishments in which food is served variable menu item as defined in this
for immediate human consumption or paragraph where the components may
which is sold for sale or use in such es- vary. For example, the side dish may
tablishments. It also includes food vary among several options (e.g., fries,
which is processed and prepared pri- salad, or onion rings) or the drinks
marily in a retail establishment, which may vary (e.g., soft drinks, milk, or
is ready for human consumption, which juice) and the customer selects which
is of the type described in the previous of these items will be included in the
sentence, and which is offered for sale meal.
to consumers but not for immediate Covered establishment means a res-
human consumption in such establish- taurant or similar retail food establish-
ment and which is not offered for sale ment that is a part of a chain with 20
outside such establishment. For stand- or more locations doing business under
ard menu items that are offered for the same name (regardless of the type
sale in covered establishments (as de- of ownership, e.g., individual fran-
fined in § 101.11(a)), the information in chises) and offering for sale substan-
the written nutrition information re- tially the same menu items, as well as
quired by § 101.11(b)(2)(ii)(A) will serve a restaurant or similar retail food es-
to meet the requirements of this sec- tablishment that is registered to be
tion. Nutrient levels may be deter- covered under paragraph (d) of this sec-
mined by nutrient databases, cook- tion.
books, or analyses or by other reason- Custom order means a food order that
able bases that provide assurance that is prepared in a specific manner based
the food or meal meets the nutrient re- on an individual customer’s request,
quirements for the claim. Presentation which requires the covered establish-
of nutrition labeling may be in various ment to deviate from its usual prepara-
forms, including those provided in tion of a standard menu item, e.g., a
§ 101.45 and other reasonable means. club sandwich without the bacon if the
[79 FR 71253, Dec. 1, 2014] establishment usually includes bacon
in its club sandwich.
§ 101.11 Nutrition labeling of standard Daily special means a menu item that
menu items in covered establish- is prepared and offered for sale on a
ments. particular day, that is not routinely
(a) Definitions. The definitions of listed on a menu or menu board or of-
terms in section 201 of the Federal fered by the covered establishment,
Food, Drug, and Cosmetic Act apply to and that is promoted by the covered es-
such terms when used in this section. tablishment as a special menu item for
In addition, for purposes of this sec- that particular day.
tion: Doing business under the same name
Authorized official of a restaurant or means sharing the same name. The
similar retail food establishment means term ‘‘name’’ refers to either:

the owner, operator, agent in charge, (i) The name of the establishment
or other person authorized by the presented to the public; or
64
(ii) If there is no name of the estab- are prepared in substantially the same
lishment presented to the public (e.g., way with substantially the same food
an establishment with the generic components, even if the name of the
descriptor ‘‘concession stand’’), the menu item varies, (e.g., ‘‘Bay View
name of the parent entity of the estab- Crab Cake’’ and ‘‘Ocean View Crab
lishment. When the term ‘‘name’’ re- Cake’’). ‘‘Menu items’’ in this defini-
fers to the name of the establishment tion refers to food items that are listed
presented to the public under para- on a menu or menu board or that are
graph (i) of this definition, the term offered as self-service food or food on
‘‘same’’ includes names that are slight display. Restaurants and similar retail
variations of each other, for example, food establishments that are part of a
due to the region, location, or size (e.g., chain can still be offering for sale sub-
‘‘New York Ave. Burgers’’ and ‘‘Penn- stantially the same menu items if the
sylvania Ave. Burgers’’ or ‘‘ABC’’ and availability of some menu items varies
‘‘ABC Express’’). within the chain. Having the same
Food on display means restaurant- name may indicate, but does not nec-
type food that is visible to the cus- essarily guarantee, that menu items
tomer before the customer makes a se- are substantially the same.
lection, so long as there is not an ordi- Restaurant or similar retail food estab-
nary expectation of further preparation lishment means a retail establishment
by the consumer before consumption. that offers for sale restaurant-type
Food that is part of a customary market food, except if it is a school as defined
test means food that appears on a menu by 7 CFR 210.2 or 220.2.
or menu board for less than 90 consecu- Restaurant-type food means food that
tive days in order to test consumer ac- is:
ceptance of the product. (i) Usually eaten on the premises,
Location means a fixed position or while walking away, or soon after ar-
site. riving at another location; and
Menu or menu board means the pri- (ii) Either:
mary writing of the covered establish- (A) Served in restaurants or other es-
ment from which a customer makes an tablishments in which food is served
order selection, including, but not lim- for immediate human consumption or
ited to, breakfast, lunch, and dinner which is sold for sale or use in such es-
menus; dessert menus; beverage menus; tablishments; or
children’s menus; other specialty (B) Processed and prepared primarily
menus; electronic menus; and menus in a retail establishment, ready for
on the Internet. Determining whether human consumption, of the type de-
a writing is or is part of the primary scribed in paragraph (ii)(A) of this defi-
writing of the covered establishment nition, and offered for sale to con-
from which a customer makes an order sumers but not for immediate human
selection depends on a number of fac- consumption in such establishment and
tors, including whether the writing which is not offered for sale outside
lists the name of a standard menu item such establishment.
(or an image depicting the standard Self-service food means restaurant-
menu item) and the price of the stand- type food that is available at a salad
ard menu item, and whether the writ- bar, buffet line, cafeteria line, or simi-
ing can be used by a customer to make lar self-service facility and that is
an order selection at the time the cus- served by the customers themselves.
tomer is viewing the writing. The Self-service food also includes self-
menus may be in different forms, e.g., service beverages.
booklets, pamphlets, or single sheets of Standard menu item means a res-
paper. Menu boards include those in- taurant-type food that is routinely in-
side a covered establishment as well as cluded on a menu or menu board or
drive-through menu boards at covered routinely offered as a self-service food
establishments. or food on display.
Offering for sale substantially the same Temporary menu item means a food
menu items means offering for sale a that appears on a menu or menu board
significant proportion of menu items for less than a total of 60 days per cal-
that use the same general recipe and endar year. The 60 days includes the
65
§ 101.11 21 CFR Ch. I (4–1–23 Edition)
total of consecutive and non-consecu- of the associated standard menu item,

tive days the item appears on the in a type size no smaller than the type
menu. size of the name or the price of the as-
Variable menu item means a standard sociated standard menu item, which-
menu item that comes in different fla- ever is smaller, in the same color, or a
vors, varieties, or combinations, and is color at least as conspicuous as that
listed as a single menu item. used for the name of the associated
(b) Requirements for nutrition labeling standard menu item, and with the
for food sold in covered establishments— same contrasting background or a
(1) Applicability. (i) The labeling re- background at least as contrasting as
quirements in this paragraph (b) apply that used for the name of the associ-
to standard menu items offered for sale ated standard menu item.
in covered establishments. (2) To the nearest 5-calorie increment
(ii)(A) The labeling requirements in up to and including 50 calories and to
this paragraph (b) do not apply to foods the nearest 10-calorie increment above
that are not standard menu items, in- 50 calories, except that amounts less
cluding: than 5 calories may be expressed as
(1) Items such as condiments that are zero.
for general use, including those placed (3) The term ‘‘Calories’’ or ‘‘Cal’’
on the table or on or behind the must appear as a heading above a col-
counter; daily specials; temporary umn listing the number of calories for
menu items; custom orders; food that each standard menu item or adjacent
is part of a customary market test; and to the number of calories for each
(2) Self-service food and food on dis- standard menu item. If the term ‘‘Cal-
play that is offered for sale for less ories’’ or ‘‘Cal’’ appears as a heading
than a total of 60 days per calendar above a column of calorie declarations,
year or fewer than 90 consecutive days the term must be in a type size no
in order to test consumer acceptance. smaller than the smallest type size of
(B) The labeling requirements of the name or price of any menu item on
paragraph (b)(2)(iii) of this section do that menu or menu board in the same
not apply to alcoholic beverages that color or a color at least as conspicuous
are foods on display and are not self- as that used for that name or price and
service foods. in the same contrasting background or
(2) Nutrition information. (i) Except as a background at least as contrasting as
provided by paragraph (b)(2)(i)(A)(8) of that used for that name or price. If the
this section, the following must be pro- term ‘‘Calories’’ or ‘‘Cal’’ appears adja-
vided on menus and menu boards: cent to the number of calories for the
(A) The number of calories contained standard menu item, the term ‘‘Cal-
in each standard menu item listed on ories’’ or ‘‘Cal’’ must appear in the
the menu or menu board, as usually same type size and in the same color
prepared and offered for sale. In the and contrasting background as the
case of multiple-serving standard menu number of calories.
items, this means the calories declared (4) Additional requirements that
must be for the whole menu item listed apply to each individual variable menu
on the menu or menu board as usually item:
prepared and offered for sale (e.g., (i) When the menu or menu board
‘‘pizza pie: 1600 cal’’); or per discrete lists flavors or varieties of an entire in-
serving unit as long as the discrete dividual variable menu item (such as
serving unit (e.g., pizza slice) and total soft drinks, ice cream, doughnuts, dips,
number of discrete serving units con- and chicken that can be grilled or
tained in the menu item are declared fried), the calories must be declared
on the menu or menu board, and the separately for each listed flavor or va-
menu item is usually prepared and of- riety. Where flavors or varieties have
fered for sale divided in discrete serv- the same calorie amounts (after round-
ing units (e.g., ‘‘pizza pie: 200 cal/slice, ing in accordance with paragraph
8 slices’’). The calories must be de- (b)(2)(i)(A)(2) of this section), the cal-
clared in the following manner: orie declaration for such flavors or va-
(1) The number of calories must be rieties can be listed as a single calorie
listed adjacent to the name or the price declaration adjacent to the flavors or
66
varieties, provided that the calorie dec- calorie declaration adjacent to the top-
laration specifies that the calorie pings, provided that the calorie dec-
amount listed represents the calorie laration specifies that the calorie
amounts for each individual flavor or amount listed represents the calorie
variety. amount for each individual topping.
(ii) When the menu or menu board (iii) The calories for the basic prepa-
does not list flavors or varieties for an ration of the menu item must be de-
entire individual variable menu item, clared for each size of the menu item.
and only includes a general description The calories for each topping listed on
of the variable menu item (e.g., ‘‘soft the menu or menu board must be de-
drinks’’), the calories must be declared clared for each size of the menu item,
for each option with a slash between or declared using a slash between the
the two calorie declarations where only two calorie declarations for each top-
two options are available (e.g., ‘‘150/250 ping where only two sizes of the menu
calories’’) or as a range in accordance item are available (e.g., ‘‘adds 150/250
with the requirements of paragraph cal’’) or as a range for each topping in
(b)(2)(i)(A)(7) of this section where accordance with the requirements of
more than two options are available paragraph (b)(2)(i)(A)(7) of this section
(e.g., ‘‘100–250 calories’’). where more than two sizes of the menu
(iii) When the menu or menu board item are available (e.g., ‘‘adds 100–250
describes flavors or varieties for only cal’’). If a slash between two calorie
part of an individual variable menu declarations or a range of calorie dec-
item (such as different types of cheese larations is used, the menu or menu
offered in a grilled cheese sandwich board must indicate that the variation
(e.g., ‘‘Grilled Cheese (Cheddar or in calories for each topping arises from
Swiss)’’), the calories must be declared the size of the menu item to which the
for each option with a slash between toppings are added.
the two calorie declarations where only (iv) If the amount of the topping in-
two options are available (e.g., ‘‘450/500 cluded on the basic preparation of the
calories’’) or as a range in accordance menu item decreases based on the total
with the requirements of paragraph number of toppings ordered for the
(b)(2)(i)(A)(7) of this section where menu item (such as is sometimes the
more than two options are available case with pizza toppings), the calories
(e.g., ‘‘450–550 calories’’). for each topping must be declared as
(5) Additional requirements that single values representing the calories
apply to a variable menu item that is for each topping when added to a one-
offered for sale with the option of add- topping menu item, specifying that the
ing toppings listed on the menu or calorie declaration is for the topping
menu board. When the menu or menu when added to a one-topping menu
board lists toppings that can be added item.
to a menu item (such as pizza or ice (6) Additional requirements that
cream): apply to a combination meal. Except as
(i) The calories must be declared for provided in paragraph (b)(2)(i)(A)(6)(iv)
the basic preparation of the menu item of this section:
as listed (e.g., ‘‘small pizza pie,’’ ‘‘sin- (i) When the menu or menu board
gle scoop ice cream’’). lists two options for menu items in a
(ii) The calories must be separately combination meal (e.g., a sandwich
declared for each topping listed on the with a side salad or chips), the calories
menu or menu board (e.g., pepperoni, must be declared for each option with a
sausage, green peppers, onions on pizza; slash between the two calorie declara-
fudge, almonds, sprinkles on ice tions (e.g., ‘‘350/450 calories’’).
cream), specifying that the calories are (ii) When the menu or menu board
added to the calories contained in the lists three or more options for menu
basic preparation of the menu item. items in a combination meal (e.g., a
Where toppings have the same calorie sandwich with chips, a side salad, or
amounts (after rounding in accordance fruit), the calories must be declared as
with paragraph (b)(2)(i)(A)(2) of this a range in accordance with the require-

section), the calorie declaration for ments of paragraph (b)(2)(i)(A)(7) of
such toppings can be listed as a single this section (e.g., ‘‘350–500 calories’’).
67
§ 101.11 21 CFR Ch. I (4–1–23 Edition)
(iii) When the menu or menu board item, whichever is smaller, and in the
includes a choice to increase or de- same color or a color at least as con-
crease the size of a combination meal, spicuous as that used for that name or
the calorie difference must be declared price, with the same contrasting back-
for the increased or decreased size with ground or a background at least as con-
a slash between two calorie declara- trasting as that used for that name or
tions (e.g., ‘‘Adds 100/150 calories,’’ price.
‘‘Subtracts 100/150 calories’’) if the (9) Additional requirements that
menu or menu board lists two options apply to beverages that are not self-
for menu items in the combination service. For beverages that are not
meal, or as a range in accordance with self-service, calories must be declared
the requirements of paragraph based on the full volume of the cup
(b)(2)(i)(A)(7) of this section (e.g., served without ice, unless the covered
‘‘Adds 100–250 calories,’’ ‘‘Subtracts establishment ordinarily dispenses and
100–250 calories’’) if the menu or menu offers for sale a standard beverage fill
board lists three or more options for (i.e., a fixed amount that is less than
menu items in the combination meal. the full volume of the cup per cup size)
(iv) Where the menu or menu board or dispenses a standard ice fill (i.e., a
describes an opportunity for a con- fixed amount of ice per cup size). If the
sumer to combine standard menu items covered establishment ordinarily dis-
for a special price (e.g.,’’Combine Any penses and offers for sale a standard
Sandwich with Any Soup or Any Salad beverage fill or dispenses a standard
for $8.99’’), and the calories for each ice fill, the covered establishment
standard menu item, including each must declare calories based on such
size option as described in paragraph standard beverage fill or standard ice
(b)(2)(i)(A)(6)(iii) of this section if appli- fill.
cable, available for the consumer to (B) The following statement designed
combine are declared elsewhere on the to enable consumers to understand, in
menu or menu board, the requirements the context of a total daily diet, the
of paragraphs (b)(2)(i)(A)(6)(i), (ii), and significance of the calorie information
(iii) of this section do not apply. provided on menus and menu boards:
(7) Additional format requirements ‘‘2,000 calories a day is used for general
for declaring calories for an individual nutrition advice, but calorie needs
variable menu item, a combination vary.’’ For menus and menu boards tar-
meal, and toppings as a range, if appli- geted to children, the following options
cable. Calories declared as a range may be used as a substitute for or in
must be in the format ‘‘xx–yy,’’ where addition to the succinct statement:
‘‘xx’’ is the caloric content of the low- ‘‘1,200 to 1,400 calories a day is used for
est calorie variety, flavor, or combina- general nutrition advice for children
tion, and ‘‘yy’’ is the caloric content of ages 4 to 8 years, but calorie needs
the highest calorie variety, flavor, or vary.’’ or ‘‘1,200 to 1,400 calories a day
combination. is used for general nutrition advice for
(8) Exception for a variable menu children ages 4 to 8 years and 1,400 to
item that has no clearly identifiable 2,000 calories a day for children ages 9
upper bound to the range of calories: If to 13 years, but calorie needs vary.’’
the variable menu item appears on the (1) This statement must be posted
menu or menu board and is a self-serv- prominently and in a clear and con-
ice food or food on display, and there is spicuous manner in a type size no
no clearly identifiable upper bound to smaller than the smallest type size of
the range, e.g., all-you-can-eat buffet, any calorie declaration appearing on
then the menu or menu board must in- the same menu or menu board and in
clude a statement, adjacent to the the same color or in a color at least as
name or price of the item, referring conspicuous as that used for the calorie
customers to the self-service facility declarations and with the same con-
for calorie information, e.g., ‘‘See buf- trasting background or a background
fet for calorie declarations.’’ This at least as contrasting as that used for
statement must appear in a type size the calorie declarations.

no smaller than the type size of the (2) For menus, this statement must
name or price of the variable menu appear on the bottom of each page of
68
the menu. On menu pages that also derstood by the ordinary individual
bear the statement required by para- under customary conditions of pur-
graph (b)(2)(i)(C) of this section, this chase and use. Covered establishments
statement must appear immediately may use the abbreviations allowed for
above, below, or beside the statement Nutrition Facts for certain packaged
required by paragraph (b)(2)(i)(C) of foods in § 101.9(j)(13)(ii)(B):
this section. (A)(1) Total calories (cal);
(3) For menu boards, this statement (2) Calories from fat (fat cal);
must appear on the bottom of the (3) Total fat (g);
menu board, immediately above, below,
(4) Saturated fat (g);
or beside the statement required by
(5) Trans fat (g);
paragraph (b)(2)(i)(C) of this section.
(C) The following statement regard- (6) Cholesterol (mg);
ing the availability of the additional (7) Sodium (mg);
written nutrition information required (8) Total carbohydrate (g);
in paragraph (b)(2)(ii) of this section (9) Dietary fiber (g);
must be on all forms of the menu or (10) Sugars (g); and
menu board: ‘‘Additional nutrition in- (11) Protein (g).
formation available upon request.’’ (B) If a standard menu item contains
(1) This statement must be posted insignificant amounts of all the nutri-
prominently and in a clear and con- ents required to be disclosed in para-
spicuous manner in a type size no graph (b)(2)(ii)(A) of this section, the
smaller than the smallest type size of establishment is not required to in-
any calorie declaration appearing on clude nutrition information regarding
the same menu or menu board and in the standard menu item in the written
the same color or in a color at least as form. However, if the covered estab-
conspicuous as that used for the caloric lishment makes a nutrient content
declarations, and with the same con- claim or health claim, the establish-
trasting background or a background ment is required to provide nutrition
at least as contrasting as that used for information on the nutrient that is the
the caloric declarations. subject of the claim in accordance with
(2) For menus, the statement must § 101.10. For standard menu items that
appear on the bottom of the first page contain insignificant amounts of six or
with menu items immediately above, more of the required nutrients, the dec-
below, or beside the succinct statement laration of nutrition information re-
required by paragraph (b)(2)(i)(B) of quired by paragraph (b)(2)(ii)(A) of this
this section. section may be presented in a sim-
(3) For menu boards, the statement plified format.
must appear on the bottom of the
(1) An insignificant amount is defined
menu board immediately above, below,
as that amount that allows a declara-
or beside the succinct statement re-
tion of zero in nutrition labeling, ex-
quired by paragraph (b)(2)(i)(B) of this
cept that for total carbohydrates, die-
section.
tary fiber, and protein, it must be an
(ii) The following nutrition informa-
amount that allows a declaration of
tion for a standard menu item must be
‘‘less than one gram.’’
available in written form on the prem-
ises of the covered establishment and (2) The simplified format must in-
provided to the customer upon request. clude information, in a column, list, or
This nutrition information must be table, on the following nutrients:
presented in the order listed and using (i) Total calories, total fat, total car-
the measurements listed, except as pro- bohydrates, protein, and sodium; and
vided in paragraph (b)(2)(ii)(B) of this (ii) Calories from fat, and any other
section. Rounding of these nutrients nutrients identified in paragraph
must be in compliance with § 101.9(c). (b)(2)(ii)(A) of this section that are
The information must be presented in a present in more than insignificant
clear and conspicuous manner, includ- amounts.
ing using a color, type size, and con- (3) If the simplified format is used,
trasting background that render the the statement ‘‘Not a significant
information likely to be read and un- source of ____’’ (with the blank filled in
69
§ 101.11 21 CFR Ch. I (4–1–23 Edition)
with the names of the nutrients re- (iii) The following must be provided
quired to be declared in the written nu- for a standard menu item that is self-
trient information and calories from service or on display.
fat that are present in insignificant (A) Calories per displayed food item
amounts) must be included at the bot- (e.g., a bagel, a slice of pizza, or a muf-
tom of the list of nutrients. fin), or if the food is not offered for sale
(C) For variable menu items, the nu- in a discrete unit, calories per serving
trition information listed in paragraph (e.g., scoop, cup), and the serving or
(b)(2)(ii)(A) of this section must be de- discrete unit used to determine the cal-
clared as follows for each size offered orie content (e.g., ‘‘per scoop’’ or ‘‘per
for sale: muffin’’) on either: A sign adjacent to
(1) The nutrition information re- and clearly associated with the cor-
quired in paragraph (b)(2)(ii)(A) of this responding food; (e.g., ‘‘150 calories per
section must be declared for the basic scoop); a sign attached to a sneeze
preparation of the item and, sepa- guard with the calorie declaration and
rately, for each topping, flavor, or vari- the serving or unit used to determine
able component. the calorie content above each specific
(2) Additional format requirements food so that the consumer can clearly
for toppings if the amount of the top- associate the calorie declaration with
ping included on the basic preparation the food, except that if it is not clear
of the menu item decreases based on to which food the calorie declaration
the total number of toppings ordered and serving or unit refers, then the
for the menu item (such as is some- sign must also include the name of the
times the case with pizza toppings). food, e.g., ‘‘Broccoli and cheese cas-
The nutrients for such topping must be serole—200 calories per scoop’’; or a
declared as single values representing single sign or placard listing the cal-
the nutrients for each topping when orie declaration for several food items
added to a one-topping menu item, along with the names of the food items,
specifying that the nutrient declara- so long as the sign or placard is located
tion is for the topping when added to a where a consumer can view the name,
one-topping menu item. calorie declaration, and serving or unit
(3) If the calories and other nutrients of a particular item while selecting
are the same for different flavors, vari- that item.
eties, and variable components of the
(1) For purposes of paragraph
combination meal, each variety, flavor,
(b)(2)(iii)(A) of this section, ‘‘per dis-
and variable component of the com-
played food item’’; means per each dis-
bination meal is not required to be list-
crete unit offered for sale, for example,
ed separately. All items that have the
same nutrient values could be listed to- a bagel, a slice of pizza, or a muffin.
gether with the nutrient values listed (2) For purposes of paragraph
only once. (b)(2)(iii)(A) of this section, ‘‘per serv-
(D) The written nutrition informa- ing’’ means, for each food:
tion required in paragraph (b)(2)(ii)(A) (i) Per serving instrument used to
of this section may be provided on a dispense the food offered for sale, pro-
counter card, sign, poster, handout, vided that the serving instrument dis-
booklet, loose leaf binder, or electronic penses a uniform amount of the food
device such as a computer, or in a (e.g., a scoop or ladle);
menu, or in any other form that simi- (ii) If a serving instrument that dis-
larly permits the written declaration penses a uniform amount of food is not
of the required nutrient content infor- used to dispense the food, per each
mation for all standard menu items. If common household measure (e.g., cup
the written nutrition information is or tablespoon) offered for sale or per
not in a form that can be given to the unit of weight offered for sale, e.g., per
customer upon request, it must be quarter pound or per 4 ounces; or
readily available in a manner and loca- (iii) Per total number of fluid ounces
tion on the premises that allows the in the cup in which a self-service bev-
customer/consumer to review the writ- erage is served and, if applicable, the

ten nutrition information upon re- description of the cup size (e.g., ‘‘140
quest. calories per 12 fluid ounces (small)’’).
70
(3) The calories must be declared in (b)(2)(ii) of this section and the pack-
the following manner: aged food, including its label, can be
(i) To the nearest 5-calorie increment examined by a consumer before pur-
up to and including 50 calories and to chasing the food.
the nearest 10-calorie increment above (c) Determination of nutrient content.
50 calories except that amounts less (1) A covered establishment must have
than 5 calories may be expressed as a reasonable basis for its nutrient dec-
zero. larations. Nutrient values may be de-
(ii) If the calorie declaration is pro- termined by using nutrient databases
vided on a sign with the food’s name, (with or without computer software
price, or both, the calorie declaration, programs), cookbooks, laboratory anal-
accompanied by the term ‘‘Calories’’ or yses, or other reasonable means, in-
‘‘Cal’’ and the amount of the serving or cluding the use of Nutrition Facts on
displayed food item on which the cal- labels on packaged foods that comply
ories declaration is based must be in a with the nutrition labeling require-
type size no smaller than the type size ments of section 403(q)(1) of the Fed-
of the name or price of the menu item eral Food, Drug, and Cosmetic Act and
whichever is smaller, in the same § 101.9, FDA nutrient values for raw
color, or a color that is at least as con- fruits and vegetables in Appendix C of
spicuous as that used for that name or this part, or FDA nutrient values for
price, using the same contrasting back- cooked fish in Appendix D of this part.
ground or a background at least as con- (2) Nutrient declarations for standard
trasting as that used for that name or menu items must be accurate and con-
price. If the calorie declaration is pro- sistent with the specific basis used to
vided on a sign that does not include determine nutrient values. A covered
the food’s name, price, or both, the cal- establishment must take reasonable
orie declaration, accompanied by the steps to ensure that the method of
term ‘‘Calories’’ or ‘‘Cal’’ and the preparation (e.g., types and amounts of
amount of the serving or displayed food ingredients, cooking temperatures) and
item on which the calorie declaration amount of a standard menu item of-
is based must be clear and conspicuous. fered for sale adhere to the factors on
(iii) For self-service beverages, cal- which its nutrient values were deter-
orie declarations must be accompanied mined.
by the term ‘‘fluid ounces’’ and, if ap- (3) A covered establishment must
plicable, the description of the cup size provide to FDA, within a reasonable
(e.g., ‘‘small,’’ ‘‘medium’’). period of time upon request, informa-
(B) For food that is self-service or on tion substantiating nutrient values in-
display and is identified by an indi- cluding the method and data used to
vidual sign adjacent to the food itself derive these nutrient values. This in-
where such sign meets the definition of formation must include the following:
a menu or menu board under paragraph (i) For nutrient databases:
(a) of this section, the statement re- (A) The name and version (including
quired by paragraph (b)(2)(i)(B) of this the date of the version) of the data-
section and the statement required by base, and, as applicable, the name of
paragraph (b)(2)(i)(C) of this section. the applicable software company and
These two statements may appear on any Web site address for the database.
the sign adjacent to the food itself; on The name and version of a database
a separate, larger sign, in close prox- would include the name and version of
imity to the food that can be easily the computer software, if applicable;
read as the consumer is making order (B) The recipe or formula used as a
selections; or on a large menu board basis for the nutrient declarations;
that can be easily read as the consumer (C)(1) Information on:
is viewing the food. (i) The amount of each nutrient that
(C) The nutrition information in the specified amount of each ingredient
written form required by paragraph identified in the recipe contributes to
(b)(2)(ii) of this section, except for the menu item; and
packaged food insofar as it bears nutri- (ii) How the database was used in-
tion labeling information required by cluding calculations or operations (e.g.,
and in accordance with paragraph worksheets or computer printouts) to
71
§ 101.11 21 CFR Ch. I (4–1–23 Edition)
determine the nutrient values for the fered for sale adhere to the factors on
standard menu items; which its nutrient values were deter-
(2) If the information in paragraph mined. (Recipes may be divided as nec-
(c)(3)(i)(C)(1) of this section is not essary to accommodate differences in
available, certification attesting that the portion size derived from the recipe
the database will provide accurate re- and that are served as the standard
sults when used appropriately and that menu item but no changes may be
the database was used in accordance made to the proportion of ingredients
with its instructions; used.)
(D) A detailed listing (e.g., printout) (iii) For laboratory analyses:
of the nutrient values determined for (A) A copy of the recipe for the
each standard menu item. standard menu item used for the nutri-
(E) Any other information pertinent ent analysis;
to the final nutrient values of the (B) The name and address of the lab-
standard menu item (e.g., information oratory performing the analysis;
about what might cause slight vari- (C) Copies of analytical worksheets,
ations in the nutrient profile such as including the analytical method, used
moisture variations); to determine and verify nutrition in-
(F) A statement signed and dated by formation;
a responsible individual, employed at (D) A statement signed and dated by
the covered establishment or its cor- a responsible individual, employed at
porate headquarters or parent entity, the covered establishment or its cor-
who can certify that the information porate headquarters or parent entity,
contained in the nutrient analysis is who can certify that the information
complete and accurate; and contained in the nutrient analysis is
(G) A statement signed and dated by complete and accurate; and
a responsible individual employed at (E) A statement signed and dated by
the covered establishment certifying a responsible individual employed at
that the covered establishment has the covered establishment certifying
taken reasonable steps to ensure that that the covered establishment has
the method of preparation (e.g., types taken reasonable steps to ensure that
and amounts of ingredients in the rec- the method of preparation (e.g., types
ipe, cooking temperatures) and amount and amounts of ingredients in the rec-
of a standard menu item offered for ipe, cooking temperatures) and amount
sale adhere to the factors on which its of a standard menu item offered for
nutrient values were determined. sale adhere to the factors on which its
(ii) For published cookbooks that nutrient values were determined.
contain nutritional information for (iv) For nutrition information pro-
recipes in the cookbook: vided by other reasonable means:
(A) The name, author, and publisher (A) A detailed description of the
of the cookbook used; means used to determine the nutrition
(B) If available, information provided information;
by the cookbook or from the author or (B) A recipe or formula used as a
publisher about how the nutrition in- basis for the nutrient determination;
formation for the recipes was obtained; (C) Any data derived in determining
(C) A copy of the recipe used to pre- the nutrient values for the standard
pare the standard menu item and a menu item, e.g., nutrition information
copy of the nutrition information for about the ingredients used with the
that standard menu item as provided source of the nutrient information;
by the cookbook; and (D) A statement signed and dated by
(D) A statement signed and dated by a responsible individual, employed at
a responsible individual employed at the covered establishment or its cor-
the covered establishment certifying porate headquarters or parent entity,
that that the covered establishment who can certify that the information
has taken reasonable steps to ensure contained in the nutrient analysis is
that the method of preparation (e.g., complete and accurate; and
types and amounts of ingredients in (E) A statement signed and dated by

the recipe, cooking temperatures) and a responsible individual employed at
amount of a standard menu item of- the covered establishment certifying
72
that the covered establishment has ment will be subject to the require-
taken reasonable steps to ensure that ments of section 403(q)(5)(H) of the Fed-
the method of preparation (e.g., types eral Food, Drug, and Cosmetic Act and
and amounts of ingredients in the rec- this section.
ipe, cooking temperatures) and amount (4) How to register. Authorized offi-
of a standard menu item offered for cials of restaurants and similar retail
sale adhere to the factors on which its food establishments who elect to be
nutrient values were determined. subject to requirements in section
(d) Voluntary registration to be subject 403(q)(5)(H) of the Federal Food, Drug,
to the menu labeling requirements—(1) and Cosmetic Act can register by vis-
Applicability. A restaurant or similar iting http://www.fda.gov/food/
retail food establishment that is not ingredientspackaginglabeling/
part of a chain with 20 or more loca-
labelingnutrition/ucm217762.htm. FDA
tions doing business under the same
has created a form (Form 3757) that
name and offering for sale substan-
contains fields requesting the informa-
tially the same menu items may volun-
tion in paragraph (d)(3) of this section
tarily register to be subject to the re-
quirements established in this section. and made the form available at this
Restaurants and similar retail food es- Web site. Registrants must use this
tablishments that voluntarily register form to ensure that complete informa-
will no longer be subject to non-iden- tion is submitted.
tical State or local nutrition labeling (i) Information should be submitted
requirements. by email by typing complete informa-
(2) Who may register? The authorized tion into the form (PDF), saving it on
official of a restaurant or similar retail the registrant’s computer, and sending
food establishment as defined in para- it by email to
graph (a) of this section, which is not menulawregistration@fda.hhs.gov.
otherwise subject to paragraph (b) of (ii) If email is not available, the reg-
this section, may register with FDA. istrant can either fill in the form (PDF)
(3) What information is required? Au- and print it out (or print out the blank
thorized officials for restaurants and PDF and fill in the information by
similar retail food establishments hand or typewriter), and either fax the
must provide FDA with the following completed form to 301–436–2804 or mail
information on Form FDA 3757: it to FDA, CFSAN Menu and Vending
(i) The contact information (includ- Machine Registration, White Oak
ing name, address, phone number, and Building 22, Rm. 0209, 10903 New Hamp-
email address) for the authorized offi- shire Ave., Silver Spring, MD 20993.
cial; (5) When to renew the registration. To
(ii) The contact information (includ-
keep the establishment’s registration
ing name, address, phone number, and
active, the authorized official of the
email address) of each restaurant or
restaurant or similar retail food estab-
similar retail food establishment being
lishment must register every other
registered, as well as the name and
year within 60 days prior to the expira-
contact information for an official on-
site, such as the owner or manager, for tion of the establishment’s current reg-
each specific restaurant or similar re- istration with FDA. Registration will
tail food establishment; automatically expire if not renewed.
(iii) All trade names the restaurant (e) Signatures. Signatures obtained
or similar retail food establishment under paragraph (d) of this section that
uses; meet the definition of electronic signa-
(iv) Preferred mailing address (if dif- tures in § 11.3(b)(7) of this chapter are
ferent from location address for each exempt from the requirements of part
establishment) for purposes of receiv- 11 of this chapter.
ing correspondence; and (f) Misbranding. A standard menu
(v) Certification that the information item offered for sale in a covered estab-
submitted is true and accurate, that lishment shall be deemed misbranded
the person submitting it is authorized under sections 201(n), 403(a), 403(f) and/
to do so, and that each registered res- or 403(q) of the Federal Food, Drug, and
taurant or similar retail food establish- Cosmetic Act if its label or labeling is
73
§ 101.12 21 CFR Ch. I (4–1–23 Edition)
not in conformity with paragraph (b) sion, FDA considered the mean, me-
or (c) of this section. dian, and mode of the consumed
[79 FR 71253, Dec. 1, 2014]
amount per eating occasion.
(5) When survey data were insuffi-
§ 101.12 Reference amounts custom- cient, FDA took various other sources
arily consumed per eating occasion. of information on serving sizes of food
(a) The general principles and factors into consideration. These other sources
that the Food and Drug Administra- of information included:
tion (FDA) considered in arriving at (i) Serving sizes used in dietary guid-
the reference amounts customarily ance recommendations or rec-
consumed per eating occasion (ref- ommended by other authoritative sys-
erence amounts) which are set forth in tems or organizations;
paragraph (b) of this section, are that: (ii) Serving sizes recommended in
(1) FDA calculated the reference comments;
amounts for persons 4 years of age or (iii) Serving sizes used by manufac-
older to reflect the amount of food cus- turers and grocers; and
tomarily consumed per eating occasion (iv) Serving sizes used by other coun-
by persons in this population group. tries.
These reference amounts are based on (6) Because they reflect the amount
data set forth in appropriate national customarily consumed, the reference
food consumption surveys. amount and, in turn, the serving size
(2) FDA calculated the reference declared on the product label are based
amounts for an infant or child under 4 on only the edible portion of food, and
years of age to reflect the amount of not bone, seed, shell, or other inedible
food customarily consumed per eating components.
occasion by infants up to 12 months of (7) The reference amount is based on
age or by children 1 through 3 years of the major intended use of the food
age, respectively. These reference (e.g., milk as a beverage and not as an
amounts are based on data set forth in addition to cereal).
appropriate national food consumption (8) The reference amounts for prod-
surveys. Such reference amounts are to ucts that are consumed as an ingre-
be used only when the food is specially dient of other foods, but that may also
formulated or processed for use by an be consumed in the form in which they
infant or by a child under 4 years of are purchased (e.g., butter), are based
age. on use in the form purchased.
(3) An appropriate national food con- (9) FDA sought to ensure that foods
sumption survey includes a large sam- that have similar dietary usage, prod-
ple size representative of the demo- uct characteristics, and customarily
graphic and socioeconomic characteris- consumed amounts have a uniform ref-
tics of the relevant population group erence amount.
and must be based on consumption (b) The following reference amounts
data under actual conditions of use. shall be used as the basis for deter-
(4) To determine the amount of food mining serving sizes for specific prod-
customarily consumed per eating occa- ucts:
TABLE 1—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION: FOODS FOR
INFANTS AND YOUNG CHILDREN 1 THROUGH 3 YEARS OF AGE 1 2 3
Product category Reference amount Label statement 4
Cereals, dry instant ................. 15 g ........................................ __ cup (__ g)

Cereals, prepared, ready-to- 110 g ...................................... __ cup(s) (__ g)
serve.
Other cereal and grain prod- 7 g for infants and 20 g for __ cup(s) (__ g) for ready-to-
ucts, dry ready-to-eat, e.g., young children (1 through 3 eat cereals; piece(s) (__ g)
ready-to-eat cereals, cook- years of age) for ready-to- for others
ies, teething biscuits, and eat cereals; 7 g for all oth-
toasts. ers.
Dinners, deserts, fruits, vege- 15 g ........................................ __ tbsp(s) (__ g); __ cup(s)
tables or soups, dry mix. (__ g)
74
TABLE 1—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION: FOODS FOR
INFANTS AND YOUNG CHILDREN 1 THROUGH 3 YEARS OF AGE 1 2 3—Continued
Dinners, desserts, fruits, vege- 110 g ...................................... __ cup(s) (__ g); cup(s) (__ mL)
tables or soups, ready-to-
serve, junior type.
Dinners, desserts, fruits, vege- 110 g ...................................... __ cup(s) (__ g); cup(s) (__ mL)
tables or soups, ready-to-
serve, strained type.
Dinners, stews or soups for 170 g ...................................... __ cup(s) (__ g); cup(s) (__ mL)
young children, ready-to-
serve.
Fruits for young children, 125 g ...................................... __ cup(s) (__ g)
ready-to-serve.
Vegetables for young children, 70 g ........................................ __ cup(s) (__ g)
ready-to-serve.
Eggs/egg yolks, ready-to serve 55 g ........................................ __ cup(s) (__ g)
Juices all varieties ................... 120 mL ................................... 4 fl oz (120 mL)
1 These values represent the amount of food customarily consumed per eating occasion and
were primarily derived from the 1977–1978 and the 1987–1988 Nationwide Food Consumption
Surveys conducted by the U.S. Department of Agriculture. We further considered data from the
National Health and Nutrition Examination Survey, 2003–2004, 2005–2006, and 2007–2008 con-
ducted by the Centers for Disease Control and Prevention, in the U.S. Department of Health and
Human Services.
2 Unless otherwise noted in the reference amount column, the reference amounts are for the
ready-to-serve or almost ready-to-serve form of the product (e.g., heat and serve, brown and
serve). If not listed separately, the reference amount for the unprepared form (e.g., dry mixes,
concentrates, dough, batter, fresh and frozen pasta) is the amount required to make the ref-
erence amount of the prepared form. Prepared means prepared for consumption (e.g., cooked).
3 Manufacturers are required to convert the reference amount to the label serving size in a
household measure most appropriate to their specific product using the procedures in 21 CFR
101.9(b).
4 The label statements are meant to provide examples of serving size statements that may be
used on the label, but the specific wording may be changed as appropriate for individual prod-
ucts. The term ‘‘piece’’ is used as a generic description of a discrete unit. Manufacturers should
use the description of a unit that is most appropriate for the specific product (e.g., sandwich for
sandwiches, cookie for cookies, and bar for frozen novelties).
TABLE 2—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION: GENERAL FOOD
SUPPLY 1 2 3
Bakery Products:
Bagels, toaster pastries, 110 g ...................................... __ piece(s) (__ g)
muffins (excluding
English muffins).
Biscuits, croissants, tor- 55 g ........................................ __ piece(s) (__ g)
tillas, soft bread sticks,
soft pretzels, corn
bread, hush puppies,
scones, crumpets,
English muffins.
Breads (excluding sweet 50 g ........................................ __ piece(s) (__ g) for sliced
quick type), rolls. bread and distinct pieces
(e.g., rolls); 2 oz (56 g/
__ inch slice) for unsliced
bread
Bread sticks—see crack-

ers.
75
§ 101.12 21 CFR Ch. I (4–1–23 Edition)
SUPPLY 1 2 3—Continued
Toaster pastries—see ba-

gels, toaster pastries,
muffins (excluding
English muffins).
Brownies ........................... 40 g ........................................ __ piece(s) (__ g) for distinct
pieces; fractional slice (__ g)
for bulk
Cakes, heavyweight 125 g ...................................... __ piece(s) (__ g) for distinct
(cheese cake; pineapple pieces (e.g., sliced or indi-
upside-down cake; fruit, vidually packaged prod-
nut, and vegetable ucts); __ fractional slice
cakes with more than or (__ g) for large discrete
equal to 35 percent of units
the finished weight as
fruit, nuts, or vegetables
or any of these com-
binations) 5.
Cakes, mediumweight 80 g ........................................ __ piece(s) (__ g) for distinct
(chemically leavened pieces (e.g., cupcake);
cake with or without __ fractional slice (__ g) for
icing or filling except large discrete units
those classified as light
weight cake; fruit, nut,
and vegetable cake with
less than 35 percent of
the finished weight as
fruit, nuts, or vegetables
or any of these com-
binations; light weight
cake with icing; Boston
cream pie; cupcake;
eclair; cream puff) 6.
Cakes, lightweight (angel 55 g ........................................ __ piece(s) (__ g) for distinct
food, chiffon, or sponge pieces (e.g., sliced or indi-
cake without icing or fill- vidually packaged prod-
ing) 7. ucts); __ fractional slice
(__ g) for large discrete
units
Coffee cakes, crumb 55 g ........................................ __ piece(s) (__ g) for sliced
cakes, doughnuts, Dan- bread and distinct pieces
ish, sweet rolls, sweet (e.g., doughnut); 2 oz (56 g/
quick type breads. visual unit of measure) for
bulk products (e.g., unsliced
bread)
Cookies ............................. 30 g ........................................ __ piece(s) (__ g)
Crackers that are usually 15 g ........................................ __ piece(s) (__ g)
not used as snack,
melba toast, hard bread
sticks, ice cream
cones 8.
Crackers that are usually 30 g ........................................ __ piece(s) (__ g)
used as snacks.
Croutons ........................... 7 g .......................................... __ tbsp(s) (__ g); __ cup(s)
(__ g); __ piece(s) (__ g) for
large pieces
Eggroll, dumpling, wonton, 20 g ........................................ __ sheet (__ g); wrapper (__ g)
or potsticker wrappers.
French toast, crepes, pan- 110 g prepared for French __ piece(s) (__ g); __ cup(s)
cakes, variety mixes. toast, crepes, and pan- (__ g) for dry mix
cakes; 40 g dry mix for vari-
ety mixes.
76
Grain-based bars with or 40 g ........................................ __ piece(s) (__ g)

without filling or coating,
e.g., breakfast bars,
granola bars, rice cereal
bars.
Ice cream cones—see
crackers.
Pies, cobblers, fruit crisps, 125 g ...................................... __ piece(s) (__ g) for distinct
turnovers, other pastries. pieces; __ fractional slice
(__ g) for large discrete
units
Pie crust, pie shells, pas- the allowable declaration clos- __ fractional slice(s) (__ g) for
try sheets, (e.g., phyllo, est to an 8 square inch sur- large discrete units;
puff pastry sheets). face area. __ shells (__ g); __ fractional
__ sheet(s) (__ g) for distinct
pieces (e.g., Pastry sheet).
Pizza crust ........................ 55 g ........................................ __ fractional slice (__ g)
Taco shells, hard .............. 30 g ........................................ __ shell(s) (__ g)
Waffles .............................. 85 g ........................................ __ piece(s) (__ g)
Beverages:
Carbonated and non- 360 mL ................................... 12 fl oz (360 mL)
carbonated beverages,
wine coolers, water.
Coffee or tea, flavored 360 mL prepared .................... 12 fl oz (360 mL)
and sweetened.
Cereals and Other Grain Prod-
ucts:
Breakfast cereals (hot ce- 1 cup prepared; 40 g plain dry __ cup(s) (__ g)
real type), hominy grits. cereal; 55 g flavored,
sweetened cereal.
Breakfast cereals, ready- 15 g ........................................ __ cup(s) (__ g)
to-eat, weighing less
than 20 g per cup, e.g.,
plain puffed cereal
grains.
Breakfast cereals, ready- 40 g ........................................ __ cup(s) (__ g)
to-eat, weighing 20 g or
more but less than 43 g
per cup; high fiber cere-
als containing 28 g or
more of fiber per 100 g.
Breakfast cereals, ready- 60 g ........................................ __ piece(s) (__ g) for large dis-
to-eat, weighing 43 g or tinct pieces (e.g., biscuit
more per cup; biscuit type); __ cup(s) (__ g) for all
types. others
Bran or wheat germ ......... 15 g ........................................ __ tbsp(s) (__ g); __ cup(s)
(__ g)
Flours or cornmeal ........... 30 g ........................................ __ tbsp(s) (__ g); __ cup(s)
(__ g)
Grains, e.g., rice, barley, 140 g prepared; 45 g dry ....... __ cup(s) (__ g)
plain.
Pastas, plain ..................... 140 g prepared; 55 g dry ....... __ cup(s) (__ g); __ piece(s)
(__ g) for large pieces (e.g.,
large shells or lasagna noo-
dles) or 2 oz (56 g/visual
unit of measure) for dry
bulk products (e.g., spa-
ghetti)
Pastas, dry, ready-to-eat, 25 g ........................................ __ cup(s) (__ g)

e.g., fried canned chow
mein noodles.
77
§ 101.12 21 CFR Ch. I (4–1–23 Edition)
Starches, e.g., cornstarch, 10 g ........................................ __ tbsp (__ g)

potato starch, tapioca,
etc.
Stuffing ............................. 100 g ...................................... __ cup(s) (__ g)
Dairy Products and Sub-
stitutes:
Cheese, cottage ............... 110 g ...................................... __ cup (__ g)
Cheese used primarily as 55 g ........................................ __ cup (__ g)
ingredients, e.g., dry
cottage cheese, ricotta
cheese.
Cheese, grated hard, e.g., 5 g .......................................... __ tbsp (__ g)
Parmesan, Romano.
Cheese, all others except 30 g ........................................ __ piece(s) (__ g) for distinct
those listed as separate pieces; __ tbsp(s) (__ g) for
categories—includes cream cheese and cheese
cream cheese and spread; 1 oz (28 g/visual
cheese spread. unit of measure) for bulk
Cheese sauce—see
sauce category.
Cream or cream sub- 15 mL ..................................... 1 tbsp (15 mL)
stitutes, fluid.
Cream or cream sub- 2 g .......................................... __ tsp (__ g)
stitutes, powder.
Cream, half & half ............ 30 mL ..................................... 2 tbsp (30 mL)
Eggnog ............................. 120 mL ................................... ⁄ cup (120 mL); 4 fl oz (120
12
mL)
Milk, condensed, undiluted 30 mL ..................................... 2 tbsp (30 mL)
Milk, evaporated, undi- 30 mL ..................................... 2 tbsp (30 mL)
luted.
Milk, milk-substitute bev- 240 mL ................................... 1 cup (240 mL); 8 fl oz (240
erages, milk-based mL)
drinks, e.g., instant
breakfast, meal replace-
ment, cocoa, soy bev-
erage.
Shakes or shake sub- 240 mL ................................... 1 cup (240 mL); 8 fl oz (240
stitutes, e.g., dairy mL)
shake mixes, fruit frost
mixes.
Sour cream ....................... 30 g ........................................ __ tbsp (__ g)
Yogurt ............................... 170 g ...................................... __ cup (__ g)
Desserts:
Ice cream, frozen yogurt, ⁄ cup—includes the volume
23 ⁄ cup (__ g), __ piece(s)
23
sherbet, frozen flavored for coatings and wafers. (__ g) for individually
and sweetened ice and wrapped or packaged prod-
pops, frozen fruit juices: ucts
all types bulk and nov-
elties (e.g., bars, sand-
wiches, cones, cups).
Sundae ............................. 1 cup ....................................... 1 cup (__ g)
Custards, gelatin, or pud- ⁄ cup prepared; amount to
12 __ piece(s) (__ g) for distinct
ding. make 1⁄2 cup prepared unit (e.g., individually pack-
when dry. aged products); 1⁄2 cup
(__ g) for bulk
Dessert Toppings and Fillings:
Cake frostings or icings .... 2 tbsp ...................................... __ tbsp(s) (__ g)
78
Other dessert toppings, 2 tbsp ...................................... 2 tbsp (__ g); 2 tbsp (30 mL)
e.g., fruits, syrups,
spreads, marshmallow
cream, nuts, dairy and
non-dairy whipped top-
pings.
Pie fillings ......................... 85 g ........................................ __ cup(s) (__ g)
Egg and Egg Substitutes:
Egg mixtures, e.g., egg 110 g ...................................... __ piece(s) (__ g) for discrete
foo young, scrambled pieces; __ cup(s) (__ g)
eggs, omelets.
Eggs (all sizes) 8 ............... 50 g ........................................ 1 large, medium, etc. (__ g)
Egg whites, sugared eggs, An amount to make 1 large __ cup(s) (__ g); __ cup(s)
sugared egg yolks, and (50 g) egg. (__ mL)
egg substitutes (fresh,
frozen, dried).
Fats and Oils:
Butter, margarine, oil, 1 tbsp ...................................... 1 tbsp (__ g); 1 tbsp (15 mL)
shortening.
Butter replacement, pow- 2 g .......................................... __ tsp(s) (__ g)
der.
Dressings for salads ......... 30 g ........................................ __ tbsp (__ g); __ tbsp (__ mL)
Mayonnaise, sandwich 15 g ........................................ __ tbsp (__ g)
spreads, mayonnaise-
type dressings.
Spray types ...................... 0.25 g ..................................... About __ seconds spray (__ g)
Fish, Shellfish, Game Meats,9
and Meat or Poultry Sub-
stitutes:
Bacon substitutes, canned 15 g ........................................ __ piece(s) (__ g) for discrete
anchovies,10 anchovy pieces; __ tbsp(s) (__ g) for
pastes, caviar. others
Dried, e.g., jerky ............... 30 g ........................................ __ piece(s) (__ g)
Entrees with sauce, e.g., 140 g cooked .......................... __ cup(s) (__ g); 5 oz (140 g/
fish with cream sauce, visual unit of measure) if
shrimp with lobster not measurable by cup
sauce.
Entrees without sauce, 85 g cooked; 110 g __ piece(s) (__ g) for discrete
e.g., plain or fried fish uncooked 11. pieces; __ cup(s) (__ g);
and shellfish, fish and __ oz (__ g/visual unit of
shellfish cake. measure) if not measurable
by cup 12
Fish, shellfish, or game 85 g ........................................ __ piece(s) (__ g) for discrete
meat 9, canned 10. pieces; __ cup(s) (__ g); 3
oz (85 g/__ cup) for prod-
ucts that are difficult to
measure the g weight of
cup measure (e.g., tuna); 3
oz (85 g/__ pieces) for prod-
ucts that naturally vary in
size (e.g., sardines)
Substitute for luncheon 55 g ........................................ __ piece(s) (__ g) for distinct
meat, meat spreads, pieces (e.g., slices, links);
Canadian bacon, sau- __ cup(s) (__ g); 2 oz (56 g/
sages, frankfurters, and visual unit of measure) for
seafood. nondiscrete bulk product
Smoked or pickled fish,10 55 g ........................................ __ piece(s) (__ g) for distinct
shellfish, or game pieces (e.g., slices, links) or
meat 9; fish or shellfish __ cup(s) (__ g); 2 oz (56 g/

spread. visual unit of measure) for
nondiscrete bulk product
79
§ 101.12 21 CFR Ch. I (4–1–23 Edition)
Substitutes for bacon

bits—see Miscellaneous.
Fruits and Fruit Juices:
Candied or pickled 10 ........ 30 g ........................................ __ piece(s) (__ g)
Dehydrated fruits—see
snack category.
Dried ................................. 40 g ........................................ __ piece(s) (__ g) for large
pieces (e.g., dates, figs,
prunes); __ cup(s) (__ g) for
small pieces (e.g., raisins)
Fruits for garnish or flavor, 4 g .......................................... 1 cherry (__ g); __ piece(s)
e.g., maraschino cher- (__ g)
ries 10.
Fruit relishes, e.g., cran- 70 g ........................................ __ cup(s) (__ g)
berry sauce, cranberry
relish.
Fruits used primarily as in- 50 g ........................................ See footnote 12
gredients, avocado.
Fruits used primarily as in- 50 g ........................................ __ piece(s) (__ g) for large
gredients, others (cran- fruits; __ cup(s) (__ g) for
berries, lemon, lime). small fruits measurable by
cup12
Watermelon ...................... 280 g ...................................... See footnote 12
All other fruits (except 140 g ...................................... __ piece(s) (__ g) for large
those listed as separate pieces (e.g., strawberries,
categories), fresh, prunes, apricots, etc.);
canned or frozen. __ cup(s) (__ g) for small
pieces (e.g., blueberries,
raspberries, etc.) 12
Juices, nectars, fruit drinks 240 mL ................................... 8 fl oz (240 mL)
Juices used as ingredi- 5 mL ....................................... 1 tsp (5 mL)
ents, e.g., lemon juice,
lime juice.
Legumes:
Tofu,10 tempeh ................. 85 g ........................................ __ piece(s) (__ g) for discrete
pieces; 3 oz (84 g/visual
unit of measure) for bulk
products
Beans, plain or in sauce .. 130 g for beans in sauce or __ cup (__ g)
canned in liquid and refried
beans prepared; 90 g for
others prepared; 35 g dry.
Miscellaneous:
Baking powder, baking 0.6 g ....................................... __ tsp (__ g)
soda, pectin.
Baking decorations, e.g., 1 tsp or 4 g if not measurable __ piece(s) (__ g) for discrete
colored sugars and by teaspoon. pieces; 1 tsp (__ g)
sprinkles for cookies,
cake decorations.
Batter mixes, bread 30 g ........................................ __ tbsp(s) (__ g); __ cup(s)
crumbs. (__ g)
Chewing gum 8 ................. 3 g .......................................... __ piece(s) (__ g)
Cocoa powder, carob 1 tbsp ...................................... 1 tbsp (__ g)
powder, unsweetened.
Cooking wine .................... 30 mL ..................................... 2 tbsp (30 mL)
80
Dietary supplements ......... The maximum amount rec- __ tablet(s), __ capsules(s),

ommended, as appropriate, __ packet(s), __ tsp(s) (__ g),
on the label for consump- etc.
tion per eating occasion or,
in the absence of rec-
ommendations, 1 unit, e.g.,
tablet, capsule, packet, tea-
spoonful, etc.
Meat, poultry, and fish Amount to make one ref- __ tsp(s) (__ g); __ tbsp(s)
coating mixes, dry; sea- erence amount of final dish. (__ g)
soning mixes, dry, e.g.,
chili seasoning mixes,
pasta salad seasoning
mixes.
Milk, milk substitute, and Amount to make 240 mL drink __ fl oz (__ mL); __ tsp (__ g);
fruit juice concentrates (without ice). tbsp (__ g)
(without alcohol) (e.g.,
drink mixers, frozen fruit
juice concentrate,
sweetened cocoa pow-
der).
Drink mixes (without alco- Amount to make 360 mL drink __ fl oz (__ mL); __ tsp (__ g);
hol): All other types (without ice). __ tbsp (__ g)
(e.g., flavored syrups
and powdered drink
mixes).
Salad and potato toppers, 7 g .......................................... __ tbsp(s) (__ g)
e.g., salad crunchies,
salad crispins, sub-
stitutes for bacon bits.
Salt, salt substitutes, sea- ⁄ tsp ......................................
14 ⁄ tsp (__ g); __ piece(s) (__ g)
14
soning salts (e.g., garlic for discrete pieces (e.g., in-

salt). dividually packaged prod-
ucts)
Seasoning oils and sea- 1 tbsp ...................................... 1 tbsp (__ g)
soning sauces (e.g., co-
conut concentrate, ses-
ame oil, almond oil, chili
oil, coconut oil, walnut
oil).
Seasoning pastes (e.g., 1 tsp ........................................ 1 tsp (__ g)
garlic paste, ginger
paste, curry paste, chili
paste, miso paste),
fresh or frozen.
Spices, herbs (other than ⁄ tsp or 0.5 g if not measur-
14 ⁄ tsp (__ g); __ piece(s) (__ g)
14
dietary supplements). able by teaspoon. if not measurable by

teaspoons (e.g., bay leaf)
Mixed Dishes:
Appetizers, hors 85 g, add 35 g for products __ piece(s) (__ g)
d’oeuvres, mini mixed with gravy or sauce topping.
dishes, e.g., mini bagel
pizzas, breaded mozza-
rella sticks, egg rolls,
dumplings, potstickers,
wontons, mini
quesadillas, mini
quiches, mini sand-

wiches, mini pizza rolls,
potato skins.
81
§ 101.12 21 CFR Ch. I (4–1–23 Edition)
Measurable with cup, e.g., 1 cup ....................................... 1 cup (__ g)

casseroles, hash, maca-
roni and cheese, pot
pies, spaghetti with
sauce, stews, etc.
Not measurable with cup, 140 g, add 55 g for products __ piece(s) (__ g) for discrete
e.g., burritos, enchi- with gravy or sauce topping, pieces; __ fractional slice
ladas, pizza, pizza rolls, e.g., enchilada with cheese (__ g) for large discrete
quiche, all types of sauce, crepe with white units
sandwiches. sauce 13.
Nuts and Seeds:
Nuts, seeds and mixtures, 30 g ........................................ __ piece(s) (__ g) for large
all types: Sliced, pieces (e.g., unshelled
chopped, slivered, and nuts); __ tbsp(s) (__ g);
whole. __ cup(s) (__ g) for small
pieces (e.g., peanuts, sun-
flower seeds)
Nut and seed butters, 2 tbsp ...................................... 2 tbsp (__ g)
pastes, or creams.
Coconut, nut and seed 15 g ........................................ __ tbsp(s) (__ g); __ cup (__ g)
flours.
Potatoes and Sweet Potatoes/
Yams:
French fries, hash browns, 70 g prepared; 85 g for frozen __ piece(s) (__ g) for large dis-
skins, or pancakes. unprepared French fries. tinct pieces (e.g., patties,
skins); 2.5 oz (70 g/
__ pieces) for prepared
fries; 3 oz (84 g/__ pieces)
for unprepared fries
Mashed, candied, stuffed 140 g ...................................... __ piece(s) (__ g) for discrete
or with sauce. pieces (e.g., stuffed potato);
__ cup(s) (__ g)
Plain, fresh, canned, or 110 g for fresh or frozen; 125 __ piece(s) (__ g) for discrete
frozen. g for vacuum packed; 160 g pieces; __ cup(s) (__ g) for
for canned in liquid. sliced or chopped products
Salads:
Gelatin salad .................... 120 g ...................................... __ cup (__ g)
Pasta or potato salad ....... 140 g ...................................... __ cup(s) (__ g)
All other salads, e.g., egg, 100 g ...................................... __ cup(s) (__ g)
fish, shellfish, bean,
fruit, or vegetable sal-
ads.
Sauces, Dips, Gravies, and
Condiments:
Barbecue sauce, hollan- 2 tbsp ...................................... 2 tbsp (__ g); 2 tbsp (30 mL)
daise sauce, tartar
sauce, tomato chili
sauce, other sauces for
dipping (e.g., mustard
sauce, sweet and sour
sauce), all dips (e.g.,
bean dips, dairy-based
dips, salsa).
Major main entree sauces, 125 g ...................................... __ cup (__ g); __ cup (__ mL)
e.g., spaghetti sauce.
82
Minor main entree sauces ⁄ cup .....................................

14 ⁄ cup (__ g); 1⁄4 cup (60 mL)
14
(e.g., pizza sauce, pesto

sauce, Alfredo sauce),
other sauces used as
toppings (e.g., gravy,
white sauce, cheese
sauce), cocktail sauce.
Major condiments, e.g., 1 tbsp ...................................... 1 tbsp (__ g); 1 tbsp (15 mL)
catsup, steak sauce,
soy sauce, vinegar, teri-
yaki sauce, marinades.
Minor condiments, e.g., 1 tsp ........................................ 1 tsp (__ g); 1 tsp (5 mL)
horseradish, hot sauces,
mustards, Worcester-
shire sauce.
Snacks:
All varieties, chips, pret- 30 g ........................................ __ cup (__ g) for small pieces
zels, popcorn, extruded (e.g., popcorn); __ piece(s)
snacks, fruit and vege- (__ g) for large pieces (e.g.,
table-based snacks large pretzels; pressed
(e.g., fruit chips), grain- dried fruit sheet); 1 oz (28g/
based snack mixes. visual unit of measure) for
bulk products (e.g., potato
chips)
Soups:
All varieties ....................... 245 g ...................................... __ cup (__ g); __ cup (__ mL)
Dry soup mixes, bouillon .. Amount to make 245 g ........... __ cup (__ g); __ cup (__ mL)
Sugars and Sweets:
Baking candies (e.g., 15 g ........................................ __ piece(s) (__ g) for large
chips). pieces; __ tbsp(s) (__ g) for
small pieces; 1⁄2 oz (14 g/
visual unit of measure) for
bulk products
After-dinner confection- 10 g ........................................ __ piece(s) (__ g)
eries.
Hard candies, breath 2 g .......................................... __ piece(s) (__ g)
mints 8.
Hard candies, roll-type, 5 g .......................................... __ piece(s) (__ g)
mini-size in dispenser
packages.
Hard candies, others; 15 mL for liquid candies; 15 g __ piece(s) (__ g) for large
powdered candies, liq- for all others. pieces; __ tbsp(s) (__ g) for
uid candies. ‘‘mini-size’’ candies measur-
able by tablespoon;
__ straw(s) (__ g) for pow-
dered candies; __ wax bot-
tle(s) (__ mL) for liquid
candies; 1⁄2 oz (14 g/visual
unit of measure) for bulk
products
All other candies ............... 30 g ........................................ __ piece(s) (__ g); 1 oz (30 g/
visual unit of measure) for
bulk products
Confectioner’s sugar ........ 30 g ........................................ __ cup (__ g)
Honey, jams, jellies, fruit 1 tbsp ...................................... 1 tbsp (__ g); 1 tbsp (15 mL)
butter, molasses, fruit
pastes, fruit chutneys.
Marshmallows ................... 30 g ........................................ __ cup(s) (__ g) for small

pieces; __ piece(s) (__ g) for
large pieces
83
§ 101.12 21 CFR Ch. I (4–1–23 Edition)
Sugar ................................ 8 g .......................................... __ tsp (__ g); __ piece(s) (__ g)

for discrete pieces (e.g.,
sugar cubes, individually
packaged products)
Sugar substitutes .............. An amount equivalent to one __ tsp(s) (__ g) for solids;
reference amount for sugar __ drop(s) (__ g) for liquid;
in sweetness. __ piece(s) (__ g) (e.g., indi-
vidually packaged products)
Syrups .............................. 30 mL for all syrups ............... 2 tbsp (30 mL)
Vegetables:
Dried vegetables, dried to- 5 g, add 5 g for products __ piece(s); 1⁄3 cup (__ g)
matoes, sun-dried toma- packaged in oil.
toes, dried mushrooms,
dried seaweed.
Dried seaweed sheets ...... 3 g .......................................... __ piece(s) (__ g); __ cup(s)
(__ g)
Vegetables primarily used 4 g .......................................... __ piece(s) (__ g); __ tbsp(s)
for garnish or flavor (__ g) for chopped products
(e.g., pimento,10 pars-
ley, fresh or dried).
Fresh or canned chili pep- 30 g ........................................ __ piece(s) (__ g) 12; __ tbsp(s)
pers, jalapeno peppers, (__ g); __ cup(s) (__ g) for
other hot peppers, sliced or chopped products
green onion.
All other vegetables with- 85 g for fresh or frozen; 95 g __ piece(s) (__ g) for large
out sauce: Fresh, for vacuum packed; 130 g pieces (e.g., Brussels
canned, or frozen. for canned in liquid, cream- sprouts); __ cup(s) (__ g) for
style corn, canned or small pieces (e.g., cut corn,
stewed tomatoes, pumpkin, green peas); 3 oz (84 g/vis-
or winter squash. ual unit of measure) if not
measurable by cup
All other vegetables with 110 g ...................................... __ piece(s) (__ g) for large
sauce: Fresh, canned, pieces (e.g., Brussels
or frozen. sprouts); __ cup(s) (__ g) for
small pieces (e.g., cut corn,
green peas); 4 oz (112 g/
visual unit of measure) if
not measurable by cup
Vegetable juice ................. 240 mL ................................... 8 fl oz (240 mL)
Olives 10 ............................ 15 g ........................................ __ piece(s) (__ g); __ tbsp(s)
(__ g) for sliced products
Pickles and pickled vege- 30 g ........................................ 1 oz (28 g/visual unit of meas-
tables, all types 10. ure)
Pickle relishes .................. 15 g ........................................ __ tbsp (__ g)
Sprouts, all types: Fresh 1/4 cup .................................... 1⁄4 cup (__ g)
or canned.
Vegetable pastes, e.g., to- 30 g ........................................ __ tbsp (__ g)
mato paste.
Vegetable sauces or pu- 60 g ........................................ __ cup (__ g); __ cup (__ mL)
rees, e.g., tomato
sauce, tomato puree.
1 These values represent the amount (edible portion) of food customarily consumed per eating
occasion and were primarily derived from the 1977–1978 and the 1987–1988 Nationwide Food
Consumption Surveys conducted by the U.S. Department of Agriculture and updated with data
from the National Health and Nutrition Examination Survey, 2003–2004, 2005–2006 and 2007–
2008 conducted by the Centers for Diseases Control and Prevention, in the Department of
Health and Human Services.
84
2 Unless otherwise noted in the Reference Amount column, the reference amounts are for the
ready-to-serve or almost ready-to-serve form of the product (e.g., heat and serve, brown and
serve). If not listed separately, the reference amount for the unprepared form (e.g., dry mixes,
concentrates, dough, batter, fresh and frozen pasta) is the amount required to make the ref-
erence amount of the prepared form. Prepared means prepared for consumption (e.g., cooked).
3 Manufacturers are required to convert the reference amount to the label serving size in a
household measure most appropriate to their specific product using the procedures in 21 CFR
101.9(b).
4 The label statements are meant to provide examples of serving size statements that may be
used on the label, but the specific wording may be changed as appropriate for individual prod-
ucts. The term ‘‘piece’’ is used as a generic description of a discrete unit. Manufacturers should
use the description of a unit that is most appropriate for the specific product (e.g., sandwich for
sandwiches, cookie for cookies, and bar for ice cream bars). The guidance provided is for the
label statement of products in ready-to-serve or almost ready-to-serve form. The guidance does
not apply to the products which require further preparation for consumption (e.g., dry mixes, con-
centrates) unless specifically stated in the product category, reference amount, or label state-
ment column that it is for these forms of the product. For products that require further prepara-
tion, manufacturers must determine the label statement following the rules in § 101.9(b) using
the reference amount determined according to § 101.12(c).
5 Includes cakes that weigh 10 g or more per cubic inch. The serving size for fruitcake is 1 1⁄2
ounces.
6 Includes cakes that weigh 4 g or more per cubic inch but less than 10 g per cubic inch.
7 Includes cakes that weigh less than 4 g per cubic inch.
8 Label serving size for ice cream cones, eggs, and breath mints of all sizes will be 1 unit.
Label serving size of all chewing gums that weigh more than the reference amount that can rea-
sonably be consumed at a single-eating occasion will be 1 unit.
9 Animal products not covered under the Federal Meat Inspection Act or the Poultry Products
Inspection Act, such as flesh products from deer, bison, rabbit, quail, wild turkey, geese, ostrich,
etc.
10 If packed or canned in liquid, the reference amount is for the drained solids, except for
products in which both the solids and liquids are customarily consumed (e.g., canned chopped
clam in juice).
11 The reference amount for the uncooked form does not apply to raw fish in § 101.45 or to
single-ingredient products that consist of fish or game meat as provided for in § 101.9(j)(11).
12 For raw fruit, vegetables, and fish, manufacturers should follow the label statement for the
serving size specified in Appendices C and D to part 101 (21 CFR part 101) Code of Federal
Regulations.
13 Pizza sauce is part of the pizza and is not considered to be sauce topping.
(c) If a product requires further prep- reference amount of the regular food is
aration, e.g., cooking or the addition of in grams, the manufacturer may deter-
water or other ingredients, and if para- mine the reference amount of the aer-
graph (b) of this section provides a ref- ated food by adjusting for the dif-
erence amount for the product in the ference in density of the aerated food
prepared form, but not the unprepared relative to the density of the appro-
form, then the reference amount for priate reference food provided that the
the unprepared product must be the manufacturer will show FDA detailed
amount of the unprepared product re- protocol and records of all data that
quired to make the reference amount were used to determine the density-ad-
for the prepared product as established justed reference amount for the aer-
in paragraph (b) of this section. ated food. The reference amount for
(d) The reference amount for an imi- the aerated food shall be rounded to
tation or substitute food or altered the nearest 5-g increment. Such prod-
food, such as a ‘‘low calorie’’ version, ucts shall bear a descriptive term indi-
shall be the same as for the food for cating that extra air has been incor-
which it is offered as a substitute. porated (e.g., whipped, aerated). The
(e) If a food is modified by incor- density-adjusted reference amounts de-
porating air (aerated), and thereby the scribed in paragraph (b) of this section
density of the food is lowered by 25 per- may not be used for cakes except for
cent or more in weight than that of an cheese cake. The differences in the den-
appropriate reference regular food as sities of different types of cakes having
described in § 101.13(j)(1)(ii)(A), and the different degrees of air incorporation
85
§ 101.12 21 CFR Ch. I (4–1–23 Edition)
have already been taken into consider- incompatible units, all amounts must
ation in determining the reference be converted to weights and summed,
amounts for cakes in § 101.12(b). In de- e.g., the reference amount for pancakes
termining the difference in density of and syrup would be 110 g (the reference
the aerated and the regular food, the amount for pancakes) plus the weight
manufacturer shall adhere to the fol- of the proportioned amount of syrup.
lowing: (g) The reference amounts set forth
(1) The regular and the aerated prod- in paragraphs (b) through (f) of this
uct must be the same in size, shape, section shall be used in determining
and volume. To compare the densities whether a product meets the criteria
of products having nonsmooth surfaces for nutrient content claims, such as
(e.g., waffles), manufacturers shall use ‘‘low calorie,’’ and for health claims. If
a device or method that ensures that the serving size declared on the prod-
the volumes of the regular and the aer- uct label differs from the reference
ated products are the same. amount, and the product meets the cri-
(2) Sample selections for the density teria for the claim only on the basis of
measurements shall be done in accord- the reference amount, the claim shall
ance with the provisions in § 101.9(g). be followed by a statement that sets
(3) Density measurements of the reg- forth the basis on which the claim is
ular and the aerated products shall be made. That statement shall include the
conducted by the same trained oper- reference amount as it appears in para-
ator using the same methodology (e.g., graph (b) of this section followed, in
the same equipment, procedures, and parenthesis, by the amount in common
techniques) under the same conditions. household measure if the reference
(4) Density measurements shall be amount is expressed in measures other
replicated a sufficient number of times than common household measures
to ensure that the average of the meas- (e.g., for a beverage, ‘‘Very low sodium,
urements is representative of the true 35 mg or less per 240 mL (8 fl oz)’’).
differences in the densities of the reg- (h) The Commissioner of Food and
ular and the ‘‘aerated’’ products. Drugs, either on his or her own initia-
(f) For products that have no ref- tive or in response to a petition sub-
erence amount listed in paragraph (b) mitted pursuant to part 10 of this chap-
of this section for the unprepared or ter, may issue a proposal to establish
the prepared form of the product and or amend a reference amount in para-
that consist of two or more foods pack- graph (b) of this section. A petition to
aged and presented to be consumed to- establish or amend a reference amount
gether (e.g., peanut butter and jelly, shall include:
cracker and cheese pack, pancakes and
(1) Objective of the petition;
syrup, cake and frosting), the reference
(2) A description of the product;
amount for the combined product shall
be determined using the following (3) A complete sample product label
rules: including nutrition label, using the for-
(1) The reference amount for the mat established by regulation;
combined product must be the ref- (4) A description of the form (e.g., dry
erence amount, as established in para- mix, frozen dough) in which the prod-
graph (b) of this section, for the ingre- uct will be marketed;
dient that is represented as the main (5) The intended dietary uses of the
ingredient (e.g., peanut butter, pan- product with the major use identified
cakes, cake) plus proportioned (e.g., milk as a beverage and chips as a
amounts of all minor ingredients. snack);
(2) If the reference amounts are in (6) If the intended use is primarily as
compatible units, the weights or vol- an ingredient in other foods, list of
umes must be summed (e.g., the ref- foods or food categories in which the
erence amount for equal volumes of product will be used as an ingredient
peanut butter and jelly for which pea- with information on the prioritization
nut butter is represented as the main of the use;
ingredient would be 4 tablespoons (7) The population group for which

(tbsp) (2 tbsp peanut butter plus 2 tbsp the product will be offered for use (e.g.,
jelly)). If the reference amounts are in infants, children under 4 years of age);
86
(8) The names of the most closely re- from the reference amount for the par-
lated products (or in the case of foods ent category to warrant a separate ref-
for special dietary use and imitation or erence amount. Data must include
substitute foods, the names of the sample size; and the mean, standard de-
products for which they are offered as viation, median, and modal consumed
substitutes); amount per eating occasion for the pe-
(9) The suggested reference amount titioned product and for other products
(the amount of edible portion of food as in the category, excluding the peti-
consumed, excluding bone, seed, shell, tioned product. All data must be de-
or other inedible components) for the
rived from the same survey data.
population group for which the product
is intended with full description of the (ii) Documentation supporting the
methodology and procedures that were difference in dietary usage and product
used to determine the suggested ref- characteristics that affect the con-
erence amount. In determining the ref- sumption size that distinguishes the
erence amount, general principles and petitioned product from the rest of the
factors in paragraph (a) of this section products in the category.
should be followed. (12) A claim for categorical exclusion
(10) The suggested reference amount under § 25.30 or § 25.32 of this chapter or
shall be expressed in metric units. Ref- an environmental assessment under
erence amounts for fluids shall be ex- § 25.40 of this chapter, and
pressed in milliliters. Reference (13) In conducting research to collect
amounts for other foods shall be ex- or process food consumption data in
pressed in grams except when common support of the petition, the following
household units such as cups, table- general guidelines should be followed.
spoons, and teaspoons, are more appro-
(i) Sampled population selected
priate or are more likely to promote
uniformity in serving sizes declared on should be representative of the demo-
product labels. For example, common graphic and socioeconomic characteris-
household measures would be more ap- tics of the target population group for
propriate if products within the same which the food is intended.
category differ substantially in den- (ii) Sample size (i.e., number of eat-
sity, such as frozen desserts. ers) should be large enough to give reli-
(i) In expressing the reference able estimates for customarily con-
amounts in milliliters, the following sumed amounts.
rules shall be followed: (iii) The study protocol should iden-
(A) For volumes greater than 30 mil- tify potential biases and describe how
liliters (mL), the volume shall be ex- potential biases are controlled for or, if
pressed in multiples of 30 mL. not possible to control, how they affect
(B) For volumes less than 30 mL, the interpretation of results.
volume shall be expressed in milliliters (iv) The methodology used to collect
equivalent to a whole number of or process data should be fully docu-
teaspoons or 1 tbsp, i.e., 5, 10, or 15 mL.
mented and should include: study de-
(ii) In expressing the reference
sign, sampling procedures, materials
amounts in grams, the following gen-
used (e.g., questionnaire, and inter-
eral rules shall be followed:
(A) For quantities greater than 10 g, viewer’s manual), procedures used to
the quantity shall be expressed in the collect or process data, methods or pro-
nearest 5-g increment. cedures used to control for unbiased es-
(B) For quantities less than 10 g, timates, and procedures used to correct
exact gram weights shall be used. for nonresponse.
(11) A petition to create a new sub- (14) A statement concerning the fea-
category of food with its own reference sibility of convening associations, cor-
amount shall include the following ad- porations, consumers, and other inter-
ditional information: ested parties to engage in negotiated
(i) Data that demonstrate that the rulemaking to develop a proposed rule
new subcategory of food will be con-
sumed in amounts that differ enough
87
§ 101.13 21 CFR Ch. I (4–1–23 Edition)
consistent with the Negotiated Rule- these variations are not misleading
making Act (5 U.S.C. 561). (e.g., ‘‘hi’’ or ‘‘lo’’).
(5) For dietary supplements, claims
[58 FR 44051, Aug. 18, 1993; 58 FR 60109, Nov.
15, 1993, as amended at 59 FR 371, Jan. 4, 1994; for calories, fat, saturated fat, and cho-
59 FR 24039, May 10, 1994; 62 FR 40598, July 29, lesterol may not be made on products
1997; 62 FR 49848, Sept. 23, 1997; 63 FR 14818, that meet the criteria in § 101.60(b)(1) or
Mar. 27, 1998; 64 FR 12890, Mar. 16, 1999; 66 FR (b)(2) for ‘‘calorie free’’ or ‘‘low cal-
56035, Nov. 6, 2001; 81 FR 34041, May 27, 2016] orie’’ claims, except, in the case of cal-
orie claims, when an equivalent
§ 101.13 Nutrient content claims—gen- amount of a similar dietary supple-
eral principles. ment (e.g., another protein supple-
(a) This section and the regulations ment) that the labeled food resembles
in subpart D of this part apply to foods and for which it substitutes, normally
that are intended for human consump- exceeds the definition for ‘‘low calorie’’
tion and that are offered for sale, in- in § 101.60(b)(2).
cluding conventional foods and dietary (c) Information that is required or
supplements. permitted by § 101.9 or § 101.36, as appli-
(b) A claim that expressly or implic- cable, to be declared in nutrition label-
itly characterizes the level of a nutri- ing, and that appears as part of the nu-
ent of the type required to be in nutri- trition label, is not a nutrient content
tion labeling under § 101.9 or under claim and is not subject to the require-
§ 101.36 (that is, a nutrient content ments of this section. If such informa-
claim) may not be made on the label or tion is declared elsewhere on the label
in labeling of foods unless the claim is or in labeling, it is a nutrient content
made in accordance with this regula- claim and is subject to the require-
tion and with the applicable regula- ments for nutrient content claims.
tions in subpart D of this part or in (d) A ‘‘substitute’’ food is one that
part 105 or part 107 of this chapter. may be used interchangeably with an-
(1) An expressed nutrient content other food that it resembles, i.e., that
claim is any direct statement about it is organoleptically, physically, and
the level (or range) of a nutrient in the functionally (including shelf life) simi-
food, e.g., ‘‘low sodium’’ or ‘‘contains lar to, and that it is not nutritionally
100 calories.’’ inferior to unless it is labeled as an
(2) An implied nutrient content claim ‘‘imitation.’’
is any claim that: (1) If there is a difference in perform-
(i) Describes the food or an ingre- ance characteristics that materially
dient therein in a manner that sug- limits the use of the food, the food may
gests that a nutrient is absent or still be considered a substitute if the
present in a certain amount (e.g., label includes a disclaimer adjacent to
‘‘high in oat bran’’); or the most prominent claim as defined in
(ii) Suggests that the food, because of paragraph (j)(2)(iii) of this section, in-
its nutrient content, may be useful in forming the consumer of such dif-
maintaining healthy dietary practices ference (e.g., ‘‘not recommended for
and is made in association with an ex- frying’’).
plicit claim or statement about a nu- (2) This disclaimer shall be in easily
trient (e.g., ‘‘healthy, contains 3 grams legible print or type and in a size no
(g) of fat’’). less than that required by § 101.7(i) for
(3) Except for claims regarding vita- the net quantity of contents state-
mins and minerals described in para- ment, except where the size of the
graph (q)(3) of this section, no nutrient claim is less than two times the re-
content claims may be made on food quired size of the net quantity of con-
intended specifically for use by infants tents statement, in which case the dis-
and children less than 2 years of age claimer shall be no less than one-half
unless the claim is specifically pro- the size of the claim but no smaller
vided for in parts 101, 105, or 107 of this than one-sixteenth of an inch, unless
chapter. the package complies with § 101.2(c)(5),
(4) Reasonable variations in the spell- in which case the disclaimer may be in
ing of the terms defined in part 101 and type of not less than one thirty-second
their synonyms are permitted provided of an inch.
88
(e)(1) Because the use of a ‘‘free’’ or (2) If a food is a meal product as de-
‘‘low’’ claim before the name of a food fined in § 101.13(l), and contains more
implies that the food differs from other than 26 g of fat, 8.0 g of saturated fat,
foods of the same type by virtue of its 120 mg of cholesterol, or 960 mg of so-
having a lower amount of the nutrient, dium per labeled serving, then that
only foods that have been specially food must disclose, in accordance with
processed, altered, formulated, or re- the requirements as provided in para-
formulated so as to lower the amount graph (h)(1) of this section, that the
of the nutrient in the food, remove the nutrient exceeding the specified level
nutrient from the food, or not include is present in the food.
the nutrient in the food, may bear such (3) If a food is a main dish product as
a claim (e.g., ‘‘low sodium potato defined in § 101.13(m), and contains
chips’’).
more than 19.5 g of fat, 6.0 g of satu-
(2) Any claim for the absence of a nu-
rated fat, 90 mg of cholesterol, or 720
trient in a food, or that a food is low in
mg of sodium per labeled serving, then
a nutrient when the food has not been
that food must disclose, in accordance
specially processed, altered, formu-
lated, or reformulated to qualify for with the requirements as provided in
that claim shall indicate that the food paragraph (h)(1) of this section, that
inherently meets the criteria and shall the nutrient exceeding the specified
clearly refer to all foods of that type level is present in the food.
and not merely to the particular brand (4)(i) The disclosure statement ‘‘See
to which the labeling attaches (e.g., nutrition information for ____ content’’
‘‘corn oil, a sodium-free food’’). shall be in easily legible boldface print
(f) A nutrient content claim shall be or type, in distinct contrast to other
in type size no larger than two times printed or graphic matter, and in a size
the statement of identity and shall not no less than that required by § 101.7(i)
be unduly prominent in type style com- for the net quantity of contents state-
pared to the statement of identity. ment, except where the size of the
(g) [Reserved] claim is less than two times the re-
(h)(1) If a food, except a meal product quired size of the net quantity of con-
as defined in § 101.13(l), a main dish tents statement, in which case the dis-
product as defined in § 101.13(m), or food closure statement shall be no less than
intended specifically for use by infants one-half the size of the claim but no
and children less than 2 years of age, smaller than one-sixteenth of an inch,
contains more than 13.0 g of fat, 4.0 g of unless the package complies with
saturated fat, 60 milligrams (mg) of § 101.2(c)(2), in which case the disclo-
cholesterol, or 480 mg of sodium per sure statement may be in type of not
reference amount customarily con- less than one thirty-second of an inch.
sumed, per labeled serving, or, for a (ii) The disclosure statement shall be
food with a reference amount custom-
immediately adjacent to the nutrient
arily consumed of 30 g or less or 2 ta-
content claim and may have no inter-
blespoons or less, per 50 g (for dehy-
vening material other than, if applica-
drated foods that must be reconsti-
tuted before typical consumption with ble, other information in the statement
water or a diluent containing an insig- of identity or any other information
nificant amount, as defined in that is required to be presented with
§ 101.9(f)(1), of all nutrients per ref- the claim under this section (e.g., see
erence amount customarily consumed, paragraph (j)(2) of this section) or
the per 50 g criterion refers to the ‘‘as under a regulation in subpart D of this
prepared’’ form), then that food must part (e.g., see §§ 101.54 and 101.62). If the
bear a statement disclosing that the nutrient content claim appears on
nutrient exceeding the specified level more than one panel of the label, the
is present in the food as follows: ‘‘See disclosure statement shall be adjacent
nutrition information for ____ content’’ to the claim on each panel except for
with the blank filled in with the iden- the panel that bears the nutrition in-
formation where it may be omitted.
tity of the nutrient exceeding the spec-

ified level, e.g., ‘‘See nutrition infor- (iii) If a single panel of a food label or
mation for fat content.’’ labeling contains multiple nutrient
89
§ 101.13 21 CFR Ch. I (4–1–23 Edition)
content claims or a single claim re- (1) To bear a relative claim about the
peated several times, a single disclo- level of a nutrient, the amount of that
sure statement may be made. The nutrient in the food must be compared
statement shall be adjacent to the to an amount of nutrient in an appro-
claim that is printed in the largest priate reference food as specified
type on that panel. below.
(i) Except as provided in § 101.9 or (i)(A) For ‘‘less’’ (or ‘‘fewer’’) and
§ 101.36, as applicable, or in paragraph ‘‘more’’ claims, the reference food may
(q)(3) of this section, the label or label- be a dissimilar food within a product
ing of a product may contain a state- category that can generally be sub-
ment about the amount or percentage stituted for one another in the diet
of a nutrient if: (e.g., potato chips as reference for pret-
(1) The use of the statement on the zels, orange juice as a reference for vi-
food implicitly characterizes the level tamin C tablets) or a similar food (e.g.,
of the nutrient in the food and is con- potato chips as reference for potato
sistent with a definition for a claim, as chips, one brand of multivitamin as
provided in subpart D of this part, for reference for another brand of multi-
the nutrient that the label addresses. vitamin).
Such a claim might be, ‘‘less than 3 g (B) For ‘‘light,’’ ‘‘reduced,’’ ‘‘added,’’
of fat per serving;’’ ‘‘extra,’’ ‘‘plus,’’ ‘‘fortified,’’ and ‘‘en-
(2) The use of the statement on the riched’’ claims, the reference food shall
food implicitly characterizes the level be a similar food (e.g., potato chips as
of the nutrient in the food and is not a reference for potato chips, one brand
consistent with such a definition, but of multivitamin for another brand of
the label carries a disclaimer adjacent multivitamin), and
to the statement that the food is not (ii)(A) For ‘‘light’’ claims, the ref-
‘‘low’’ in or a ‘‘good source’’ of the nu- erence food shall be representative of
trient, such as ‘‘only 200 mg sodium per the type of food that includes the prod-
serving, not a low sodium food.’’ The uct that bears the claim. The nutrient
disclaimer must be in easily legible value for the reference food shall be
print or type and in a size no less than representative of a broad base of foods
that required by § 101.7(i) for the net of that type; e.g., a value in a rep-
quantity of contents statement except resentative, valid data base; an average
where the size of the claim is less than value determined from the top three
two times the required size of the net national (or regional) brands, a market
quantity of contents statement, in basket norm; or, where its nutrient
which case the disclaimer shall be no value is representative of the food
less than one-half the size of the claim type, a market leader. Firms using
but no smaller than one-sixteenth of an such a reference nutrient value as a
inch unless the package complies with basis for a claim, are required to pro-
§ 101.2(c)(5), in which case the dis- vide specific information upon which
claimer may be in type of not less than the nutrient value was derived, on re-
one thirty-second of an inch, or quest, to consumers and appropriate
(3) The statement does not in any regulatory officials.
way implicitly characterize the level of (B) For relative claims other than
the nutrient in the food and it is not ‘‘light,’’ including ‘‘less’’ and ‘‘more’’
false or misleading in any respect (e.g., claims, the reference food may be the
‘‘100 calories’’ or ‘‘5 grams of fat’’), in same as that provided for ‘‘light’’ in
which case no disclaimer is required. paragraph (j)(1)(ii)(A) of this section,
(4) ‘‘Percent fat free’’ claims are not or it may be the manufacturer’s reg-
authorized by this paragraph. Such ular product, or that of another manu-
claims shall comply with § 101.62(b)(6). facturer, that has been offered for sale
(j) A food may bear a statement that to the public on a regular basis for a
compares the level of a nutrient in the substantial period of time in the same
food with the level of a nutrient in a geographic area by the same business
reference food. These statements shall entity or by one entitled to use its
be known as ‘‘relative claims’’ and in- trade name. The nutrient values used
clude ‘‘light,’’ ‘‘reduced,’’ ‘‘less’’ (or to determine the claim when com-
‘‘fewer’’), and ‘‘more’’ claims. paring a single manufacturer’s product
90
to the labeled product shall be either the label or in labeling of a food if the
the values declared in nutrition label- nutrient content of the reference food
ing or the actual nutrient values, pro- meets the requirement for a ‘‘low’’
vided that the resulting label is inter- claim for that nutrient (e.g., 3 g fat or
nally consistent to (i.e., that the val- less).
ues stated in the nutrition informa- (k) The term ‘‘modified’’ may be used
tion, the nutrient values in the accom- in the statement of identity of a food
panying information and the declara- that bears a relative claim that com-
tion of the percentage of nutrient by plies with the requirements of this
which the food has been modified are part, followed immediately by the
consistent and will not cause consumer name of the nutrient whose content
confusion when compared), and that has been altered (e.g., ‘‘Modified fat
the actual modification is at least cheesecake’’). This statement of iden-
equal to the percentage specified in the tity must be immediately followed by
definition of the claim. the comparative statement such as
(2) For foods bearing relative claims: ‘‘Contains 35 percent less fat than
(i) The label or labeling must state ______.’’ The label or labeling must also
the identity of the reference food and bear the information required by para-
the percentage (or fraction) of the graph (j)(2) of this section in the man-
amount of the nutrient in the reference ner prescribed.
food by which the nutrient in the la- (l) For purposes of making a claim, a
beled food differs (e.g., ‘‘50 percent less ‘‘meal product shall be defined as a
fat than (reference food)’’ or ‘‘1/3 fewer food that:
calories than (reference food)’’), (1) Makes a major contribution to the
(ii) This information shall be imme- total diet by:
diately adjacent to the most prominent (i) Weighing at least 10 ounces (oz)
claim. The type size shall be in accord- per labeled serving; and
ance with paragraph (h)(4)(i) of this (ii) Containing not less than three 40-
section. g portions of food, or combinations of
(iii) The determination of which use foods, from two or more of the fol-
of the claim is in the most prominent lowing four food groups, except as
location on the label or labeling will be noted in paragraph (l)(1)(ii)(E) of this
made based on the following factors, section.
considered in order: (A) Bread, cereal, rice, and pasta
(A) A claim on the principal display group;
panel adjacent to the statement of (B) Fruits and vegetables group;
identity; (C) Milk, yogurt, and cheese group;
(B) A claim elsewhere on the prin- (D) Meat, poultry, fish, dry beans,
cipal display panel; eggs, and nuts group; except that;
(C) A claim on the information panel; (E) These foods shall not be sauces
or (except for foods in the above four food
(D) A claim elsewhere on the label or groups that are in the sauces), gravies,
labeling. condiments, relishes, pickles, olives,
(iv) The label or labeling must also jams, jellies, syrups, breadings or
bear: garnishes; and
(A) Clear and concise quantitative in- (2) Is represented as, or is in a form
formation comparing the amount of commonly understood to be, a break-
the subject nutrient in the product per fast, lunch, dinner, or meal. Such rep-
labeled serving with that in the ref- resentations may be made either by
erence food; and statements, photographs, or vignettes.
(B) This statement shall appear adja- (m) For purposes of making a claim,
cent to the most prominent claim or to a ‘‘main dish product’’ shall be defined
the nutrition label, except that if the as a food that:
nutrition label is on the information (1) Makes a major contribution to a
panel, the quantitative information meal by
may be located elsewhere on the infor- (i) Weighing at least 6 oz per labeled
mation panel in accordance with § 101.2. serving; and

(3) A relative claim for decreased lev- (ii) Containing not less than 40 g of
els of a nutrient may not be made on food, or combinations of foods, from
91
§ 101.13 21 CFR Ch. I (4–1–23 Edition)
each of at least two of the following are contained in the brand name of a
four food groups, except as noted in specific food product that was the
paragraph (m)(1)(ii)(E) of this section. brand name in use on such food before
(A) Bread, cereal, rice, and pasta October 25, 1989, may continue to be
group; used as part of that brand name for
(B) Fruits and vegetables group; such product, provided that they are
(C) Milk, yogurt, and cheese group; not false or misleading under section
(D) Meat, poultry, fish, dry beans, 403(a) of the Federal Food, Drug, and
eggs, and nuts groups; except that: Cosmetic Act (the act). However, foods
(E) These foods shall not be sauces bearing such claims must comply with
(except for foods in the above four food section 403(f), (g), and (h) of the act;
groups that are in the sauces) gravies, (2) A soft drink that used the term
condiments, relishes, pickles, olives,
diet as part of its brand name before
jams, jellies, syrups, breadings, or
October 25, 1989, and whose use of that
garnishes; and
term was in compliance with § 105.66 of
(2) Is represented as, or is in a form
this chapter as that regulation ap-
commonly understood to be, a main
dish (e.g., not a beverage or a dessert). peared in the Code of Federal Regula-
Such representations may be made ei- tions on that date, may continue to use
ther by statements, photographs, or vi- that term as part of its brand name,
gnettes. provided that its use of the term is not
(n) Nutrition labeling in accordance false or misleading under section 403(a)
with § 101.9, § 101.10, or § 101.36, as appli- of the act. Such claims are exempt
cable, shall be provided for any food for from the requirements of section
which a nutrient content claim is 403(r)(2) of the act (e.g., the disclosure
made. statement also required by § 101.13(h)).
(o) Except as provided in § 101.10, Soft drinks marketed after October 25,
compliance with requirements for nu- 1989, may use the term ‘‘diet’’ provided
trient content claims in this section they are in compliance with the cur-
and in the regulations in subpart D of rent § 105.66 of this chapter and the re-
this part, will be determined using the quirements of § 101.13.
analytical methodology prescribed for (3)(i) A statement that describes the
determining compliance with nutrition percentage of a vitamin or mineral in
labeling in § 101.9. the food, including foods intended spe-
(p)(1) Unless otherwise specified, the cifically for use by infants and children
reference amount customarily con- less than 2 years of age, in relation to
sumed set forth in § 101.12(b) through (f) a Reference Daily Intake (RDI) as de-
shall be used in determining whether a fined in § 101.9 may be made on the
product meets the criteria for a nutri- label or in labeling of a food without a
ent content claim. If the serving size regulation authorizing such a claim for
declared on the product label differs a specific vitamin or mineral unless
from the reference amount customarily
such claim is expressly prohibited by
consumed, and the amount of the nu-
regulation under section 403(r)(2)(A)(vi)
trient contained in the labeled serving
of the act.
does not meet the maximum or min-
imum amount criterion in the defini- (ii) Percentage claims for dietary
tion for the descriptor for that nutri- supplements. Under section 403(r)(2)(F)
ent, the claim shall be followed by the of the act, a statement that character-
criteria for the claim as required by izes the percentage level of a dietary
§ 101.12(g) (e.g., ‘‘very low sodium, 35 ingredient for which a reference daily
mg or less per 240 milliliters (8 fl oz.)’’). intake (RDI) or daily reference value
(2) The criteria for the claim shall be (DRV) has not been established may be
immediately adjacent to the most made on the label or in labeling of die-
prominent claim in easily legible print tary supplements without a regulation
or type and in a size in accordance with that specifically defines such a state-
paragraph (h)(4)(i) of this section. ment. All such claims shall be accom-
(q) The following exemptions apply: panied by any disclosure statement re-
(1) Nutrient content claims that have quired under paragraph (h) of this sec-
not been defined by regulation and that tion.
92
(A) Simple percentage claims. When- factors on which the reasonable basis
ever a statement is made that charac- was determined (e.g., types and
terizes the percentage level of a die- amounts of ingredients, cooking tem-
tary ingredient for which there is no peratures, etc.). Firms making claims
RDI or DRV, the statement of the ac- on foods based on this reasonable basis
tual amount of the dietary ingredient criterion are required to provide to ap-
per serving shall be declared next to propriate regulatory officials on re-
the percentage statement (e.g., ‘‘40 per- quest the specific information on which
cent omega-3 fatty acids, 10 mg per their determination is based and rea-
capsule’’). sonable assurance of operational adher-
(B) Comparative percentage claims. ence to the preparation methods or
Whenever a statement is made that other basis for the claim; and
characterizes the percentage level of a (iii) A term or symbol that may in
dietary ingredient for which there is no some contexts constitute a claim under
RDI or DRV and the statement draws a this section may be used, provided that
comparison to the amount of the die- the use of the term or symbol does not
tary ingredient in a reference food, the characterize the level of a nutrient,
reference food shall be clearly identi- and a statement that clearly explains
fied, the amount of that food shall be the basis for the use of the term or
identified, and the information on the symbol is prominently displayed and
actual amount of the dietary ingre- does not characterize the level of a nu-
dient in both foods shall be declared in trient. For example, a term such as
accordance with paragraph (j)(2)(iv) of ‘‘lite fare’’ followed by an asterisk re-
this section (e.g., ‘‘twice the omega-3 ferring to a note that makes clear that
fatty acids per capsule (80 mg) as in 100 in this restaurant ‘‘lite fare’’ means
mg of menhaden oil (40 mg)’’). smaller portion sizes than normal; or
(4) The requirements of this section an item bearing a symbol referring to a
do not apply to: note that makes clear that this item
(i) Infant formulas subject to section meets the criteria for the dietary guid-
412(h) of the act; and ance established by a recognized die-
(ii) Medical foods defined by section tary authority would not be considered
5(b) of the Orphan Drug Act. a nutrient content claim under § 101.13.
(5) A nutrient content claim used on (6) Nutrient content claims that were
food that is served in restaurants or part of the common or usual names of
other establishments in which food is foods that were subject to a standard of
served for immediate human consump- identity on November 8, 1990, are not
tion or which is sold for sale or use in subject to the requirements of para-
such establishments shall comply with graphs (b) and (h) of this section or to
definitions in subpart D of this part.
the requirements of this section and
(7) Implied nutrient content claims
the appropriate definition in subpart D
may be used as part of a brand name,
of this part, except that:
provided that the use of the claim has
(i) Such claim is exempt from the re-
been authorized by the Food and Drug
quirements for disclosure statements
Administration. Petitions requesting
in paragraph (h) of this section and
approval of such a claim may be sub-
§§ 101.54(d), 101.62(c), (d)(1)(ii)(D),
mitted under § 101.69(o).
(d)(2)(iii)(C), (d)(3), (d)(4)(ii)(C), and
(8) The term fluoridated, fluoride
(d)(5)(ii)(C); and
added or with added fluoride may be
(ii) In lieu of analytical testing, com-
used on the label or in labeling of bot-
pliance may be determined using a rea-
tled water that contains added fluo-
sonable basis for concluding that the
ride.
food that bears the claim meets the
definition for the claim. This reason- [58 FR 2410, Jan. 6, 1993; 58 FR 17341, 17342,
able basis may derive from recognized Apr. 2, 1993, as amended at 58 FR 44030, Aug.
data bases for raw and processed foods, 18, 1993; 59 FR 393, Jan. 4, 1994; 59 FR 15051,
Mar. 31, 1994; 60 FR 17205, Apr. 5, 1995; 61 FR
recipes, and other means to compute
11731, Mar. 22, 1996; 61 FR 40332, Aug. 2, 1996;
nutrient levels in the foods or meals 61 FR 67452, Dec. 23, 1996; 62 FR 31339, June 9,
and may be used provided reasonable 1997; 62 FR 49867, Sept. 23, 1997; 63 FR 14818,
steps are taken to ensure that the Mar. 27, 1998; 63 FR 26980, May 15, 1998; 81 FR
method of preparation adheres to the 59131, Aug. 29, 2016]
93
§ 101.14 21 CFR Ch. I (4–1–23 Edition)
§ 101.14 Health claims: general re- (i) The levels for a meal product as
quirements. defined in § 101.13(l) are 26.0 g of fat, 8.0
(a) Definitions. For purposes of this g of saturated fat, 120 mg of choles-
section, the following definitions terol, or 960 mg of sodium per label
apply: serving size, and
(1) Health claim means any claim (ii) The levels for a main dish product
made on the label or in labeling of a as defined in § 101.13(m) are 19.5 g of fat,
food, including a dietary supplement, 6.0 g of saturated fat, 90 mg of choles-
that expressly or by implication, in- terol, or 720 mg of sodium per label
cluding ‘‘third party’’ references, writ- serving size.
ten statements (e.g., a brand name in- (5) Disease or health-related condition
cluding a term such as ‘‘heart’’), sym- means damage to an organ, part, struc-
bols (e.g., a heart symbol), or vi- ture, or system of the body such that it
gnettes, characterizes the relationship does not function properly (e.g., cardio-
of any substance to a disease or health- vascular disease), or a state of health
related condition. Implied health leading to such dysfunctioning (e.g.,
claims include those statements, sym- hypertension); except that diseases re-
bols, vignettes, or other forms of com- sulting from essential nutrient defi-
munication that suggest, within the ciencies (e.g., scurvy, pellagra) are not
context in which they are presented, included in this definition (claims per-
that a relationship exists between the taining to such diseases are thereby
presence or level of a substance in the not subject to § 101.14 or § 101.70).
food and a disease or health-related (b) Eligibility. For a substance to be
condition. eligible for a health claim:
(2) Substance means a specific food or (1) The substance must be associated
component of food, regardless of with a disease or health-related condi-
whether the food is in conventional tion for which the general U.S. popu-
food form or a dietary supplement that lation, or an identified U.S. population
includes vitamins, minerals, herbs, or subgroup (e.g., the elderly) is at risk,
other similar nutritional substances. or, alternatively, the petition sub-
(3) Nutritive value means a value in mitted by the proponent of the claim
sustaining human existence by such otherwise explains the prevalence of
processes as promoting growth, replac- the disease or health-related condition
ing loss of essential nutrients, or pro- in the U.S. population and the rel-
viding energy. evance of the claim in the context of
(4) Disqualifying nutrient levels means the total daily diet and satisfies the
the levels of total fat, saturated fat, other requirements of this section.
cholesterol, or sodium in a food above (2) If the substance is to be consumed
which the food will be disqualified from as a component of a conventional food
making a health claim. These levels at decreased dietary levels, the sub-
are 13.0 grams (g) of fat, 4.0 g of satu- stance must be a nutrient listed in 21
rated fat, 60 milligrams (mg) of choles- U.S.C. 343(q)(1)(C) or (q)(1)(D), or one
terol, or 480 mg of sodium, per ref- that the Food and Drug Administra-
erence amount customarily consumed, tion (FDA) has required to be included
per label serving size, and, only for in the label or labeling under 21 U.S.C.
foods with reference amounts custom- 343(q)(2)(A); or
arily consumed of 30 g or less or 2 ta- (3) If the substance is to be consumed
blespoons or less, per 50 g. For dehy- at other than decreased dietary levels:
drated foods that must have water (i) The substance must, regardless of
added to them prior to typical con- whether the food is a conventional food
sumption, the per 50-g criterion refers or a dietary supplement, contribute
to the as prepared form. Any one of the taste, aroma, or nutritive value, or any
levels, on a per reference amount cus- other technical effect listed in § 170.3(o)
tomarily consumed, a per label serving of this chapter, to the food and must
size or, when applicable, a per 50 g retain that attribute when consumed
basis, will disqualify a food from mak- at levels that are necessary to justify a
ing a health claim unless an exception claim; and

is provided in subpart E of this part, (ii) The substance must be a food or
except that: a food ingredient or a component of a
94
food ingredient whose use at the levels (iv) All information required to be in-
necessary to justify a claim has been cluded in the claim appears in one
demonstrated by the proponent of the place without other intervening mate-
claim, to FDA’s satisfaction, to be safe rial, except that the principal display
and lawful under the applicable food panel of the label or labeling may bear
safety provisions of the Federal Food, the reference statement, ‘‘See ______
Drug, and Cosmetic Act. for information about the relationship
(c) Validity requirement. FDA will pro- between ______ and ______,’’ with the
mulgate regulations authorizing a blanks filled in with the location of the
health claim only when it determines, labeling containing the health claim,
based on the totality of publicly avail- the name of the substance, and the dis-
able scientific evidence (including evi- ease or health-related condition (e.g.,
dence from well-designed studies con- ‘‘See attached pamphlet for informa-
ducted in a manner which is consistent tion about calcium and osteoporosis’’),
with generally recognized scientific with the entire claim appearing else-
procedures and principles), that there where on the other labeling, Provided
is significant scientific agreement, that, where any graphic material (e.g.,
among experts qualified by scientific a heart symbol) constituting an ex-
training and experience to evaluate plicit or implied health claim appears
such claims, that the claim is sup- on the label or labeling, the reference
ported by such evidence. statement or the complete claim shall
(d) General health claim labeling re- appear in immediate proximity to such
quirements. (1) When FDA determines graphic material;
that a health claim meets the validity (v) The claim enables the public to
requirements of paragraph (c) of this comprehend the information provided
section, FDA will propose a regulation and to understand the relative signifi-
in subpart E of this part to authorize cance of such information in the con-
text of a total daily diet; and
the use of that claim. If the claim per-
(vi) If the claim is about the effects
tains to a substance not provided for in
of consuming the substance at de-
§ 101.9 or § 101.36, FDA will propose
creased dietary levels, the level of the
amending that regulation to include
substance in the food is sufficiently
declaration of the substance.
low to justify the claim. To meet this
(2) When FDA has adopted a regula- requirement, if a definition for use of
tion in subpart E of this part providing the term low has been established for
for a health claim, firms may make that substance under this part, the sub-
claims based on the regulation in substance must be present at a level that
part E of this part, provided that: meets the requirements for use of that
(i) All label or labeling statements term, unless a specific alternative level
about the substance-disease relation- has been established for the substance
ship that is the subject of the claim are in subpart E of this part. If no defini-
based on, and consistent with, the con- tion for ‘‘low’’ has been established,
clusions set forth in the regulations in the level of the substance must meet
subpart E of this part; the level established in the regulation
(ii) The claim is limited to describing authorizing the claim; or
the value that ingestion (or reduced in- (vii) If the claim is about the effects
gestion) of the substance, as part of a of consuming the substance at other
total dietary pattern, may have on a than decreased dietary levels, the level
particular disease or health-related of the substance is sufficiently high
condition; and in an appropriate form to justify
(iii) The claim is complete, truthful, the claim. To meet this requirement, if
and not misleading. Where factors a definition for use of the term high for
other than dietary intake of the sub- that substance has been established
stance affect the relationship between under this part, the substance must be
the substance and the disease or present at a level that meets the re-
health-related condition, such factors quirements for use of that term, unless
may be required to be addressed in the a specific alternative level has been es-
claim by a specific regulation in sub- tablished for the substance in subpart
part E of this part; E of this part. If no definition for
95
§ 101.15 21 CFR Ch. I (4–1–23 Edition)
‘‘high’’ has been established (e.g., tablished for the substance in subpart
where the claim pertains to a food ei- E of this part; or unless FDA has per-
ther as a whole food or as an ingredient mitted a claim despite the fact that a
in another food), the claim must speci- disqualifying level of a nutrient is
fy the daily dietary intake necessary present in the food based on a finding
to achieve the claimed effect, as estab- that such a claim will assist consumers
lished in the regulation authorizing the in maintaining healthy dietary prac-
claim; Provided That: tices, and, in accordance with the regu-
(A) Where the food that bears the lation in subpart E of this part that
claim meets the requirements of para- makes such a finding, the label bears a
graphs (d)(2)(vi) or (d)(2)(vii) of this disclosure statement that complies
section based on its reference amount with § 101.13(h), highlighting the nutri-
customarily consumed, and the labeled ent that exceeds the disqualifying
serving size differs from that amount, level;
the claim shall be followed by a state- (4) Except as provided in paragraph
ment explaining that the claim is (e)(3) of this section, no substance is
based on the reference amount rather present at an inappropriate level as de-
than the labeled serving size (e.g., termined in the specific provision au-
‘‘Diets low in sodium may reduce the thorizing the claim in subpart E of this
risk of high blood pressure, a disease part;
associated with many factors. A serv- (5) The label does not represent or
ing of __ ounces of this product con- purport that the food is for infants and
forms to such a diet.’’). toddlers less than 2 years of age except
(B) Where the food that bears the if the claim is specifically provided for
claim is sold in a restaurant or in other in subpart E of this part; and
establishments in which food that is (6) Except for dietary supplements or
ready for immediate human consump- where provided for in other regulations
tion is sold, the food can meet the rein part 101, subpart E, the food con-
quirements of paragraphs (d)(2)(vi) or tains 10 percent or more of the Ref-
(d)(2)(vii) of this section if the firm erence Daily Intake or the Daily Ref-
that sells the food has a reasonable erence Value for vitamin A, vitamin C,
basis on which to believe that the food iron, calcium, protein, or fiber per ref-
that bears the claim meets the require- erence amount customarily consumed
ments of paragraphs (d)(2)(vi) or prior to any nutrient addition.
(d)(2)(vii) of this section and provides (f) The requirements of this section
that basis upon request. do not apply to:
(3) Nutrition labeling shall be pro- (1) Infant formulas subject to section
vided in the label or labeling of any 412(h) of the Federal Food, Drug, and
food for which a health claim is made Cosmetic Act, and
in accordance with § 101.9; for res- (2) Medical foods defined by section
taurant foods, in accordance with 5(b) of the Orphan Drug Act.
§ 101.10; or for dietary supplements, in (g) Applicability. The requirements of
accordance with § 101.36. this section apply to foods intended for
(e) Prohibited health claims. No ex- human consumption that are offered
pressed or implied health claim may be for sale, regardless of whether the
made on the label or in labeling for a foods are in conventional food form or
food, regardless of whether the food is dietary supplement form.
in conventional food form or dietary
[58 FR 2533, Jan. 6, 1993; 58 FR 17097, Apr. 1,
supplement form, unless: 1993, as amended at 58 FR 44038, Aug. 18, 1993;
(1) The claim is specifically provided 59 FR 425, Jan. 4, 1994; 59 FR 15050, Mar. 31,
for in subpart E of this part; and 1994; 61 FR 40332, Aug. 2, 1996; 62 FR 49867,
(2) The claim conforms to all general Sept. 23, 1997; 63 FR 26980, May 15, 1998; 66 FR
provisions of this section as well as to 17358, Mar. 30, 2001]
all specific provisions in the appro-
priate section of subpart E of this part; § 101.15 Food; prominence of required
(3) None of the disqualifying levels statements.
identified in paragraph (a)(4) of this (a) A word, statement, or other infor-

section is exceeded in the food, unless mation required by or under authority
specific alternative levels have been es- of the act to appear on the label may
96
lack that prominence and conspicuous- (3) The use of label space for any rep-
ness required by section 403(f) of the resentation in a foreign language.
act by reason (among other reasons) of: (c)(1) All words, statements, and
(1) The failure of such word, state- other information required by or under
ment, or information to appear on the authority of the act to appear on the
part or panel of the label which is pre- label or labeling shall appear thereon
sented or displayed under customary in the English language: Provided, how-
conditions of purchase; ever, That in the case of articles dis-
(2) The failure of such word, state- tributed solely in the Commonwealth
ment, or information to appear on two of Puerto Rico or in a Territory where
or more parts or panels of the label, the predominant language is one other
each of which has sufficient space than English, the predominant lan-
therefor, and each of which is so de- guage may be substituted for English.
(2) If the label contains any represen-
signed as to render it likely to be,
tation in a foreign language, all words,
under customary conditions of pur-
statements, and other information re-
chase, the part or panel displayed;
quired by or under authority of the act
(3) The failure of the label to extend to appear on the label shall appear
over the area of the container or pack- thereon in the foreign language: Pro-
age available for such extension, so as vided, however, That individual serving-
to provide sufficient label space for the size packages of foods containing no
prominent placing of such word, state- more than 11⁄2 avoirdupois ounces or no
ment, or information; more than 11⁄2 fluid ounces served with
(4) Insufficiency of label space (for meals in restaurants, institutions, and
the prominent placing of such word, passenger carriers and not intended for
statement, or information) resulting sale at retail are exempt from the re-
from the use of label space for any quirements of this paragraph (c)(2), if
word, statement, design, or device the only representation in the foreign
which is not required by or under au- language(s) is the name of the food.
thority of the act to appear on the (3) If any article of labeling (other
label; than a label) contains any representa-
(5) Insufficiency of label space (for tion in a foreign language, all words,
the prominent placing of such word, statements, and other information re-
statement, or information) resulting quired by or under authority of the act
from the use of label space to give ma- to appear on the label or labeling shall
terially greater conspicuousness to any appear on such article of labeling.
other word, statement, or information,
or to any design or device; or § 101.17 Food labeling warning, notice,
and safe handling statements.
(6) Smallness or style of type in
which such word, statement, or infor- (a) Self-pressurized containers. (1) The
mation appears, insufficient back- label of a food packaged in a self-pres-
ground contrast, obscuring designs or surized container and intended to be
vignettes, or crowding with other writ- expelled from the package under pres-
ten, printed, or graphic matter. sure shall bear the following warning:
(b) No exemption depending on insuf- WARNING—Avoid spraying in eyes. Con-
ficiency of label space, as prescribed in tents under pressure. Do not puncture or in-
regulations promulgated under section cinerate. Do not store at temperature above
403 (e) or (i) of the act, shall apply if 120 °F. Keep out of reach of children.
such insufficiency is caused by: (2) In the case of products intended
(1) The use of label space for any for use by children, the phrase ‘‘except
word, statement, design, or device under adult supervision’’ may be added
which is not required by or under au- at the end of the last sentence in the
thority of the act to appear on the warning required by paragraph (a)(1) of
label; this section.
(2) The use of label space to give (3) In the case of products packaged
greater conspicuousness to any word, in glass containers, the word ‘‘break’’
statement, or other information than may be substituted for the word

is required by section 403(f) of the act; ‘‘puncture’’ in the warning required by
or paragraph (a)(1) of this section.
97
§ 101.17 21 CFR Ch. I (4–1–23 Edition)
(4) The words ‘‘Avoid spraying in (2) Products described in paragraph

eyes’’ may be deleted from the warning (d)(1) of this section are exempt from
required by paragraph (a)(1) of this sec- the labeling requirements of that para-
tion in the case of a product not ex- graph if the protein products are rep-
pelled as a spray. resented as part of a nutritionally bal-
(b) Self-pressurized containers with anced diet plan providing 400 or more
halocarbon or hydrocarbon propellants. Calories (kilocalories) per day and the
(1) In addition to the warning required label or labeling of the product speci-
by paragraph (a) of this section, the fies the diet plan in detail or provides
label of a food packaged in a self-pres- a brief description of that diet plan and
surized container in which the propel- adequate information describing where
lant consists in whole or in part of a the detailed diet plan may be obtained
halocarbon or a hydrocarbon shall bear and the label and labeling bear the fol-
the following warning: lowing statement:
WARNING—Use only as directed. Inten- Notice: For weight reduction, use only as
tional misuse by deliberately concentrating directed in the accompanying diet plan (the
and inhaling the contents can be harmful or name and specific location in labeling of the
fatal. diet plan may be included in this statement
in place of ‘‘accompanying diet plan’’). Do
(2) The warning required by para- not use in diets supplying less than 400 Cal-
graph (b)(1) of this section is not re- ories per day without medical supervision.
quired for the following products:
(3) The label and labeling of food
(i) Products expelled in the form of a products represented or intended for
foam or cream, which contain less than dietery (food) supplementation that de-
10 percent propellant in the container. rive more than 50 percent of their total
(ii) Products in a container with a caloric value from either whole pro-
physical barrier that prevents escape of tein, protein hydrolysates, amino acid
the propellant at the time of use. mixtures, or a combination of these,
(iii) Products of a net quantity of that are represented specifically for
contents of less than 2 ounces that are purposes other than weight reduction;
designed to release a measured amount and that are not covered by the re-
of product with each valve actuation. quirements of paragraph (d) (1) and (2)
(iv) Products of a net quantity of of this section; shall bear the following
contents of less than one-half ounce. statement:
(c) Food containing or manufactured
with a chlorofluorocarbon or other ozone- NOTICE: Use this product as a food supple-
ment only. Do not use for weight reduction.
depleting substance. Labeling require-
ments for foods that contain or are (4) The provisions of this paragraph
manufactured with a are separate from and in addition to
chlorofluorocarbon or other ozone-de- any labeling requirements promulgated
pleting substance designated by the by the Federal Trade Commission for
Environmental Protection Agency protein supplements.
(EPA) are set forth in 40 CFR part 82. (5) Protein products shipped in bulk
(d) Protein products. (1) The label and form for use solely in the manufacture
labeling of any food product in liquid, of other foods and not for distribution
powdered, tablet, capsule, or similar to consumers in such container are ex-
forms that derives more than 50 per- empt from the labeling requirements of
cent of its total caloric value from ei- this paragraph.
ther whole protein, protein hydroly- (6) The warning and notice state-
sates, amino acid mixtures, or a comments required by paragraphs (d) (1),
bination of these, and that is rep- (2), and (3) of this section shall appear
resented for use in reducing weight prominently and conspicuously on the
shall bear the following warning: principal display panel of the package
label and any other labeling.
WARNING: Very low calorie protein diets
(e) Dietary supplements containing iron
(below 400 Calories per day) may cause seri-
ous illness or death. Do Not Use for Weight or iron salts. (1) The labeling of any die-
Reduction in Such Diets Without Medical tary supplement in solid oral dosage
Supervision. Not for use by infants, children, form (e.g., tablets or capsules) that
or pregnant or nursing women. contains iron or iron salts for use as an
98
iron source shall bear the following ventional food form may be exempt
statement: from this requirement if a viscous ad-
WARNING: Accidental overdose of iron-
hesive mass is not formed when the
containing products is a leading cause of food is exposed to fluids.
fatal poisoning in children under 6. Keep this (2) The statement shall appear promi-
product out of reach of children. In case of nently and conspicuously on the infor-
accidental overdose, call a doctor or poison mation panel or principal display panel
control center immediately. of the package label and any other la-
(2)(i) The warning statement required beling to render it likely to be read and
by paragraph (e)(1) of this section shall understood by the ordinary individual
appear prominently and conspicuously under customary conditions of pur-
on the information panel of the imme- chase and use. The statement shall be
diate container label. preceded by the word ‘‘NOTICE’’ in
(ii) If a product is packaged in unit- capital letters.
dose packaging, and if the immediate (g) Juices that have not been specifi-
container bears labeling but not a cally processed to prevent, reduce, or
label, the warning statement required eliminate the presence of pathogens. (1)
by paragraph (e)(1) of this section shall For purposes of this paragraph (g),
appear prominently and conspicuously ‘‘juice’’ means the aqueous liquid ex-
on the immediate container labeling in pressed or extracted from one or more
a way that maximizes the likelihood fruits or vegetables, purees of the edi-
that the warning is intact until all of ble portions of one or more fruits or
the dosage units to which it applies are vegetables, or any concentrate of such
used. liquid or puree.
(3) Where the immediate container is (2) The label of:
not the retail package, the warning (i) Any juice that has not been proc-
statement required by paragraph (e)(1) essed in the manner described in para-
of this section shall also appear promi- graph (g)(7) of this section; or
nently and conspicuously on the infor- (ii) Any beverage containing juice
mation panel of the retail package where neither the juice ingredient nor
label. the beverage has been processed in the
(4) The warning statement shall ap- manner described in paragraph (g)(7) of
pear on any labeling that contains this section, shall bear the following
warnings. warning statement:
(5) The warning statement required
by paragraph (e)(1) of this section shall WARNING: This product has not been pas-
be set off in a box by use of hairlines. teurized and, therefore, may contain harmful
(f) Foods containing psyllium husk. (1) bacteria that can cause serious illness in
children, the elderly, and persons with weak-
Foods containing dry or incompletely ened immune systems.
hydrated psyllium husk, also known as
psyllium seed husk, and bearing a (3) The warning statement required
health claim on the association be- by this paragraph (g) shall not apply to
tween soluble fiber from psyllium husk juice that is not for distribution to re-
and reduced risk of coronary heart dis- tail consumers in the form shipped and
ease, shall bear a label statement in- that is for use solely in the manufac-
forming consumers that the appro- ture of other foods or that is to be
priate use of such foods requires con- processed, labeled, or repacked at a
sumption with adequate amounts of site other than originally processed,
fluids, alerting them of potential con- provided that for juice that has not
sequences of failing to follow usage been processed in the manner described
recommendations, and informing per- in paragraph (g)(7) of this section, the
sons with swallowing difficulties to lack of such processing is disclosed in
avoid consumption of the product (e.g., documents accompanying the juice, in
‘‘NOTICE: This food should be eaten accordance with the practice of the
with at least a full glass of liquid. Eat- trade.
ing this product without enough liquid (4) The warning statement required
may cause choking. Do not eat this by paragraph (g)(2) of this section shall
product if you have difficulty in swal- appear prominently and conspicuously
lowing.’’). However, a product in con- on the information panel or on the
99
§ 101.17 21 CFR Ch. I (4–1–23 Edition)
principal display panel of the label of quirements of paragraph (h) of this sec-
the container. tion.
(5) The word ‘‘WARNING’’ shall be (5) The safe handling statement for
capitalized and shall appear in bold shell eggs that are not for direct sale
type. to consumers, e.g., those that are to be
(6) The warning statement required repacked or labeled at a site other than
by paragraph (g)(2) of this section, where originally processed, or are sold
when on a label, shall be set off in a for use in food service establishments,
box by use of hairlines. may be provided on cartons or in label-
(7)(i) The requirements in this para- ing, e.g., invoices or bills of lading in
graph (g) shall not apply to a juice that accordance with the practice of the
has been processed in a manner that trade.
will produce, at a minimum, a reduc-
(6) Under sections 311 and 361 of the
tion in the pertinent microorganism
Public Health Service Act (PHS Act),
for a period at least as long as the shelf
life of the product when stored under any State or locality that is willing
normal and moderate abuse conditions, and able to assist the agency in the en-
of the following magnitude: forcement of paragraphs (h)(1) through
(A) A 5-log (i.e., 100,000-fold) reduc- (h)(5) of this section, and is authorized
tion; or to inspect or regulate establishments
(B) A reduction that is equal to, or handling packed shell eggs, may in its
greater than, the criterion established own jurisdiction, enforce paragraphs
for process controls by any final regu- (h)(1) through (h)(5) of this section
lation requiring the application of Haz- through inspections under paragraph
ard Analysis and Critical Control Point (h)(8) of this section and through ad-
(HACCP) principles to the processing of ministrative enforcement remedies
juice. identified in paragraph (h)(7) of this
(ii) For the purposes of this para- section until FDA notifies the State or
graph (g), the ‘‘pertinent microorga- locality in writing that such assistance
nism’’ is the most resistant microorga- is no longer needed. When providing
nism of public health significance that such assistance, a State or locality
is likely to occur in the juice. may follow the hearing procedures set
(h) Shell eggs. (1) The label of all shell out in paragraphs (h)(7)(ii)(C) through
eggs, whether in intrastate or inter- (h)(7)(ii)(D) of this section, sub-
state commerce, shall bear the fol- stituting, where necessary, appropriate
lowing statement: State or local officials for designated
SAFE HANDLING INSTRUCTIONS: To FDA officials or may utilize State or
prevent illness from bacteria: keep eggs re- local hearing procedures if such proce-
frigerated, cook eggs until yolks are firm, dures satisfy due process.
and cook foods containing eggs thoroughly. (7) This paragraph (h) is established
(2) The label statement required by under authority of both the Federal
paragraph (h)(1) of this section shall Food, Drug, and Cosmetic Act (the act)
appear prominently and conspicuously, and the PHS Act. Under the act, the
with the words ‘‘SAFE HANDLING IN- agency can enforce the food mis-
STRUCTIONS’’ in bold type, on the branding provisions under 21 U.S.C. 331,
principal display panel, the informa- 332, 333, and 334. However, 42 U.S.C. 264
tion panel, or on the inside of the lid of provides for the issuance of imple-
egg cartons. If this statement appears menting enforcement regulations;
on the inside of the lid, the words therefore, FDA has established the fol-
‘‘Keep Refrigerated’’ must appear on lowing administrative enforcement
the principal display panel or informa- procedures for the relabeling, diver-
tion panel. sion, or destruction of shell eggs and
(3) The label statement required by informal hearings under the PHS Act:
paragraph (h)(1) of this section shall be (i) Upon finding that any shell eggs
set off in a box by use of hairlines. are in violation of this section an au-
(4) Shell eggs that have been, before thorized FDA representative or State
distribution to consumers, specifically or local representative in accordance

processed to destroy all viable Sal- with paragraph (h)(6) of this section
monella shall be exempt from the re- may order such eggs to be relabeled
100
under the supervision of said represent- (10) The name and phone number of
ative, diverted, under the supervision the person issuing the order; and
of said representative for processing in (11) The location and telephone num-
accordance with the Egg Products In- ber of the responsible office or agency
spection Act (EPIA) (21 U.S.C. 1031 et and the name of its director.
seq.), or destroyed by or under the su- (C) Approval of director. An order, be-
pervision of an officer or employee of fore issuance, shall be approved by the
the FDA, or, if applicable, of the State director of the office or agency issuing
or locality, in accordance with the fol- the order. If prior written approval is
lowing procedures: not feasible, prior oral approval shall
(A) Order for relabeling, diversion, or be obtained and confirmed by written
destruction under the PHS Act. Any divi- memorandum as soon as possible.
sion office of FDA or any State or lo- (D) Labeling or marking of shell eggs
cality acting under paragraph (h)(6) of under order. An FDA, State, or local
this section, upon finding shell eggs representative issuing an order under
held in violation of this section, may paragraph (h)(7)(i)(A) of this section
serve upon the person in whose posses- shall label or mark the shell eggs with
sion such eggs are found a written official tags that include the following
order that such eggs be relabeled with information:
the required statement in paragraph (1) A statement that the shell eggs
(h)(1) of this section before further dis- are detained in accordance with regula-
tribution. If the person chooses not to tions issued under section 361(a) of the
relabel, the division office of FDA or, if PHS Act (42 U.S.C. 264(a)).
applicable, the appropriate State or (2) A statement that the shell eggs
local agency may serve upon the per- shall not be sold, distributed or other-
son a written order that such eggs be wise disposed of or moved except, after
diverted (from direct consumer sale, notifying the issuing entity in writing,
e.g., to food service) under the super- to:
vision of an officer or employee of the (i) Relabel, divert them for proc-
issuing entity, for processing in accord- essing in accordance with the EPIA, or
ance with the EPIA (21 U.S.C. 1031 et destroy them, or
seq.) or destroyed by or under the su-
(ii) Move them to another location
pervision of the issuing entity, within
for holding pending appeal.
10 working days from the date of re-
ceipt of the order. (3) A statement that the violation of
the order or the removal or alteration
(B) Issuance of order. The order shall
of the tag is punishable by fine or im-
include the following information:
prisonment or both (section 368 of the
(1) A statement that the shell eggs PHS Act, 42 U.S.C. 271).
identified in the order are subject to
(4) The order number and the date of
relabeling, diversion for processing in
the order, and the name of the govern-
accordance with the EPIA, or destruc-
ment representative who issued the
tion;
order.
(2) A detailed description of the facts
(E) Sale or other disposition of shell
that justify the issuance of the order;
eggs under order. After service of the
(3) The location of the eggs; order, the person in possession of the
(4) A statement that these eggs shall shell eggs that are the subject of the
not be sold, distributed, or otherwise order shall not sell, distribute, or oth-
disposed of or moved except as pro- erwise dispose of or move any eggs sub-
vided in paragraph (h)(7)(i)(E) of this ject to the order unless and until the
section; notice is withdrawn after an appeal ex-
(5) Identification or description of cept, after notifying FDA’s division of-
the eggs; fice or, if applicable, the State or local
(6) The order number; agency in writing, to:
(7) The date of the order; (1) Relabel, divert, or destroy them
(8) The text of this entire section; as specified in paragraph (h)(7)(i) of
(9) A statement that the order may this section, or

be appealed by written appeal or by re- (2) Move them to another location for
questing an informal hearing; holding pending appeal.
101
§ 101.17 21 CFR Ch. I (4–1–23 Edition)
(ii) The person on whom the order for to enforce the requirements concerning
relabeling, diversion, or destruction is the conduct of hearings.
served may either comply with the (2) Employees of FDA will first give a
order or appeal the order to an Office of full and complete statement of the ac-
Regulatory Affairs Program Director. tion which is the subject of the hear-
(A) Appeal of a detention order. Any ing, together with the information and
appeal shall be submitted in writing to reasons supporting it, and may present
the FDA Division Director in whose di- oral or written information relevant to
vision the shell eggs are located within the hearing. The party requesting the
5 working days of the issuance of the hearing may then present oral or writ-
order. If the appeal includes a request ten information relevant to the hear-
for an informal hearing, the hearing ing. All parties may conduct reason-
shall be held within 5 working days able examination of any person (except
after the appeal is filed or, if requested for the presiding officer and counsel for
by the appellant, at a later date, which the parties) who makes any statement
shall not be later than 20 calendar days on the matter at the hearing.
after the issuance of the order. The (3) The hearing shall be informal in
order may also be appealed within the nature, and the rules of evidence do not
same period of 5 working days by any apply. No motions or objections relat-
other person having an ownership or ing to the admissibility of information
proprietary interest in such shell eggs. and views will be made or considered,
The appellant of an order shall state but any party may comment upon or
the ownership or proprietary interest rebut any information and views pre-
the appellant has in the shell eggs. sented by another party.
(B) Summary decision. A request for a (4) The party requesting the hearing
hearing may be denied, in whole or in may have the hearing transcribed, at
part and at any time after a request for the party’s expense, in which case a
a hearing has been submitted, if the Of- copy of the transcript is to be fur-
fice of Regulatory Affairs Program Di- nished to FDA. Any transcript of the
rector or another FDA official senior hearing will be included with the pre-
to an FDA Division Director deter- siding FDA official’s report of the hear-
mines that no genuine and substantial ing.
issue of fact has been raised by the ma- (5) The presiding FDA official shall
terial submitted in connection with the prepare a written report of the hearing.
hearing or from matters officially no- All written material presented at the
ticed. If the presiding FDA official de- hearing will be attached to the report.
termines that a hearing is not justi- Whenever time permits, the presiding
fied, written notice of the determina- FDA official may give the parties the
tion will be given to the parties ex- opportunity to review and comment on
plaining the reason for denial. the report of the hearing.
(C) Informal hearing. Appearance by (6) The presiding FDA official shall
any appellant at the hearing may be by include as part of the report of the
mail or in person, with or without hearing a finding on the credibility of
counsel. The informal hearing shall be witnesses (other than expert witnesses)
conducted by an Office of Regulatory whenever credibility is a material
Affairs Program Director or another issue, and shall include a recommended
FDA official senior to an FDA Division decision, with a statement of reasons.
Director, and a written summary of the (D) Written appeal. If the appellant
proceedings shall be prepared by the appeals the detention order but does
presiding FDA official. not request a hearing, the presiding
(1) The presiding FDA official may FDA official shall render a decision on
direct that the hearing be conducted in the appeal affirming or revoking the
any suitable manner permitted by law detention within 5-working days after
and this section. The presiding FDA of- the receipt of the appeal.
ficial has the power to take such ac- (E) Presiding FDA official’s decision. If,
tions and make such rulings as are nec- based on the evidence presented at the
essary or appropriate to maintain hearing or by the appellant in a writ-

order and to conduct an informal, fair, ten appeal, the presiding FDA official
expeditious, and impartial hearing, and finds that the shell eggs were held in
102
violation of this section, he shall af- quired in paragraphs (h)(1) through

firm the order that they be relabeled, (h)(5) of this section.
diverted under the supervision of an of-
[42 FR 14308, Mar. 15, 1977]
ficer or employee of FDA for processing
under the EPIA, or destroyed by or EDITORIAL NOTE: For FEDERAL REGISTER ci-
under the supervision of an officer or tations affecting § 101.17, see the List of CFR
employee of FDA; otherwise, the pre- Sections Affected, which appears in the
Finding Aids section of the printed volume
siding FDA official shall issue a writ-
and at www.govinfo.gov.
ten notice that the prior order is with-
drawn. If the presiding FDA official af- § 101.18 Misbranding of food.
firms the order, he shall order that the
relabeling, diversion, or destruction be (a) Among representations in the la-
accomplished within 10-working days beling of a food which render such food
from the date of the issuance of his de- misbranded is a false or misleading
cision. The presiding FDA official’s de- representation with respect to another
cision shall be accompanied by a state- food or a drug, device, or cosmetic.
ment of the reasons for the decision. (b) The labeling of a food which con-
The decision of the presiding FDA offi- tains two or more ingredients may be
cial shall constitute final agency ac- misleading by reason (among other rea-
tion, reviewable in the courts. sons) of the designation of such food in
(F) No appeal. If there is no appeal of such labeling by a name which includes
the order and the person in possession or suggests the name of one or more
of the shell eggs that are subject to the but not all such ingredients, even
order fails to relabel, divert, or destroy though the names of all such ingredi-
them within 10 working days, or if the ents are stated elsewhere in the label-
demand is affirmed by the presiding ing.
FDA official after an appeal and the (c) Among representations in the la-
person in possession of such eggs fails beling of a food which render such food
to relabel, divert, or destroy them misbranded is any representation that
within 10 working days, the FDA divi- expresses or implies a geographical ori-
sion office, or, if applicable, the State gin of the food or any ingredient of the
or local agency may designate an offi- food except when such representation
cer or employee to divert or destroy is either:
such eggs. It shall be unlawful to pre- (1) A truthful representation of geo-
vent or to attempt to prevent such di- graphical origin.
version or destruction of the shell eggs (2) A trademark or trade name pro-
by the designated officer or employee. vided that as applied to the article in
(8) Persons engaged in handling or question its use is not deceptively
storing packed shell eggs for retail dis- misdescriptive. A trademark or trade
tribution shall permit authorized rep- name composed in whole or in part of
resentatives of FDA to make at any geographical words shall not be consid-
reasonable time such inspection of the ered deceptively misdescriptive if it:
establishment in which shell eggs are (i) Has been so long and exclusively
being held, including inspection and used by a manufacturer or distributor
sampling of the labeling of such eggs as that it is generally understood by the
may be necessary in the judgment of consumer to mean the product of a par-
such representatives to determine com- ticular manufacturer or distributor; or
pliance with the provisions of this sec- (ii) Is so arbitrary or fanciful that it
tion. Inspections may be made with or is not generally understood by the con-
without notice and will ordinarily be sumer to suggest geographic origin.
made during regular business hours. (3) A part of the name required by ap-
(9) No State or local governing entity plicable Federal law or regulation.
shall establish or continue in effect (4) A name whose market signifi-
any law, rule, regulation, or other re- cance is generally understood by the
quirement requiring safe handling in- consumer to connote a particular class,

structions on unpasteurized shell eggs kind, type, or style of food rather than
that are less stringent than those re- to indicate geographical origin.
103
§ 101.22 21 CFR Ch. I (4–1–23 Edition)
Subpart B—Specific Food Labeling rather than nutritional. Natural fla-

Requirements vors include the natural essence or ex-
tractives obtained from plants listed in
§ 101.22 Foods; labeling of spices, §§ 182.10, 182.20, 182.40, and 182.50 and
flavorings, colorings and chemical part 184 of this chapter, and the sub-
preservatives. stances listed in § 172.510 of this chap-
(a)(1) The term artificial flavor or arti- ter.
ficial flavoring means any substance, (4) The term artificial color or artificial
the function of which is to impart fla- coloring means any ‘‘color additive’’ as
vor, which is not derived from a spice, defined in § 70.3(f) of this chapter.
fruit or fruit juice, vegetable or vege- (5) The term chemical preservative
table juice, edible yeast, herb, bark, means any chemical that, when added
bud, root, leaf or similar plant mate- to food, tends to prevent or retard de-
rial, meat, fish, poultry, eggs, dairy terioration thereof, but does not in-
products, or fermentation products clude common salt, sugars, vinegars,
thereof. Artificial flavor includes the spices, or oils extracted from spices,
substances listed in §§ 172.515(b) and substances added to food by direct ex-
182.60 of this chapter except where posure thereof to wood smoke, or
these are derived from natural sources. chemicals applied for their insecticidal
(2) The term spice means any aro- or herbicidal properties.
matic vegetable substance in the (b) A food which is subject to the re-
whole, broken, or ground form, except quirements of section 403(k) of the act
for those substances which have been shall bear labeling, even though such
traditionally regarded as foods, such as food is not in package form.
onions, garlic and celery; whose signifi- (c) A statement of artificial fla-
cant function in food is seasoning rath- voring, artificial coloring, or chemical
er than nutritional; that is true to preservative shall be placed on the food
name; and from which no portion of or on its container or wrapper, or on
any volatile oil or other flavoring prin- any two or all three of these, as may be
ciple has been removed. Spices include necessary to render such statement
the spices listed in § 182.10 and part 184 likely to be read by the ordinary per-
of this chapter, such as the following: son under customary conditions of pur-
Allspice, Anise, Basil, Bay leaves, Caraway chase and use of such food. The specific
seed, Cardamon, Celery seed, Chervil, Cin- artificial color used in a food shall be
namon, Cloves, Coriander, Cumin seed, Dill identified on the labeling when so re-
seed, Fennel seed, Fenugreek, Ginger, quired by regulation in part 74 of this
Horseradish, Mace, Marjoram, Mustard chapter to assure safe conditions of use
flour, Nutmeg, Oregano, Paprika, Parsley, for the color additive.
Pepper, black; Pepper, white; Pepper, red;
(d) A food shall be exempt from com-
Rosemary, Saffron, Sage, Savory, Star ani-
seed, Tarragon, Thyme, Turmeric. pliance with the requirements of sec-
tion 403(k) of the act if it is not in
Paprika, turmeric, and saffron or other package form and the units thereof are
spices which are also colors, shall be so small that a statement of artificial
declared as ‘‘spice and coloring’’ unless flavoring, artificial coloring, or chem-
declared by their common or usual ical preservative, as the case may be,
name. cannot be placed on such units with
(3) The term natural flavor or natural such conspicuousness as to render it
flavoring means the essential oil, oleo- likely to be read by the ordinary indi-
resin, essence or extractive, protein hy- vidual under customary conditions of
drolysate, distillate, or any product of purchase and use.
roasting, heating or enzymolysis, (e) A food shall be exempt while held
which contains the flavoring constitu- for sale from the requirements of sec-
ents derived from a spice, fruit or fruit tion 403(k) of the act (requiring label
juice, vegetable or vegetable juice, edi- statement of any artificial flavoring,
ble yeast, herb, bark, bud, root, leaf or artificial coloring, or chemical preserv-
similar plant material, meat, seafood, atives) if said food, having been re-
poultry, eggs, dairy products, or fer- ceived in bulk containers at a retail es-
mentation products thereof, whose sig- tablishment, is displayed to the pur-
nificant function in food is flavoring chaser with either (1) the labeling of
104
the bulk container plainly in view or be declared in the statement of ingredi-

(2) a counter card, sign, or other appro- ents if it meets the requirements of
priate device bearing prominently and § 101.100(a)(3).
conspicuously the information required (3) Substances obtained by cutting,
to be stated on the label pursuant to grinding, drying, pulping, or similar
section 403(k). processing of tissues derived from fruit,
(f) A fruit or vegetable shall be ex- vegetable, meat, fish, or poultry, e.g.,
empt from compliance with the re- powdered or granulated onions, garlic
quirements of section 403(k) of the act powder, and celery powder, are com-
with respect to a chemical preservative monly understood by consumers to be
applied to the fruit or vegetable as a food rather than flavor and shall be de-
pesticide chemical prior to harvest. clared by their common or usual name.
(g) A flavor shall be labeled in the (4) Any salt (sodium chloride) used as
following way when shipped to a food an ingredient in food shall be declared
manufacturer or processor (but not a by its common or usual name ‘‘salt.’’
consumer) for use in the manufacture (5) Any monosodium glutamate used
of a fabricated food, unless it is a fla- as an ingredient in food shall be de-
vor for which a standard of identity clared by its common or usual name
has been promulgated, in which case it ‘‘monosodium glutamate.’’
shall be labeled as provided in the (6) Any pyroligneous acid or other ar-
standard: tificial smoke flavors used as an ingre-
(1) If the flavor consists of one ingredient in a food may be declared as arti-
dient, it shall be declared by its com- ficial flavor or artificial smoke flavor.
mon or usual name. No representation may be made, either
(2) If the flavor consists of two or directly or implied, that a food fla-
more ingredients, the label either may vored with pyroligneous acid or other
declare each ingredient by its common artificial smoke flavor has been
or usual name or may state ‘‘All flavor smoked or has a true smoked flavor, or
ingredients contained in this product that a seasoning sauce or similar prod-
are approved for use in a regulation of uct containing pyroligneous acid or
the Food and Drug Administration.’’ other artificial smoke flavor and used
Any flavor ingredient not contained in to season or flavor other foods will re-
one of these regulations, and any non- sult in a smoked product or one having
flavor ingredient, shall be separately a true smoked flavor.
listed on the label. (7) Because protein hydrolysates
(3) In cases where the flavor contains function in foods as both flavorings and
a solely natural flavor(s), the flavor flavor enhancers, no protein hydroly-
shall be so labeled, e.g., ‘‘strawberry sate used in food for its effects on fla-
flavor’’, ‘‘banana flavor’’, or ‘‘natural vor may be declared simply as ‘‘fla-
strawberry flavor’’. In cases where the vor,’’ ‘‘natural flavor,’’ or ‘‘flavoring.’’
flavor contains both a natural flavor The ingredient shall be declared by its
and an artificial flavor, the flavor shall specific common or usual name as pro-
be so labeled, e.g., ‘‘natural and artifi- vided in § 102.22 of this chapter.
cial strawberry flavor’’. In cases where (i) If the label, labeling, or adver-
the flavor contains a solely artificial tising of a food makes any direct or in-
flavor(s), the flavor shall be so labeled, direct representations with respect to
e.g., ‘‘artificial strawberry flavor’’. the primary recognizable flavor(s), by
(h) The label of a food to which flavor word, vignette, e.g., depiction of a
is added shall declare the flavor in the fruit, or other means, or if for any
statement of ingredients in the fol- other reason the manufacturer or dis-
lowing way: tributor of a food wishes to designate
(1) Spice, natural flavor, and artifi- the type of flavor in the food other
cial flavor may be declared as ‘‘spice’’, than through the statement of ingredi-
‘‘natural flavor’’, or ‘‘artificial flavor’’, ents, such flavor shall be considered
or any combination thereof, as the case the characterizing flavor and shall be
may be. declared in the following way:
(2) An incidental additive in a food, (1) If the food contains no artificial

originating in a spice or flavor used in flavor which simulates, resembles or
the manufacture of the food, need not reinforces the characterizing flavor,
105
§ 101.22 21 CFR Ch. I (4–1–23 Edition)
the name of the food on the principal ‘‘artificially flavored’’, in letters not
display panel or panels of the label less than one-half the height of the let-
shall be accompanied by the common ters in the name of the characterizing
or usual name of the characterizing fla- flavor, e.g., ‘‘artificial vanilla’’, ‘‘arti-
vor, e.g., ‘‘vanilla’’, in letters not less ficially flavored strawberry’’, or ‘‘grape
than one-half the height of the letters artificially flavored’’.
used in the name of the food, except (3) Wherever the name of the charac-
that: terizing flavor appears on the label
(i) If the food is one that is com- (other than in the statement of ingre-
monly expected to contain a character- dients) so conspicuously as to be easily
izing food ingredient, e.g., strawberries seen under customary conditions of
in ‘‘strawberry shortcake’’, and the purchase, the words prescribed by this
food contains natural flavor derived paragraph shall immediately and con-
from such ingredient and an amount of spicuously precede or follow such
characterizing ingredient insufficient name, without any intervening writ-
to independently characterize the food, ten, printed, or graphic matter, except:
or the food contains no such ingre- (i) Where the characterizing flavor
dient, the name of the characterizing and a trademark or brand are pre-
flavor may be immediately preceded by sented together, other written, printed,
the word ‘‘natural’’ and shall be imme- or graphic matter that is a part of or is
diately followed by the word ‘‘fla- associated with the trademark or
vored’’ in letters not less than one-half brand may intervene if the required
the height of the letters in the name of words are in such relationship with the
the characterizing flavor, e.g., ‘‘natural trademark or brand as to be clearly re-
strawberry flavored shortcake,’’ or lated to the characterizing flavor; and
‘‘strawberry flavored shortcake’’. (ii) If the finished product contains
(ii) If none of the natural flavor used more than one flavor subject to the re-
in the food is derived from the product quirements of this paragraph, the
whose flavor is simulated, the food in statements required by this paragraph
which the flavor is used shall be la- need appear only once in each state-
beled either with the flavor of the prod- ment of characterizing flavors present
uct from which the flavor is derived or in such food, e.g., ‘‘artificially flavored
as ‘‘artificially flavored.’’ vanilla and strawberry’’.
(iii) If the food contains both a char- (iii) If the finished product contains
acterizing flavor from the product three or more distinguishable charac-
whose flavor is simulated and other terizing flavors, or a blend of flavors
natural flavor which simulates, resem- with no primary recognizable flavor,
bles or reinforces the characterizing the flavor may be declared by an appro-
flavor, the food shall be labeled in ac- priately descriptive generic term in
cordance with the introductory text lieu of naming each flavor, e.g., ‘‘arti-
and paragraph (i)(1)(i) of this section ficially flavored fruit punch’’.
and the name of the food shall be im- (4) A flavor supplier shall certify, in
mediately followed by the words ‘‘with writing, that any flavor he supplies
other natural flavor’’ in letters not less which is designated as containing no
than one-half the height of the letters artificial flavor does not, to the best of
used in the name of the characterizing his knowledge and belief, contain any
flavor. artificial flavor, and that he has added
(2) If the food contains any artificial no artificial flavor to it. The require-
flavor which simulates, resembles or ment for such certification may be sat-
reinforces the characterizing flavor, isfied by a guarantee under section
the name of the food on the principal 303(c)(2) of the act which contains such
display panel or panels of the label a specific statement. A flavor user
shall be accompanied by the common shall be required to make such a writ-
or usual name(s) of the characterizing ten certification only where he adds to
flavor, in letters not less than one-half or combines another flavor with a fla-
the height of the letters used in the vor which has been certified by a flavor
name of the food and the name of the supplier as containing no artificial fla-
characterizing flavor shall be accom- vor, but otherwise such user may rely
panied by the word(s) ‘‘artificial’’ or upon the supplier’s certification and
106
need make no separate certification. the certification as may be reasonably

All such certifications shall be re- expected to enable the Secretary’s rep-
tained by the certifying party through- resentatives to determine which rel-
out the period in which the flavor is evant raw and finished materials and
supplied and for a minimum of three flavor ingredient records are reason-
years thereafter, and shall be subject ably necessary to verify the certifi-
to the following conditions: cations. The examination conducted by
(i) The certifying party shall make the Secretary’s representative shall be
such certifications available upon re- limited to inspection and review of in-
quest at all reasonable hours to any ventories and ingredient records for
duly authorized office or employee of those certifications which are to be
the Food and Drug Administration or verified.
any other employee acting on behalf of (v) Review of flavor ingredient
the Secretary of Health and Human records shall be limited to the quali-
Services. Such certifications are re- tative formula and shall not include
garded by the Food and Drug Adminis- the quantitative formula. The person
tration as reports to the government verifying the certifications may make
and as guarantees or other under- only such notes as are necessary to en-
takings within the meaning of section able him to verify such certification.
301(h) of the act and subject the certi- Only such notes or such flavor ingre-
fying party to the penalties for making dient records as are necessary to verify
any false report to the government such certification or to show a poten-
under 18 U.S.C. 1001 and any false guar-
tial or actual violation may be re-
antee or undertaking under section
moved or transmitted from the certi-
303(a) of the act. The defenses provided
fying party’s place of business: Pro-
under section 303(c)(2) of the act shall
vided, That, where such removal or
be applicable to the certifications pro-
transmittal is necessary for such pur-
vided for in this section.
poses the relevant records and notes
(ii) Wherever possible, the Food and
shall be retained as separate docu-
Drug Administration shall verify the
ments in Food and Drug Administra-
accuracy of a reasonable number of
tion files, shall not be copied in other
certifications made pursuant to this
reports, and shall not be disclosed pub-
section, constituting a representative
sample of such certifications, and shall licly other than in a judicial pro-
not request all such certifications. ceeding brought pursuant to the act or
(iii) Where no person authorized to 18 U.S.C. 1001.
provide such information is reasonably (j) A food to which a chemical pre-
available at the time of inspection, the servative(s) is added shall, except when
certifying party shall arrange to have exempt pursuant to § 101.100 bear a
such person and the relevant materials label declaration stating both the com-
and records ready for verification as mon or usual name of the ingredient(s)
soon as practicable: Provided, That, and a separate description of its func-
whenever the Food and Drug Adminis- tion, e.g., ‘‘preservative’’, ‘‘to retard
tration has reason to believe that the spoilage’’, ‘‘a mold inhibitor’’, ‘‘to help
supplier or user may utilize this period protect flavor’’ or ‘‘to promote color
to alter inventories or records, such ad- retention’’.
ditional time shall not be permitted. (k) The label of a food to which any
Where such additional time is pro- coloring has been added shall declare
vided, the Food and Drug Administra- the coloring in the statement of ingre-
tion may require the certifying party dients in the manner specified in para-
to certify that relevant inventories graphs (k)(1) and (k)(2) of this section,
have not been materially disturbed and except that colorings added to butter,
relevant records have not been altered cheese, and ice cream, if declared, may
or concealed during such period. be declared in the manner specified in
(iv) The certifying party shall pro- paragraph (k)(3) of this section, and
vide, to an officer or representative colorings added to foods subject to
duly designated by the Secretary, such §§ 105.62 and 105.65 of this chapter shall
qualitative statement of the composi- be declared in accordance with the re-
tion of the flavor or product covered by quirements of those sections.
107
§ 101.30 21 CFR Ch. I (4–1–23 Edition)
(1) A color additive or the lake of a on the name of, or makes any other di-
color additive subject to certification rect or indirect representation with re-
under 721(c) of the act shall be declared spect to, any fruit or vegetable juice),
by the name of the color additive listed or the label or labeling bears any vi-
in the applicable regulation in part 74 gnette (i.e., depiction of a fruit or vege-
or part 82 of this chapter, except that table) or other pictorial representation
it is not necessary to include the of any fruit or vegetable, or the prod-
‘‘FD&C’’ prefix or the term ‘‘No.’’ in uct contains color and flavor that gives
the declaration, but the term ‘‘Lake’’ the beverage the appearance and taste
shall be included in the declaration of of containing a fruit or vegetable juice.
the lake of the certified color additive The beverage may be carbonated or
(e.g., Blue 1 Lake). Manufacturers may noncarbonated, concentrated, full-
parenthetically declare an appropriate strength, diluted, or contain no juice.
alternative name of the certified color For example, a soft drink (soda) that
additive following its common or usual does not represent or suggest by its
name as specified in part 74 or part 82 physical characteristics, name, label-
of this chapter. ing, ingredient statement, or adver-
(2) Color additives not subject to cer- tising that it contains fruit or vege-
tification and not otherwise required table juice does not purport to contain
by applicable regulations in part 73 of juice and therefore does not require a
this chapter to be declared by their re- percent juice declaration.
spective common or usual names may (b)(1) If the beverage contains fruit or
be declared as ‘‘Artificial Color,’’ ‘‘Ar- vegetable juice, the percentage shall be
tificial Color Added,’’ or ‘‘Color Added’’ declared by the words ‘‘Contains __ per-
(or by an equally informative term cent (or %) ______ juice’’ or ‘‘__ percent
that makes clear that a color additive (or %) juice,’’ or a similar phrase, with
has been used in the food). Alter- the first blank filled in with the per-
natively, such color additives may be centage expressed as a whole number
declared as ‘‘Colored with not greater than the actual percentage
________________’’ or ‘‘________________ of the juice and the second blank (if
color,’’ the blank to be filled in with used) filled in with the name of the
the name of the color additive listed in particular fruit or vegetable (e.g.,
the applicable regulation in part 73 of ‘‘Contains 50 percent apple juice’’ or
this chapter. ‘‘50 percent juice’’).
(3) When a coloring has been added to (2) If the beverage contains less than
butter, cheese, or ice cream, it need 1 percent juice, the total percentage
not be declared in the ingredient list juice shall be declared as ‘‘less than 1
unless such declaration is required by a percent juice’’ or ‘‘less than 1 percent
regulation in part 73 or part 74 of this ______ juice’’ with the blank filled in
chapter to ensure safe conditions of use with the name of the particular fruit or
for the color additive. Voluntary dec- vegetable.
laration of all colorings added to but- (3) If the beverage contains 100 per-
ter, cheese, and ice cream, however, is cent juice and also contains non-juice
recommended. ingredients that do not result in a dim-
inution of the juice soluble solids or, in
the case of expressed juice, in a change
FR 3963, Jan. 19, 1979; 44 FR 37220, June 26,
1979; 54 FR 24891, June 12, 1989; 58 FR 2875, in the volume, when the 100 percent
Jan. 6, 1993; 63 FR 14818, Mar. 27, 1998; 74 FR juice declaration appears on a panel of
216, Jan. 5, 2009] the label that does not also bear the in-
gredient statement, it must be accom-
§ 101.30 Percentage juice declaration panied by the phrase ‘‘with added
for foods purporting to be bev- ______,’’ the blank filled in with a term
erages that contain fruit or vege- such as ‘‘ingredient(s),’’ ‘‘preserva-
table juice. tive,’’ or ‘‘sweetener,’’ as appropriate
(a) This section applies to any food (e.g., ‘‘100% juice with added sweet-
that purports to be a beverage that ener’’), except that when the presence
contains any fruit or vegetable juice of the non-juice ingredient(s) is de-

(i.e., the product’s advertising, label, or clared as a part of the statement of
labeling bears the name of, or variation identity of the product, this phrase
108
need not accompany the 100 percent formation appearing above the state-
juice declaration. ment except the brand name, product
(c) If a beverage contains minor name, logo, or universal product code;
amounts of juice for flavoring and is la- and
beled with a flavor description using (2) In easily legible boldface print or
terms such as ‘‘flavor’’, ‘‘flavored’’, or type in distinct contrast to other
‘‘flavoring’’ with a fruit or vegetable printed or graphic matter, in a height
name and does not bear: not less than the largest type found on
(1) The term ‘‘juice’’ on the label the information panel except that used
other than in the ingredient statement; for the brand name, product name,
or logo, universal product code, the title
(2) An explicit vignette depicting the phrase ‘‘Nutrition Facts,’’ the declara-
fruit or vegetable from which the flation of ‘‘Serving size,’’ ‘‘Calories’’ and
vor derives, such as juice exuding from the numerical value for ‘‘Calories ap-
a fruit or vegetable; or pearing in the nutrition information as
(3) Specific physical resemblance to a required by § 101.9.
juice or distinctive juice characteristic (f) The percentage juice declaration
such as pulp then total percentage may also be placed on the principal dis-
juice declaration is not required. play panel, provided that the declara-
(d) If the beverage does not meet the tion is consistent with that presented
criteria for exemption from total juice on the information panel.
percentage declaration as described in (g) If the beverage is sold in a pack-
paragraph (c) of this section and con- age that does not bear an information
tains no fruit or vegetable juice, but panel as defined in § 101.2, the percent-
the labeling or color and flavor of the age juice declaration shall be placed on
beverage represents, suggests, or im- the principal display panel, in type size
plies that fruit or vegetable juice may not less than that required for the dec-
be present (e.g., the product adver- laration of net quantity of contents
tising or labeling bears the name, a statement in § 101.7(i), and be placed
variation of the name, or a pictorial near the name of the food.
representation of any fruit or vege- (h)(1) In enforcing these regulations,
table, or the product contains color the Food and Drug Administration will
and flavor that give the beverage the calculate the labeled percentage of
appearance and taste of containing a juice from concentrate found in a juice
fruit or vegetable juice), then the label or juice beverage using the minimum
shall declare ‘‘contains zero (0) percent Brix levels listed below where single-
(or %) juice’’. Alternatively, the label strength (100 percent) juice has at least
may declare ‘‘Containing (or contains) the specified minimum Brix listed
no ______ juice’’, or ‘‘no ______ juice’’, or below:
‘‘does not contain ______ juice’’, the 100
blank to be filled in with the name of Juice percent
juice 1
the fruits or vegetables represented,
suggested, or implied, but if there is a Acerola ....................................................................... 6.0
general suggestion that the product Apple .......................................................................... 11.5
Apricot ........................................................................ 11.7
contains fruit or vegetable juice, such Banana ...................................................................... 22.0
as the presence of fruit pulp, the blank Blackberry .................................................................. 10.0
shall be filled in with the word ‘‘fruit’’ Blueberry ................................................................... 10.0
Boysenberry ............................................................... 10.0
or ‘‘vegetable’’ as applicable (e.g., Cantaloupe Melon ..................................................... 9.6
‘‘contains no fruit juice’’, or ‘‘does not Carambola ................................................................. 7.8
contain fruit juice’’). Carrot ......................................................................... 8.0
Casaba Melon ........................................................... 7.5
(e) If the beverage is sold in a pack- Cashew (Caju) ........................................................... 12.0
age with an information panel as de- Celery ........................................................................ 3.1
fined in § 101.2, the declaration of Cherry, dark, sweet ................................................... 20.0
amount of juice shall be prominently Cherry, red, sour ....................................................... 14.0
Crabapple .................................................................. 15.4
placed on the information panel in Cranberry ................................................................... 7.5
lines generally parallel to other re- Currant (Black) .......................................................... 11.0
Currant (Red) ............................................................. 10.5
quired information, appearing:

Date ........................................................................... 18.5
(1) Near the top of the information Dewberry ................................................................... 10.0
panel, with no other printed label in- Elderberry .................................................................. 11.0
109
§ 101.36 21 CFR Ch. I (4–1–23 Edition)
100 to which such a major modification has

Juice percent
juice 1 been made shall not be included in the
total percentage juice declaration.
Fig .............................................................................. 18.2 (l) A beverage required to bear a per-
Gooseberry ................................................................ 8.3
Grape ......................................................................... 16.0 centage juice declaration on its label,
Grapefruit ................................................................... 310.0
that contains less than 100 percent
Guanabana (soursop) ................................................ 16.0
Guava ........................................................................ 7.7
juice, shall not bear any other percent-
Honeydew melon ....................................................... 9.6 age declaration that describes the juice
Kiwi ............................................................................ 15.4 content of the beverage in its label or
Lemon ........................................................................ 2 4.5
Lime ...........................................................................
in its labeling (e.g., ‘‘100 percent nat-
2 4.5
Loganberry ................................................................. 10.5 ural’’ or ‘‘100 percent pure’’). However,
Mango ........................................................................ 13.0 the label or labeling may bear percent-
Nectarine ................................................................... 11.8
Orange ....................................................................... 311.8 age statements clearly unrelated to
Papaya ....................................................................... 11.5 juice content (e.g., ‘‘provides 100 per-
Passion Fruit .............................................................. 14.0 cent of U.S. RDA of vitamin C’’).
Peach ......................................................................... 10.5
Pear ........................................................................... 12.0 (m) Products purporting to be bev-
Pineapple ................................................................... 12.8 erages that contain fruit or vegetable
Plum ........................................................................... 14.3 juices are exempted from the provi-
Pomegranate ............................................................. 16.0
Prune ......................................................................... 18.5 sions of this section until May 8, 1994.
Quince ....................................................................... 13.3 All products that are labeled on or
Raspberry (Black) ...................................................... 11.1 after that date shall comply with this
Raspberry (Red) ........................................................ 9.2
Rhubarb ..................................................................... 5.7 section.
Strawberry ................................................................. 8.0
Tangerine ................................................................... 311.8 [58 FR 2925, Jan. 6, 1993, as amended at 58 FR
Tomato ....................................................................... 5.0 44063, Aug. 18, 1993; 58 FR 49192, Sept. 22, 1993;
Watermelon ............................................................... 7.8 81 FR 33994, May 27, 2016; 81 FR 59131, Aug. 29,
Youngberry ................................................................ 10.0 2016]
1 Indicates Brix value unless other value specified.
2 Indicates anhydrous citrus acid percent by weight.
3 Brix values determined by refractometer for citrus juices Subpart C—Specific Nutrition La-
may be corrected for citric acid.
beling Requirements and
(2) If there is no Brix level specified Guidelines
in paragraph (h)(1) of this section, the
labeled percentage of that juice from
SOURCE: 55 FR 60890, Nov. 27, 1991, unless
concentrate in a juice or juice beverage otherwise noted.
will be calculated on the basis of the
soluble solids content of the single- § 101.36 Nutrition labeling of dietary
strength (unconcentrated) juice used to supplements.
produce such concentrated juice.
(i) Juices directly expressed from a (a) The label of a dietary supplement
fruit or vegetable (i.e., not con- that is offered for sale shall bear nutri-
centrated and reconstituted) shall be tion labeling in accordance with this
considered to be 100 percent juice and regulation unless an exemption is pro-
shall be declared as ‘‘100 percent juice.’’ vided for the product in paragraph (h)
(j) Calculations of the percentage of of this section.
juice in a juice blend or a diluted juice (b) The declaration of nutrition infor-
product made directly from expressed mation on the label and in labeling
juice (i.e., not from concentrate) shall shall contain the following informa-
be based on the percentage of the ex- tion, using the subheadings and the
pressed juice in the product computed format specified in paragraph (e) of
on a volume/volume basis. this section.
(k) If the product is a beverage that (1) Serving size. (i) The subheading
contains a juice whose color, taste, or ‘‘Serving Size’’ shall be placed under
other organoleptic properties have the heading ‘‘Supplement Facts’’ and
been modified to the extent that the aligned on the left side of the nutrition
original juice is no longer recognizable label. The serving size shall be deter-
at the time processing is complete, or mined in accordance with §§ 101.9(b) and
if its nutrient profile has been dimin- 101.12(b), Table 2. Serving size for die-
ished to a level below the normal nutri- tary supplements shall be expressed
ent range for the juice, then that juice using a term that is appropriate for the
110
form of the supplement, such as ‘‘tab- Other appropriate terms, such as cap-
lets,’’ ‘‘capsules,’’ ‘‘packets,’’ or ‘‘tea- sule, packet, or teaspoonful, also may
spoonfuls.’’ be used in place of the term ‘‘Serving.’’
(ii) The subheading ‘‘Servings Per (B) The names of dietary ingredients
Container’’ shall be placed under the that are declared under paragraph
subheading ‘‘Serving Size’’ and aligned (b)(2)(i) of this section shall be pre-
on the left side of the nutrition label, sented in a column aligned on the left
except that this information need not side of the nutritional label in the
be provided when it is stated in the net order and manner of indentation speci-
quantity of contents declaration. fied in § 101.9(c), except that calcium
(2) Information on dietary ingredients and iron shall follow choline, and so-
that have a Reference Daily Intake (RDI) dium and potassium shall follow chlo-
or a Daily Reference Value (DRV) as es- ride. This results in the following order
tablished in § 101.9(c) and their subcompo- for vitamins and minerals: Vitamin A,
nents (hereinafter referred to as ‘‘(b)(2)- vitamin C, vitamin D, vitamin E, vita-
dietary ingredients’’). (i) The (b)(2)-die- min K, thiamin, riboflavin, niacin, vi-
tary ingredients to be declared, that is, tamin B6, folate and folic acid, vitamin
total calories, total fat, saturated fat, B12, biotin, pantothenic acid, choline,
trans fat, cholesterol, sodium, total calcium, iron, phosphorus, iodine, mag-
carbohydrate, dietary fiber, total sug- nesium, zinc, selenium, copper, man-
ars, added sugars, protein, vitamin D, ganese, chromium, molybdenum, chlo-
calcium, iron, and potassium, shall be ride, sodium, potassium, and fluoride.
declared when they are present in a di- The (b)(2)-dietary ingredients shall be
etary supplement in quantitative listed according to the nomenclature
amounts by weight that exceed the specified in § 101.9 or in paragraph
amount that can be declared as zero in (b)(2)(i)(B)(2) of this section.
nutrition labeling of foods in accord- (1) When ‘‘Calories’’ are declared,
ance with § 101.9(c). Calories from satu- they shall be listed first in the column
rated fat, polyunsaturated fat, of names, beneath a light bar sepa-
monounsaturated fat, soluble fiber, in- rating the heading ‘‘Amount Per Serv-
soluble fiber, and sugar alcohol may be ing’’ from the list of names. When
declared, but they shall be declared ‘‘Calories from saturated fat’’ are de-
when a claim is made about them. Any clared, they shall be indented under
(b)(2)-dietary ingredients that are not ‘‘Calories.’’
present, or that are present in amounts (2) The following synonyms may be
that can be declared as zero in added in parentheses immediately fol-
§ 101.9(c), shall not be declared (e.g., lowing the name of these (b)(2)-dietary
amounts corresponding to less than 2 ingredients: Vitamin C (ascorbic acid),
percent of the RDI for vitamins and thiamin (vitamin B1), riboflavin (vita-
minerals). Protein shall not be de- min B2), and calories (energy). Energy
clared on labels of products that, other content per serving may be expressed
than ingredients added solely for tech- in kilojoule units, added in parentheses
nological reasons, contain only indi- immediately following the statement
vidual amino acids. of caloric content.
(A) The names and the quantitative (3) Beta-carotene may be declared as
amounts by weight of each (b)(2)-die- the percent of vitamin A that is
tary ingredient shall be presented present as beta-carotene, except that
under the heading ‘‘Amount Per Serv- the declaration is required when a
ing.’’ When the quantitative amounts claim is made about beta-carotene.
by weight are presented in a separate When declared, the percent shall be de-
column, the heading may be centered clared to the nearest whole percent,
over a column of quantitative immediately adjacent to or beneath
amounts, described by paragraph the name vitamin A (e.g., ‘‘Vitamin A
(b)(2)(ii) of this section, if space per- (90% as beta-carotene)’’). The amount
mits. A heading consistent with the of beta-carotene in terms of
declaration of the serving size, such as micrograms (mcg) may be included in
‘‘Each Tablet Contains,’’ or ‘‘Amount the parentheses following the percent

Per 2 Tablets’’ may be used in place of statement (e.g., ‘‘Vitamin A (90% (810
the heading ‘‘Amount Per Serving.’’ mcg) as beta-carotene)’’).
111
§ 101.36 21 CFR Ch. I (4–1–23 Edition)
(ii) The number of calories, if de- aligned under the heading of ‘‘% Daily
clared, and the quantitative amount by Value’’ and to the right of the column
weight per serving of each dietary in- of amounts. The headings ‘‘% Daily
gredient required to be listed under Value (DV),’’ ‘‘% DV,’’ ‘‘Percent Daily
paragraph (b)(2)(i) of this section shall Value,’’ or ‘‘Percent DV’’ may be sub-
be presented either in a separate col- stituted for ‘‘% Daily Value.’’ The
umn aligned to the right of the column heading ‘‘% Daily Value’’ shall be
of names or immediately following the placed on the same line as the heading
listing of names within the same col- ‘‘Amount Per Serving.’’ When the acro-
umn. The quantitative amounts by nym ‘‘DV’’ is unexplained in the head-
weight shall represent the weight of ing and a footnote is required under
the dietary ingredient rather than the (b)(2)(iii)(D), (b)(2)(iii)(F), or (b)(3)(iv)
weight of the source of the dietary in- of this section, the footnote shall ex-
gredient (e.g., the weight of calcium plain the acronym (e.g. ‘‘Daily Value
rather than that of calcium carbonate). (DV) not established’’).
(A) The amounts shall be expressed (B) The percent of Daily Value shall
in the increments specified in be calculated by dividing the quan-
§ 101.9(c)(1) through (7), which includes titative amount by weight of each
increments for sodium. (b)(2)-dietary ingredient by the RDI as
(B) The amounts of vitamins and established in § 101.9(c)(8)(iv) or the
minerals, excluding sodium, shall be DRV as established in § 101.9(c)(9) for
the amount of the vitamin or mineral the specified dietary ingredient and
included in one serving of the product, multiplying by 100, except that the per-
using the units of measurement and cent of Daily Value for protein, when
the levels of significance given in present, shall be calculated as specified
§ 101.9(c)(8)(iv), except that zeros fol- in § 101.9(c)(7)(ii). The quantitative
lowing decimal points may be dropped, amount by weight of each dietary in-
and additional levels of significance gredient in this calculation shall be the
may be used when the number of dec- unrounded amount, except that for
imal places indicated is not sufficient total fat, saturated fat, cholesterol, so-
to express lower amounts (e.g., the RDI dium, potassium, total carbohydrate,
for zinc is given in whole milligrams and dietary fiber, the quantitative
(mg), but the quantitative amount may amount by weight declared on the label
be declared in tenths of a mg). The (i.e., rounded amount) may be used.
amount of vitamin D may, but is not The numerical value shall be followed
required to, be expressed in IUs, in ad- by the symbol for percent (i.e., %).
dition to the mandatory declaration in (C) The percentages based on RDI’s
mcg. Any declaration of the amount of and on DRV’s shall be expressed to the
vitamin D in IUs must appear in paren- nearest whole percent, except that for
theses after the declaration of the dietary ingredients for which DRV’s
amount of vitamin D in mcg. have been established, ‘‘Less than 1%’’
(iii) The percent of the Daily Value of or ‘‘<1%’’ shall be used to declare the
all dietary ingredients declared under ‘‘% Daily Value’’ when the quan-
paragraph (b)(2)(i) of this section shall titative amount of the dietary ingre-
be listed, except that the percent Daily dient by weight is great enough to re-
Value for protein, when present, shall quire that the dietary ingredient be
be calculated using the corrected listed, but the amount is so small that
amount of protein as specified in the ‘‘% Daily Value’’ when rounded to
§ 101.9(c)(7)(ii); no percent of the Daily the nearest percent is zero (e.g., a prod-
Value shall be given for subcomponents uct that contains 1 gram of total car-
for which DRVs or RDIs have not been bohydrate would list the percent Daily
established (e.g., total sugars). Addi- Value as ‘‘Less than 1%’’ or ‘‘<1%’’).
tionally, the percentage of the RDI for (D) If the percent of Daily Value is
protein shall be omitted when a food is declared for total fat, saturated fat,
purported to be for infants through 12 total carbohydrate, dietary fiber, or
months of age. protein, or added sugars, a symbol
(A) When information on the percent shall follow the value listed for those
of Daily Values is listed, this informa- nutrients that refers to the same sym-
tion shall be presented in one column bol that is placed at the bottom of the
112
nutrition label, below the bar required tary ingredient listed under ‘‘Amount
under paragraph (e)(6) of this section Per Serving.’’
and inside the box, that is followed by (3) Information on dietary ingredients
the statement ‘‘Percent Daily Values for which RDI’s and DRV’s have not been
are based on a 2,000 calorie diet.’’ If the established. (i) Dietary ingredients for
product is represented or purported to which FDA has not established RDI’s
be for use by children 1 through 3 years or DRV’s and that are not subject to
of age, and if the percent of Daily regulation under paragraph (b)(2) of
Value is declared for total fat, total this section (hereinafter referred to as
carbohydrate, dietary fiber, or protein, ‘‘other dietary ingredients’’) shall be
or added sugars, a symbol shall follow declared by their common or usual
the value listed for those nutrients name when they are present in a die-
that refers to the same symbol that is tary supplement, in a column that is
placed at the bottom of the nutrition under the column of names described in
label, below the bar required under paragraph (b)(2)(i)(B) of this section or,
paragraph (e)(6) of this section and in- as long as the constituents of an other
side the box, that is followed by the dietary ingredient are not listed, in a
statement ‘‘Percent Daily Values are linear display, under the heavy bar de-
based on a 1,000 calorie diet.’’ scribed in paragraph (e)(6) of this sec-
(E) The percent of Daily Value shall tion, except that if no (b)(2)-dietary in-
be based on RDI or DRV values for gredients are declared, other dietary
adults and children 4 or more years of ingredients shall be declared directly
beneath the heading ‘‘Amount Per
age, unless the product is represented
Serving’’ described in paragraph
or purported to be specifically for in-
(b)(2)(i)(A) of this section.
fants through 12 months of age, chil-
(ii) The quantitative amount by
dren 1 through 3 years of age, pregnant
weight per serving of other dietary in-
women, or lactating women, in which
gredients shall be presented in the
case the column heading shall clearly
same manner as the corresponding in-
state the intended group. If the product
formation required in paragraph
is for persons within more than one
(b)(2)(ii) of this section or, when a lin-
group, the percent of Daily Value for
ear display is used, shall be presented
each group shall be presented in sepa-
immediately following the name of the
rate columns as shown in paragraph other dietary ingredient. The quan-
(e)(11)(ii) of this section. titative amount by weight shall be the
(F) For declared subcomponents that weight of the other dietary ingredient
have no DRVs or RDIs, a symbol (e.g., listed and not the weight of any com-
an asterisk) shall be placed in the ponent, or the source, of that dietary
‘‘Percent Daily Value’’ column that ingredient.
shall refer to the same symbol that is (A) These amounts shall be expressed
placed at the bottom of the nutrition using metric measures in appropriate
label, below the last heavy bar and in- units.
side the box, and followed by a state- (B) For any dietary ingredient that is
ment ‘‘Daily Value not established.’’ a liquid extract from which the solvent
(G) When calories or calories from has not been removed, the quantity
saturated fat are declared, the space listed shall be the volume or weight of
under the ‘‘% DV’’ column shall be left the total extract. Information on the
blank for these items. When there are condition of the starting material shall
no other (b)(2)-dietary ingredients list- be indicated when it is fresh and may
ed for which a value must be declared be indicated when it is dried. Informa-
in the ‘‘% DV’’ column, the column tion may be included on the concentra-
may be omitted as shown in paragraph tion of the dietary ingredient and the
(e)(11)(vii) of this section. When the ‘‘% solvent used, e.g., ‘‘fresh dandelion
DV’’ column is not required, but the di- root extract, x (y:z) in 70% ethanol,’’
etary ingredients listed are subject to where x is the number of milliliters
paragraph (b)(2)(iii)(F) of this section, (mL) or mg of the entire extract, y is
the symbol required in that paragraph the weight of the starting material and
shall immediately follow the quan- z is the volume (mL) of solvent. Where
titative amount by weight for each die- the solvent has been partially removed
113
§ 101.36 21 CFR Ch. I (4–1–23 Edition)
(not to dryness), the final concentra- shall be declared in accordance with

tion, when indicated, shall be stated paragraph (b)(2) of this section.
(e.g., if the original extract was 1:5 and (2) Dietary ingredients contained in
50 percent of the solvent was removed, the proprietary blend that are listed
then the final concentration shall be under paragraph (b)(3) of this section
stated as 1:2.5). Where the name of the (i.e., ‘‘other dietary ingredients’’) shall
solvent used is not included in the nu- be declared in descending order of pre-
trition label, it is required to be listed dominance by weight, in a column or
in the ingredient statement in accord- linear fashion, and indented under the
ance with § 101.4(g). term ‘‘Proprietary Blend’’ or other ap-
(C) For a dietary ingredient that is propriately descriptive term or fanciful
an extract from which the solvent has name.
been removed, the weight of the ingre- (3) The quantitative amount by
dient shall be the weight of the dried weight specified for the proprietary
extract. blend shall be the total weight of all
(iii) The constituents of a dietary in- other dietary ingredients contained in
gredient described in paragraph (b)(3)(i) the proprietary blend and shall be
of this section may be listed indented placed on the same line to the right of
under the dietary ingredient and fol- the term ‘‘Proprietary Blend’’ or other
lowed by their quantitative amounts appropriately descriptive term or fan-
by weight per serving, except that die- ciful name underneath the column of
tary ingredients described in paragraph amounts described in paragraph
(b)(2) of this section shall be listed in (b)(2)(ii) of this section. A symbol (e.g.,
accordance with that section. When the asterisk), which refers to the same
constituents of a dietary ingredient de- symbol placed at the bottom of the nu-
scribed in paragraph (b)(3)(i) of this trition label that is followed by the
section are listed, all other dietary instatement ‘‘Daily Value not estab-
lished,’’ shall be placed under the head-
gredients shall be declared in a col-
ing ‘‘% Daily Value,’’ if present, or im-
umn; however, the constituents them-
mediately following the quantitative
selves may be declared in a column or
amount by weight for the proprietary
in a linear display.
blend.
(iv) Other dietary ingredients shall (4) The sample label shown in para-
bear a symbol (e.g., an asterisk) in the graph (e)(11)(v) of this section illus-
column under the heading of ‘‘% Daily trates one method of nutrition labeling
Value’’ that refers to the same symbol a proprietary blend of dietary ingredi-
placed at the bottom of the nutrition ents.
label and followed by the statement (d) The source ingredient that sup-
‘‘Daily Value not established,’’ except plies a dietary ingredient may be iden-
that when the heading ‘‘% Daily tified within the nutrition label in pa-
Value’’ is not used, the symbol shall rentheses immediately following or in-
follow the quantitative amount by dented beneath the name of a dietary
weight for each dietary ingredient list- ingredient and preceded by the words
ed. ‘‘as’’ or ‘‘from’’, e.g., ‘‘Calcium (as cal-
(c) A proprietary blend of dietary in- cium carbonate),’’ except that manner
gredients shall be included in the list of presentation is unnecessary when
of dietary ingredients described in the name of the dietary ingredient
paragraph (b)(3)(i) of this section and (e.g., Oriental ginseng) or its synonym
identified by the term ‘‘Proprietary (e.g., ascorbic acid) is itself the source
Blend’’ or other appropriately descrip- ingredient. When a source ingredient is
tive term or fanciful name and may be identified in parentheses within the nu-
highlighted by bold type. Except as trition label, or when the name of the
specified in this paragraph, all other dietary ingredient or its synonym is
requirements for the listing of dietary the source ingredient, it shall not be
ingredients in dietary supplements are required to be listed again in the ingre-
applicable. dient statement that appears outside of
(1) Dietary ingredients contained in the nutrition label. When a source in-
the proprietary blend that are listed gredient is not identified within the
under paragraph (b)(2) of this section nutrition label, it shall be listed in an
114
ingredient statement in accordance be utilized for packages that have a

with § 101.4(g), which shall appear out- total surface area available to bear la-
side and immediately below the nutri- beling of less than 12 square inches,
tion label or, if there is insufficient (iv) At least one point leading (i.e.,
space below the nutrition label, imme- space between lines of text), and
diately contiguous and to the right of (v) Letters that do not touch.
the nutrition label. (4) Except as provided for small and
(1) Source ingredients shall be identi- intermediate-sized packages under
fied in accordance with § 101.4 (i.e., paragraph (i)(2) of this section, infor-
shall be listed by common or usual mation other than the title, headings,
name, and the listing of botanicals and footnotes shall be in uniform type
shall specify the part of the plant from size no smaller than 8 point. Type size
which the ingredient is derived) regard- no smaller than 6 point may be used for
less of whether they are listed in an in- column headings (e.g., ‘‘Amount Per
gredient statement or in the nutrition Serving’’ and ‘‘% Daily Value’’) and for
label. footnotes (e.g., ‘‘Percent Daily Values
(2) When source ingredients are listed are based on a 2,000 calorie diet’’).
within the nutrition label, and two or (5) A hairline rule that is centered
more are used to provide a single die- between the lines of text shall separate
tary ingredient, all of the sources shall each dietary ingredient required in
be listed within the parentheses in de- paragraph (b)(2) and (b)(3) of this sec-
scending order by weight. tion from the dietary ingredient above
(3) Representations that the source and beneath it, as shown in paragraph
ingredient conforms to an official com- (e)(10) of this section.
pendium may be included either in the (6) A heavy bar shall be placed:
nutrition label or in the ingredient list (i) Beneath the subheading ‘‘Servings
(e.g., ‘‘Calcium (as calcium carbonate Per Container’’ except that if
USP)’’). ‘‘Servings Per Container’’ is not re-
(e) Except as provided for small and quired and, as a result, not declared,
intermediate sized packages under the bar shall be placed beneath the sub-
paragraph (h)(3)(i)(2) of this section, in- heading ‘‘Serving Size,’’
formation other than the title, head- (ii) Beneath the last dietary ingre-
ings, and footnotes shall be in uniform dient to be listed under paragraph
type size no smaller than 8 point. Type (b)(2)(i) of this section, if any, and
size no smaller than 6 point may be (iii) Beneath the last other dietary
used for column headings (e.g., ingredient to be listed under paragraph
‘‘Amount Per Serving’’ and ‘‘% Daily (b)(3) of this section, if any.
Value’’) and for footnotes (e.g., ‘‘Per- (7) A light bar shall be placed be-
cent Daily Values are based on a 2,000 neath the headings ‘‘Amount Per Serv-
calorie diet’’). ing’’ and ‘‘% Daily Value.’’
(1) The title, ‘‘Supplement Facts,’’ (8) If the product contains two or
shall be set in a type size larger than more separately packaged dietary sup-
all other print size in the nutrition plements that differ from each other
label and, unless impractical, shall be (e.g., the product has a packet of sup-
set full width of the nutrition label. plements to be taken in the morning
The title and all headings shall be and a different packet to be taken in
bolded to distinguish them from other the afternoon), the quantitative
information. amounts and percent of Daily Value
(2) The nutrition information shall be may be presented as specified in this
enclosed in a box by using hairlines. paragraph in individual nutrition la-
(3) All information within the nutri- bels or in one aggregate nutrition label
tion label shall utilize: as illustrated in paragraph (e)(11)(iii) of
(i) A single easy-to-read type style, this section.
(ii) All black or one color type, print- (9)(i) The quantitative amount by
ed on a white or other neutral con- weight (or volume, if permitted) and
trasting background whenever prac- the percent of Daily Value of each die-
tical, tary ingredient may be presented on a

(iii) Upper- and lowercase letters, ex- ‘‘per unit’’ basis in addition to the ‘‘per
cept that all uppercase lettering may serving’’ basis required by paragraphs
115
§ 101.36 21 CFR Ch. I (4–1–23 Edition)
(b)(2)(ii) and (b)(2)(iii) of this section trated, the additional ‘‘Per Day’’ col-
for (b)(2)-dietary ingredients and umn heading is followed parentheti-
(b)(3)(ii) and (b)(3)(iv) of this section cally by the number of servings rec-
for other dietary ingredients. If ‘‘per ommended per day in other parts of the
unit’’ information is provided, it must label (e.g., ‘‘Per Day (3 Caplets)’’).
be presented in additional columns to When the parenthetical statement for-
the right of the ‘‘per serving’’ informa- mat following the ‘‘Serving Size’’ dec-
tion and be clearly identified by appro- laration is used as an alternative to
priate headings. the column format, the statement
(ii) Alternatively, if a recommenda- must provide no more than simple in-
tion is made in other parts of the label structions regarding how to calculate
that a dietary supplement be consumed the ‘‘per day’’ amount for the number
more than once per day, the total of servings per day recommended in
quantitative amount by weight (or vol- other parts of the label (e.g., ‘‘Serving
ume, if permitted) and the percent of Size: 1 Caplet (Multiply amounts by 3
Daily Value of each dietary ingredient for total daily amount)’’). When the
may be presented on a ‘‘per day’’ basis parenthetical statement format fol-
in addition to the ‘‘per serving’’ basis lowing the ‘‘Serving Size’’ declaration
required by paragraphs (b)(2)(ii) and is used in addition to the column for-
(b)(2)(iii) of this section for (b)(2)-die- mat, the statement must provide no
tary ingredients and (b)(3)(ii) and more than a simple declaration of the
(b)(3)(iv) of this section for other die- number of servings recommended in
tary ingredients. If ‘‘per day’’ informa- other parts of the label (e.g., ‘‘Serving
tion is provided, it must be presented Size: 1 Caplet (Total daily amount: 3
in additional columns to the right of caplets per day)’’).
the ‘‘per serving’’ information and be (10) In the interest of uniformity of
clearly identified by appropriate head- presentation, FDA urges that the infor-
ings and/or be presented in a parenthet- mation be presented using the graphic
ical statement as part of the ‘‘Serving specifications set forth in appendix B
Size’’ declaration. A sample illustra- to part 101, as applicable.
tion for ‘‘per day’’ information in a col- (11) The following sample labels are
umn format is provided in paragraph presented for the purpose of illustra-
(e)(11)(viii) of this section. As illus- tion:
116
(ii) Multiple vitamins for children tainer which is stated in the net quan-
and adults (excludes Servings Per Con- tity of contents declaration):
117
ER27MY16.413</GPH>
§ 101.36 21 CFR Ch. I (4–1–23 Edition)
118
ER21DE18.014</GPH>
(iv) Dietary supplement containing dietary ingredients with and without RDIs
and DRVs:
ER21DE18.015</GPH>
119
ER27MY16.415</GPH>
§ 101.36 21 CFR Ch. I (4–1–23 Edition)
ER27MY16.418</GPH> ER27MY16.419</GPH>
120
ER27MY16.417</GPH>
(12) If space is not adequate to list the right must be set off by a line that
the required information as shown in distinguishes it and sets it apart from
the sample labels in paragraph (e)(11) the dietary ingredients and percent of
of this section, the list may be split Daily Value information given to the
and continued to the right as long as left. The following sample label illus-
the headings are repeated. The list to trates this display:
ER21DE18.016</GPH>
(f)(1) Compliance with this section § 101.9(g)(1) through (g)(8), (g)(10), and
will be determined in accordance with
121
ER25MR22.000</GPH>
§ 101.36 21 CFR Ch. I (4–1–23 Edition)
(g)(11), except that the sample for anal- tributor, that qualifies to claim the ex-
ysis shall consist of a composite of 12 emption under the requirements for av-
subsamples (consumer packages) or 10 erage full-time equivalent employees
percent of the number of packages in in § 101.9(j)(18)(i) or (j)(18)(ii), and whose
the same inspection lot, whichever is labels, labeling, and advertising do not
smaller, randomly selected to be rep- provide nutrition information or make
resentative of the lot. The criteria on a nutrient content or health claim;
class I and class II nutrients given in (3) Section 101.9(j)(9) for foods
§ 101.9(g)(3) and (g)(4) also are applica- shipped in bulk form that are not for
ble to other dietary ingredients de- distribution to consumers in such form
scribed in paragraph (b)(3)(i) of this and that are for use solely in the man-
section. Reasonable excesses over la- ufacture of other dietary supplements
beled amounts are acceptable within or that are to be processed, labeled, or
current good manufacturing practice. repacked at a site other than where
(2) When it is not technologically fea- originally processed or packed.
sible, or some other circumstance (i)(1) Dietary supplements are subject
makes it impracticable, for firms to to the special labeling provisions speci-
comply with the requirements of this fied in § 101.9(j)(5)(i) for foods other
section, FDA may permit alternative than infant formula, represented or
means of compliance or additional ex- purported to be specifically for infants
emptions to deal with the situation in through 12 months of age and children
accordance with § 101.9(g)(9). Firms in 1 through 3 years of age.
need of such special allowances shall (2) Section 101.9(j)(13) for foods in
make their request in writing to the small or intermediate-sized packages,
Office of Nutrition and Food Labeling except that:
(HFS–800), Food and Drug Administra- (i) All information within the nutri-
tion, 5001 Campus Dr., College Park, tion label on small-sized packages,
MD 20740. which have a total surface area avail-
(g) Except as provided in paragraphs able to labeling of less than 12 square
(i)(2) and (i)(5) of this section, the loca- inches, shall be in type size no smaller
tion of nutrition information on a label than 4.5 point;
shall be in compliance with § 101.2. (ii) All information within the nutri-
(h) Dietary supplements are subject tion label on intermediate-sized pack-
to the exemptions specified as follows ages, which have from 12 to 40 square
in: inches of surface area available to bear
(1) Section 101.9(j)(1) for foods that labeling, shall be in type size no small-
are offered for sale by a person who er than 6 point, except that type size
makes direct sales to consumers (i.e., a no smaller than 4.5 point may be used
retailer) who has annual gross sales or on packages that have less than 20
business done in sales to consumers square inches available for labeling and
that is not more than $500,000 or has more than 8 dietary ingredients to be
annual gross sales made or business listed and on packages that have 20 to
done in sales of food to consumers of 40 square inches available for labeling
not more than $50,000, and whose la- and more than 16 dietary ingredients to
bels, labeling, and advertising do not be listed.
provide nutrition information or make (iii) When the nutrition information
a nutrient content or health claim; is presented on any panel under
(2) Section 101.9(j)(18) for foods that § 101.9(j)(13)(ii)(D), the ingredient list
are low-volume products (that is, they shall continue to be located imme-
meet the requirements for units sold in diately below the nutrition label, or, if
§ 101.9(j)(18)(i) or (j)(18)(ii)); that, except there is insufficient space below the
as provided in § 101.9(j)(18)(iv), are the nutrition label, immediately contig-
subject of a claim for an exemption uous and to the right of the nutrition
that provides the information required label as specified in § 101.4(g).
under § 101.9(j)(18)(iv), that is filed be- (iv) When it is not possible for a
fore the beginning of the time period small or intermediate-sized package
for which the exemption is claimed, that is enclosed in an outer package to

and that is filed by a person, whether it comply with these type size require-
is the manufacturer, packer, or dis- ments, the type size of the nutrition
122
label on the primary (inner) container that conforms to the guidelines in

may be as small as needed to accom- § 101.45.
modate all of the required label infor- (b) In § 101.44, FDA has listed the 20
mation provided that the primary con- varieties of raw fruit, vegetables, and
tainer is securely enclosed in outer fish that are most frequently consumed
packaging, the nutrition labeling on during a year and to which the guide-
the outer packaging meets the applica- lines apply.
ble type size requirements, and such (c) FDA has also defined in § 101.43,
outer packaging is not intended to be the circumstances that constitute sub-
separated from the primary container stantial compliance by food retailers
under conditions of retail sale. with the guidelines.
(v) Where there is not sufficient (d) By May 8, 1993, FDA will issue a
space on a small or intermediate-sized report on actions taken by food retail-
package for a nutrition label that ers to provide consumers with nutri-
meets minimum type size requirements tion information for raw fruit, vegeta-
of 4.5 points if hairlines are used in ac- bles, and fish under the guidelines es-
cordance with paragraph (e)(5) of this tablished in § 101.45.
section, the hairlines may be omitted (1) The report will include a deter-
and replaced by a row of dots con- mination of whether there is substan-
necting the columns containing the tial compliance, as defined in § 101.43,
name of each dietary ingredient and with the guidelines.
the quantitative amounts (by weight (2) In evaluating substantial compli-
and as a percent of Daily Value). ance, FDA will consider only the 20 va-
(3) Section 101.9(j)(15) for foods in rieties of raw fruit, vegetables, and fish
multiunit food containers; most frequently consumed as identified
(4) Section 101.9(j)(16) for foods sold in § 101.44.
in bulk containers; and (e) If FDA finds that there is substan-
(5) Section 101.9(j)(17) for foods in tial compliance with the guidelines for
packages that have a total surface area the nutrition labeling of raw fruit and
available to bear labeling greater than vegetables or of fish, the agency will so
40 square inches but whose principal state in the report, and the guidelines
display panel and information panel do will remain in effect. FDA will reevalu-
not provide sufficient space to accom- ate the market place for substantial
modate all required label information, compliance every 2 years.
except that the ingredient list shall (f) If FDA determines that there is
continue to be located immediately not substantial compliance with the
below the nutrition label, or, if there is guidelines for raw fruit and vegetables
insufficient space below the nutrition or for raw fish, the agency will at that
label, immediately contiguous and to time issue proposed regulations requir-
the right of the nutrition label as spec- ing that any person who offers raw
ified in § 101.4(g). fruit and vegetables or fish to con-
(j) Dietary supplements shall be sub- sumers provide, in a manner prescribed
ject to the misbranding provisions of by regulations, the nutrition informa-
§ 101.9(k). tion required by § 101.9. Final regula-
[62 FR 49849, Sept. 23, 1997, as amended at 63 tions would have to be issued 6 months
FR 30620, June 5, 1998; 66 FR 56035, Nov. 6, after issuance of proposed regulations,
2001; 71 FR 51726, Aug. 31, 2006; 71 FR 74791, and they would become effective 6
Dec. 13, 2006; 81 FR 33994, May 27, 2016; 83 FR months after the date of their promul-
65502, Dec. 21, 2018] gation.
§ 101.42 Nutrition labeling of raw fruit, § 101.43 Substantial compliance of
vegetables, and fish. food retailers with the guidelines
(a) The Food and Drug Administra- for the voluntary nutrition labeling
tion (FDA) urges food retailers to proof raw fruit, vegetables, and fish.
vide nutrition information, as provided (a) The Food and Drug Administra-
in § 101.9(c), for raw fruit, vegetables, tion (FDA) will judge a food retailer
and fish at the point-of-purchase. If re- who sells raw agricultural commodities
tailers choose to provide such informa- or raw fish to be in compliance with
tion, they should do so in a manner the guidelines in § 101.45 with respect to
123
§ 101.44 21 CFR Ch. I (4–1–23 Edition)
raw agricultural commodities if the re- potato, radishes, summer squash, sweet
tailer displays or provides nutrition la- corn, sweet potato, and tomato.
beling for at least 90 percent of the raw (c) The 20 most frequently consumed
agricultural commodities listed in raw fish are: Blue crab, catfish, clams,
§ 101.44 that it sells, and with respect to cod, flounder/sole, haddock, halibut,
raw fish if the retailer displays or pro- lobster, ocean perch, orange roughy,
vides nutrition labeling for at least 90 oysters, pollock, rainbow trout, rock-
percent of the types of raw fish listed fish, salmon (Atlantic/coho/Chinook/
in § 101.44 that it sells. To be in compli- sockeye, chum/pink), scallops, shrimp,
ance, the nutrition labeling shall: swordfish, tilapia, and tuna.
(1) Be presented in the store or other [71 FR 42044, July 25, 2006]
type of establishment in a manner that
is consistent with § 101.45(a)(1); § 101.45 Guidelines for the voluntary
(2) Be presented in content and for- nutrition labeling of raw fruits,
mat that are consistent with § 101.45 vegetables, and fish.
(a)(2), (a)(3), and (a)(4); and (a) Nutrition labeling for raw fruits,
(3) Include data that have been pro- vegetables, and fish listed in § 101.44
vided by FDA in appendices C and D to should be presented to the public in the
part 101 of this chapter, except that the following manner:
information on potassium is voluntary. (1) Nutrition labeling information
(b) To determine whether there is should be displayed at the point of pur-
substantial compliance by food retail- chase by an appropriate means such as
ers with the guidelines in § 101.45 for by a label affixed to the food or
the voluntary nutrition labeling of raw through labeling including shelf labels,
fruit and vegetables and of raw fish, signs, posters, brochures, notebooks, or
FDA will select a representative sam- leaflets that are readily available and
ple of 2,000 stores, allocated by store in close proximity to the foods. The nu-
type and size, for raw fruit and vegeta- trition labeling information may also
bles and for raw fish. be supplemented by a video, live dem-
(c) FDA will find that there is sub- onstration, or other media.
stantial compliance with the guide- (2) Serving sizes should be deter-
lines in § 101.45 if it finds based on para- mined, and nutrients declared, in ac-
graph (a) of this section that at least 60 cordance with § 101.9 (b) and (c), respec-
percent of all stores that are evaluated tively, except that the nutrition label-
are in compliance. ing data should be based on the raw ed-
(d) FDA will evaluate substantial ible portion for fruits and vegetables
compliance separately for raw agricul- and on the cooked edible portion for
tural commodities and for raw fish. fish. The methods used to cook fish
[55 FR 60890, Nov. 27, 1991, as amended at 61 should be those that do not add fat,
FR 42759, Aug. 16, 1996] breading, or seasoning (e.g., salt or
spices).
§ 101.44 What are the 20 most fre- (3) When nutrition labeling informa-
quently consumed raw fruits, vege- tion is provided for more than one raw
tables, and fish in the United fruit, vegetable, or fish on signs, post-
States? ers, brochures, notebooks, or leaflets,
(a) The 20 most frequently consumed it may be presented in charts with hor-
raw fruits are: Apple, avocado (Cali- izontal or vertical columns or as a
fornia), banana, cantaloupe, grapefruit, compilation of individual nutrition la-
grapes, honeydew melon, kiwifruit, bels. Nutrition labeling that is pre-
lemon, lime, nectarine, orange, peach, sented in a linear display (see
pear, pineapple, plums, strawberries, § 101.9(j)(13)(ii)(A)(2)) will not be consid-
sweet cherries, tangerine, and water- ered to be in compliance. The heading
melon. ‘‘Nutrition Facts’’ must be in a type
(b) The 20 most frequently consumed size larger than all other print in the
raw vegetables are: Asparagus, bell nutrition label. The required informa-
pepper, broccoli, carrot, cauliflower, tion (i.e., headings, serving sizes, list of
celery, cucumber, green (snap) beans, nutrients, quantitative amounts by

green cabbage, green onion, iceberg let- weight (except for vitamins and min-
tuce, leaf lettuce, mushrooms, onion, erals), and percent of Daily Values
124
(DV’s) (except for sugars and protein) in § 101.9(d)(9) may be shortened to

must be clearly presented and of suffi- ‘‘Percent Daily Values are based on a
cient type size and color contrast to be 2,000 calorie diet.’’
plainly legible, with numeric values for (b) Nutrition label values provided by
percent of DV highlighted in contrast the Food and Drug Administration
to the quantitative amounts by weight (FDA) in Appendices C and D to part
and hairlines between all nutrients. 101 for the 20 most frequently con-
(i) Declaration of the number of sumed raw fruits, vegetables, and fish
servings per container need not be in- listed in § 101.44 shall be used to ensure
cluded in the nutrition labeling of raw uniformity in declared values. FDA
fruits, vegetables, and fish. will publish proposed updates of the 20
(ii) Except for the statement ‘‘Per- most frequently consumed raw fruits,
cent Daily Values are based on a 2,000
vegetables, and fish and nutrition label
calorie diet,’’ the footnote required in
data for these foods (or a notice that
§ 101.9(d)(9) is not required. However,
the data sets have not changed from
when labeling is provided in brochures,
the previous publication) at least every
notebooks, leaflets, or similar types of
materials, retailers are encouraged to 4 years in the FEDERAL REGISTER.
include the footnote. (1) The agency encourages the sub-
(iii) When retailers provide nutrition mission of data bases with new or addi-
labeling information for more than one tional nutrient data for any of the
raw fruit or vegetable on signs or post- most frequently consumed raw fruits,
ers or in brochures, notebooks, or leaf- vegetables, and fish to the Office of Nu-
lets, the listings for saturated fat, trans trition and Food Labeling (HFS–800),
fat, and cholesterol may be omitted Center for Food Safety and Applied Nu-
from the charts or individual nutrition trition, Food and Drug Administration,
labels if a footnote states that most 5001 Campus Dr., College Park, MD
fruits and vegetables provide negligible 20740, for review and evaluation. FDA
amounts of these nutrients, but that may incorporate these data in the next
avocados contain 0.5 gram (g) of satu- revision of the nutrition labeling infor-
rated fat per ounce (e.g., ‘‘Most fruits mation for the top 20 raw fruits, vege-
and vegetables provide negligible tables, and fish.
amounts of saturated fat, trans fat, and (i) Guidance in the development of
cholesterol; avocados provide 0.5 g of data bases may be found in the ‘‘FDA
saturated fat per ounce’’). The footnote Nutrition Labeling Manual: A Guide
also may contain information about for Developing and Using Data Bases,’’
the polyunsaturated and available from the Office of Nutrition
monounsaturated fat content of avoca- and Food Labeling (HFS–800), Center
dos. for Food Safety and Applied Nutrition,
(iv) When retailers provide nutrition Food and Drug Administration, 5001
labeling information for more than one Campus Dr., College Park, MD 20740.
raw fish on signs or posters or in bro-
(ii) The submission to FDA should in-
chures, notebooks, or leaflets, the list-
clude, but need not be limited to, infor-
ings for trans fat, dietary fiber, and
mation on the following: Source of the
sugars may be omitted from the charts
or individual nutrition labels if the fol- data (names of investigators, name of
lowing footnote is used, ‘‘Fish provide organization, place of analyses, dates
negligible amounts of trans fat, dietary of analyses), number of samples, sam-
fiber, and sugars.’’ pling design, analytical methods, and
(4) When nutrition labeling is pro- statistical treatment of the data. Pro-
vided for individual raw fruits, vegeta- posed quantitative label declarations
bles, or fish on packages or on signs, may be included. The proposed values
posters, brochures, notebooks, or leaf- for declaration should be determined in
lets, it should be displayed in accord- accordance with the ‘‘FDA Nutrition
ance with § 101.9, except that the dec- Labeling Manual: A Guide for Devel-
laration of the number of servings per oping and Using Data Bases.’’
(2) [Reserved]
container need not be included. For in-

dividual labels provided by retailers on (c) Data bases of nutrient values for
signs and posters, the footnote required raw fruits, vegetables, and fish that are
125
§ 101.54 21 CFR Ch. I (4–1–23 Edition)
not among the 20 most frequently con- submitted in accordance with the pro-
sumed may be used to develop nutri- vision of § 101.30 of this chapter.
tion labeling values for these foods. (ii) [Reserved]
This includes data bases of nutrient
[61 FR 42760, Aug. 16, 1996, as amended at 66
values for specific varieties, species, or FR 56035, Nov. 6, 2001; 71 FR 42044, July 25,
cultivars of raw fruits, vegetables, and 2006; 88 FR 17718, Mar. 24, 2023]
fish not specifically identified among
the 20 most frequently consumed.
Subpart D—Specific Requirements
(1) The food names and descriptions
for the fruits, vegetables, and fish
for Nutrient Content Claims
should clearly identify these foods as
distinct from foods among the most SOURCE: 58 FR 2413, Jan. 6, 1993, unless oth-
erwise noted.
frequently consumed list for which
FDA has provided data. § 101.54 Nutrient content claims for
(2) Guidance in the development of ‘‘good source,’’ ‘‘high,’’ ‘‘more,’’ and
data bases may be found in the ‘‘FDA ‘‘high potency.’’
Nutrition Labeling Manual: A Guide (a) General requirements. Except as
for Developing and Using Data Bases.’’ provided in paragraph (e) of this sec-
(3) Nutrition labeling values com- tion, a claim about the level of a nutri-
puted from data bases are subject to ent in a food in relation to the Ref-
the compliance provisions of § 101.9(g). erence Daily Intake (RDI) established
(i) Compliance with the provisions of for that nutrient in § 101.9(c)(8)(iv) or
§ 101.9(g) may be achieved by use of a Daily Reference Value (DRV) estab-
data base that has been developed fol- lished for that nutrient in § 101.9(c)(9),
lowing FDA guideline procedures and (excluding total carbohydrates) may
approved by FDA. only be made on the label or in labeling
(A) The submission to FDA for ap- of the food if:
proval should include but need not be (1) The claim uses one of the terms
limited to information on the fol- defined in this section in accordance
lowing: Source of the data (names of with the definition for that term;
investigators, name of organization, (2) The claim is made in accordance
place of analyses, dates of analyses), with the general requirements for nu-
number of samples, sampling design, trient content claims in § 101.13; and
analytical methods, statistical treat- (3) The food for which the claim is
ment of the data, and proposed quan- made is labeled in accordance with
titative label declarations. The values § 101.9, § 101.10, or § 101.36, as applicable.
for declaration should be determined in (b) ‘‘High’’ claims. (1) The terms
accordance with the ‘‘FDA Nutrition ‘‘high,’’ ‘‘rich in,’’ or ‘‘excellent source
Labeling Manual: A Guide for Devel- of’’ may be used on the label and in the
oping and Using Databases.’’ labeling of foods, except meal products
(B) FDA approval of a data base and as defined in § 101.13(l) and main dish
nutrition labeling values shall not be products as defined in § 101.13(m), pro-
considered granted until the Center for vided that the food contains 20 percent
Food Safety and Applied Nutrition has or more of the RDI or the DRV per ref-
agreed to all aspects of the data base in erence amount customarily consumed.
writing. Approvals will be in effect for (2) The terms defined in paragraph
a limited time, e.g., 10 years, and will (b)(1) of this section may be used on
be eligible for renewal in the absence of the label and in the labeling of meal
significant changes in agricultural or products as defined in § 101.13(l) and
industry practices (e.g., a change oc- main dish products as defined in
curs in a predominant variety pro- § 101.13(m), provided that:
duced). FDA will take steps to revoke (i) The product contains a food that
its approval of the data base and nutri- meets the definition of ‘‘high’’ in para-
tion labeling values if FDA monitoring graph (b)(1) of this section; and
suggests that the data base or nutri- (ii) The label or labeling clearly iden-
tion labeling values are no longer rep- tifies the food that is the subject of the
resentative of the item sold in this claim (e.g., the serving of broccoli in
country. Approval requests shall be this product is high in vitamin C).
126
(c) ‘‘Good Source’’ claims. (1) The minerals or of the DRV for protein, die-
terms ‘‘good source,’’ ‘‘contains,’’ or tary fiber, or potassium (expressed as a
‘‘provides’’ may be used on the label percent of the Daily Value) per ref-
and in the labeling of foods, except erence amount customarily consumed
meal products as defined in § 101.13(l) than an appropriate reference food; and
and main dish products as defined in (ii) Where the claim is based on a nu-
§ 101.13(m), provided that the food con- trient that has been added to the food,
tains 10 to 19 percent of the RDI or the that fortification is in accordance with
DRV per reference amount customarily the policy on fortification of foods in
consumed. § 104.20 of this chapter; and
(2) The terms defined in paragraph (iii) As required in § 101.13(j)(2) for
(c)(1) of this section may be used on the relative claims:
label and in the labeling of meal prod- (A) The identity of the reference food
ucts as defined in § 101.13(l) and main and the percentage (or fraction) that
dish products as defined in 101.13(m), the nutrient is greater relative to the
provided that: RDI or DRV are declared in immediate
(i) The product contains a food that proximity to the most prominent such
meets the definition of ‘‘good source’’ claim (e.g., ‘‘contains 10 percent more
in paragraph (c)(1) of this section; and of the Daily Value for fiber than white
(ii) The label or labeling clearly iden- bread’’); and
tifies the food that is the subject of the (B) Quantitative information com-
claim (e.g., the serving of sweet pota- paring the level of the nutrient in the
toes in this product is a ‘‘good source’’ product per labeled serving with that
of fiber). of the reference food that it replaces
(d) ‘‘Fiber’’ claims. (1) If a nutrient (e.g., ‘‘Fiber content of white bread is 1
content claim is made with respect to gram (g) per serving; (this product) 3.5
the level of dietary fiber, that is, that g per serving’’) is declared adjacent to
the product is high in fiber, a good the most prominent claim or to the nu-
source of fiber, or that the food con- trition label, except that if the nutri-
tains ‘‘more’’ fiber, and the food is not tion label is on the information panel,
‘‘low’’ in total fat as defined in the quantitative information may be
§ 101.62(b)(2) or, in the case of a meal located elsewhere on the information
product, as defined in § 101.13(l), or panel in accordance with § 101.2.
main dish product, as defined in (2) A relative claim using the terms
§ 101.13(m), is not ‘‘low’’ in total fat as ‘‘more,’’ ‘‘fortified,’’ ‘‘enriched,’’
defined in § 101.62(b)(3), then the label ‘‘added,’’ ‘‘extra,’’ and ‘‘plus’’ may be
shall disclose the level of total fat per used on the label or in labeling to de-
labeled serving. scribe the level of protein, vitamins,
(2) The disclosure shall appear in im- minerals, dietary fiber or potassium,
mediate proximity to such claim, be in except as limited in § 101.13(j)(1)(i), in
a type size no less than one-half the meal products as defined in § 101.13(l) or
size of the claim and precede any dis- main dish products as defined in
closure statement required under § 101.13(m), provided that:
§ 101.13(h) (e.g., ‘‘contains [x amount] of (i) The food contains at least 10 per-
total fat per serving. See nutrition in- cent more of the RDI for vitamins or
formation for fat content’’). minerals or of the DRV for protein, die-
(e) ‘‘More’’ claims. (1) A relative claim tary fiber, or potassium (expressed as a
using the terms ‘‘more,’’ ‘‘fortified,’’ percent of the Daily Value) per 100 g of
‘‘enriched,’’ ‘‘added,’’ ‘‘extra,’’ and food than an appropriate reference
‘‘plus’’ may be used on the label or in food.
labeling of foods to describe the level (ii) Where the claim is based on a nu-
of protein, vitamins, minerals, dietary trient that has been added to the food,
fiber, or potassium, except as limited that fortification is in accordance with
by § 101.13(j)(1)(i) and except meal prod- the policy on fortification of foods in
ucts as defined in § 101.13(l) and main § 104.20 of this chapter; and
dish products as defined in § 101.13(m), (iii) As required in § 101.13(j)(2) for
provided that: relative claims:

(i) The food contains at least 10 per- (A) The identity of the reference food
cent more of the RDI for vitamins or and the percentage (or fraction) that
127
§ 101.54 21 CFR Ch. I (4–1–23 Edition)
the nutrient was increased relative to claim that characterizes the level of
the RDI or DRV are declared in imme- antioxidant nutrients present in a food
diate proximity to the most prominent may be used on the label or in the la-
such claim (e.g., ‘‘contains 10 percent beling of that food when:
more of the Daily Value for fiber per 3 (1) An RDI has been established for
oz than does ‘X brand of product’ ’’), each of the nutrients;
and (2) The nutrients that are the subject
(B) Quantitative information com- of the claim have recognized anti-
paring the level of the nutrient in the oxidant activity; that is, when there
product per specified weight with that exists scientific evidence that, fol-
of the reference food that it replaces lowing absorption from the gastro-
(e.g., ‘‘The fiber content of ‘X brand of intestinal tract, the substance partici-
product’ is 2 g per 3 oz. This product pates in physiological, biochemical, or
contains 4.5 g per 3 oz.’’) is declared ad- cellular processes that inactivate free
jacent to the most prominent claim or radicals or prevent free radical-initi-
to the nutrition label, except that if
ated chemical reactions;
the nutrition label is on the informa-
(3) The level of each nutrient that is
tion panel, the quantitative informa-
tion may be located elsewhere on the the subject of the claim is sufficient to
information panel in accordance with qualify for the § 101.54 (b), (c), or (e)
§ 101.2. claim (e.g., to bear the claim ’’high in
(f) ‘‘High potency’’ claims. (1)(i) The antioxidant vitamin C,’’ the product
term ‘‘high potency’’ may be used on must contain 20 percent or more of the
the label or in the labeling of foods to RDI for vitamin C). Beta-carotene may
describe individual vitamins or min- be a subject of the claim when the level
erals that are present at 100 percent or of vitamin A present as beta-carotene
more of the RDI per reference amount in the food that bears the claim is suf-
customarily consumed. ficient to qualify for the claim. For ex-
(ii) When the term ‘‘high potency’’ is ample, for the claim ‘‘good source of
used to describe individual vitamins or antioxidant beta-carotene,’’ 10 percent
minerals in a product that contains or more of the RDI for vitamin A must
other nutrients or dietary ingredients, be present as beta-carotene per ref-
the label or labeling shall clearly iden- erence amount customarily consumed;
tify which vitamin or mineral is de- and
scribed by the term ‘‘high potency’’ (4) The names of the nutrients that
(e.g., ‘‘Botanical ‘X’ with high potency are the subject of the claim are in-
vitamin E’’). cluded as part of the claim (e.g., ‘‘high
(2) The term ‘‘high potency’’ may be in antioxidant vitamins C and E’’). Al-
used on the label or in the labeling of ternatively, when used as part of a nu-
a multiingredient food product to de- trient content claim, the term ‘‘anti-
scribe the product if the product con- oxidant’’ or ‘‘antioxidants’’ (as in
tains 100 percent or more of the RDI for ‘‘high in antioxidants’’) may be linked
at least two-thirds of the vitamins and by a symbol (e.g., an asterisk) that re-
minerals that are listed in fers to the same symbol that appears
§ 101.9(c)(8)(iv) and that are present in elsewhere on the same panel of a prod-
the product at 2 percent or more of the uct label followed by the name or
RDI (e.g., ‘‘High potency multivitamin, names of the nutrients with recognized
multimineral dietary supplement tab- antioxidant activity. The list of nutri-
lets’’). ents shall appear in letters of a type
(3) Where compliance with para- size height no smaller than the larger
graphs (f)(1)(i), (f)(1)(ii), or (f)(2) of this of one-half of the type size of the larg-
section is based on a nutrient that has est nutrient content claim or 1⁄16 inch.
been added to a food (other than a die-
[58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2,
tary supplement), that fortification
1993, as amended at 59 FR 394, Jan. 4, 1994; 59
shall be in accordance with the policy FR 15051, Mar. 31, 1994; 60 FR 17206, Apr. 5,
on fortification of foods in § 104.20 of 1995; 61 FR 11731, Mar. 22, 1996; 62 FR 31339,
this chapter. June 9, 1997; 62 FR 49867, 49880, Sept. 23, 1997;

(g) Nutrient content claims using the 63 FR 26980, May 15, 1998; 66 FR 17358, Mar. 30,
term ‘‘antioxidant.’’ A nutrient content 2001]
128
§ 101.56 Nutrient content claims for or to the nutrition label, except that if
‘‘light’’ or ‘‘lite.’’ the nutrition label is on the informa-
(a) General requirements. A claim tion panel, the quantitative informa-
using the term light or lite to describe tion may be located elsewhere on the
a food may only be made on the label information panel in accordance with
or in labeling of the food if: § 101.2; and
(1) The claim uses one of the terms (iii) If the labeled food contains less
defined in this section in accordance than 40 calories or less than 3 g fat per
with the definition for that term; reference amount customarily con-
(2) The claim is made in accordance sumed, the percentage reduction for
with the general requirements for nu- that nutrient need not be declared.
trient content claims in § 101.13; and (4) A ‘‘light’’ claim may not be made
(3) The food is labeled in accordance on a food for which the reference food
with § 101.9 or § 101.10, where applicable. meets the definition of ‘‘low fat’’ and
(b) ‘‘Light’’ claims. The terms ‘‘light’’ ‘‘low calorie.’’
or ‘‘lite’’ may be used on the label or in (c)(1)(i) A product for which the ref-
the labeling of foods, except meal prod- erence food contains 40 calories or less
ucts as defined in § 101.13(l) and main and 3 g fat or less per reference amount
dish products as defined in § 101.13(m), customarily consumed may use the
without further qualification, provided term ‘‘light’’ or ‘‘lite’’ without further
that: qualification if it is reduced by 50 per-
(1) If the food derives 50 percent or cent or more in sodium content com-
more of its calories from fat, its fat pared to the reference food; and
content is reduced by 50 percent or (ii) As required in § 101.13(j)(2) for rel-
more per reference amount custom- ative claims:
arily consumed compared to an appro-
(A) The identity of the reference food
priate reference food as specified in
and the percent (or fraction) that the
§ 101.13(j)(1); or
(2) If the food derives less than 50 per- sodium was reduced shall be declared
cent of its calories from fat: in immediate proximity to the most
(i) The number of calories is reduced prominent such claim (e.g., 50 percent
by at least one-third (331⁄3 percent) per less sodium than our regular soy
reference amount customarily con- sauce); and
sumed compared to an appropriate ref- (B) Quantitative information com-
erence food; or paring the level of sodium per labeled
(ii) Its fat content is reduced by 50 serving size with that of the reference
percent or more per reference amount food that it replaces (e.g., ‘‘lite soy
customarily consumed compared to the sauce 500 milligrams (mg) sodium per
reference food that it resembles or for serving; regular soy sauce 1,000 mg per
which it substitutes as specified in serving’’) is declared adjacent to the
§ 101.13(j)(1); and most prominent claim or to the nutri-
(3) As required in § 101.13(j)(2) for rel- tion label, except that if the nutrition
ative claims: label is on the information panel, the
(i) The identity of the reference food quantitative information may be lo-
and the percent (or fraction) that the cated elsewhere on the information
calories and the fat were reduced are panel in accordance with § 101.2.
declared in immediate proximity to the (2)(i) A product for which the ref-
most prominent such claim, (e.g., ‘‘1/3 erence food contains more than 40 cal-
fewer calories and 50 percent less fat ories or more than 3 g fat per reference
than our regular cheese cake’’); amount customarily consumed may
(ii) Quantitative information com- use the term ‘‘light in sodium’’ or ‘‘lite
paring the level of calories and fat con- in sodium’’ if it is reduced by 50 per-
tent in the product per labeled serving cent or more in sodium content com-
size with that of the reference food pared to the reference food, provided
that it replaces (e.g., ‘‘lite cheese- that ‘‘light’’ or ‘‘lite’’ is presented in
cake—200 calories, 4 grams (g) fat per immediate proximity with ‘‘in sodium’’
serving; regular cheesecake—300 cal- and the entire term is presented in uni-
ories, 8 g fat per serving’’) is declared form type size, style, color, and promi-
adjacent to the most prominent claim nence; and
129
§ 101.60 21 CFR Ch. I (4–1–23 Edition)
(ii) As required in § 101.13(j)(2) for rel- (e) Except as provided in paragraphs

ative claims: (b) through (d) of this section, the term
(A) The identity of the reference food ‘‘light’’ or ‘‘lite’’ may not be used to
and the percent (or fraction) that the refer to a food that is not reduced in
sodium was reduced shall be declared fat by 50 percent, or, if applicable, in
in immediate proximity to the most calories by 1⁄3 or, when properly quali-
prominent such claim (e.g., 50 percent fied, in sodium by 50 percent unless:
less sodium than our regular canned (1) It describes some physical or
peas); and organoleptic attribute of the food such
(B) Quantitative information com- as texture or color and the information
paring the level of sodium per labeled (e.g., ‘‘light in color’’ or ‘‘light in tex-
serving size with that of the reference ture’’) so stated, clearly conveys the
food that it replaces (e.g., ‘‘lite canned nature of the product; and
peas, 175 mg sodium per serving; reg- (2) The attribute (e.g., ‘‘color’’ or
ular canned peas 350 mg per serving’’) ‘‘texture’’) is in the same style, color,
is declared adjacent to the most promi- and at least one-half the type size as
nent claim or to the nutrition label, the word ‘‘light’’ and in immediate
except that if the nutrition label is on proximity thereto.
the information panel, the quantitative (f) If a manufacturer can dem-
information may be located elsewhere onstrate that the word ‘‘light’’ has
on the information panel in accordance been associated, through common use,
with § 101.2.
with a particular food to reflect a phys-
(iii) Except for meal products as de- ical or organoleptic attribute (e.g.,
fined in § 101.13(l) and main dish prod- light brown sugar, light corn syrup, or
ucts as defined in § 101.13(m), a ‘‘light light molasses) to the point where it
in sodium’’ claim may not be made on
has become part of the statement of
a food for which the reference food
identity, such use of the term ‘‘light’’
meets the definition of ‘‘low in so-
shall not be considered a nutrient con-
dium’’.
tent claim subject to the requirements
(d)(1) The terms ‘‘light’’ or ‘‘lite’’
in this part.
may be used on the label or in the la-
(g) The term ‘‘lightly salted’’ may be
beling of a meal product as defined in
§ 101.13(l) and a main dish product as used on a product to which has been
defined in § 101.13(m), provided that: added 50 percent less sodium than is
normally added to the reference food as
(i) The food meets the definition of:
described in § 101.13(j)(1)(i)(B) and
(A) ‘‘Low in calories’’ as defined in
(j)(1)(ii)(B), provided that if the prod-
§ 101.60(b)(3); or
uct is not ‘‘low in sodium’’ as defined
(B) ‘‘Low in fat’’ as defined in in § 101.61(b)(4), the statement ‘‘not a
§ 101.62(b)(3); and
low sodium food,’’ shall appear adja-
(ii)(A) A statement appears on the cent to the nutrition label of the food
principal display panel that explains bearing the claim, or, if the nutrition
whether ‘‘light’’ is used to mean ‘‘low label is on the information panel, it
fat,’’ ‘‘low calories,’’ or both (e.g.,
may appear elsewhere on the informa-
‘‘Light Delight, a low fat meal’’); and
tion panel in accordance with § 101.2
(B) The accompanying statement is and the information required to accom-
no less than one-half the type size of pany a relative claim shall appear on
the ‘‘light’’ or ‘‘lite’’ claim.
the label or labeling as specified in
(2)(i) The term ‘‘light in sodium’’ or § 101.13(j)(2).
‘‘lite in sodium’’ may be used on the
label or in the labeling of a meal prod- [58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2,
uct as defined in § 101.13(l) and a main 1993, as amended at 60 FR 17206, Apr. 5, 1995]
dish product as defined in § 101.13(m),
provided that the food meets the defi- § 101.60 Nutrient content claims for
nition of ‘‘low in sodium’’ as defined in the calorie content of foods.
§ 101.61(b)(5)(i); and (a) General requirements. A claim
(ii) ‘‘Light’’ or ‘‘lite’’ and ‘‘in so- about the calorie or sugar content of a
dium’’ are presented in uniform type food may only be made on the label or
size, style, color, and prominence. in the labeling of a food if:
130
(1) The claim uses one of the terms and, except for sugar substitutes, per 50
defined in this section in accordance g (for dehydrated foods that must be
with the definition for that term; reconstituted before typical consump-
(2) The claim is made in accordance tion with water or a diluent containing
with the general requirements for nu- an insignificant amount, as defined in
trient content claims in § 101.13; § 101.9(f)(1), of all nutrients per ref-
(3) The food for which the claim is erence amount customarily consumed,
made is labeled in accordance with the per 50 g criterion refers to the ‘‘as
§ 101.9, § 101.10, or § 101.36, as applicable; prepared’’ form).
and (ii) If a food meets these conditions
(4) For dietary supplements, claims without the benefit of special proc-
regarding calories may not be made on essing, alteration, formulation, or re-
products that meet the criteria in
formulation to vary the caloric con-
§ 101.60(b)(1) or (b)(2) for ‘‘calorie free’’
tent, it is labeled to clearly refer to all
or ‘‘low calorie’’ claims except when an
foods of its type and not merely to the
equivalent amount of a similar dietary
particular brand to which the label at-
supplement (e.g., another protein sup-
plement) that the labeled food resem- taches (e.g., ‘‘celery, a low calorie
bles and for which it substitutes, nor- food’’).
mally exceeds the definition for ‘‘low (3) The terms defined in paragraph
calorie’’ in § 101.60(b)(2). (b)(2) of this section may be used on
(b) Calorie content claims. (1) The the label or in labeling of meal prod-
terms ‘‘calorie free,’’ ‘‘free of calories,’’ ucts as defined in § 101.13(l) or main
‘‘no calories,’’ ‘‘zero calories,’’ ‘‘with- dish products as defined in § 101.13(m),
out calories,’’ ‘‘trivial source of cal- provided that:
ories,’’ ‘‘negligible source of calories,’’ (i) The product contains 120 calories
or ‘‘dietarily insignificant source of or less per 100 g; and
calories’’ may be used on the label or (ii) If the product meets this condi-
in the labeling of foods, provided that: tion without the benefit of special
(i) The food contains less than 5 cal- processing, alteration, formulation, or
ories per reference amount customarily reformulation to lower the calorie con-
consumed and per labeled serving. tent, it is labeled to clearly refer to all
(ii) As required in § 101.13(e)(2), if the foods of its type and not merely to the
food meets this condition without the particular brand to which it attaches.
benefit of special processing, alter- (4) The terms ‘‘reduced calorie,’’ ‘‘re-
ation, formulation, or reformulation to duced in calories,’’ ‘‘calorie reduced,’’
lower the caloric content, it is labeled ‘‘fewer calories,’’ ‘‘lower calorie,’’ or
to disclose that calories are not usu- ‘‘lower in calories’’ may be used on the
ally present in the food (e.g., ‘‘cider label or in the labeling of foods, except
vinegar, a calorie free food’’). as limited by § 101.13(j)(1)(i) and except
(2) The terms ‘‘low calorie,’’ ‘‘few cal- meal products as defined in § 101.13(l)
ories,’’ ‘‘contains a small amount of and main dish products as defined in
calories,’’ ‘‘low source of calories,’’ or
§ 101.13(m), provided that:
‘‘low in calories’’ may be used on the
(i) The food contains at least 25 per-
label or in labeling of foods, except
meal products as defined in § 101.13(l) cent fewer calories per reference
and main dish products as defined in amount customarily consumed than an
§ 101.13(m), provided that: appropriate reference food as described
(i)(A) The food has a reference in § 101.13(j)(1); and
amount customarily consumed greater (ii) As required in § 101.13(j)(2) for rel-
than 30 grams (g) or greater than 2 ta- ative claims:
blespoons and does not provide more (A) The identity of the reference food
than 40 calories per reference amount and the percent (or fraction) that the
customarily consumed; or calories differ between the two foods
(B) The food has a reference amount are declared in immediate proximity to
customarily consumed of 30 g or less or the most prominent such claim (e.g.,
2 tablespoons or less and does not pro- reduced calorie cupcakes ‘‘331⁄3 percent
vide more than 40 calories per ref- fewer calories than regular cupcakes’’);
erence amount customarily consumed and
131
§ 101.60 21 CFR Ch. I (4–1–23 Edition)
(B) Quantitative information com- ‘‘without sugar,’’ ‘‘sugarless,’’ ‘‘trivial

paring the level of the nutrient per la- source of sugar,’’ ‘‘negligible source of
beled serving size with that of the ref- sugar,’’ or ‘‘dietarily insignificant source
erence food that it replaces (e.g., ‘‘Cal- of sugar.’’ Consumers may reasonably
orie content has been reduced from 150 be expected to regard terms that rep-
to 100 calories per serving.’’) is declared resent that the food contains no sugars
adjacent to the most prominent claim or sweeteners e.g., ‘‘sugar free,’’ or ‘‘no
or to the nutrition label, except that if sugar,’’ as indicating a product which
the nutrition label is on the informa- is low in calories or significantly re-
tion panel, the quantitative informa- duced in calories. Consequently, except
tion may be located elsewhere on the as provided in paragraph (c)(2) of this
information panel in accordance with section, a food may not be labeled with
§ 101.2. such terms unless:
(iii) Claims described in paragraph (i) The food contains less than 0.5 g of
(b)(4) of this section may not be made sugars, as defined in § 101.9(c)(6)(ii), per
on the label or labeling of foods if the reference amount customarily con-
reference food meets the definition for sumed and per labeled serving or, in
‘‘low calorie.’’ the case of a meal product or main dish
(5) The terms defined in paragraph product, less than 0.5 g of sugars per la-
(b)(4) of this section may be used on beled serving; and
the label or in the labeling of meal (ii) The food contains no ingredient
products as defined in § 101.13(l) and that is a sugar or that is generally un-
main dish products as defined in derstood by consumers to contain sug-
§ 101.13(m), provided that: ars unless the listing of the ingredient
(i) The food contains at least 25 per- in the ingredient statement is followed
cent fewer calories per 100 g of food by an asterisk that refers to the state-
than an appropriate reference food as ment below the list of ingredients,
described in § 101.13(j)(1); and
which states ‘‘adds a trivial amount of
(ii) As required in § 101.13(j)(2) for rel-
sugar,’’ ‘‘adds a negligible amount of
ative claims:
sugar,’’ or ‘‘adds a dietarily insignifi-
(A) The identity of the reference food
cant amount of sugar;’’ and
calories differ between the two foods (iii)(A) It is labeled ‘‘low calorie’’ or
are declared in immediate proximity to ‘‘reduced calorie’’ or bears a relative
the most prominent such claim (e.g., claim of special dietary usefulness la-
Larry’s Reduced Calorie Lasagna, ‘‘25 beled in compliance with paragraphs
percent fewer calories per oz (or 3 oz) (b)(2), (b)(3), (b)(4), or (b)(5) of this sec-
than our regular Lasagna’’); and tion, or, if a dietary supplement, it
(B) Quantitative information com- meets the definition in paragraph (b)(2)
paring the level of the nutrient in the of this section for ‘‘low calorie’’ but is
product per specified weight with that prohibited by §§ 101.13(b)(5) and
of the reference food that it replaces 101.60(a)(4) from bearing the claim; or
(e.g., ‘‘Calorie content has been re- (B) Such term is immediately accom-
duced from 108 calories per 3 oz to 83 panied, each time it is used, by either
calories per 3 oz.’’) is declared adjacent the statement ‘‘not a reduced calorie
to the most prominent claim or to the food,’’ ‘‘not a low calorie food,’’ or ‘‘not
nutrition label, except that if the nu- for weight control.’’
trition label is on the information (2) The terms ‘‘no added sugar,’’
panel, the quantitative information ‘‘without added sugar,’’ or ‘‘no sugar
may be located elsewhere on the infor- added’’ may be used only if:
mation panel in accordance with § 101.2. (i) No amount of sugars, as defined in
(iii) Claims described in paragraph § 101.9(c)(6)(ii), or any other ingredient
(b)(5) of this section may not be made that contains sugars that functionally
on the label or labeling of food if the substitute for added sugars is added
reference food meets the definition for during processing or packaging; and
‘‘low calorie.’’ (ii) The product does not contain an
(c) Sugar content claims—(1) Use of ingredient containing added sugars

terms such as ‘‘sugar free,’’ ‘‘free of such as jam, jelly, or concentrated
sugar,’’ ‘‘no sugar,’’ ‘‘zero sugar,’’ fruit juice; and
132
(iii) The sugars content has not been (B) Quantitative information com-
increased above the amount present in paring the level of the sugar in the
the ingredients by some means such as product per labeled serving with that
the use of enzymes, except where the of the reference food that it replaces
intended functional effect of the proc- (e.g., ‘‘Sugar content has been lowered
ess is not to increase the sugars con- from 8 g to 6 g per serving.’’) is de-
tent of a food, and a functionally insig- clared adjacent to the most prominent
nificant increase in sugars results; and claim or to the nutrition label, except
(iv) The food that it resembles and that if the nutrition label is on the in-
for which it substitutes normally con- formation panel, the quantitative in-
tains added sugars; and formation may be located elsewhere on
(v) The product bears a statement the information panel in accordance
that the food is not ‘‘low calorie’’ or with § 101.2.
‘‘calorie reduced’’ (unless the food (6) The terms defined in paragraph
meets the requirements for a ‘‘low’’ or (c)(5) of this section may be used on the
‘‘reduced calorie’’ food) and that di- label or in the labeling of a meal prod-
rects consumers’ attention to the nu- uct as defined in § 101.13(l) and a main
trition panel for further information dish product as defined in § 101.13(m),
on sugar and calorie content. provided that:
(3) Paragraph (c)(1) of this section (i) The food contains at least 25 per-
shall not apply to a factual statement cent less sugars per 100 g of food than
that a food, including foods intended an appropriate reference food as de-
specifically for infants and children scribed in § 101.13(j)(1), and
less than 2 years of age, is unsweetened (ii) As required in § 101.13(j)(2) for rel-
or contains no added sweeteners in the ative claims:
case of a food that contains apparent (A) The identity of the reference food
substantial inherent sugar content, and the percent (or fraction) that the
e.g., juices. sugars differ between the two foods are
(4) The claims provided for in para- declared in immediate proximity to the
graph (c)(1) and (c)(2) of this section most prominent such claim (e.g., re-
may be used on labels or in labeling of duced sweet and sour shrimp dinner,
dietary supplements of vitamins or ‘‘25 percent less sugar per 3 oz than our
minerals that are intended specifically regular sweet and sour shrimp din-
for use by infants and children less ner’’); and
than 2 years of age. (B) Quantitative information com-
(5) The terms ‘‘reduced sugar,’’ ‘‘re- paring the level of the nutrient in the
duced in sugar,’’ ‘‘sugar reduced,’’ ‘‘less product per specified weight with that
sugar,’’ ‘‘lower sugar’’ or ‘‘lower in of the reference food that it replaces
sugar’’ may be used on the label or in (e.g., ‘‘Sugar content has been reduced
labeling of foods, except meal products from 17 g per 3 oz to 13 g per 3 oz.’’) is
as defined in § 101.13(l), main dish prod- declared adjacent to the most promi-
ucts as defined in § 101.13(m), and die- nent claim or to the nutrition label,
tary supplements of vitamins or min- except that if the nutrition label is on
erals, provided that: the information panel, the quantitative
(i) The food contains at least 25 per- information may be located elsewhere
cent less sugar per reference amount on the information panel in accordance
customarily consumed than an appro- with § 101.2.
priate reference food as described in [58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2,
§ 101.13(j)(1); and 1993, as amended at 58 FR 44031, Aug. 18, 1993;
(ii) As required in § 101.13(j)(2) for rel- 59 FR 394, Jan. 4, 1994; 60 FR 17206, Apr. 5,
ative claims: 1995; 62 FR 15342, Mar. 31, 1997; 62 FR 49881,
(A) The identity of the reference food Sept. 23, 1997]
sugar differs between the two foods are § 101.61 Nutrient content claims for
declared in immediate proximity to the the sodium content of foods.
most prominent such claim (e.g., (a) General requirements. A claim
‘‘these corn flakes contain 25 percent about the level of sodium or salt in a
less sugar than our sugar coated corn food may only be made on the label or
flakes’’); and in the labeling of the food if:
133
§ 101.61 21 CFR Ch. I (4–1–23 Edition)
(1) The claim uses one of the terms amount customarily consumed and per
defined in this section in accordance 50 g (for dehydrated foods that must be
with the definition for that term; reconstituted before typical consump-
(2) The claim is made in accordance tion with water or a diluent containing
with the general requirements for nu- an insignificant amount, as defined in
trient content claims in § 101.13; and § 101.9(f)(1), of all nutrients per ref-
(3) The food for which the claim is erence amount customarily consumed,
made is labeled in accordance with the per 50-g criterion refers to the ‘‘as
§ 101.9, § 101.10, or § 101.36, as applicable. prepared’’ form);
(b) Sodium content claims. (1) The (ii) If the food meets these conditions
terms ‘‘sodium free,’’ ‘‘free of sodium,’’ without the benefit of special proc-
‘‘no sodium,’’ ‘‘zero sodium,’’ ‘‘without essing, alteration, formulation, or re-
sodium,’’ ‘‘trivial source of sodium,’’ formulation to vary the sodium con-
‘‘negligible source of sodium,’’ or ‘‘die- tent, it is labeled to clearly refer to all
tary insignificant source of sodium’’ foods of its type and not merely to the
may be used on the label or in the la- particular brand to which the label at-
beling of foods, provided that: taches (e.g., ‘‘potatoes, a very low-so-
(i) The food contains less than 5 mil- dium food’’).
ligrams (mg) of sodium per reference (3) The terms defined in paragraph
amount customarily consumed and per (b)(2) of this section may be used on
labeled serving or, in the case of a meal the label or in labeling of meal prod-
product or a main dish product, less ucts as defined in § 101.13(l) and main
than 5 mg of sodium per labeled serv- dish products as defined in § 101.13(m),
ing; and provided that:
(ii) The food contains no ingredient (i) The product contains 35 mg or less
that is sodium chloride or is generally of sodium per 100 g of product; and
understood by consumers to contain (ii) If the product meets this condi-
sodium, unless the listing of the ingre- tion without the benefit of special
dient in the ingredient statement is processing, alteration, formulation, or
followed by an asterisk that refers to reformulation to lower the sodium con-
the statement below the list of ingredi- tent, it is labeled to clearly refer to all
ents, which states: ‘‘Adds a trivial foods of its type and not merely to the
amount of sodium,’’ ‘‘adds a negligible particular brand to which the label at-
amount of sodium’’ or ‘‘adds a dietarily taches.
insignificant amount of sodium;’’ and (4) The terms ‘‘low sodium,’’ or ‘‘low
(iii) As required in § 101.13(e)(2) if the in sodium,’’ ‘‘little sodium,’’ ‘‘contains
food meets these conditions without a small amount of sodium,’’ or ‘‘low
the benefit of special processing, alter- source of sodium’’ may be used on the
ation, formulation, or reformulation to label or in the labeling of foods, except
lower the sodium content, it is labeled meal products as defined in § 101.13(l)
to disclose that sodium is not usually and main dish products as defined in
present in the food (e.g., ‘‘leaf lettuce, § 101.13(m), provided that:
a sodium free food’’). (i)(A) The food has a reference
(2) The terms ‘‘very low sodium,’’ or amount customarily consumed greater
‘‘very low in sodium,’’ may be used on than 30 g or greater than 2 tablespoons
the label or in labeling of foods, except and contains 140 mg or less sodium per
meal products as defined in § 101.13(l) reference amount customarily con-
and main dish products as defined in sumed; or
§ 101.13(m), provided that: (B) The food has a reference amount
(i)(A) The food has a reference customarily consumed of 30 g or less or
amount customarily consumed greater 2 tablespoons or less and contains 140
than 30 grams (g) or greater than 2 ta- mg or less sodium per reference
blespoons and contains 35 mg or less amount customarily consumed and per
sodium per reference amount custom- 50 g (for dehydrated foods that must be
arily consumed; or reconstituted before typical consump-
(B) The food has a reference amount tion with water or a diluent containing
customarily consumed of 30 g or less or an insignificant amount, as defined in

2 tablespoons or less and contains 35 § 101.9(f)(1), of all nutrients per ref-
mg or less sodium per reference erence amount customarily consumed,
134
the per 50-g criterion refers to the ‘‘as information may be located elsewhere
prepared’’ form); and on the information panel in accordance
(ii) If the food meets these conditions with § 101.2.
without the benefit of special proc- (iii) Claims described in paragraph
essing, alteration, formulation, or re- (b)(6) of this section may not be made
formulation to vary the sodium con- on the label or in the labeling of a food
tent, it is labeled to clearly refer to all if the nutrient content of the reference
foods of its type and not merely to the food meets the definition for ‘‘low so-
particular brand to which the label at- dium.’’
taches (e.g., ‘‘fresh spinach, a low so- (7) The terms defined in paragraph
dium food’’); and (b)(6) of this section may be used on
(5) The terms defined in paragraph the label or in the labeling of meal
(b)(4) of this section may be used on products as defined in § 101.13(l) and
the label or in labeling of meal prod- main dish products as defined in
ucts as defined in § 101.13(l) and main § 101.13(m), provided that:
dish products as defined in § 101.13(m), (i) The food contains at least 25 per-
provided that: cent less sodium per 100 g of food than
(i) The product contains 140 mg or an appropriate reference food as de-
less sodium per 100 g; and scribed in § 101.13(j)(1), and
(ii) If the product meets these condi- (ii) As required in § 101.13(j)(2) for rel-
tions without the benefit of special ative claims:
processing, alteration, formulation, or (A) The identity of the reference food
reformulation to lower the sodium con- and the percent (or fraction) that the
tent, it is labeled to clearly refer to all sodium differs from the reference food
foods of its type and not merely to the are declared in immediate proximity to
particular brand to which the label at- the most prominent such claim (e.g.,
taches. reduced sodium eggplant parmigiana
(6) The terms ‘‘reduced sodium,’’ dinner ‘‘30 percent less sodium per oz
‘‘reduced in sodium,’’ ‘‘sodium re- (or 3 oz) than our regular eggplant
duced,’’ ‘‘less sodium,’’ ‘‘lower so- parmigiana dinner’’).
dium,’’ or ‘‘lower in sodium’’ may be (B) Quantitative information com-
used on the label or in labeling of paring the level of sodium in the prod-
foods, except meal products as defined uct per specified weight with that of
in § 101.13(l) and main dish products as the reference food that it replaces (e.g.,
defined in § 101.13(m), provided that: ‘‘Sodium content has been reduced
(i) The food contains at least 25 per- from 217 mg per 3 oz to 150 mg per 3
cent less sodium per reference amount oz.’’) is declared adjacent to the most
customarily consumed than an appro- prominent claim or to the nutrition
priate reference food as described in label, except that if the nutrition label
§ 101.13(j)(1). is on the information panel, the quan-
(ii) As required for § 101.13(j)(2) for titative information may be located
relative claims: elsewhere on the information panel in
(A) The identity of the reference food accordance with § 101.2.
and the percent (or fraction) that the (iii) Claims described in paragraph
sodium differs from the labeled food (b)(7) of this section may not be made
are declared in immediate proximity to on the label or in the labeling of a food
the most prominent such claim (e.g., if the nutrient content of the reference
‘‘reduced sodium ______, 50 percent less food meets the definition for ‘‘low so-
sodium than regular ______’’); and dium.’’
(B) Quantitative information com- (c) The term ‘‘salt’’ is not synony-
paring the level of the sodium in the mous with ‘‘sodium.’’ Salt refers to so-
product per labeled serving with that dium chloride. However, references to
of the reference food that it replaces salt content such as ‘‘unsalted,’’ ‘‘no
(e.g., ‘‘Sodium content has been low- salt,’’ ‘‘no salt added’’ are potentially
ered from 300 to 150 mg per serving.’’) is misleading.
declared adjacent to the most promi- (1) The term ‘‘salt free’’ may be used
nent claim or to the nutrition label, on the label or in labeling of foods only
except that if the nutrition label is on if the food is ‘‘sodium free’’ as defined
the information panel, the quantitative in paragraph (b)(1) of this section.
135
§ 101.62 21 CFR Ch. I (4–1–23 Edition)
(2) The terms ‘‘unsalted,’’ ‘‘without the label or in labeling of foods, pro-
added salt,’’ and ‘‘no salt added’’ may vided that:
be used on the label or in labeling of (i) The food contains less than 0.5
foods only if: gram (g) of fat per reference amount
(i) No salt is added during processing; customarily consumed and per labeled
(ii) The food that it resembles and for serving or, in the case of a meal prod-
which it substitutes is normally proc- uct or main dish product, less than 0.5
essed with salt; and g of fat per labeled serving; and
(iii) If the food is not sodium free, the (ii) The food contains no added ingre-
statement, ‘‘not a sodium free food’’ or dient that is a fat or is generally un-
‘‘not for control of sodium in the diet’’ derstood by consumers to contain fat
appears adjacent to the nutrition label unless the listing of the ingredient in
of the food bearing the claim, or, if the the ingredient statement is followed by
nutrition label is on the information an asterisk that refers to the state-
panel, it may appear elsewhere on the ment below the list of ingredients,
information panel in accordance with which states ‘‘adds a trivial amount of
§ 101.2. fat,’’ ‘‘adds a negligible amount of fat,’’
(3) Paragraph (c)(2) of this section or ‘‘adds a dietarily insignificant
shall not apply to a factual statement amount of fat;’’ and
that a food intended specifically for in- (iii) As required in § 101.13(e)(2), if the
fants and children less than 2 years of
food meets these conditions without
age is unsalted, provided such state-
the benefit of special processing, alter-
ment refers to the taste of the food and
ation, formulation, or reformulation to
is not otherwise false and misleading.
lower fat content, it is labeled to dis-
[58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, close that fat is not usually present in
1993, as amended at 58 FR 44032, Aug. 18, 1993; the food (e.g., ‘‘broccoli, a fat free
59 FR 394, Jan. 4, 1994; 60 FR 17206, Apr. 5, food’’).
1995]
(2) The terms ‘‘low fat,’’ ‘‘low in fat,’’
§ 101.62 Nutrient content claims for ‘‘contains a small amount of fat,’’ ‘‘low
fat, fatty acid, and cholesterol con- source of fat,’’ or ‘‘little fat’’ may be
tent of foods. used on the label or in labeling of
(a) General requirements. A claim foods, except meal products as defined
about the level of fat, fatty acid, and in § 101.13(l) and main dish products as
cholesterol in a food may only be made defined in § 101.13(m), provided that:
on the label or in the labeling of foods (i)(A) The food has a reference
if: amount customarily consumed greater
(1) The claim uses one of the terms than 30 g or greater than 2 tablespoons
defined in this section in accordance and contains 3 g or less of fat per ref-
with the definition for that term; erence amount customarily consumed;
(2) The claim is made in accordance or
with the general requirements for nu- (B) The food has a reference amount
trient content claims in § 101.13; customarily consumed of 30 g or less or
(3) The food for which the claim is 2 tablespoons or less and contains 3 g
made is labeled in accordance with or less of fat per reference amount cus-
§ 101.9, § 101.10, or § 101.36, as applicable; tomarily consumed and per 50 g of food
and (for dehydrated foods that must be re-
(4) For dietary supplements, claims constituted before typical consumption
for fat, saturated fat, and cholesterol with water or a diluent containing an
may not be made on products that insignificant amount, as defined in
meet the criteria in § 101.60(b)(1) or § 101.9(f)(1), of all nutrients per ref-
(b)(2) for ‘‘calorie free’’ or ‘‘low cal- erence amount customarily consumed,
orie’’ claims. the per 50-g criterion refers to the ‘‘as
(b) Fat content claims. (1) The terms prepared’’ form); and
‘‘fat free,’’ ‘‘free of fat,’’ ‘‘no fat,’’ (ii) If the food meets these conditions
‘‘zero fat,’’ ‘‘without fat,’’ ‘‘negligible without the benefit of special proc-
source of fat,’’ or ‘‘dietarily insignifi- essing, alteration, formulation, or re-

cant source of fat’’ or, in the case of formulation to lower fat content, it is
milk products, ‘‘skim’’ may be used on labeled to clearly refer to all foods of
136
its type and not merely to the par- (5) The terms defined in paragraph
ticular brand to which the label at- (b)(4) of this section may be used on
taches (e.g., ‘‘frozen perch, a low fat the label or in the labeling of meal
food’’). products as defined in § 101.13(l) and
(3) The terms defined in paragraph main dish products as defined in
(b)(2) of this section may be used on § 101.13(m), provided that:
the label or in labeling of meal prod- (i) The food contains at least 25 per-
ucts as defined in § 101.13(l) or main cent less fat per 100 g of food than an
dish products as defined in § 101.13(m), appropriate reference food as described
provided that: in § 101.13(j)(1); and
(i) The product contains 3 g or less of (ii) As required in § 101.13(j)(2) for rel-
total fat per 100 g and not more than 30 ative claims:
percent of calories from fat; and (A) The identity of the reference food
(ii) If the product meets these condi- and the percent (or fraction) that the
tions without the benefit of special fat differs between the two foods are
processing, alteration, formulation, or declared in immediate proximity to the
reformulation to lower fat content, it most prominent such claim (e.g., re-
is labeled to clearly refer to all foods of duced fat spinach souffle, ‘‘33 percent
its type and not merely to the par- less fat per 3 oz than our regular spin-
ticular brand to which the label at- ach souffle’’); and
taches. (B) Quantitative information com-
(4) The terms ‘‘reduced fat,’’ ‘‘re- paring the level of fat in the product
duced in fat,’’ ‘‘fat reduced,’’ ‘‘less fat,’’ per specified weight with that of the
‘‘lower fat,’’ or ‘‘lower in fat’’ may be reference food that it replaces (e.g.,
used on the label or in the labeling of ‘‘Fat content has been reduced from 7.5
foods, except meal products as defined g per 3 oz to 5 g per 3 oz.’’) is declared
in § 101.13(l) and main dish products as adjacent to the most prominent claim,
defined in § 101.13(m), provided that: to the nutrition label, or, if the nutri-
(i) The food contains at least 25 per- tion label is located on the information
cent less fat per reference amount cus- panel, it may appear elsewhere on the
tomarily consumed than an appro- information panel in accordance with
priate reference food as described in § 101.2.
§ 101.13(j)(1); and (iii) Claims described in paragraph
(ii) As required in § 101.13(j)(2) for rel- (b)(5) of this section may not be made
ative claims: on the label or in the labeling of a food
(A) The identity of the reference food if the nutrient content of the reference
and the percent (or fraction) that the food meets the definition for ‘‘low fat.’’
fat differs between the two foods and (6) The term ‘‘__ percent fat free’’
are declared in immediate proximity to may be used on the label or in the la-
the most prominent such claim (e.g., beling of foods, provided that:
‘‘reduced fat—50 percent less fat than (i) The food meets the criteria for
our regular brownies’’); and ‘‘low fat’’ in paragraph (b)(2) or (b)(3) of
(B) Quantitative information com- this section;
paring the level of fat in the product (ii) The percent declared and the
per labeled serving with that of the ref- words ‘‘fat free’’ are in uniform type
erence food that it replaces (e.g., ‘‘Fat size; and
content has been reduced from 8 g to 4 (iii) A ‘‘100 percent fat free’’ claim
g per serving.’’) is declared adjacent to may be made only on foods that meet
the most prominent claim or to the nu- the criteria for ‘‘fat free’’ in paragraph
trition label, except that if the nutri- (b)(1) of this section, that contain less
tion label is on the information panel, than 0.5 g of fat per 100 g, and that con-
the quantitative information may be tain no added fat.
located elsewhere on the information (c) Fatty acid content claims. The label
panel in accordance with § 101.2. or labeling of foods that bear claims
(iii) Claims described in paragraph with respect to the level of saturated
(b)(4) of this section may not be made fat shall disclose the level of total fat
on the label or in the labeling of a food and cholesterol in the food in imme-
if the nutrient content of the reference diate proximity to such claim each
food meets the definition for ‘‘low fat.’’ time the claim is made and in type
137
§ 101.62 21 CFR Ch. I (4–1–23 Edition)
that shall be no less than one-half the (iii) As required in § 101.13(e)(2), if the
size of the type used for the claim with food meets these conditions without
respect to the level of saturated fat. the benefit of special processing, alter-
Declaration of cholesterol content may ation, formulation, or reformulation to
be omitted when the food contains less lower saturated fat content, it is la-
than 2 milligrams (mg) of cholesterol beled to disclose that saturated fat is
per reference amount customarily con- not usually present in the food.
sumed or in the case of a meal or main (2) The terms ‘‘low in saturated fat,’’
dish product less than 2 mg of choles- ‘‘low saturated fat,’’ ‘‘contains a small
terol per labeled serving. Declaration amount of saturated fat,’’ ‘‘low source
of total fat may be omitted with the of saturated fat,’’ or ‘‘a little saturated
term defined in paragraph (c)(1) of this fat’’ may be used on the label or in the
section when the food contains less labeling of foods, except meal products
than 0.5 g of total fat per reference as defined in § 101.13(l) and main dish
amount customarily consumed or, in products as defined in § 101.13(m), pro-
the case of a meal product or a main vided that:
dish product, when the product con- (i) The food contains 1 g or less of
tains less than 0.5 g of total fat per la- saturated fatty acids per reference
beled serving. The declaration of total amount customarily consumed and not
fat may be omitted with the terms de- more than 15 percent of calories from
fined in paragraphs (c)(2) through (c)(5) saturated fatty acids; and
of this section when the food contains (ii) If a food meets these conditions
3 g or less of total fat per reference without benefit of special processing,
amount customarily consumed or in alteration, formulation, or reformula-
the case of a meal product or a main tion to lower saturated fat content, it
dish product, when the product con- is labeled to clearly refer to all foods of
tains 3 g or less of total fat per 100 g its type and not merely to the par-
and not more than 30 percent calories ticular brand to which the label at-
from fat. taches (e.g., ‘‘raspberries, a low satu-
(1) The terms ‘‘saturated fat free,’’ rated fat food’’).
‘‘free of saturated fat,’’ ‘‘no saturated (3) The terms defined in paragraph
fat,’’ ‘‘zero saturated fat,’’ ‘‘without (c)(2) of this section may be used on the
saturated fat,’’ ‘‘trivial source of satu- label or in the labeling of meal prod-
rated fat,’’ ‘‘negligible source of satu- ucts as defined in § 101.13(l) and main
rated fat,’’ or ‘‘dietarily insignificant dish products as defined in § 101.13(m),
source of saturated fat’’ may be used provided that:
on the label or in the labeling of foods, (i) The product contains 1 g or less of
provided that: saturated fatty acids per 100 g and less
(i) The food contains less than 0.5 g of than 10 percent calories from saturated
saturated fat and less than 0.5 g trans fat; and
fatty acid per reference amount cus- (ii) If the product meets these condi-
tomarily consumed and per labeled tions without the benefit of special
serving, or in the case of a meal prod- processing, alteration, formulation, or
uct or main dish product, less than 0.5 reformulation to lower saturated fat
g of saturated fat and less than 0.5 g content, it is labeled to clearly refer to
trans fatty acid per labeled serving; and all foods of its type and not merely to
(ii) The food contains no ingredient the particular brand to which the label
that is generally understood by con- attaches.
sumers to contain saturated fat unless (4) The terms ‘‘reduced saturated
the listing of the ingredient in the in- fat,’’ ‘‘reduced in saturated fat,’’
gredient statement is followed by an ‘‘saturated fat reduced,’’ ‘‘less satu-
asterisk that refers to the statement rated fat,’’ ‘‘lower saturated fat,’’ or
below the list of ingredients which ‘‘lower in saturated fat’’ may be used
states, ‘‘adds a trivial amount of satu- on the label or in the labeling of foods,
rated fat,’’ ‘‘adds a negligible amount except as limited by § 101.13(j)(1)(i) and
of saturated fat,’’ or ‘‘adds a dietarily except meal products as defined in

insignificant amount of saturated fat;’’ § 101.13(l) and main dish products as de-
and fined in § 101.13(m), provided that:
138
(i) The food contains at least 25 per- (e.g., ‘‘Saturated fat content has been
cent less saturated fat per reference reduced from 2.5 g per 3 oz to 1.7 g per
amount customarily consumed than an 3 oz.’’) is declared adjacent to the most
appropriate reference food as described prominent claim or to the nutrition
in § 101.13(j)(1); and label, except that if the nutrition label
(ii) As required in § 101.13(j)(2) for rel- in on the information panel, the quan-
ative claims: titative information may be located
(A) The identity of the reference food elsewhere on the information panel in
and the percent (or fraction) that the accordance with § 101.2.
saturated fat differs between the two (iii) Claims described in paragraph
foods are declared in immediate prox- (c)(5) of this section may not be made
imity to the most prominent such on the label or in the labeling of a food
claim (e.g., ‘‘reduced saturated fat. if the nutrient content of the reference
Contains 50 percent less saturated fat food meets the definition for ‘‘low satu-
than the national average for nondairy rated fat.’’
creamers’’); and (d) Cholesterol content claims. (1) The
(B) Quantitative information com- terms ‘‘cholesterol free,’’ ‘‘free of cho-
paring the level of saturated fat in the lesterol,’’ ‘‘zero cholesterol,’’ ‘‘without
product per labeled serving with that cholesterol,’’ ‘‘no cholesterol,’’ ‘‘trivial
of the reference food that it replaces source of cholesterol,’’ ‘‘negligible
(e.g., ‘‘Saturated fat reduced from 3 g source of cholesterol,’’ or ‘‘dietarily in-
to 1.5 g per serving’’) is declared adja- significant source of cholesterol’’ may
cent to the most prominent claim or to be used on the label or in the labeling
the nutrition label, except that if the of foods, provided that:
nutrition label is on the information
(i) For foods that contain 13 g or less
panel, the quantitative information
of total fat per reference amount cus-
may be located elsewhere on the infor-
tomarily consumed, per labeled serv-
mation panel in accordance with § 101.2.
ing, and per 50 g if the reference
(iii) Claims described in paragraph
amount customarily consumed is 30 g
(c)(4) of this section may not be made
or less or 2 tablespoons or less (for de-
on the label or in the labeling of a food
if the nutrient content of the reference hydrated foods that must be reconsti-
food meets the definition for ‘‘low satu- tuted before typical consumption with
rated fat.’’ water or a diluent containing an insig-
(5) The terms defined in paragraph nificant amount, as defined in
(c)(4) of this section may be used on the § 101.9(f)(1), of all nutrients per ref-
label or in the labeling of meal prod- erence amount customarily consumed,
ucts as defined in § 101.13(l) and main the per 50-g criterion refers to the ‘‘as
dish products as defined in § 101.13(m), prepared’’ form), or, in the case of meal
provided that: products, 26.0 g or less total fat per la-
(i) The food contains at least 25 per- beled serving, or, in the case of main
cent less saturated fat per 100 g of food dish products, 19.5 g or less total fat
than an appropriate reference food as per labeled serving:
described in § 101.13(j)(1), and (A) The food contains less than 2 mg
(ii) As required in § 101.13(j)(2) for rel- of cholesterol per reference amount
ative claims: customarily consumed and per labeling
(A) The identity of the reference serving or, in the case of a meal prod-
food, and the percent (or fraction) that uct or main dish product, less than 2
the fat differs between the two foods mg of cholesterol per labeled serving;
are declared in immediate proximity to and
the most prominent such claim (e.g., (B) The food contains no ingredient
reduced saturated fat Macaroni and that is generally understood by con-
Cheese, ‘‘33 percent less saturated fat sumers to contain cholesterol, unless
per 3 oz than our regular Macaroni and the listing of the ingredient in the in-
Cheese’’). gredient statement is followed by an
(B) Quantitative information com- asterisk that refers to the statement
paring the level of saturated fat in the below the list of ingredients, which
product per specified weight with that states ‘‘adds a trivial amount of choles-
of the reference food that it replaces terol,’’ ‘‘adds a negligible amount of
139
§ 101.62 21 CFR Ch. I (4–1–23 Edition)
cholesterol,’’ or ‘‘adds a dietarily insig- amount customarily consumed or, in

nificant amount of cholesterol;’’ and the case of a meal product or main dish
(C) The food contains 2 g or less of product less than 2 g of saturated fatty
saturated fatty acids per reference acids per labeled serving; and
amount customarily consumed or, in (D) The label or labeling discloses the
the case of a meal product or main dish level of total fat in a serving (as de-
product, 2 g or less of saturated fatty clared on the label) of the food. Such
acids per labeled serving; and disclosure shall appear in immediate
(D) As required in § 101.13(e)(2), if the proximity to such claim preceding any
food contains less than 2 mg of choles- disclosure statement required under
terol per reference amount customarily § 101.13(h) in type that shall be no less
consumed or in the case of a meal prod- than one-half the size of the type used
uct or main dish product, less than 2 for such claim. If the claim appears on
mg of cholesterol per labeled serving more than one panel, the disclosure
without the benefit of special proc- shall be made on each panel except for
essing, alteration, formulation, or re- the panel that bears nutrition labeling.
formulation to lower cholesterol con- If the claim appears more than once on
tent, it is labeled to disclose that cho- a panel, the disclosure shall be made in
lesterol is not usually present in the immediate proximity to the claim that
food (e.g., ‘‘applesauce, a cholesterol- is printed in the largest type; and
free food’’). (E) As required in § 101.13(e)(2), if the
(ii) For food that contain more than food contains less than 2 mg of choles-
13 g of total fat per reference amount terol per reference amount customarily
customarily consumed, per labeling consumed or in the case of a meal prod-
serving, or per 50 g if the reference uct or main dish product less than 2 mg
amount customarily consumed is 30 g of cholesterol per labeled serving with-
or less or 2 tablespoons or less (for de- out the benefit of special processing,
hydrated foods that must be reconsti- alteration, formulation, or reformula-
tuted before typical consumption with tion to lower cholesterol content, it is
water or a diluent containing an insig- labeled to disclose that cholesterol is
nificant amount, as defined in not usually present in the food (e.g.,
§ 101.9(f)(1), of all nutrients per ref- ‘‘canola oil, a cholesterol-free food,
erence amount customarily consumed, contains 14 g of fat per serving’’); or
the per 50-g criterion refers to the ‘‘as (F) If the food contains less than 2
prepared’’ form), or in the case of a mg of cholesterol per reference amount
meal product, more than 26 g of total customarily consumed or in the case of
fat per labeled serving, or, in the case a meal product or main dish product
of a main dish product more than 19.5 g less than 2 mg of cholesterol per la-
of total fat per labeled serving: beled serving only as a result of special
(A) The food contains less than 2 mg processing, alteration, formulation, or
of cholesterol per reference amount reformulation, the amount of choles-
customarily consumed and per labeling terol is substantially less (i.e., meets
serving or, in the case of a meal prod- requirements of paragraph (d)(4)(ii)(A)
uct or main dish product, less than 2 of this section) than the food for which
mg of cholesterol per labeled serving; it substitutes as specified in § 101.13(d)
and that has a significant (e.g., 5 percent or
(B) The food contains no ingredient more of a national or regional market)
that is generally understood by con- market share. As required in
sumers to contain cholesterol, unless § 101.13(j)(2) for relative claims:
the listing of the ingredient in the in- (1) The identity of the reference food
gredient statement is followed by an and the percent (or fraction) that the
asterisk that refers to the statement cholesterol was reduced are declared in
below the list of ingredients, which immediate proximity to the most
states ‘‘adds a trivial amount of choles- prominent such claim (e.g., ‘‘choles-
terol,’’ ‘‘adds a negligible amount of terol-free margarine, contains 100 per-
cholesterol,’’ or ‘‘adds a dietarily insig- cent less cholesterol than butter’’); and
nificant amount of cholesterol;’’ and (2) Quantitative information com-

(C) The food contains 2 g or less of paring the level of cholesterol in the
saturated fatty acids per reference product per labeled serving with that
140
of the reference food that it replaces hydrated foods that must be reconsti-
(e.g., ‘‘Contains no cholesterol com- tuted before typical consumption with
pared with 30 mg cholesterol in one water or a diluent containing an insig-
serving of butter. Contains 13 g of fat nificant amount, as defined in
per serving.’’) is declared adjacent to § 101.9(f)(1), of all nutrients per ref-
the most prominent claim or to the nu- erence amount customarily consumed,
trition label, except that if the nutri- the per 50-g criterion refers to the ‘‘as
tion label is on the information panel, prepared’’ form);
the quantitative information may be (B) The food contains 2 g or less of
located elsewhere on the information saturated fatty acids per reference
panel in accordance with § 101.2. amount customarily consumed; and
(2) The terms ‘‘low in cholesterol,’’
(C) As required in § 101.13(e)(2), if the
‘‘low cholesterol,’’ ‘‘contains a small
food meets these conditions without
amount of cholesterol,’’ ‘‘low source of
the benefit of special processing, alter-
cholesterol,’’ or ‘‘little cholesterol’’
may be used on the label or in the la- ation, formulation, or reformulation to
beling of foods, except meal products lower cholesterol content, it is labeled
as defined in § 101.13(l) and main dish to clearly refer to all foods of that type
products as defined in § 101.13(m), pro- and not merely to the particular brand
vided that: to which the label attaches (e.g., ‘‘low
(i) For foods that have a reference fat cottage cheese, a low cholesterol
amount customarily consumed greater food’’).
than 30 g or greater than 2 tablespoons (iii) For foods that have a reference
and contain 13 g or less of total fat per amount customarily consumed greater
reference amount customarily con- than 30 g or greater than 2 tablespoons
sumed and per labeled serving: and contain more than 13 g of total fat
(A) The food contains 20 mg or less of per reference amount customarily con-
cholesterol per reference amount cus- sumed or per labeled serving,
tomarily consumed; (A) The food contains 20 mg or less of
(B) The food contains 2 g or less of cholesterol per reference amount cus-
saturated fatty acids per reference tomarily consumed;
amount customarily consumed; and (B) The food contains 2 g or less of
(C) As required in § 101.13(e)(2), if the saturated fatty acids per reference
food meets these conditions without amount customarily consumed;
the benefit of special processing, alter- (C) The label or labeling discloses the
ation, formulation, or reformulation to
level of total fat in a serving (as de-
lower cholesterol content, it is labeled
clared on the label) of the food. Such
to clearly refer to all foods of that type
disclosure shall appear in immediate
and not merely to the particular brand
proximity to such claim preceding any
to which the label attaches (e.g., ‘‘low
disclosure statement required under
fat cottage cheese, a low cholesterol
food.’’). § 101.13(h) in type that shall be no less
(ii) For foods that have a reference than one-half the size of the type used
amount customarily consumed of 30 g for such claim. If the claim appears on
or less or 2 tablespoons or less and con- more than one panel, the disclosure
tain 13 g or less of total fat per ref- shall be made on each panel except for
erence amount customarily consumed, the panel that bears nutrition labeling.
per labeled serving, and per 50 g (for de- If the claim is made more than once on
hydrated foods that must be reconsti- a panel, the disclosure shall be made in
tuted before typical consumption with immediate proximity to the claim that
water or a diluent containing an insig- is printed in the largest type; and
nificant amount, as defined in (D) As required in § 101.13(e)(2), if the
§ 101.9(f)(1), of all nutrients per ref- food meets these conditions without
erence amount customarily consumed, the benefit of special processing, alter-
the per 50-g criterion refers to the ‘‘as ation, formulation, or reformulation to
prepared’’ form); lower cholesterol content, it is labeled
(A) The food contains 20 mg or less of to clearly refer to all foods of that type
cholesterol per reference amount cus- and not merely to the particular brand
tomarily consumed and per 50 g (for de- to which the label attaches; or
141
§ 101.62 21 CFR Ch. I (4–1–23 Edition)
(E) If the food contains 20 mg or less the per 50-g criterion refers to the ‘‘as
of cholesterol only as a result of spe- prepared’’ form),
cial processing, alteration, formula- (B) The food contains 2 g or less of
tion, or reformulation, the amount of saturated fatty acids per reference
cholesterol is substantially less (i.e., amount customarily consumed;
meets requirements of paragraph (C) The label or labeling discloses the
(d)(4)(ii)(A) of this section) than the level of total fat in a serving (as de-
food for which it substitutes as speci- clared on the label) of the food. Such
fied in § 101.13(d) that has a significant disclosure shall appear in immediate
(e.g., 5 percent or more of a national or proximity to such claim preceding any
regional market) market share. As re- disclosure statement required under
quired in § 101.13(j)(2) for relative § 101.13(h) in type that shall be no less
claims: than one-half the size of the type used
(1) The identity of the reference food for such claim. If the claim appears on
and the percent (or fraction) that the more than one panel, the disclosure
cholesterol has been reduced are de- shall be made on each panel except for
clared in immediate proximity to the the panel that bears nutrition labeling.
most prominent such claim (e.g., ‘‘low- If the claim is made more than once on
cholesterol peanut butter sandwich a panel, the disclosure shall be made in
crackers, contains 83 percent less cho- immediate proximity to the claim that
lesterol than our regular peanut butter is printed in the largest type; and
sandwich crackers’’); and (D) As required in § 101.13(e)(2), if the
(2) Quantitative information com- food meets these conditions without
paring the level of cholesterol in the the benefit of special processing, alter-
product per labeled serving with that ation, formulation, or reformulation to
of the reference food that it replaces lower cholesterol content, it is labeled
(e.g., ‘‘Cholesterol lowered from 30 mg to clearly refer to all foods of that type
to 5 mg per serving; contains 13 g of fat and not merely to the particular brand
per serving.’’) is declared adjacent to to which the label attaches; or
the most prominent claim or to the nu- (E) If the food contains 20 mg or less
trition label, except that if the nutri- of cholesterol only as a result of spe-
tion label is on the information panel, cial processing, alteration, formula-
the quantitative information may be tion, or reformulation, the amount of
located elsewhere on the information cholesterol is substantially less (i.e.,
panel in accordance with § 101.2. meets requirements of paragraph
(iv) For foods that have a reference (d)(4)(ii)(A) of this section) than the
amount customarily consumed of 30 g food for which it substitutes as speci-
or less or 2 tablespoons or less and con- fied in § 101.13(d) that has a significant
tain more than 13 g of total fat per ref- (i.e., 5 percent or more of a national or
erence amount customarily consumed, regional market) market share. As re-
per labeled serving, or per 50 g (for de- quired in § 101.13(j)(2) for relative
hydrated foods that must be reconsti- claims:
tuted before typical consumption with (1) The identity of the reference food
water or a diluent containing an insig- and the percent (or fraction) that the
nificant amount, as defined in cholesterol has been reduced are de-
§ 101.9(f)(1), of all nutrients per ref- clared in immediate proximity to the
erence amount customarily consumed, most prominent such claim (e.g., ‘‘low-
the per 50-g criterion refers to the ‘‘as cholesterol peanut butter sandwich
prepared’’ form), crackers, contains 83 percent less cho-
(A) The food contains 20 mg or less of lesterol than our regular peanut butter
cholesterol per reference amount cus- sandwich crackers’’); and
tomarily consumed and per 50 g (for de- (2) Quantitative information com-
hydrated foods that must be reconsti- paring the level of cholesterol in the
tuted before typical consumption with product per labeled serving with that
water or a diluent containing an insig- of the reference food that it replaces
nificant amount, as defined in (e.g., ‘‘Cholesterol lowered from 30 mg

§ 101.9(f)(1), of all nutrients per ref- to 5 mg per serving; contains 13 g of fat
erence amount customarily consumed, per serving.’’) is declared adjacent to
142
the most prominent claim or to the nu- more from the reference food it resem-
trition label, except that if the nutri- bles as defined in § 101.13(j)(1) and for
tion label is on the information panel, which it substitutes as specified in
the quantitative information may be § 101.13(d) that has a significant (i.e., 5
located elsewhere on the information percent or more) market share; and
panel in accordance with § 101.2. (B) The food contains 2 g or less of
(3) The terms defined in paragraph saturated fatty acids per reference
(d)(2) of this section may be used on amount customarily consumed; and
the label and in labeling of meal prod- (C) As required in § 101.13(j)(2) for rel-
ucts as defined in § 101.13(l) or a main ative claims:
dish product as defined in § 101.13(m) (1) The identity of the reference food
provided that the product meets the re- and the percent (or fraction) that the
quirements of paragraph (d)(2) of this cholesterol has been reduced are de-
section except that the determination clared in immediate proximity to the
as to whether paragraph (d)(2)(i) or most prominent such claim; and
(d)(2)(iii) of this section applies to the (2) Quantitative information com-
product will be made only on the basis paring the level of cholesterol in the
of whether the meal product contains product per labeled serving with that
26 g or less of total fat per labeled serv- of the reference food that it replaces
ing or the main dish product contain (e.g., ‘‘[labeled product] 50 mg choles-
19.5 g or less of total fat per labeled terol per serving; [reference product] 30
serving, the requirement in paragraphs mg cholesterol per serving’’) is de-
(d)(2)(i)(A) and (d)(2)(iii)(A) of this sec- clared adjacent to the most prominent
tion shall be limited to 20 mg of choles- claim or to the nutrition label, except
terol per 100 g, and the requirement in that if the nutrition label is on the in-
paragraphs (d)(2)(i)(B) and (d)(2)(iii)(B) formation panel, the quantitative in-
of this section shall be modified to re- formation may be located elsewhere on
quire that the food contain 2 g or less the information panel in accordance
of saturated fat per 100 g rather than with § 101.2.
per reference amount customarily con- (ii) For foods that contain more than
sumed. 13 g of total fat per reference amount
(4) The terms ‘‘reduced cholesterol,’’ customarily consumed, per labeled
‘‘reduced in cholesterol,’’ ‘‘cholesterol serving, or per 50 g if the reference
reduced,’’ ‘‘less cholesterol,’’ ‘‘lower amount customarily consumed is 30 g
cholesterol,’’ or ‘‘lower in cholesterol’’ or less or 2 tablespoons or less (for de-
except as limited by § 101.13(j)(1)(i) may hydrated foods that must be reconsti-
be used on the label or in labeling of tuted before typical consumption with
foods or foods that substitute for those water or a diluent containing an insig-
foods as specified in § 101.13(d), exclud- nificant amount, as defined in
ing meal products as defined in § 101.9(f)(1), of all nutrients per ref-
§ 101.13(l) and main dish products as de- erence amount customarily consumed,
fined in § 101.13(m), provided that: the per 50-g criterion refers to the ‘‘as
(i) For foods that contain 13 g or less prepared’’ form):
of total fat per reference amount cus- (A) The food has been specifically
tomarily consumed, per labeled serv- formulated, altered, or processed to re-
ing, and per 50 g if the reference duce its cholesterol by 25 percent or
amount customarily consumed is 30 g more from the reference food it resem-
or less or 2 tablespoons or less (for de- bles as defined in § 101.13(j)(1) and for
hydrated foods that must be reconsti- which it substitutes as specified in
tuted before typical consumption with § 101.13(d) that has a significant (i.e., 5
water or a diluent containing an insig- percent or more of a national or re-
nificant amount, as defined in gional market) market share;
§ 101.9(f)(1), of all nutrients per ref- (B) The food contains 2 g or less of
erence amount customarily consumed, saturated fatty acids per reference
the per 50-g criterion refers to the ‘‘as amount customarily consumed;
prepared’’ form): (C) The label or labeling discloses the
(A) The food has been specifically level of total fat in a serving (as de-
formulated, altered, or processed to re- clared on the label) of the food. Such
duce its cholesterol by 25 percent or disclosure shall appear in immediate
143
§ 101.62 21 CFR Ch. I (4–1–23 Edition)
proximity to such claim preceding any percent or more of a national or re-

disclosure statement required under gional market) market share;
§ 101.13(h) in type that shall be no less (B) The food contains 2 g or less of
than one-half the size of the type used saturated fatty acids per 100 g; and
for such claim. If the claim appears on (C) As required in § 101.13(j)(2) for rel-
more than one panel, the disclosure ative claims:
shall be made on each panel except for (1) The identity of the reference food,
the panel that bears nutrition labeling. and the percent (or fraction) that the
If the claim is made more than once on cholesterol has been reduced are de-
a panel, the disclosure shall be made in clared in immediate proximity to the
immediate proximity to the claim that most prominent such claim (e.g., ‘‘25%
is printed in the largest type; and less cholesterol per 3 oz than ______);
(D) As required in § 101.13(j)(2) for rel- and
ative claims: (2) Quantitative information com-
(1) The identity of the reference food paring the level of cholesterol in the
and the percent (or fraction) that the product per specified weight with that
cholesterol has been reduced are de- of the reference food that it replaces
clared in immediate proximity to the (e.g., ‘‘Cholesterol content has been re-
most prominent such claim (e.g., 25 duced from 35 mg per 3 oz to 25 mg per
percent less cholesterol than ______); 3 oz.’’) is declared adjacent to the most
and prominent claim or to the nutrition
(2) Quantitative information com- label, except that if the nutrition label
paring the level of cholesterol in the is on the information panel, the quan-
product per labeled serving with that titative information may be located
of the reference food that it replaces elsewhere on the information panel in
(e.g., ‘‘Cholesterol lowered from 55 mg accordance with § 101.2.
to 30 mg per serving. Contains 13 g of (ii) For meal products that contain
fat per serving.’’) is declared adjacent more than 26.0 g of total fat per labeled
to the most prominent claim or to the serving or for main dish products that
nutrition label, except that if the nu- contain more than 19.5 g of total fat
trition label is on the information per labeled serving:
panel, the quantitative information (A) The food has been specifically
may be located elsewhere on the infor- formulated, altered, or processed to re-
mation panel in accordance with § 101.2. duce its cholesterol by 25 percent or
(iii) Claims described in paragraph more from the reference food it resem-
(d)(4) of this section may not be made bles as defined in § 101.13(j)(1) and for
on the label or in labeling of a food if which it substitutes as specified in
the nutrient content of the reference § 101.13(d) that has a significant (e.g., 5
food meets the definition for ‘‘low cho- percent or more of a national or re-
lesterol.’’ gional market) market share.
(5) The terms defined in paragraph (B) The food contains 2 g or less of
(d)(4) of this section may be used on saturated fatty acids per 100 g;
the label or in the labeling of meal (C) The label or labeling discloses the
products as defined in § 101.13(l) and level of total fat in a serving (as de-
main dish products as defined in clared on the label) of the food. Such
§ 101.13(m), provided that: disclosure shall appear in immediate
(i) For meal products that contain proximity to such claim preceding any
26.0 g or less of total fat per labeled disclosure statement required under
serving or for main dish products that § 101.13(h) in type that shall be no less
contain 19.5 g or less of total fat per la- than one-half the size of the type used
beled serving; for such claim. If the claim appears on
(A) The food has been specifically more than one panel the disclosure
formulated, altered, or processed to re- shall be made on each panel except for
duce its cholesterol by 25 percent or the panel that bears nutrition labeling.
more from the reference food it resem- If the claim is made more than once on
bles as defined in § 101.13(j)(1) and for a panel, the disclosure shall be made in
which it substitutes as specified in immediate proximity to the claim that
§ 101.13(d) that has a significant (e.g., 5 is printed in the largest type; and
144
(D) As required in § 101.13(j)(2) for rel- (4) The term ‘‘extra lean’’ may be
ative claims: used on the label or in the labeling of
(1) The identity of the reference food foods except meal products as defined
and the percent (or fraction) that the in § 101.13(l) and main dish products as
cholesterol has been reduced are de- defined in § 101.13(m) provided that the
clared in immediate proximity to the food is a discrete seafood or game meat
most prominent such claim (e.g., 25 product and as packaged contains less
percent less cholesterol than ______); than 5 g total fat, less than 2 g satu-
and rated fat, and less than 95 mg choles-
(2) Quantitative information com- terol per reference amount customarily
paring the level of cholesterol in the consumed and per 100 g; and
product per specified weight with that (5) The term defined in paragraph
of the reference food that it replaces (e)(4) of this section may be used on the
(e.g., ‘‘Cholesterol lowered from 30 mg label or in labeling of meal products as
to 22 mg per 3 oz of product.’’) is de- defined in § 101.13(l) and main dish prod-
clared adjacent to the most prominent ucts as defined in § 101.13(m) provided
claim or to the nutrition label, except that the food contains less than 5 g of
that if the nutrition label is on the in- fat, less than 2 g of saturated fat, and
formation panel, the quantitative in- less than 95 mg of cholesterol per 100 g
formation may be located elsewhere on and per labeled serving.
the information panel in accordance (f) Misbranding. Any label or labeling
with § 101.2. containing any statement concerning
(iii) Claims described in paragraph fat, fatty acids, or cholesterol that is
not in conformity with this section
(d)(5) of this section may not be made
shall be deemed to be misbranded
on the label or in the labeling of a food
under sections 201(n), 403(a), and 403(r)
if the nutrient content of the reference
of the Federal Food, Drug, and Cos-
food meets the definition for ‘‘low cho-
metic Act.
lesterol.’’
(e) ‘‘Lean’’ and ‘‘extra lean’’ claims. (1) [58 FR 2413, Jan. 6, 1993; 58 FR 17342, 17343,
The term ‘‘lean’’ may be used on the Apr. 2, 1993, as amended at 58 FR 44032, Aug.
label or in labeling of foods except 18, 1993; 58 FR 60105, Nov. 15, 1993; 59 FR 394,
Jan. 4, 1994; 60 FR 17207, Apr. 5, 1995; 61 FR
meal products as defined in § 101.13(l) 59001, Nov. 20, 1996; 63 FR 26980, May 15, 1998;
and main dish products as defined in 72 FR 1459, Jan. 12, 2007]
§ 101.13(m) provided that the food is a
seafood or game meat product and as § 101.65 Implied nutrient content
packaged contains less than 10 g total claims and related label statements.
fat, 4.5 g or less saturated fat, and less (a) General requirements. An implied
than 95 mg cholesterol per reference nutrient content claim can only be
amount customarily consumed and per made on the label and in labeling of the
100 g; food if:
(2) The term defined in paragraph (1) The claim uses one of the terms
(e)(1) of this section may be used on the described in this section in accordance
label or in labeling of a mixed dish not with the definition for that term;
measurable with a cup as defined in (2) The claim is made in accordance
§ 101.12(b) in table 2, provided that the with the general requirements for nu-
food contains less than 8 g total fat, 3.5 trient content claims in § 101.13; and
g or less saturated fat and less than 80 (3) The food for which the claim is
mg cholesterol per reference amount made is labeled in accordance with
customarily consumed; § 101.9, § 101.10, or § 101.36, as applicable.
(3) The term defined in paragraph (b) Label statements that are not im-
(e)(1) of this section may be used on the plied claims. Certain label statements
label or in the labeling of meal prod- about the nature of a product are not
ucts as defined in § 101.13(l) or main nutrient content claims unless such
dish products as defined in § 101.13(m) statements are made in a context that
provided that the food contains less would make them an implied claim
than 10 g total fat, 4.5 g or less satu- under § 101.13(b)(2). The following types
rated fat, and less than 95 mg choles- of label statements are generally not
terol per 100 g and per labeled serving; implied nutrient content claims and, as
145
§ 101.65 21 CFR Ch. I (4–1–23 Edition)
such, are not subject to the require- ent content claims and must comply
ments of § 101.13 and this section: with paragraph (a) of this section.
(1) A claim that a specific ingredient (2) The phrases ‘‘contains the same
or food component is absent from a amount of [nutrient] as a [food]’’ and
product, provided that the purpose of ‘‘as much [nutrient] as a [food]’’ may
such claim is to facilitate avoidance of be used on the label or in the labeling
the substances because of food allergies of foods, provided that the amount of
(see § 105.62 of this chapter), food intol- the nutrient in the reference food is
erance, religious beliefs, or dietary enough to qualify that food as a ‘‘good
practices such as vegetarianism or source’’ of that nutrient, and the la-
other nonnutrition related reason, e.g., beled food, on a per serving basis, is an
‘‘100 percent milk free;’’ equivalent, good source of that nutri-
(2) A claim about a substance that is ent (e.g., ‘‘as much fiber as an apple,’’
nonnutritive or that does not have a ‘‘Contains the same amount of Vitamin
nutritive function, e.g., ‘‘contains no C as an 8 oz glass of orange juice.’’).
preservatives,’’ ‘‘no artificial colors;’’ (3) Claims may be made that a food
(3) A claim about the presence of an contains or is made with an ingredient
ingredient that is perceived to add that is known to contain a particular
value to the product, e.g., ‘‘made with
nutrient, or is prepared in a way that
real butter,’’ ‘‘made with whole fruit,’’
affects the content of a particular nu-
or ‘‘contains honey,’’ except that
trient in the food, if the finished food is
claims about the presence of ingredi-
either ‘‘low’’ in or a ‘‘good source’’ of
ents other than vitamins or minerals
or that are represented as a source of the nutrient that is associated with the
vitamins and minerals are not allowed ingredient or type of preparation. If a
on labels or in labeling of dietary sup- more specific level is claimed (e.g.,
plements of vitamins and minerals that ‘‘high in ______), that level of the nutri-
are not in conventional food form. ent must be present in the food. For ex-
(4) A statement of identity for a food ample, a claim that a food contains oat
in which an ingredient constitutes es- bran is a claim that it is a good source
sentially 100 percent of a food (e.g., of dietary fiber; that a food is made
‘‘corn oil,’’ ‘‘oat bran,’’ ‘‘dietary sup- only with vegetable oil is a claim that
plement of vitamin C 60 mg tablet’’). it is low in saturated fat; and that a
(5) A statement of identity that food contains no oil is a claim that it
names as a characterizing ingredient, is fat free.
an ingredient associated with a nutri- (d) General nutritional claims. (1) This
ent benefit (e.g., ‘‘corn oil margarine,’’ paragraph covers labeling claims that
‘‘oat bran muffins,’’ or ‘‘whole wheat are implied nutrient content claims be-
bagels’’), unless such claim is made in cause they:
a context in which label or labeling (i) Suggest that a food because of its
statements, symbols, vignettes, or nutrient content may help consumers
other forms of communication suggest maintain healthy dietary practices;
that a nutrient is absent or present in and
a certain amount; and (ii) Are made in connection with an
(6) A label statement made in compli- explicit or implicit claim or statement
ance with a specific provision of part about a nutrient (e.g., ‘‘healthy, con-
105 of this chapter, solely to note that tains 3 grams of fat’’).
a food has special dietary usefulness (2) You may use the term ‘‘healthy’’
relative to a physical, physiological, or related terms (e.g., ‘‘health,’’
pathological, or other condition, where
‘‘healthful,’’ ‘‘healthfully,’’ ‘‘health-
the claim identifies the special diet of
fulness,’’ ‘‘healthier,’’ ‘‘healthiest,’’
which the food is intended to be a part.
‘‘healthily,’’ and ‘‘healthiness’’) as an
(c) Particular implied nutrient content
implied nutrient content claim on the
claims. (1) Claims about the food or an
ingredient therein that suggest that a label or in labeling of a food that is
useful in creating a diet that is con-
nutrient or an ingredient is absent or

present in a certain amount (e.g., sistent with dietary recommendations
‘‘high in oat bran’’) are implied nutri- if:
146
(i) The food meets the following conditions for fat, saturated fat, cholesterol,
and other nutrients:
The fat level must The saturated fat The cholesterol level The food must con-
If the food is... be... level must be... must be... tain...
(A) A raw fruit or vegetable Low fat as defined Low saturated fat as The disclosure level N/A
in § 101.62(b)(2) defined in for cholesterol
§ 101.62(c)(2) specified in
§ 101.13(h) or less
(B) A single-ingredient or a mix- Low fat as defined Low saturated fat as The disclosure level N/A
ture of frozen or canned fruits in § 101.62(b)(2) defined in for cholesterol
and vegetables1 § 101.62(c)(2) specified in
§ 101.13(h) or less
(C) An enriched cereal-grain Low fat as defined Low saturated fat as The disclosure level N/A
product that conforms to a in § 101.62(b)(2) defined in for cholesterol
standard of identity in part 136, § 101.62(c)(2) specified in
137 or 139 of this chapter § 101.13(h) or less
(D) A raw, single-ingredient sea- Less than 5 grams Less than 2 g satu- Less than 95 mg At least 10 percent
food or game meat (g) total fat per rated fat per RA cholesterol per RA of the RDI3 or the
RA2 and per 100 and per 100 g and per 100 g DRV4 per RA of
g one or more of vi-
tamin A, vitamin
C, calcium, iron,
protein, or fiber
(E) A meal product as defined in Low fat as defined Low saturated fat as 90 mg or less cho- At least 10 percent
§ 101.13(l) or a main dish prod- in § 101.62(b)(3) defined in lesterol per LS5 of the RDI or DRV
uct as defined in § 101.13(m) § 101.62(c)(3) per LS of two nu-
trients (for a main
dish product) or of
three nutrients (for
a meal product)
of: vitamin A, vita-
min C, calcium,
iron, protein, or
fiber
(F) A food not specifically listed in Low fat as defined Low saturated fat as The disclosure level At least 10 percent
this table in § 101.62(b)(2) defined in for cholesterol of the RDI or the
§ 101.62(c)(2) specified in DRV per RA of
§ 101.13(h) or less one or more of vi-
tamin A, vitamin
C, calcium, iron,
protein or fiber
1 May include ingredients whose addition does not change the nutrient profile of the fruit or vegetable.
2 RA means Reference Amount Customarily Consumed per Eating Occasion (§ 101.12(b)).
3 RDI means Reference Daily Intake (§ 101.9(c)(8)(iv)).
4 DRV means Daily Reference Value (§ 101.9(c)(9)).
5 LS means Labeled Serving, i.e., the serving size that is specified in the nutrition information on the product label (§ 101.9(b)).
(ii) The food meets the following con- If the food is... The sodium level must be...
ditions for sodium: (C) A meal product as defined 600 mg or less sodium per
in § 101.13(l) or a main dish LS
If the food is... The sodium level must be...
product as defined in
§ 101.13(m)
(A) A food with a RA that is 480 mg or less sodium per
greater than 30 g or 2 ta- RA and per LS 1 For dehydrated food that is typically reconstituted with
blespoons (tbsp.) water or a liquid that contains insignificant amounts per RA of
all nutrients (as defined in § 101.9(f)(1)), the 50 g refers to the
(B) A food with a RA that is 480 mg or less sodium per ‘‘prepared’’ form of the product.
equal to or less than 30 g 50 g1
or 2 tbsp. (iii) The food complies with the defi-
nition and declaration requirements in
this part 101 for any specific nutrient
content claim on the label or in label-
ing, and
(iv) If you add a nutrient to the food

specified in paragraphs (d)(2)(i)(D),
147
§ 101.67 21 CFR Ch. I (4–1–23 Edition)
(d)(2)(i)(E), or (d)(2)(i)(F) of this section (b) Deviations from the ingredient

to meet the 10 percent requirement, provisions of 21 U.S.C. 321a must be the
that addition must be in accordance minimum necessary to achieve similar
with the fortification policy for foods performance characteristics as butter
in § 104.20 of this chapter. as produced under 21 U.S.C. 321a, or the
food will be deemed to be adulterated
[58 FR 2413, Jan. 6, 1993; 58 FR 17343, Apr. 2, under section 402(b) of the act. The per-
1993, as amended at 59 FR 394, Jan. 4, 1994; 59
formance characteristics (e.g., physical
FR 24249, May 10, 1994; 59 FR 50828, Oct. 6,
1994; 62 FR 49858, Sept. 23, 1997; 63 FR 14355, properties, organoleptic characteris-
Mar. 25, 1998; 70 FR 56848, Sept. 29, 2005] tics, functional properties, shelf life) of
the product shall be similar to butter
§ 101.67 Use of nutrient content claims as produced under 21 U.S.C. 321a. If
for butter. there is a significant difference in per-
formance characteristics (that materi-
(a) Claims may be made to charac-
ally limits the uses of the product com-
terize the level of nutrients, including
pared to butter,) the label shall include
fat, in butter if: a statement informing the consumer of
(1) The claim complies with the re- such difference (e.g., if appropriate,
quirements of § 101.13 and with the re- ‘‘not recommended for baking pur-
quirements of the regulations in this poses’’). Such statement shall comply
subpart that define the particular nu- with the requirements of § 101.13(d).
trient content claim that is used and The modified product shall perform at
how it is to be presented. In deter- least one of the principal functions of
mining whether a claim is appropriate, butter substantially as well as butter
the calculation of the percent fat reas produced under 21 U.S.C. 321a.
duction in milkfat shall be based on (c)(1) Each of the ingredients used in
the 80 percent milkfat requirement the food shall be declared on the label
provided by the statutory standard for as required by the applicable sections
butter (21 U.S.C. 321a); of this part.
(2) The product contains cream or (2) Safe and suitable ingredients
milk, including milk constituents (in- added to improve texture, prevent syn-
cluding, but not limited to, whey, ca- eresis, add flavor, extend shelf life, im-
sein, modified whey, and salts of ca- prove appearance, or add sweetness and
sein), or both, with or without added water added to replace milkfat shall be
salt, with or without safe and suitable identified with an asterisk in the ingre-
colorings, with or without nutrients dient statement. The statement
added to comply with paragraph (a)(3) ‘‘*Ingredients not in regular butter’’
of this section, and with or without shall immediately follow the ingre-
safe and suitable bacterial cultures. dient statement in the same type size.
The product may contain safe and suit- [58 FR 2455, Jan. 6, 1993]
able ingredients to improve texture,
prevent syneresis, add flavor, extend § 101.69 Petitions for nutrient content
shelf life, improve appearance, and add claims.
sweetness. The product may contain (a) This section pertains to petitions
water to replace milkfat although the for claims, expressed or implied, that:
amount of water in the product shall (1) Characterize the level of any nu-
be less than the amount of cream, trient which is of the type required to
milk, or milk constituents; be in the label or labeling of food by
(3) The product is not nutritionally section 403(q)(1) or (q)(2) of the Federal
inferior, as defined in § 101.3(e)(4), to Food, Drug, and Cosmetic Act (the
butter as produced under 21 U.S.C. 321a; act); and
and (2) That are not exempted under sec-
(4) If the product would violate 21 tion 403(r)(5)(A) through (r)(5)(C) of the
U.S.C. 321a but for the nutrient content act from the requirements for such
claim that characterizes the level of claims in section 403(r)(2).
nutrients, that claim shall be an ex- (b) Petitions included in this section
plicit claim that is included as part of are:

the common or usual name of the prod- (1) Petitions for a new (heretofore un-
uct. authorized) nutrient content claim;
148
(2) Petitions for a synonymous term shall include a statement regarding

(i.e., one that is consistent with a term each such clinical investigation relied
defined by regulation) for character- upon in the petition that the study ei-
izing the level of a nutrient; and ther was conducted in compliance with
(3) Petitions for the use of an implied the requirements for institutional re-
claim in a brand name. view set forth in part 56 of this chapter
(c) An original and one copy of the or was not subject to such require-
petition to be filed under the provi- ments in accordance with § 56.104 or
sions of section 403(r)(4) of the act shall § 56.105 of this chapter, and that it was
be submitted, or the petitioner may conducted in compliance with the re-
submit an original and a computer quirements for informed consent set
readable disk containing the petition. forth in part 50 of this chapter.
Contents of the disk should be in a (g) The availability for public disclo-
standard format, such as ASCII format. sure of petitions submitted to the
Petitioners interested in submitting a agency under this section will be gov-
disk should contact the Food and Drug erned by the rules specified in § 10.20(j)
Administration’s (FDA) Center for of this chapter.
Food Safety and Applied Nutrition for (h) All petitions submitted under this
details. If any part of the material sub- section shall include either a claim for
mitted is in a foreign language, it shall a categorical exclusion under § 25.30 or
be accompanied by an accurate and 25.32 of this chapter or an environ-
complete English translation. The peti- mental assessment under § 25.40 of this
tion shall state the petitioner’s post of- chapter.
fice address to which published notices (i) The data specified under the sev-
as required by section 403 of the act eral lettered headings should be sub-
may be sent. mitted on separate sheets or sets of
(d) Pertinent information may be in- sheets, suitably identified. If such data
corporated in, and will be considered as have already been submitted with an
part of, a petition on the basis of spe- earlier application from the petitioner,
cific reference to such information sub- the present petition may incorporate it
mitted to and retained in the files of by specific reference to the earlier peti-
FDA. However, any reference to unpub- tion.
lished information furnished by a per- (j) The petition must be signed by the
son other than the applicant will not petitioner or by his attorney or agent,
be considered unless use of such infor- or (if a corporation) by an authorized
mation is authorized (with the under- official.
standing that such information may in (k) The petition shall include a state-
whole or part be subject to release to ment signed by the person responsible
the public) in a written statement for the petition, that to the best of his
signed by the person who submitted it. knowledge, it is a representative and
Any reference to published information balanced submission that includes un-
should be accompanied by reprints or favorable information, as well as favor-
photostatic copies of such references. able information, known to him perti-
(e) If nonclinical laboratory studies nent to the evaluation of the petition.
are included in a petition submitted
(l) All applicable provisions of part
under section 403(r)(4) of the act, the
10—Administrative Practices and Pro-
petition shall include, with respect to
cedures, may be used by FDA, the peti-
each nonclinical study contained in the
tioner or any outside party with re-
petition, either a statement that the
spect to any agency action on the peti-
study has been, or will be, conducted in
tion.
compliance with the good laboratory
practice regulations as set forth in part (m)(1) Petitions for a new nutrient
58 of this chapter or, if any such study content claim shall include the fol-
was not conducted in compliance with lowing data and be submitted in the
such regulations, a brief statement of following form.
the reason for the noncompliance. (Date) ____________
(f) If clinical investigations are in- Name of petitioner ____________

cluded in a petition submitted under Post office address ____________
section 403(r)(4) of the act, the petition Subject of the petition ____________
149
§ 101.69 21 CFR Ch. I (4–1–23 Edition)
Office of Nutritional Products, Labeling and tended for a specific group within the popu-
Dietary Supplements (HFS–800) lation, the above analysis shall specifically
Food and Drug Administration, address the dietary practices of such group
Department of Health and Human Services, and shall include data sufficient to dem-
Washington, DC 20204. onstrate that the dietary analysis is rep-
To Whom It May Concern: resentative of such group.
The undersigned, ________________________ E. The petitioner is required to submit ei-
submits this petition under section 403(r)(4) ther a claim for categorical exclusion under
of the Federal Food, Drug, and Cosmetic Act § 25.30 or § 25.32 of this chapter or an environ-
(the act) with respect to (statement of the mental assessment under § 25.40 of this chap-
claim and its proposed use). ter.
Attached hereto and constituting a part of Yours very truly,
this petition, are the following: Petitioner ____________
A. A statement identifying the descriptive By ____________
term and the nutrient that the term is in- (Indicate authority)
tended to characterize with respect to the
level of such nutrient. The statement should (2) Within 15 days of receipt of the pe-
address why the use of the term as proposed tition, the petitioner will be notified
will not be misleading. The statement should by letter of the date on which the peti-
provide examples of the nutrient content tion was received by the agency. Such
claim as it will be used on labels or labeling, notice will inform the petitioner:
as well as the types of foods on which the (i) That the petition is undergoing
claim will be used. The statement shall agency review (in which case a docket
specify the level at which the nutrient must
be present or what other conditions con-
number will be assigned to the peti-
cerning the food must be met for the use of tion), and the petitioner will subse-
the term in labels or labeling to be appro- quently be notified of the agency’s de-
priate, as well as any factors that would cision to file or deny the petition; or
make the use of the term inappropriate. (ii) That the petition is incomplete,
B. A detailed explanation, supported by e.g., it lacks any of the data required
any necessary data, of why use of the food by this part, it presents such data in a
component characterized by the claim is of manner that is not readily understood,
importance in human nutrition by virtue of
its presence or absence at the levels that
or it has not been submitted in quadru-
such claim would describe. This explanation plicate, in which case the petition will
shall also state what nutritional benefit to be denied, and the petitioner will be
the public will derive from use of the claim notified as to what respect the petition
as proposed, and why such benefit is not is incomplete.
available through the use of existing terms (3) Within 100 days of the date of re-
defined by regulation under section ceipt of the petition, FDA will notify
403(r)(2)(A)(i) of the act. If the claim is in- the petitioner by letter that the peti-
tended for a specific group within the popu-
tion has either been filed or denied. If
lation, the analysis should specifically ad-
dress nutritional needs of such group, and denied, the notification shall state the
should include scientific data sufficient for reasons therefor. If filed, the date of
such purpose. the notification letter becomes the
C. Analytical data that shows the amount date of filing for the purposes of sec-
of the nutrient that is the subject of the tion 403(r)(4)(A)(i) of the act. If FDA
claim and that is present in the types of does not act within such 100 days, the
foods for which the claim is intended. The petition shall be deemed to be denied
assays should be performed on representative unless an extension is mutually agreed
samples using the AOAC INTERNATIONAL
(AOAC International) methods where avail-
upon by the FDA and the petitioner. A
able. If no AOAC International method is petition that has been denied, or has
available, the petitioner shall submit the been deemed to be denied, without fil-
assay method used, and data establishing the ing shall not be made available to the
validity of the method for assaying the nu- public. A filed petition shall be avail-
trient in the particular food. The validation able to the public as provided under
data should include a statistical analysis of paragraph (g) of this section.
the analytical and product variability. (4) Within 90 days of the date of filing
D. A detailed analysis of the potential ef- FDA will by letter of notification to
fect of the use of the proposed claim on food
consumption and of any corresponding
the petitioner:
changes in nutrient intake. The latter item (i) Deny the petition; or
shall specifically address the intake of nutri- (ii) Inform the petitioner that a pro-
ents that have beneficial and negative con- posed regulation to provide for the re-
sequences in the total diet. If the claim is in- quested use of the new term will be
150
published in the FEDERAL REGISTER. characterizing the level of a nutrient. This

FDA will publish the proposal to item shall also state what nutritional ben-
amend the regulations to provide for efit to the public will derive from use of the
claim as proposed, and why such benefit is
the requested use of the nutrient con-
not available through the use of existing
tent claim in the FEDERAL REGISTER term defined by regulation. If the claim is
within 90 days of the date of filing. The intended for a specific group within the pop-
proposal will also announce the avail- ulation, the analysis should specifically ad-
ability of the petition for public disclo- dress nutritional needs of such group, and
sure. should include scientific data sufficient for
(iii) If FDA does not act within 90 such purpose.
days of the date of filing, the petition C. The petitioner is required to submit ei-
shall be deemed to be denied unless an ther a claim for categorical exclusion under
§ 25.30 or § 25.32 of this chapter or an environ-
extension is mutually agreed upon by
mental assessment under § 25.40 of this chap-
FDA and the petitioner. ter.
(5) If FDA issues a proposal, the rule- Yours very truly,
making shall be completed within 540 Petitioner ____________
days of the date of receipt of the peti- By ____________
tion. (Indicate authority)
(n)(1) Petitions for a synonymous (2) Within 15 days of receipt of the pe-
term shall include the following data tition the petitioner will be notified by
and be submitted in the following form. letter of the date on which the petition
(Date)____________ was received. Such notice will inform
Name of petitioner ____________ the petitioner:
Post office address ____________ (i) That the petition is undergoing
Subject of the petition ____________ agency review (in which case a docket
Office of Nutritional Products, Labeling and
number will be assigned to the peti-
Dietary Supplements (HFS–800)
Food and Drug Administration, tion) and the petitioner will subse-
Department of Health and Human Services, quently be notified of the agency’s de-
Washington, DC 20204. cision to grant the petitioner permis-
To Whom It May Concern: sion to use the proposed term or to
The undersigned, ____________ submits this deny the petition; or
petition under section 403(r)(4) of the Federal (ii) That the petition is incomplete,
Food, Drug, and Cosmetic Act (the act) with
respect to (statement of the synonymous
e.g., it lacks any of the data required
term and its proposed use in a nutrient con- by this part, it presents such data in a
tent claim that is consistent with an exist- manner that is not readily understood,
ing term that has been defined under section or it has not been submitted in quadru-
403(r)(2) of the act). plicate, in which case the petition will
Attached hereto and constituting a part of be denied, and the petitioner will be
this petition, are the following: notified as to what respect the petition
A. A statement identifying the synony-
mous descriptive term, the existing term de-
is incomplete.
fined by a regulation under section (3) Within 90 days of the date of re-
403(r)(2)(A)(i) of the act with which the syn- ceipt of the petition that is accepted
onymous term is claimed to be consistent. for review (i.e., that has not been found
The statement should address why the pro- to be incomplete and consequently de-
posed synonymous term is consistent with nied, FDA will notify the petitioner by
the term already defined by the agency, and letter of the agency’s decision to grant
why the use of the synonymous term as pro-
the petitioner permission to use the
posed will not be misleading. The statement
should provide examples of the nutrient con- proposed term, with any conditions or
tent claim as it will be used on labels or la- limitations on such use specified, or to
beling, as well as the types of foods on which deny the petition, in which case the
the claim will be used. The statement shall letter shall state the reasons therefor.
specify whether any limitations not applica- Failure of the petition to fully address
ble to the use of the defined term are in- the requirements of this section shall
tended to apply to the use of the synony- be grounds for denial of the petition.
mous term.
(4) As soon as practicable following
B. A detailed explanation, supported by
any necessary data, of why use of the pro- the agency’s decision to either grant or
posed term is requested, including an expla- deny the petition, FDA will publish a
nation of whether the existing defined term notice in the FEDERAL REGISTER in-
is inadequate for the purpose of effectively forming the public of his decision. If
151
§ 101.69 21 CFR Ch. I (4–1–23 Edition)
the petition is granted the Food and mental assessment under § 25.40 of this chap-
Drug Administration will list, the ap- ter.
proved synonymous term in the regula- Yours very truly,
tions listing terms permitted for use in Petitioner ____________
nutrient content claims. By ____________
(o)(1) Petitions for the use of an im- (2) Within 15 days of receipt of the pe-
plied nutrient content claim in a brand tition the petitioner will be notified by
name shall include the following data letter of the date on which the petition
and be submitted in the following form:
was received. Such notice will inform
(Date)____________ the petitioner:
Name of petitioner ____________ (i) That the petition is undergoing
Post office address ____________
Subject of the petition ____________
agency review (in which case a docket
Office of Nutritional Products, Labeling and number will be assigned to the peti-
Dietary Supplements (HFS–800), tion); or
Food and Drug Administration, (ii) That the petition is incomplete,
Department of Health and Human Services, e.g., it lacks any of the data required
Washington, DC 20204.
To Whom It May Concern: by this part, it presents such data in a
The undersigned, ______________________ sub- manner that is not readily understood,
mits this petition under section 403(r)(4) of or it has not been submitted in quadru-
the Federal Food, Drug, and Cosmetic Act plicate, in which case the petition will
(the act) with respect to (statement of the be denied, and the petitioner will be
implied nutrient content claim and its pro-
notified as to what respect the petition
posed use in a brand name).
Attached hereto and constituting a part of is incomplete.
this petition, are the following: (3) FDA will publish a notice of the
A. A statement identifying the implied nu- petition in the FEDERAL REGISTER an-
trient content claim, the nutrient the claim nouncing its availability to the public
is intended to characterize, the cor-
and seeking comment on the petition.
responding term for characterizing the level
of such nutrient as defined by a regulation The petition shall be available to the
under section 403(r)(2)(A)(i) of the act, and public to the extent provided under
the brand name of which the implied claim is paragraph (g) of this section. The no-
intended to be a part. The statement should tice shall allow 30 days for comments.
address why the use of the brandname as pro- (4) Within 100 days of the date of re-
posed will not be misleading. It should ad-
dress in particular what information is receipt of the petition that is accepted
quired to accompany the claim or other ways for review (i.e., that has not been found
in which the claim meets the requirements to be incomplete and subsequently re-
of sections 201(n) and 403(a) of the act. The turned to the petitioner), FDA will:
statement should provide examples of the (i) Notify the petitioner by letter of
types of foods on which the brand name will
the agency’s decision to grant the peti-
appear. It shall also include data showing
that the actual level of the nutrient in the tioner permission to use the proposed
food qualifies the food to bear the cor- brand name if such use is not mis-
responding term defined by regulation. leading, with any conditions or limita-
Assay methods used to determine the level of tions on such use specified; or
a nutrient should meet the requirements (ii) Deny the petition, in which case
stated under petition format item C in para-
graph (k)(1) of this section. the letter shall state the reasons there-
B. A detailed explanation, supported by for. Failure of the petition to fully ad-
any necessary data, of why use of the pro- dress the requirements of this section
posed brand name is requested. This item shall be grounds for denial of the peti-
shall also state what nutritional benefit to tion. Should FDA not notify the peti-
the public will derive from use of the brand
tioner of his decision on the petition
name as proposed. If the branded product is
intended for a specific group within the pop- within 100 days, the petition shall be
ulation, the analysis should specifically ad- considered to be granted.
dress nutritional needs of such group and (5) As soon as practicable following
should include scientific data sufficient for the granting of a petition, the Commis-
such purpose. sioner of Food and Drugs will publish a
C. The petitioner is required to submit ei-

ther a claim for categorical exclusion under
§ 25.30 or § 25.32 of this chapter or an environ-
152
notice in the FEDERAL REGISTER in- (d) If clinical or other human inves-
forming the public of such fact. tigations are included in a petition, the
petition shall include a statement that
[58 FR 2413, Jan. 6, 1993; 58 FR 17343, Apr. 2,
1993, as amended at 58 FR 44033, Aug. 18, 1993;
they were either conducted in compli-
62 FR 40598, July 29, 1997; 63 FR 26718, May 14, ance with the requirements for institu-
1998; 63 FR 40024, July 27, 1998; 67 FR 9585, tional review set forth in part 56 of this
Mar. 4, 2002; 69 FR 16481, Mar. 30, 2004] chapter, or were not subject to such re-
quirements in accordance with § 56.104
Subpart E—Specific Requirements or § 56.105, and a statement that they
were conducted in compliance with the
for Health Claims requirements for informed consent set
§ 101.70 Petitions for health claims. forth in part 50 of this chapter.
(e) All data and information in a
(a) Any interested person may peti- health claim petition are available for
tion the Food and Drug Administration public disclosure after the notice of fil-
(FDA) to issue a regulation regarding a ing of petition is issued to the peti-
health claim. An original and one copy tioner, except that clinical investiga-
of the petition shall be submitted, or tion reports, adverse reaction reports,
the petitioner may submit an original product experience reports, consumer
and a computer readable disk con- complaints, and other similar data and
taining the petition. Contents of the information shall only be available
disk should be in a standard format, after deletion of:
such as ASCII format. (Petitioners in- (1) Names and any information that
terested in submitting a disk should would identify the person using the
contact the Center for Food Safety and product.
Applied Nutrition for details.) If any (2) Names and any information that
part of the material submitted is in a would identify any third party involved
foreign language, it shall be accom- with the report, such as a physician or
panied by an accurate and complete hospital or other institution.
English translation. The petition shall (f) Petitions for a health claim shall
state the petitioner’s post office ad- include the following data and be sub-
dress to which any correspondence re- mitted in the following form:
quired by section 403 of the Federal
(Date)____________
Food, Drug, and Cosmetic Act may be Name of petitioner ____________
sent. Post office address ____________
(b) Pertinent information may be in- Subject of the petition ____________
corporated in, and will be considered as Food and Drug Administration,
part of, a petition on the basis of spe- Office of Nutritional Products, Labeling and
cific reference to such information sub- Dietary Supplements (HFS–800),
5001 Campus Dr.,
mitted to and retained in the files of
College Park, MD 20740,
FDA. Such information may include The undersigned, __________________ submits
any findings, along with the basis of this petition pursuant to section 403(r)(4) or
the findings, of an outside panel with 403(r)(5)(D) of the Federal Food, Drug, and
expertise in the subject area. Any ref- Cosmetic Act with respect to (statement of
erence to published information shall the substance and its health claim).
be accompanied by reprints, or easily Attached hereto, and constituting a part of
readable copies of such information. this petition, are the following:
A. Preliminary requirements. A complete
(c) If nonclinical laboratory studies explanation of how the substance conforms
are included in a petition, the petition to the requirements of § 101.14(b) (21 CFR
shall include, with respect to each non- 101.14(b)). For petitions where the subject
clinical study contained in the peti- substance is a food ingredient or a compo-
tion, either a statement that the study nent of a food ingredient, the petitioner
has been conducted in compliance with should compile a comprehensive list of the
the good laboratory practice regula- specific ingredients that will be added to the
food to supply the substance in the food
tions as set forth in part 58 of this
bearing the health claim. For each such in-
chapter, or, if any such study was not gredient listed, the petitioner should state
conducted in compliance with such reg- how the ingredient complies with the re-
ulations, a brief statement of the rea- quirements of § 101.14(b)(3)(ii), e.g., that its
son for the noncompliance. use is generally recognized as safe (GRAS),
153
§ 101.70 21 CFR Ch. I (4–1–23 Edition)
listed as a food additive, or authorized by a the relevance of the claim in the context of
prior sanction issued by the agency, and the total daily diet.
what the basis is for the GRAS claim, the Also, the summary shall demonstrate that
food additive status, or prior sanctioned sta- the substance that is the subject of the pro-
tus. posed claim conforms to the definition of the
B. Summary of scientific data. The sum- term ‘‘substance’’ in § 101.14(a)(2).
mary of scientific data provides the basis C. Analytical data that show the amount
upon which authorizing a health claim can of the substance that is present in represent-
be justified as providing the health benefit. ative foods that would be candidates to bear
The summary must establish that, based on the claim should be obtained from represent-
the totality of publicly available scientific ative samples using methods from the AOAC
evidence (including evidence from well-de- INTERNATIONAL (AOAC), where available.
signed studies conducted in a manner which If no AOAC method is available, the peti-
is consistent with generally recognized sci- tioner shall submit the assay method used
entific procedures and principles), there is and data establishing the validity of the
significant scientific agreement among ex- method for assaying the substance in food.
perts qualified by scientific training and ex- The validation data should include a statis-
perience to evaluate such claims, that the tical analysis of the analytical and product
claim is supported by such evidence. variability.
The summary shall state what public D. Model health claim. One or more model
health benefit will derive from use of the health claims that represent label state-
claim as proposed. If the claim is intended ments that may be used on a food label or in
for a specific group within the population, labeling for a food to characterize the rela-
the summary shall specifically address nu- tionship between the substance in a food to
tritional needs of such group and shall in- a disease or health-related condition that is
clude scientific data showing how the claim justified by the summary of scientific data
is likely to assist in meeting such needs. provided in section C of the petition. The
The summary shall concentrate on the model health claim shall include:
findings of appropriate review articles, Na- 1. A brief capsulized statement of the rel-
tional Institutes of Health consensus devel- evant conclusions of the summary, and
opment conferences, and other appropriate 2. A statement of how this substance helps
resource materials. Issues addressed in the the consumer to attain a total dietary pat-
summary shall include answers to such ques- tern or goal associated with the health ben-
tions as: efit that is provided.
1. Is there an optimum level of the par- E. The petition shall include the following
ticular substance to be consumed beyond attachments:
which no benefit would be expected? 1. Copies of any computer literature
2. Is there any level at which an adverse ef- searches done by the petitioner (e.g.,
fect from the substance or from foods con- Medline).
taining the substance occurs for any seg- 2. Copies of articles cited in the literature
ment of the population? searches and other information as follows:
3. Are there certain populations that must a. All information relied upon for the sup-
receive special consideration? port of the health claim, including copies of
4. What other nutritional or health factors publications or other information cited in re-
(both positive and negative) are important to view articles and used to perform meta-anal-
consider when consuming the substance? yses.
In addition, the summary of scientific data b. All information concerning adverse con-
shall include a detailed analysis of the po- sequences to any segment of the population
tential effect of the use of the proposed (e.g., sensitivity to the substance).
claim on food consumption, specifically any c. All information pertaining to the U.S.
change due to significant alterations in eat- population.
ing habits and corresponding changes in nu- F. The petitioner is required to submit ei-
trient intake resulting from such changes in ther a claim for categorical exclusion under
food consumption. The latter item shall spe- § 25.30 or § 25.32 of this chapter or an environ-
cifically address the effect on the intake of mental assessment under § 25.40 of this chap-
nutrients that have beneficial and negative ter.
consequences in the total diet. Yours very truly,
If the claim is intended for a significant Petitioner ____________
subpopulation within the general U.S. popu- By ____________
lation, the analysis shall specifically address (Indicate authority)
the dietary practices of such group, and shall (g) The data specified under the sev-
include data sufficient to demonstrate that
eral lettered headings should be sub-
the dietary analysis is representative of such
group (e.g., adolescents or the elderly). mitted on separate pages or sets of
If appropriate, the petition shall explain pages, suitably identified. If such data
the prevalence of the disease or health-re- have already been submitted with an
lated condition in the U.S. population and earlier application from the petitioner
154
or any other final petition, the present (i) Deny the petition, or
petition may incorporate it by specific (ii) Inform the petitioner that a pro-
reference to the earlier petition. posed regulation to provide for the re-
(h) The petition shall include a state- quested use of the health claim will be
ment signed by the person responsible published in the FEDERAL REGISTER. If
for the petition that, to the best of his/ the petition is denied, the notification
her knowledge, it is a representative will state the reasons therefor, includ-
and balanced submission that includes ing justification for the rejection of
unfavorable information as well as fa- any report from an authoritative sci-
vorable information, known to him/her entific body of the U.S. Government.
to be pertinent to the evaluation of the
FDA will publish the proposal to
proposed health claim.
amend the regulations to provide for
(i) The petition shall be signed by the
petitioner or by his/her attorney or the requested use of the health claim
agent, or (if a corporation) by an au- in the FEDERAL REGISTER within 90
thorized official. days of the date of filing. The proposal
(j) Agency action on the petition. (1) will also announce the availability of
Within 15 days of receipt of the peti- the petition for public review.
tion, the petitioner will be notified by (iii) If FDA does not act within 90
letter of the date on which the petition days of the date of filing, the petition
was received. Such notice will inform shall be deemed to be denied unless an
the petitioner that the petition is un- extension is mutually agreed upon by
dergoing agency review and that the FDA and the petitioner.
petitioner will subsequently be notified (4)(i) Within 270 of the date of publi-
of the agency’s decision to file for com- cation of the proposal, FDA will pub-
prehensive review or deny the petition. lish a final rule that either authorizes
(2) Within 100 days of the date of reuse of the health claim or explains why
ceipt of the petition, FDA will notify the agency has decided not to author-
the petitioner by letter that the peti- ize one.
tion has either been filed for com- (ii) For cause, FDA may extend, no
prehensive review or denied. The agen-
more than twice, the period in which it
cy will deny a petition without review-
will publish a final rule; each such ex-
ing the information contained in ‘‘B.
Summary of Scientific Data’’ if the in- tension will be for no more than 90
formation in ‘‘A. Preliminary Require- days. FDA will publish a notice of each
ments’’ is inadequate in explaining how extension in the FEDERAL REGISTER.
the substance conforms to the require- The document will state the basis for
ments of § 101.14(b). If the petition is the extension, the length of the exten-
denied, the notification will state the sion, and the date by which the final
reasons therefor, including justifica- rule will be published, which date shall
tion of the rejection of any report from be within 540 days of the date of receipt
an authoritative scientific body of the of the petition.
U.S. Government. If filed, the date of [58 FR 2534, Jan. 6, 1993; 58 FR 17097, Apr. 1,
the notification letter becomes the 1993, as amended at 59 FR 425, Jan. 4, 1994; 62
date of filing for the purposes of this FR 28232, May 22, 1997; 62 FR 40599, July 29,
regulation. If FDA does not act within 1997; 63 FR 26719, May 14, 1998; 63 FR 40024,
such 100 days, the petition shall be July 27, 1998; 66 FR 56035, Nov. 6, 2001]
deemed to be denied unless an exten-
sion is mutually agreed upon by FDA § 101.71 Health claims: claims not au-
and the petitioner. A petition that has thorized.
been denied, or has been deemed to be Health claims not authorized for
denied, without filing will not be made foods in conventional food form or for
available to the public. A filed petition
dietary supplements of vitamins, min-
will be available to the public to the
erals, herbs, or other similar sub-
extent provided under paragraph (e) of
this section. stances:
(a) Dietary fiber and cardiovascular
(3) Within 90 days of the date of fil-

ing, FDA will by letter of notification disease.
to the petitioner:
155
§ 101.72 21 CFR Ch. I (4–1–23 Edition)
(b) Zinc and immune function in the thought to be important in reducing

elderly. the rate of bone loss particularly in the
[58 FR 2534, Jan. 6, 1993, as amended at 58 FR
elderly and in women during the first
2548, 2578, 2620, 2639, 2664, 2714, Jan. 6, 1993; 58 decade following menopause, but a sig-
FR 17100, Apr. 1, 1993; 59 FR 437, Jan. 4, 1994; nificant protective effect is also seen
65 FR 58918, Oct. 3, 2000] among men and younger women.
(b) Significance of calcium or calcium
§ 101.72 Health claims: calcium, vita- and vitamin D. Adequate calcium in-
min D, and osteoporosis. take, or adequate calcium and vitamin
(a) Relationship between calcium, vita- D intake, is not the only recognized
min D, and osteoporosis. An inadequate risk factor in the development of
intake of calcium or calcium and vita- osteoporosis, which is a multifactorial
min D contributes to low peak bone bone disease. Maintenance of adequate
mass, which has been identified as one calcium and vitamin D intakes
of many risk factors in the develop- throughout life is necessary to achieve
ment of osteoporosis. Peak bone mass optimal peak bone mass and to reduce
is the total quantity of bone present at the risk of osteoporosis in later life.
maturity, and experts believe that it However, vitamin D is most effective
has the greatest bearing on whether a in this regard when calcium intake is
person will be at risk of developing adequate. Increasing intake of calcium
osteoporosis and related bone fractures has been shown to have beneficial ef-
later in life. Another factor that influ- fects on bone health independent of di-
ences total bone mass and suscepti- etary vitamin D.
bility to osteoporosis is the rate of (c) Requirements. (1) All requirements
bone loss after skeletal maturity. Vita- set forth in § 101.14 shall be met.
min D is required for normal absorp- (2) Specific requirements—(i) Nature of
tion of calcium and to prevent the oc- the claim. A health claim associating
currence of high serum parathyroid calcium or, when appropriate, calcium
hormone (PTH) concentration, which and vitamin D with a reduced risk of
stimulates mobilization of calcium osteoporosis may be made on the label
from the skeleton and can lower bone or labeling of a food described in para-
mass. Calcium, along with vitamin D graphs (c)(2)(ii) and (d)(1) of this sec-
and several other nutrients, is required tion, provided that:
for normal bone mineralization. While (A) The claim makes clear the impor-
vitamin D is required for optimal bone tance of adequate calcium intake, or
mineralization, it is more effective when appropriate, adequate calcium
when calcium intake is adequate. An and vitamin D intake, throughout life,
adequate intake of calcium and vita- in a healthful diet, are essential to re-
min D is thought to exert a positive ef- duce osteoporosis risk. The claim does
fect during adolescence and early not imply that adequate calcium in-
adulthood in optimizing the amount of take, or when appropriate, adequate
bone that is laid down. However, the calcium and vitamin D intake, is the
upper limit of peak bone mass is ge- only recognized risk factor for the de-
netically determined. The mechanism velopment of osteoporosis;
through which adequate intakes of cal- (B) The claim does not attribute any
cium and vitamin D and optimal peak degree of reduction in risk of
bone mass reduce the risk of osteoporosis to maintaining an ade-
osteoporosis is thought to be as fol- quate dietary calcium intake, or when
lows. All persons lose bone with age. appropriate, an adequate dietary cal-
Hence, those with higher bone mass at cium and vitamin D intake, through-
maturity take longer to reach the out life.
critically reduced mass at which bones (ii) Nature of the food. (A) The food
can fracture easily. The rate of bone shall meet or exceed the requirements
loss after skeletal maturity also influ- for a ‘‘high’’ level of calcium as defined
ences the amount of bone present at in § 101.54(b);
old age and can influence an individ- (B) The calcium content of the prod-
ual’s risk of developing osteoporosis. uct shall be assimilable;

Maintenance of adequate intakes of (C) Dietary supplements shall meet
calcium and vitamin D later in life is the United States Pharmacopeia (USP)
156
standards for disintegration and dis- Adequate calcium as part of a healthful

solution applicable to their component diet, along with physical activity, may
calcium salts, except that dietary sup- reduce the risk of osteoporosis in later
plements for which no USP standards life.
exist shall exhibit appropriate assimi- (f) Model additional health claims for
lability under the conditions of use calcium and vitamin D. The following
stated on the product label; model health claims may be used in
(D) A food or total daily rec- food labeling to describe the relation-
ommended supplement intake shall not ship between calcium, vitamin D, and
contain more phosphorus than calcium osteoporosis:
on a weight per weight basis.
(d) Optional information. (1) The claim Adequate calcium and vitamin D
may include the term ‘‘vitamin D’’ if throughout life, as part of a well-bal-
the food meets or exceeds the require- anced diet, may reduce the risk of
ments for a ‘‘high’’ level of vitamin D osteoporosis.
as defined in § 101.54(b); Adequate calcium and vitamin D as
(2) The claim may include informa- part of a healthful diet, along with
tion from paragraphs (a) and (b) of this physical activity, may reduce the risk
section. of osteoporosis in later life.
(3) The claim may make reference to
physical activity. [73 FR 56486, Sept. 29, 2008]
(4) The claim may include informa-
tion on the number of people in the § 101.73 Health claims: dietary lipids
and cancer.
United States, including the number of
people in certain subpopulations in the (a) Relationship between fat and can-
United States, who have osteoporosis cer. (1) Cancer is a constellation of
or low bone density. The sources of this more than 100 different diseases, each
information must be identified, and it characterized by the uncontrolled
must be current information from the growth and spread of abnormal cells.
National Center for Health Statistics, Cancer has many causes and stages in
the National Institutes of Health, or its development. Both genetic and en-
the National Osteoporosis Foundation. vironmental risk factors may affect
(5) The claim may state that the role the risk of cancer. Risk factors include
of adequate calcium intake, or when a family history of a specific type of
appropriate, the role of adequate cal- cancer, cigarette smoking, alcohol con-
cium and vitamin D intake, through- sumption, overweight and obesity, ul-
out life is linked to reduced risk of traviolet or ionizing radiation, expo-
osteoporosis through the mechanism of sure to cancer-causing chemicals, and
optimizing peak bone mass during ado-
dietary factors.
lescence and early adulthood. The
(2) Among dietary factors, the
phrase ‘‘build and maintain good bone
health’’ may be used to convey the con- strongest positive association has been
cept of optimizing peak bone mass. The found between total fat intake and risk
claim may also state that adequate in- of some types of cancer. Based on the
take of calcium, or when appropriate, totality of the publicly available sci-
adequate intake of calcium and vita- entific evidence, there is significant
min D, is linked to reduced risk of scientific agreement among experts,
osteoporosis through the mechanism of qualified by training and experience to
slowing the rate of bone loss for per- evaluate such evidence, that diets high
sons with a family history of the dis- in total fat are associated with an in-
ease, post-menopausal women, and el- creased cancer risk. Research to date,
derly men and women. although not conclusive, demonstrates
(e) Model health claims. The following that the total amount of fats, rather
model health claims may be used in than any specific type of fat, is posi-
food labeling to describe the relation- tively associated with cancer risk. The
ship between calcium and osteoporosis: mechanism by which total fat affects
cancer has not yet been established.
Adequate calcium throughout life, as

part of a well-balanced diet, may re- (3) A question that has been the sub-
duce the risk of osteoporosis. ject of considerable research is whether
157
§ 101.73 21 CFR Ch. I (4–1–23 Edition)
the effect of fat on cancer is site-spe- (C) In specifying the nutrient, the
cific. Neither human nor animal stud- claim uses the term ‘‘total fat’’ or
ies are consistent in the association of ‘‘fat’’;
fat intake with specific cancer sites. (D) The claim does not specify types
(4) Another question that has been of fat or fatty acid that may be related
raised is whether the association of to the risk of cancer;
total fat intake to cancer risk is inde- (E) The claim does not attribute any
pendently associated with energy in- degree of cancer risk reduction to diets
takes, or whether the association of fat low in fat; and
with cancer risk is the result of the (F) The claim indicates that the de-
higher energy (caloric) intake nor- velopment of cancer depends on many
mally associated with high fat intake. factors.
(ii) Nature of the food. The food shall
FDA has concluded that evidence from
meet all of the nutrient content re-
both animal and human studies indi-
quirements of § 101.62 for a ‘‘low fat’’
cates that total fat intake alone, inde-
food; except that fish and game meats
pendent of energy intake, is associated (i.e., deer, bison, rabbit, quail, wild tur-
with cancer risk. key, geese, ostrich) may meet the re-
(b) Significance of the relationship be- quirements for ‘‘extra lean’’ in § 101.62.
tween fat intake and risk of cancer. (1) (d) Optional information. (1) The claim
Cancer is ranked as a leading cause of may identify one or more of the fol-
death in the United States. The overall lowing risk factors for development of
economic costs of cancer, including di- cancer: Family history of a specific
rect health care costs and losses due to type of cancer, cigarette smoking, al-
morbidity and mortality, are very cohol consumption, overweight and
high. obesity, ultraviolet or ionizing radi-
(2) U.S. diets tend to be high in fat ation, exposure to cancer-causing
and high in calories. The average U.S. chemicals, and dietary factors.
diet is estimated to contain 36 to 37 (2) The claim may include informa-
percent of calories from total fat. Cur- tion from paragraphs (a) and (b) of this
rent dietary guidelines from the Fed- section which summarize the relation-
eral Government and other national ship between dietary fat and cancer
health professional organizations rec- and the significance of the relation-
ommend that dietary fat intake be re- ship.
duced to a level of 30 percent or less of (3) The claim may indicate that it is
energy (calories) from total fat. In consistent with ‘‘Nutrition and Your
order to reduce intake of total fat, in- Health: Dietary Guidelines for Ameri-
dividuals should choose diets which are cans,’’ U.S. Department of Agriculture
high in vegetables, fruits, and grain (USDA) and Department of Health and
products (particularly whole grain Human Services (DHHS), Government
products), choose lean cuts of meats, Printing Office.
fish, and poultry, substitute low-fat (4) The claim may include informa-
dairy products for higher fat products, tion on the number of people in the
and use fats and oils sparingly. United States who have cancer. The
sources of this information must be
(c) Requirements. (1) All requirements
identified, and it must be current infor-
set forth in § 101.14 shall be met.
mation from the National Center for
(2) Specific requirements—(i) Nature of Health Statistics, the National Insti-
the claim. A health claim associating tutes of Health, or ‘‘Nutrition and Your
diets low in fat with reduced risk of Health: Dietary Guidelines for Ameri-
cancer may be made on the label or la- cans,’’ USDA and DHHS, Government
beling of a food described in paragraph Printing Office.
(c)(2)(ii) of this section, provided that: (e) Model health claims. The following
(A) The claim states that diets low in model health claims may be used in
fat ‘‘may’’ or ‘‘might’’ reduce the risk food labeling to describe the relation-
of some cancers; ship between dietary fat and cancer:
(B) In specifying the disease, the (1) Development of cancer depends on

claim uses the following terms: ‘‘some many factors. A diet low in total fat
types of cancer’’ or ‘‘some cancers’’; may reduce the risk of some cancers.
158
(2) Eating a healthful diet low in fat but not all normotensive individuals as
may help reduce the risk of some types well.
of cancers. Development of cancer is (2) The populations at greatest risk
associated with many factors, includ- for high blood pressure, and those most
ing a family history of the disease, cig- likely to benefit from sodium reduc-
arette smoking, and what you eat. tion, include those with family his-
[58 FR 2801, Jan. 6, 1993; 58 FR 17343, Apr. 2, tories of high blood pressure, the elder-
1993] ly, males because they develop hyper-
tension earlier in life than females, and
§ 101.74 Health claims: sodium and hy- black males and females. Although
pertension. some population groups are at greater
(a) Relationship between sodium and risk than others, high blood-pressure is
hypertension (high blood pressure). (1) a disease of public health concern for
Hypertension, or high blood pressure, all population groups. Sodium intake,
generally means a systolic blood pres- alcohol consumption, and obesity are
sure of greater than 140 millimeters of identified risk factors for high blood
mercury (mm Hg) or a diastolic blood pressure.
pressure of greater than 90 mm Hg. (3) Sodium intakes exceed rec-
Normotension, or normal blood pres- ommended levels in almost every group
sure, is a systolic blood pressure below in the United States. One of the major
140 mm Hg and diastolic blood pressure public health recommendations rel-
below 90 mm Hg. Sodium is specified ative to high blood pressure is to de-
here as the chemical entity or electro- crease consumption of salt. On a popu-
lyte ‘‘sodium’’ and is distinguished lation-wide basis, reducing the average
from sodium chloride, or salt, which is sodium intake would have a small but
39 percent sodium by weight. significant effect on reducing the aver-
(2) The scientific evidence establishes age blood pressure, and, consequently,
that diets high in sodium are associ- reducing mortality from coronary
ated with a high prevalence of hyper- heart disease and stroke.
tension or high blood pressure and with (4) Sodium is an essential nutrient,
increases in blood pressure with age, and experts have recommended a safe
and that diets low in sodium are asso- minimum level of 500 milligrams (mg)
ciated with a low prevalence of hyper- sodium per day and an upper level of
tension or high blood pressure and with 2,400 mg sodium per day, the FDA
a low or no increase of blood pressure Daily Value for sodium.
with age. (c) Requirements. (1) All requirements
(b) Significance of sodium in relation to set forth in § 101.14 shall be met.
high blood pressure. (1) High blood pres- (2) Specific requirements—(i) Nature of
sure is a public health concern pri- the claim. A health claim associating
marily because it is a major risk factor diets low in sodium with reduced risk
for mortality from coronary heart dis- of high blood pressure may be made on
ease and stroke. Early management of the label or labeling of a food described
high blood pressure is a major public in paragraph (c)(2)(ii) of this section,
health goal that can assist in reducing provided that:
mortality associated with coronary (A) The claim states that diets low in
heart disease and stroke. There is a sodium ‘‘may’’ or ‘‘might’’ reduce the
continuum of mortality risk that in- risk of high blood pressure;
creases as blood pressures rise. Individ- (B) In specifying the disease, the
uals with high blood pressure are at claim uses the term ‘‘high blood pres-
greatest risk, and individuals with sure’’;
moderately high, high normal, and nor- (C) In specifying the nutrient, the
mal blood pressure are at steadily de- claim uses the term ‘‘sodium’’;
creasing risk. The scientific evidence (D) The claim does not attribute any
indicates that reducing sodium intake degree of reduction in risk of high
lowers blood pressure and associated blood pressure to diets low in sodium;
risks in many but not all hypertensive and
individuals. There is also evidence that (E) The claim indicates that develop-
reducing sodium intake lowers blood ment of high blood pressure depends on
pressure and associated risks in many many factors.
159
§ 101.75 21 CFR Ch. I (4–1–23 Edition)
(ii) Nature of the food. The food shall (1) Diets low in sodium may reduce
meet all of the nutrient content re- the risk of high blood pressure, a dis-
quirements of § 101.61 for a ‘‘low so- ease associated with many factors.
dium’’ food. (2) Development of hypertension or
(d) Optional information. (1) The claim high blood pressure depends on many
may identify one or more of the fol- factors. [This product] can be part of a
lowing risk factors for development of low sodium, low salt diet that might
high blood pressure in addition to die- reduce the risk of hypertension or high
tary sodium consumption: Family his- blood pressure.
tory of high blood pressure, growing
[58 FR 2836, Jan. 6, 1993; 58 FR 17100, Apr. 1,
older, alcohol consumption, and excess 1993]
weight.
(2) The claim may include informa- § 101.75 Health claims: dietary satu-
tion from paragraphs (a) and (b) of this rated fat and cholesterol and risk of
section, which summarizes the rela- coronary heart disease.
tionship between dietary sodium and (a) Relationship between dietary satu-
high blood pressure and the signifi- rated fat and cholesterol and risk of coro-
cance of the relationship. nary heart disease. (1) Cardiovascular
(3) The claim may include informa- disease means diseases of the heart and
tion on the number of people in the circulatory system. Coronary heart
United States who have high blood disease is the most common and seri-
pressure. The sources of this informa- ous form of cardiovascular disease and
tion must be identified, and it must be refers to diseases of the heart muscle
current information from the National and supporting blood vessels. High
Center for Health Statistics, the Na- blood total- and low density
tional Institutes of Health, or ‘‘Nutri- lipoprotein (LDL)- cholesterol levels
tion and Your Health: Dietary Guide- are major modifiable risk factors in
lines for Americans,’’ U.S. Department the development of coronary heart dis-
of Health and Human Services (DHHS) ease. High coronary heart disease rates
and U.S. Department of Agriculture occur among people with high blood
(USDA), Government Printing Office. cholesterol levels of 240 milligrams/dec-
(4) The claim may indicate that it is aliter (mg/dL) (6.21 millimoles per liter
consistent with ‘‘Nutrition and Your (mmol/L)) or above and LDL-choles-
Health: U.S. Dietary Guidelines for terol levels of 160 mg/dL (4.13 mmol/L)
Americans, DHHS and USDA, Govern- or above. Borderline high risk blood
ment Printing Office. cholesterol levels range from 200 to 239
(5) In specifying the nutrient, the mg/dL (5.17 to 6.18 mmol/L) and 130 to
claim may include the term ‘‘salt’’ in 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-
addition to the term ‘‘sodium.’’ cholesterol. Dietary lipids (fats) in-
(6) In specifying the disease, the clude fatty acids and cholesterol. Total
claim may include the term ‘‘hyper- fat, commonly referred to as fat, is
tension’’ in addition to the term ‘‘high composed of saturated fat (fatty acids
blood pressure.’’ containing no double bonds), and
(7) The claim may state that individ- monounsaturated and polyunsaturated
uals with high blood pressure should fat (fatty acids containing one or more
consult their physicians for medical double bonds).
advice and treatment. If the claim de- (2) The scientific evidence establishes
fines high or normal blood pressure, that diets high in saturated fat and
then the health claim must state that cholesterol are associated with in-
individuals with high blood pressure creased levels of blood total- and LDL-
should consult their physicians for cholesterol and, thus, with increased
medical advice and treatment. risk of coronary heart disease. Diets
(e) Model health claims. The following low in saturated fat and cholesterol are
are model health claims that may be associated with decreased levels of
used in food labeling to describe the re- blood total- and LDL-cholesterol, and
lationship between dietary sodium and thus, with decreased risk of developing
high blood pressure: coronary heart disease.
160
(b) Significance of the relationship be- terol with reduced risk of coronary
tween dietary saturated fat and choles- heart disease may be made on the label
terol and risk of coronary heart disease. or labeling of a food described in para-
(1) Coronary heart disease is a major graph (c)(2)(ii) of this section provided
public health concern in the United that:
States, primarily because it accounts (A) The claim states that diets low in
for more deaths than any other disease saturated fat and cholesterol ‘‘may’’ or
or group of diseases. Early manage- ‘‘might’’ reduce the risk of heart dis-
ment of risk factors for coronary heart ease;
disease is a major public health goal (B) In specifying the disease, the
that can assist in reducing risk of coro- claim uses the terms ‘‘heart disease’’
nary heart disease. There is a con- or ‘‘coronary heart disease;’’
tinuum of mortality risk from coro- (C) In specifying the nutrient, the
nary heart disease that increases with claim uses the terms ‘‘saturated fat’’
increasing levels of blood LDL-choles- and ‘‘cholesterol’’ and lists both;
terol. Individuals with high blood LDL- (D) The claim does not attribute any
cholesterol are at greatest risk. A larg- degree of risk reduction for coronary
er number of individuals with more heart disease to diets low in dietary
moderately elevated cholesterol also saturated fat and cholesterol; and
have increased risk of coronary events; (E) The claim states that coronary
such individuals comprise a substantial heart disease risk depends on many
proportion of the adult U.S. popu- factors.
lation. The scientific evidence indi- (ii) Nature of the food. (A) The food
cates that reducing saturated fat and shall meet all of the nutrient content
cholesterol intakes lowers blood LDL- requirements of § 101.62 for a ‘‘low satu-
cholesterol and risk of heart disease in rated fat’’ and ‘‘low cholesterol’’ food.
most individuals. There is also evi- (B) The food shall meet the nutrient
dence that reducing saturated fat and content requirements of § 101.62 for a
cholesterol intakes in persons with ‘‘low fat’’ food, unless it is a raw fruit
blood cholesterol levels in the normal or vegetable; except that fish and game
range also reduces risk of heart dis- meats (i.e., deer, bison, rabbit, quail,
ease. wild turkey, geese, and ostrich) may
(2) Other risk factors for coronary meet the requirements for ‘‘extra lean’’
heart disease include a family history in § 101.62.
of heart disease, high blood pressure, (d) Optional information. (1) The claim
diabetes, cigarette smoking, obesity may identify one or more of the fol-
(body weight 30 percent greater than lowing risk factors in addition to satu-
ideal body weight), and lack of regular rated fat and cholesterol about which
physical exercise. there is general scientific agreement
(3) Intakes of saturated fat exceed that they are major risk factors for
recommended levels in many people in this disease: A family history of coro-
the United States. Intakes of choles- nary heart disease, elevated blood total
terol are, on average, at or above rec- and LDL-cholesterol, excess body
ommended levels. One of the major weight, high blood pressure, cigarette
public health recommendations rel- smoking, diabetes, and physical inac-
ative to coronary heart disease risk is tivity.
to consume less than 10 percent of cal- (2) The claim may indicate that the
ories from saturated fat, and an aver- relationship of saturated fat and cho-
age of 30 percent or less of total cal- lesterol to heart disease is through the
ories from all fat. Recommended daily intermediate link of ‘‘blood choles-
cholesterol intakes are 300 mg or less terol’’ or ‘‘blood total- and LDL choles-
per day. terol.’’
(c) Requirements. (1) All requirements (3) The claim may include informa-
set forth in § 101.14 shall be met, except tion from paragraphs (a) and (b) of this
§ 101.14(e)(6) with respect to a raw fruit section, which summarize the relation-
or vegetable. ship between dietary saturated fat and
(2) Specific requirements—(i) Nature of cholesterol and risk of coronary heart

the claim. A health claim associating disease, and the significance of the re-
diets low in saturated fat and choles- lationship.
161
§ 101.76 21 CFR Ch. I (4–1–23 Edition)
(4) In specifying the nutrients, the (4) Many factors, such as a family
claim may include the term ‘‘total fat’’ history of the disease, increased blood-
in addition to the terms ‘‘saturated and LDL-cholesterol levels, high blood
fat’’ and ‘‘cholesterol’’. pressure, cigarette smoking, diabetes,
(5) The claim may include informa- and being overweight, contribute to de-
tion on the number of people in the veloping heart disease. A diet low in
United States who have coronary heart saturated fat, cholesterol, and total fat
disease. The sources of this informa- may help reduce the risk of heart dis-
tion shall be identified, and it shall be ease; and
current information from the National (5) Diets low in saturated fat, choles-
Center for Health Statistics, the Na- terol, and total fat may reduce the risk
tional Institutes of Health, or ‘‘Nutri- of heart disease. Heart disease is de-
tion and Your Health: Dietary Guide- pendent upon many factors, including
lines for Americans,’’ U.S. Department diet, a family history of the disease,
of Health and Human Services (DHHS) elevated blood LDL-cholesterol levels,
and U.S. Department of Agriculture and physical inactivity.
(USDA), Government Printing Office. [58 FR 2757, Jan. 6, 1993, as amended at 81 FR
(6) The claim may indicate that it is 91722, Dec. 19, 2016]
consistent with ‘‘Nutrition and Your
Health: Dietary Guidelines for Ameri- § 101.76 Health claims: fiber-con-
cans,’’ DHHS and USDA, Government taining grain products, fruits, and
Printing Office. vegetables and cancer.
(7) The claim may state that individ- (a) Relationship between diets low in
uals with elevated blood total- or LDL- fat and high in fiber-containing grain
cholesterol should consult their physi- products, fruits, and vegetables and can-
cians for medical advice and treat- cer risk. (1) Cancer is a constellation of
ment. If the claim defines high or nor- more than 100 different diseases, each
mal blood total- or LDL-cholesterol characterized by the uncontrolled
levels, then the claim shall state that growth and spread of abnormal cells.
individuals with high blood cholesterol Cancer has many causes and stages in
should consult their physicians for its development. Both genetic and en-
medical advice and treatment. vironmental risk factors may affect
(e) Model health claims.The following the risk of cancer. Risk factors include:
are model health claims that may be A family history of a specific type of
used in food labeling to describe the re- cancer, cigarette smoking, overweight
lationship between dietary saturated and obesity, alcohol consumption, ul-
fat and cholesterol and risk of heart traviolet or ionizing radiation, expo-
disease: sure to cancer-causing chemicals, and
(1) While many factors affect heart dietary factors.
disease, diets low in saturated fat and (2) The scientific evidence establishes
cholesterol may reduce the risk of this that diets low in fat and high in fiber-
disease; containing grain products, fruits, and
(2) Development of heart disease de- vegetables are associated with a re-
pends upon many factors, but its risk duced risk of some types of cancer. Al-
may be reduced by diets low in satu- though the specific role of total dietary
rated fat and cholesterol and healthy fiber, fiber components, and the mul-
lifestyles; tiple nutrients and other substances
(3) Development of heart disease de- contained in these foods are not yet
pends upon many factors, including a fully understood, many studies have
family history of the disease, high shown that diets low in fat and high in
blood LDL-cholesterol, diabetes, high fiber-containing foods are associated
blood pressure, being overweight, ciga- with reduced risk of some types of can-
rette smoking, lack of exercise, and cer.
the type of dietary pattern. A healthful (b) Significance of the relationship be-
diet low in saturated fat, total fat, and tween consumption of diets low in fat and
cholesterol, as part of a healthy life- high in fiber-containing grain products,
style, may lower blood cholesterol lev- fruits, and vegetables and risk of cancer.
els and may reduce the risk of heart (1) Cancer is ranked as a leading cause
disease; of death in the United States. The
162
overall economic costs of cancer, in- (ii) Nature of the food. (A) The food
cluding direct health care costs and shall be or shall contain a grain prod-
losses due to morbidity and mortality, uct, fruit, or vegetable.
are very high. (B) The food shall meet the nutrient
(2) U.S. diets tend to be high in fat content requirements of § 101.62 for a
and low in grain products, fruits, and ‘‘low fat’’ food.
vegetables. Studies in various parts of (C) The food shall meet, without for-
the world indicate that populations tification, the nutrient content re-
who habitually consume a diet high in quirements of § 101.54 for a ‘‘good
plant foods have lower risks of some source’’ of dietary fiber.
cancers. These diets generally are low (d) Optional information. (1) The claim
in fat and rich in many nutrients, in- may include information from para-
cluding, but not limited to, dietary graphs (a) and (b) of this section, which
fiber. Current dietary guidelines from summarize the relationship between
Federal government agencies and na- diets low in fat and high in fiber-con-
tionally recognized health professional taining grain products, fruits, and
organizations recommend decreased vegetables, and some types of cancer
consumption of fats (less than 30 per- and the significance of the relation-
cent of calories), maintenance of desir- ship.
able body weight, and increased con- (2) The claim may identify one or
sumption of fruits and vegetables (five more of the following risk factors for
or more servings daily), and grain prod- development of cancer: Family history
ucts (six or more servings daily). of a specific type of cancer, cigarette
(c) Requirements. (1) All requirements smoking, overweight and obesity, alco-
set forth in § 101.14 shall be met. hol consumption, ultraviolet or ion-
(2) Specific requirements—(i) Nature of izing radiation, exposure to cancer
the claim. A health claim associating causing chemicals, and dietary factors.
diets low in fat and high in fiber-con- (3) The claim may indicate that it is
taining grain products, fruits, and consistent with ‘‘Nutrition and Your
vegetables with reduced risk of cancer Health: Dietary Guidelines for Ameri-
may be made on the label or labeling of cans,’’ U.S. Department of Agriculture
a food described in paragraph (c)(2)(ii) (USDA) and Department of Health and
of this section, provided that: Human Services (DHHS), Government
Printing Office.
(A) The claim states that diets low in
(4) The claim may include informa-
fat and high in fiber-containing grain
tion on the number of people in the
products, fruits, and vegetables ‘‘may’’
United States who have cancer. The
or ‘‘might’’ reduce the risk of some
sources of this information must be
cancers;
identified, and it must be current infor-
(B) In specifying the disease, the mation from the National Center for
claim uses the following terms: ‘‘some Health Statistics, the National Insti-
types of cancer,’’ or ‘‘some cancers’’; tutes of Health, or ‘‘Nutrition and Your
(C) The claim is limited to grain Health: Dietary Guidelines for Ameri-
products, fruits, and vegetables that cans,’’ USDA and DHHS, Government
contain dietary fiber; Printing Office.
(D) The claim indicates that develop- (e) Model health claims. The following
ment of cancer depends on many fac- model health claims may be used in
tors; food labeling to characterize the rela-
(E) The claim does not attribute any tionship between diets low in fat and
degree of cancer risk reduction to diets high in fiber-containing grain products,
low in fat and high in fiber-containing fruits, and vegetables and cancer risk:
grain products, fruits, and vegetables; (1) Low fat diets rich in fiber-con-
(F) In specifying the dietary fiber taining grain products, fruits, and
component of the labeled food, the vegetables may reduce the risk of some
claim uses the term ‘‘fiber’’, ‘‘dietary types of cancer, a disease associated
fiber’’ or ‘‘total dietary fiber’’; and with many factors.
(G) The claim does not specify types (2) Development of cancer depends on
of dietary fiber that may be related to many factors. Eating a diet low in fat
risk of cancer. and high in grain products, fruits, and
163
§ 101.77 21 CFR Ch. I (4–1–23 Edition)
vegetables that contain dietary fiber these plant foods are not yet fully un-
may reduce your risk of some cancers. derstood, many studies have shown
[58 FR 2548, Jan. 6, 1993]
that diets high in plant foods are asso-
ciated with reduced risk of coronary
§ 101.77 Health claims: fruits, vegeta- heart disease. These studies correlate
bles, and grain products that con- diets rich in fruits, vegetables, and
tain fiber, particularly soluble fiber, grain products and nutrients from
and risk of coronary heart disease. these diets, such as some types of fiber,
(a) Relationship between diets low in with reduced coronary heart disease
saturated fat and cholesterol and high in risk. Persons consuming these diets
fruits, vegetables, and grain products that frequently have high intakes of dietary
contain fiber, particularly soluble fiber, fiber, particularly soluble fibers. Cur-
and risk of coronary heart disease. (1) rently, there is not scientific agree-
Cardiovascular disease means diseases ment as to whether a particular type of
of the heart and circulatory system. soluble fiber is beneficial, or whether
Coronary heart disease is the most the observed protective effects of
common and serious form of cardio- fruits, vegetables, and grain products
vascular disease and refers to diseases against heart disease are due to other
of the heart muscle and supporting components, or a combination of com-
blood vessels. High blood total- and low ponents, in these diets, including, but
density lipoprotein (LDL)- cholesterol not necessarily limited to, some types
levels are major modifiable risk factors of soluble fiber, other fiber compo-
in the development of coronary heart nents, other characteristics of the com-
disease. High coronary heart disease plex carbohydrate content of these
rates occur among people with high foods, other nutrients in these foods, or
blood cholesterol levels of 240 milli- displacement of saturated fat and cho-
grams per deciliter (mg/dL) (6.21 lesterol from the diet.
(mmol/L)) or above and LDL-choles- (b) Significance of the relationship be-
terol levels of 160 mg/dL (4.13 mmol/L) tween diets low in saturated fat and cho-
or above. Borderline high risk blood lesterol, and high in fruits, vegetables,
cholesterol levels range from 200 to 239 and grain products that contain fiber,
mg/dL (5.17 to 6.18 mmol/L) and 130 to particularly soluble fiber, and risk of cor-
159 mg/dL (3.36 to 4.11 mmol/L) of LDL- onary heart disease. (1) Coronary heart
cholesterol. Dietary lipids (fats) in- disease is a major public health con-
clude fatty acids and cholesterol. Total cern in the United States, primarily
fat, commonly referred to as fat, is because it accounts for more deaths
composed of saturated fat (fatty acids than any other disease or group of dis-
containing no double bonds), and eases. Early management of risk fac-
monounsaturated and polyunsaturated tors for coronary heart disease is a
fat (fatty acids containing one or more major public health goal that can as-
double bonds). sist in reducing risk of coronary heart
(2) The scientific evidence establishes disease. There is a continuum of mor-
that diets high in saturated fat and tality risk from coronary heart disease
cholesterol are associated with in- that increases with increasing levels of
creased levels of blood total- and LDL- blood LDL-cholesterol. Individuals
cholesterol and, thus, with increased with high blood LDL-cholesterol are at
risk of coronary heart disease. Diets greatest risk. A larger number of indi-
low in saturated fat and cholesterol are viduals with more moderately elevated
associated with decreased levels of cholesterol also have increased risk of
blood total- and LDL-cholesterol, and coronary events; such individuals com-
thus, with decreased risk of developing prise a substantial proportion of the
coronary heart disease. adult U.S. population. The scientific
(3) Populations with relatively low evidence indicates that reducing satu-
blood cholesterol levels tend to have rated fat and cholesterol intakes low-
dietary patterns that are not only low ers blood LDL-cholesterol and risk of
in total fat, especially saturated fat heart disease in most individuals, in-
and cholesterol, but are also relatively cluding persons with blood cholesterol
high in fruits, vegetables, and grain levels in the normal range. Addition-
products. Although the specific roles of ally, consuming diets high in fruits,
164
vegetables, and grain products, foods (B) In specifying the disease, the
that contain soluble fiber, may be a claim uses the following terms: ‘‘heart
useful adjunct to a low saturated fat disease’’ or ‘‘coronary heart disease;’’
and low cholesterol diet. (C) The claim is limited to those
(2) Other risk factors for coronary fruits, vegetables, and grains that con-
heart disease include a family history tain fiber;
of heart disease, high blood pressure, (D) In specifying the dietary fiber,
diabetes, cigarette smoking, obesity the claim uses the term ‘‘fiber,’’ ‘‘die-
(body weight 30 percent greater than tary fiber,’’ ‘‘some types of dietary
ideal body weight), and lack of regular fiber,’’ ‘‘some dietary fibers,’’ or ‘‘some
physical exercise. fibers;’’ the term ‘‘soluble fiber’’ may
(3) Intakes of saturated fat exceed be used in addition to these terms;
recommended levels in many people in (E) In specifying the fat component,
the United States. Intakes of choles- the claim uses the terms ‘‘saturated
terol are, on average, at or above rec- fat’’ and ‘‘cholesterol;’’ and
ommended levels. Intakes of fiber-con- (F) The claim indicates that develop-
taining fruits, vegetables, and grain ment of heart disease depends on many
products are about half of rec- factors; and
ommended intake levels. One of the (G) The claim does not attribute any
major public health recommendations degree of risk reduction for coronary
relative to coronary heart disease risk heart disease to diets low in saturated
is to consume less than 10 percent of fat and cholesterol and high in fruits,
calories from saturated fat, and an av- vegetables, and grain products that
erage of 30 percent or less of total cal- contain fiber.
ories from all fat. Recommended daily (ii) Nature of the food. (A) The food
cholesterol intakes are 300 mg or less shall be or shall contain a fruit, vege-
per day. Recommended total dietary table, or grain product.
(B) The food shall meet the nutrient
fiber intakes are about 25 grams (g)
content requirements of § 101.62 for a
daily, of which about 25 percent (about
‘‘low saturated fat,’’ ‘‘low cholesterol,’’
6 g) should be soluble fiber.
and ‘‘low fat’’ food.
(4) Current dietary guidance rec- (C) The food contains, without for-
ommendations encourage decreased tification, at least 0.6 g of soluble fiber
consumption of dietary fat, especially per reference amount customarily con-
saturated fat and cholesterol, and in- sumed;
creased consumption of fiber-rich foods (D) The content of soluble fiber shall
to help lower blood LDL-cholesterol be declared in the nutrition informa-
levels. Results of numerous studies tion panel, consistent with
have shown that fiber-containing § 101.9(c)(6)(i)(A).
fruits, vegetables, and grain products (d) Optional information. (1) The claim
can help lower blood LDL-cholesterol. may identify one or more of the fol-
(c) Requirements. (1) All requirements lowing risk factors for heart disease
set forth in § 101.14 shall be met. about which there is general scientific
(2) Specific requirements—(i) Nature of agreement: A family history of coro-
the claim. A health claim associating nary heart disease, elevated blood-,
diets low in saturated fat and choles- total- and LDL-cholesterol, excess
terol and high in fruits, vegetables, and body weight, high blood pressure, ciga-
grain products that contain fiber, par- rette smoking, diabetes, and physical
ticularly soluble fiber, with reduced inactivity.
risk of heart disease may be made on (2) The claim may indicate that the
the label or labeling of a food described relationship of diets low in saturated
in paragraph (c)(2)(ii) of this section, fat and cholesterol, and high in fruits,
provided that: vegetables, and grain products that
(A) The claim states that diets low in contain fiber to heart disease is
saturated fat and cholesterol and high through the intermediate link of
in fruits, vegetables, and grain prod- ‘‘blood cholesterol’’ or ‘‘blood total-
ucts that contain fiber ‘‘may’’ or and LDL-cholesterol.’’

‘‘might’’ reduce the risk of heart dis- (3) The claim may include informa-
ease; tion from paragraphs (a) and (b) of this
165
§ 101.78 21 CFR Ch. I (4–1–23 Edition)
section, which summarize the relation- lower blood cholesterol levels and re-
ship between diets low in saturated fat duce your risk of heart disease.
and cholesterol and high in fruits,
[58 FR 2578, Jan. 6, 1993]
vegetables, and grain products that
contain fiber and coronary heart dis- § 101.78 Health claims: fruits and vege-
ease, and the significance of the rela- tables and cancer.
tionship.
(a) Relationship between substances in
(4) In specifying the nutrients, the
diets low in fat and high in fruits and
claim may include the term ‘‘total fat’’
vegetables and cancer risk. (1) Cancer is
in addition to the terms ‘‘saturated
a constellation of more than 100 dif-
fat’’ and ‘‘cholesterol.’’
ferent diseases, each characterized by
(5) The claim may indicate that it is the uncontrolled growth and spread of
consistent with ‘‘Nutrition and Your abnormal cells. Cancer has many
Health: Dietary Guidelines for Ameri- causes and stages in its development.
cans,’’ U.S. Department of Agriculture Both genetic and environmental risk
(USDA) and Department of Health and factors may affect the risk of cancer.
Human Services (DHHS), Government Risk factors include a family history of
Printing Office (GPO). a specific type of cancer, cigarette
(6) The claim may state that individ- smoking, alcohol consumption, over-
uals with elevated blood total- and weight and obesity, ultraviolet or ion-
LDL-cholesterol should consult their izing radiation, exposure to cancer-
physicians for medical advice and causing chemicals, and dietary factors.
treatment. If the claim defines high or (2) Although the specific roles of the
normal blood total- and LDL-choles- numerous potentially protective sub-
terol levels, then the claim shall state stances in plant foods are not yet un-
that individuals with high blood cho- derstood, many studies have shown
lesterol should consult their physicians that diets high in plant foods are asso-
for medical advice and treatment. ciated with reduced risk of some types
(7) The claim may include informa- of cancers. These studies correlate
tion on the number of people in the diets rich in fruits and vegetables and
United States who have heart disease. nutrients from these diets, such as vi-
The sources of this information shall tamin C, vitamin A, and dietary fiber,
be identified, and it shall be current in- with reduced cancer risk. Persons con-
formation from the National Center for suming these diets frequently have
Health Statistics, the National Insti- high intakes of these nutrients. Cur-
tutes of Health, or ‘‘Nutrition and Your rently, there is not scientific agree-
Health: Dietary Guidelines for Ameri- ment as to whether the observed pro-
cans,’’ USDA and DHHS, GPO. tective effects of fruits and vegetables
(e) Model health claims. The following against cancer are due to a combina-
model health claims may be used in tion of the nutrient components of
food labeling to characterize the rela- diets rich in fruits and vegetables, in-
tionship between diets low in saturated cluding but not necessarily limited to
fat and cholesterol and high in fruits, dietary fiber, vitamin A (as beta-caro-
vegetables, and grain products that tene) and vitamin C, to displacement of
contain soluble fiber: fat from such diets, or to intakes of
(1) Diets low in saturated fat and other substances in these foods which
cholesterol and rich in fruits, vegeta- are not nutrients but may be protec-
bles, and grain products that contain tive against cancer risk.
some types of dietary fiber, particu- (b) Significance of the relationship be-
larly soluble fiber, may reduce the risk tween consumption of diets low in fat and
of heart disease, a disease associated high in fruits and vegetables and risk of
with many factors. cancer. (1) Cancer is ranked as a leading
(2) Development of heart disease de- cause of death in the United States.
pends on many factors. Eating a diet The overall economic costs of cancer,
low in saturated fat and cholesterol including direct health care costs and
and high in fruits, vegetables, and losses due to morbidity and mortality,
grain products that contain fiber may are very high.
166
(2) U.S. diets tend to be high in fat claim uses the term ‘‘fiber’’, ‘‘dietary
and low in fruits and vegetables. Stud- fiber’’, or ‘‘total dietary fiber’’;
ies in various parts of the world indi- (I) The claim does not specify types
cate that populations who habitually of dietary fiber that may be related to
consume a diet high in plant foods have risk of cancer; and
lower risks of some cancers. These (J) The claim indicates that develop-
diets generally are low in fat and rich ment of cancer depends on many fac-
in many nutrients, including, but not tors.
limited to, dietary fiber, vitamin A (as (ii) Nature of the food. (A) The food
beta-carotene), and vitamin C. Current shall be or shall contain a fruit or veg-
dietary guidelines from Federal Gov- etable.
ernment agencies and nationally recog- (B) The food shall meet the nutrient
nized health professional organizations content requirements of § 101.62 for a
recommend decreased consumption of
‘‘low fat’’ food.
fats (less than 30 percent of calories),
(C) The food shall meet, without for-
maintenance of desirable body weight,
tification, the nutrient content re-
and increased consumption of fruits
quirements of § 101.54 for a ‘‘good
and vegetables (5 or more servings
source’’ of at least one of the following:
daily), particularly those fruits and
vitamin A, vitamin C, or dietary fiber.
vegetables which contain dietary fiber,
vitamin A, and vitamin C. (d) Optional information. (1) The claim
(c) Requirements. (1) All requirements may include information from para-
set forth in § 101.14 shall be met. graphs (a) and (b) of this section, which
(2) Specific requirements—(i) Nature of summarize the relationship between
the claim. A health claim associating diets low in fat and high in fruits and
substances in diets low in fat and high vegetables and some types of cancer
in fruits and vegetables with reduced and the significance of the relation-
risk of cancer may be made on the ship.
label or labeling of a food described in (2) The claim may identify one or
paragraph (c)(2)(ii) of this section, pro- more of the following risk factors for
vided that: development of cancer: Family history
(A) The claim states that diets low in of a specific type of cancer, cigarette
fat and high in fruits and vegetables smoking, alcohol consumption, over-
‘‘may’’ or ‘‘might’’ reduce the risk of weight and obesity, ultraviolet or ion-
some cancers; izing radiation, exposure to cancer-
(B) In specifying the disease, the causing chemicals, and dietary factors.
claim uses the following terms: ‘‘some (3) The claim may use the word
types of cancer’’, or ‘‘some cancers’’; ‘‘beta-carotene’’ in parentheses after
(C) The claim characterizes fruits the term vitamin A, provided that the
and vegetables as foods that are low in vitamin A in the food bearing the
fat and may contain vitamin A, vita- claim is beta-carotene.
min C, and dietary fiber; (4) The claim may indicate that it is
(D) The claim characterizes the food consistent with ‘‘Nutrition and Your
bearing the claim as containing one or Health: Dietary Guidelines for Ameri-
more of the following, for which the cans,’’ U.S. Department of Agriculture
food is a good source under § 101.54: die- (USDA) and the Department of Health
tary fiber, vitamin A, or vitamin C; and Human Services (DHHS), Govern-
(E) The claim does not attribute any ment Printing Office.
degree of cancer risk reduction to diets (5) The claim may include informa-
low in fat and high in fruits and vege- tion on the number of people in the
tables; United States who have cancer. The
(F) In specifying the fat component sources of this information must be
of the labeled food, the claim uses the identified, and it must be current infor-
term ‘‘total fat’’ or ‘‘fat’’; mation from the National Center for
(G) The claim does not specify types Health Statistics, the National Insti-
of fats or fatty acids that may be re- tutes of Health, or ‘‘Nutrition and Your
lated to risk of cancer; Health: Dietary Guidelines for Ameri-

(H) In specifying the dietary fiber cans,’’ USDA and DHHS, Government
component of the labeled food, the Printing Office.
167
§ 101.79 21 CFR Ch. I (4–1–23 Edition)
(e) Model health claims. The following drugs). In addition, based on its review
model health claims may be used in of a Hungarian intervention trial that
food labeling to characterize the rela- reported periconceptional use of a
tionship between substances in diets multivitamin and multimineral prepa-
low in fat and high in fruits and vege- ration containing 800 mcg (0.8 mg) of
tables and cancer: folic acid, and its review of the obser-
(1) Low fat diets rich in fruits and vational studies that reported
vegetables (foods that are low in fat periconceptional use of multivitamins
and may contain dietary fiber, vitamin containing 0 to 1,000 mcg of folic acid,
A, and vitamin C) may reduce the risk the Food and Drug Administration con-
of some types of cancer, a disease asso- cluded that most of these studies had
ciated with many factors. Broccoli is results consistent with the conclusion
high in vitamins A and C, and it is a that folate, at levels attainable in
good source of dietary fiber. usual diets, may reduce the risk of neu-
(2) Development of cancer depends on ral tube defects.
many factors. Eating a diet low in fat (b) Significance of folate—(1) Public
and high in fruits and vegetables, foods health concern. Neural tube defects
that are low in fat and may contain vi- occur in approximately 0.6 of 1,000 live
tamin A, vitamin C, and dietary fiber, births in the United States (i.e., ap-
may reduce your risk of some cancers. proximately 6 of 10,000 live births;
Oranges, a food low in fat, are a good about 2,500 cases among 4 million live
source of fiber and vitamin C. births annually). Neural tube defects
[58 FR 2639, Jan. 6, 1993] are believed to be caused by many fac-
tors. The single greatest risk factor for
§ 101.79 Health claims: Folate and neu- a neural tube defect-affected pregnancy
ral tube defects. is a personal or family history of a
(a) Relationship between folate and pregnancy affected with a such a de-
neural tube defects—(1) Definition. Neu- fect. However, about 90 percent of in-
ral tube defects are serious birth de- fants with a neural tube defect are
fects of the brain or spinal cord that born to women who do not have a fam-
can result in infant mortality or seri- ily history of these defects. The avail-
ous disability. The birth defects able evidence shows that diets ade-
anencephaly and spina bifida are the quate in folate may reduce the risk of
most common forms of neural tube de- neural tube defects but not of other
fects and account for about 90 percent birth defects.
of these defects. These defects result (2) Populations at risk. Prevalence
from failure of closure of the covering rates for neural tube defects have been
of the brain or spinal cord during early reported to vary with a wide range of
embryonic development. Because the factors including genetics, geography,
neural tube forms and closes during socioeconomic status, maternal birth
early pregnancy, the defect may occur cohort, month of conception, race, nu-
before a woman realizes that she is trition, and maternal health, including
pregnant. maternal age and reproductive history.
(2) Relationship. The available data Women with a close relative (i.e., sib-
show that diets adequate in folate may ling, niece, nephew) with a neural tube
reduce the risk of neural tube defects. defect, those with insulin-dependent di-
The strongest evidence for this rela- abetes mellitus, and women with sei-
tionship comes from an intervention zure disorders who are being treated
study by the Medical Research Council with valproic acid or carbamazepine
of the United Kingdom that showed are at significantly increased risk com-
that women at risk of recurrence of a pared with women without these char-
neural tube defect pregnancy who con- acteristics. Rates for neural tube de-
sumed a supplement containing 4 milli- fects vary within the United States,
grams (mg)(4,000 micrograms (mcg)) with lower rates observed on the west
folic acid daily before conception and coast than on the east coast.
continuing into early pregnancy had a (3) Those who may benefit. Based on a
reduced risk of having a child with a synthesis of information from several

neural tube defect. (Products con- studies, including those which used
taining this level of folic acid are multivitamins containing folic acid at
168
a daily dose level of ≥400 mcg (≥0.4 mg), fects of the brain or spinal cord;’’ or
the Public Health Service has inferred ‘‘brain or spinal cord birth defects.’’
that folate alone at levels of 400 mcg (D) Multifactorial nature. The claim
(0.4 mg) per day may reduce the risk of shall not imply that folate intake is
neural tube defects. The protective ef- the only recognized risk factor for neu-
fect found in studies of lower dose ral tube defects.
folate measured by the reduction in (E) Reduction in risk. The claim shall
neural tube defect incidence, ranges not attribute any specific degree of re-
from none to substantial; a reasonable duction in risk of neural tube defects
estimate of the expected reduction in from maintaining an adequate folate
the United States is 50 percent. It is ex- intake throughout the childbearing
pected that consumption of adequate years. The claim shall state that some
folate will avert some, but not all, neu- women may reduce their risk of a neu-
ral tube defects. The underlying causes ral tube defect pregnancy by maintain-
of neural tube defects are not known. ing adequate intakes of folate during
Thus, it is not known what proportion their childbearing years. Optional
of neural tube defects will be averted statements about population-based es-
by adequate folate consumption. From timates of risk reduction may be made
the available evidence, the Public in accordance with paragraph (c)(3)(vi)
Health Service estimates that there is of this section.
the potential for averting 50 percent of (F) Safe upper limit of daily intake.
cases that now occur (i.e., about 1,250 Claims on foods that contain more
cases annually). However, until further than 100 percent of the Daily Value
research is done, no firm estimate of (DV) (400 mcg) when labeled for use by
this proportion will be available. adults and children 4 or more years of
(c) Requirements. The label or labeling age, or 800 mcg when labeled for use by
of food may contain a folate/neural pregnant or lactating women) shall
tube defect health claim provided that: identify the safe upper limit of daily
(1) General requirements. The health intake with respect to the DV. The safe
claim for a food meets all of the gen- upper limit of daily intake value of
eral requirements of § 101.14 for health 1,000 mcg (1 mg) may be included in pa-
claims, except that a food may qualify rentheses.
to bear the health claim if it meets the (G) The claim shall state that folate
definition of the term ‘‘good source.’’ needs to be consumed as part of a
(2) Specific requirements—(i) Nature of healthful diet.
the claim—(A) Relationship. A health (ii) Nature of the food—(A) Require-
claim that women who are capable of ments. The food shall meet or exceed
becoming pregnant and who consume the requirements for a ‘‘good source’’
adequate amounts of folate daily dur- of folate as defined in § 101.54;
ing their childbearing years may re- (B) Dietary supplements. Dietary sup-
duce their risk of having a pregnancy plements shall meet the United States
affected by spina bifida or other neural Pharmacopeia (USP) standards for dis-
tube defects may be made on the label integration and dissolution, except
or labeling of food provided that: that if there are no applicable USP
(B) Specifying the nutrient. In speci- standards, the folate in the dietary
fying the nutrient, the claim shall use supplement shall be shown to be bio-
the terms ‘‘folate,’’ ‘‘folic acid,’’ available under the conditions of use
‘‘folacin,’’ ‘‘folate, a B vitamin,’’ ‘‘folic stated on the product label.
acid, a B vitamin,’’ or ‘‘folacin, a B vi- (iii) Limitation. The claim shall not
tamin.’’ be made on foods that contain more
(C) Specifying the condition. In speci- than 100 percent of the RDI for vitamin
fying the health- related condition, the A as retinol or preformed vitamin A or
claim shall identify the birth defects as vitamin D per serving or per unit.
‘‘neural tube defects,’’ ‘‘birth defects (iv) Nutrition labeling. The nutrition
spina bifida or anencephaly,’’ ‘‘birth label shall include information about
defects of the brain or spinal cord the amount of folate in the food. This
anencephaly or spina bifida,’’ ‘‘spina information shall be declared after the

bifida and anencephaly, birth defects of declaration for iron if only the levels of
the brain or spinal cord,’’ ‘‘birth de- vitamin A, vitamin C, calcium, and
169
§ 101.79 21 CFR Ch. I (4–1–23 Edition)
iron are provided, or in accordance tube defect-affected births that might

with § 101.9 (c)(8) and (c)(9) if other op- occur in the United States if all women
tional vitamins or minerals are de- consumed adequate folate throughout
clared. their childbearing years may be in-
(3) Optional information—(i) Risk fac- cluded in the claim. Information con-
tors. The claim may specifically iden- tained in paragraph (b)(3) of this sec-
tify risk factors for neural tube de- tion may be used. If such an estimate
fects. Where such information is pro- (i.e., 50 percent) is provided, the esti-
vided, it may consist of statements mate shall be accompanied by addi-
from § 101.79(b)(1) or (b)(2) (e.g., Women tional information that states that the
at increased risk include those with a estimate is population-based and that
personal history of a neural tube de- it does not reflect risk reduction that
fect-affected pregnancy, those with a may be experienced by individual
close relative (i.e., sibling, niece, neph- women.
ew) with a neural tube defect; those (vii) Diets adequate in folate. The
with insulin-dependent diabetes claim may identify diets adequate in
mellitus; those with seizure disorders folate by using phrases such as
who are being treated with valproic ‘‘Sources of folate include fruits, vege-
acid or carbamazepine) or from other tables, whole grain products, fortified
parts of this paragraph (c)(3)(i). cereals, and dietary supplements.’’ or
(ii) Relationship between folate and ‘‘Adequate amounts of folate can be ob-
neural tube defects. The claim may in- tained from diets rich in fruits, dark
clude statements from paragraphs (a) green leafy vegetables, legumes, whole
and (b) of this section that summarize grain products, fortified cereals, or die-
the relationship between folate and tary supplements.’’ or ‘‘Adequate
neural tube defects and the signifi- amounts of folate can be obtained from
cance of the relationship except for in- diets rich in fruits, including citrus
formation specifically prohibited from fruits and juices, vegetables, including
the claim. dark green leafy vegetables, legumes,
(iii) Personal history of a neural tube whole grain products, including breads,
defect-affected pregnancy. The claim rice, and pasta, fortified cereals, or a
may state that women with a history dietary supplement.’’
of a neural tube defect pregnancy (d) Model health claims. The following
should consult their physicians or are examples of model health claims
health care providers before becoming that may be used in food labeling to de-
pregnant. If such a statement is pro- scribe the relationship between folate
vided, the claim shall also state that and neural tube defects:
all women should consult a health care (1) Examples 1 and 2. Model health
provider when planning a pregnancy. claims appropriate for foods containing
(iv) Daily value. The claim may iden- 100 percent or less of the DV for folate
tify 100 percent of the DV (100% DV; 400 per serving or per unit (general popu-
mcg) for folate as the target intake lation). The examples contain only the
goal. required elements:
(v) Prevalence. The claim may provide (i) Healthful diets with adequate
estimates, expressed on an annual folate may reduce a woman’s risk of
basis, of the number of neural tube de- having a child with a brain or spinal
fect-affected births among live births cord birth defect.
in the United States. Current esti- (ii) Adequate folate in healthful diets
mates are provided in § 101.79(b)(1), and may reduce a woman’s risk of having a
are approximately 6 of 10,000 live births child with a brain or spinal cord birth
annually (i.e., about 2,500 cases among defect.
4 million live births annually). Data (2) Example 3. Model health claim ap-
provided in § 101.79(b)(1) shall be used, propriate for foods containing 100 per-
unless more current estimates from the cent or less of the DV for folate per
U.S. Public Health Service are avail- serving or per unit. The example con-
able, in which case the latter may be tains all required elements plus op-
cited. tional information: Women who con-

(vi) Reduction in risk. An estimate of sume healthful diets with adequate
the reduction in the number of neural folate throughout their childbearing
170
years may reduce their risk of having a ernment dietary guidelines recommend
child with a birth defect of the brain or that Americans choose diets that are
spinal cord. Sources of folate include moderate in sugars and avoid excessive
fruits, vegetables, whole grain prod- snacking. Frequent between-meal
ucts, fortified cereals, and dietary sup- snacks that are high in sugars and
plements. starches may be more harmful to teeth
(3) Example 4. Model health claim ap- than eating such foods at meals and
propriate for foods intended for use by then brushing.
the general population and containing (4) Noncariogenic carbohydrate
more than 100 percent of the DV of sweeteners, such as sugar alcohols, can
folate per serving or per unit: Women be used to replace dietary sugars, such
who consume healthful diets with ade- as sucrose and corn sweeteners, in
quate folate may reduce their risk of foods such as chewing gums and cer-
having a child with birth defects of the tain confectioneries. Noncariogenic
brain or spinal cord. Folate intake carbohydrate sweeteners are signifi-
should not exceed 250% of the DV (1,000 cantly less cariogenic than dietary sug-
mcg). ars and other fermentable carbo-
[61 FR 8779, Mar. 5, 1996; 61 FR 48529, Sept. 13, hydrates.
1996, as amended at 65 FR 58918, Oct. 3, 2000] (b) Significance of the relationship be-
tween noncariogenic carbohydrate sweet-
§ 101.80 Health claims: dietary eners and dental caries. Noncariogenic
noncariogenic carbohydrate sweet-
eners and dental caries. carbohydrate sweeteners do not pro-
mote dental caries. The noncariogenic
(a) Relationship between dietary carbo- carbohydrate sweeteners listed in para-
hydrates and dental caries. (1) Dental graph (c)(2)(ii) of this section are slow-
caries, or tooth decay, is a disease ly metabolized by bacteria to form
caused by many factors. Both environ- some acid. The rate and amount of acid
mental and genetic factors can affect production is significantly less than
the development of dental caries. Risk that from sucrose and other ferment-
factors include tooth enamel crystal able carbohydrates and does not cause
structure and mineral content, plaque the loss of important minerals from
quantity and quality, saliva quantity
tooth enamel.
and quality, individual immune re-
(c) Requirements. (1) All requirements
sponse, types and physical characteris-
set forth in § 101.14 shall be met, except
tics of foods consumed, eating behav-
iors, presence of acid producing oral that noncariogenic carbohydrate
bacteria, and cultural influences. sweetener-containing foods listed in
(2) The relationship between con- paragraph (c)(2)(ii) of this section are
sumption of fermentable carbo- exempt from § 101.14(e)(6).
hydrates, i.e., dietary sugars and (2) Specific requirements—(i) Nature of
starches, and tooth decay is well estab- the claim. A health claim relating
lished. Sucrose, also known as sugar, is noncariogenic carbohydrate sweet-
one of the most, but not the only, eners, compared to other carbo-
cariogenic sugars in the diet. Bacteria hydrates, and the nonpromotion of den-
found in the mouth are able to metabo- tal caries may be made on the label or
lize most dietary carbohydrates, pro- labeling of a food described in para-
ducing acid and forming dental plaque. graph (c)(2)(iii) of this section, pro-
The more frequent and longer the expo- vided that:
sure of teeth to dietary sugars and (A) The claim shall state that fre-
starches, the greater the risk for tooth quent between-meal consumption of
decay. foods high in sugars and starches can
(3) Dental caries continues to affect a promote tooth decay.
large proportion of Americans. Al- (B) The claim shall state that the
though there has been a decline in the noncariogenic carbohydrate sweetener
prevalence of dental caries among chil- present in the food ‘‘does not pro-
dren in the United States, the disease mote,’’ ‘‘may reduce the risk of,’’
remains widespread throughout the ‘‘useful [or is useful] in not pro-

population, imposing a substantial bur- moting,’’ or ‘‘expressly [or is expressly]
den on Americans. Recent Federal gov- for not promoting’’ dental caries.
171
§ 101.80 21 CFR Ch. I (4–1–23 Edition)
(C) In specifying the nutrient, the utes after consumption, as measured

claim shall state ‘‘sugar alcohol,’’ by the indwelling plaque pH test found
‘‘sugar alcohols,’’ or the name or in ‘‘Identification of Low Caries Risk
names of the substances listed in para- Dietary Components,’’ dated 1983, by T.
graph (c)(2)(ii) of this section, e.g., N. Imfeld, in Volume 11, Monographs in
‘‘sorbitol.’’ D-tagatose may be identi- Oral Science, 1983. The Director of the
fied as ‘‘tagatose.’’ Office of the Federal Register has ap-
(D) In specifying the disease, the proved the incorporation by reference
claim uses the following terms: ‘‘dental of this material in accordance with 5
caries’’ or ‘‘tooth decay.’’ U.S.C. 552(a) and 1 CFR part 51. You
(E) The claim shall not attribute any may obtain copies from Karger AG
degree of the reduction in risk of den-
Publishing Co., P.O. Box, Ch–4009
tal caries to the use of the
Basel, Switzerland, or you may exam-
noncariogenic carbohydrate sweetener-
containing food. ine a copy at the Dockets Management
(F) The claim shall not imply that Staff (HFA–305), Food and Drug Admin-
consuming noncariogenic carbohydrate istration, 5630 Fishers Lane, Rm. 1061,
sweetener-containing foods is the only Rockville, MD 20852, 240–402–7500, be-
recognized means of achieving a re- tween 9 a.m. and 4 p.m., Monday
duced risk of dental caries. through Friday, or at the National Ar-
(G) Packages with less than 15 square chives and Records Administration
inches of surface area available for la- (NARA). For information on the avail-
beling are exempt from paragraphs (A) ability of this material at NARA, call
and (C) of this section. 202–741–6030, or go to: http://
(H) When the substance that is the www.archives.gov/federal_register/
subject of the claim is a noncariogenic code_of_federal_regulations/
sugar, the claim shall identify the sub- ibr_locations.html.
stance as a sugar that, unlike other (d) Optional information. (1) The claim
sugars, does not promote the develop- may include information from para-
ment of dental caries. graphs (a) and (b) of this section, which
(ii) Nature of the substance. Eligible describe the relationship between diets
noncariogenic carbohydrate sweeteners containing noncariogenic carbohydrate
are: sweeteners and dental caries.
(A) The sugar alcohols xylitol, sor-
(2) The claim may indicate that de-
bitol, mannitol, maltitol, isomalt,
velopment of dental caries depends on
lactitol, hydrogenated starch hydroly-
sates, hydrogenated glucose syrups, many factors and may identify one or
and erythritol, or a combination of more of the following risk factors for
these. dental caries: Frequent consumption of
(B) The sugars D-tagatose and fermentable carbohydrates, such as di-
isomaltulose. etary sugars and starches; presence of
(C) Sucralose. oral bacteria capable of fermenting
(iii) Nature of the food. (A) The food carbohydrates; length of time ferment-
shall meet the requirement in able carbohydrates are in contact with
§ 101.60(c)(1)(i) with respect to sugars the teeth; lack of exposure to fluoride;
content, except that the food may con- individual susceptibility; socio-
tain D-tagatose or isomaltulose. economic and cultural factors; and
(B) A food whose labeling includes a characteristics of tooth enamel, saliva,
health claim under this section shall and plaque.
contain one or more of the (3) The claim may indicate that oral
noncariogenic carbohydrate sweeteners hygiene and proper dental care may
listed in paragraph (c)(2)(ii) of this sec- help to reduce the risk of dental dis-
tion. ease.
(C) When carbohydrates other than (4) The claim may indicate that a
those listed in paragraph (c)(2)(ii) of
substance listed in paragraph (c)(2)(ii)
this section are present in the food, the
of this section serves as a sweetener.
food shall not lower plaque pH below

5.7 by bacterial fermentation either (e) Model health claim. The following
during consumption or up to 30 min- model health claims may be used in
172
food labeling to describe the relation- that include soluble fiber from certain
ship between noncariogenic carbo- foods and the risk of CHD. (1) Cardio-
hydrate sweetener-containing foods vascular disease means diseases of the
and dental caries. heart and circulatory system. Coro-
(1) Examples of the full claim: nary heart disease (CHD) is one of the
(i) Frequent eating of foods high in most common and serious forms of car-
sugars and starches as between-meal diovascular disease and refers to dis-
snacks can promote tooth decay. The eases of the heart muscle and sup-
sugar alcohol [name, optional] used to porting blood vessels. High blood total
sweeten this food may reduce the risk cholesterol and low density lipoprotein
of dental caries. (LDL)-cholesterol levels are associated
(ii) Frequent between-meal consump- with increased risk of developing coro-
tion of foods high in sugars and starch- nary heart disease. High CHD rates
es promotes tooth decay. The sugar al- occur among people with high total
cohols in [name of food] do not pro- cholesterol levels of 240 milligrams per
mote tooth decay. deciliter (mg/dL) (6.21 (mmol/L)) or
(iii) Frequent eating of foods high in above and LDL-cholesterol levels of 160
sugars and starches as between-meal mg/dL (4.13 mmol/L) or above. Border-
snacks can promote tooth decay. line high risk total cholesterol levels
[Name of sugar from paragraph range from 200 to 239 mg/dL (5.17 to 6.18
(c)(2)(ii)(B) of this section], the sugar mmol/L) and 130 to 159 mg/dL (3.36 to
used to sweeten this food, unlike other 4.11 mmol/L) of LDL-cholesterol. The
sugars, may reduce the risk of dental scientific evidence establishes that
caries. diets high in saturated fat and choles-
(iv) Frequent between-meal consump- terol are associated with increased lev-
tion of foods high in sugars and starch- els of blood total- and LDL-cholesterol
es promotes tooth decay. [Name of and, thus, with increased risk of CHD.
sugar from paragraph (c)(2)(ii)(B) of (2) Populations with a low incidence
this section], the sugar in [name of of CHD tend to have relatively low
food], unlike other sugars, does not blood total cholesterol and LDL-cho-
promote tooth decay. lesterol levels. These populations also
(v) Frequent eating of foods high in tend to have dietary patterns that are
sugars and starches as between-meal not only low in total fat, especially
snacks can promote tooth decay. saturated fat and cholesterol, but are
Sucralose, the sweetening ingredient also relatively high in fiber-containing
used to sweeten this food, unlike sug- fruits, vegetables, and grain products,
ars, does not promote tooth decay. such as whole oat products.
(2) Example of the shortened claim (3) Scientific evidence demonstrates
for small packages: that diets low in saturated fat and cho-
(i) Does not promote tooth decay. lesterol may reduce the risk of CHD.
(ii) May reduce the risk of tooth Other evidence demonstrates that the
decay. addition of soluble fiber from certain
(iii) [Name of sugar from paragraph foods to a diet that is low in saturated
(c)(2)(ii)(B) of this section] sugar does fat and cholesterol may also help to re-
not promote tooth decay. duce the risk of CHD.
(iv) [Name of sugar from paragraph (b) Significance of the relationship be-
(c)(2)(ii)(B) of this section] sugar may tween diets that are low in saturated fat
reduce the risk of tooth decay. and cholesterol and that include soluble
fiber from certain foods and the risk of
CHD. (1) CHD is a major public health
FR 63655, Dec. 2, 1997; 66 FR 66742, Dec. 27,
2001; 67 FR 71470, Dec. 2, 2002; 71 FR 15563, concern in the United States. It ac-
Mar. 29, 2006; 72 FR 52789, Sept. 17, 2007; 81 FR counts for more deaths than any other
5590, Feb. 3, 2016; 88 FR 17718, Mar. 24, 2023] disease or group of diseases. Early
management of risk factors for CHD is
§ 101.81 Health claims: Soluble fiber a major public health goal that can as-
from certain foods and risk of coro- sist in reducing risk of CHD. High
nary heart disease (CHD).
blood total and LDL-cholesterol are

(a) Relationship between diets that are major modifiable risk factors in the de-
low in saturated fat and cholesterol and velopment of CHD.
173
§ 101.81 21 CFR Ch. I (4–1–23 Edition)
(2) Intakes of saturated fat exceed (F) The claim does not imply that
recommended levels in the diets of consumption of diets that are low in
many people in the United States. One saturated fat and cholesterol and that
of the major public health rec- include soluble fiber from the eligible
ommendations relative to CHD risk is food sources from paragraph (c)(2)(ii) of
to consume less than 10 percent of cal- this section is the only recognized
ories from saturated fat and an average means of achieving a reduced risk of
of 30 percent or less of total calories CHD.
from all fat. Recommended daily cho- (G) The claim specifies the daily die-
lesterol intakes are 300 milligrams tary intake of the soluble fiber source
(mg) or less per day. Scientific evi- that is necessary to reduce the risk of
dence demonstrates that diets low in coronary heart disease and the con-
saturated fat and cholesterol are asso- tribution one serving of the product
ciated with lower blood total- and makes to the specified daily dietary in-
LDL-cholesterol levels. Soluble fiber take level. Daily dietary intake levels
from certain foods, when included in a of soluble fiber sources listed in para-
low saturated fat and cholesterol diet, graph (c)(2)(ii) of this section that have
also helps to lower blood total- and been associated with reduced risk coro-
LDL-cholesterol levels. nary heart disease are:
(c) Requirements. (1) All requirements (1) 3 g or more per day of b-glucan
set forth in § 101.14 shall be met. The soluble fiber from either whole oats or
label and labeling of foods containing barley, or a combination of whole oats
psyllium husk shall be consistent with and barley.
the provisions of § 101.17(f). (2) 7 g or more per day of soluble fiber
(2) Specific requirements—(i) Nature of from psyllium seed husk.
the claim. A health claim associating (ii) Nature of the substance—Eligible
diets that are low in saturated fat and sources of soluble fiber. (A) Beta (b)
cholesterol and that include soluble glucan soluble fiber from the whole oat
fiber from certain foods with reduced and barley sources listed below. b-
risk of heart disease may be made on glucan soluble fiber will be determined
the label or labeling of a food described by method No. 992.28 from the ‘‘Official
in paragraph (c)(2)(iii) of this section, Methods of Analysis of the AOAC
provided that: INTERNATIONAL,’’ 16th ed. (1995),
(A) The claim states that diets that which is incorporated by reference in
are low in saturated fat and cholesterol accordance with 5 U.S.C. 552(a) and 1
and that include soluble fiber from cer- CFR part 51. Copies may be obtained
tain foods ‘‘may’’ or ‘‘might’’ reduce from the AOAC INTERNATIONAL, 481
the risk of heart disease. North Frederick Ave., suite 500, Gai-
(B) In specifying the disease, the thersburg, MD 20877, or may be exam-
claim uses the following terms: ‘‘heart ined at the Dockets Management Staff
disease’’ or ‘‘coronary heart disease’’; (HFA–305), Food and Drug Administra-
(C) In specifying the substance, the tion, 5630 Fishers Lane, Rm. 1061, Rock-
claim uses the term ‘‘soluble fiber’’ ville, MD 20852, 240–402–7500, between 9
qualified by the name of the eligible a.m. and 4 p.m., Monday through Fri-
source of soluble fiber (provided in day, or at the National Archives and
paragraph (c)(2)(ii)) of this section. Ad- Records Administration (NARA). For
ditionally, the claim may use the name information on the availability of this
of the food product that contains the material at NARA, call 202–741–6030, or
eligible source of soluble fiber; go to: http://www.archives.gov/fed-
(D) In specifying the fat component, eral_register/code_of_federal_regulations/
the claim uses the terms ‘‘saturated ibr_locations.html;
fat’’ and ‘‘cholesterol’’; (1) Oat bran. Oat bran is produced by
(E) The claim does not attribute any grinding clean oat groats or rolled oats
degree of risk reduction for CHD to and separating the resulting oat flour
diets that are low in saturated fat and by suitable means into fractions such
cholesterol and that include soluble that the oat bran fraction is not more
fiber from the eligible food sources than 50 percent of the original starting
from paragraph (c)(2)(ii) of this section; material and provides at least 5.5 per-
and cent (dry weight basis (dwb)) b-glucan
174
soluble fiber and a total dietary fiber minimum b-glucan soluble fiber con-
content of 16 percent (dwb), and such tent is 5.5 percent (dwb) and minimum
that at least one-third of the total die- total dietary fiber content is 15 percent
tary fiber is soluble fiber; (dwb). Dehulled barley, hull-less bar-
(2) Rolled oats. Rolled oats, also ley, barley bran, barley flakes, barley
known as oatmeal, produced from 100 grits, pearl barley, and barley flour are
percent dehulled, clean oat groats by as defined in the Barley Glossary
steaming, cutting, rolling, and flaking, (AACC Method 55–99), published in Ap-
and provides at least 4 percent (dwb) of proved Methods of the American Asso-
b-glucan soluble fiber and a total die- ciation of Cereal Chemists, 10th ed.
tary fiber content of at least 10 per- (2000), pp. 1 and 2, which is incor-
cent. porated by reference in accordance
(3) Whole oat flour. Whole oat flour is with 5 U.S.C. 552(a) and 1 CFR part 51.
produced from 100 percent dehulled, Copies may be obtained from the Amer-
clean oat groats by steaming and ican Association of Cereal Chemists,
grinding, such that there is no signifi- Inc., 3340 Pilot Knob Rd., St. Paul, Min-
cant loss of oat bran in the final prod- nesota, 55121, or may be examined at
uct, and provides at least 4 percent the Dockets Management Staff (HFA–
(dwb) of b-glucan soluble fiber and a 305), Food and Drug Administration,
total dietary fiber content of at least 5630 Fishers Lane, Rm. 1061, Rockville,
10 percent (dwb). MD 20852, 240–402–7500, between 9 a.m.
(4) Oatrim. The soluble fraction of
and 4 p.m., Monday through Friday, or
alpha-amylase hydrolyzed oat bran or
at the National Archives and Records
whole oat flour, also known as oatrim.
Administration (NARA). For informa-
Oatrim is produced from either oat
tion on the availability of this mate-
bran as defined in paragraph
rial at NARA, call 202–741–6030, or go
(c)(2)(ii)(A)(1) of this section or whole
oat flour as defined in paragraph to: http://www.archives.gov/fed-
(c)(2)(ii)(A)(3) of this section by eral_register/code_of_federal_regulations/
solubilization of the starch in the ibr_locations.html. Barley meal is
starting material with an alpha-amy- unsifted, ground barley grain not sub-
lase hydrolysis process, and then rejected to any processing to separate
moval by centrifugation of the insol- the bran, germ, and endosperm. Sieved
uble components consisting of a high barley meal is an endosperm cell wall-
portion of protein, lipid, insoluble die- enriched fraction of ground barley sep-
tary fiber, and the majority of the fla- arated from meal by sieving or by air
vor and color components of the start- classification.
ing material. Oatrim shall have a beta- (6) Barley betafiber. Barley betafiber
glucan soluble fiber content up to 10 is the ethanol precipitated soluble frac-
percent (dwb) and not less than that of tion of cellulase and alpha-amylase
the starting material (dwb). hydrolyzed whole grain barley. Barley
(5) Whole grain barley and dry milled betafiber is produced by hydrolysis of
barley. Dehulled and hull-less whole whole grain barley flour, as defined in
grain barley with a b-glucan soluble paragraph (c)(2)(ii)(A)(5) of this sec-
fiber content of at least 4 percent (dwb) tion, with a cellulase and alpha-amy-
and a total dietary fiber content of at lase enzyme preparation, to produce a
least 10 percent (dwb). Dry milled bar- clear aqueous extract that contains
ley grain products include barley bran, mainly partially hydrolyzed beta-
barley flakes, barley grits, pearl bar- glucan and substantially hydrolyzed
ley, barley flour, barley meal, and starch. The soluble, partially
sieved barley meal that are produced hydrolyzed beta-glucan is separated
from clean, sound dehulled or hull-less from the insoluble material by cen-
barley grain using standard dry milling trifugation, and after removal of the
techniques, which may include steam- insoluble material, the partially
ing or tempering, and that contain at hydrolyzed beta-glucan soluble fiber is
least 4 percent (dwb) of b-glucan solu- separated from the other soluble com-
ble fiber and at least 8 percent (dwb) of pounds by precipitation with ethanol.
total dietary fiber, except barley bran The product is then dried, milled and
and sieved barley meal for which the sifted. Barley betafiber shall have a
175
§ 101.81 21 CFR Ch. I (4–1–23 Edition)
beta-glucan soluble fiber content of at National Archives and Records Admin-

least 70 percent on a dry weight basis. istration (NARA). For information on
(B)(1) Psyllium husk from the dried the availability of this material at
seed coat (epidermis) of the seed of NARA, call 202–741–6030, or go to: http://
Plantago (P.) ovata, known as blond www.archives.gov/federal_register/
psyllium or Indian psyllium, P. indica, code_of_federal_regulations/
or P. psyllium. To qualify for this ibr_locations.html;
claim, psyllium seed husk, also known (iii) Nature of the food eligible to bear
as psyllium husk, shall have a purity of the claim. (A) The food product shall in-
no less than 95 percent, such that it clude:
contains 3 percent or less protein, 4.5 (1) One or more of the whole oat or
percent or less of light extraneous mat- barley foods from paragraphs
ter, and 0.5 percent or less of heavy ex- (c)(2)(ii)(A)(1), (2), (3), and (5) of this
traneous matter, but in no case may section, and the whole oat or barley
the combined extraneous matter ex- foods shall contain at least 0.75 gram
ceed 4.9 percent, as determined by U.S. (g) of soluble fiber per reference
Pharmacopeia (USP) methods de- amount customarily consumed of the
scribed in USP’s ‘‘The National For- food product; or
mulary,’’ USP 23, NF 18, p. 1341, (1995), (2) The food containing the oatrim
which is incorporated by reference in from paragraph (c)(2)(ii)(A)(4) of this
accordance with 5 U.S.C. 552(a) and 1
section or the barley betafiber from
CFR part 51. Copies may be obtained
paragraph (c)(2)(ii)(A)(6) of this section
from the U.S. Pharmacopeial Conven-
shall contain at least 0.75 g of beta-
tion, Inc., 12601 Twinbrook Pkwy.,
glucan soluble fiber per reference
Rockville, MD 20852, or may be exam-
amount customarily consumed of the
ined at the Dockets Management Staff
food product; or
(HFA–305), Food and Drug Administra-
tion, 5630 Fishers Lane, Rm. 1061, Rock- (3) Psyllium husk that complies with
ville, MD 20852, 240–402–7500, between 9 paragraph (c)(2)(ii)(B) of this section,
a.m. and 4 p.m., Monday through Fri- and the psyllium food shall contain at
day, or at the National Archives and least 1.7 g of soluble fiber per reference
Records Administration (NARA). For amount customarily consumed of the
information on the availability of this food product;
material at NARA, call 202–741–6030, or (B) The amount of soluble fiber shall
go to: http://www.archives.gov/fed- be declared in the nutrition label, con-
eral_register/code_of_federal_regulations/ sistent with § 101.9(c)(6)(i)(A).
ibr_locations.html; (C) The food shall meet the nutrient
(2) FDA will determine the amount of content requirement in § 101.62 for a
soluble fiber that is provided by psyl- ‘‘low saturated fat’’ and ‘‘low choles-
lium husk by using a modification of terol’’ food; and
the Association of Official Analytical (D) The food shall meet the nutrient
Chemists’ International (AOAC’s) content requirement in § 101.62(b)(2) for
method for soluble dietary fiber (991.43) a ‘‘low fat’’ food, unless the food ex-
described by Lee et al., ‘‘Determination ceeds this requirement due to fat con-
of Soluble and Insoluble Dietary Fiber tent derived from whole oat sources
in Psyllium-containing Cereal Prod- listed in paragraph (c)(2)(ii)(A) of this
ucts,’’ Journal of the AOAC Inter- section.
national, 78 (No. 3):724–729, 1995, which (d) Optional information. (1) The claim
is incorporated by reference in accord- may state that the development of
ance with 5 U.S.C. 552(a) and 1 CFR heart disease depends on many factors
part 51. Copies may be obtained from and may identify one or more of the
the AOAC INTERNATIONAL, 481 North following risk factors for heart disease
Frederick Ave., suite 500, Gaithersburg, about which there is general scientific
MD 20877, or may be examined at the agreement: A family history of CHD;
Dockets Management Staff (HFA–305), elevated blood total and LDL-choles-
Food and Drug Administration, 5630 terol; excess body weight; high blood
Fishers Lane, Rm. 1061, Rockville, MD pressure; cigarette smoking; diabetes;

20852, 240–402–7500, between 9 a.m. and 4 and physical inactivity. The claim may
p.m., Monday through Friday or at the also provide additional information
176
about the benefits of exercise and man- (1) Soluble fiber from foods such as
agement of body weight to help lower [name of soluble fiber source from
the risk of heart disease; paragraph (c)(2)(ii) of this section and,
(2) The claim may state that the re- if desired, the name of food product], as
lationship between intake of diets that part of a diet low in saturated fat and
are low in saturated fat and cholesterol cholesterol, may reduce the risk of
and that include soluble fiber from the heart disease. A serving of [ name of
eligible food sources from paragraph food] supplies ________ grams of the
(c)(2)(ii) of this section and reduced [grams of soluble fiber specified in
risk of heart disease is through the in- paragraph (c)(2)(i)(G) of this section]
termediate link of ‘‘blood cholesterol’’ soluble fiber from [name of the soluble
or ‘‘blood total- and LDL-cholesterol;’’ fiber source from paragraph (c)(2)(ii) of
(3) The claim may include informa- this section] necessary per day to have
tion from paragraphs (a) and (b) of this this effect.
section, which summarize the relation- (2) Diets low in saturated fat and
ship between diets that are low in satu- cholesterol that include [________ grams
rated fat and cholesterol and that in- of soluble fiber specified in paragraph
clude soluble fiber from certain foods (c)(2)(i)(G) of this section] of soluble
and coronary heart disease and the sig- fiber per day from [name of soluble
nificance of the relationship; fiber source from paragraph (c)(2)(ii) of
(4) The claim may specify the name this section and, if desired, the name of
of the eligible soluble fiber; the food product] may reduce the risk
(5) The claim may state that a diet of heart disease. One serving of [name
low in saturated fat and cholesterol of food] provides ________ grams of this
that includes soluble fiber from whole soluble fiber.
oats or barley is consistent with ‘‘Nu- [62 FR 3600, Jan. 23, 1997, as amended at 62
trition and Your Health: Dietary FR 15344, Mar. 31, 1997; 63 FR 8119, Feb. 18,
Guidelines for Americans,’’ U.S. De- 1998; 66 FR 66742, Dec. 27, 2001; 67 FR 61782,
partment of Agriculture (USDA) and Oct. 2, 2002; 68 FR 15355, Mar. 31, 2003; 70 FR
Department of Health and Human 40880, July 15, 2005; 70 FR 76162, Dec. 23, 2005;
73 FR 9947, Feb. 25, 2008; 73 FR 23953, May 1,
Services (DHHS), Government Printing 2008; 81 FR 5590, Feb. 3, 2016; 88 FR 17718, Mar.
Office (GPO); 24, 2023]
(6) The claim may state that individ-
uals with elevated blood total- and § 101.82 Health claims: Soy protein and
LDL-cholesterol should consult their risk of coronary heart disease
physicians for medical advice and (CHD).
treatment. If the claim defines high or (a) Relationship between diets that are
normal blood total- and LDL-choles- low in saturated fat and cholesterol and
terol levels, then the claim shall state that include soy protein and the risk of
that individuals with high blood cho- CHD. (1) Cardiovascular disease means
lesterol should consult their physicians diseases of the heart and circulatory
for medical advice and treatment; system. CHD is one of the most com-
(7) The claim may include informa- mon and serious forms of cardio-
tion on the number of people in the vascular disease and refers to diseases
United States who have heart disease. of the heart muscle and supporting
The sources of this information shall blood vessels. High blood total choles-
be identified, and it shall be current in- terol and low density lipoprotein
formation from the National Center for (LDL)-cholesterol levels are associated
Health Statistics, the National Insti- with increased risk of developing CHD.
tutes of Health, or ‘‘Nutrition and Your High CHD rates occur among people
Health: Dietary Guidelines for Ameri- with high total cholesterol levels of 240
cans,’’ USDA and DHHS, GPO. milligrams per deciliter (mg/dL) (6.21
(e) Model health claim. The following millimole per liter (mmol/L)) or above
model health claims may be used in and LDL-cholesterol levels of 160 mg/
food labeling to describe the relation- dL (4.13 mmol/L) or above. Borderline
ship between diets that are low in satu- high risk total cholesterol levels range
rated fat and cholesterol and that in- from 200 to 239 mg/dL (5.17 to 6.18
clude soluble fiber from certain foods mmol/L) and 130 to 159 mg/dL (3.36 to
and reduced risk of heart disease: 4.11 mmol/L) of LDL-cholesterol. The
177
§ 101.82 21 CFR Ch. I (4–1–23 Edition)
scientific evidence establishes that cholesterol and that include soy pro-
diets high in saturated fat and choles- tein with reduced risk of heart disease
terol are associated with increased lev- may be made on the label or labeling of
els of blood total and LDL-cholesterol a food described in paragraph (c)(2)(iii)
and, thus, with increased risk of CHD. of this section, provided that:
(2) Populations with a low incidence (A) The claim states that diets that
of CHD tend to have relatively low are low in saturated fat and cholesterol
blood total cholesterol and LDL-cho- and that include soy protein ‘‘may’’ or
lesterol levels. These populations also ‘‘might’’ reduce the risk of heart dis-
tend to have dietary patterns that are ease;
not only low in total fat, especially (B) In specifying the disease, the
saturated fat and cholesterol, but are claim uses the following terms: ‘‘heart
also relatively high in plant foods that disease’’ or ‘‘coronary heart disease’’;
contain dietary fiber and other compo- (C) In specifying the substance, the
nents. claim uses the term ‘‘soy protein’’;
(3) Scientific evidence demonstrates (D) In specifying the fat component,
that diets low in saturated fat and cho- the claim uses the terms ‘‘saturated
lesterol may reduce the risk of CHD. fat’’ and ‘‘cholesterol’’;
Other evidence demonstrates that the (E) The claim does not attribute any
addition of soy protein to a diet that is degree of risk reduction for CHD to
low in saturated fat and cholesterol diets that are low in saturated fat and
may also help to reduce the risk of cholesterol and that include soy pro-
CHD. tein;
(b) Significance of the relationship be- (F) The claim does not imply that
tween diets that are low in saturated fat consumption of diets that are low in
and cholesterol and that include soy pro- saturated fat and cholesterol and that
tein and the risk of CHD. (1) CHD is a include soy protein is the only recog-
major public health concern in the nized means of achieving a reduced
United States. It accounts for more risk of CHD; and
deaths than any other disease or group (G) The claim specifies the daily die-
of diseases. Early management of risk tary intake of soy protein that is nec-
factors for CHD is a major public essary to reduce the risk of coronary
health goal that can assist in reducing heart disease and the contribution one
risk of CHD. High blood total and LDL- serving of the product makes to the
cholesterol are major modifiable risk specified daily dietary intake level.
factors in the development of CHD. The daily dietary intake level of soy
(2) Intakes of saturated fat exceed protein that has been associated with
recommended levels in the diets of reduced risk of coronary heart disease
many people in the United States. One is 25 grams (g) or more per day of soy
of the major public health rec- protein.
ommendations relative to CHD risk is (ii) Nature of the substance. (A) Soy
to consume less than 10 percent of cal- protein from the legume seed Glycine
ories from saturated fat and an average max.
of 30 percent or less of total calories (B) FDA will assess qualifying levels
from all fat. Recommended daily cho- of soy protein in the following fashion:
lesterol intakes are 300 mg or less per FDA will measure total protein con-
day. Scientific evidence demonstrates tent by the appropriate method of
that diets low in saturated fat and cho- analysis given in the ‘‘Official Methods
lesterol are associated with lower blood of Analysis of the AOAC Inter-
total and LDL-cholesterol levels. Soy national,’’ as described at § 101.9(c)(7).
protein, when included in a low satu- For products that contain no sources of
rated fat and cholesterol diet, also protein other than soy, FDA will con-
helps to lower blood total and LDL- sider the amount of soy protein as
cholesterol levels. equivalent to the total protein content.
(c) Requirements. (1) All requirements For products that contain a source or
set forth in § 101.14 shall be met. sources of protein in addition to soy,
(2) Specific requirements—(i) Nature of FDA will, using the measurement of

the claim. A health claim associating total protein content, calculate the soy
diets that are low in saturated fat and protein content based on the ratio of
178
soy protein ingredients to total protein rated fat and cholesterol and that in-
ingredients in the product. FDA will clude soy protein and CHD and the sig-
base its calculation on information nificance of the relationship;
identified and supplied by manufactur- (4) The claim may state that a diet
ers, such as nutrient data bases or low in saturated fat and cholesterol
analyses, recipes or formulations, pur- that includes soy protein is consistent
chase orders for ingredients, or any with ‘‘Nutrition and Your Health: Die-
other information that reasonably sub- tary Guidelines for Americans,’’ U.S.
stantiates the ratio of soy protein to Department of Agriculture (USDA) and
total protein. Manufacturers must Department of Health and Human
maintain records sufficient to substan- Services (DHHS), Government Printing
tiate the claim for as long as the prod- Office (GPO);
ucts are marketed and provide these (5) The claim may state that individ-
records, on written request, to appro- uals with elevated blood total and
priate regulatory officials. LDL-cholesterol should consult their
(iii) Nature of the food eligible to bear physicians for medical advice and
the claim. (A) The food product shall treatment. If the claim defines high or
contain at least 6.25 g of soy protein normal blood total and LDL-choles-
per reference amount customarily con- terol levels, then the claim shall state
sumed of the food product; that individuals with high blood cho-
(B) The food shall meet the nutrient lesterol should consult their physicians
content requirements in § 101.62 for a for medical advice and treatment;
‘‘low saturated fat’’ and ‘‘low choles- (6) The claim may include informa-
terol’’ food; and tion on the number of people in the
(C) The food shall meet the nutrient United States who have heart disease.
content requirement in § 101.62 for a The sources of this information shall
‘‘low fat’’ food, unless it consists of or be identified, and it shall be current in-
is derived from whole soybeans and formation from the National Center for
contains no fat in addition to the fat Health Statistics, the National Insti-
inherently present in the whole soy- tutes of Health, or ‘‘Nutrition and Your
beans it contains or from which it is Health: Dietary Guidelines for Ameri-
derived. cans,’’ USDA and DHHS, GPO;
(d) Optional information. (1) The claim (e) Model health claim. The following
may state that the development of model health claims may be used in
heart disease depends on many factors food labeling to describe the relation-
and may identify one or more of the ship between diets that are low in satu-
following risk factors for heart disease rated fat and cholesterol and that in-
about which there is general scientific clude soy protein and reduced risk of
agreement: A family history of CHD; heart disease:
elevated blood total and LDL-choles- (1) 25 grams of soy protein a day, as
terol; excess body weight; high blood part of a diet low in saturated fat and
pressure; cigarette smoking; diabetes; cholesterol, may reduce the risk of
and physical inactivity. The claim may heart disease. A serving of [name of
also provide additional information food] supplies ____ grams of soy pro-
about the benefits of exercise and man- tein.
agement of body weight to help lower (2) Diets low in saturated fat and
the risk of heart disease; cholesterol that include 25 grams of
(2) The claim may state that the re- soy protein a day may reduce the risk
lationship between intake of diets that of heart disease. One serving of [name
are low in saturated fat and cholesterol of food] provides ____ grams of soy pro-
and that include soy protein and re- tein.
duced risk of heart disease is through [64 FR 57732, Oct. 26, 1999]
the intermediate link of ‘‘blood choles-
terol’’ or ‘‘blood total and LDL-choles- EFFECTIVE DATE NOTE: At 64 FR 57732, Oct.
26, 1999, § 101.82 was added. Paragraph
terol’’;
(c)(2)(ii)(B) of this section contains informa-
(3) The claim may include information collection and recordkeeping require-
tion from paragraphs (a) and (b) of this ments and will not become effective until ap-
section, which summarize the relation- proval has been given by the Office of Man-
ship between diets that are low in satu- agement and Budget.
179
§ 101.83 21 CFR Ch. I (4–1–23 Edition)
§ 101.83 Health claims: plant sterol/ (c) Requirements—(1) General. All re-
stanol esters and risk of coronary quirements set forth in § 101.14 shall be
heart disease (CHD). met, except § 101.14(a)(4) with respect to
(a) Relationship between diets that in- the disqualifying level for total fat per
clude plant sterol/stanol esters and the 50 grams (g) in dressings for salad and
risk of CHD. (1) Cardiovascular disease spreads and § 101.14(e)(6) with respect to
means diseases of the heart and cir- dressings for salad.
culatory system. Coronary heart dis- (2) Specific requirements—(i) Nature of
ease (CHD) is one of the most common the claim. A health claim associating
and serious forms of cardiovascular dis- diets that include plant sterol/stanol
ease and refers to diseases of the heart esters with reduced risk of heart dis-
muscle and supporting blood vessels. ease may be made on the label or label-
High blood total cholesterol and low ing of a food described in paragraph
density lipoprotein (LDL) cholesterol (c)(2)(iii) of this section, provided that:
levels are associated with increased (A) The claim states that plant ste-
risk of developing coronary heart dis- rol/stanol esters should be consumed as
ease. High CHD rates occur among peo- part of a diet low in saturated fat and
ple with high total cholesterol levels of cholesterol;
240 milligrams per deciliter (mg/dL) (B) The claim states that diets that
(6.21 millimole per liter (mmol/l)) or include plant sterol/stanol esters
above and LDL cholesterol levels of 160 ‘‘may’’ or ‘‘might’’ reduce the risk of
mg/dL (4.13 mmol/l) or above. Border- heart disease;
line high risk blood cholesterol levels (C) In specifying the disease, the
range from 200 to 239 mg/dL (5.17 to 6.18 claim uses the following terms: ‘‘heart
mmol/l) for total cholesterol, and 130 to disease’’ or ‘‘coronary heart disease’’;
159 mg/dL (3.36 to 4.11 mmol/l) of LDL (D) In specifying the substance, the
cholesterol. claim uses the term ‘‘plant sterol
(2) Populations with a low incidence esters’’ or ‘‘plant stanol esters,’’ except
of CHD tend to have relatively low that if the sole source of the plant
blood total cholesterol and LDL choles- sterols or stanols is vegetable oil, the
terol levels. These populations also claim may use the term ‘‘vegetable oil
tend to have dietary patterns that are sterol esters’’ or ‘‘vegetable oil stanol
not only low in total fat, especially esters’’;
saturated fat and cholesterol, but are (E) The claim does not attribute any
also relatively high in plant foods that degree of risk reduction for CHD to
contain dietary fiber and other compo- diets that include plant sterol/stanol
nents. esters;
(3) Scientific evidence demonstrates (F) The claim does not imply that
that diets that include plant sterol/ consumption of diets that include plant
stanol esters may reduce the risk of sterol/stanol esters is the only recog-
CHD. nized means of achieving a reduced
(b) Significance of the relationship be- risk of CHD; and
tween diets that include plant sterol/ (G) The claim specifies the daily die-
stanol esters and the risk of CHD. (1) tary intake of plant sterol or stanol
CHD is a major public health concern esters that is necessary to reduce the
in the United States. It accounts for risk of CHD and the contribution one
more deaths than any other disease or serving of the product makes to the
group of diseases. Early management specified daily dietary intake level.
of risk factors for CHD is a major pub- Daily dietary intake levels of plant
lic health goal that can assist in reduc- sterol and stanol esters that have been
ing risk of CHD. High blood total and associated with reduced risk of are:
LDL cholesterol are major modifiable (1) 1.3 g or more per day of plant ste-
risk factors in the development of rol esters.
CHD. (2) 3.4 g or more per day of plant
(2) The scientific evidence establishes stanol esters.
that including plant sterol/stanol (H) The claim specifies that the daily
esters in the diet helps to lower blood dietary intake of plant sterol or stanol
total and LDL cholesterol levels. esters should be consumed in two
180
servings eaten at different times of the are incorporated by reference in ac-

day with other foods. cordance with 5 U.S.C. 552(a) and 1 CFR
(ii) Nature of the substance—(A) Plant part 51. Copies may be obtained from
sterol esters. (1) Plant sterol esters pre- the Center for Food Safety and Applied
pared by esterifying a mixture of plant Nutrition, Office of Nutrition, Labeling
sterols from edible oils with food-grade and Dietary Supplements, Nutrition
fatty acids. The plant sterol mixture Programs Staff, 5001 Campus Dr., Col-
shall contain at least 80 percent beta- lege Park, MD 20740, or may be exam-
sitosterol, campesterol, and stigmas- ined at the Dockets Management Staff
terol (combined weight). (HFA–305), Food and Drug Administra-
(2) FDA will measure plant sterol tion, 5630 Fishers Lane, Rm. 1061, Rock-
esters by the method entitled ‘‘Deter- ville, MD 20852, 240–402–7500, between 9
mination of the Sterol Content in Mar- a.m. and 4 p.m., Monday through Fri-
garines, Halvarines, Dressings, Fat day, and at the National Archives and
Blends and Sterol Fatty Acid Ester Records Administration (NARA). For
Concentrates by Capillary Gas Chroma- information on the availability of this
tography,’’ developed by Unilever material at NARA, call 202–741–6030, or
United States, Inc., dated February 1, go to: http://www.archives.gov/fed-
2000. The method, which is incor- eral_register/code_of_federal_regulations/
porated by reference in accordance ibr_locations.html.
with 5 U.S.C. 552(a) and 1 CFR part 51, (iii) Nature of the food eligible to bear
may be obtained from the Center for the claim. (A) The food product shall
Food Safety and Applied Nutrition, Of- contain:
fice of Nutrition, Labeling and Dietary (1) At least 0.65 g of plant sterol
Supplements, Nutrition Programs esters that comply with paragraph
Staff, 5001 Campus Dr., College Park, (c)(2)(ii)(A)(1) of this section per ref-
MD 20740, and may be examined at the erence amount customarily consumed
Dockets Management Staff (HFA–305), of the food products eligible to bear the
Food and Drug Administration, 5630 health claim, specifically spreads and
Fishers Lane, Rm. 1061, Rockville, MD dressings for salad, or
20852, 240–402–7500, between 9 a.m. and 4 (2) At least 1.7 g of plant stanol
p.m., Monday through Friday, or at the esters that comply with paragraph
National Archives and Records Admin- (c)(2)(ii)(B)(1) of this section per ref-
istration (NARA). For information on erence amount customarily consumed
the availability of this material at of the food products eligible to bear the
NARA, call 202–741–6030, or go to: http:// health claim, specifically spreads,
www.archives.gov/federal_register/ dressings for salad, snack bars, and die-
code_of_federal_regulations/ tary supplements in softgel form.
ibr_locations.html. (B) The food shall meet the nutrient
(B) Plant stanol esters. (1) Plant stanol content requirements in § 101.62 for a
esters prepared by esterifying a mix- ‘‘low saturated fat’’ and ‘‘low choles-
ture of plant stanols derived from edi- terol’’ food; and
ble oils or byproducts of the kraft (C) The food must meet the limit for
paper pulping process with food-grade total fat in § 101.14(a)(4), except that
fatty acids. The plant stanol mixture spreads and dressings for salad are not
shall contain at least 80 percent required to meet the limit for total fat
sitostanol and campestanol (combined per 50 g if the label of the food bears a
weight). disclosure statement that complies
(2) FDA will measure plant stanol with § 101.13(h); and
esters by the following methods devel- (D) The food must meet the min-
oped by McNeil Consumer Healthcare imum nutrient contribution require-
dated February 15, 2000: ‘‘Determina- ment in § 101.14(e)(6) unless it is a dress-
tion of Stanols and Sterols in Benecol ing for salad.
Tub Spread’’; ‘‘Determination of (d) Optional information. (1) The claim
Stanols and Sterols in Benecol Dress- may state that the development of
ing’’; ‘‘Determination of Stanols and heart disease depends on many factors
Sterols in Benecol Snack Bars’’; or and may identify one or more of the
‘‘Determination of Stanols and Sterols following risk factors for heart disease
in Benecol Softgels.’’ These methods about which there is general scientific
181
§ 101.83 21 CFR Ch. I (4–1–23 Edition)
agreement: A family history of CHD; cians for medical advice and treat-
elevated blood total and LDL choles- ment. If the claim defines high or nor-
terol; excess body weight; high blood mal blood total and LDL cholesterol
pressure; cigarette smoking; diabetes; levels, then the claim shall state that
and physical inactivity. The claim may individuals with high blood cholesterol
also provide additional information should consult their physicians for
about the benefits of exercise and man- medical advice and treatment.
agement of body weight to help lower (7) The claim may include informa-
the risk of heart disease. tion on the number of people in the
(2) The claim may state that the re- United States who have heart disease.
lationship between intake of diets that The sources of this information shall
include plant sterol/stanol esters and be identified, and it shall be current in-
reduced risk of heart disease is through formation from the National Center for
the intermediate link of ‘‘blood choles- Health Statistics, the National Insti-
terol’’ or ‘‘blood total and LDL choles- tutes of Health, or ‘‘Nutrition and Your
terol.’’ Health: Dietary Guidelines for Ameri-
(3) The claim may include informa- cans,’’ U.S. Department of Agriculture
tion from paragraphs (a) and (b) of this (USDA) and Department of Health and
section, which summarize the relation- Human Services (DHHS), Government
ship between diets that include plant Printing Office (GPO).
sterol/stanol esters and the risk of CHD (e) Model health claim. The following
and the significance of the relation- model health claims may be used in
ship. food labeling to describe the relation-
(4) The claim may include informa- ship between diets that include plant
tion from the following paragraph on sterol or stanol esters and reduced risk
the relationship between saturated fat of heart disease:
and cholesterol in the diet and the risk (1) For plant sterol esters: (i) Foods
of CHD: The scientific evidence estab- containing at least 0.65 g per serving of
lishes that diets high in saturated fat plant sterol esters, eaten twice a day
and cholesterol are associated with in- with meals for a daily total intake of
creased levels of blood total and LDL at least 1.3 g, as part of a diet low in
cholesterol and, thus, with increased saturated fat and cholesterol, may re-
risk of CHD. Intakes of saturated fat duce the risk of heart disease. A serv-
exceed recommended levels in the diets ing of [name of the food] supplies
of many people in the United States. ______grams of vegetable oil sterol
One of the major public health rec- esters.
ommendations relative to CHD risk is (ii) Diets low in saturated fat and
to consume less than 10 percent of cal- cholesterol that include two servings of
ories from saturated fat and an average foods that provide a daily total of at
of 30 percent or less of total calories least 1.3 g of vegetable oil sterol esters
from all fat. Recommended daily cho- in two meals may reduce the risk of
lesterol intakes are 300 mg or less per heart disease. A serving of [name of the
day. Scientific evidence demonstrates food] supplies ______grams of vegetable
that diets low in saturated fat and cho- oil sterol esters.
lesterol are associated with lower blood (2) For plant stanol esters: (i) Foods
total and LDL cholesterol levels. containing at least 1.7 g per serving of
(5) The claim may state that diets plant stanol esters, eaten twice a day
that include plant sterol or stanol with meals for a total daily intake of
esters and are low in saturated fat and at least 3.4 g, as part of a diet low in
cholesterol are consistent with ‘‘Nu- saturated fat and cholesterol, may re-
trition and Your Health: Dietary duce the risk of heart disease. A serv-
Guidelines for Americans,’’ U.S. De- ing of [name of the food] supplies
partment of Agriculture (USDA) and ______grams of plant stanol esters.
Department of Health and Human (ii) Diets low in saturated fat and
Services (DHHS), Government Printing cholesterol that include two servings of
Office (GPO). foods that provide a daily total of at
(6) The claim may state that individ- least 3.4 g of vegetable oil stanol esters
uals with elevated blood total and LDL in two meals may reduce the risk of
cholesterol should consult their physi- heart disease. A serving of [name of the
182
food] supplies ______grams of vegetable paragraph (a)(3) of this section and, if

oil stanol esters. applicable, paragraphs (c)(2) through
[65 FR 54717, Sept. 8, 2000; 65 FR 70466, Nov. (4) of this section will be deemed mis-
24, 2000, as amended at 66 FR 66742, Dec. 27, branded.
2001; 68 FR 15355, Mar. 31, 2003; 70 FR 41958, (2) A food that bears the claim ‘‘no
July 21, 2005; 88 FR 17718, Mar. 24, 2023] gluten,’’ ‘‘free of gluten,’’ or ‘‘without
gluten’’ in its labeling and fails to
Subpart F—Specific Requirements meet the requirements of paragraph
for Descriptive Claims That (a)(3) of this section and, if applicable,
Are Neither Nutrient Content paragraphs (c)(2) through (4) of this
Claims nor Health Claims section will be deemed misbranded.
(3) A food that bears the term
§ 101.91 Gluten-free labeling of food. ‘‘wheat’’ in the ingredient list or in a
(a) Definitions. (1) The term ‘‘gluten- separate ‘‘Contains wheat’’ statement
containing grain’’ means any one of in its labeling, as required by 21 U.S.C.
the following grains or their crossbred 343(w)(1)(A), and also bears the claim
hybrids (e.g., triticale, which is a cross ‘‘gluten-free’’ or a claim identified in
between wheat and rye): paragraph (b)(2) of this section will be
(i) Wheat, including any species be- deemed misbranded unless the word
longing to the genus Triticum; ‘‘wheat’’ in the ingredient list or in the
(ii) Rye, including any species be-
‘‘Contains wheat’’ statement is fol-
longing to the genus Secale; or
lowed immediately by an asterisk (or
(iii) Barley, including any species be-
longing to the genus Hordeum. other symbol) that refers to another
(2) The term ‘‘gluten’’ means the pro- asterisk (or other symbol) in close
teins that naturally occur in a gluten- proximity to the ingredient statement
containing grain and that may cause that immediately precedes the fol-
adverse health effects in persons with lowing: ‘‘The wheat has been processed
celiac disease (e.g., prolamins and to allow this food to meet the Food and
glutelins). Drug Administration (FDA) require-
(3) The labeling claim ‘‘gluten-free’’ ments for gluten-free foods.’’
means: (c) Compliance. (1) When compliance
(i) That the food bearing the claim in with paragraph (b) of this section is
its labeling: based on an analysis of the food, FDA
(A) Does not contain any one of the will use a scientifically valid method
following: that can reliably detect and quantify
(1) An ingredient that is a gluten- the presence of 20 ppm gluten in a vari-
containing grain (e.g., spelt wheat);
ety of food matrices, including both
(2) An ingredient that is derived from
raw and cooked or baked products.
a gluten-containing grain and that has
not been processed to remove gluten (2) When a scientifically valid meth-
(e.g., wheat flour); or od pursuant to paragraph (c)(1) of this
(3) An ingredient that is derived from section is not available because the
a gluten-containing grain and that has food is fermented or hydrolyzed, the
been processed to remove gluten (e.g., manufacturer of such foods bearing the
wheat starch), if the use of that ingre- claim must make and keep records re-
dient results in the presence of 20 parts garding the fermented or hydrolyzed
per million (ppm) or more gluten in the food demonstrating adequate assurance
food (i.e., 20 milligrams (mg) or more that:
gluten per kilogram (kg) of food); or (i) The food is ‘‘gluten-free’’ in com-
(B) Inherently does not contain glu- pliance with paragraph (a)(3) of this
ten; and section before fermentation or hydrol-
(ii) Any unavoidable presence of glu- ysis;
ten in the food bearing the claim in its
(ii) The manufacturer has adequately
labeling is below 20 ppm gluten (i.e.,
evaluated their processing for any po-
below 20 mg gluten per kg of food).
tential for gluten cross-contact; and
(b) Requirements. (1) A food that bears

the claim ‘‘gluten-free’’ in its labeling (iii) Where a potential for gluten
and fails to meet the requirements of cross-contact has been identified, the
183
§ 101.93 21 CFR Ch. I (4–1–23 Edition)
manufacturer has implemented meas- (HFS–810), Center for Food Safety and
ures to prevent the introduction of glu- Applied Nutrition, Food and Drug Ad-
ten into the food during the manufac- ministration, 5001 Campus Dr., College
turing process. Park, MD 20740, that it has included
(3) When a scientifically valid meth- such a statement on the label or in the
od pursuant to paragraph (c)(1) of this labeling of its product. An original and
section is not available because the two copies of this notification shall be
food contains one or more ingredients submitted.
that are fermented or hydrolyzed, the (2) The notification shall include the
manufacturer of such foods bearing the following:
claim must make and keep records (i) The name and address of the man-
demonstrating adequate assurance that ufacturer, packer, or distributor of the
the fermented or hydrolyzed ingredi- dietary supplement that bears the
ents are ‘‘gluten-free’’ as described in statement;
paragraph (c)(2) of this section. (ii) The text of the statement that is
(4) Records necessary to verify com- being made;
pliance with paragraphs (c)(2) and (3) of (iii) The name of the dietary ingre-
this section must be retained for at dient or supplement that is the subject
least 2 years after introduction or de- of the statement, if not provided in the
livery for introduction of the food into text of the statement; and
interstate commerce and may be kept (iv) The name of the dietary supple-
as original records, as true copies, or as ment (including brand name), if not
electronic records. Manufacturers must provided in response to paragraph
provide those records to us for exam- (a)(2)(iii) on whose label, or in whose
ination and copying during an inspec- labeling, the statement appears.
tion upon request. (3) The notice shall be signed by a re-
(5) When a scientifically valid meth- sponsible individual or the person who
od pursuant to paragraph (c)(1) of this can certify the accuracy of the infor-
section is not available because the mation presented and contained in the
food is distilled, FDA will evaluate notice. The individual shall certify
compliance with paragraph (b) of this that the information contained in the
section by verifying the absence of pro- notice is complete and accurate, and
tein in the distilled component using that the notifying firm has substan-
scientifically valid analytical methods tiation that the statement is truthful
that can reliably detect the presence or and not misleading.
absence of protein or protein fragments (b) Disclaimer. The requirements in
in the food. this section apply to the label or label-
(d) Preemption. A State or political ing of dietary supplements where the
subdivision of a State may not estab- dietary supplement bears a statement
lish or continue into effect any law, that is provided for by section 403(r)(6)
rule, regulation, or other requirement of the Federal Food, Drug, and Cos-
that is different from the requirements metic Act (the act), and the manufac-
in this section for the definition and turer, packer, or distributor wishes to
use of the claim ‘‘gluten-free,’’ as well take advantage of the exemption to
as the claims ‘‘no gluten,’’ ‘‘free of glu- section 201(g)(1)(C) of the act that is
ten,’’ or ‘‘without gluten.’’ provided by compliance with section
403(r)(6) of the act.
[78 FR 47178, Aug. 5, 2013, as amended at 85 (c) Text for disclaimer. (1) Where there
FR 49260, Aug. 13, 2020]
is one statement, the disclaimer shall
§ 101.93 Certain types of statements be placed in accordance with paragraph
for dietary supplements. (d) of this section and shall state:
(a)(1) No later than 30 days after the This statement has not been evaluated by
first marketing of a dietary supple- the Food and Drug Administration. This
ment that bears one of the statements product is not intended to diagnose, treat,
cure, or prevent any disease.
listed in section 403(r)(6) or the Federal
Food, Drug, and Cosmetic Act, the (2) Where there is more than one such
manufacturer, packer, or distributor of statement on the label or in the label-

the dietary supplement shall notify the ing, each statement shall bear the dis-
Office of Dietary Supplement Programs claimer in accordance with paragraph
184
(c)(1) of this section, or a plural dis- (e.g., scurvy, pellagra) are not included
claimer may be placed in accordance in this definition.
with paragraph (d) of this section and (2) FDA will find that a statement
shall state: about a product claims to diagnose,
These statements have not been eval- mitigate, treat, cure, or prevent dis-
uated by the Food and Drug Adminis- ease (other than a classical nutrient
tration. This product is not intended to deficiency disease) under 21 U.S.C.
diagnose, treat, cure, or prevent any 343(r)(6) if it meets one or more of the
disease. criteria listed below. These criteria are
(d) Placement. The disclaimer shall be not intended to classify as disease
placed adjacent to the statement with claims statements that refer to the
no intervening material or linked to ability of a product to maintain
the statement with a symbol (e.g., an healthy structure or function, unless
asterisk) at the end of each such state- the statement implies disease preven-
ment that refers to the same symbol tion or treatment. In determining
placed adjacent to the disclaimer speci- whether a statement is a disease claim
fied in paragraphs (c)(1) or (c)(2) of this under these criteria, FDA will consider
section. On product labels and in label- the context in which the claim is pre-
ing (e.g., pamphlets, catalogs), the dis- sented. A statement claims to diag-
claimer shall appear on each panel or nose, mitigate, treat, cure, or prevent
page where there such is a statement. disease if it claims, explicitly or im-
The disclaimer shall be set off in a box plicitly, that the product:
where it is not adjacent to the state-
(i) Has an effect on a specific disease
ment in question.
or class of diseases;
(e) Typesize. The disclaimer in para-
(ii) Has an effect on the char-
graph (c) of this section shall appear in
acteristic signs or symptoms of a spe-
boldface type in letters of a typesize no
cific disease or class of diseases, using
smaller than one-sixteenth inch.
scientific or lay terminology;
(f) Permitted structure/function state-
(iii) Has an effect on an abnormal
ments. Dietary supplement labels or la-
condition associated with a natural
beling may, subject to the require-
state or process, if the abnormal condi-
ments in paragraphs (a) through (e) of
tion is uncommon or can cause signifi-
this section, bear statements that de-
cant or permanent harm;
scribe the role of a nutrient or dietary
ingredient intended to affect the struc- (iv) Has an effect on a disease or dis-
ture or function in humans or that eases through one or more of the fol-
characterize the documented mecha- lowing factors:
nism by which a nutrient or dietary in- (A) The name of the product;
gredient acts to maintain such struc- (B) A statement about the formula-
ture or function, provided that such tion of the product, including a claim
statements are not disease claims that the product contains an ingre-
under paragraph (g) of this section. If dient (other than an ingredient that is
the label or labeling of a product mar- an article included in the definition of
keted as a dietary supplement bears a ‘‘dietary supplement’’ under 21 U.S.C.
disease claim as defined in paragraph 321(ff)(3)) that has been regulated by
(g) of this section, the product will be FDA as a drug and is well known to
subject to regulation as a drug unless consumers for its use or claimed use in
the claim is an authorized health claim preventing or treating a disease;
for which the product qualifies. (C) Citation of a publication or ref-
(g) Disease claims. (1) For purposes of erence, if the citation refers to a dis-
21 U.S.C. 343(r)(6), a ‘‘disease’’ is dam- ease use, and if, in the context of the
age to an organ, part, structure, or sys- labeling as a whole, the citation im-
tem of the body such that it does not plies treatment or prevention of a dis-
function properly (e.g., cardiovascular ease, e.g., through placement on the
disease), or a state of health leading to immediate product label or packaging,
such dysfunctioning (e.g., hyper- inappropriate prominence, or lack of

tension); except that diseases resulting relationship to the product’s express
from essential nutrient deficiencies claims;
185
§ 101.95 21 CFR Ch. I (4–1–23 Edition)
(D) Use of the term ‘‘disease’’ or contains pasteurized ingredients would

‘‘diseased,’’ except in general state- be subject to paragraph (a) of this sec-
ments about disease prevention that do tion because the term implies that the
not refer explicitly or implicitly to a food is not processed or preserved. Uses
specific disease or class of diseases or of fresh not subject to this regulation
to a specific product or ingredient; or will be governed by the provisions of
(E) Use of pictures, vignettes, sym- 403(a) of the Federal Food, Drug, and
bols, or other means; Cosmetic Act (the act).
(v) Belongs to a class of products
(a) The term ‘‘fresh,’’ when used on
that is intended to diagnose, mitigate,
the label or in labeling of a food in a
treat, cure, or prevent a disease;
(vi) Is a substitute for a product that manner that suggests or implies that
is a therapy for a disease; the food is unprocessed, means that the
(vii) Augments a particular therapy food is in its raw state and has not
or drug action that is intended to diag- been frozen or subjected to any form of
nose, mitigate, treat, cure, or prevent a thermal processing or any other form
disease or class of diseases; of preservation, except as provided in
(viii) Has a role in the body’s re- paragraph (c) of this section.
sponse to a disease or to a vector of (b) The terms ‘‘fresh frozen’’ and
disease; ‘‘frozen fresh,’’ when used on the label
(ix) Treats, prevents, or mitigates ad- or in labeling of a food, mean that the
verse events associated with a therapy food was quickly frozen while still
for a disease, if the adverse events con- fresh (i.e., the food had been recently
stitute diseases; or harvested when frozen). Blanching of
(x) Otherwise suggests an effect on a the food before freezing will not pre-
disease or diseases. clude use of the term ‘‘fresh frozen’’ to
[62 FR 49886, Sept. 23, 1997, as amended at 62 describe the food. ‘‘Quickly frozen’’
FR 49867, Sept. 23, 1997; 65 FR 1050, Jan. 6, means frozen by a freezing system such
2000; 66 FR 17358, Mar. 30, 2001; 66 FR 56035, as blast-freezing (sub-zero Fahrenheit
Nov. 6, 2001; 88 FR 17718, Mar. 24, 2023]
temperature with fast moving air di-
§ 101.95 ‘‘Fresh,’’ ‘‘freshly frozen,’’ rected at the food) that ensures the
‘‘fresh frozen,’’ ‘‘frozen fresh.’’ food is frozen, even to the center of the
The terms defined in this section food, quickly and that virtually no de-
may be used on the label or in labeling terioration has taken place.
of a food in conformity with the provi- (c) Provisions and restrictions. (1) The
sions of this section. The requirements following do not preclude the food from
of the section pertain to any use of the use of the term ‘‘fresh:’’
subject terms as described in para- (i) The addition of approved waxes or
graphs (a) and (b) of this section that coatings;
expressly or implicitly refers to the (ii) The post-harvest use of approved
food on labels or labeling, including pesticides;
use in a brand name and use as a sen- (iii) The application of a mild chlo-
sory modifier. However, the use of the rine wash or mild acid wash on
term ‘‘fresh’’ on labels or labeling is
produce; or
not subject to the requirements of
paragraph (a) of this section if the (iv) The treatment of raw foods with
term does not suggest or imply that a ionizing radiation not to exceed the
food is unprocessed or unpreserved. For maximum dose of 1 kiloGray in accord-
example, the term ‘‘fresh’’ used to de- ance with § 179.26 of this chapter.
scribe pasteurized whole milk is not (2) A food meeting the definition in
subject to paragraph (a) of this section paragraph (a) of this section that is re-
because the term does not imply that frigerated is not precluded from use of
the food is unprocessed (consumers ‘‘fresh’’ as provided by this section.
commonly understand that milk is
[58 FR 2426, Jan. 6, 1993]
nearly always pasteurized). However,

the term ‘‘fresh’’ to describe pasta
sauce that has been pasteurized or that
186
Subpart G—Exemptions From did have a functional or technical ef-

Food Labeling Requirements fect.
(ii) Processing aids, which are as fol-
§ 101.100 Food; exemptions from label- lows:
ing. (a) Substances that are added to a
(a) The following foods are exempt food during the processing of such food
from compliance with the require- but are removed in some manner from
ments of section 403(i)(2) of the act (re- the food before it is packaged in its fin-
quiring a declaration on the label of ished form.
the common or usual name of each in- (b) Substances that are added to a
gredient when the food is fabricated food during processing, are converted
from two or more ingredients). into constituents normally present in
(1) An assortment of different items the food, and do not significantly in-
of food, when variations in the items crease the amount of the constituents
that make up different packages naturally found in the food.
packed from such assortment normally (c) Substances that are added to a
occur in good packing practice and food for their technical or functional
when such variations result in vari- effect in the processing but are present
ations in the ingredients in different in the finished food at insignificant
packages, with respect to any ingre- levels and do not have any technical or
dient that is not common to all pack- functional effect in that food.
ages. Such exemption, however, shall (iii) Substances migrating to food
be on the condition that the label shall from equipment or packaging or other-
bear, in conjunction with the names of wise affecting food that are not food
such ingredients as are common to all additives as defined in section 201(s) of
packages, a statement (in terms that the act; or if they are food additives as
are as informative as practicable and so defined, they are used in conformity
that are not misleading) indicating by with regulations established pursuant
name other ingredients which may be to section 409 of the act.
present.
(2) A food having been received in (4) For the purposes of paragraph
bulk containers at a retail establish- (a)(3) of this section, any sulfiting
ment, if displayed to the purchaser agent (sulfur dioxide, sodium sulfite,
with either: sodium bisulfite, potassium bisulfite,
(i) The labeling of the bulk container sodium metabisulfite, and potassium
plainly in view, provided ingredient in- metabisulfite) that has been added to
formation appears prominently and any food or to any ingredient in any
conspicuously in lettering of not less food and that has no technical effect in
than one-fourth of an inch in height; or that food will be considered to be
(ii) A counter card, sign, or other ap- present in an insignificant amount
propriate device bearing prominently only if no detectable amount of the
and conspicuously, but in no case with agent is present in the finished food. A
lettering of less than one-fourth of an detectable amount of sulfiting agent is
inch in height, the information re- 10 parts per million (ppm or mg/kg) or
quired to be stated on the label pursu- more of the sulfite in the finished food.
ant to section 403(i)(2) of the Federal Compliance with this paragraph (a)(4)
Food, Drug, and Cosmetic Act (the will be determined using either:
act). (i) Determination of Sulfite in Food
(3) Incidental additives that are by Liquid Chromatography Tandem
present in a food at insignificant levels Mass Spectrometry; or
and do not have any technical or func- (ii) AOAC Official Method 990.28.
tional effect in that food. For the pur- (b) A food repackaged in a retail es-
poses of this paragraph (a)(3), inci- tablishment is exempt from the fol-
dental additives are: lowing provisions of the act if the con-
(i) Substances that have no technical ditions specified are met.
or functional effect but are present in a (1) Section 403(e)(1) of the act (requir-
food by reason of having been incor- ing a statement on the label of the
porated into the food as an ingredient name and place of business of the man-
of another food, in which the substance ufacturer, packer, or distributor).
187
§ 101.100 21 CFR Ch. I (4–1–23 Edition)
(2) Section 403(g)(2) of the act (requir- lishment, from compliance with the la-
ing the label of a food which purports beling requirements of section 403 (c),
to be or is represented as one for which (e), (g), (h), (i), (k), and (q) of the act if:
a definition and standard of identity (1) The person who introduced such
has been prescribed to bear the name of shipment or delivery into interstate
the food specified in the definition and commerce is the operator of the estab-
standard and, insofar as may be re- lishment where such food is to be proc-
quired by the regulation establishing essed, labeled, or repacked; or
the standard the common names of the (2) In case such person is not such op-
optional ingredients present in the erator, such shipment or delivery is
food), if the food is displayed to the made to such establishment under a
purchaser with its interstate labeling written agreement, signed by and con-
clearly in view, or with a counter card, taining the post office addresses of
sign, or other appropriate device bear- such person and such operator, and
ing prominently and conspicuously the containing such specifications for the
information required by these provi- processing, labeling, or repacking, as
sions. the case may be, of such food in such
(3) Section 403(i)(1) of the act (requir- establishment as will ensure, if such
ing the label to bear the common or specifications are followed, that such
usual name of the food), if the food is food will not be adulterated or mis-
displayed to the purchaser with its branded within the meaning of the act
interstate labeling clearly in view, or upon completion of such processing, la-
with a counter card, sign, or other ap- beling, or repacking. Such person and
propriate device bearing prominently such operator shall each keep a copy of
and conspicuously the common or such agreement until 2 years after the
usual name of the food, or if the com- final shipment or delivery of such food
mon or usual name of the food is clear- from such establishment, and shall
ly revealed by its appearance. make such copies available for inspec-
(c) An open container (a container of tion at any reasonable hour to any offi-
rigid or semirigid construction, which cer or employee of the Department who
is not closed by lid, wrapper, or other- requests them.
wise other than by an uncolored trans- (3) The article is an egg product sub-
parent wrapper which does not obscure ject to a standard of identity promul-
the contents) of a fresh fruit or fresh gated in part 160 of this chapter, is to
vegetable, the quantity of contents of be shipped under the conditions speci-
which is not more than 1 dry quart, fied in paragraph (d) (1) or (2) of this
shall be exempt from the labeling re- section and for the purpose of pasteur-
quirements of sections 403(e), (g)(2) ization or other treatment as required
(with respect to the name of the food in such standard, and each container of
specified in the definition and stand- such egg product bears a conspicuous
ard), and (i)(1) of the act; but such ex- tag or label reading ‘‘Caution—This
emption shall be on the condition that egg product has not been pasteurized or
if two or more such containers are en- otherwise treated to destroy viable
closed in a crate or other shipping Salmonella microorganisms’’. In addi-
package, such crate or package shall tion to safe and suitable bactericidal
bear labeling showing the number of processes designed specifically for Sal-
such containers enclosed therein and monella destruction in egg products,
the quantity of the contents of each. the term ‘‘other treatment’’ in the first
(d) Except as provided by paragraphs sentence of this paragraph shall in-
(e) and (f) of this section, a shipment or clude use in acidic dressings in the
other delivery of a food which is, in ac- processing of which the pH is not above
cordance with the practice of the trade, 4.1 and the acidity of the aqueous
to be processed, labeled, or repacked in phase, expressed as acetic acid, is not
substantial quantity at an establish- less than 1.4 percent, subject also to
ment other than that where originally the conditions that:
processed or packed, shall be exempt, (i) The agreement required in para-
during the time of introduction into graph (d)(2) of this section shall also
and movement in interstate commerce state that the operator agrees to uti-
and the time of holding in such estab- lize such unpasteurized egg products in
188
the processing of acidic dressings ac- ing of cheese in a suitable warehouse at

cording to the specifications for pH and a temperature of not less than 35 °F for
acidity set forth in this paragraph, the purpose of aging or curing to bring
agrees not to deliver the acidic dress- the cheese into compliance with re-
ing to a user until at least 72 hours quirements of an applicable definition
after such egg product is incorporated and standard of identity. The exemp-
in such acidic dressing, and agrees to tions provided for in paragraph (d) of
maintain for inspection adequate this section shall apply to cheese which
records covering such processing for 2 is, in accordance with the practice of
years after such processing. the trade, shipped to a warehouse for
(ii) In addition to the caution state- aging or curing, on condition that the
ment referred to above, the container cheese is identified in the manner set
of such egg product shall also bear the forth in one of the applicable following
statement ‘‘Unpasteurized ______ for paragraphs, and in such case the provi-
use in acidic dressings only’’, the blank sions of paragraph (e) of this section
being filled in with the applicable shall also apply:
name of the eggs or egg product. (1) In the case of varieties of cheese
(e) Conditions affecting expiration of for which definitions and standards of
exemptions: identity require a period of aging
(1) An exemption of a shipment or whether or not they are made from
other delivery of a food under para- pasteurized milk, each such cheese
graph (d) (1) or (3) of this section shall, shall bear on the cheese a legible mark
at the beginning of the act of removing showing the date at which the prelimi-
such shipment or delivery, or any part nary manufacturing process has been
thereof, from such establishment be- completed and at which date curing
come void ab initio if the food com- commences, and to each cheese, on its
prising such shipment, delivery, or part wrapper or immediate container, shall
is adulterated or misbranded within be affixed a removable tag bearing the
the meaning of the act when so re- statement ‘‘Uncured ______ cheese for
moved. completion of curing and proper label-
(2) An exemption of a shipment or ing’’, the blank being filled in with the
other delivery of a food under para- applicable name of the variety of
graph (d) (2) or (3) of this section shall cheese. In the case of swiss cheese, the
become void ab initio with respect to date at which the preliminary manu-
the person who introduced such ship- facturing process had been completed
ment or delivery into interstate com- and at which date curing commences is
merce upon refusal by such person to the date on which the shaped curd is
make available for inspection a copy of removed from immersion in saturated
the agreement, as required by para- salt solution as provided in the defini-
graph (d) (2) or (3) of this section. tion and standard of identity for swiss
(3) An exemption of a shipment or cheese, and such cheese shall bear a re-
other delivery of a food under para- movable tag reading, ‘‘To be cured and
graph (d) (2) or (3) of this section shall labeled as ‘swiss cheese,’ but if eyes do
expire: not form, to be labeled as ‘swiss cheese
(i) At the beginning of the act of re- for manufacturing’ ’’.
moving such shipment or delivery, or (2) In the case of varieties of cheeses
any part thereof, from such establish- which when made from unpasteurized
ment if the food constituting such milk are required to be aged for not
shipment, delivery, or part is adulter- less than 60 days, each such cheese
ated or misbranded within the meaning shall bear a legible mark on the cheese
of the act when so removed; or showing the date at which the prelimi-
(ii) Upon refusal by the operator of nary manufacturing process has been
the establishment where such food is to completed and at which date curing
be processed, labeled, or repacked, to commences, and to each such cheese or
make available for inspection a copy of its wrapper or immediate container
the agreement, as required by such shall be affixed a removable tag read-
paragraph. ing, ‘‘______ cheese made from

(f) The word ‘‘processed’’ as used in unpasteurized milk. For completion of
this paragraph shall include the hold- curing and proper labeling’’, the blank
189
§ 101.100 21 CFR Ch. I (4–1–23 Edition)
being filled in with the applicable statement setting forth the weight of
name of the variety of cheese. the wrapper;
(3) In the case of cheddar cheese, (2) Provided further, That it is the
washed curd cheese, colby cheese, practice of the retail establishment to
granular cheese, and brick cheese made weigh and mark the individual pack-
from unpasteurized milk, each such ages with a correct net-weight state-
cheese shall bear a legible mark on the ment prior to or at the point of retail
cheese showing the date at which the sale. A statement of the weight of the
preliminary manufacturing process has wrapper shall be set forth so as to be
been completed and at which date cur- readily read and understood, using
ing commences, and to each such such term as ‘‘wrapper tare—ounce’’,
cheese or its wrapper or immediate the blank being filled in with the cor-
container shall be affixed a removable rect average weight of the wrapper
tag reading ‘‘______ cheese made from used.
unpasteurized milk. For completion of (3) The act of delivering the wrapped
curing and proper labeling, or for label- fish fillets during the retail sale with-
ing as ______ cheese for manufac- out the correct net-weight statement
turing’’, the blank being filled in with shall be deemed an act which results in
the applicable name of the variety of the product’s being misbranded while
cheese. held for sale. Nothing in this paragraph
(g) The label declaration of a harm- shall be construed as requiring net-
less marker used to identify a par- weight statements for wrapped fish fil-
ticular manufacturer’s product may re- lets delivered into institutional trade
sult in unfair competition through re- provided the outside container bears
vealing a trade secret. Exemption from the required information.
the label declaration of such a marker (i) Wrapped clusters (consumer units)
is granted, therefore, provided that the of bananas of nonuniform weight in-
tended to be unpacked from a master
following conditions are met:
carton or container and weighed at or
(1) The person desiring to use the
before the point of retail sale in an es-
marker without label declaration of its
tablishment other than that where
presence has submitted to the Commis- originally packed shall be exempt from
sioner of Food and Drugs full informa- the requirements of section 403(e)(2) of
tion concerning the proposed usage and the act during introduction and move-
the reasons why he believes label dec- ment in interstate commerce and while
laration of the marker should be sub- held for sale prior to weighing:
ject to this exemption; and (1) Provided, That (i) The master car-
(2) The person requesting the exemp- ton or container bears a label declara-
tion has received from the Commis- tion of the total net weight; and
sioner of Food and Drugs a finding that (ii) The individual packages bear a
the marker is harmless and that the conspicuous statement ‘‘To be weighed
exemption has been granted. at or before the time of sale’’ and a cor-
(h) Wrapped fish fillets of nonuniform rect statement setting forth the weight
weight intended to be unpacked and of the wrapper; using such term as
marked with the correct weight at or ‘‘wrapper tare __ ounce’’, the blank
before the point of retail sale in an es- being filled in with the correct average
tablishment other than that where weight of the wrapper used;
originally packed shall be exempt from (2) Provided further, That it is the
the requirement of section 403(e)(2) of practice of the retail establishment to
the act during introduction and move- weigh the individual packages either
ment in interstate commerce and while prior to or at the time of retail sale.
held for sale prior to weighing and (3) The act of delivering the wrapped
marking: clusters (consumer units) during the
(1) Provided, That (i) The outside con- retail sale without an accurate net
tainer bears a label declaration of the weight statement or alternatively
total net weight; and without weighing at the time of sale
(ii) The individual packages bear a shall be deemed an act which results in
conspicuous statement ‘‘To be weighed the product’s being misbranded while
at or before time of sale’’ and a correct held for sale. Nothing in this paragraph
190
shall be construed as requiring net- (b) Any firm that intends to under-
weight statements for clusters (con- take a labeling experiment that re-
sumer units) delivered into institu- quires exemptions from certain re-
tional trade, provided that the master quirements of §§ 101.9 and 105.66 of this
container or carton bears the required chapter should submit a written pro-
information. posal containing a thorough discussion
(j) The standards required in this sec- of each of the following information
tion are incorporated by reference into items that apply to the particular ex-
this section with the approval of the periment:
Director of the Federal Register under (1) A description of the labeling for-
5 U.S.C. 552(a) and 1 CFR part 51. All mat to be tested;
approved material is available for in- (2) A statement of the criteria to be
spection at the Food and Drug Admin- used in the experiment for assigning
istration’s, Dockets Management Staff, foods to categories, e.g., nutrient or
5630 Fishers Lane, Rm. 1061, Rockville, other values defining ‘‘low’’ and ‘‘re-
MD 20852, 240–402–7500, and available duced’’;
from the other sources listed in this (3) A draft of the material to be used
paragraph (j). It is also available for in- in the store, e.g., shelf tags, booklets,
spection at the National Archives and posters, etc.;
Records Administration (NARA). For (4) The dates on which the experi-
information on the availability of this ment will begin and end and on which
material at NARA, email a written report of analysis of the ex-
fedreg.legal@nara.gov or go to perimental data will be submitted to
www.archives.gov/federal-register/cfr/ibr- FDA, together with a commitment not
locations.html. to continue the experiment beyond the
(1) AOAC International, 2275 Re- proposed ending date without FDA ap-
proval;
search Blvd., Ste. 300, Rockville, MD
(5) The geographic area or areas in
20850–3250.
which the experiment is to be con-
(i) AOAC Official Method 990.28, Sul-
ducted;
fites in Foods, Optimized Monier-Wil- (6) The mechanism to measure the ef-
liams Method, Section 47.3.43, Official fectiveness of the experiment;
Methods of Analysis, 21st edition, 2019. (7) The method for conveying to con-
(ii) Determination of Sulfite in Food sumers the required nutrition and
by Liquid Chromatography Tandem other labeling information that is ex-
Mass Spectrometry: Collaborative empted from the label during the ex-
Study, Katherine S. Carlos and Lowri periment;
S. De Jager; Journal of AOAC Inter- (8) The method that will be or has
national, Vol. 100, No. 6, 2017, pp. 1785– been used to determine the actual nu-
1794. tritional characteristics of foods for
(2) [Reserved] which a claim is made; and
[42 FR 14308, Mar. 15, 1977, as amended at 51 (9) A statement of the sections of the
FR 25017, July 9, 1986; 58 FR 2188, 2876, Jan. 6, regulations for which an exemption is
1993; 66 FR 17358, Mar. 30, 2001; 87 FR 2546, sought.
Jan. 18, 2022] (c) The written proposal should be
sent to the Dockets Management Staff
§ 101.108 Temporary exemptions for (HFA–305), Food and Drug Administra-
purposes of conducting authorized tion, 5630 Fishers Lane, Rm. 1061, Rock-
food labeling experiments. ville, MD 20852, 240–402–7500, between 9
(a) The food industry is encouraged a.m. and 4 p.m., Monday through Fri-
to experiment voluntarily, under con- day. The proposal should be clearly
trolled conditions and in collaboration identified as a request for a temporary
with the Food and Drug Administra- exemption for purposes of conducting
tion, with and other formats for pre- authorized food labeling experiments
senting nutrition and other related and submitted as a citizen petition
food labeling information that is con- under § 10.30 of this chapter.
sistent with the current quantitative (d) Approval for food labeling experi-
system in §§ 101.9 and 105.66 of this ments will be given by FDA in writing.
chapter. Foods labeled in violation of existing
191
§ 101.108 21 CFR Ch. I (4–1–23 Edition)
regulations will be subject to regu- this Office of Management and Budget

latory action unless an FDA-approved and assigned number 0910–0151.
exemption to the specific regulation [48 FR 15240, Apr. 8, 1983, as amended at 59
has been granted for that specific prod- FR 14364, Mar. 28, 1994; 62 FR 15343, Mar. 31,
uct. 1997; 88 FR 17718, Mar. 24, 2023]
(e) Reporting requirements contained
in § 101.108(b) have been approved by
APPENDIX A TO PART 101 [RESERVED]

192
Food and Drug Administration, HHS Pt. 101, App. B
APPENDIX B TO PART 101—GRAPHIC ENHANCEMENTS USED BY THE FDA

193
ER21DE18.017</GPH>
Pt. 101, App. B 21 CFR Ch. I (4–1–23 Edition)
[83 FR 65504, Dec. 21, 2018]

194
ER21DE18.018</GPH>
Food and Drug Administration, HHS Pt. 101, App. C
APPENDIX C TO PART 101—NUTRITION FACTS FOR RAW FRUITS AND VEGETABLES

195
ER17AU06.007</GPH>
Pt. 101, App. D 21 CFR Ch. I (4–1–23 Edition)
[71 FR 47439, AUG. 17, 2006]

196
ER17AU06.008
Food and Drug Administration, HHS Pt. 101, App. D
APPENDIX D TO PART 101—NUTRITION FACTS FOR COOKED FISH

[71 FR 47439, AUG. 17, 2006]
197
ER17AU06.009
PART 102—COMMON OR USUAL (b) The common or usual name of a

NAME FOR NONSTANDARDIZED food shall include the percentage(s) of
FOODS any characterizing ingredient(s) or
component(s) when the proportion of
Subpart A—General Provisions such ingredient(s) or component(s) in
the food has a material bearing on
Sec. price or consumer acceptance or when
102.5 General principles. the labeling or the appearance of the
102.19 Petitions. food may otherwise create an erro-
Subpart B—Requirements for Specific neous impression that such ingre-
Nonstandardized Foods dient(s) or component(s) is present in
an amount greater than is actually the
102.22 Protein hydrolysates. case. The following requirements shall
102.23 Peanut spreads. apply unless modified by a specific reg-
102.26 Frozen ‘‘heat and serve’’ dinners. ulation in subpart B of this part.
102.28 Foods packaged for use in the prepa-
ration of ‘‘main dishes’’ or ‘‘dinners.’’ (1) The percentage of a characterizing
102.33 Beverages that contain fruit or vege- ingredient or component shall be de-
table juice. clared on the basis of its quantity in
102.37 Mixtures of edible fat or oil and olive the finished product (i.e., weight/
oil. weight in the case of solids, or volume/
102.39 Onion rings made from diced onion. volume in the case of liquids).
102.41 Potato chips made from dried pota- (2) The percentage of a characterizing
toes.
102.45 Fish sticks or portions made from
ingredient or component shall be de-
minced fish. clared by the words ‘‘containing (or
102.46 Pacific whiting. contains) __ percent (or %) ______’’ or
102.47 Bonito. ‘‘__ percent (or %) ______’’ with the first
102.49 Fried clams made from minced clams. blank filled in with the percentage ex-
102.50 Crabmeat. pressed as a whole number not greater
102.54 Seafood cocktails. than the actual percentage of the in-
102.55 Nonstandardized breaded composite
gredient or component named and the
shrimp units.
102.57 Greenland turbot (Reinhardtius second blank filled in with the common
hippoglossoides). or usual name of the ingredient or
component. The word ‘‘containing’’ (or
AUTHORITY: 21 U.S.C. 321, 343, 371.
‘‘contains’’), when used, shall appear
SOURCE: 42 FR 14322, Mar. 15, 1977, unless on a line immediately below the part of
otherwise noted. the common or usual name of the food
EDITORIAL NOTE: Nomenclature changes to required by paragraph (a) of this sec-
part 102 appear at 81 FR 49895, July 29, 2016. tion. For each characterizing ingre-
dient or component, the words ‘‘__ per-
Subpart A—General Provisions cent or %) ______’’ shall appear fol-
lowing or directly below the word
§ 102.5 General principles. ‘‘containing’’ (or contains), or directly
(a) The common or usual name of a below the part of the common or usual
food, which may be a coined term, shall name of the food required by paragraph
accurately identify or describe, in as (a) of this section when the word ‘‘con-
simple and direct terms as possible, the taining’’ (or contains) is not used, in
basic nature of the food or its charac- easily legible boldface print or type in
terizing properties or ingredients. The distinct contrast to other printed or
name shall be uniform among all iden- graphic matter, and in a height not
tical or similar products and may not less than the larger of the following al-
be confusingly similar to the name of ternatives:
any other food that is not reasonably (i) Not less than one-sixteenth inch
encompassed within the same name. in height on packages having a prin-
Each class or subclass of food shall be cipal display panel with an area of 5
given its own common or usual name square inches or less and not less than
that states, in clear terms, what it is in one-eighth inch in height if the area of
a way that distinguishes it from dif- the principal display panel is greater
ferent foods. than 5 square inches; or
198
(ii) Not less than one-half the height § 102.19 Petitions.

of the largest type appearing in the
(a) The Commissioner of Food and
part of the common or usual name of
Drugs, either on his own initiative or
the food required by paragraph (a) of on behalf of any interested person who
this section. has submitted a petition, may publish
(c) The common or usual name of a a proposal to issue, amend, or revoke,
food shall include a statement of the under this part, a regulation pre-
presence or absence of any character- scribing a common or usual name for a
izing ingredient(s) or component(s) food, pursuant to part 10 of this chap-
and/or the need for the user to add any ter.
characterizing ingredient(s) or compo- (b) If the principal display panel of a
nent(s) when the presence or absence of food for which a common or usual
such ingredient(s) or component(s) in name regulation is established is too
the food has a material bearing on small to accommodate all mandatory
price or consumer acceptance or when requirements, the Commissioner may
the labeling or the appearance of the establish by regulation an acceptable
food may otherwise create an erro- alternative, e.g., a smaller type size. A
neous impression that such ingre- petition requesting such a regulation,
dient(s) or component(s) is present which would amend the applicable reg-
when it is not, and consumers may oth- ulation, shall be submitted pursuant to
erwise be misled about the presence or part 10 of this chapter.
absence of the ingredient(s) or compo-
nent(s) in the food. The following re- [42 FR 14322, Mar. 15, 1977, as amended at 42
FR 15673, Mar. 22, 1977]
quirements shall apply unless modified
by a specific regulation in subpart B of
this part. Subpart B—Requirements for
(1) The presence or absence of a char- Specific Nonstandardized Foods
acterizing ingredient or component
§ 102.22 Protein hydrolysates.
shall be declared by the words ‘‘con-
taining (or contains) ______’’ or ‘‘con- The common or usual name of a pro-
taining (or contains) no ______’’ or ‘‘no tein hydrolysate shall be specific to the
______’’ or ‘‘does not contain ______’’, ingredient and shall include the iden-
with the blank being filled in with the tity of the food source from which the
common or usual name of the ingre- protein was derived.
dient or component. (a) ‘‘Hydrolyzed wheat gluten,’’
(2) The need for the user of a food to ‘‘hydrolyzed soy protein,’’ and
add any characterizing ingredient(s) or ‘‘autolyzed yeast extract’’ are exam-
component(s) shall be declared by an ples of acceptable names. ‘‘Hydrolyzed
appropriate informative statement. casein’’ is also an example of an ac-
(3) The statement(s) required under ceptable name, whereas ‘‘hydrolyzed
paragraph (c)(1) and/or (2) of this sec- milk protein’’ is not an acceptable
tion shall appear following or directly name for this ingredient because it is
below the part of the common or usual not specific to the ingredient (hydroly-
name of the food required by para- sates can be prepared from other milk
graphs (a) and (b) of this section, in proteins). The names ‘‘hydrolyzed vege-
easily legible boldface print or type in table protein’’ and ‘‘hydrolyzed pro-
tein’’ are not acceptable because they
distinct contrast to other printed or
do not identify the food source of the
graphic matter, and in a height not
protein.
less than the larger of the alternatives
(b) [Reserved]
established under paragraphs (b)(2) (i)
and (ii) of this section. [58 FR 2876, Jan. 6, 1993]
(d) A common or usual name of a
food may be established by common § 102.23 Peanut spreads.
usage or by establishment of a regula- (a) The common or usual name of a
tion in subpart B of this part, in part spreadable peanut product that does
104 of this chapter, in a standard of not conform to § 164.150 of this chapter,

identity, or in other regulations in this and more than 10 percent of which con-
chapter. sists of nonpeanut ingredients, shall
199
§ 102.23 21 CFR Ch. I (4–1–23 Edition)
consist of the term ‘‘peanut spread’’ suite 500, Gaithersburg, MD 20877, or

and a statement of the percentage by may be examined at the National Ar-
weight of peanuts in the product in the chives and Records Administration
manner set forth in § 102.5(b), except (NARA). For information on the avail-
that peanut percentages shall be based ability of this material at NARA, call
on the amount of peanuts used to make 202–741–6030, or go to: http://
the finished food and shall be declared www.archives.gov/federal_register/
in 5-percent increments expressed as a code_of_federal_regulations/
multiple of 5, not to exceed the actual ibr_locations.html.
percentage of peanuts in the products. (2) Biological quality of protein:
(b) A spreadable peanut product that AOAC, 13th Ed. (1980), using the meth-
is nutritionally inferior to peanut but- od described in sections 43.212–43.216,
ter shall be labeled as an imitation of which is incorporated by reference. The
peanut butter under § 101.3(e)(2) of this availability of this incorporation by
chapter; a spreadable peanut product reference is given in paragraph (c)(1) of
shall be considered nutritionally equiv- this section.
alent to peanut butter if it meets all of (3) Niacin: AOAC, 13th Ed. (1980),
the following conditions: using the method described in sections
(1) Protein. (i) The protein content of 43.044–43.046, which is incorporated by
the product is at least 24 percent by reference. The availability of this in-
weight of the finished product, and the corporation by reference is given in
overall biological quality of the pro- paragraph (c)(1) of this section.
tein contained in the product is at (4) Vitamin B6: AOAC, 13th Ed. (1980),
least 68 percent that of casein; or using the method described in sections
(ii) The protein content of the prod- 43.188–43.193, which is incorporated by
uct is at least 16.6 percent by weight of reference. The availability of this in-
the finished product, and the overall corporation by reference is given in
biological quality of the protein con- paragraph (c)(1) of this section.
tained in the product is equal to or (5) Folic acid: Using the method de-
greater than that of casein. scribed in U.S. Department of Agri-
(2) Other nutrients. The product con- culture Handbook No. 29, modified by
tains the following levels of nutrients use of ascorbate buffer as described by
per 100 grams of product: Ford and Scott, Journal of Dairy Re-
search, 35:85–90 (1968), which is incor-
Amount
Nutrient (milli- porated by reference. Copies are avail-
grams) able from the Center for Food Safety
Niacin ................................................................... 15.3
and Applied Nutrition (HFS–800), Food
Vitamin B6 ............................................................ 0.33 and Drug Administration, 5001 Campus
Folic acid ............................................................. 0.08 Dr., College Park, MD 20740, or avail-
Iron ....................................................................... 2.0 able for inspection at the National Ar-
Zinc ...................................................................... 2.9
Magnesium .......................................................... 173.0 chives and Records Administration
Copper ................................................................. 0.6 (NARA). For information on the avail-
ability of this material at NARA, call
(c) Compliance with the require- 202–741–6030, or go to: http://
ments of paragraph (b) of this section www.archives.gov/federal_register/
shall be determined by methods de- code_of_federal_regulations/
scribed in the following references ex- ibr_locations.html.
cept that in determining protein quan- (6) Iron: AOAC, 13th Ed. (1980), using
tity in products with mixed protein the method described in sections 43.217–
sources a nitrogen conversion factor of 43.219, which is incorporated by ref-
6.25 may be used. erence. The availability of this incor-
(1) Protein quantity: ‘‘Official Meth- poration by reference is given in para-
ods of Analysis of the Association of graph (c)(1) of this section.
Official Analytical Chemists’’ (AOAC), (7) Zinc: AOAC, 13th Ed. (1980), using
13th Ed. (1980), using the method de- the method described in sections 25.150–
scribed in section 27.007, which is incor- 25.153, which is incorporated by ref-
porated by reference. Copies may be erence. The availability of this incor-

obtained from the AOAC INTER- poration by reference is given in para-
NATIONAL, 481 North Frederick Ave., graph (c)(1) of this section.
200
(8) Copper: AOAC, 13th Ed. (1980), (e.g., onion soup, enriched white bread,
using the method described in sections and artificially flavored vanilla pud-
25.038–25.043, which is incorporated by ding) in their order of descending pre-
reference. The availability of this in- dominance by weight. This part of the
corporation by reference is given in name shall be placed immediately fol-
paragraph (c)(1) of this section. lowing or directly below the part speci-
(9) Magnesium: AOAC, 13th Ed. (1980), fied in paragraph (b)(1) of this section
using the method described in sections in the manner set forth in § 102.5(c)(3).
2.109–2.113, which is incorporated by The words ‘‘contains’’ or ‘‘containing’’
reference. The availability of this in- are optional.
corporation by reference is given in (3) If the labeling implies that the
paragraph (c)(1) of this section. package contains other foods and these
[42 FR 36455, July 15, 1977, as amended at 47
foods are not present in the package,
FR 11821, Mar. 19, 1982; 49 FR 5609, Feb. 14, e.g., if a vignette on the package de-
1984; 54 FR 24891, June 12, 1989; 61 FR 14479, picts a ‘‘serving suggestion’’ which in-
Apr. 2, 1996; 63 FR 14035, Mar. 24, 1998; 66 FR cludes any foods not present in the
17358, Mar. 30, 2001; 66 FR 56035, Nov. 6, 2001] package, the principal display panel
shall bear a statement that such foods
§ 102.26 Frozen ‘‘heat and serve’’ din- are not present, in type size not less
ners. than that specified in § 102.5(b)(2)(i).
(a) A frozen ‘‘heat and serve’’ dinner:
(1) Shall contain at least three com- § 102.28 Foods packaged for use in the
ponents, one of which shall be a signifi- preparation of ‘‘main dishes’’ or
cant source of protein and each of ‘‘dinners.’’
which shall consist of one or more of (a) The common or usual name of a
the following: meat, poultry, fish, packaged food which is represented on
cheese, eggs, vegetables, fruit, pota- the principal display panel by word or
toes, rice, or other cereal based prod- vignette to be used in the preparation
ucts (other than bread or rolls). of a ‘‘main dish’’, ‘‘dinner’’, or other
(2) May also contain other servings of such food serving, and to which some
food (e.g., soup, bread or rolls, bev- other important characterizing ingre-
erage, dessert). dient(s) or component(s) not present in
(b) The common or usual name of the the package must be added, consists of
food consists of all of the following: all the following:
(1) The phrase ‘‘frozen ‘heat and (1) The common or usual name of
serve’ dinner,’’ except that the name of each important ingredient or compo-
the predominant characterizing ingre- nent in the package, in descending
dient or other appropriately descrip- order of predominance by weight (e.g.,
tive term may immediately precede ‘‘noodles and tomato sauce’’).
the word ‘‘dinner’’ (e.g., ‘‘frozen chick- (2) An appropriate informative state-
en dinner’’ or ‘‘frozen heat and serve ment identifying the food to be pre-
beef dinner’’). The words ‘‘heat and pared by use of the package contents
serve’’ are optional. The word ‘‘frozen’’ (e.g., ‘‘for preparation of chicken cas-
is also optional, provided that the serole’’).
words ‘‘Keep Frozen’’ or the equivalent (3) An appropriate informative state-
are prominently and conspicuously ment that additional characterizing in-
placed on the principal display panel in gredient(s) or component(s) must be
type size not less than that specified in added and which names the additional
§ 102.5(b)(2)(i). characterizing ingredient(s) or compo-
(2) The phrase ‘‘containing (or con- nent(s) (e.g., ‘‘you must add ______ to
tains) ______’’ the blank to be filled in complete the recipe,’’ the blank to be
with an accurate description of each of filled in with the name(s) of the impor-
the three or more dish components list- tant characterizing ingredient(s) or
ed in paragraph (a)(1) of this section in component(s) that must be added).
their order of descending predominance (b) The labeling required by para-
by weight (e.g., ham, mashed potatoes, graph (a) of this section shall appear on
and peas), followed by any of the other the principal display panel.
servings specified in paragraph (a)(2) of (1) No word in the statement required
this section contained in the package by paragraph (a)(2) of this section may
201
§ 102.33 21 CFR Ch. I (4–1–23 Edition)
appear on the principal display panel height of the largest type appearing in
more conspicuously or in larger type such brand name or other designation.
than the smallest and least con-
spicuous type employed on the panel § 102.33 Beverages that contain fruit
for any word, phrase or statement or vegetable juice.
within the scope of paragraph (a)(1) of (a) For a carbonated or noncarbon-
this section. ated beverage that contains less than
(2) Every word in the statement re- 100 percent and more than 0 percent
quired by paragraph (a)(3) of this sec- fruit or vegetable juice, the common or
tion shall appear on the principal dis- usual name shall be a descriptive name
play panel in easily legible bold face that meets the requirements of
print or type in distinct contrast to § 102.5(a) and, if the common or usual
other printed or graphic matter, and in name uses the word ‘‘juice,’’ shall in-
a height not less than the larger of the clude a qualifying term such as ‘‘bev-
following alternatives: erage,’’ ‘‘cocktail,’’ or ‘‘drink’’ appro-
(i) Not less than one-sixteenth inch priate to advise the consumer that the
in height on packages having a prin- product is less than 100 percent juice
cipal display panel with an area of 5 (e.g., ‘‘diluted grape juice beverage’’ or
square inches or less and not less than ‘‘grape juice drink’’).
one-eighth inch in height if the area of (b) If the product is a diluted mul-
the principal display panel is greater tiple-juice beverage or blend of single-
than 5 square inches; or strength juices and names, other than
(ii) Not less than one-half the height in the ingredient statement, more than
of the largest type appearing in the one juice, then the names of those
part of the common or usual name of juices, except in the ingredient state-
the food required by paragraphs (a) (1) ment, must be in descending order of
and (2) of this section. predominance by volume unless the
(c) Any vignette which shows any name specifically shows that the juice
food or characterizing ingredient(s) or with the represented flavor is used as a
component(s) not included in the pack- flavor (e.g., raspberry-flavored apple
age shall be accompanied either by the and pear juice drink). In accordance
statement required by paragraph (a)(3) with § 101.22(i)(1)(iii) of this chapter,
of this section or by a separate state- the presence of added natural flavors is
ment specifying the food or character- not required to be declared in the name
izing ingredient(s) or component(s) of the beverage unless the declared
shown in the vignette but not included juices alone do not characterize the
in the package. product before the addition of the
(d) If the statement specified in para- added flavors.
graph (a)(2) of this section is used on (c) If a diluted multiple-juice bev-
any panel in addition to the principal erage or blend of single-strength juices
display panel as a product identifica- contains a juice that is named or im-
tion statement, the complete common plied on the label or labeling other
or usual name shall appear on such than in the ingredient statement (rep-
panel in the manner specified in para- resented juice), and also contains a
graph (b) of this section. juice other than the named or implied
(e) When a brand name or other juice (nonrepresented juice), then the
prominent product designation con- common or usual name for the product
tains a word or words that includes or shall indicate that the represented
suggests an important characterizing juice is not the only juice present (e.g.,
ingredient(s) or component(s) that ‘‘Apple blend; apple juice in a blend of
must be added, or otherwise states or two other fruit juices.’’)
implies that the package contains a (d) In a diluted multiple-juice bev-
complete main dish, dinner, or other erage or blend of single-strength juices
food serving, the part of the common where one or more, but not all, of the
or usual name of the food required by juices are named on the label other
paragraph (a)(3) of this section shall than in the ingredient statement, and
appear in direct conjunction with such where the named juice is not the pre-
brand name or other designation and in dominant juice, the common or usual
type size not less than one-half the name for the product shall:
202
(1) Indicate that the named juice is beled with the term ‘‘from con-
present as a flavor or flavoring (e.g., centrate’’ or ‘‘reconstituted.’’
‘‘Raspcranberry’’; raspberry and cran- [58 FR 2926, Jan. 6, 1993; 58 FR 17103, Apr. 1,
berry flavored juice drink); or 1993, as amended at 58 FR 44063, Aug. 18, 1993;
(2) Include the amount of the named 62 FR 15343, Mar. 31, 1997]
juice, declared in a 5- percent range
(e.g., Raspcranberry; raspberry and § 102.37 Mixtures of edible fat or oil
cranberry juice beverage, 10- to 15-per- and olive oil.
cent cranberry juice and 3- to 8-percent The common or usual name of a mix-
raspberry juice). The 5-percent range, ture of edible fats and oils containing
when used, shall be declared in the less than 100 percent and more than 0
manner set forth in § 102.5(b)(2). percent olive oil shall be as follows:
(e) The common or usual name of a (a) A descriptive name for the prod-
juice that has been modified shall in- uct meeting the requirements of
clude a description of the exact nature § 102.5(a), e.g., ‘‘cottonseed oil and olive
of the modification (e.g., ‘‘acid-reduced oil’’ or another descriptive phrase, and
cranberry juice,’’ ‘‘deflavored, de- (b) When the label bears any rep-
colored grape juice’’). resentation, other than in the ingre-
(f) If the product is a beverage that dient listing, of the presence of olive
contains a juice whose color, taste, or oil in the mixture, the descriptive
other organoleptic properties have name shall be followed by a statement
been modified to the extent that the of the percentage of olive oil contained
original juice is no longer recognizable in the product in the manner set forth
at the time processing is complete, or in § 102.5(b)(2).
if its nutrient profile has been dimin- § 102.39 Onion rings made from diced
ished to a level below the normal nutri- onion.
ent range for the juice, then the source
(a) The common or usual name of the
fruits or vegetables from which the
food product that resembles and is of
modified juice was derived may not be
the same composition as onion rings,
depicted on the label by vignette or
except that it is composed of
other pictorial representation.
comminuted onions, shall be as follows:
(g)(1) If one or more juices in a juice (1) When the product is composed of
beverage is made from concentrate, the dehydrated onions, the name shall be
name of the juice must include a term ‘‘onion rings made from dried diced on-
indicating that fact, such as ‘‘from ions.’’
concentrate,’’ or ‘‘reconstituted.’’ Such (2) When the product is composed of
terms must be included in the name of any form of onion other than dehy-
each individual juice or it may be stat- drated, the name shall be ‘‘onion rings
ed once adjacent to the product name made from diced onions.’’
so that it applies to all the juices, (e.g., (b) The words ‘‘made from dried diced
‘‘cherry juice (from concentrate) in a onions’’ or ‘‘made from diced onions’’
blend of two other juices’’ or ‘‘cherry shall immediately follow or appear on
juice in a blend of 2 other juices (from a line(s) immediately below the words
concentrate)’’). The term shall be in a ‘‘onion rings’’ in easily legible boldface
type size no less than one-half the print or type in distinct contrast to
height of the letters in the name of the other printed or graphic matter, and in
juice. a height not less than the larger of the
(2) If the juice is 100 percent single following alternatives:
species juice consisting of juice di- (1) Not less than one-sixteenth inch
rectly expressed from a fruit or vege- in height on packages having a prin-
table whose Brix level has been raised cipal display panel with an area of 5
by the addition of juice concentrate square inches or less and not less than
from the same fruit or vegetable, the one-eighth inch in height if the area of
name of the juice need not include a the principal display panel is greater
statement that the juice is from con- than 5 square inches; or
centrate. However, if water is added to (2) Not less than one-half the height
this 100 percent juice mixture to adjust of the largest type used in the words
the Brix level, the product shall be la- ‘‘onion rings.’’
203
§ 102.41 21 CFR Ch. I (4–1–23 Edition)
§ 102.41 Potato chips made from dried § 102.46 Pacific whiting.

potatoes.
‘‘Pacific whiting’’ or ‘‘North Pacific
(a) The common or usual name of the whiting’’ is the common or usual name
food product that resembles and is of of the food fish Merluccius productus.
the same composition as potato chips,
[44 FR 45617, Aug. 3, 1979]
except that it is composed of dehy-
drated potatoes (buds, flakes, granules, § 102.47 Bonito.
or other form), shall be ‘‘potato chips
made from dried potatoes.’’ ‘‘Bonito’’ or ‘‘bonito fish’’ is the com-
(b) The words ‘‘made from dried pota- mon or usual name of the following
toes’’ shall immediately follow or ap- food fishes:
pear on a line(s) immediately below the Cybiosarda elegans (Whitely, 1935)—Leaping
words ‘‘potato chips’’ in easily legible bonito
boldface print or type in distinct con- Gymnosarda unicolor (Ruppell, 1838)—
trast to other printed or graphic mat- Dogtooth tuna
ter, and in a height not less than the Orcynopsis unicolor (Geoffroy St. Hilaire,
larger of the following alternatives: 1817)—Plain bonito
Sarda australis (Macleay, 1880)—Australian
(1) Not less than one-sixteenth inch bonito
in height on packages having a prin- Sarda chiliensis (Cuvier, 1831)—Eastern Pa-
cipal display panel with an area of 5 cific bonito
square inches or less and not less than Sarda orientalis (Temminck and Schlegel,
one-eighth inch in height if the area of 1844)—Striped bonito
the principal display panel is greater Sarda sarda (Bloch, 1793)—Atlantic bonito
than 5 square inches; or [55 FR 45797, Oct. 31, 1990]
(2) Not less than one-half the height
of the largest type used in the words § 102.49 Fried clams made from
‘‘potato chips.’’ minced clams.
(a) The common or usual name of the
§ 102.45 Fish sticks or portions made
from minced fish. food product that resembles and is of
the same composition as fried clams,
(a) The common or usual name of the except that it is composed of
food product that resembles and is of comminuted clams, shall be ‘‘fried
the same composition as fish sticks or clams made from minced clams.’’
fish portions, except that it is com- (b) The words ‘‘made from minced
posed of comminuted fish flesh, shall clams’’ shall immediately follow or ap-
be ‘‘fish ______ made from minced fish,’’ pear on a line(s) immediately below the
the blank to be filled in with the word words ‘‘fried clams’’ and in easily leg-
‘‘sticks’’ or ‘‘portions’’ as the case may ible boldface print or type in distinct
be. contrast to other printed or graphic
(b) The words ‘‘made from minced matter, and in a height not less than
fish’’ shall immediately follow or ap- the larger of the following alternatives:
pear on a line(s) immediately below the (1) Not less than one-sixteenth inch
words ‘‘fish ______’’ in easily legible in height on packages having a prin-
boldface print or type in distinct con- cipal display panel with an area of 5
trast to other printed or graphic mat- square inches or less and not less than
ter, and in a height not less than the one-eighth inch in height if the area of
larger of the following alternatives: the principal display panel is greater
(1) Not less than one-sixteenth inch than 5 square inches; or
in height on packages having a prin- (2) Not less than one-half the height
cipal display panel with an area of 5 of the largest type used in the words
square inches or less and not less than ‘‘fried clams.’’
one-eighth inch in height if the area of
the principal display panel is greater § 102.50 Crabmeat.
than 5 square inches; or The common or usual name of crab-
(2) Not less than one-half the height meat derived from each of the fol-
of the largest type used in the words lowing designated species of crabs shall
‘‘fish ______.’’ be as follows:
204
Common or usual name (b) The words ‘‘made from minced

Scientific name of crab of crabmeat shrimp’’ shall immediately follow or
appear on a line(s) immediately below
Chionoecetes opilio, Snow crabmeat. the other words required by this sec-
Chionoecetes tanneri,
Chionoecetes bairdii,
tion in easily legible boldface print or
and Chionoecetes type in distinct contrast to other
angulatus. printed or graphic matter, and in a
Erimacrus isenbeckii ....... Korean variety crabmeat height not less than the larger of the
or Kegani crabmeat. following alternatives:
Lithodes aequispinus ...... Golden King crabmeat. (1) Not less than one-sixteenth inch
Paralithodes brevipes ..... King crabmeat or
in height on packages having a prin-
Hanasaki crabmeat.
Paralithodes King crabmeat. cipal display panel with an area of 5
camtschaticus and square inches or less and no less than
Paralithodes platypus. one-eighth inch in height if the area of
the principal display panel is greater
than 5 square inches; or
FR 34460, July 3, 1995; 83 FR 19431, May 3, (2) Not less than one-half the height
2018] of the largest type used in the words
‘‘breaded shrimp sticks’’ or the other
§ 102.54 Seafood cocktails. comparable words required by this sec-
The common or usual name of a sea- tion.
food cocktail in package form fab-
ricated with one or more seafood ingre- § 102.57 Greenland turbot
(Reinhardtius hippoglossoides).
dients shall be:
(a) When the cocktail contains only ‘‘Greenland turbot’’ is the common
one seafood ingredient, the name of the or usual name of the food fish
seafood ingredient followed by the Reinhardtius hippoglossoides, a species
word ‘‘cocktail’’ (e.g., shrimp cocktail, of Pleuronectidae right-eye flounders.
crabmeat cocktail) and a statement of The term ‘‘halibut’’ may be associated
the percentage by weight of that sea- only with Atlantic halibut
food ingredient in the product in the (Hippoglossus hippoglossus) or Pacific
manner set forth in § 102.5(b). halibut (Hippoglossus stenolepis).
(b) When the cocktail contains more
than one seafood ingredient, the term PART 104—NUTRITIONAL QUALITY
‘‘seafood cocktail’’ and a statement of GUIDELINES FOR FOODS
the percentage by weight of each sea-
food ingredient in the product in the
manner set forth in § 102.5(b).
Sec.
§ 102.55 Nonstandardized breaded 104.5 General principles.
composite shrimp units.
(a) The common on usual name of the Subpart B—Fortification Policy
food product that conforms to the defi-
104.20 Statement of purpose.
nition and standard of identity de-
scribed by § 161.175(c)(6) of this chapter, Subpart C—Specific Nutritional Quality
except that the food is made from Guidelines
comminuted shrimp and is not in raw
frozen form, shall be ‘‘______ made from 104.47 Frozen ‘‘heat and serve’’ dinner.
minced shrimp,’’ the blank to be filled AUTHORITY: 21 U.S.C. 321, 343, 371(a).
in with the words ‘‘breaded shrimp
sticks’’ or ‘‘breaded shrimp cutlets’’ de- SOURCE: 42 FR 14327, Mar. 15, 1977, unless
otherwise noted.
pending upon the shape of the product,
or if prepared in a shape other than
that of sticks or cutlets ‘‘breaded Subpart A—General Provisions
shrimp ______ made from minced
shrimp,’’ the blank to be filled by a § 104.5 General principles.
word or phrase that accurately de- (a) A nutritional quality guideline

scribes the shape and that is not mis- prescribes the minimum level or range
leading. of nutrient composition (nutritional
205
§ 104.20 21 CFR Ch. I (4–1–23 Edition)
quality) appropriate for a given class of ance has been established as appro-
food. priate in the nutritional quality guide-
(b) Labeling for a product which com- line, or at a level that exceeds any
plies with all of the requirements of maximum established as appropriate in
the nutritional quality guideline estab- the guideline, shall be ineligible to
lished for its class of food may state bear the guideline statement provided
‘‘This product provides nutrients in for in paragraph (b) of this section, and
amounts appropriate for this class of such a product shall also be deemed to
food as determined by the U.S. Govern- be misbranded under the act unless the
ment,’’ except that the words ‘‘this label and all labeling bear the fol-
product’’ are optional. This statement, lowing prominent and conspicuous
if used, shall be printed on the prin- statement: ‘‘The addition of ______ to
cipal display panel, and may also be (or ‘‘The addition of ______ at the level
printed on the information panel, in contained in) this product has been de-
letters not larger than twice the size of termined by the U.S. Government to be
the minimum type required for the unnecessary and inappropriate and
declaration of net quantity of contents does not increase the dietary value of
by § 101.7 of this chapter. Labeling of the food,’’ the blank to be filled in with
noncomplying products may not in- the common or usual name of the nu-
clude any such statement or otherwise trient(s) involved.
represent, suggest, or imply the prod- [42 FR 14327, Mar. 15, 1977, as amended at 63
uct as being, in whole or in part, in FR 14818, Mar. 27, 1998; 81 FR 59131, Aug. 29,
compliance with a guideline. 2016]
(c) A product bearing the statement
provided for in paragraph (b) of this Subpart B—Fortification Policy
section, in addition to meeting the re-
quirements of the applicable nutri- § 104.20 Statement of purpose.
tional quality guideline, shall comply (a) The fundamental objective of this
with the following requirements: subpart is to establish a uniform set of
(1) The label of the product shall bear principles that will serve as a model for
the common or usual name of the food the rational addition of nutrients to
in accordance with the provisions of foods. The achievement and mainte-
the guideline and §§ 101.3 and 102.5(a) of nance of a desirable level of nutritional
this chapter. quality in the nation’s food supply is
(2) The label of the product shall bear an important public health objective.
nutrition labeling in accordance with The addition of nutrients to specific
§§ 101.2 and 101.9 of this chapter and all foods can be an effective way of main-
other labeling required by applicable taining and improving the overall nu-
sections of part 101 of this chapter. tritional quality of the food supply.
(d) No claim or statement may be However, random fortification of foods
made on the label or in labeling rep- could result in over- or underfortifica-
resenting, suggesting, or implying any tion in consumer diets and create nu-
nutritional or other differences be- trient imbalances in the food supply. It
tween a product to which nutrient ad- could also result in deceptive or mis-
dition has or has not been made in leading claims for certain foods. The
order to meet the guideline, except Food and Drug Administration does
that a nutrient addition shall be de- not encourage indiscriminate addition
clared in the ingredient statement. of nutrients to foods, nor does it con-
(e) Compliance with a nutrient level sider it appropriate to fortify fresh
specified in a nutritional quality guide- produce; meat, poultry, or fish prod-
line shall be determined by the proce- ucts; sugars; or snack foods such as
dures and requirements established in candies and carbonated beverages. To
§ 101.9(g) of this chapter. preserve a balance of nutrients in the
(f) A product within a class of food diet, manufacturers who elect to for-
for which a nutritional quality guide- tify foods are urged to utilize these
line has been established and to which principles when adding nutrients to
has been added a discrete nutrient ei- food. It is reasonable to anticipate that
ther for which no minimum nutrient the Reference Daily Intakes (RDI’s) as
level or nutrient range or other allow- delineated in § 101.9 of this chapter and
206
in paragraph (d) of this section will be (3) All nutrients, including protein,
amended from time to time to list ad- iodine and vitamin D, that are lost in
ditional nutrients and/or to change the a measurable amount are restored and
levels of specific RDI’s as improved all ingredients of the food product that
knowledge about human nutrient re- contribute nutrients are considered in
quirements and allowances develops. determining restoration levels; and
The policy set forth in this section is (4) The food is not the subject of any
based on U.S. dietary practices and nu- other Federal regulation that requires
tritional needs and may not be applica- or prohibits nutrient addition(s), or the
ble in other countries. food has not been fortified in accord-
(b) A nutrient(s) listed in paragraph ance with any other Federal regulation
(d)(3) of this section may appropriately that permits voluntary nutrient addi-
be added to a food to correct a dietary tions.
insufficiency recognized by the sci- (d) A nutrient(s) listed in paragraph
entific community to exist and known (d)(3) of this section may be added to a
to result in nutritional deficiency dis- food in proportion to the total caloric
ease if: content of the food, to balance the vi-
(1) Sufficient information is available tamin, mineral, and protein content if:
to identify the nutritional problem and (1) A normal serving of the food con-
the affected population groups, and the tains at least 40 kilocalories (that is, 2
food is suitable to act as a vehicle for percent of a daily intake of 2,000
the added nutrients. Manufacturers kilocalories);
contemplating using this principle are (2) The food is not the subject of any
urged to contact the Food and Drug other Federal regulation for a food or
Administration before implementing a class of food that requires, permits, or
fortification plan based on this prin- prohibits nutrient additions; and
ciple. (3) The food contains all of the fol-
lowing nutrients per 100 calories based
(2) The food is not the subject of any
on 2,000 calorie total intake as a daily
other Federal regulation for a food or
standard:
class of food that requires, permits, or
prohibits nutrient additions. (Other DRV or Amount
Federal regulations include, but are Nutrient Unit of measurement per 100
RDI 1 calories
not limited to, standards of identity
promulgated under section 401 of the Protein .............. grams (g) .................. 50 2.5
Vitamin A .......... International Unit (IU) 5,000 250
Federal Food, Drug, and Cosmetic Act, Vitamin C .......... milligrams (mg) ......... 60 3
nutritional quality guidelines estab- Calcium ............. g ............................... 1 0.05
lished in subpart C of this part, and Iron .................... mg ............................ 18 0.9
common or usual name regulations es- Vitamin D .......... IU .............................. 400 20
Vitamin E .......... do ............................. 30 1.5
tablished in part 102 of this chapter.) Thiamin ............. mg ............................ 1.5 0.08
(c) A nutrient(s) listed in paragraph Riboflavin .......... do ............................. 1.7 0.09
(d)(3) of this section may appropriately Niacin ................ do ............................. 20 1
Vitamin B6 ......... do ............................. 2.0 0.1
be added to a food to restore such nu- Folate ................ micrograms (μg) ....... 400 20
trient(s) to a level(s) representative of Vitamin B12 ....... do ............................. 6.0 0.3
the food prior to storage, handling, and Biotin ................. mg ............................ 0.3 0.015
processing, when: Pantothenic acid do ............................. 10 0.5
Phosphorus ....... g ............................... 1.0 0.05
(1) The nutrient is shown by adequate Magnesium ....... mg ............................ 400 20
scientific documentation to have been Zinc ................... do ............................. 15 0.8
lost in storage, handling, or processing Iodine ................ μg ............................. 150 7.5
Copper .............. mg ............................ 2.0 0.1
in a measurable amount equal to at Potassium ......... do ............................. 3,500 175
least 2 percent of the Daily Reference 1 RDI’s for adults and children 4 or more years of age.
Value (DRV) of protein and of potas-
sium and 2 percent of the Reference (e) A nutrient(s) may appropriately
Daily Intake (RDI) in a normal serving be added to a food that replaces tradi-
of the food. tional food in the diet to avoid nutri-
(2) Good manufacturing practices and tional inferiority in accordance with
normal storage and handling proce- § 101.3(e)(2) of this chapter.

dures cannot prevent the loss of such (f) Nutrient(s) may be added to foods
nutrient(s), as permitted or required by applicable
207
§ 104.47 21 CFR Ch. I (4–1–23 Edition)
regulations established elsewhere in food to which nutrients have been

this chapter. added pursuant to paragraph (e) of this
(g) A nutrient added to a food is ap- section.
propriate only when the nutrient:
(1) Is stable in the food under cus- [45 FR 6323, Jan. 25, 1980, as amended at 58
FR 2228, Jan. 6, 1993]
tomary conditions of storage, distribu-
tion, and use;
(2) Is physiologically available from Subpart C—Specific Nutritional
the food; Quality Guidelines
(3) Is present at a level at which
there is a reasonable assurance that § 104.47 Frozen ‘‘heat and serve’’ din-
consumption of the food containing the ner.
added nutrient will not result in an ex- (a) A product, for which a common or
cessive intake of the nutrient, consid- usual name is established in § 102.26 of
ering cumulative amounts from other this chapter, in order to be eligible to
sources in the diet; and bear the guideline statement set forth
(4) Is suitable for its intended pur- at § 104.5(b), shall contain at least the
pose and is in compliance with applica-
following three components:
ble provisions of the act and regula-
(1) One or more sources of protein de-
tions governing the safety of sub-
stances in food. rived from meat, poultry, fish, cheese,
(h) Any claims or statements in the or eggs.
labeling of food about the addition of a (2) One or more vegetables or vege-
vitamin, mineral, or protein to a food table mixtures other than potatoes,
shall be made only if the claim or rice, or cereal-based product.
statement is not false or misleading (3) Potatoes, rice, or cereal-based
and otherwise complies with the act product (other than bread or rolls) or
and any applicable regulations. The another vegetable or vegetable mix-
following label claims are acceptable: ture.
(1) The labeling claim ‘‘fully restored (b) The three or more components
with vitamins and minerals’’ or ‘‘fully named in paragraph (a) of this section,
restored with vitamins and minerals to including their sauces, gravies,
the level of unprocessed ______’’ (the breading, etc.:
blank to be filled in with the common (1) Shall contribute not less than the
or usual name of the food) may be used minimum levels of nutrients prescribed
to describe foods fortified in accord-
in paragraph (d) of this section.
ance with the principles established in
(2) Shall be selected so that one or
paragraph (c) of the section.
(2) The labeling claim, ‘‘vitamins and more of the listed protein sources of
minerals (and ‘‘protein’’ when appro- paragraph (a)(1) of this section, exclud-
priate) added are in proportion to ca- ing their sauces, gravies, breading,
loric content’’ may be used to describe etc., shall provide not less than 70 per-
food fortified in accordance with the cent of the total protein supplied by
principles established in paragraph (d) the components named in paragraph (a)
of this section. of this section.
(3) When labeling claims are per- (c) If it is necessary to add any nutri-
mitted, the term ‘‘enriched,’’ ‘‘for- ent(s) in order to meet the minimum
tified,’’ ‘‘added,’’ or similar terms may nutrient levels prescribed in paragraph
be used interchangeably to indicate the (d) of this section, the addition of each
addition of one or more vitamins or such nutrient may not result in a total
minerals or protein to a food, unless an nutrient level exceeding 150 percent of
applicable Federal regulation requires the minimum level prescribed. Nutri-
the use of specific words or statements. ents used for such addition shall be bio-
(i) It is inappropriate to make any logically available in the final product.
claim or statement on a label or in la- (d) Minimum levels of nutrients for a
beling, other than in a listing of the frozen ‘‘heat and serve’’ dinner are as
nutrient ingredients as part of the in-

follows:
gredient statement, that any vitamin,
mineral, or protein has been added to a
208
Minimum levels for fro- (f) For the purposes of labeling, an

zen ‘‘heat and serve’’ ‘‘average serving’’ shall be one entire
dinner—
frozen ‘‘heat and serve’’ dinner.
For each
100 Cal- [42 FR 14327, Mar. 5, 1977]
Nutrient For the
ories (keal) total com-
of the total ponents
compo-
nents specified in PART 105—FOODS FOR SPECIAL
par. (a)
specified in DIETARY USE
par. (a)
Protein, grams ............................... 4.60 16.0 Subpart A—General Provisions

Vitamin A, IU ................................. 150.00 520.0
Thiamine, mg ................................. .05 .2 Sec.
Riboflavin, mg ................................ .06 .2 105.3 Definitions and interpretations.
Niacin, mg ..................................... .99 3.4
Pantothenic acid, mg ..................... .32 1.1 Subpart B—Label Statements
Vitamin, B6, mg ............................. .15 .5
105.62 Hypoallergenic foods.
Vitamin, B1 ..................................... .33 1.1
Iron, mg ......................................... .62 2.2
105.65 Infant foods.
105.66 Label statements relating to useful-
ness in reducing or maintaining body
(1) A frozen ‘‘heat and serve’’ dinner weight.
prepared from conventional food ingre-
dients listed in paragraph (a) of this Subpart C [Reserved]
section will also contain folic acid,
magnesium, iodine, calcium, and zinc. Subpart D—Standards of Identity
Minimum levels for these nutrients [Reserved]
cannot be established at the present
time but may be specified as additional AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 350,
data are obtained. 371, 379e.
(2) The minimum levels for panto- SOURCE: 42 FR 14328, Mar. 15, 1977, unless
thenic acid, vitamin B–6, and vitamin otherwise noted.
B–12 are tentative. Final levels will be
established when sufficient data are Subpart A—General Provisions
available. Until final levels are estab-
lished, a product containing less than § 105.3 Definitions and interpretations.
the tentative levels will not be deemed The definitions and interpretations
to be misbranded when labeled in ac- of terms contained in section 201 of the
cordance with § 104.5(b). Federal Food, Drug, and Cosmetic Act
(3) When technologically practicable, (hereafter ‘‘the act’’) shall be applica-
iodized salt shall be used or iodine ble with the following additions:
shall be present at a level equivalent to (a)(1) The term special dietary uses, as
that which would be present if iodized applied to food for man, means par-
salt were used in the manufacture of ticular (as distinguished from general)
the product. uses of food, as follows:
(4) When technologically practicable, (i) Uses for supplying particular die-
product components and ingredients tary needs which exist by reason of a
shall be selected to obtain the desir- physical, physiological, pathological or
able calcium to phosphorous ratio of other condition, including but not lim-
1:1. Technological addition of ited to the conditions of diseases, con-
phosphates shall be minimized and valescence, pregnancy, lactation, aller-
shall not exceed the amount necessary gic hypersensitivity to food, under-
for the intended effect. weight, and overweight;
(e) If the product includes servings of (ii) Uses for supplying particular die-
food which are not prescribed by para- tary needs which exist by reason of
graph (a) of this section (e.g., soup, age, including but not limited to the
bread or rolls, beverage, or dessert), ages of infancy and childhood;
their contribution shall not be consid- (iii) Uses for supplementing or for-
ered in determining compliance with tifying the ordinary or usual diet with
the nutrient levels established in para- any vitamin, mineral, or other dietary
graph (d) of this section but shall be in- property. Any such particular use of a
cluded in any nutrition labeling. food is a special dietary use, regardless
209
§ 105.62 21 CFR Ch. I (4–1–23 Edition)
of whether such food also purports to erals alone) purports to be or is rep-

be or is represented for general use. resented for special dietary use for in-
(2) The use of an artificial sweetener fants, the label shall bear, if such food
in a food, except when specifically and is fabricated from two or more ingredi-
solely used for achieving a physical ents, the common or usual name of
characteristic in the food which cannot each ingredient, including spices, fla-
be achieved with sugar or other nutri- voring, and coloring.
tive sweetener, shall be considered a (b) If such food, or any ingredient
use for regulation of the intake of cal- thereof, consists in whole or in part of
ories and available carbohydrate, or for plant or animal matter and the name
use in the diets of diabetics and is of such food or ingredient does not
therefore a special dietary use. clearly reveal the specific plant or ani-
(b)–(d) [Reserved] mal which is its source, such name
(e) For the purposes of the regula- shall be so qualified as to reveal clear-
tions in this part, the terms infant, ly the specific plant or animal that is
child, and adult mean persons not more such source.
than 12 months old, more than 12
months but less than 12 years old, and [42 FR 14328, Mar. 15, 1977, as amended at 47
FR 947, Jan. 8, 1982; 49 FR 10090, Mar. 19, 1984;
12 years or more old, respectively. 50 FR 1840, Jan. 14, 1985]
FR 16006, Mar. 16, 1979; 44 FR 49665, Aug. 24, § 105.66 Label statements relating to
1979] usefulness in reducing or maintain-
ing body weight.
Subpart B—Label Statements (a) General requirements. Any food
that purports to be or is represented
§ 105.62 Hypoallergenic foods. for special dietary use because of use-
If a food purports to be or is rep- fulness in reducing or maintaining
resented for special dietary use by rea- body weight shall bear:
son of the decrease or absence of any (1) Nutrition labeling in conformity
allergenic property or by reason of with § 101.9, or, where applicable,
being offered as food suitable as a sub- § 101.36 of this chapter, unless exempt
stitute for another food having an al- under that section; and
lergenic property, the label shall bear: (2) A conspicuous statement of the
(a) The common or usual name and basis upon which the food claims to be
the quantity or proportion of each in- of special dietary usefulness.
gredient (including spices, flavoring, (b) Nonnutritive ingredients. (1) Any
and coloring) in case the food is fab- food subject to paragraph (a) of this
ricated from two or more ingredients. section that achieves its special die-
(b) A qualification of the name of the tary usefulness by use of a nonnutri-
food, or the name of each ingredient tive ingredient (i.e., one not utilized in
thereof in case the food is fabricated normal metabolism) shall bear on its
from two or more ingredients, to reveal label a statement that it contains a
clearly the specific plant or animal nonnutritive ingredient and the per-
that is the source of such food or of centage by weight of the nonnutritive
such ingredient, if such food or such in- ingredient.
gredient consists in whole or in part of (2) A special dietary food may con-
plant or animal matter and such name tain a nonnutritive sweetener or other
does not reveal clearly the specific ingredient only if the ingredient is safe
plant or animal that is such a source. for use in the food under the applicable
(c) An informative statement of the law and regulations of this chapter.
nature and effect of any treatment or Any food that achieves its special die-
processing of the food or any ingre- tary usefulness in reducing or main-
dient thereof, if the changed allergenic taining body weight through the use of
property results from such treatment a nonnutritive sweetener shall bear on
or processing. its label the statement required by
paragraph (b)(1) of this section, but
§ 105.65 Infant foods.
need not state the percentage by

(a) If a food (other than a dietary weight of the nonnutritive sweetener.
supplement of vitamins and/or min- If a nutritive sweetener(s) as well as
210
Food and Drug Administration, HHS Pt. 106
nonnutritive sweetener(s) is added, the Subpart D—Standards of Identity

statement shall indicate the presence [Reserved]
of both types of sweetener, e.g.,
‘‘Sweetened with nutritive sweetener(s)
and nonnutritive sweetener(s).’’ PART 106—INFANT FORMULA RE-
(c) ‘‘Low calorie’’ foods. A food pur- QUIREMENTS PERTAINING TO
porting to be ‘‘low calorie’’ must com- CURRENT GOOD MANUFAC-
ply with the criteria set forth for such TURING PRACTICE, QUALITY
foods in § 101.60(b)(2) and (b)(3) of this CONTROL PROCEDURES, QUALITY
chapter. FACTORS, RECORDS AND RE-
(d) ‘‘Reduced calorie’’ foods and other PORTS, AND NOTIFICATIONS
comparative calorie claims. A food pur-
porting to be ‘‘reduced calorie’’ or oth- Subpart A—General Provisions
erwise containing fewer calories than a
reference food must comply with the Sec.
criteria set forth for such food in 106.1 Status and applicability of the regula-
§ 101.60(b)(4) and (b)(5) of this chapter. tions in part 106.
106.3 Definitions.
(e) Label terms suggesting usefulness as
low calorie or reduced calorie foods. (1) Subpart B—Current Good Manufacturing
Except as provided in paragraphs (e)(2) Practice
and (e)(3) of this section, and in
§ 101.13(q)(2) of this chapter for soft 106.5 Current good manufacturing practice.
drinks, a food may be labeled with 106.6 Production and in-process control sys-
terms such as ‘‘diet,’’ ‘‘dietetic,’’ ‘‘ar- tem.
tificially sweetened,’’ or ‘‘sweetened 106.10 Controls to prevent adulteration by
with nonnutritive sweetener’’ only if workers.
the claim is not false and misleading, 106.20 Controls to prevent adulteration
caused by facilities.
and the food is labeled ‘‘low calorie’’ or
106.30 Controls to prevent adulteration
‘‘reduced calorie’’ or bears another caused by equipment or utensils.
comparative calorie claim in compli- 106.35 Controls to prevent adulteration due
ance with part 101 of this chapter and to automatic (mechanical or electronic)
this section. equipment.
(2) Paragraph (e)(1) of this section 106.40 Controls to prevent adulteration
shall not apply to any use of such caused by ingredients, containers, and
terms that is specifically authorized by closures.
regulation governing a particular food, 106.50 Controls to prevent adulteration dur-
ing manufacturing.
or, unless otherwise restricted by regu-
106.55 Controls to prevent adulteration from
lation, to any use of the term ‘‘diet’’ microorganisms.
that clearly shows that the food is of- 106.60 Controls to prevent adulteration dur-
fered solely for a dietary use other ing packaging and labeling of infant for-
than regulating body weight, e.g., ‘‘for mula.
low-sodium diets.’’ 106.70 Controls on the release of finished in-
(3) Paragraph (e)(1) of this section fant formula.
shall not apply to any use of such 106.80 Traceability.
terms on a formulated meal replace- 106.90 Audits of current good manufacturing
ment or other food that is represented practice.
to be of special dietary use as a whole
Subpart C—Quality Control Procedures
meal, pending the issuance of a regula-
tion governing the use of such terms on 106.91 General quality control.
foods. 106.92 Audits of quality control procedures.
(f) ‘‘Sugar free,’’ and ‘‘no added
sugar.’’ Criteria for the use of the Subpart D—Conduct of Audits
terms ‘‘sugar free’’ and ‘‘no added 106.94 Audit plans and procedures.
sugar’’ are provided for in § 101.60(c) of
this chapter. Subpart E—Quality Factors for Infant
[58 FR 2430, Jan. 6, 1993] Formulas
106.96 Requirements for quality factors for

Subpart C [Reserved] infant formulas.
211
§ 106.1 21 CFR Ch. I (4–1–23 Edition)
Subpart F—Records and Reports record requirements in subpart F of

this part with respect to an infant for-
106.100 Records.
mula, the formula will be deemed to be
Subpart G—Registration, Submission, and adulterated under section 412(a)(2) of
Notification Requirements the Federal Food, Drug, and Cosmetic
Act. If an infant formula manufacturer
106.110 New infant formula registration. fails to comply with the good manufac-
106.120 New infant formula submission.
106.121 Quality factor assurances for infant turing practices or quality control pro-
formulas. cedures record requirements in subpart
106.130 Verification submission. F of this part with respect to an infant
106.140 Submission concerning a change in formula, the infant formula will be
infant formula that may adulterate the deemed to be adulterated under section
product.
106.150 Notification of an adulterated or
412(a)(3) of the Federal Food, Drug, and
misbranded infant formula. Cosmetic Act. The criteria set forth in
106.160 Incorporation by reference. subpart F of this part also implement
AUTHORITY: 21 U.S.C. 321, 342, 350a, 371. record retention requirements under
section 412(b)(4) of the Federal Food,
SOURCE: 79 FR 8059, Feb. 10, 2014, unless
Drug, and Cosmetic Act. Failure to
otherwise noted.
comply with any regulation in subpart
EDITORIAL NOTE: Nomenclature changes to F of this part is a violation of section
part 106 appear at 81 FR 49895, July 29, 2016.
301(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(e)).
Subpart A—General Provisions (d) The criteria set forth in subpart G
§ 106.1 Status and applicability of the of this part describe, in part, certain
regulations in part 106. good manufacturing practices, quality
control procedures, and quality factor
(a) The criteria set forth in subparts
B, C, and D of this part prescribe the records requirements under section
steps that manufacturers shall take 412(b)(1) and (b)(2) of the Federal Food,
under section 412(b)(2) and (b)(3) of the Drug and Cosmetic Act. If an infant
Federal Food, Drug, and Cosmetic Act formula manufacturer fails to comply
(21 U.S.C. 350a(b)(2) and (b)(3)) in proc- with such records requirements with
essing infant formula. If the processing respect to an infant formula, the infant
of the formula does not comply with formula will be deemed to be adulter-
any regulation in subparts B, C, or D of ated under section 412(a)(2) or (a)(3) of
this part, the formula will be deemed the Federal Food, Drug, and Cosmetic
to be adulterated under section Act, as applicable. The criteria set
412(a)(3) of the Federal Food, Drug, and forth in subpart G of this part also de-
Cosmetic Act. scribe the circumstances in which an
(b) The criteria set forth in subpart E infant formula manufacturer is re-
of this part prescribe the requirements quired to register with, submit to, or
for quality factors that infant formula notify the Food and Drug Administra-
shall meet under section 412(b)(1) of the tion, and the content of a registration,
Federal Food, Drug, and Cosmetic Act. submission, or notification, under sec-
If the formula fails to comply with any tion 412(c), (d), and (e) of the Federal
regulation in subpart E of this part, it Food, Drug, and Cosmetic Act. Failure
will be deemed to be adulterated under to comply with any regulation in sub-
section 412(a)(2) of the Federal Food, part G of this part is a violation of sec-
Drug, and Cosmetic Act.
tion 301(s) of the Federal Food, Drug,
(c) The criteria set forth in subpart F
and Cosmetic Act.
of this part prescribe records require-
ments for quality factors under section § 106.3 Definitions.
412(b)(1) of the Federal Food, Drug, and
Cosmetic Act and for good manufac- The definitions in this section and
turing practices and quality control the definitions contained in section 201
procedures, including distribution and of the Federal Food, Drug, and Cos-
audit records, under section 412(b)(2). If metic Act (21 U.S.C. 321) shall apply to
an infant formula manufacturer fails infant formula requirements in 21 CFR
to comply with the quality factor parts 106 and 107 of this chapter.
212
Eligible infant formula means an in- (4) Any infant formula manufactured
fant formula that could be lawfully dis- on a new processing line or in a new
tributed in the United States on De- plant;
cember 8, 2014. (5) Any infant formula manufactured
Final product stage means the point in containing a new constituent not listed
the manufacturing process, before dis- in section 412(i) of the Federal Food,
tribution of an infant formula, at Drug, and Cosmetic Act (21 U.S.C.
which the infant formula is homo- 350a(i)), such as taurine or L-carnitine;
geneous and is not subject to further (6) Any infant formula processed by a
degradation due to processing. manufacturer on new equipment that
utilizes a new technology or principle
Indicator nutrient means a nutrient
(e.g., from terminal sterilization to
whose concentration is measured dur-
aseptic processing); or
ing the manufacture of an infant for-
(7) An infant formula for which there
mula to confirm complete addition and
has been a fundamental change in the
uniform distribution of a premix or type of packaging used (e.g., changing
other substance of which the indicator from metal cans to plastic pouches).
nutrient is a part. Manufacturer means a person who
Infant means a person not more than prepares, reconstitutes, or otherwise
12 months of age. changes the physical or chemical char-
Infant formula means a food which acteristics of an infant formula or
purports to be or is represented for spe- packages or labels the product in a
cial dietary use solely as a food for in- container for distribution. The term
fants by reason of its simulation of ‘‘manufacturer’’ does not include a per-
human milk or its suitability as a com- son who prepares, reconstitutes, or
plete or partial substitute for human mixes infant formula exclusively for an
milk. infant under his/her direct care or the
In-process production aggregate means direct care of the institution employ-
a combination of ingredients at any ing such person.
point in the manufacturing process be- Microorganisms means yeasts, molds,
fore packaging. bacteria, and viruses and includes, but
Major change in an infant formula is not limited to, species having public
means any new formulation, or any health significance.
change of ingredients or processes New infant formula means:
where experience or theory would pre- (1) An infant formula manufactured
dict a possible significant adverse im- by a person that has not previously
pact on levels of nutrients or bio- manufactured an infant formula, and
availability of nutrients, or any change (2) An infant formula manufactured
that causes an infant formula to differ by a person that has previously manu-
fundamentally in processing or in com- factured infant formula and in which
position from any previous formulation there is a major change in processing
or formulation from a current or any
produced by the manufacturer. Exam-
previous formulation produced by such
ples of infant formulas deemed to differ
manufacturer, or which has not pre-
fundamentally in processing or in com-
viously been the subject of a submis-
position include:
sion under section 412(c) of the Federal
(1) Any infant formula produced by a Food, Drug, and Cosmetic Act for the
manufacturer who is entering the U.S. U.S. market.
market; Nutrient means any vitamin, mineral,
(2) Any infant formula powder proc- or other substance or ingredient that is
essed and distributed by a manufac- required in accordance with the ‘‘Nu-
turer who previously only produced liq- trients’’ table set out in section
uids (or vice versa); 412(i)(1) of the Federal Food, Drug, and
(3) Any infant formula having a sig- Cosmetic Act or by regulations issued
nificant revision, addition, or substi- under section 412(i)(2) or that is identi-
tution of a macronutrient (i.e., protein, fied as essential for infants by the Food
fat, or carbohydrate), with which the and Nutrition Board of the Institute of
manufacturer has not had previous ex- Medicine through its development of a
perience; Dietary Reference Intake, or that has
213
§ 106.5 21 CFR Ch. I (4–1–23 Edition)
been identified as essential for infants to be used in, and the facilities or con-
by the Food and Drug Administration trols that are to be used for, the manu-
through a FEDERAL REGISTER publica- facture, processing, packing, or holding
tion. of an infant formula. Compliance with
Nutrient premix means a combination these provisions is necessary to ensure
of ingredients containing two or more that such infant formula provides the
nutrients received from a supplier or nutrients required under § 107.100 of
prepared by an infant formula manu- this chapter and is manufactured in a
facturer. manner designed to prevent its adulter-
Production aggregate means a quan- ation. A liquid infant formula that is a
tity of product, or, in the case of an in- thermally processed low-acid food
fant formula produced by continuous packaged in a hermetically sealed con-
process, a specific identified amount tainer is also subject to the regulations
produced in a unit of time, that is in- in part 113 of this chapter, and an in-
tended to have uniform composition, fant formula that is an acidified food,
character, and quality, within specified as defined in § 114.3(b) of this chapter, is
limits, and is produced according to a also subject to the regulations in part
master manufacturing order.
114 of this chapter.
Production unit means a specific
quantity of an infant formula produced (b) The failure to comply with any
during a single cycle of manufacture regulation in this subpart in the manu-
that has uniform composition, char- facture, processing, packing, or holding
acter, and quality, within specified of an infant formula shall render such
limits. infant formula adulterated under sec-
Production unit number or production tion 412(a)(3) of the Federal Food,
aggregate number means any distinctive Drug, and Cosmetic Act (21 U.S.C.
combination of letters, numbers, sym- 350a(a)(3)); the failure to comply with
bols, or any combination of them, from any regulation in part 113 of this chap-
which the complete history of the man- ter in the manufacture, processing,
ufacture, processing, packing, holding, packing, or holding of a liquid infant
and distribution of a production aggre- formula shall render such infant for-
gate or a production unit of infant formula adulterated under section
mula can be determined. 412(a)(3); and the failure to comply
Quality factors means those factors with any regulation in part 114 of this
necessary to demonstrate the safety of chapter in the manufacture, proc-
the infant formula and the bio- essing, packing, or holding of an infant
availability of its nutrients, as pre- formula that is an acidified food shall
pared for market and when fed as the render such infant formula adulterated
sole source of nutrition, to ensure the under section 412(a)(3).
healthy growth of infants.
Representative sample means a sample § 106.6 Production and in-process con-
that consists of a number of units that trol system.
are drawn based on rational criteria, (a) A manufacturer shall conform to
such as random sampling, and intended the requirements of this subpart by im-
to ensure that the sample accurately plementing a system of production and
portrays the material being sampled. in-process controls. This production
Shall is used to state mandatory re- and in-process control system shall
quirements. cover all stages of processing, from the
[79 FR 8059, Feb. 10, 2014, as amended at 79 receipt and acceptance of the raw ma-
FR 33070, June 10, 2014] terials, ingredients, and components
through the storage and distribution of
Subpart B—Current Good the finished product and shall be de-
Manufacturing Practice signed to ensure that all the require-
ments of this subpart are met.
§ 106.5 Current good manufacturing (b) The production and in-process
practice. control system shall be set out in a
(a) The regulations set forth in this written plan or set of procedures that
subpart define the minimum current is designed to ensure that an infant
good manufacturing practices that are formula is manufactured in a manner
214
that will prevent adulteration of the terials, infant formula packaging, or

infant formula. infant formula equipment or utensil
(c) At any point, step, or stage in the contact surfaces shall practice good
production process where control is personal hygiene to protect the infant
necessary to prevent adulteration, a formula against contamination. Good
manufacturer shall: personal hygiene includes:
(1) Establish specifications to be met; (1) Wearing clean outer garments
(2) Monitor the production and in- and, as necessary, protective apparel
process control point, step, or stage; such as head, face, hand, and arm cov-
(3) Establish a corrective action plan erings; and
for use when a specification established (2) Washing hands thoroughly in a
in accordance with paragraph (c)(1) of hand washing facility with soap and
this section is not met; running water at a suitable tempera-
(4) Review the results of the moni- ture before starting work, after each
toring required by paragraph (c)(2) of absence from the work station, and at
this section, and review and evaluate any other time when the hands may be-
the public health significance of any come soiled or contaminated.
deviation from specifications that have (c) Any person who reports that he or
been established in accordance with she has, or appears by medical exam-
paragraph (c)(1) of this section. For ination or supervisory observation to
any specification established in accord- have, an illness, open lesion (including
ance with paragraph (c)(1) of this sec- boils, sores, or infected wounds), or any
tion that a manufacturer fails to meet, other source of microbial contamina-
an individual qualified by education, tion that creates a reasonable possi-
training, or experience shall conduct a bility that the safety of an infant for-
documented review and shall make a mula may be adversely affected, shall
material disposition decision to reject be excluded from direct contact with
the affected article, to reprocess or ingredients, containers, closures, in-
otherwise recondition the affected arti- process materials, equipment, utensils,
cle, or to approve and release the arti- and infant formula product until the
cle for use or distribution; and condition is corrected or determined by
(5) Establish recordkeeping proce- competent medical personnel not to
dures, in accordance with § 106.100(e)(3), jeopardize the safety of the infant for-
that ensure that compliance with the mula.
requirements of this section is docu-
mented. § 106.20 Controls to prevent adultera-
(d) Any article that fails to meet a tion caused by facilities.
specification established in accordance (a) Buildings used in the manufac-
with paragraph (c)(1) of this section ture, processing, packing, or holding of
shall be controlled under a quarantine infant formula shall be maintained in a
system designed to prevent its use clean and sanitary condition and shall
pending the completion of a docu- have space for the separation of incom-
mented review and material disposi- patible operations, such as the han-
tion decision. dling of raw materials, the manufac-
ture of the product, and packaging and
§ 106.10 Controls to prevent adultera- labeling operations.
tion by workers. (b) Separate areas or another system
(a) A manufacturer shall employ suf- of separation, such as a computerized
ficient personnel, qualified by edu- inventory control, a written card sys-
cation, training, or experience, to per- tem, or an automated system of seg-
form all operations, including all re- regation, shall be used for holding raw
quired recordkeeping, in the manufac- materials, in-process materials, and
ture, processing, packing, and holding final infant formula product at the fol-
of each infant formula and to supervise lowing times:
such operations to ensure that the op- (1) Pending release for use in infant
erations are correctly and fully per- formula production or pending release
formed. of the final product;

(b) Personnel working directly with (2) After rejection for use in, or as,
infant formula, infant formula raw ma- infant formula; and
215
§ 106.30 21 CFR Ch. I (4–1–23 Edition)
(3) After release for use in infant for- (3) A manufacturer shall conduct the
mula production or after release of the tests required by paragraph (f)(2) of
final product. this section with sufficient frequency
(c) Lighting shall allow easy identi- to ensure that the water meets the
fication of raw materials, packaging, EPA’s Primary Drinking Water Regu-
labeling, in-process materials, and fin- lations but shall not conduct these
ished products that have been released tests less frequently than annually for
for use in infant formula production chemical contaminants, every 4 years
and shall permit the easy reading of infor radiological contaminants, and
struments and controls necessary in weekly for bacteriological contami-
processing, packaging, and laboratory nants.
analysis. Any lighting fixtures directly (4) A manufacturer shall make and
over or adjacent to exposed raw mate- retain records, in accordance with
rials, in-process materials, or bulk § 106.100(f)(1), of the frequency and re-
(unpackaged) finished product shall be sults of testing of the water used in the
protected to prevent glass from con- production of infant formula.
taminating the product in the event of (g) There shall be no backflow from,
breakage. or cross-connection between, piping
(d) A manufacturer shall provide ade- systems that discharge waste water or
quate ventilation or control equipment sewage and piping systems that carry
to minimize odors and vapors (includ- water for infant formula manufac-
ing steam and noxious fumes) in areas turing.
where they may contaminate the in- (h) Only culinary steam shall be used
fant formula; and shall minimize the at all direct infant formula product
potential for contamination of raw ma- contact points. Culinary steam shall be
terials, in-process materials, final in compliance with the 3–A Sanitary
product infant formula, packing mate- Standards, No. 60903, which is incor-
rials, and infant formula-contact sur- porated by reference at § 106.160. Boiler
faces, through the use of appropriate
water additives in the steam shall be
measures, which may include the use of
used in accordance with § 173.310 of this
air filtration.
chapter.
(e) All rodenticides, insecticides, fun-
(i) Each infant formula manufac-
gicides, fumigating agents, and clean-
turing site shall provide its employees
ing and sanitizing agents shall be
with readily accessible toilet facilities
stored and used in a manner that pro-
and hand washing facilities that in-
tects against contamination of infant
clude hot and cold water, soap or deter-
formula.
gent, single-service towels or air dryers
(f) Potable water used in the manu-
in toilet facilities. These facilities
facture of infant formula shall meet
shall be maintained in good repair and
the standards prescribed in the Envi-
in a sanitary condition at all times.
ronmental Protection Agency’s (EPA’s)
These facilities shall provide for proper
Primary Drinking Water regulations in
disposal of the sewage. Doors to the
40 CFR part 141, except that the water
toilet facility shall not open into areas
used in infant formula manufacturing
where infant formula, ingredients, con-
shall not be fluoridated or shall be
tainers, or closures are processed, han-
defluoridated to a level as low as pos-
dled, or stored, except where alternate
sible prior to use.
means have been taken to protect
(1) The water shall be supplied under
against contamination.
continuous positive pressure in a
plumbing system that is free of defects [79 FR 8059, Feb. 10, 2014, as amended at 79
that could contaminate an infant for- FR 33070, June 10, 2014]
mula.
(2) A manufacturer shall test rep- § 106.30 Controls to prevent adultera-
resentative samples of the potable tion caused by equipment or uten-
sils.
water drawn at a point in the system
at which the water is in the same con- (a) A manufacturer shall ensure that
dition that it will be when it is used in equipment and utensils used in the
infant formula manufacturing. manufacture, processing, packing, or
216
holding of an infant formula are of ap- manufacturer of the instrument or con-

propriate design and are installed to fa- trol, or as otherwise deemed necessary
cilitate their intended function and to ensure the accuracy of the instru-
their cleaning and maintenance. ment or control. The known reference
(b) A manufacturer shall ensure that standard shall be certified for accuracy
equipment and utensils used in the at the intervals specified in writing by
manufacture, processing, packing, or the manufacturer of the instrument or
holding of an infant formula are con- control, or at routine intervals other-
structed so that surfaces that contact wise deemed necessary to ensure the
ingredients, in-process materials, or in- accuracy of the instrument or control.
fant formula are made of nontoxic ma- A manufacturer shall make and retain
terials and are not reactive or absorp- records of the calibration activities in
tive. A manufacturer shall ensure that accordance with § 106.100(f)(2).
such equipment and utensils are de-
(2) Instruments and controls that
signed to be easily cleanable and to
cannot be adjusted to agree with the
withstand the environment of their in-
reference standard shall be repaired or
tended use and that all surfaces that
contact ingredients, in-process mate- replaced.
rials, or infant formula are cleaned and (3) If calibration of an instrument
sanitized, as necessary, and are main- shows a failure to meet a specification
tained to protect infant formula from for a point where control is deemed
being contaminated by any source. All necessary to prevent adulteration of
sanitizing agents used on such equip- infant formula product, a written eval-
ment and utensils that are regulated as uation of all affected product, and of
pesticide chemicals under 21 U.S.C. any actions that need to be taken with
346a(a) shall comply with the Environ- respect to that product, shall be made,
mental Protection Agency’s regula- in accordance with § 106.100(f)(2).
tions established under such section, (e) The following provisions apply to
and all other such sanitizers shall com- thermal processing and cold storage of
ply with all applicable Food and Drug infant formulas:
Administration laws and regulations. (1) Equipment and procedures for
(c) A manufacturer shall ensure that thermal processing of infant formula
any substance, such as a lubricant or a packaged in hermetically sealed con-
coolant, that is required for operation tainers shall conform to the require-
of infant formula manufacturing equip- ments in 21 CFR parts 108 and 113.
ment and which would render the in- (2)(i) Except as provided in paragraph
fant formula adulterated if such sub- (e)(2)(ii) of this section, a manufacturer
stance were to come in contact with shall maintain all areas of cold storage
the formula, does not come in contact
at a temperature of 40 °F (4.4 °C) or
with formula ingredients, containers,
below.
closures, in-process materials, or with
infant formula product during the (ii) A manufacturer may maintain a
manufacture of an infant formula. cold storage area for an in-process in-
(d) A manufacturer shall ensure that fant formula or for a final infant for-
each instrument used for measuring, mula at a temperature not to exceed 45
regulating, or controlling mixing time °F (7.2 °C) for a defined period of time
and speed, temperature, pressure, mois- provided that the manufacturer has
ture, water activity, or other param- scientific data and other information
eter at any point, step, or stage where to demonstrate that the time and tem-
control is necessary to prevent adulter- perature conditions of such storage are
ation of an infant formula during proc- sufficient to ensure that there is no
essing is accurate, easily read, properly significant growth of microorganisms
maintained, and present in sufficient of public health significance during the
number for its intended use. period of storage of the in-process or
(1) The instruments and controls final infant formula product.
shall be calibrated against a known ref- (3)(i) Cold storage compartments and
erence standard at the time of or be- thermal processing equipment shall be

fore first use and thereafter at routine equipped with easily readable, accurate
intervals, as specified in writing by the temperature-indicating devices.
217
§ 106.35 21 CFR Ch. I (4–1–23 Edition)
(ii) A manufacturer shall ensure that (2) A manufacturer shall make and
the temperature of each cold storage retain records on equipment cleaning,
compartment is maintained by: sanitizing, and maintenance, in accord-
(A) Monitoring the temperature of ance with § 106.100(f)(4).
the cold storage compartment on a (g) A manufacturer shall ensure that
temperature-indicating device and re- compressed air or other gases that are
cording this temperature in a record mechanically introduced into infant
with such frequency as is necessary to formula, that are used to clean any
ensure that temperature control is equipment, or that come into contact
maintained; with any other surface that contacts
(B) Equipping the cold storage com- ingredients, in-process materials, or in-
partment with one or more tempera- fant formula product are treated in
ture-recording devices that will reflect, such a way that their use will not con-
on a continuing basis, the true tem- taminate the infant formula with un-
perature, within the compartment; lawful or other chemical, physical, or
(C) Equipping the cold storage com- microbiological contaminants. When
partment with a high temperature compressed gases are used at product
alarm that has been validated to func- filling machines to replace air removed
tion properly and recording the tem- from the headspace of containers, a
perature in a record with such fre- manufacturer shall install, as close as
quency as is necessary to ensure that practical to the end of the gas line that
temperature control is maintained; or feeds gas into the space, a filter capa-
(D) Equipping the cold storage com- ble of retaining particles 0.5 microm-
partment with a maximum-indicating eter or smaller.
thermometer that has been validated [79 FR 8059, Feb. 10, 2014, as amended at 79
to function properly and recording this FR 33071, June 10, 2014]
temperature in a record with such fre-
quency as is necessary to ensure that § 106.35 Controls to prevent adultera-
temperature control is maintained. tion due to automatic (mechanical
(iii) A manufacturer shall, in accord- or electronic) equipment.
ance with § 106.100(f)(3), make and re- (a) For the purposes of this section:
tain records of the temperatures re- (1) ‘‘Hardware’’ means all automatic
corded in compliance with equipment, including mechanical and
§ 106.30(e)(3)(ii). electronic equipment (such as com-
(4) When a manufacturer uses a tem- puters), that is used in production or
perature-recording device for a cold quality control of infant formula.
storage compartment, such device shall (2) ‘‘Software’’ means any programs,
not read lower than the reference tem- procedures, rules, and associated docu-
perature-indicating device. mentation used in the operation of a
(5) A manufacturer shall monitor the system.
temperature in thermal processing (3) ‘‘System’’ means a collection of
equipment at points where tempera- components (including software and
ture control is necessary to prevent hardware) organized to accomplish a
adulteration. Such monitoring shall be specific function or set of functions in
at such frequency as is required by reg- a specified environment.
ulation or is necessary to ensure that (4) ‘‘Validation’’ means establishing
temperature control is maintained. documented evidence that provides a
(f) A manufacturer shall ensure that high degree of assurance that a system
equipment and utensils used in the will consistently produce a product
manufacture of infant formula are meeting its predetermined specifica-
cleaned, sanitized, and maintained at tions and quality characteristics. Vali-
regular intervals to prevent adultera- dation can be accomplished through
tion of the infant formula. any suitable means, such as
(1) An individual qualified by edu- verification studies or modeling.
cation, training, or experience to con- (b) All systems shall be designed, in-
duct such a review shall review all stalled, tested, and maintained in a
cleaning, sanitizing, and maintenance manner that will ensure that they are
to ensure that it has been satisfac- capable of performing their intended
torily completed. function and of producing or analyzing
218
infant formula in accordance with this safe (GRAS) for such use, or is author-
subpart and subpart C of this part. ized by a prior sanction.
(1) A manufacturer shall ensure, at (b) Infant formula containers and clo-
any point, step, or stage where control sures shall not be reactive or absorp-
is necessary to prevent adulteration of tive so as to affect the safety of the in-
the infant formula, that all hardware is fant formula. The following substances
routinely inspected and checked ac- may be used as packaging material
cording to written procedures and that that comes in contact with an infant
hardware that is capable of being cali- formula:
brated is routinely calibrated accord- (1) A food additive that is the subject
ing to written procedures. of a regulation issued under section
(2) A manufacturer shall check and 409(c) of the Federal Food, Drug, and
document the accuracy of input into, Cosmetic Act (21 U.S.C. 348(c)) and is
and output generated by, any system used consistent with the conditions of
used in the production or quality con- use of that regulation;
trol of an infant formula to ensure that
(2) A food contact substance that is
the infant formula is not adulterated.
the subject of an effective notification
The degree and frequency of input/out-
under section 409(h) of the Federal
put verification shall be based on the
Food, Drug, and Cosmetic Act and is
complexity and reliability of the sys-
used consistent with the conditions of
tem and the level of risk associated
use in that notification;
with the safe operation of the system.
(3) A manufacturer shall ensure that (3) A substance that is exempt from
each system is validated prior to the regulation as a food additive under
release for distribution of any infant § 170.39 of this chapter and its use con-
formula manufactured using the sys- forms to the use identified in the ex-
tem. emption letter;
(4) A manufacturer shall ensure that (4) A substance that is generally rec-
any system that is modified is revali- ognized as safe for use in or on infant
dated following the modification and formula or for use in infant formula
prior to the release for distribution of packaging;
any infant formula manufactured using (5) A substance the use of which is
the modified system. All modifications authorized by a prior sanction from the
to software shall be made by a des- Food and Drug Administration or from
ignated individual and shall be checked the U.S. Department of Agriculture;
by the infant formula manufacturer to and
ensure that infant formula that is pro- (6) A substance that is not a food ad-
duced or analyzed using the modified ditive within the meaning of section
software complies with this subpart 201(s) of the Federal Food, Drug, and
and with subpart C of this part. Cosmetic Act (21 U.S.C. 321(s)) because
(c) A manufacturer shall make and the substance is not reasonably ex-
retain records, in accordance with pected to become a component of food
§ 106.100(f)(5), concerning mechanical or or otherwise affect the characteristics
electronic equipment. of food.
[79 FR 8059, Feb. 10, 2014, as amended at 79 (c) Ingredients, containers, and clo-
FR 33071, June 10, 2014] sures used in the manufacture of infant
formula shall be identified with a lot
§ 106.40 Controls to prevent adultera- number to be used in recording their
tion caused by ingredients, con- disposition.
tainers, and closures. (d) A manufacturer shall develop
(a) The only substances that may be written specifications for ingredients,
used in an infant formula are sub- containers, and closures used in manu-
stances that are safe and suitable for facturing infant formula and shall de-
use in infant formula under the appli- velop and follow written procedures to
cable food safety provisions of the Fed- determine whether all ingredients, con-
eral Food, Drug, and Cosmetic Act; tainers, and closures meet these speci-
that is, a substance is used in accord- fications. When any specification is not
ance with the Agency’s food additive met, an individual qualified by edu-
regulations, is generally recognized as cation, training, or experience shall
219
§ 106.40 21 CFR Ch. I (4–1–23 Edition)
conduct a documented review, shall de- (f) If an ingredient, container, or clo-

termine whether a failure to meet such sure that complies with a manufactur-
a specification could result in an adul- er’s specifications, or that has been re-
terated infant formula, and shall make leased for use following a material re-
and document a material disposition view and disposition decision, is subse-
decision to reject the ingredient, con- quently exposed to air, heat, or other
tainer, or closure or the affected infant conditions that may adversely affect
formula; to reprocess or otherwise re- it, or if a manufacturer reasonably be-
condition the ingredient, container, or lieves that an ingredient, container, or
closure or the affected infant formula; closure that complies with a manufac-
or to approve and release the ingre- turer’s specifications, or that has been
dient, container, or closure or the af- released for use following a material
fected infant formula for use. review and disposition decision, has
(e) Ingredients, containers, and clo- been exposed to air, heat, or other con-
sures shall be stored in separate areas ditions that may adversely affect it,
or separated by a system of segrega- the ingredient, container, or closure
tion, such as a computerized inventory shall be quarantined under a system
control, a written card system, or an designed to prevent its use in the man-
automated system of segregation, ufacture of infant formula until an in-
clearly designated for materials pend- dividual qualified by education, train-
ing release for use; materials released ing, or experience has conducted a doc-
for use; or materials rejected for use in umented review and has made and doc-
infant formula production. umented a material disposition deci-
(1) Any lot of an ingredient, a con- sion to reject the ingredient, container,
tainer, or a closure that does not meet or closure; to reprocess or otherwise re-
the manufacturer’s specifications shall condition the ingredient, container, or
be quarantined under a system de- closure; or to approve and release the
signed to prevent its use in the manu- ingredient, container, or closure for
facture of infant formula until an indi- use.
vidual qualified by education, training, (1) Any ingredient, container, or clo-
or experience has conducted a docu- sure that is reprocessed or otherwise
mented review, has determined wheth- reconditioned shall be retested or reex-
er such failure could result in an adul- amined and be the subject of a docu-
terated infant formula, and has made mented review and material disposi-
and documented a material disposition tion decision by an individual qualified
decision to reject the ingredient, con- by education, training, or experience to
tainer, closure, or the affected infant determine whether the ingredient, con-
formula; to reprocess or otherwise re- tainer, or closure should be rejected,
condition the ingredient, container, further reprocessed or otherwise fur-
closure, or the affected infant formula; ther reconditioned, or approved and re-
or to approve and release the ingre- leased for use.
dient, container, closure, or the af- (2) Any rejected ingredient, con-
fected infant formula for use. tainer, or closure shall be clearly iden-
(2) Any ingredient, container, or clo- tified as having been rejected for use in
sure that has been reprocessed or oth- infant formula manufacturing or proc-
erwise reconditioned shall be the sub- essing operations and shall be con-
ject of a documented review and mate- trolled under a quarantine system de-
rial disposition decision by an indi- signed to prevent its use in infant for-
vidual qualified by education, training, mula manufacturing or processing op-
or experience to determine whether it erations.
may be released for use. (3) Any ingredient, container, or clo-
(3) A manufacturer shall not reproc- sure that has not been manufactured,
ess or otherwise recondition an ingre- packaged, labeled, or held under condi-
dient, container, or closure rejected be- tions to prevent adulteration under
cause it is contaminated with micro- section 402(a)(1) through (a)(4) of the
organisms of public health significance Federal Food, Drug, and Cosmetic Act
or other contaminants, such as heavy (21 U.S.C. 342(a)(1) through (a)(4)) shall
metals. not be approved and released for use.
220
(g) A manufacturer shall make and that the formula is not contaminated
retain records, in accordance with with microorganisms or other contami-
§ 106.100(f)(6), on the ingredients, con- nants. Such controls shall include:
tainers, and closures used in the manu- (1) The mixing time; the speed, tem-
facture of infant formula. perature, and flow rate of product; and
other critical parameters necessary to
§ 106.50 Controls to prevent adultera- ensure the addition of required ingredi-
tion during manufacturing. ents to, and the homogeneity of, the
(a) A manufacturer shall prepare and formula;
follow a written master manufacturing (2) The spray-drying process for pow-
order that establishes controls and pro- dered infant formula, including the fil-
cedures for the production of an infant tering of the intake air before heating,
formula. to prevent microbial and other con-
(1) The manufacturer shall make and tamination;
retain records, in accordance with (3) The removal of air from the fin-
§ 106.100(e), that include complete infor- ished product to ensure that nutrient
mation relating to the production and deterioration does not occur;
control of the production aggregate. (4) Ensuring that each container of
An individual qualified by education, finished product is properly sealed.
training, or experience shall conduct Such controls shall involve use of es-
an investigation of any deviations from tablished procedures, specifications,
the master manufacturing order and and intervals of examination that are
document any corrective action taken. designed by qualified individuals and
(2) Changes made to the master man- are sufficient to:
ufacturing order shall be reviewed and (i) Detect visible closure or seal de-
approved by a responsible official and fects, and
include an evaluation of the effect of (ii) Determine closure strength
the change on the nutrient content and through destructive testing. A manu-
the suitability of the formula for in- facturer of a liquid infant formula that
fants. is a thermally processed low-acid food
(b) A manufacturer shall establish packaged in a hermetically sealed con-
controls to ensure that each raw or in- tainer shall perform such closure integ-
process ingredient required by the mas- rity testing in accordance with
ter manufacturing order is examined § 113.60(a) of this chapter.
by one person and checked by a second (e) A manufacturer shall establish
person or system. This checking shall controls that ensure that the equip-
ensure that the correct ingredient is ment used at points where control is
added during the manufacturing proc- deemed necessary to prevent adultera-
ess, that the ingredient has been re- tion is monitored, so that personnel
leased for use in infant formula, and will be alerted to malfunctions.
that the correct weight or measure of (f) A manufacturer shall establish
the ingredient is added to the produc- controls for in-process material as fol-
tion unit. lows:
(c) A manufacturer shall establish a (1) For any specification established
system of identification for the con- in accordance with § 106.6(c)(1) that a
tents of all compounding and storage manufacturer fails to meet for in-proc-
containers, processing lines, and major ess material, an individual qualified by
equipment used during the manufac- education, training, or experience shall
ture of a production aggregate of an in- conduct a documented review and shall
fant formula. The system shall permit make a material disposition decision
the identification of the processing to reject the affected in-process mate-
stage and the unique identification rial, to reprocess or otherwise recondi-
number for the particular production tion the affected in-process material,
unit or production aggregate of infant or to approve and release the affected
formula. in-process material for use or distribu-
(d) A manufacturer shall establish tion;
controls to ensure that the nutrient (2) Pending a documented review and
levels required by § 107.100 of this chap- material disposition decision, any in-
ter are maintained in the formula, and process material that fails to meet any
221
§ 106.55 21 CFR Ch. I (4–1–23 Edition)
specification established in accordance (b) A manufacturer of liquid infant

with § 106.6(c)(1) shall be clearly identi- formula shall comply, as appropriate,
fied as such and shall be controlled with the procedures specified in part
under a quarantine system designed to 113 of this chapter for thermally proc-
prevent its use in manufacturing or essed low-acid foods packaged in her-
processing operations until completion metically sealed containers and part
of the documented review and material 114 of this chapter for acidified foods.
disposition decision; (c) A manufacturer of powdered in-
(3) Any in-process material that has fant formula shall test representative
been reprocessed or otherwise recondi- samples of each production aggregate
tioned shall be the subject of a docu- of powdered infant formula at the final
mented review and material disposi- product stage, before distribution, to
tion decision by an individual qualified ensure that each production aggregate
by education, training, or experience to meets the microbiological quality
determine whether it may be released standards in the table in paragraph (e)
for use; and of this section.
(4) Any rejected in-process material (d) A manufacturer shall make and
shall be clearly identified as having retain records, in accordance with
been rejected for use in infant formula § 106.100(e)(5)(ii) and (f)(7), on the test-
and shall be controlled under a quar- ing of infant formulas for microorga-
antine system designed to prevent its nisms.
use in infant formula manufacturing or (e) A powdered infant formula that
processing operations. contains any microorganism that ex-
ceeds the M value listed for that micro-
[79 FR 8059, Feb. 10, 2014, as amended at 79 organism in the table in paragraph (e)
FR 33071, June 10, 2014] of this section shall be deemed adulter-
ated under sections 402(a)(1), 402(a)(4),
§ 106.55 Controls to prevent adultera- and 412(a)(3) of the Federal Food, Drug,
tion from microorganisms. and Cosmetic Act (21 U.S.C. 350a(a)(3)).
(a) A manufacturer of infant formula The Food and Drug Administration
shall establish a system of process con- will determine compliance with the M
trols covering all stages of processing values listed below using the latest edi-
that is designed to ensure that infant tion of the Bacteriological Analytical
formula does not become adulterated Manual (BAM) (http://www.fda.gov/Food/
due to the presence of microorganisms FoodScienceResearch/LaboratoryMethods/
in the formula or in the processing en- BacteriologicalAnalyticalManualBAM/de-
vironment. fault.htm) (accessed April 8, 2013).
Microorganism n1 Sample size M value
Cronobacter spp. ............................................. 30 10 g (grams) .................................................... 2 0.
Salmonella spp. ............................................... 60 25 g ................................................................. 2 0.
1 Number of samples.
2 None detected.
§ 106.60 Controls to prevent adultera- tions of processing, storage, handling,

tion during packaging and labeling distribution, and use.
of infant formula. (c) Packaging used to hold multiple
(a) A manufacturer shall examine containers of an infant formula prod-
packaged and labeled infant formula uct shall be labeled as follows:
during finishing operations to ensure (1) Where all containers are the same
that all containers and packages in the infant formula product and all bear the
production aggregate have the correct same code established under § 106.80,
label, the correct use-by date, and the the packaging label shall include the
correct code established under § 106.80. product name, the name of the manu-
facturer, distributor, or shipper, and
(b) Labels shall be designed, printed,
the code established under § 106.80.

and applied so that the labels remain
(2) Where the containers are not the
legible and attached during the condi-
same infant formula product or do not
222
all bear the same code established fant formula that is reprocessed or oth-
under § 106.80, the packaging label erwise reconditioned shall be the sub-
shall: ject of a documented review and mate-
(i) Include the product name of each rial disposition decision by an indi-
product, the name of the manufacturer, vidual qualified by education, training,
distributor, or shipper of each product, or experience to determine whether it
the code established under § 106.80 for may be released for use or distribution.
each product, and a ‘‘use by’’ date that (c) Any rejected infant formula shall
is no later than the ‘‘use by’’ date of be clearly identified as having been re-
the container exhibiting the closest jected for use and shall be controlled
‘‘use by’’ date applied to satisfy the re- under a quarantine system designed to
quirement of § 107.20(c) of this chapter; prevent its release or distribution.
or (d) A production aggregate of infant
(ii) Include a unique identification formula, including a reprocessed or re-
number assigned by the packager, pro- conditioned production aggregate, that
vided that the distributor of the pack- does not meet the nutrient require-
age maintains a record linked to such ments of section 412(i) of the Federal
unique number that identifies the prod- Food, Drug, and Cosmetic Act (21
uct name of each product, the name of U.S.C. 350a(i)) or that has not been
the manufacturer, distributor, or ship- manufactured, packaged, labeled, and
per of each product, the code estab- held under conditions to prevent adul-
lished under § 106.80 for each product, teration under sections 402(a)(1)
and the ‘‘use by’’ date for each product through (a)(4) of the Federal Food,
applied to satisfy the requirement of Drug, and Cosmetic Act (21 U.S.C.
§ 107.20(c) of this chapter. 342(a)(1) through (a)(4)) shall not be ap-
§ 106.70 Controls on the release of fin- proved and released for distribution.
ished infant formula.
§ 106.80 Traceability.
(a) A manufacturer shall control
under a quarantine system designed to Each production aggregate of infant
prevent use or distribution of each pro- formula shall be coded with a sequen-
duction aggregate of infant formula tial number that identifies the product
until it determines that the production and the establishment where the prod-
aggregate meets all of the manufactur- uct was packed and that permits trac-
er’s specifications, including those ing of all stages of manufacture of that
adopted to meet the standards of production aggregate, including the
§ 106.55 on microbiological contamina- year, the days of the year, and the pe-
tion and of § 106.91(a) on quality control riod during those days that the product
procedures, or until the documented re- was packed, and the receipt and han-
view of the failure to meet any of the dling of raw materials used.
manufacturer’s specifications finds
that the failure does not result in, or § 106.90 Audits of current good manu-
facturing practice.
could not lead to, adulteration of the
product. (a) A manufacturer of an infant for-
(b) Any production aggregate of in- mula, or an agent of such manufac-
fant formula that fails to meet any of turer, shall conduct regularly sched-
the manufacturer’s specifications shall uled audits to determine whether the
be quarantined under a system de- manufacturer has complied with the
signed to prevent its use in the manu- current good manufacturing practice
facture of infant formula or its dis- regulations in this subpart. Such au-
tribution until an individual qualified dits shall be conducted at a frequency
by education, training, or experience that is required to ensure compliance
has conducted a documented review with such regulations.
and has made and documented a mate- (b) The audits required by paragraph
rial disposition decision to reject the (a) of this section shall be performed by
infant formula; to reprocess or other- an individual or a team of individuals
wise recondition the infant formula; or who, as a result of education, training,

to approve and release the infant for- or experience, is knowledgeable in all
mula. Any production aggregate of in- aspects of infant formula production
223
§ 106.91 21 CFR Ch. I (4–1–23 Edition)
and of the Agency’s regulations con- shall collect, from each manufacturing
cerning current good manufacturing site and at the final product stage, a
practice that such individual or team representative sample of the first pro-
is responsible for auditing. This indi- duction aggregate of packaged, fin-
vidual or team of individuals shall ished formula in each physical form
have no direct responsibility for the (powder, ready-to-feed, or concentrate)
matters that such individual or team is and evaluate the levels of all nutrients
auditing and shall have no direct inter- required under § 107.100 of this chapter
est in the outcome of the audit. and all other nutrients added by the
manufacturer. The manufacturer shall
Subpart C—Quality Control repeat such testing every 4 months
Procedures thereafter throughout the shelf life of
the product.
§ 106.91 General quality control.
(ii) The Food and Drug Administra-
(a) During manufacture, a manufac- tion will exempt the manufacturer
turer shall test each production aggre- from the requirements of paragraph
gate for nutrients as follows: (b)(1)(i) of this section if the manufac-
(1) Each nutrient premix used in the turer of a new infant formula requests
manufacture of an infant formula shall an exemption and provides analytical
be tested for each nutrient (required
data, as required under § 106.120(b)(7),
under § 107.100 of this chapter or other-
that demonstrates that the stability of
wise added by the manufacturer) that
the manufacturer is relying on the pre- the new infant formula will likely not
mix to provide, to ensure that the pre- differ from the stability of formulas
mix is in compliance with the manu- with similar composition, processing,
facturer’s specifications; and packaging for which there are ex-
(2) During the manufacturing proc- tensive stability data. A manufacturer
ess, after the addition of the premix, or exempt from the requirements of para-
at the final product stage but before graph (b)(1)(i) of this section would be
distribution, each production aggre- required to test the first production ag-
gate of infant formula shall be tested gregate according to the requirements
for at least one indicator nutrient for of § 106.91(b)(2).
each of the nutrient premixes used in (2) The manufacturer shall collect,
the infant formula to confirm that the from each manufacturing site and at
nutrients supplied by each of the pre- the final product stage, a representa-
mixes are present, in the proper con- tive sample of each subsequent produc-
centration, in the production aggregate tion aggregate of packaged, finished
of infant formula. formula in each physical form (powder,
(3) At the final product stage, before ready-to-feed, or concentrate) and
distribution of an infant formula, each evaluate the levels of all nutrients re-
production aggregate shall be tested quired under § 107.100 of this chapter
for vitamins A, C, E, and thiamin. and all other nutrients added by the
(4) During the manufacturing process manufacturer. The manufacturer shall
or at the final product stage, before
repeat such testing at the end of the
distribution, each production aggre-
shelf life of the product.
gate shall be tested for all nutrients re-
quired to be included in such formula (3) If the results of the testing re-
under § 107.100 of this chapter for which quired by paragraph (b)(1) of this sec-
testing is not conducted for compliance tion do not substantiate the shelf life
with paragraphs (a)(1) or (a)(3) of this of the infant formula, the manufac-
section and for any nutrient added by turer shall address, as appropriate, all
the manufacturer for which testing is production aggregates of formula re-
not conducted for compliance with leased and pending release for distribu-
paragraph (a)(1) of this section. tion that are implicated by the testing
(b) A manufacturer shall test each results, such as by conducting the test-
production aggregate of finished prod- ing required by paragraph (b)(1) of this
uct for nutrients as follows: section on a subsequently produced

(1)(i) For an infant formula that is a production aggregate to substantiate
new infant formula the manufacturer the shelf life of the infant formula or
224
revising the use by date for such prod- ducted at a frequency that is required
uct so that such date is substantiated to ensure compliance with the require-
by the stability testing results. ments for quality control procedures.
(4) If results of the testing required (b) The audits required by paragraph
by paragraph (b)(2) of this section show (a) of this section shall be performed by
that any required nutrient is not an individual or a team of individuals
present in the production aggregate of who, as a result of education, training,
infant formula at the level required by or experience, is knowledgeable in all
§ 107.100 of this chapter or that any nu- aspects of infant formula production
trient added by the manufacturer is and of the regulations concerning qual-
not present at the level declared on the ity control procedures that such indi-
label of the production aggregate of in- vidual or team is responsible for audit-
fant formula, the manufacturer shall: ing. This individual or team of individ-
(i) Investigate the cause of such vari- uals shall have no direct responsibility
ance in the level of any required or for the matters that such individual or
added nutrient; team is auditing and shall have no di-
(ii) Evaluate the significance, if any, rect interest in the outcome of the
of the results for other production ag- audit.
gregates of the same formula that have
been released for distribution; Subpart D—Conduct of Audits
(iii) Address, as appropriate, all pro-
duction aggregates of formula released § 106.94 Audit plans and procedures.
and pending release for distribution (a) A manufacturer shall develop and
that are implicated by the testing re- follow a written audit plan that is
sults; and available at the manufacturing facility
(iv) Determine whether it is nec- for Food and Drug Administration in-
essary to conduct the testing required spection.
by paragraph (b)(1) of this section. (b) The audit plan shall include audit
(5) The testing required by para- procedures that set out the methods
graphs (b)(1) and (b)(2) of this section is the manufacturer uses to determine
not required to evaluate the level of whether the facility is operating in ac-
minerals present in the infant formula. cordance with current good manufac-
(c) All quality control testing shall turing practice, with the quality con-
be conducted using appropriate, sci- trol procedures that are necessary to
entifically valid test methods. ensure that an infant formula provides
(d) A manufacturer shall make and nutrients in accordance with sections
retain quality control records in ac- 412(b) and (i) of the Federal Food, Drug,
cordance with § 106.100(e)(5)(i). and Cosmetic Act, and in a manner de-
[79 FR 8059, Feb. 10, 2014, as amended at 79 signed to prevent adulteration of the
FR 33071, June 10, 2014] infant formula.
(c) The audit procedures shall in-
§ 106.92 Audits of quality control pro- clude:
cedures. (1) An evaluation of the production
(a) A manufacturer of an infant for- and in-process control system estab-
mula, or an agent of such a manufac- lished under § 106.6(b) by:
turer, shall conduct regularly sched- (i) Observing the production of infant
uled audits to determine whether the formula and comparing the observed
manufacturer has complied with the process to the written production and
requirements for quality control proce- in-process control plan required under
dures that are necessary to ensure that § 106.6(b);
an infant formula provides nutrients in (ii) Reviewing records of the moni-
accordance with section 412(b) and (i) toring of points, steps, or stages where
of the Federal Food, Drug, and Cos- control is deemed necessary to prevent
metic Act (21 U.S.C. 350a(b) and (i)) and adulteration; and
is manufactured in a manner designed (iii) Reviewing records of how devi-
to prevent adulteration of the infant ations from any specification at points,
formula under section 412(a)(1) and steps, or stages where control is

(a)(3) of the Federal Food, Drug, and deemed necessary to prevent adultera-
Cosmetic Act. Such audits shall be con- tion were handled; and
225
§ 106.96 21 CFR Ch. I (4–1–23 Edition)
(2) A review of a representative sam- rent control group or groups and a sci-
ple of all records maintained in accord- entifically appropriate reference.
ance with § 106.100(e) and (f). (c) The Food and Drug Administra-
tion will exempt a manufacturer from
Subpart E—Quality Factors for the requirements of paragraph (b) of
Infant Formulas this section, if:
(1) The manufacturer requests an ex-
§ 106.96 Requirements for quality fac- emption and provides assurances, as re-
tors for infant formulas. quired under § 106.121(b), that the
The regulations set forth in this sub- changes made by the manufacturer to
part define the minimum requirements an existing infant formula are limited
for quality factors for infant formulas: to changing the type of packaging of
(a) An infant formula shall meet the an existing infant formula (e.g., chang-
quality factor of normal physical ing from metal cans to plastic pouch-
growth. es); or
(b) A manufacturer of an infant for- (2) The manufacturer requests an ex-
mula that is not an eligible infant for- emption and provides assurances, as re-
mula shall demonstrate that a formula quired under § 106.121, which dem-
supports normal physical growth in in- onstrate that:
fants when fed as a sole source of nutri- (i) An alternative method or study
tion by conducting, in accordance with design that is based on sound scientific
good clinical practice, an adequate and
principles is available to show that the
well-controlled growth monitoring
formula supports normal physical
study of the infant formula that:
growth in infants when the formula is
(1) Is no less than 15 weeks in dura-
fed as the sole source of nutrition;
tion, enrolling infants no more than 2
weeks old at time of entry into the (ii) The change made by the manu-
study; facturer to an existing formula does
(2) Includes the collection and main- not affect the ability of the formula to
tenance of data on formula intake and support normal physical growth; or
anthropometric measures of physical (iii) The manufacturer markets a for-
growth, including body weight, recum- mulation in more than one form (e.g.,
bent length, head circumference, aver- liquid and powdered forms) and the
age daily weight increment, and aver- quality factor requirements are met by
age daily recumbent length increment; the form of the formula that is proc-
(3) Includes anthropometric measure- essed using the method that has the
ments made at the beginning and end greatest potential for adversely affect-
of the study, and at least four addi- ing nutrient content and bio-
tional measurements made at inter- availability.
mediate time points with three of the (d) A manufacturer of a new infant
six total measurements made within formula that is not an eligible infant
the first 4 weeks of the study and three formula shall, in accordance with
measurements made at approximately § 106.100(p)(1), make and retain records
4-week intervals over the remaining 11 demonstrating that the formula meets
weeks of the study; the quality factor of normal physical
(4) Compares the anthropometric growth.
data for the test group to a concurrent (e) An infant formula shall meet the
control group or groups at each time
quality factor of sufficient biological
point and compares the anthropo-
quality of protein.
metric data for each infant (body
weight for age, body length for age, (f) A manufacturer of an infant for-
head circumference for age, and weight mula that is not an eligible infant for-
for length) in the test group and the mula shall demonstrate that a formula
control group to the 2009 CDC growth meets the quality factor of sufficient
charts, which are incorporated by ref- biological quality of protein by estab-
lishing the biological quality of the
erence at § 106.160; and

(5) Compares the data on formula in- protein in the infant formula when fed
take of the test group with a concur- as the sole source of nutrition using an
226
appropriate modification of the Pro- (i) The scientific evidence on such in-
tein Efficiency Ratio (PER) rat bio- fant formula meets the requirements of
assay described in the ‘‘Official Meth- paragraph (b) of this section that apply
ods of Analysis of AOAC Inter- to infant formula that is not an eligi-
national,’’ 18th ed., sections 45.3.04 and ble infant formula;
45.3.05, ‘‘AOAC Official Method 960.48 (ii) The scientific evidence on such
Protein Efficiency Ratio Rat Bio- infant formula meets the following
assay,’’ which is incorporated by ref- provisions:
erence at § 106.160. The PER rat bio- (A) The evidence is an adequate and
assay shall be conducted on a formula well-controlled growth study, con-
and the results evaluated prior to the ducted in accordance with good clinical
initiation of a growth monitoring practice, to determine whether an in-
study of the formula that is required fant formula supports normal physical
under paragraph (b) of this section. growth in infants when the formula is
(g) The Food and Drug Administra- fed as the sole source of nutrition;
tion will exempt a manufacturer from (B) The growth study is no less than
the requirements of paragraph (f) of 4 months in duration, enrolling infants
this section, if: no more than 1 month old at time of
(1) The manufacturer requests an ex- entry into the study;
emption and provides assurances as re- (C) The growth study collects from
quired under § 106.121(g) that the the study subjects data on anthropo-
changes made by the manufacturer to metric measures of physical growth,
an existing infant formula are limited including body weight, recumbent
to changing the type of packaging of length, head circumference, and aver-
an existing infant formula (e.g., chang- age daily weight increment, and plots
ing from metal cans to plastic pouch- the data on the following charts from
es); or ‘‘Physical Growth: National Center for
Health Statistics Percentiles’’ for body
(2) The manufacturer requests an ex-
weight, body length, and head circum-
emption and provides assurances, as re-
ference, which are incorporated by ref-
quired under § 106.121(h), that dem-
erence at § 106.160:
onstrate that the change made by the (1) Figure 1. Length by age percent-
manufacturer to an existing formula iles for girls aged birth–36 months (p.
does not affect the bioavailability of 609);
the protein. (2) Figure 2. Length by age percent-
(3) The manufacturer requests an ex- iles for boys aged birth–36 months (p.
emption and provides assurances, as re- 610);
quired under § 106.121(i), that dem- (3) Figure 3. Weight by age percentiles
onstrate that an alternative method to for girls aged birth–36 months (p. 611);
the PER that is based on sound sci- (4) Figure 4. Weight by age percentiles
entific principles is available to dem- for boys aged birth–36 months (p. 612);
onstrate that the formula supports the (5) Figure 5. Head circumference by
quality factor for the biological qual- age percentiles for girls aged birth–36
ity of the protein. months (p. 613);
(h) A manufacturer of a new infant (6) Figure 6. Weight by length per-
formula that is not an eligible infant centiles for girls aged birth–36 months
formula shall, in accordance with (p. 613);
§ 106.100(q), make and retain records (7) Figure 7. Head circumference by
demonstrating that the formula meets age percentiles for boys aged birth–36
the quality factor of sufficient biologi- months (p. 614); and
cal quality of protein. (8) Figure 8. Weight by length per-
(i) The following provisions for re- centiles for boys aged birth–36 months
quirements for quality factors apply (p. 614); and
only to an ‘‘eligible infant formula’’ as (D) The growth study collects an-
defined in § 106.3: thropometric measurements at the be-
(1) An eligible infant formula that ginning of the growth study, at 2
fulfills one or more of the following weeks, at 4 weeks, at least monthly

criteria meets the quality factor of thereafter, and at the conclusion of the
normal physical growth: study; or
227
§ 106.100 21 CFR Ch. I (4–1–23 Edition)
(iii) The scientific evidence on such in infants when fed as the sole source
infant formula otherwise demonstrates of nutrition and shall make and retain,
that such formula supports normal in accordance with § 106.100(q)(2),
physical growth. records to demonstrate that that the
(2) An eligible infant formula that protein in such infant formula is of suf-
fulfills one or more of the following ficient biological quality. The records
criteria meets the quality factor of suf- required by this paragraph shall in-
ficient biological quality of the pro- clude all relevant scientific data and
tein: information and a narrative expla-
(i) The scientific evidence on such in- nation of why the data and information
fant formula meets the requirements of demonstrate that the formula supports
paragraph (f) of this section that apply normal physical growth and a nar-
to infant formula that is not an eligi- rative explanation of why the data and
ble infant formula; information demonstrate that the pro-
(ii) The scientific evidence on such tein in such infant formula is of suffi-
infant formula is a study that estab- cient biological quality.
lishes the biological quality of the pro-
[79 FR 8059, Feb. 10, 2014, as amended at 79
tein in an infant formula by dem- FR 33071, June 10, 2014]
onstrating that the protein source sup-
ports adequate growth using the Pro-
tein Efficiency Ratio (PER) rat bio- Subpart F—Records and Reports
assay described in sections 45.3.04 and
§ 106.100 Records.
45.3.05 of the ‘‘Official Methods of Anal-
ysis of the Association of Official Ana- (a) Every manufacturer of infant for-
lytical Chemists,’’ 16th ed., which are mula shall maintain the records speci-
incorporated by reference at § 106.160; fied in this regulation in order to per-
or mit the Food and Drug Administration
(iii) The scientific evidence on such to determine whether each manufac-
infant formula otherwise demonstrates turer is in compliance with section 412
that the protein in such infant formula of the Federal Food, Drug, and Cos-
is of sufficient biological quality. metic Act (21 U.S.C. 350a)).
(3) The manufacturer of an eligible (b) The manufacturer shall maintain
infant formula may, not later than No- all records that pertain to food-pack-
vember 12, 2015, submit a petition to aging materials subject to § 174.5 of this
the Food and Drug Administration chapter and that bear on whether such
under § 10.30 of this chapter that: materials would cause an infant for-
(i) Demonstrates that such formula mula to be adulterated within the
fulfills one or more of the criteria in meaning of section 402(a)(2)(C) of the
paragraph (i)(1) of this section; or Federal Food, Drug, and Cosmetic Act
(ii) Demonstrates that such formula (21 U.S.C. 342(a)(2)(C)).
fulfills one or more of the criteria in (c) The manufacturer shall maintain
paragraph (i)(2) of this section. all records that pertain to nutrient
(4) A petition filed under paragraph premix testing that it generates or re-
(i)(3) of this section shall address only ceives. Such records shall include, but
one infant formula formulation and are not limited to:
shall contain all data and information (1) Any results of testing conducted
relied upon by the manufacturer to to ensure that each nutrient premix is
demonstrate that such formulation ful- in compliance with the premix certifi-
fills one or more of the criteria in para- cate and guarantee and specifications
graph (i)(1) or in paragraph (i)(2) of this that have been provided to the manu-
section. A manufacturer may combine facturer by the premix supplier, includ-
petitions submitted under paragraphs ing tests conducted when nutrients ex-
(i)(3)(i) and (i)(3)(ii) of this section that ceed their expiration date or shelf life
relate to the same formulation. (retest date).
(5) The manufacturer of each eligible (2) All certificates and guarantees
infant formula shall make and retain, given by premix suppliers concerning
in accordance with § 106.100(p)(2), the nutrients required by section 412(i)

records to demonstrate that such for- of the Federal Food, Drug, and Cos-
mula supports normal physical growth metic Act and § 107.100 of this chapter.
228
(d) The premix supplier shall main- the finishing operations to provide as-
tain the results of all testing con- surance that the containers and pack-
ducted to provide all certificates and ages have the correct label.
guarantees concerning nutrient pre- (2) Any deviations from the master
mixes for infant formulas. Such records manufacturing order and any correc-
shall include but are not limited to: tive actions taken because of the devi-
(1) The results of tests conducted to ations.
determine the purity of each nutrient (3) Documentation, in accordance
required by section 412(i) of the Federal with § 106.6(c), of the monitoring at any
Food, Drug, and Cosmetic Act or point, step, or stage in the manufac-
§ 107.100 of this chapter and any other turer ’s production process where con-
nutrient listed in the certificate and trol is deemed necessary to prevent
guarantee; adulteration. These records shall in-
(2) The weight of each nutrient clude:
added; (i) A list of the specifications estab-
(3) The results of any quantitative lished at each point, step, or stage in
tests conducted to determine the the production process where control is
amount of each nutrient certified or deemed necessary to prevent adultera-
guaranteed; and tion, in accordance with § 106.6(c)(1), in-
(4) The results of any quantitative cluding documentation of the scientific
tests conducted to identify the nutri- basis for each specification;
ent levels present when nutrient pre- (ii) The actual values obtained during
mixes exceed their expiration date or the monitoring operation, any devi-
shelf life (retest date). ations from established specifications,
(e) For each production aggregate of and any corrective actions taken; and
infant formula, a manufacturer shall (iii) Identification of the person mon-
prepare and maintain records that in- itoring each point, step, or stage in the
clude complete information relating to production process where control is
the production and control of the pro- deemed necessary to prevent adultera-
duction aggregate. These records shall tion.
include: (4) The conclusions and followup,
(1) The master manufacturing order. along with the identity of the indi-
The master manufacturing order shall vidual qualified by education, training,
include: or experience who investigated:
(i) The significant steps in the pro- (i) Any deviation from the master
duction of the production aggregate manufacturing order and any correc-
and the date on which each significant tive actions taken;
step occurred; (ii) A finding that a production ag-
(ii) For a manufacturing facility that gregate or any of its ingredients failed
has more than one set of equipment or to meet the infant formula manufac-
more than one processing line, the turer’s specifications; and
identity of equipment and processing (iii) A failure to meet any specifica-
lines for which the manufacturer has tion at any point, step, or stage in the
identified points, steps, or stages in the production process where control is
production process where control is deemed necessary to prevent adultera-
necessary to prevent adulteration; tion.
(iii) The identity of each lot of ingre- (5) The results of all testing per-
dients, containers, and closures used in formed on the production aggregate of
producing the production aggregate of infant formula, including testing on
formula; the in-process production aggregate, at
(iv) The amount of each ingredient to the final product stage, and on finished
be added to the production aggregate of product throughout the shelf life of the
infant formula and a check product. The results recorded shall in-
(verification) that the correct amount clude:
was added; and (i) The results of all quality control
(v) A copy of each infant formula testing conducted in accordance with
label used on a finished production ag- § 106.91(a) and (b) to verify that each
gregate of infant formula and the re- nutrient required by § 107.100 of this
sults of examinations conducted during chapter is present in each production
229
§ 106.100 21 CFR Ch. I (4–1–23 Edition)
aggregate of infant formula at the tizing, and maintenance and the pro-
level required by § 107.100 of this chap- duction aggregate number of each in-
ter, and that all other nutrients added fant formula processed between equip-
by the manufacturer are present at the ment startup and shutdown for clean-
appropriate level. The record of the re- ing, sanitizing, and maintenance. The
sults of the quality control testing person performing and checking the
shall include: cleaning, sanitizing, and maintenance
(A) A summary document identifying shall date and sign or initial the record
the stages of the manufacturing proc- indicating that the work was per-
ess at which the nutrient analysis for formed.
each required nutrient is conducted as (5) Records, in accordance with
required under § 106.91(a); and § 106.35(c), on all mechanical and elec-
(B) A summary document on the sta- tronic equipment used in the produc-
bility testing program conducted under tion or quality control of infant for-
§ 106.91(b), including the nutrients test- mula. These records shall include:
ed and the frequency of nutrient test- (i) A list of all systems used with a
ing throughout the shelf life of the description of the computer files and
product. the defined capabilities and inherent
(ii) For powdered infant formula, the limitations of each system;
results of any testing conducted in ac- (ii) A copy of all software used;
cordance with § 106.55(c) to verify com- (iii) Records that document installa-
pliance with the microbiological qual- tion, calibration, testing or validation,
ity standards in § 106.55(e). and maintenance of the systems used;
(f) A manufacturer shall make and (iv) A list of all persons authorized to
retain all records described in subparts create or modify software;
B and C of this part, including: (v) Records that document modifica-
(1) Records, in accordance with tions to software, including the iden-
§ 106.20(f)(4), of the frequency and re- tity of the person who modified the
sults of testing of the water used in the software;
production of infant formula;
(vi) Records that document retesting
(2) Records, in accordance with
or revalidation of modified systems;
§ 106.30(d), of accuracy checks of instru-
and
ments and controls. A certification of
(vii) A backup file of data entered
accuracy of any known reference
into a computer or related system. The
standard used and a history of recer-
backup file shall consist of a hard copy
tification shall be maintained. At a
or alternative system, such as dupli-
minimum, such records shall specify
cate electronic records, tapes, or
the instrument or control being
microfilm, designed to ensure that
checked, the date of the accuracy
backup data are exact and complete,
check, the standard used, the calibra-
and that they are secure from alter-
tion method used, the results found,
ation, inadvertent erasures, or loss.
any actions taken if the instrument is
found to be out of calibration, and the (6) Records, in accordance with
initials or name of the individual per- § 106.40(g), on ingredients, containers,
forming the test. If calibration of an and closures used in the manufacture
instrument shows that a specification of infant formula. These records shall
at a point, step, or stage in the produc- include:
tion process where control is deemed (i) The identity and quantity of each
necessary to prevent adulteration has lot of ingredients, containers, and clo-
not been met, a written evaluation of sures;
all affected product, and any actions (ii) The name of the supplier;
that need to be taken with respect to (iii) The supplier’s lot numbers;
that product, shall be made. (iv) The name and location of the
(3) Records, in accordance with manufacturer of the ingredient, con-
§ 106.30(e)(3)(iii). tainer, or closure, if different from the
(4) Records, in accordance with supplier;
§ 106.30(f), on equipment cleaning, sani- (v) The date of receipt;

tizing, and maintenance that show the (vi) The receiving code as specified;
date and time of such cleaning, sani- and
230
(vii) The results of any test or exam- plaint’’ as any communication that
ination (including retesting and reex- contains any allegation, written or
amination) performed on the ingredi- oral, expressing dissatisfaction with a
ents, containers, or closures and the product for any reason, including con-
conclusions derived there from and the cerns about the possible existence of a
disposition of all ingredients, con- hazard to health and about appearance,
tainers, or closures. taste, odor, and quality. Correspond-
(7) A full description of the method- ence about prices, package size or
ology used to test powdered infant for- shape, or other matters that could not
mula to verify compliance with the possibly reveal the existence of a haz-
microbiological quality standards of ard to health shall not, for compliance
§ 106.55(c) and the methodology used to purposes, be considered a complaint
do quality control testing, in accord- and therefore need not be made avail-
ance with § 106.91(a). able to a Food and Drug Administra-
(g) A manufacturer shall maintain all tion investigator.
records pertaining to distribution of (2) When a complaint shows that a
the infant formula, including records hazard to health possibly exists, the
that show that formula produced for manufacturer shall conduct an inves-
export only is exported. Such records tigation into the validity of the com-
shall include all information and data plaint. Where such an investigation is
necessary to effect and monitor recalls conducted, the manufacturer shall in-
of the manufacturer’s infant formula clude in its file on the complaint the
products in accordance with subpart E determination as to whether a hazard
of part 107 of this chapter. to health exists and the basis for that
(h) The manufacturer shall maintain determination. No investigation is nec-
all records pertaining to the micro- essary when the manufacturer deter-
biological quality and purity of raw mines that there is no possibility of a
materials and finished powdered infant hazard to health. When no investiga-
formula. tion is necessary, the manufacturer
(i) [Reserved] shall include in the record the reason
(j) The manufacturer shall make and that an investigation was found to be
retain records pertaining to regularly unnecessary and the name of the re-
scheduled audits, including the audit sponsible person making that deter-
plans and procedures, the findings of mination.
the audit, and a listing of any changes (3) When there is a reasonable possi-
made in response to these findings. The bility of a causal relationship between
manufacturer shall make readily avail- the consumption of an infant formula
able for authorized inspection the audit and an infant’s death, the manufac-
plans and procedures and a statement turer shall, within 15 days of receiving
of assurance that the regularly sched- such information, conduct an inves-
uled audits are being conducted. The tigation and notify the Agency as re-
findings of the audit and any changes quired in § 106.150.
made in response to these findings (4) The manufacturer shall maintain
shall be maintained for the time period in designated files all records per-
required under paragraph (n) of this taining to the complaints it receives.
section, but need not be made available The manufacturer shall separate the
to the Food and Drug Administration. files into two classes:
(k) The manufacturer shall maintain (i) Those complaints that allege that
procedures describing how all written the infant became ill from consuming
and oral complaints regarding infant the product or required treatment by a
formula will be handled. The manufac- physician or health care provider and
turer shall follow these procedures and (ii) Those complaints that may in-
shall include in them provisions for the volve a possible existence of a hazard
review of any complaint involving an to health but do not refer to an infant
infant formula and for determining the becoming ill or the need for treatment
need for an investigation of the pos- by physician or a health care provider.
sible existence of a hazard to health. (5) The manufacturer shall include in

(1) For purposes of this section, every a complaint file the following informa-
manufacturer shall interpret a ‘‘com- tion concerning the complaint:
231
§ 106.100 21 CFR Ch. I (4–1–23 Edition)
(i) The name of the infant formula; meeting the requirements of this para-
(ii) The production aggregate num- graph.
ber; (m) A manufacturer shall maintain
(iii) The name of complainant; all records required under this part in
(iv) A copy of the complaint or a a manner that ensures that both the
memo of the telephone conversation or manufacturer and the Food and Drug
meeting and all correspondence with Administration can be provided with
the complainant; access to such records within 24 hours.
(v) By reference or copy, all the asso- The manufacturer may maintain the
ciated manufacturing records and com- records required under this part as
plaint investigation records needed to original records, as true copies such as
evaluate the complaint. When copies of photocopies, microfilm, microfiche, or
such records are not maintained in the other accurate reproductions of the
complaint file, they must be available original records, or as electronic
within 24 hours when requested by a records. Where reduction techniques,
Food and Drug Administration official. such as microfilming, are used, suit-
(vi) All actions taken to followup on able reader and photocopying equip-
the complaint; and ment shall be readily available. All
(vii) All findings and evaluations of electronic records maintained under
the complaint. this part shall comply with part 11 of
(6) The manufacturer should main- this chapter.
tain the files regarding infant formula (n) Production control, product test-
complaints at the establishment where ing, testing results, complaints, and
the infant formula was manufactured, distribution records necessary to verify
processed, or packed. When the manu- compliance with parts 106, 107, 109, 110,
facturer wishes to maintain all con- 113, and 117 of this chapter, or with
sumer complaints for the entire firm at other appropriate regulations, shall be
one location other than at the facility
retained for 1 year after the expiration
where an infant formula was manufac-
of the shelf life of the infant formula or
tured, processed, or packed, the manu-
3 years from the date of manufacture,
facturer may do so as long as all
whichever is greater.
records required by this section are
(o) The manufacturer shall maintain
available within 24 hours of request for
quality control records that contain
inspection at that facility. However,
sufficient information to permit a pub-
all records of consumer complaints, in-
lic health evaluation of any production
cluding summaries, any reports, and
aggregate of infant formula.
any files, maintained at the manufac-
turing facility or at any other facility (p) A manufacturer shall make and
shall be made available to investiga- retain records that demonstrate that
tors for review and copying upon re- the formula meets the quality factor of
quest. normal physical growth.
(l) The manufacturer shall make (1) For an infant formula that is not
readily available for authorized inspec- an eligible infant formula, in accord-
tion all records required under this ance with § 106.96(d), these records shall
part or copies of such records. Records include:
shall be available at any reasonable (i) Records demonstrating compli-
time at the establishment where the ance with the requirements in
activities described in such records oc- § 106.96(b), including records made in
curred. (Infant formula complaint files compliance with § 106.121; or
may be maintained at one facility, as (ii) Records demonstrating satisfac-
provided in paragraph (k)(6) of this section of an applicable exemption under
tion, if all required records are readily § 106.96(c), including records made in
available at that facility.) These compliance with § 106.121.
records or copies thereof shall be sub- (2) For an eligible infant formula, in
ject to photocopying or other means of accordance with § 106.96(i)(5), these
reproduction as part of such inspec- records shall include records dem-
tion. Records that can be immediately onstrating that the formula fulfills one
retrieved from another location by or more of the criteria listed in
electronic means shall be considered as § 106.96(i)(1).
232
(q) A manufacturer shall make and tion into interstate commerce, includ-
retain records that demonstrate that a ing a new infant formula for export
formula meets the quality factor of only, the manufacturer of the formula
sufficient biological quality of protein. shall register with the Food and Drug
(1) For an infant formula that is not Administration, Center for Food Safety
an eligible infant formula, in accord- and Applied Nutrition, Office of Nutri-
ance with § 106.96(h), these records shall tion, Labeling, and Dietary Supple-
include: ments, Infant Formula and Medical
(i) Records demonstrating compli- Foods Staff (HFS–850), 5001 Campus
ance with the requirements in Dr., College Park, MD 20740–3835.
§ 106.96(f), including records made in (b) The new infant formula registra-
compliance with § 106.121; or tion shall include:
(ii) Records demonstrating satisfac- (1) The name of the new infant for-
tion of an applicable exemption under mula;
§ 106.96(g), including records made in (2) The name of the manufacturer;
compliance with § 106.121. (3) The street address of the place of
(2) For an eligible infant formula, in business of the manufacturer; and
accordance with § 106.96(i)(5), these (4) The name and street address of
records shall include records dem- each establishment at which the manu-
onstrating that the formula fulfills one facturer intends to manufacture such
or more of the criteria listed in new infant formula.
§ 106.96(i)(2).
(r) The failure to comply with the § 106.120 New infant formula submis-
records requirements in this section sion.
applicable to the quality factors shall (a) At least 90 days before a new in-
render the formula adulterated under fant formula is introduced or delivered
section 412(a)(2) of the Federal Food, for introduction into interstate com-
Drug, and Cosmetic Act. The failure to merce, a manufacturer shall submit no-
comply with the records requirements tice of its intent to do so to the Food
in this section applicable to the good and Drug Administration at the ad-
manufacturing practices and quality dress given in § 106.110(a). An original
control procedures, including distribu- and two paper copies of such notice of
tion and audit records requirements, intent shall be submitted, unless the
with respect to an infant formula shall notice is submitted in conformance
render the formula adulterated under with part 11 of this chapter, in which
section 412(a)(3) of the Federal Food, case a single copy shall be sufficient.
Drug, and Cosmetic Act. A failure to
(b) The new infant formula submis-
retain or make available records appli-
sion shall include:
cable to the quality factor require-
(1) The name and description of the
ments, quality control procedures, or
physical form (e.g., powder, ready-to
current good manufacturing practices
feed, or concentrate) of the infant for-
requirements in compliance with para-
mula;
graph (l), (m), or (n) of this section
(2) An explanation of why the for-
with respect to a formula shall render
mula is a new infant formula;
the formula adulterated under section
(3) The quantitative formulation of
412(a)(2) or (a)(3) of the Federal Food,
Drug, and Cosmetic Act, as applicable. each form of the infant formula that is
the subject of the notice in units per
[79 FR 8059, Feb. 10, 2014, as amended at 79 volume or units per weight for liquid
FR 33072, June 10, 2014; 80 FR 56144, Sept. 17, formulas, specified either as sold or as
2015] fed, and units per dry weight for pow-
dered formulas, and the weight of pow-
Subpart G—Registration, Submis- der to be reconstituted with a specified
sion, and Notification Require- volume of water, and, when applicable,
ments a description of any reformulation of
the infant formula, including a listing
§ 106.110 New infant formula registra- of each new or changed ingredient and
tion.
a discussion of the effect of such

(a) Before a new infant formula may changes on the nutrient levels in the
be introduced or delivered for introduc- formulation;
233
§ 106.120 21 CFR Ch. I (4–1–23 Edition)
(4) A description, when applicable, of is relying on to demonstrate that the

any change in processing of the infant stability of the new infant formula will
formula. Such description shall iden- likely not differ from the stability of
tify the specific change in processing, formulas with similar composition,
including side-by-side, detailed sche- processing, and packaging for which
matic diagrams comparing the new there are extensive stability data.
processing to the previous processing (c) For a new infant formula for ex-
and processing times and tempera- port only, a manufacturer may submit,
tures; in lieu of the information required
(5) Assurance that the infant formula under paragraphs (b)(5) and (b)(6) of
will not be marketed unless the for- this section, a statement certifying
mula meets the requirements for qual- that the infant formula meets the spec-
ity factors of section 412(b)(1) of the ifications of the foreign purchaser, the
Federal Food, Drug, and Cosmetic Act infant formula does not conflict with
(21 U.S.C. 350a(b)(1)) and the nutrient the laws of the country to which it is
content requirements of section 412(i) intended for export, the infant formula
of the Federal Food, Drug, and Cos- is labeled on the outside of the ship-
metic Act. ping package to indicate that it is in-
(i) Assurance that the formula meets tended for export only, and the infant
the requirements for quality factors, formula will not be sold or offered for
which are set forth in § 106.96, shall be sale in domestic commerce. Such man-
provided by a submission that complies ufacturer shall also submit a state-
with § 106.121; ment certifying that it has adequate
(ii) Assurance that the formula com- controls in place to ensure that such
plies with the nutrient content require- formula is actually exported.
ments, which are set forth in § 107.100 of (d) The submission will not con-
this chapter, shall be provided by a stitute notice under section 412 of the
statement that the formula will not be Federal Food, Drug, and Cosmetic Act
marketed unless it meets the nutrient unless it complies fully with paragraph
requirements of § 107.100 of this chap- (b) of this section, as applicable, and
ter, as demonstrated by testing re- the information that it contains is set
quired under subpart C of this part; and forth in a manner that is readily un-
(6) Assurance that the processing of derstandable. The Agency will notify
the infant formula complies with sec- the manufacturer if the notice is not
tion 412(b)(2) of the Federal Food, complete because it does not meet the
Drug, and Cosmetic Act. Such assur- requirements in section 412(c) and (d)
ance shall include: of the Federal Food, Drug, and Cos-
(i) A statement that the formula will metic Act.
be produced in accordance with sub- (e) If a new infant formula submis-
parts B and C of this part; and sion contains all the information re-
(ii) The basis on which each ingre- quired by paragraph (b) of this section,
dient meets the requirements of as applicable, the Food and Drug Ad-
§ 106.40(a), e.g. that it is an approved ministration will acknowledge its re-
food additive, that it is authorized by a ceipt and notify the manufacturer of
prior sanction, or that it is generally the date of receipt. The date that the
recognized as safe (GRAS) for its in- Agency receives a new infant formula
tended use. Any claim that an ingre- submission that is complete is the fil-
dient is GRAS shall be supported by a ing date for such submission. The man-
citation to the Agency’s regulations or ufacturer shall not market the new in-
by an explanation, including a list of fant formula before the date that is 90
published studies and a copy of those days after the filing date. If the infor-
publications, for why, based on the mation in the submission does not pro-
published studies, there is general rec- vide the assurances required under sec-
ognition of the safety of the use of the tion 412(d)(1) of the Federal Food,
ingredient in infant formula. Drug, and Cosmetic Act and the regula-
(7) If the manufacturer is requesting tions of this chapter, the Food and
an exemption under § 106.91(b)(1)(ii), the Drug Administration will so notify the

manufacturer shall include the sci- manufacturer before the expiration of
entific evidence that the manufacturer the 90th day.
234
(f) If the manufacturer provides addi- (ii) Calculations of the statistical

tional information in support of a new power of the study before study initi-
infant formula submission, the Agency ation and at study completion.
will determine whether the additional (4) A report on attrition and on all
information is a substantive amend- occurrences of adverse events during
ment to the new infant formula sub- the study, which shall include:
mission. If the Agency determines that (i) Identification of the infant by sub-
the new submission is a substantive ject number and feeding group and a
amendment, the Food and Drug Admin- complete description of the adverse
istration will assign the new infant for- event, including comparisons of the
mula submission a new filing date. The frequency and nature of occurrence in
Food and Drug Administration will ac- each feeding group and information on
knowledge receipt of the additional in- the health of the infant during the
formation and, when applicable, notify course of the study, including the oc-
the manufacturer of the new filing currence and duration of any illness;
date, which is the date of receipt by (ii) A clinical assessment by a health
the Food and Drug Administration of care provider of the infant’s health
the information that constitutes the during each suspected adverse event;
substantive amendment to the new in- and
fant formula submission. (iii) A list of all subjects who did not
(g) Submissions relating to exempt complete the study, including the sub-
infant formulas are subject to the pro- ject number and the reason that each
visions of § 107.50 of this chapter. subject did not complete the study.
[79 FR 8059, Feb. 10, 2014, as amended at 79 (b) If the manufacturer is requesting
FR 33072, June 10, 2014] an exemption from the growth moni-
toring study requirements under
§ 106.121 Quality factor assurances for § 106.96(c)(1), the manufacturer shall in-
infant formulas. clude a detailed description of the
To provide assurance that an infant change made by the manufacturer to
formula meets the requirements for an existing infant formula and an ex-
quality factors set forth in § 106.96, the planation of why the change made by
manufacturer shall submit the fol- the manufacturer to an existing infant
lowing data and information: formula satisfies the criteria of
(a) Unless the manufacturer of a new § 106.96(c)(1).
infant formula can claim an exemption (c) If the manufacturer is requesting
under § 106.96(c)(1) or (c)(2), the fol- an exemption under § 106.96(c)(2)(i), the
lowing assurances shall be provided to manufacturer shall include a detailed
ensure that the requirements of description of the alternative method
§ 106.96(a) and (b) have been met: or alternative study design, an expla-
(1) An explanation, in narrative form, nation of why the method or study de-
setting forth how requirements for sign is based on sound scientific prin-
quality factors in § 106.96(b) have been ciples, and data that demonstrate that
met; the formula supports normal physical
(2) Records that contain the informa- growth in infants when the formula is
tion required by § 106.96(b) to be col- fed as the sole source of nutrition.
lected during the study for each infant (d) If the manufacturer is requesting
enrolled in the study. The records shall an exemption under § 106.96(c)(2)(ii), the
be identified by subject number, age, manufacturer shall include a detailed
feeding group, gender, and study day of description of the change and an expla-
collection. nation of why the change made by the
(3) Data, which shall include: manufacturer to an existing infant for-
(i) Statistical evaluation for all mula does not the affect the ability of
measurements, including group means, the formula to support normal physical
group standard deviations, and meas- growth.
ures of statistical significance for all (e) If the manufacturer is requesting
measurements for each feeding group an exemption under § 106.96(c)(2)(iii),
at the beginning of the study and at the manufacturer shall include a de-
every point where measurements were tailed description of the two formula-
made throughout the study, and tions and an explanation of why the
235
§ 106.130 21 CFR Ch. I (4–1–23 Edition)
quality factor requirement of normal written submission to the Food and

physical growth is met by the form of Drug Administration at the address
the formula that is processed using the given in § 106.110(a) that the infant for-
method that has the greatest potential mula complies with the requirements
for adversely affecting nutrient con- of the Federal Food, Drug, and Cos-
tent and bioavailability. metic Act and is not adulterated.
(f) Unless the manufacturer of a new (b) The verification submission shall
infant formula is requesting an exemp- include the following information:
tion under § 106.96(g), the results of the (1) The name of the new infant for-
Protein Efficiency Ratio bioassay shall mula; the filing date for the new infant
be provided in accordance with formula submission, in accordance
§ 106.96(f). with § 106.120, for the subject formula;
(g) If the manufacturer is requesting and the identification number assigned
an exemption under § 106.96(g)(1), the by the Agency to the new infant for-
manufacturer shall include a detailed mula submission:
description of the change made by the (2) A statement that the infant for-
manufacturer to an existing infant formula to be introduced into interstate
mula and an explanation of why the commerce is the same as the infant for-
change made by the manufacturer to mula that was the subject of the new
an existing infant formula satisfies the infant formula notification and for
criteria listed in § 106.96(g)(1). which the manufacturer provided as-
(h) If the manufacturer is requesting surances in accordance with the re-
an exemption under § 106.96(g)(2), the quirements of § 106.120;
manufacturer shall include a detailed (3) A summary of test results of the
description of the change and an expla- level of each nutrient required by
nation of why the change made by the § 107.100 of this chapter and any nutri-
manufacturer to an existing infant for- ent added by the manufacturer in the
mula does not affect the bio- formula, presented in units per 100
availability of the protein. kilocalories at the final product stage.
(i) If the manufacturer is requesting (4) A certification that the manufac-
an exemption under § 106.96(g)(3), the turer has established current good
manufacturer shall include a detailed manufacturing practices, including
explanation of the alternative method, quality control procedures and in-proc-
an explanation of why the method is ess controls, and testing required by
based on sound scientific principles, current good manufacturing practice,
and the data that demonstrate that the designed to prevent adulteration of
quality factor for the biological qual- this formula in accordance with sub-
ity of the protein has been met. parts B and C of this part.
(j) A statement certifying that the
(c) The submission shall not con-
manufacturer has collected and consid-
stitute written verification under sec-
ered all information and data con-
tion 412(d)(2) of the Federal Food,
cerning the ability of the infant for-
Drug, and Cosmetic Act (21 U.S.C.
mula to meet the requirements for
350a(d)(2)) when any data prescribed in
quality factors and that the manufac-
paragraph (b) of this section are lack-
turer is not aware of any information
ing or are not set forth so as to be read-
or data that would show that the for-
ily understood. In such circumstances,
mula does not meet the requirements
the Agency will notify the manufac-
for quality factors.
turer that the notice is not adequate.
[79 FR 8059, Feb. 10, 2014, as amended at 79
FR 33072, June 10, 2014] § 106.140 Submission concerning a
change in infant formula that may
§ 106.130 Verification submission. adulterate the product.
(a) A manufacturer shall, after the (a) When a manufacturer makes a
first production and before the intro- change in the formulation or proc-
duction into interstate commerce of a essing of the formula that may affect
new infant formula (except for a new whether the formula is adulterated
infant formula that is for export only under section 412(a) of the Federal
for which a submission is received in Food, Drug, and Cosmetic Act (21
compliance with § 106.120(c)), verify in a U.S.C. 350a(a)), the manufacturer shall,
236
before the first processing of such for- ject to the control of the manufac-
mula, make a submission to the Food turer:
and Drug Administration at the ad- (1) May not provide the nutrients re-
dress given in § 106.110(a). An original quired by section 412(i) of the Federal
and two copies shall be submitted. Food, Drug, and Cosmetic Act (21
(b) The submission shall include: U.S.C. 350a(i)) or by regulations issued
(1) The name and physical form of under section 412(i)(2); or
the infant formula (i.e., powder, ready- (2) May be otherwise adulterated or
to-feed, or concentrate); misbranded.
(2)(i) An explanation of why the (b) The notification made according
change in formulation or processing to paragraph (a) of this section shall be
may affect whether the formula is made by telephone, to the Director of
adulterated; and the appropriate Food and Drug Admin-
(ii) What steps will be taken to en- istration district office. After normal
sure that, before the formula is intro- business hours (8 a.m. to 4:30 p.m.), the
duced into interstate commerce, the Food and Drug Administration’s emer-
formula will not be adulterated; and gency number, 1–866–300–4374 shall be
(3) A statement that the submission used. The manufacturer shall promptly
complies with § 106.120(b)(3), (b)(4), send written confirmation of the notifi-
(b)(5), and (b)(6). When appropriate, a cation to the Food and Drug Adminis-
statement to the effect that the infor- tration, Center for Food Safety and Ap-
mation required by § 106.120(b)(3), (b)(4), plied Nutrition, Office of Compliance,
(b)(5), or (b)(6) has been provided to the Division of Enforcement (HFS–605), Re-
Agency previously and has not been af- call Coordinator, 5001 Campus Dr., Col-
fected by the changes that are the sub- lege Park, MD 20740, and to the appro-
ject of the current submission, to- priate Food and Drug Administration
gether with the identification number district office.
assigned by the Agency to the relevant
infant formula submission, may be pro- [79 FR 8059, Feb. 10, 2014, as amended at 88
vided in lieu of such statement. FR 17718, Mar. 24, 2023]
(c) The submission shall not con-
§ 106.160 Incorporation by reference.
stitute notice under section 412 of the
Federal Food, Drug, and Cosmetic Act (a) Certain material is incorporated
unless it complies fully with paragraph by reference into this part with the ap-
(b) of this section, and the information proval of the Director of the Federal
that it contains is set forth in a man- Register under 5 U.S.C. 552(a) and 1
ner that is readily understandable. The CFR part 51. To enforce any edition
Agency will notify the manufacturer if other than that specified in this sec-
the notice is not adequate because it tion, the Food and Drug Administra-
does not meet the requirements of section must publish notice of change in
tion 412(d)(3) of the Federal Food, the FEDERAL REGISTER and the mate-
Drug, and Cosmetic Act. rial must be available to the public. All
approved material is available for in-
§ 106.150 Notification of an adulter- spection at the Food and Drug Admin-
ated or misbranded infant formula. istration library at 10903 New Hamp-
(a) A manufacturer shall promptly shire Ave., Building 2, Third Floor, Sil-
notify the Food and Drug Administra- ver Spring, MD 20993, 301–796–2039, and
tion in accordance with paragraph (b) is available from the sources listed
of this section when the manufacturer below. This material is also available
has knowledge (that is, actual knowl- for inspection at the National Archives
edge that the manufacturer had, or the and Records Administration (NARA).
knowledge which a reasonable person For information on the availability of
would have had under like cir- this material at NARA, call 202–741–
cumstances or which would have been 6030 or go to: http://www.archives.gov/
obtained upon the exercise of due care) federal_register/
that reasonably supports the conclu- code_of_federal_regulations/
sion that an infant formula that has ibr_locations.html.

been processed by the manufacturer (b) 3–A Sanitary Standards, Inc., 6888
and that has left an establishment sub- Elm St., Suite 2D, McLean, VA 22101–
237
3829, 703–790–0295, and may be ordered dated November 1, 2009, into

online at http://www.3-a.org/: § 106.96(b)(4).
(1) 3–A Sanitary Standards, No. 609–
03: A Method of Producing Culinary PART 107—INFANT FORMULA
Steam, adopted November 21, 2004, into
§ 106.20(h). Subpart A—General Provisions
(2) [Reserved]
(c) American Society for Nutrition, Sec.
9650 Rockville Pike, Bethesda, MD 107.1 Status and applicability of the regula-
tions in part 107.
20814–3998, 301–634–7279, http:// 107.3 Definitions.
www.nutrition.org:
(1) Physical growth: National Center for Subpart B—Labeling
Health Statistics percentiles, Hamill,
P.V.V., T.A. Drizd, C.L. Johnson, R.B. 107.10 Nutrient information.
107.20 Directions for use.
Reed, A.F. Roche, and W.M. Moore,
107.30 Exemptions.
American Journal of Clinical Nutrition,
vol. 32, pp. 607–614, dated March 1979, Subpart C—Exempt Infant Formulas
into § 106.96(i)(1)(ii)(c).
(2) [Reserved] 107.50 Terms and conditions.
(d) AOAC International, 481 North
Subpart D—Nutrient Requirements
Frederick Ave., suite 500, Gaithersburg,
MD 20877–2417, 301–924–7078: 107.100 Nutrient specifications.
(1) Official Methods of Analysis of
AOAC International, 16th ed., dated Subpart E—Infant Formula Recalls
1995, into § 106.96(i)(2)(ii): 107.200 Food and Drug Administration-re-
(i) Section 45.3.04, AOAC Official quired recall.
Method 960.48 Protein Efficiency Ratio 107.210 Firm-initiated product removals.
Rat Bioassay, and 107.220 Scope and effect of infant formula
(ii) Section 45.3.05, AOAC Official recalls.
Method 982.30 Protein Efficiency Ratio 107.230 Elements of an infant formula re-
Calculation Method. call.
107.240 Notification requirements.
(2) Official Methods of Analysis of
107.250 Termination of an infant formula re-
AOAC International, 18th ed., dated call.
2005, into § 106.96(f): 107.260 Revision of an infant formula recall.
(i) Section 45.3.04, AOAC Official 107.270 Compliance with this subpart.
Method 960.48 Protein Efficiency Ratio 107.280 Records retention.
Rat Bioassay, and AUTHORITY: 21 U.S.C. 321, 343, 350a, 371.
(ii) Section 45.3.05, AOAC Official
Method 982.30 Protein Efficiency Ratio SOURCE: 50 FR 1840, Jan. 14, 1985, unless
otherwise noted.
Calculation Method.
(e) Centers for Disease Control and EDITORIAL NOTE: Nomenclature changes to
Prevention, 1600 Clifton Rd., Atlanta, part 107 appear at 81 FR 49895, July 29, 2016.
GA 30333, 1–800–232–4636, http://
www.cdc.gov/growthcharts/ Subpart A—General Provisions
who_charts.htm.
(1) Birth to 24 months: Boys Head cir- § 107.1 Status and applicability of the
cumference-for-age and Weight-for- regulations in part 107.
length percentiles, dated November 1, (a) The criteria in subpart B of this
2009, into § 106.96(b)(4). part describe the labeling requirements
(2) Birth to 24 months: Boys Length- applicable to infant formula under sec-
for-age and Weight-for-age percentiles, tion 403 of the Federal Food, Drug, and
dated November 1, 2009, into Cosmetic Act (21 U.S.C 343). Failure to
§ 106.96(b)(4). comply with any regulation in subpart
(3) Birth to 24 months: Girls Head cir- B of this part will render an infant for-
cumference-for-age and Weight-formula misbranded under section 403 of
length percentiles, dated November 1, the Federal Food, Drug, and Cosmetic
2009, into § 106.96(b)(4). Act.

(4) Birth to 24 months: Girls Length- (b) The criteria in subpart C of this
for-age and Weight-for-age percentiles, part describe the terms and conditions
238
for the exemption of an infant formula Subpart B—Labeling

from the requirements of section 412(a),
(b), and (c) of the Federal Food, Drug, § 107.10 Nutrient information.
and Cosmetic Act (21 U.S.C. 350a(a), (b), (a) The labeling of infant formulas,
and (c)). Failure to comply with any as defined in section 201(z) of the Fed-
regulations in subpart C of this part eral Food, Drug, and Cosmetic Act,
will result in withdrawal of the exemp- shall bear in the order given, in the
tion given under section 412(h)(1) of the units specified, and in tabular format,
Federal Food, Drug, and Cosmetic Act. the following information regarding
(c) Subpart D of this part contains the product as prepared in accordance
the nutrient requirements for infant with label directions for infant con-
formula under section 412(i) of the Fed- sumption:
eral Food, Drug, and Cosmetic Act. (1) A statement of the number of
Failure to comply with any regulation fluid ounces supplying 100 kilocalories
in subpart D of this part will render an (in case of food label statements, a
kilocalorie is represented by the word
infant formula adulterated under sec-
‘‘Calorie’’); and
tion 412(a)(1) of the Federal Food,
(2) A statement of the amount, sup-
Drug, and Cosmetic Act. plied by 100 kilocalories, of each of the
(d) An exempt infant formula is sub- following nutrients and of any other
ject to the provisions of § 107.50 and nutrient added by the manufacturer:
other applicable Food and Drug Admin-
istration food regulations. Nutrients Unit of measurement
Protein ............................................ Grams

[79 FR 8074, Feb. 10, 2014]
Fat .................................................. Do.
Carbohydrate ................................. Do.
§ 107.3 Definitions. Water .............................................. Do.
Linoleic acid ................................... Milligrams
The following definitions shall apply,
in addition to the definitions contained Vitamins
in section 201 of the Federal Food, Vitamin A ........................................ International Units
Drug, and Cosmetic Act (the act): Vitamin D ....................................... Do.
Vitamin E ........................................ Do.
Exempt formula. An exempt infant for- Vitamin K ........................................ Micrograms
mula is an infant formula intended for Thiamine (Vitamin B1) .................... Do.
commercial or charitable distribution Riboflavin (Vitamin B2) ................... Do.
Vitamin B6 ...................................... Do.
that is represented and labeled for use Vitamin B12 ..................................... Do.
by infants who have inborn errors of Niacin ............................................. Do.
metabolism or low birth weight, or who Folic acid (Folacin) ......................... Do.
Pantothenic acid ............................ Do.
otherwise have unusual medical or die- Biotin .............................................. Do.
tary problems. Vitamin C (Ascorbic acid) .............. Milligrams
Choline ........................................... Do.
Manufacturer. A person who prepares, Inositol ............................................ Do.
reconstitutes, or otherwise changes the
physical or chemical characteristics of Minerals
an infant formula or packages or labels Calcium .......................................... Milligrams

the product in a container for distribu- Phosphorus .................................... Do.
Magnesium ..................................... Do.
tion. The term ‘‘manufacturer’’ does Iron ................................................. Do.
not include a person who prepares, re- Zinc ................................................ Do.
constitutes, or mixes infant formula Manganese .................................... Micrograms
Copper ........................................... Do.
exclusively for an infant under his/her Iodine ............................................. Do.
direct care or the direct care of the in- Selenium ........................................ Do.
Sodium ........................................... Milligrams
stitution employing such person. Potassium ...................................... Do.
References. References in this part to Chloride .......................................... Do.
regulatory sections of the Code of Fed-
eral Regulations are to chapter I of (b) In addition the following apply:
title 21, unless otherwise noted. (1) Vitamin A content may also be
declared on the label in units of
[50 FR 48186, Nov. 22, 1985, as amended at 79
microgram retinol equivalents, vita-

FR 8074, Feb. 10, 2014] min D content in units of micrograms
cholecalciferol, vitamin E content in
239
§ 107.20 21 CFR Ch. I (4–1–23 Edition)
units of milligram alpha-tocopherol Institute of Medicine through its devel-

equivalents, and sodium, potassium, opment of a Dietary Reference Intake,
and chloride content in units of or has been identified as essential by
millimoles, micromoles, or milli- the Food and Drug Administration
equivalents. When these declarations through a FEDERAL REGISTER publica-
are made they shall appear in paren- tion; and
theses immediately following the dec- (ii) Is provided at a level considered
larations in International Units for vi-
in these publications as having biologi-
tamins A, D, and E, and immediately
cal significance, when these levels are
following the declarations in milli-
known.
grams for sodium, potassium, and chlo-
ride. [50 FR 1840, Jan. 14, 1985, as amended at 67
(2) Biotin, choline, and inositol con- FR 9585, Mar. 4, 2002; 79 FR 8074, Feb. 10, 2014;
tent shall be declared except when they 80 FR 35840, June 23, 2015]
are not added to milk-based infant for-
mulas. § 107.20 Directions for use.
(3) Each of the listed nutrients, and In addition to the applicable labeling
the caloric density, may also be de- requirements in parts 101 and 105 of
clared on the label on other bases, such
this chapter, the product label shall
as per 100 milliliters or per liter, as
bear:
prepared for infant consumption.
(4) One of the following statements (a) Under the heading ‘‘Directions
shall appear on the principal display For Preparation and Use’’, directions
panel, as appropriate: for:
(i) The statement ‘‘Infant Formula (1) Storage of infant formula before
With Iron’’, or a similar statement, if and after the container has been
the product contains 1 milligram or opened, including a statement indi-
more of iron in a quantity of product cating that prolonged storage at exces-
that supplies 100 kilocalories when pre- sive temperatures should be avoided;
pared in accordance with label direc- (2) Agitating liquid infant formula
tions for infant consumption. before opening the container, such as
(ii) The statement ‘‘Additional Iron ‘‘Shake Well Before Opening’’;
May Be Necessary’’, or a similar state- (3) ‘‘Sterilization’’ of water, bottle,
ment, if the product contains less than and nipples when necessary for pre-
1 milligram of iron in a quantity of paring infant formula for use;
product that supplies 100 kilocalories
(4) Dilution of infant formula, when
when prepared in accordance with label
directions for infant consumption. appropriate. Directions for powdered
(5) Any additional vitamin may be infant formula shall contain the weight
declared at the bottom of the vitamin and volume of powdered formula to be
list and any additional minerals may reconstituted.
be declared between iodine and sodium, (b) In close proximity to the ‘‘Direc-
provided that any additionally de- tions for Preparation and Use’’ a picto-
clared nutrient: gram depicting the major steps for
(i) Has been identified as essential by preparation of that infant formula,
the Food and Nutrition Board of the such as (for a concentrated formula):
240
if the addition of water is necessary.

The symbol shall be placed on a white
background encircled by a dark border.
(e) A warning statement beneath or
in close proximity to the ‘‘Directions
For Preparation and Use’’ that cau-
tions against improper preparation or
use of an infant formula, such as ‘‘THE
HEALTH OF YOUR INFANT DE-
PENDS ON CAREFULLY FOLLOWING
THE DIRECTIONS FOR PREPARA-
TION AND USE’’.
(f) A statement indicating that par-
ents should consult their physicians
about the use of infant formulas, such
as ‘‘USE AS DIRECTED BY A PHYSI-
CIAN’’.
(c) A ‘‘Use by ______’’ date, the blank [50 FR 1840, Jan. 14, 1985, as amended at 67
to be filled in with the month and year FR 9585, Mar. 4, 2002]
selected by the manufacturer, packer,
or distributor of the infant formula on § 107.30 Exemptions.
the basis of tests or other information When containers of ready-to-feed in-
showing that the infant formula, until fant formula, to be sold at the retail
that date, under the conditions of han- level, are contained within a multiunit
dling, storage, preparation, and use package, the labels of the individual
prescribed by label directions, will: (1) containers shall contain all of the label
when consumed, contain not less than information required by section 403 of
the quantity of each nutrient, as set the Federal Food, Drug, and Cosmetic
forth on its label; and (2) otherwise be Act (the act), §§ 107.10 and 107.20, and all
of an acceptable quality (e.g., pass appropriate sections of part 101 of this
through an ordinary bottle nipple). chapter, except that the labels of the
(d) The statement ‘‘Add Water’’ or individual containers contained within
‘‘Do Not Add Water’’, as appropriate, to the outer package shall be exempt
appear on the principal display panel of from compliance with the require-
concentrated or ready-to-feed infant ments of section 403 (e)(1) and (i)(2) of
formulas. In close proximity to the the act; and §§ 107.10 (a) and (b)(2) and
statement ‘‘Add Water’’, a symbol such 107.20 (b), (e), and (f), provided that (a)
the multiunit package meets all the re-
as
quirements of this part; (b) individual

EC01MR93.000</GPH>
containers are securely enclosed within

and are not intended to be separated
241
ER01JA93.366</GPH>
§ 107.50 21 CFR Ch. I (4–1–23 Edition)
from the retail package under condi- day before the first processing of the
tions of retail sale; and (c) the label on infant formula for commercial or char-
each individual container includes the itable distribution, whichever occurs
statement ‘‘This Unit Not Intended For later, the label and other labeling of
Individual Sale’’ in type size not less the infant formula, a complete quan-
than one-sixteenth inch in height. The titative formulation for the infant for-
word ‘‘Retail’’ may be used in lieu of or mula, and a detailed description of the
immediately following the word ‘‘Indi- medical conditions for which the infant
vidual’’ in the statement. formula is represented. FDA will re-
view the information under paragraph
Subpart C—Exempt Infant (d) of this section.
Formulas (4) To retain the exempt status of an
infant formula covered by this para-
§ 107.50 Terms and conditions. graph, when any change in ingredients
(a) Terms and conditions. Section or processes that may result in an ad-
412(f)(1) of the act exempts from the reverse impact on levels of nutrients or
quirements of section 412(a), (b), and availability of nutrients is instituted,
(c)(1)(A) of the act infant formulas that the manufacturer shall submit to FDA
are represented and labeled for use by at the address specified in paragraph
an infant who has an inborn error of (e)(1) of this section, before the first
metabolism or low birth weight or who processing of the infant formula, the
otherwise has an unusual medical or label and other labeling of the infant
dietary problem, if such formulas com- formula, a complete quantitative for-
ply with regulations prescribed by the mulation for the infant formula, a de-
Secretary. The regulations in this sub- tailed description of the reformulation
part establish the terms and conditions and the rationale for the reformula-
that a manufacturer must meet with tion, a complete description of the
respect to such infant formulas. change in processing, and a detailed de-
(b) Infant formulas generally available scription of the medical conditions for
at the retail level. (1) These exempt in- which the infant formula is rep-
fant formulas can generally be pur- resented. FDA will review that infor-
chased from retail store shelves that mation under paragraph (d) of this sec-
are readily available to the public. tion.
Such formulas are also typically rep- (5) A manufacturer may deviate from
resented and labeled for use to provide the requirements of paragraph (b)(2) of
dietary management for diseases or this section only with respect to those
conditions that are not clinically seri- specific requirements for which it sub-
ous or life-threatening, even though mits to FDA, at the address specified
such formulas may also be represented in paragraph (e)(1) of this section, the
and labeled for use in clinically serious medical, nutritional, scientific, or
or life-threatening disorders. technological rationale (including any
(2) Except as provided in paragraphs appropriate animal or human clinical
(b)(4) and (5) of this section, an infant studies). FDA will review that informa-
formula manufacturer shall, with re- tion under paragraph (d) of this sec-
spect to each formula covered by this tion.
paragraph, comply with the nutrient (c) Infant formulas not generally avail-
requirements of section 412(g) of the able at the retail level. (1) These exempt
act or of regulations promulgated infant formulas are not generally found
under section 412(a)(2) of the act, the on retail shelves for general consumer
quality control procedure requirements purchase. Such formulas typically are
of part 106, and the labeling require- prescribed by a physician, and must be
ments of subpart B of this part. requested from a pharmacist or are dis-
(3) To retain the exempt status of an tributed directly to institutions such
infant formula covered by this para- as hospitals, clinics, and State or Fed-
graph, the manufacturer shall submit eral agencies. Such formulas are also
to the Food and Drug Administration generally represented and labeled sole-
(FDA), at the address specified in para- ly to provide dietary management for

graph (e)(1) of this section, on or before specific diseases or conditions that are
May 21, 1986, or on or before the 90th clinically serious or life-threatening
242
and generally are required for pro- or more specific infants on a physi-
longed periods of time. Exempt infant cian’s request.
formulas distributed directly to insti- (d) FDA review of exempt status. (1)
tutions such as hospitals, clinics, and FDA’s Center for Food Safety and Ap-
State or Federal agencies that are of plied Nutrition will review information
the same formulation as those gen- submitted by infant formula manufac-
erally available at the retail level are turers under paragraph (b) (3), (b) (4),
subject to the requirements of para- or (c)(4) of this section. On the basis of
graph (b) of this section rather than to such review and other information
the requirements of this paragraph. available to the agency, the Center for
(2) Except as provided for in para- Food Safety and Applied Nutrition
graph (c)(5) of this section, an infant may impose additional conditions on,
formula manufacturer shall, with re- or modify requirements for, the quality
spect to each formula covered by this control procedures, nutrient specifica-
paragraph, comply with the nutrient tions, or labeling of an infant formula,
requirements of section 412(g) of the or withdraw a product’s exempt status.
act or of regulations promulgated Such determinations will be made by
under section 412(a)(2) of the act, and the Director of the Center for Food
the labeling requirements of subpart B Safety and Applied Nutrition.
of this part. (2)(i) If after completing its review of
(3) Each manufacturer of an infant all information submitted, the Center
formula covered by this paragraph for Food Safety and Applied Nutrition
shall establish quality control proce- concludes that additional or modified
dures designed to ensure that the in- quality control, nutrient, or labeling
fant formula meets applicable nutrient requirements are needed, or that a
requirements of this section, including product’s exempt status is withdrawn,
any special nutritional characteristics the Center for Food Safety and Applied
for the specific disorders or conditions Nutrition will so notify the manufac-
for which the formula is represented turer and this notification will specify
for use. Each manufacturer shall main- the reasons therefor. Upon receipt of
tain records of such quality control this notification, the manufacturer has
procedures sufficient to permit a public 10 working days to have the decision
health evaluation of each manufac- reviewed under § 10.75 by the office of
tured batch of infant formula and shall the Commissioner of Food and Drugs.
permit any authorized FDA employee A determination by the Director of the
at all reasonable times to have access Center for Food Safety and Applied Nu-
to and to copy and verify the records trition that is not appealed becomes a
referred to in this paragraph. final agency decision.
(4) To retain the exempt status of an (ii) After a final decision by the Di-
infant formula covered by this para- rector or by the office of the Commis-
graph, the manufacturer shall submit sioner that a product’s exempt status
the information required by paragraphs is withdrawn, the manufacturer shall
(b)(3) and (4) of this section. comply with the nutrient requirements
(5) A manufacturer may deviate from of section 412(g) of the act or of regula-
the requirements of paragraph (c)(2) of tions promulgated under section
this section only with respect to those 412(a)(2) of the act, the quality control
specific requirements for which it sub- requirements of part 106, and the label-
mits to FDA, at the address specified ing requirements of subpart B of this
in paragraph (e)(1) of this section, the part.
medical, nutritional, scientific, or (iii) The compliance date for the
technological rationale (including any withdrawal of a product’s exempt sta-
appropriate animal or human clinical tus or the imposition of additional or
studies). FDA will review that informa- modified quality control, nutrient, or
tion under paragraph (d) of this sec- labeling requirements is 60 calendar
tion. days after issuance of the final decision
(6) The requirements of this section except as otherwise provided for rea-
do not apply to an infant formula spe- sons stated in the decision. If the agen-
cially and individually prepared for one cy determines that a health hazard
243
§ 107.100 21 CFR Ch. I (4–1–23 Edition)
may exist and so notifies the manufac- trition, Office of Nutrition, Labeling,
turer, withdrawal of a product’s ex- and Dietary Supplements, Infant For-
empt status shall be effective on the mula and Medical Foods Staff (HFS–
date of receipt of notification from the 850), Food and Drug Administration,
Director of the Center for Food Safety 5001 Campus Dr., College Park, MD
and Applied Nutrition. Additional or 20740.
modified requirements, or the with- (2) The manufacturer shall promptly
drawal of an exemption, apply only to notify the Food and Drug Administra-
those formulas that are manufactured tion when the manufacturer has knowl-
after the compliance date. A postpone- edge (as defined in section 412(c)(2) of
ment of the compliance date may be
the Federal Food, Drug, and Cosmetic
granted for good cause.
Act) that reasonably supports the con-
(3) FDA may decide that withdrawal
of an exemption is necessary when, on clusion that an exempt infant formula
the basis of its review under paragraph that has been processed by the manu-
(d)(1) of this section, it concludes that facturer and that has left an establish-
quality control procedures are not ade- ment subject to the control of the man-
quate to ensure that the formula con- ufacturer may not provide the nutri-
tains all required nutrients, that devi- ents required by paragraph (b) or (c) of
ations in nutrient levels are not sup- this section, or when there is an ex-
ported by generally accepted scientific, empt infant formula that may be oth-
nutritional, or medical rationale, or erwise adulterated or misbranded and
that deviations from subpart B of this if so adulterated or misbranded pre-
part are not necessary to provide ap- sents a risk of human health. This no-
propriate directions for preparation tification shall be made, by telephone,
and use of the infant formula, or that to the Director of the appropriate Food
additional labeling information is nec- and Drug Administration district office
essary. specified in part 5, subpart M of this
(4) FDA will use the following cri- chapter. After normal business hours (8
teria in determining whether devi- a.m. to 4:30 p.m.), contact the Food and
ations from the requirements of this Drug Administration Emergency Call
subpart are necessary and will ade- Center at 866–300–4374. The manufac-
quately protect the public health: turer shall send a followup written con-
(i) A deviation from the nutrient re-
firmation to the Center for Food Safe-
quirements of section 412(g) of the act
ty and Applied Nutrition (HFS–605),
or of regulations promulgated under
Food and Drug Administration, 5001
section 412(a)(2) of the act is necessary
to provide an infant formula that is ap- Campus Dr., College Park, MD 20740,
propriate for the dietary management and to the appropriate FDA district of-
of a specific disease, disorder, or med- fice specified in part 5, subpart M of
ical condition; this chapter.
(ii) For exempt infant formulas sub- [50 FR 48187, Nov. 22, 1985, as amended at 61
ject to paragraph (b) of this section, a FR 14479, Apr. 2, 1996; 66 FR 17358, Mar. 30,
deviation from the quality control pro- 2001; 66 FR 56035, Nov. 6, 2001; 67 FR 9585,
cedures requirements of part 106 is nec- Mar. 4, 2002; 75 FR 32659, June 9, 2010; 79 FR
essary because of unusual or difficult 8074, Feb. 10, 2014]
technological problems in manufac-
turing the infant formula; and Subpart D—Nutrient Requirements
(iii) A deviation from the labeling re-
quirements of subpart B of this part is § 107.100 Nutrient specifications.
necessary because label information,
including pictograms and symbols re- (a) An infant formula shall contain
quired by those regulations, could lead the following nutrients at a level not
to inappropriate use of the product. less than the minimum level specified
(e) Notification requirements. (1) Infor- and not more than the maximum level
mation required by paragraphs (b) and specified for each 100 kilocalories of
the infant formula in the form pre-
(c) of this section shall be submitted to

the Food and Drug Administration, pared for consumption as directed on
Center for Food Safety and Applied Nu- the container:
244
Nutrients Unit of measurement Minimum level Maximum level
Protein .................................................................. Grams ................................................. 1.8 4.5

Fat ........................................................................ Do. ...................................................... 3.3 6.0
Percent calories .................................. 30 54
Linoleic acid ......................................................... Milligrams ............................................ 300
Percent calories .................................. 2.7
Vitamins
Vitamin A .............................................................. International Units ............................... 250 750

Vitamin D ............................................................. Do. ...................................................... 40 100
Vitamin E .............................................................. Do. ...................................................... 0.7
Vitamin K .............................................................. Micrograms ......................................... 4
Thiamine (Vitamin B1) .......................................... Do. ...................................................... 40
Riboflavin (Vitamin B2) ......................................... Do. ...................................................... 60
Vitamin B6 ............................................................ Do. ...................................................... 35
Vitamin B12 ........................................................... Do. ...................................................... 0.15
Niacin 1 ................................................................. Do. ...................................................... 250
Folic acid (Folacin) ............................................... Do. ...................................................... 4
Pantothenic acid .................................................. Do. ...................................................... 300
Biotin 2 .................................................................. Do. ...................................................... 1.5
Vitamin C (Ascorbic acid) .................................... Milligrams ............................................ 8
Choline 2 ............................................................... Do. ...................................................... 7
Inositol 2 ................................................................ Do. ...................................................... 4
Minerals
Calcium ................................................................ Do. ...................................................... 60

Phosphorus .......................................................... Do. ...................................................... 30
Magnesium ........................................................... Do. ...................................................... 6
Iron ....................................................................... Do. ...................................................... 0.15 3.0
Zinc ...................................................................... Do. ...................................................... 0.5
Manganese .......................................................... Micrograms ......................................... 5
Copper ................................................................. Do. ...................................................... 60
Iodine ................................................................... Do. ...................................................... 5 75
Selenium .............................................................. Do. ...................................................... 2 7
Sodium ................................................................. Milligrams ............................................ 20 60
Potassium ............................................................ Do. ...................................................... 80 200
Chloride ................................................................ Do. ...................................................... 55 150
1 The generic term ‘‘niacin’’ includes niacin (nicotinic acid) and niacinamide (nicotinamide).
2 Required only for non-milk-based infant formulas.
(b) Vitamin E shall be present at a logical quality is equivalent to or bet-

level of at least 0.7 International Unit ter than that of casein. If the biologi-
of vitamin E per gram of linoleic acid. cal quality of the protein is less than
(c) Any vitamin K added shall be in that of casein, the minimum amount of
the form of phylloquinone. protein shall be increased proportion-
(d) Vitamin B6 shall be present at a ately to compensate for its lower bio-
level of at least 15 micrograms of vita- logical quality. For example, an infant
min B6 for each gram of protein in ex- formula containing protein with a bio-
cess of 1.8 grams of protein per 100 logical quality of 75 percent of casein
kilocalories of infant formula in the shall contain at least 2.4 grams of pro-
form prepared for consumption as di- tein (1.8/0.75). No protein with a bio-
rected on the container. logical quality less than 70 percent of
(e) The ratio of calcium to phos-
casein shall be used.
phorus in infant formula in the form
prepared for consumption as directed [50 FR 45108, Oct. 30, 1985, as amended at 80
on the container shall be no less than FR 35841, June 23, 2015]
1.1 and not more than 2.0.
(f) Protein shall be present in an Subpart E—Infant Formula Recalls
amount not to exceed 4.5 grams per 100
kilocalories regardless of quality, and
SOURCE: 54 FR 4008, Jan. 27, 1989, unless
not less than 1.8 grams per 100
otherwise noted.
kilocalories of infant formula in the

form prepared for consumption as di-
rected on the container when its bio-
245
§ 107.200 21 CFR Ch. I (4–1–23 Edition)
§ 107.200 Food and Drug Administra- (i) Is no longer subject to the manu-
tion-required recall. facturer’s control;
When the Food and Drug Administra- (ii) Is in violation of the laws and
tion determines that an adulterated or regulations administered by the Food
misbranded infant formula presents a and Drug Administration and against
risk to human health, a manufacturer which the agency could initiate legal
shall immediately take all actions nec- or regulatory action; and
essary to recall that formula, extend- (iii) Does not present a human risk.
ing to and including the retail level, (b) The Food and Drug Administra-
consistent with the requirements of tion will monitor continually the re-
this subpart. call action and will take appropriate
actions to ensure that the violative in-
§ 107.210 Firm-initiated product re- fant formula is removed from the mar-
movals. ket.
(a) If a manufacturer has determined § 107.230 Elements of an infant for-
to recall voluntarily from the market mula recall.
an infant formula that is not subject to A recalling firm shall conduct an in-
§ 107.200 but that otherwise violates the fant formula recall with the following
laws and regulations administered by elements:
the Food and Drug Administration (a) The recalling firm shall evaluate
(FDA) and that would be subject to in writing the hazard to human health
legal action, the manufacturer, upon associated with the use of the infant
prompt notification to FDA, shall ad- formula. This health hazard evaluation
minister such voluntary recall con- shall include consideration of any dis-
sistent with the requirements of this ease, injury, or other adverse physio-
subpart. logical effect that has been or that
(b) If a manufacturer has determined could be caused by the infant formula
to withdraw voluntarily from the mar- and of the seriousness, likelihood, and
ket an infant formula that is adulter- consequences of the diseases, injury, or
ated or misbranded in only a minor other adverse physiological effect. The
way and that would not be subject to Food and Drug Administration will
legal action, such removal from the conduct its own health hazard evalua-
market is deemed to be a market with- tion and promptly notify the recalling
drawal, as defined in § 7.3(j) of this firm of the results of that evaluation if
chapter. As required by § 107.240(a), the the criteria for recall under § 107.200
manufacturer shall promptly notify have been met.
FDA of such violative formula and (b) The recalling firm shall devise a
may, but is not required to, conduct written recall strategy suited to the in-
such market withdrawal consistent dividual circumstances of the par-
with the requirements of this subpart ticular recall. The recall strategy shall
pertaining to product recalls. take into account the health hazard
evaluation and specify the following:
§ 107.220 Scope and effect of infant
formula recalls. The extent of the recall; if necessary,
the public warning to be given about
(a) The requirements of this subpart any hazard presented by the infant for-
apply: mula; the disposition of the recalled in-
(1) When the Food and Drug Adminis- fant formula; and the effectiveness
tration has determined that it is nec- checks that will be made to determine
essary to remove from the market a that the recall is carried out.
distributed infant formula that is in (c) The recalling firm shall promptly
violation of the laws and regulations notify each of its affected direct ac-
administered by the Food and Drug Ad- counts about the recall. The format of
ministration and that poses a risk to a recall communication shall be dis-
human health; or tinctive, and the content and extent of
(2) When a manufacturer has deter- a recall communication shall be com-
mined that it is necessary to remove mensurate with the hazard of the in-
from the market a distributed infant fant formula being recalled and the
formula that: strategy developed for the recall. The
246
recall communication shall instruct port to the appropriate FDA district

consignees to report back quickly to office. The report shall contain rel-
the recalling firm about whether they evant information, including the fol-
are in possession of the recalled infant lowing cumulative information con-
formula and shall include a means of cerning the infant formula that is
doing so. The recalled communication being recalled:
shall also advise consignees how to re- (1) Number of consignees notified of
turn the recall infant formula to the the recall and date and method of noti-
manufacturer or otherwise dispose of
fication, including recalls required by
it. The recalling firm shall send a fol-
§ 107.200, information about the notice
lowup recall communication to any
consignee that does not respond to the provided for retail display, and the re-
initial recall communication. quest for its display.
(d) If the infant formula presents a (2) Number of consignees responding
risk to human health, the recalling to the recall communication and quan-
firm shall request that each establish- tity of recalled infant formula on hand
ment, at which such infant formula is at each consignee at the time the com-
sold or available for sale, post at the munication was received.
point of purchase of such formula a no- (3) Quantity of recalled infant for-
tice of such recall at such establish- mula returned or corrected by each
ment. The notice shall be provided by consignee contacted and the quantity
the recalling firm after approval of the of recalled infant formula accounted
notice by the Food and Drug Adminis- for.
tration. The recalling firm shall also (4) Number and results of effective-
request that each retail establishment ness checks that were made.
maintain such notice on display until
(5) Estimated timeframes for comple-
such time as the Food and Drug Ad-
tion of the recall.
ministration notifies the recalling firm
that the agency considers the recall (c) Status reports. The recalling firm
completed. shall submit to the appropriate FDA
(e) The recalling firm shall furnish district office a written status report
promptly to the appropriate Food and on the recall at least every 14 days
Drug Administration district office until the recall is terminated. The sta-
listed in part 5, subpart M of this chap- tus report shall describe the steps
ter, as they are available, copies of the taken by the recalling firm to carry
health hazard evaluation, the recall out the recall since the last report and
strategy, and all recall communica- the results of these steps.
tions (including, for a recall under
[79 FR 8074, Feb. 10, 2014]
§ 107.200, the notice to be displayed at
retail establishments) directed to con- § 107.250 Termination of an infant for-
signees, distributors, retailers, and mula recall.
members of the public.
The recalling firm may submit a rec-
[54 FR 4008, Jan. 27, 1989, as amended at 66 ommendation for termination of the
FR 17358, Mar. 30, 2001; 69 FR 17291, Apr. 2,
2004]
recall to the appropriate FDA district
office for transmittal to the Recall Co-
§ 107.240 Notification requirements. ordinator, Division of Enforcement
(a) Telephone report. When a deter- (HFS–605), Office of Compliance, Center
mination is made that an infant for- for Food Safety and Applied Nutrition,
mula is to be recalled, the recalling 5001 Campus Dr., College Park, MD
firm shall telephone within 24 hours 20740, or by email to
the appropriate Food and Drug Admin- CFSAN.RECALL@fda.hhs.gov, for ac-
istration district office listed in § 5.115 tion. Any such recommendation shall
of this chapter and shall provide rel- contain information supporting a con-
evant information about the infant for- clusion that the recall strategy has
mula that is to be recalled. been effective. The Agency will respond
(b) Initial written report. Within 14 within 15 days of receipt by the Divi-
days after the recall has begun, the re- sion of Enforcement of the request for
calling firm shall provide a written re- termination. The recalling firm shall
247
§ 107.260 21 CFR Ch. I (4–1–23 Edition)
continue to implement the recall strat- ing firm in determining how to comply
egy until it receives final written noti- with these regulations.
fication from the Agency that the re- [54 FR 4008, Jan. 27, 1989, as amended at 65
call has been terminated. The Agency FR 56479, Sept. 19, 2000]
will send such notification, unless the
Agency has information from FDA’s § 107.280 Records retention.
own audits or from other sources dem- Each manufacturer of an infant for-
onstrating that the recall has not been mula shall make and retain such
effective. The Agency may conclude records respecting the distribution of
that a recall has not been effective if: the infant formula through any estab-
(a) The recalling firm’s distributors lishment owned or operated by such
have failed to retrieve the recalled in- manufacturer as may be necessary to
fant formula; or effect and monitor recalls of the for-
(b) Stocks of the recalled infant formula. Such records shall be retained
mula remain in distribution channels for at least 1 year after the expiration
that are not in direct control of the re- of the shelf life of the infant formula.
calling firm.
[54 FR 4008, Jan. 27, 1989, as amended at 67
[54 FR 4008, Jan. 27, 1989, as amended at 61 FR 9585, Mar. 4, 2002]
FR 14479, Apr. 2, 1996; 66 FR 17359, Mar. 30,
2001; 69 FR 17291, Apr. 2, 2004; 79 FR 8075, Feb.
10, 2014] PART 108—EMERGENCY PERMIT
CONTROL
§ 107.260 Revision of an infant formula
recall. Subpart A—General Provisions
If after a review of the recalling
Sec.
firm’s recall strategy or periodic re- 108.3 Definitions.
ports or other monitoring of the recall, 108.5 Determination of the need for a per-
the Food and Drug Administration con- mit.
cludes that the actions of the recalling 108.6 Revocation of determination of need
firm are deficient, the agency shall no- for permit.
tify the recalling firm of any serious 108.7 Issuance or denial of permit.
deficiency. The agency may require the 108.10 Suspension and reinstatement of per-
mit.
firm to: 108.12 Manufacturing, processing, or pack-
(a) Change the extent of the recall, if ing without a permit, or in violation of a
the agency concludes on the basis of permit.
available data that the depth of the re- 108.19 Establishment of requirements for ex-
call is not adequate in light of the risk emption from section 404 of the act.
to human health presented by the in-
fant formula. Subpart B—Specific Requirements and
(b) Carry out additional effectiveness Conditions for Exemption From or
checks, if the agency’s audits, or other Compliance With an Emergency Per-
information, demonstrate that the re- mit
call has not been effective. 108.25 Acidified foods.
(c) Issue additional notifications to 108.35 Thermal processing of low-acid foods
the firm’s direct accounts, if the agen- packaged in hermetically sealed con-
cy’s audits, or other information dem- tainers.
onstrate that the original notifications AUTHORITY: 21 U.S.C. 342, 344, 371.
were not received, or were disregarded
in a significant number of cases.
otherwise noted.
§ 107.270 Compliance with this sub- EDITORIAL NOTE: Nomenclature changes to
part. part 108 appear at 81 FR 49896, July 29, 2016.
A recalling firm may satisfy the re-
quirements of this subpart by any Subpart A—General Provisions
means reasonable calculated to meet
the obligations set forth in this Sub- § 108.3 Definitions.
part E. The recall guidance in subpart (a) The definitions contained in sec-
C of part 7 of this chapter specify pro- tion 201 of the Federal Food, Drug, and
cedures that may be useful to a recall- Cosmetic Act are applicable to such
terms when used in this part.
248
(b) Commissioner means the Commis- a permit is effective immediately pend-

sioner of Food and Drugs. ing an expedited hearing.
(c) Act means the Federal Food, (b) A hearing under this section shall
Drug, and Cosmetic Act, as amended. be conducted by the Commissioner or
(d) Permit means an emergency per- his designee at a location agreed upon
mit issued by the Commissioner pursu- by the objector and the Commissioner
ant to section 404 of the act for such or, if such agreement cannot be
temporary period of time as may be reached, at a location designated by
necessary to protect the public health. the Commissioner. The manufacturer,
(e) Manufacture, processing, or packing processor, or packer shall have the
of food in any locality means activities right to cross-examine the Food and
conducted in a single plant or estab- Drug Administration’s witnesses and
to present witnesses on his own behalf.
lishment, a series of plants under a sin-
(c) Within 5 working days after the
gle management, or all plants in an in-
hearing, and based on the evidence pre-
dustry or region, by a manufacturer,
sented at the hearing, the Commis-
processor, or packer.
sioner shall determine whether a per-
§ 108.5 Determination of the need for a mit is required and shall so inform the
permit. manufacturer, processor, or packer in
writing, with the reasons for his deci-
(a) Whenever the Commissioner de- sion.
termines after investigation that a (d) The Commissioner’s determina-
manufacturer, processor, or packer of a tion of the need for a permit con-
food for which a regulation has been stitutes final agency action from which
promulgated in subpart B of this part appeal lies to the courts. The Commis-
does not meet the mandatory condi- sioner will not stay a determination of
tions and requirements established in the need for a permit pending court ap-
such regulation, he shall issue to such peal except in unusual circumstances,
manufacturer, processor, or packer an but will participate in expediting any
order determining that a permit shall such appeal.
be required before the food may be in-
troduced or delivered for introduction
FR 24891, June 12, 1989; 61 FR 14479, Apr. 2,
into interstate commerce by that per- 1996; 66 FR 56035, Nov. 6, 2001]
son. The order shall specify the manda-
tory conditions and requirements with § 108.6 Revocation of determination of
which there is a lack of compliance. need for permit.
(1) The manufacturer, processor, or (a) A permit shall be required only
packer shall have 3 working days after during such temporary period as is nec-
receipt of such order within which to essary to protect the public health.
file objections. Such objections may be (b) Whenever the Commissioner has
filed by telegram, telex, or any other reason to believe that a permit holder
mode of written communication ad- is in compliance with the mandatory
dressed to the Center for Food Safety requirements and conditions estab-
and Applied Nutrition, Food and Drug lished in subpart B of this part and is
Administration (HFS–605), 5001 Campus likely to remain in compliance, he
Dr., College Park, MD 20740. If such ob- shall, on his own initiative or on the
jections are filed, the determination is application of the permit holder, re-
stayed pending a hearing to be held voke both the determination of need
within 5 working days after the filing for a permit and the permit that had
of objections on the issues involved un- been issued. If denied, the applicant
less the Commissioner determines that shall, upon request, be afforded a hear-
the objections raise no genuine and ing conducted in accordance with § 108.5
substantial issue of fact to justify a (b) and (c) as soon as practicable. Such
hearing. revocation is without prejudice to the
(2) If the Commissioner finds that initiation of further permit pro-
there is an imminent hazard to health, ceedings with respect to the same man-
the order shall contain this finding and ufacturer, processor, or packer should
the reasons therefor, and shall state later information again show the need
that the determination of the need for for a permit.
249
§ 108.7 21 CFR Ch. I (4–1–23 Edition)
§ 108.7 Issuance or denial of permit. § 108.10 Suspension and reinstatement

of permit.
(a) After a determination and notifi-
cation by the Commissioner in accord- (a) Whenever the Commissioner finds
ance with the provisions of § 108.5 that that a permit holder is not in compli-
a manufacturer, processor, or packer ance with the mandatory requirements
requires a permit, such manufacturer, and conditions established by the per-
processor, or packer may not there- mit, he shall immediately suspend the
after introduce or deliver for introduc- permit and so inform the permit hold-
tion into interstate commerce any er, with the reasons for the suspension.
such food manufactured, processed, or (b) Upon application for reinstate-
packed by him unless he holds a permit ment of a permit, the Commissioner
issued by the Commissioner or obtains shall, within 10 working days, reinstate
advance written approval of the Food the permit if he finds that the person is
and Drug Administration pursuant to in compliance with the mandatory re-
quirements and conditions established
§ 108.12(a).
by the permit or deny the application.
(b) Any manufacturer, processor, or (c) Any person whose permit has been
packer for whom the Commissioner has suspended or whose application for re-
made a determination that a permit is instatement has been denied may re-
necessary may apply to the Commis- quest a hearing. The hearing shall be
sioner for the issuance of such a per- conducted by the Commissioner or his
mit. The application shall contain such designee within 5 working days of re-
data and information as is necessary to ceipt of the request at a location
show that all mandatory requirements agreed upon by the objector and the
and conditions for the manufacturer, Commissioner or, if an agreement can-
processing or packing of a food for not be reached, at a location des-
which regulations are established in ignated by the Commissioner. The per-
subpart B of this part are met and, in mit holder shall have the right to
particular, shall show that the devi- present witnesses on his own behalf
ations specified in the Commissioner’s and to cross-examine the Food and
determination of the need for a permit Drug Administration’s witnesses.
have been corrected or suitable interim (d) Within 5 working days after the
measures established. Within 10 work- hearing, and based on the evidence pre-
ing days after receipt of such applica- sented at the hearing, the Commis-
tion, (except that the Commissioner sioner shall determine whether the per-
may extend such time an additional 10 mit shall be reinstated and shall so in-
working days where necessary), the form the permit holder, with the rea-
Commissioner shall issue a permit, sons for his decision.
deny the permit, or offer the applicant (e) Denial of an application for rein-
a hearing conducted in accordance with statement of a permit constitutes final
§ 108.5 (b) and (c) as to whether the per- agency action from which appeal lies
mit should be issued. The Commis- to the courts. The Commissioner will
sioner shall issue such a permit to not stay such denial pending court ap-
which shall be attached, in addition to peal except in unusual circumstances,
the mandatory requirements and con- but will participate in expediting any
ditions of subpart B of this part, any such appeal.
additional requirements or conditions
which may be necessary to protect the § 108.12 Manufacturing, processing, or
public health if he finds that all man- packing without a permit, or in vio-
datory requirements and conditions of lation of a permit.
subpart B of this part are met or suit- (a) A manufacturer, processor, or
able interim measures are established. packer may continue at his own risk to
(c) Denial of a permit constitutes manufacture, process, or pack without
final agency action from which appeal a permit a food for which the Commis-
lies to the courts. The Commissioner sioner has determined that a permit is
will not stay such denial pending court required. All food so manufactured,
appeal except in unusual cir- processed, or packed during such period

cumstances, but will participate in ex- without a permit shall be retained by
pediting any such appeal. the manufacturer, processor, or packer
250
and may not be introduced or delivered termined after such articles have en-
for introduction into interstate com- tered interstate commerce, he shall
merce without the advance written ap- promulgate regulations in Subpart B of
proval of the Food and Drug Adminis- this part establishing requirements and
tration. Such approval may be granted conditions governing the manufacture,
only upon an adequate showing that processing, or packing of the food nec-
such food is free from microorganisms essary to protect the public health.
of public health significance. The man- Such regulations may be proposed by
ufacturer, processor, or packer may the Commissioner on his own initiative
provide to the Commissioner, for his or in response to a petition from any
consideration in making any such de- interested person pursuant to part 10 of
termination, an evaluation of the po- this chapter.
tential public health significance of
(b) A manufacturer, processor, or
such food by a competent authority in
packer of a food for which a regulation
accordance with procedures recognized
has been promulgated in subpart B of
as being adequate to detect any poten-
this part shall be exempt from the re-
tial hazard to public health. Within 20
working days after receipt of a written quirement for a permit only if he meets
request for such written approval the all of the mandatory requirements and
Food and Drug Administration shall ei- conditions established in that regula-
ther issue such written approval or tion.
deny the request. If the request is de- [42 FR 14334, Mar. 15, 1977, as amended at 42
nied, the applicant shall, upon request, FR 15673, Mar. 22, 1977]
be afforded a prompt hearing con-
ducted in accordance with § 108.5 (b)
and (c).
Subpart B—Specific Requirements
(b) Except as provided in paragraph and Conditions for Exemption
(a) of this section, no manufacturer, From or Compliance With an
processor, or packer may introduce or Emergency Permit
deliver for introduction into interstate
commerce without a permit or in viola- § 108.25 Acidified foods.
tion of a permit a food for which the (a) Inadequate or improper manufac-
Commissioner has determined that a ture, processing, or packing of acidified
permit is required. Where a manufac- foods may result in the distribution in
turer, processor, or packer utilizes a interstate commerce of processed foods
consolidation warehouse or other stor- that may be injurious to health. The
age facility under his control, inter- harmful nature of such foods cannot be
state shipment of any such food from adequately determined after these
the point of production to that ware- foods have entered into interstate com-
house or storage facility shall not vio- merce. The Commissioner of Food and
late this paragraph, provided that no Drugs therefore finds that, to protect
further introduction or delivery for in-
the public health, it may be necessary
troduction into interstate commerce is
to require any commercial processor,
made from that consolidated ware-
in any establishment engaged in the
house or storage facility except as pro-
vided in paragraph (a) of this section. manufacture, processing, or packing of
acidified foods, to obtain and hold a
§ 108.19 Establishment of require- temporary emergency permit provided
ments for exemption from section for under section 404 of the Federal
404 of the act. Food, Drug, and Cosmetic Act. Such a
(a) Whenever the Commissioner finds permit may be required whenever the
after investigation that the distribu- Commissioner finds, after investiga-
tion in interstate commerce of any tion, that the commercial processor
class of food may, by reason of con- has failed to fulfill all the require-
tamination with microorganisms dur- ments of this section, including reg-
ing the manufacture, processing, or istration and filing of process informa-
packing thereof in any locality, be in- tion, and the mandatory portions of
jurious to health, and that such inju- §§ 114.10, 114.80(a) (1) and (2), and (b),
rious nature cannot be adequately de- 114.83, 114.89, and 114.100 (b), (c), and (d)
251
§ 108.25 21 CFR Ch. I (4–1–23 Edition)
of this chapter as they relate to acidi- tion not later than 90 days after the
fied foods. These requirements are in- commercial processor ceases or discon-
tended to ensure safe manufacturing, tinues the manufacture, processing, or
processing, and packing processes and packing of the foods in any establish-
to permit the Food and Drug Adminis- ment, except that this notification
tration to verify that these processes shall not be required for temporary
are being followed. Failure to meet cessations due to the seasonal char-
these requirements shall constitute a acter of an establishment’s production
prima facie basis for the immediate ap- or by temporary conditions including,
plication of the emergency permit con- but not limited to, labor disputes, fire,
trol provisions of section 404 of the act or acts of God.
to that establishment, under the proce- (2) Process filing. A commercial proc-
dures established in subpart A of this essor engaged in the processing of
part. acidified foods shall, not later than 60
(b) The definitions in § 114.3 of this days after registration, and before
chapter are applicable when those packing any new product, provide the
terms are used in this section. Food and Drug Administration infor-
(c)(1) Registration. A commercial mation on the scheduled processes in-
processor, when first engaging in the cluding, as necessary, conditions for
manufacture, processing, or packing of heat processing and control of pH, salt,
acidified foods in any State, as defined sugar, and preservative levels and
in section 201(a)(1) of the act, shall, not source and date of the establishment of
later than 10 days after first so engag- the process, for each acidified food in
ing, register and file with the Food and each container size. Filing of this in-
Drug Administration on Form FDA formation does not constitute approval
2541 (food canning establishment reg- of the information by the Food and
istration) information including, but Drug Administration, and information
not limited to, the name of the estab- concerning processes and other data so
lishment, principal place of business, filed shall be regarded as trade secrets
the location of each establishment in within the meaning of 21 U.S.C. 331(j)
which that processing is carried on, the and 18 U.S.C. 1905. This information
processing method in terms of acidity shall be submitted on Form FDA 2541e
and pH control, and a list of foods so (Food Process Filing for Acidified
processed in each establishment. These Method). Forms are available from the
forms are available from the LACF LACF Registration Coordinator (HFS–
Registration Coordinator (HFS–303), 303), Center for Food Safety and Ap-
Center for Food Safety and Applied Nu- plied Nutrition, Food and Drug Admin-
trition, Food and Drug Administration, istration, 5001 Campus Dr., College
5001 Campus Dr., College Park, MD Park, MD 20740, or at any Food and
20740, or at any Food and Drug Admin- Drug Administration district office.
istration district office. The completed The completed form shall be submitted
form shall be submitted to the Center to the LACF Registration Coordinator
for Food Safety and Applied Nutrition (HFS–618), Center for Food Safety and
(HFS–565), Food and Drug Administra- Applied Nutrition, Food and Drug Ad-
tion, 5001 Campus Dr., College Park, ministration, 5001 Campus Dr., College
MD 20740. These forms also are avail- Park, MD 20740. These forms also are
able on the Food and Drug Administra- available on the Food and Drug Admin-
tion’s Web site at http://www.fda.gov/ istration’s Web site at http://
Food/GuidanceRegulation/ www.fda.gov/Food/GuidanceRegulation/
FoodFacilityRegistration/ FoodFacilityRegistration/
AcidifiedLACFRegistration/ AcidifiedLACFRegistration/
ucm2007436.htm. For electronic submis- ucm2007436.htm. For electronic submis-
sion go to FDA’s Industry Systems Web sion go to FDA’s Industry Systems Web
site at www.access.fda.gov. Foreign site at www.access.fda.gov.
processors shall register before any of- (3) Process adherence and information—
fering of foods for import into the (i) Scheduling. A commercial processor
United States. Commercial processors engaged in processing acidified foods in

duly registered under this section shall any registered establishment shall
notify the Food and Drug Administra- process each food in conformity with at
252
least the scheduled processes filed Commissioner will consider students

under paragraph (c)(2) of this section. who have satisfactorily completed the
(ii) Process and pH information avail- required portions of the courses pre-
ability. When requested by the Food sented under § 108.35 and part 113 of this
and Drug Administration in writing, a chapter before March 16, 1979, as having
commercial processor engaged in the satisfactorily completed the prescribed
processing of acidified foods shall pro- course of instruction under this section
vide the Food and Drug Administration and part 114 of this chapter. The Com-
with any process and procedure infor- missioner will not withhold approval of
mation that the Food and Drug Admin- any school qualified to give such in-
istration deems necessary to determine struction.
the adequacy of the process. Fur- (g) A commercial processor engaged
nishing of this information does not in the processing of acidified foods
constitute approval by the Food and shall prepare, review, and retain at the
Drug Administration of the content of processing plant or other reasonably
the information filed, and the informa- accessible location for a period of 3
tion concerning processes and other years from the date of manufacture, all
data so furnished shall be considered records of processing, deviations in
trade secrets within the meaning of 21 processing, pH, and other records speci-
U.S.C. 331(j) and 18 U.S.C. 1905 (to the fied in part 114 of this chapter. Upon
extent that they qualify under those written demand during the course of a
provisions). factory inspection under section 704 of
(d) A commercial processor engaged the act by a duly authorized employee
in the processing of acidified foods of the Food and Drug Administration,
shall promptly report to the Food and a commercial processor shall permit
Drug Administration any instance of the inspection and copying by that em-
spoilage, process deviation, or con- ployee of these records to verify the pH
tamination with microorganisms, the and the adequacy of processing.
nature of which has potential health- (h) This section shall not apply to
endangering significance, where any the commercial processing of any food
lot of such food has in whole or in part processed under the continuous inspec-
entered distribution in commerce. tion of the meat and poultry inspection
(e) A commercial processor engaged program of the Food Safety and Inspec-
in the processing of acidified foods tion Service of the Department of Agri-
shall prepare and maintain files on a culture under the Federal Meat Inspec-
current procedure for use for products tion Act (34 Stat. 1256, as amended by
under the processor’s control, which 81 Stat. 584 (21 U.S.C. 601 et seq.)) and
that processor will ask the distributor the Poultry Products Inspection Act
to follow, including plans for recalling (71 Stat. 441, as amended by 82 Stat. 791
products that may be injurious to (21 U.S.C. 451 et seq.)).
health; for identifying, collecting, (i) Wherever the Commissioner finds
warehousing, and controlling products; that any State regulates the commer-
for determining the effectiveness of re- cial processing of acidified foods under
calls; for notifying the Food and Drug effective regulations specifying at least
Administration of any recalls; and for the requirements of part 114 of this
implementing recall programs. chapter, the Commissioner shall issue
(f) All plant personnel involved in a notice stating that compliance with
acidification, pH control, heat treat- such State regulations shall constitute
ment, or other critical factors of the compliance with this section, if the
operation shall be under the operating State through its regulatory agency or
supervision of a person who has at- each processor of acidified foods in the
tended a school approved by the Com- State files with the Food and Drug Ad-
missioner for giving instruction in ministration the registration informa-
food-handling techniques, food protection and the processing information
tion principles, personal hygiene, plant prescribed in paragraph (c) of this sec-
sanitation practices, pH controls, and tion.
critical factors in acidification, and (j) Imports. (1) This section applies to
who has satisfactorily completed the any foreign commercial processor en-
prescribed course of instruction. The gaged in the processing of acidified
253
§ 108.35 21 CFR Ch. I (4–1–23 Edition)
foods and offering those foods for im- § 108.35 Thermal processing of low-
port into the United States except acid foods packaged in hermetically
that, in lieu of providing for the sealed containers.
issuance of an emergency permit under (a) Inadequate or improper manufac-
paragraph (a) of this section, the Com- ture, processing, or packing of ther-
missioner will request the Secretary of mally processed low-acid foods in her-
the Treasury to refuse admission into metically sealed containers may result
the United States, under section 801 of in the distribution in interstate com-
the act, to any acidified foods which merce of processed foods that may be
the Commissioner determines, after in- injurious to health. The harmful na-
vestigation, may result in the distribu- ture of such foods cannot be adequately
tion in interstate commerce of proc- determined after these foods have en-
essed foods that may be injurious to tered into interstate commerce. The
health as set forth in paragraph (a) of Commissioner of Food and Drugs there-
this section. fore finds that, in order to protect the
(2) Any acidified food so refused ad- public health, it may be necessary to
mission shall not be admitted until the require any commercial processor, in
Commissioner determines that the any establishment engaged in the man-
commercial processor offering the food ufacture, processing, or packing of
for import has complied with the re- thermally processed low-acid foods in
quirements of this section and that the hermetically sealed containers, to ob-
food is not injurious to health. To as- tain and hold a temporary emergency
sist the Commissioner in making this permit provided for under section 404 of
determination, a duly authorized em- the Federal Food, Drug, and Cosmetic
ployee of the Food and Drug Adminis- Act. Such a permit may be required
tration shall be permitted to inspect whenever the Commissioner finds, after
the commercial processor’s manufac- investigation, that the commercial
turing, processing, and packing facili- processor has failed to fulfill all the re-
ties. quirements of this section, including
(k) The following information sub- registration and the filing of process
mitted to the Food and Drug Adminis- information, and the mandatory por-
tration under this section is not avail- tions of part 113 of this chapter. These
able for public disclosure unless it has requirements are intended to ensure
been previously disclosed to the public safe manufacture, processing, and
as defined in § 20.81 of this chapter or it packing procedures and to permit the
relates to a product or ingredient that Food and Drug Administration to
has been abandoned and no longer rep- verify that these procedures are being
resents a trade secret or confidential followed. Such failure shall constitute
commercial or financial information as a prima facie basis for the immediate
defined in § 20.61 of this chapter: application of the emergency permit
(1) Manufacturing methods or proc- control provisions of section 404 of the
esses, including quality control infor- act to that establishment, pursuant to
mation. the procedures established in subpart A
(2) Production, sales, distribution, of this part.
and similar information, except that (b) The definitions in § 113.3 of this
any compilation of the information ag- chapter are applicable when such terms
gregated and prepared in a way that are used in this section.
does not reveal information which is (c) Registration and process filing—(1)
not available for public disclosure Registration. A commercial processor
under this provision is available for when first engaging in the manufac-
public disclosure. ture, processing, or packing of ther-
(3) Quantitative or semiquantitative mally processed low-acid foods in her-
formulas. metically sealed containers in any
[44 FR 16207, Mar. 16, 1979, as amended at 54 State, as defined in section 201(a)(1) of
FR 24891, June 12, 1989; 61 FR 14479, Apr. 2, the act, shall, not later than 10 days
1996; 66 FR 56035, Nov. 6, 2001; 81 FR 46831, after first so engaging, register with
July 19, 2016] the Food and Drug Administration on
254
Form FDA 2541 (food canning establish- of processing, sterilizing value (Fo), or
ment registration) information includ- other equivalent scientific evidence of
ing (but not limited to) his name, prin- process adequacy, critical control fac-
cipal place of business, the location of tors affecting heat penetration, and
each establishment in which such proc- source and date of the establishment of
essing is carried on, the processing the process, for each such low-acid food
method in terms of the type of proc- in each container size: Provided, that
essing equipment employed, and a list the filing of such information does not
of the low-acid foods so processed in constitute approval of the information
each such establishment. These forms by the Food and Drug Administration,
are available from the LACF Registra- and that information concerning proc-
tion Coordinator (HFS–303), Center for esses and other data so filed shall be
Food Safety and Applied Nutrition, regarded as trade secrets within the
Food and Drug Administration, 5001 meaning of 21 U.S.C. 331(j) and 18
Campus Dr., College Park, MD 20740, or U.S.C. 1905. This information shall be
at any Food and Drug Administration submitted on the following forms as
district office. The completed form appropriate: Form FDA 2541d (Food
shall be submitted to the LACF Reg- Process Filing for Low-Acid Retorted
istration Coordinator (HFS–618), Cen- Method), Form FDA 2541f (Food Proc-
ter for Food Safety and Applied Nutri- ess Filing for Water Activity/Formula-
tion, Food and Drug Administration, tion Control Method), or Form FDA
5001 Campus Dr., College Park, MD 2541g (Food Process Filing for Low-
20740. These forms also are available on Acid Aseptic Systems). These forms are
the Food and Drug Administration’s available from the LACF Registration
Web site at http://www.fda.gov/Food/ Coordinator (HFS–303), Center for Food
GuidanceRegulation/ Safety and Applied Nutrition, Food and
FoodFacilityRegistration/ Drug Administration, 5001 Campus Dr.,
AcidifiedLACFRegistration/default.htm. College Park, MD 20740, or at any Food
For electronic submission go to FDA’s and Drug Administration district of-
Industry Systems Web site at fice. The completed form(s) shall be
www.access.fda.gov. Commercial proc- submitted to the LACF Registration
essors duly registered in accordance Coordinator (HFS–303), Center for Food
with this section shall notify the Food Safety and Applied Nutrition, Food and
and Drug Administration not later Drug Administration, 5001 Campus Dr.,
than 90 days after such commercial College Park, MD 20740. These forms
processor ceases or discontinues the also are available on the Food and
manufacture, processing, or packing of Drug Administration’s Web site at
thermally processed foods in any estab- http://www.fda.gov/Food/
lishment: Provided, that such notifica- GuidanceRegulation/
tion shall not be required as to the FoodFacilityRegistration/
temporary cessation necessitated by AcidifiedLACFRegistration/default.htm.
the seasonal character of the par- For electronic submission, go to FDA’s
ticular establishment’s production or Industry Systems Web site at
caused by temporary conditions includ- www.access.fda.gov.
ing but not limited to strikes, (i) If all the necessary information is
lockouts, fire, or acts of God. not available for existing products, the
(2) Process filing. A commercial proc- processor shall, at the time the exist-
essor engaged in the thermal proc- ing information is provided to the Food
essing of low-acid foods packaged in and Drug Administration request in
hermetically sealed containers shall, writing an extension of time for sub-
not later than 60 days after registra- mission of such information, specifying
tion and prior to the packing of a new what additional information is to be
product, provide the Food and Drug supplied and the date by which it is to
Administration information as to the be submitted. Within 30 working days
scheduled processes including but not after receipt of such request the Food
limited to the processing method, type and Drug Administration shall either
of retort or other thermal processing grant or deny such request in writing.

equipment employed, minimum initial (ii) If a packer intentionally makes a
temperatures, times and temperatures change in a previously filed scheduled
255
§ 108.35 21 CFR Ch. I (4–1–23 Edition)
process by reducing the initial tem- in each container size in conformity

perature or retort temperature, reduc- with at least the scheduled processes
ing the time of processing, or changing and modifications filed pursuant to
the product formulation, the container, paragraph (c)(2) of this section.
or any other condition basic to the ade- (ii) Process information availability:
quacy of scheduled process, he shall When requested by the Food and Drug
prior to using such changed process ob- Administration in writing, a commer-
tain substantiation by qualified sci- cial processor engaged in thermal proc-
entific authority as to its adequacy. essing of low-acid foods packaged in
Such substantiation may be obtained hermetically sealed containers shall
by telephone, telegram, or other media, provide the Food and Drug Administra-
but must be promptly recorded, tion with any information concerning
verified in writing by the authority, processes and procedures which is
and contained in the packer’s files for deemed necessary by the Food and
review by the Food and Drug Adminis- Drug Administration to determine the
tration. Within 30 days after first use, adequacy of the process: Provided, That
the packer shall submit to the LACF the furnishing of such information does
Registration Coordinator (HFS–303), not constitute approval of the informa-
Center for Food Safety and Applied Nu- tion by the Food and Drug Administra-
trition, Food and Drug Administration, tion, and that the information con-
5001 Campus Dr., College Park, MD cerning processes and other data so
20740 a complete description of the furnished shall be regarded as trade se-
modifications made and utilized, to- crets within the meaning of 21 U.S.C.
gether with a copy of his file record 331(j) and 18 U.S.C. 1905.
showing prior substantiation by a
(d) A commercial processor engaged
qualified scientific authority as to the
in the thermal processing of low-acid
safety of the changed process. Any in-
foods packaged in hermetically sealed
tentional change of a previously filed
containers shall promptly report to the
scheduled process or modification
Food and Drug Administration any in-
thereof in which the change consists
stance of spoilage or process deviation
solely of a higher initial temperature,
the nature of which indicates potential
a higher retort temperature, or a
health significance where any lot of
longer processing time, shall not be
considered a change subject to this such food has in whole or in part en-
paragraph, but if that modification is tered distribution.
thereafter to be regularly scheduled, (e) A commercial processor engaged
the modified process shall be promptly in thermal processing of low-acid foods
filed as a scheduled process, accom- packaged in hermetically sealed con-
panied by full information on the speci- tainers shall promptly report to the
fied forms as provided in this para- Food and Drug Administration any in-
graph. stance wherein any lot of such food,
(iii) Many packers employ an ‘‘oper- which may be injurious to health by
ating’’ process in which retort opera- reason of contamination with micro-
tors are instructed to use retort tem- organisms, has in whole or in part en-
peratures and/or processing times tered distribution.
slightly in excess of those specified in (f) A commercial processor engaged
the scheduled process as a safety factor in the thermal processing of low-acid
to compensate for minor fluctuations foods packaged in hermetically sealed
in temperature or time to assure that containers shall have prepared and in
the minimum times and temperatures his files a current procedure which he
in the scheduled process are always will use for products under his control
met. This would not constitute a modi- and which he will ask his distributor to
fication of the scheduled process. follow, including plans for effecting re-
(3) Process adherence and information. calls of any product that may be inju-
(i) A commercial processor engaged in rious to health; for identifying, col-
the thermal processing of low-acid lecting, warehousing, and controlling
foods packaged in hermetically sealed the product; for determining the effec-
containers in any registered establish- tiveness of such recall; for notifying
ment shall process each low-acid food the Food and Drug Administration of
256
any such recall; and for implementing 81 Stat. 584 (21 U.S.C. 601 et seq.)) and
such recall program. the Poultry Products Inspection Act
(g) All operators of retorts, thermal (71 Stat. 441, as amended by 82 Stat. 791
processing systems, aseptic processing (21 U.S.C. 451 et seq.)).
and packaging systems, or other ther- (j) Compliance with State regulations.
mal processing systems, and container (1) Wherever the Commissioner finds
closure inspectors shall be under the that any State regulates the commer-
operating supervision of a person who cial thermal processing of low-acid
has attended a school approved by the foods in accordance with effective reg-
Commissioner for giving instruction in ulations specifying at least the require-
retort operations, aseptic processing ments of part 113 of this chapter, he
and packaging systems operations or shall issue a notice stating that com-
other thermal processing systems oper- pliance with such State regulations
ations, and container closure inspec- shall constitute compliance with part
tions, and has satisfactorily completed 113 of this chapter. However, the provi-
the prescribed course of instruction: sions of this section shall remain appli-
Provided, That this requirement shall cable to the commercial processing of
not apply in the State of California as low-acid foods in any such State, ex-
listed in paragraph (j) of this section. cept that, either the State through its
The Commissioner will not withhold regulatory agency or each processor of
approval of any school qualified to give low-acid foods in such State shall file
such instruction. with the Center for Food Safety and
(h) A commercial processor engaged Applied Nutrition the registration in-
in the thermal processing of low-acid formation and the processing informa-
foods packaged in hermetically sealed tion prescribed in paragraph (c) of this
containers shall prepare, review, and section.
retain at the processing plant for a pe- (2) The Commissioner finds that the
riod of not less than one year, and at regulations adopted by the State of
the processing plant or other reason- California under the laws relating to
ably accessible location for an addi- cannery inspections governing thermal
tional two years, all records of proc- processing of low-acid foods packaged
essing, deviations in processing, con- in hermetically sealed containers sat-
tainer closure inspections, and other isfy the requirements of part 113 of this
records specified in part 113 of this chapter.
chapter. If during the first year of the Accordingly, processors, who under the
three-year record retention period the laws relating to cannery inspections
processing plant is closed for a pro- are licensed by the State of California
longed period between seasonal packs, and who comply with such state regu-
the records may be transferred to some lations, shall be deemed to comply
other reasonably accessible location at with the requirements of part 113 of
the end of the seasonal pack. Upon this chapter.
written demand during the course of a (k) Imports. (1) This section shall
factory inspection pursuant to section apply to any foreign commercial proc-
704 of the act by a duly authorized em- essor engaged in the thermal proc-
ployee of the Food and Drug Adminis- essing of low-acid foods packaged in
tration, a commercial processor shall hermetically sealed containers and of-
permit the inspection and copying by fering such foods for import into the
such employee of these records to United States except that, in lieu of
verify the adequacy of processing, the providing for the issuance of an emer-
integrity of container closures, and the gency permit under paragraph (a) of
coding of the products. this section, the Commissioner will re-
(i) This section shall not apply to the quest the Secretary of the Treasury to
commercial processing of any food refuse admission into the United
processed under the continuous inspec- States, pursuant to section 801 of the
tion of the meat and poultry inspection act, of any such low-acid foods which
program of the Food Safety and Inspec- the Commissioner determines, after in-
tion Service of the Department of Agri- vestigation, may result in the distribu-
culture under the Federal Meat Inspec- tion in interstate commerce of proc-
tion Act (34 Stat. 1256, as amended by essed foods that may be injurious to
257
health as set forth in paragraph (a) of 109.7 Unavoidability.

this section. 109.15 Use of polychlorinated biphenyls
(2) Any such food refused admission (PCB’s) in establishments manufacturing
shall not be admitted until such time food-packaging materials.
as the Commissioner may determine 109.16 Ornamental and decorative
that the commercial processor offering ceramicware.
the food for import is in compliance
with the requirements and conditions Subpart B—Tolerances for Unavoidable
of this section and that such food is not Poisonous or Deleterious Substances
injurious to health. For the purpose of 109.30 Tolerances for polychlorinated
making such determination, the Com- biphenyls (PCB’s).
missioner reserves the right for a duly
authorized employee of the Food and Subpart C—Regulatory Limits for Added
Drug Administration to inspect the Poisonous or Deleterious Substances
commercial processor’s manufacturing, [Reserved]
processing, and packing facilities.
(l) The following data and informa- Subpart D—Naturally Occurring Poisonous
tion submitted to the Food and Drug or Deleterious Substances [Reserved]
Administration pursuant to this sec-
tion are not available for public disclo- AUTHORITY: 21 U.S.C. 321, 336, 342, 346, 346a,
sure unless they have been previously 348, 371.
disclosed to the public as defined in
SOURCE: 42 FR 52819, Sept. 30, 1977, unless
§ 20.81 of this chapter or they relate to
otherwise noted.
a product or ingredient that has been
abandoned and they no longer rep- EDITORIAL NOTE: Nomenclature changes to
resent a trade secret or confidential part 109 appear at 81 FR 49896, July 29, 2016.
commercial or financial information as
defined in § 20.81 of this chapter: Subpart A—General Provisions
(1) Manufacturing methods or proc-
esses, including quality control infor- § 109.3 Definitions and interpretations.
mation.
(a) Act means the Federal Food,
(2) Production, sales, distribution,
Drug, and Cosmetic Act.
and similar data and information, ex-
cept that any compilation of such data (b) The definitions of terms con-
and information aggregated and pre- tained in section 201 of the act are ap-
pared in a way that does not reveal plicable to such terms when used in
data or information which is not avail- this part unless modified in this sec-
able for public disclosure under this tion.
provision is available for public disclo- (c) A naturally occurring poisonous or
sure. deleterious substance is a poisonous or
(3) Quantitative or semiquantitative deleterious substance that is an inher-
formulas. ent natural constituent of a food and is
not the result of environmental, agri-
FR 15673, Mar. 22, 1977; 54 FR 24891, June 12, cultural, industrial, or other contami-
1989; 61 FR 14480, Apr. 2, 1996; 66 FR 56035, nation.
Nov. 6, 2001; 81 FR 46831, July 19, 2016] (d) An added poisonous or deleterious
substance is a poisonous or deleterious
PART 109—UNAVOIDABLE CON- substance that is not a naturally oc-
TAMINANTS IN FOOD FOR curring poisonous or deleterious sub-
HUMAN CONSUMPTION AND stance. When a naturally occurring
FOOD-PACKAGING MATERIAL poisonous or deleterious substance is
increased to abnormal levels through
Subpart A—General Provisions mishandling or other intervening acts,
it is an added poisonous or deleterious
Sec. substance to the extent of such in-
109.3 Definitions and interpretations. crease.
109.4 Establishment of tolerances, regu-
latory limits, and action levels. (e) Food includes human food and
109.6 Added poisonous or deleterious sub- substances migrating to food from
stances. food-contact articles.
258
§ 109.4 Establishment of tolerances, tion issued under section 409 of the act
regulatory limits, and action levels. when possible. When such a use cannot
(a) When appropriate under the cri- be approved under the criteria of sec-
teria of § 109.6, a tolerance for an added tion 409 of the act, or when the added
poisonous or deleterious substance, poisonous or deleterious substance is
which may be a food additive, may be not a food additive, a tolerance, regu-
established by regulation in subpart B latory limit, or action level may be es-
of this part under the provisions of sec- tablished pursuant to the criteria in
tion 406 of the act. A tolerance may paragraphs (b), (c), or (d) of this sec-
prohibit any detectable amount of the tion. Residues resulting from the use of
substance in food. an added poisonous or deleterious sub-
(b) When appropriate under the cri- stance that is also a pesticide chemical
teria of § 109.6, and under section will ordinarily be controlled by a toler-
402(a)(1) of the act, a regulatory limit ance established in a regulation issued
for an added poisonous or deleterious under sections 406, 408, or 409 of the act
substance, which may be a food addi- by the U.S. Environmental Protection
tive, may be established by regulation Agency (EPA). When such a regulation
in subpart C of this part under the pro- has not been issued, an action level for
visions of sections 402(a)(1) and 701(a) of an added poisonous or deleterious sub-
the act. A regulatory limit may pro- stance that is also a pesticide chemical
hibit any detectable amount of the sub- may be established by the Food and
stance in food. The regulatory limit es- Drug Administration. The Food and
tablished represents the level at which Drug Administration will request EPA
food is adulterated within the meaning to recommend such an action level pur-
of section 402(a)(1) of the act. suant to the criteria established in
(c)(1) When appropriate under the cri- paragraph (d) of this section.
teria of § 109.6, an action level for an (b) A tolerance for an added poi-
added poisonous or deleterious sub- sonous or deleterious substance in any
stance, which may be a food additive, food may be established when the fol-
may be established to define a level of lowing criteria are met:
contamination at which a food may be (1) The substance cannot be avoided
regarded as adulterated. by good manufacturing practice.
(2) Whenever an action level is estab- (2) The tolerance established is suffi-
lished or changed, a notice shall be cient for the protection of the public
published in the FEDERAL REGISTER as health, taking into account the extent
soon as practicable thereafter. The no- to which the presence of the substance
tice shall call attention to the mate- cannot be avoided and the other ways
rial supporting the action level which in which the consumer may be affected
shall be on file with the Division of by the same or related poisonous or
Dockets Management before the notice deleterious substances.
is published. The notice shall invite (3) No technological or other changes
public comment on the action level. are foreseeable in the near future that
(d) A regulation may be established might affect the appropriateness of the
in subpart D of this part to identify a tolerance established. Examples of
food containing a naturally occurring changes that might affect the appro-
poisonous or deleterious substance priateness of the tolerance include an-
which will be deemed to be adulterated ticipated improvements in good manu-
under section 402(a)(1) of the act. These facturing practice that would change
regulations do not constitute a com- the extent to which use of the sub-
plete list of such foods. stance is unavoidable and anticipated
[42 FR 52819, Sept. 30, 1977, as amended at 55 studies expected to provide significant
FR 20785, May 21, 1990] new toxicological or use data.
(c) A regulatory limit for an added
§ 109.6 Added poisonous or deleterious poisonous or deleterious substance in
substances. any food may be established when each
(a) Use of an added poisonous or dele- of the following criteria is met:
terious substance, other than a pes- (1) The substance cannot be avoided
ticide chemical, that is also a food ad- by current good manufacturing prac-
ditive, will be controlled by a regula- tices.
259
§ 109.7 21 CFR Ch. I (4–1–23 Edition)
(2) There is no tolerance established (b) Compliance with tolerances, regu-

for the substance in the particular food latory limits, and action levels does
under sections 406, 408, or 409 of the act. not excuse failure to observe either the
(3) There is insufficient information requirement in section 402(a)(4) of the
by which a tolerance may be estab- act that food may not be prepared,
lished for the substance under section packed, or held under insanitary condi-
406 of the act or technological changes tions or the other requirements in this
appear reasonably possible that may chapter that food manufacturers must
affect the appropriateness of a toler- observe current good manufacturing
ance. The regulatory limit established practices. Evidence obtained through
represents the level at which food is factory inspection or otherwise indi-
adulterated within the meaning of sec- cating such a violation renders the
tion 402(a)(1) of the act. food unlawful, even though the
(d) An action level for an added poi- amounts of poisonous or deleterious
sonous or deleterious substance in any substances are lower than the cur-
food may be established when the cri- rently established tolerances, regu-
teria in paragraph (b) of this section latory limits, or action levels. The
are met, except that technological or manufacturer of food must at all times
other changes that might affect the ap- utilize quality control procedures
propriateness of the tolerance are fore- which will reduce contamination to the
seeable in the near future. An action lowest level currently feasible.
level for an added poisonous or delete-
[42 FR 52819, Sept. 30, 1977, as amended at 55
rious substance in any food may be es-
FR 20785, May 21, 1990]
tablished at a level at which the Food
and Drug Administration may regard § 109.15 Use of polychlorinated
the food as adulterated within the biphenyls (PCB’s) in establishments
meaning of section 402(a)(1) of the act, manufacturing food-packaging ma-
without regard to the criteria in para- terials.
graph (b) of this section or in section
(a) Polychlorinated biphenyls (PCB’s)
406 of the act. An action level will be
represent a class of toxic industrial
withdrawn when a tolerance or regu-
chemicals manufactured and sold under
latory limit for the same substance and
a variety of trade names, including:
use has been established.
Aroclor (United States); Phenoclor
(e) Tolerances will be established (France); Colphen (Germany); and
under authority appropriate for action
Kanaclor (Japan). PCB’s are highly sta-
levels (sections 306, 402(a), and 701(a) of
ble, heat resistant, and nonflammable
the act, together with section 408 or 409
chemicals. Industrial uses of PCB’s in-
of the act, if appropriate) as well as
clude, or did include in the past, their
under authority appropriate for toler-
use as electrical transformer and ca-
ances (sections 406 and 701 of the act).
pacitor fluids, heat transfer fluids, hy-
In the event the effectiveness of a tol-
draulic fluids, and plasticizers, and in
erance is stayed pursuant to section
formulations of lubricants, coatings,
701(e)(2) of the act by the filing of an
and inks. Their unique physical and
objection, the order establishing the
chemical properties and widespread,
tolerance shall be deemed to be an
order establishing an action level until uncontrolled industrial applications
final action is taken upon such objec- have caused PCB’s to be a persistent
tion. and ubiquitous contaminant in the en-
vironment, causing the contamination
[42 FR 52819, Sept. 30, 1977, as amended at 55 of certain foods. In addition, incidents
FR 20785, May 21, 1990] have occurred in which PCB’s have di-
rectly contaminated animal feeds as a
§ 109.7 Unavoidability. result of industrial accidents (leakage
(a) Tolerances and action levels in or spillage of PCB fluids from plant
this part are established at levels based equipment). These accidents in turn
on the unavoidability of the poisonous caused the contamination of food prod-
or deleterious substance concerned and ucts intended for human consumption

do not establish a permissible level of (meat, milk and eggs). Investigations
contamination where it is avoidable. by the Food and Drug Administration
260
have revealed that a significant per- as a result of normal use or as a result

centage of paper food-packaging mate- of accident, breakage, or other mishap.
rial contains PCB’s which can migrate (iii) The toxicity and other charac-
to the packaged food. The origin of teristics of fluids selected as PCB re-
PCB’s in such material is not fully un- placements must be adequately deter-
derstood. Reclaimed fibers containing mined so that the least potentially
carbonless copy paper (contains 3 to 5 hazardous replacement is used. In mak-
percent PCB’s) have been identified as ing this determination with respect to
a primary source of PCB’s in paper a given fluid, consideration should be
products. Some virgin paper products given to (a) its toxicity; (b) the max-
have also been found to contain PCB’s, imum quantity that could be spilled
the source of which is generally attrib- onto a given quantity of food before it
uted to direct contamination from in- would be noticed, taking into account
dustrial accidents from the use of PCB- its color and odor; (c) possible signaling
containing equipment and machinery devices in the equipment to indicate a
in food packaging manufacturing es- loss of fluid, etc.; and (d) its environ-
tablishments. Since PCB’s are toxic mental stability and tendency to sur-
chemicals, the PCB contamination of vive and be concentrated through the
food-packaging materials as a result of food chain. The judgment as to wheth-
industrial accidents, which can cause er a replacement fluid is sufficiently
the PCB contamination of food, rep- non-hazardous is to be made on an indi-
resents a hazard to public health. It is vidual installation and operation basis.
therefore necessary to place certain re- (c) The provisions of this section do
strictions on the industrial uses of not apply to electrical transformers
PCB’s in establishments manufac- and condensers containing PCB’s in
turing food-packaging materials. sealed containers.
(b) The following special provisions
are necessary to preclude the acci- § 109.16 Ornamental and decorative
dental PCB contamination of food- ceramicware.
packaging materials:
(1) New equipment or machinery for (a) Lead is a toxic metal that is used
manufacturing food-packaging mate- as a component of glazes and decora-
rials shall not contain or use PCB’s. tive decals on ceramics, including some
(2) On or before September 4, 1973, the ornamental and decorative
management of establishments manu- ceramicware. The use of ornamental or
facturing food-packaging materials decorative ceramicware to prepare,
shall: serve, or hold food may result in the
(i) Have the heat exchange fluid used leaching of lead from the glaze or deco-
in existing equipment for manufac- ration into the food. The provisions of
turing food-packaging materials sam- paragraph (b) of this section are nec-
pled and tested to determine whether it essary to ensure that ornamental or
contains PCB’s or verify the absence of decorative ceramicware bear adequate
PCB’s in such formulations by other indications that they are not to be
appropriate means. On or before Sept. used for food-handling purposes.
4, 1973, any such fluid formulated with (b) Ornamental or decorative
PCB’s must to the fullest extent pos- ceramicware initially introduced or
sible commensurate with current good initially delivered for introduction into
manufacturing practices be replaced interstate commerce on or after July
with a heat exchange fluid that does 13, 1994 appears to be suitable for food
not contain PCB’s. use will be considered to be for food use
(ii) Eliminate to the fullest extent unless:
possible commensurate with current (1) It bears:
good manufacturing practices from the (i) A conspicuous stick-on label on a
establishment any other PCB-con- surface clearly visible to consumers
taining equipment, machinery and ma- that states in legible script in letters
terials wherever there is a reasonable at least 3.2 millimeters (0.125 inch) in
expectation that such articles could height one of the following messages:
cause food-packaging materials to be- ‘‘Not for Food Use. May Poison Food,’’
come contaminated with PCB’s either ‘‘Not for Food Use. Glaze contains lead.
261
§ 109.30 21 CFR Ch. I (4–1–23 Edition)
Food Use May Result in Lead Poi- Subpart B—Tolerances for Un-
soning,’’ and ‘‘Not for Food Use—Food avoidable Poisonous or Dele-
Consumed from this Vessel May be terious Substances
Harmful,’’ and
(ii) A conspicuous and legible perma- § 109.30 Tolerances for polychlorinated
nent statement of the message selected biphenyls (PCB’s).
from paragraph (b)(1)(i) of this section (a) Polychlorinated biphenyls (PCB’s)
molded or fired onto the exterior sur- are toxic, industrial chemicals. Be-
face of the base or, when the cause of their widespread, uncontrolled
ceramicware is not fired after decora- industrial applications, PCB’s have be-
tion, permanently painted onto the ex- come a persistent and ubiquitous con-
terior surface of the base. This perma- taminant in the environment. As a re-
nent statement shall be in letters at sult, certain foods and animal feeds,
least 3.2 millimeters (0.125 inch) in principally those of animal and marine
height, except that if insufficient space origin, contain PCB’s as unavoidable,
exists for the permanent statement in environmental contaminants. PCB’s
letters of such height, the statement are transmitted to the food portion
shall be in the largest letters that will (meat, milk, and eggs) of food-pro-
allow it to fit on the base of the piece, ducing animals ingesting PCB-con-
provided that the letters are at least taminated animal feed. In addition, a
1.6 millimeters (0.062 inch) in height; or significant percentage of paper food-
(2) A hole is bored through the poten- packaging materials contain PCB’s
which may migrate to the packaged
tial food-contact surface.
food. The source of PCB’s in paper
(c) In addition to steps required food-packaging materials is primarily
under paragraphs (b)(1) and (b)(2) of of certain types of carbonless copy
this section, the following optional in- paper (containing 3 to 5 percent PCB’s)
formation may be provided on the in waste paper stocks used for manu-
ware: facturing recycled paper. Therefore,
(1) A further explanatory statement temporary tolerances for residues of
concerning the decorative nature of the PCB’s as unavoidable environmental or
piece, such as ‘‘Decorative’’ or ‘‘For industrial contaminants are estab-
Decorative Purposes Only,’’ may be lished for a sufficient period of time
used; however, such additional state- following the effective date of this
ment shall be placed after the required paragraph to permit the elimination of
statement. such contaminants at the earliest prac-
(2) A symbol may be used to advise ticable time. For the purposes of this
that a piece of ornamental or decora- paragraph, the term ‘‘polychlorinated
tive ceramicware is not to be used with biphenyls (PCB’s)’’ is applicable to
food, as illustrated below. mixtures of chlorinated biphenyl com-
pounds, irrespective of which mixture
of PCB’s is present as the residue. The
temporary tolerances for residues of
PCB’s are as follows:
(1) 1.5 parts per million in milk (fat
basis).
(2) 1.5 parts per million in manufac-
tured dairy products (fat basis).
(3) 3 parts per million in poultry (fat
The circle of the above symbol should basis).
be at least 2.54 centimeters (1 inch) in (4) 0.3 parts per million in eggs.
diameter. The symbol may be used on (5) 0.2 parts per million in finished
the temporary label or applied to the animal feed for food-producing animals
(except the following finished animal
base of the piece in the same manner as
feeds: feed concentrates, feed supple-
the permanent statement.
ments, and feed premixes).

[59 FR 1641, Jan. 12, 1994] (6) 2 parts per million in animal feed
components of animal origin, including
262
ER01JA93.368</GPH>
fishmeal and other by-products of ma- for inspection at the National Archives
rine origin and in finished animal feed and Records Administration (NARA).
concentrates, supplements, and pre- For information on the availability of
mixes intended for food producing ani- this material at NARA, call 202–741–
mals. 6030, or go to: http://www.archives.gov/
(7) 2 parts per million in fish and federal_register/
shellfish (edible portion). The edible code_of_federal_regulations/
portion of fish excludes head, scales, ibr_locations.html. A class of barrier ma-
viscera, and inedible bones. terial shall be deemed functional only
(8) 0.2 parts per million in infant and if the definition of the class and the
junior foods. designation of one or more representa-
(9) 10 parts per million in paper food- tive barriers has been approved by the
packaging material intended for or Director, Center for Food Safety and
used with human food, finished animal Applied Nutrition, Food and Drug Ad-
feed and any components intended for ministration. In the event that the Di-
animal feeds. The tolerance shall not rector, Center for Food Safety and Ap-
apply to paper food-packaging material plied Nutrition, does not approve a pro-
separated from the food therein by a posal made to the Center regarding the
functional barrier which is imper- definition of a class of barrier material
meable to migration of PCB’s. or the designation of representative
(b) A compilation entitled ‘‘Analyt- barriers, the Director shall advise the
ical Methodology for Polychlorinated person making the proposal of the rea-
Biphenyls, June 1979’’ for determining sons for the Center’s disapproval with-
compliance with the tolerances estab- in 90 days of receipt of the proposal. All
lished in this section is available from proposals for definition of classes and
the Division of Dockets Management determinations of the Food and Drug
(HFA–305), Food and Drug Administra- Administration regarding such pro-
tion, 5630 Fishers Lane, rm. 1061, Rock- posals shall be on file with the Division
ville, MD 20852. of Dockets Management (HFA–305),
(c) A barrier is functional for pur- Food and Drug Administration, 5630
poses of paragraph (a)(9) of this section Fishers Lane, rm. 1061, Rockville, MD
if the barrier limits migration of PCB’s 20852.
from the packaging material to food to (d) Any person who asserts that a
a level not exceeding the migration barrier or class of barriers is functional
which occurs under the same test con- shall submit the results of tests con-
ditions from packaging material conducted to determine the functionality
taining 10 parts per million PCB with- of the barrier or class of barriers to
out the use of a barrier. A class of bar- Center for Food Safety and Applied Nu-
rier material is functional for purposes trition (HFS–308), Food and Drug Ad-
of paragraph (a)(9) of this section if a ministration, 5001 Campus Dr., College
representative barrier of the class lim- Park, MD 20740. All barriers or classes
its migration of PCB’s from the pack- of barriers shall be tested with the four
aging material to food to a level not solid food receptors specified in ‘‘Test
exceeding the migration which occurs Procedures for Determination of PCB
under the same test conditions from Permeability of Food Packaging,
packaging material containing 10 parts Inner-Wraps, September 1976, revised
per million PCB without the use of a May 1983’’, which is incorporated by
barrier. Migration levels shall be deter- reference. The availability of this ref-
mined for purpose of this paragraph erence is given in paragraph (c) of this
solely by use of testing conditions de- section. The test results as to each bar-
scribed in ‘‘Test Procedures for Deter- rier shall be accompanied by (1) a de-
mination of PCB Permeability of Food scription of the barrier’s composition
Packaging, Inner-Wraps, September adequate to enable identification; and
1976, revised May 1983’’, which is incor- (2) a specific definition of the barrier
porated by reference. Copies are avail- by relevant technical characteristics.
able from the Division of Dockets Man- The Center for Food Safety and Ap-
agement (HFA–305), Food and Drug Ad- plied Nutrition shall review submitted
ministration, 5630 Fishers Lane, rm. test results promptly. Within 60 days of
1061, Rockville, MD 20852, or available the receipt of test results, the Director,
263
Center for Food Safety and Applied Nu- 110.10 Personnel.

trition, shall notify the person submit- 110.19 Exclusions.
ting the test results whether the tests
were conducted in accordance with the Subpart B—Buildings and Facilities
‘‘Analytical Methodology for Poly- 110.20 Plant and grounds.
chlorinated Biphenyls; June 1979’’, 110.35 Sanitary operations.
which is incorporated by reference, or 110.37 Sanitary facilities and controls.
the ‘‘Test Procedures for Determina-
tion of PCB Permeability of Food Subpart C—Equipment
Packaging, Inner-Wraps, September
1976, revised May 1983’’ and whether, 110.40 Equipment and utensils.
therefore, the barrier or class of bar-
riers is deemed functional within the Subpart D [Reserved]
meaning of paragraph (c) of this sec-
tion. The test results and any response Subpart E—Production and Process
of the Food and Drug Administration Controls
shall be placed on file with the Division 110.80 Processes and controls.
of Dockets Management, Food and 110.93 Warehousing and distribution.
Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Subpart F [Reserved]
FR 38340, June 29, 1979; 46 FR 8459, Jan. 27, Subpart G—Defect Action Levels
1981; 48 FR 10811, Mar. 15, 1983; 48 FR 37021,
Aug. 16, 1983; 54 FR 24892, June 12, 1989; 59 FR 110.110 Natural or unavoidable defects in
14364, Mar. 28, 1994; 61 FR 14480, Apr. 2, 1996; food for human use that present no
66 FR 56035, Nov. 6, 2001] health hazard.
EFFECTIVE DATE NOTE: At 38 FR 22794, Aug. AUTHORITY: 21 U.S.C. 342, 371, 374; 42 U.S.C.
24, 1973, the following appeared concerning 264.
§ 109.30(a)(9) (formerly 122.10(a)(9)):
SOURCE: 51 FR 22475, June 19, 1986, unless
* * * § 109.30(a)(9) is hereby stayed pending
full review of the objections and requests for otherwise noted.
hearing. * * * EDITORIAL NOTE: Nomenclature changes to
In the interim, as stated in the final order part 110 appear at 81 FR 49896, July 29, 2016.
(38 FR 18098) the Food and Drug Administra-
tion will enforce the temporary tolerance
level established by § 109.30(a)(9) by seizing Subpart A—General Provisions
any paper food-packaging material shipped
in interstate commerce after September 4, § 110.3 Definitions.
1973 containing higher than the specified
level of PCB’s as adulterated in violation of The definitions and interpretations
sec. 402 of the act. of terms in section 201 of the Federal
Food, Drug, and Cosmetic Act (the act)
Subpart C—Regulatory Limits for are applicable to such terms when used
Added Poisonous or Delete- in this part. The following definitions
shall also apply:
rious Substances [Reserved]
(a) Acid foods or acidified foods means
foods that have an equilibrium pH of
Subpart D—Naturally Occurring 4.6 or below.
Poisonous or Deleterious Sub- (b) Adequate means that which is
stances [Reserved] needed to accomplish the intended pur-
pose in keeping with good public health
PART 110—CURRENT GOOD MAN- practice.
UFACTURING PRACTICE IN MAN- (c) Batter means a semifluid sub-
UFACTURING, PACKING, OR stance, usually composed of flour and
HOLDING HUMAN FOOD other ingredients, into which principal
components of food are dipped or with
Subpart A—General Provisions which they are coated, or which may
be used directly to form bakery foods.
Sec.
110.3 Definitions. (d) Blanching, except for tree nuts
110.5 Current good manufacturing practice. and peanuts, means a prepackaging
264
heat treatment of foodstuffs for a suffi- processing for reasons other than in-
cient time and at a sufficient tempera- sanitary conditions or that has been
ture to partially or completely inac- successfully reconditioned by reproc-
tivate the naturally occurring enzymes essing and that is suitable for use as
and to effect other physical or bio- food.
chemical changes in the food. (n) Safe-moisture level is a level of
(e) Critical control point means a point moisture low enough to prevent the
in a food process where there is a high growth of undesirable microorganisms
probability that improper control may in the finished product under the in-
cause, allow, or contribute to a hazard tended conditions of manufacturing,
or to filth in the final food or decompo- storage, and distribution. The max-
sition of the final food. imum safe moisture level for a food is
(f) Food means food as defined in sec- based on its water activity (aw). An aw
tion 201(f) of the act and includes raw will be considered safe for a food if ade-
materials and ingredients. quate data are available that dem-
(g) Food-contact surfaces are those onstrate that the food at or below the
surfaces that contact human food and given aw will not support the growth of
those surfaces from which drainage undesirable microorganisms.
onto the food or onto surfaces that (o) Sanitize means to adequately treat
contact the food ordinarily occurs dur- food-contact surfaces by a process that
ing the normal course of operations. is effective in destroying vegetative
‘‘Food-contact surfaces’’ includes uten- cells of microorganisms of public
sils and food-contact surfaces of equip- health significance, and in substan-
ment. tially reducing numbers of other unde-
(h) Lot means the food produced dur- sirable microorganisms, but without
ing a period of time indicated by a spe- adversely affecting the product or its
cific code. safety for the consumer.
(i) Microorganisms means yeasts, (p) Shall is used to state mandatory
molds, bacteria, and viruses and in- requirements.
cludes, but is not limited to, species (q) Should is used to state rec-
having public health significance. The ommended or advisory procedures or
term ‘‘undesirable microorganisms’’ in- identify recommended equipment.
cludes those microorganisms that are (r) Water activity (aw) is a measure of
of public health significance, that sub- the free moisture in a food and is the
ject food to decomposition, that indi- quotient of the water vapor pressure of
cate that food is contaminated with the substance divided by the vapor
filth, or that otherwise may cause food pressure of pure water at the same
to be adulterated within the meaning temperature.
of the act. Occasionally in these regu-
lations, FDA used the adjective ‘‘mi- § 110.5 Current good manufacturing
crobial’’ instead of using an adjectival practice.
phrase containing the word microorga- (a) The criteria and definitions in
nism. this part shall apply in determining
(j) Pest refers to any objectionable whether a food is adulterated (1) within
animals or insects including, but not the meaning of section 402(a)(3) of the
limited to, birds, rodents, flies, and lar- act in that the food has been manufac-
vae. tured under such conditions that it is
(k) Plant means the building or facil- unfit for food; or (2) within the mean-
ity or parts thereof, used for or in con- ing of section 402(a)(4) of the act in
nection with the manufacturing, pack- that the food has been prepared,
aging, labeling, or holding of human packed, or held under insanitary condi-
food. tions whereby it may have become con-
(l) Quality control operation means a taminated with filth, or whereby it
planned and systematic procedure for may have been rendered injurious to
taking all actions necessary to prevent health. The criteria and definitions in
food from being adulterated within the this part also apply in determining
meaning of the act. whether a food is in violation of sec-

(m) Rework means clean, unadulter- tion 361 of the Public Health Service
ated food that has been removed from Act (42 U.S.C. 264).
265
§ 110.10 21 CFR Ch. I (4–1–23 Edition)
(b) Food covered by specific current and sanitary condition and which effec-
good manufacturing practice regula- tively protects against the contamina-
tions also is subject to the require- tion by these objects of the food, food-
ments of those regulations. contact surfaces, or food-packaging
materials.
§ 110.10 Personnel. (5) Maintaining gloves, if they are
The plant management shall take all used in food handling, in an intact,
reasonable measures and precautions clean, and sanitary condition. The
to ensure the following: gloves should be of an impermeable
(a) Disease control. Any person who, material.
by medical examination or supervisory (6) Wearing, where appropriate, in an
observation, is shown to have, or ap- effective manner, hair nets, headbands,
pears to have, an illness, open lesion, caps, beard covers, or other effective
including boils, sores, or infected hair restraints.
wounds, or any other abnormal source (7) Storing clothing or other personal
of microbial contamination by which belongings in areas other than where
there is a reasonable possibility of food is exposed or where equipment or
food, food-contact surfaces, or food- utensils are washed.
packaging materials becoming con- (8) Confining the following to areas
taminated, shall be excluded from any other than where food may be exposed
operations which may be expected to or where equipment or utensils are
result in such contamination until the washed: eating food, chewing gum,
condition is corrected. Personnel shall drinking beverages, or using tobacco.
be instructed to report such health (9) Taking any other necessary pre-
conditions to their supervisors. cautions to protect against contamina-
(b) Cleanliness. All persons working in tion of food, food-contact surfaces, or
direct contact with food, food-contact food-packaging materials with micro-
surfaces, and food-packaging materials organisms or foreign substances includ-
shall conform to hygienic practices ing, but not limited to, perspiration,
while on duty to the extent necessary hair, cosmetics, tobacco, chemicals,
to protect against contamination of and medicines applied to the skin.
food. The methods for maintaining (c) Education and training. Personnel
cleanliness include, but are not limited responsible for identifying sanitation
to: failures or food contamination should
(1) Wearing outer garments suitable have a background of education or ex-
to the operation in a manner that pro- perience, or a combination thereof, to
tects against the contamination of provide a level of competency nec-
food, food-contact surfaces, or food- essary for production of clean and safe
packaging materials. food. Food handlers and supervisors
(2) Maintaining adequate personal should receive appropriate training in
cleanliness. proper food handling techniques and
(3) Washing hands thoroughly (and food-protection principles and should
sanitizing if necessary to protect be informed of the danger of poor per-
against contamination with undesir- sonal hygiene and insanitary practices.
able microorganisms) in an adequate (d) Supervision. Responsibility for as-
hand-washing facility before starting suring compliance by all personnel
work, after each absence from the work with all requirements of this part shall
station, and at any other time when be clearly assigned to competent super-
the hands may have become soiled or visory personnel.
contaminated. [51 FR 22475, June 19, 1986, as amended at 54
(4) Removing all unsecured jewelry FR 24892, June 12, 1989]
and other objects that might fall into
food, equipment, or containers, and re- § 110.19 Exclusions.
moving hand jewelry that cannot be (a) The following operations are not
adequately sanitized during periods in subject to this part: Establishments
which food is manipulated by hand. If engaged solely in the harvesting, stor-
such hand jewelry cannot be removed, age, or distribution of one or more

it may be covered by material which ‘‘raw agricultural commodities,’’ as de-
can be maintained in an intact, clean, fined in section 201(r) of the act, which
266
are ordinarily cleaned, prepared, treat- (2) Permit the taking of proper pre-
ed, or otherwise processed before being cautions to reduce the potential for
marketed to the consuming public. contamination of food, food-contact
(b) FDA, however, will issue special surfaces, or food-packaging materials
regulations if it is necessary to cover with microorganisms, chemicals, filth,
these excluded operations. or other extraneous material. The po-
tential for contamination may be re-
Subpart B—Buildings and Facilities duced by adequate food safety controls
and operating practices or effective de-
§ 110.20 Plant and grounds. sign, including the separation of oper-
(a) Grounds. The grounds about a food ations in which contamination is likely
plant under the control of the operator to occur, by one or more of the fol-
shall be kept in a condition that will lowing means: location, time, parti-
protect against the contamination of tion, air flow, enclosed systems, or
food. The methods for adequate main- other effective means.
tenance of grounds include, but are not (3) Permit the taking of proper pre-
limited to: cautions to protect food in outdoor
(1) Properly storing equipment, re- bulk fermentation vessels by any effec-
moving litter and waste, and cutting tive means, including:
weeds or grass within the immediate (i) Using protective coverings.
vicinity of the plant buildings or struc- (ii) Controlling areas over and around
tures that may constitute an attract- the vessels to eliminate harborages for
ant, breeding place, or harborage for
pests.
pests.
(iii) Checking on a regular basis for
(2) Maintaining roads, yards, and
pests and pest infestation.
parking lots so that they do not con-
stitute a source of contamination in (iv) Skimming the fermentation ves-
areas where food is exposed. sels, as necessary.
(3) Adequately draining areas that (4) Be constructed in such a manner
may contribute contamination to food that floors, walls, and ceilings may be
by seepage, foot-borne filth, or pro- adequately cleaned and kept clean and
viding a breeding place for pests. kept in good repair; that drip or con-
(4) Operating systems for waste densate from fixtures, ducts and pipes
treatment and disposal in an adequate does not contaminate food, food-con-
manner so that they do not constitute tact surfaces, or food-packaging mate-
a source of contamination in areas rials; and that aisles or working spaces
where food is exposed. are provided between equipment and
walls and are adequately unobstructed
If the plant grounds are bordered by
and of adequate width to permit em-
grounds not under the operator’s con-
ployees to perform their duties and to
trol and not maintained in the manner
protect against contaminating food or
described in paragraph (a) (1) through
food-contact surfaces with clothing or
(3) of this section, care shall be exer-
personal contact.
cised in the plant by inspection, exter-
mination, or other means to exclude (5) Provide adequate lighting in
pests, dirt, and filth that may be a hand-washing areas, dressing and lock-
source of food contamination. er rooms, and toilet rooms and in all
(b) Plant construction and design. areas where food is examined, proc-
Plant buildings and structures shall be essed, or stored and where equipment
suitable in size, construction, and de- or utensils are cleaned; and provide
sign to facilitate maintenance and san- safety-type light bulbs, fixtures, sky-
itary operations for food-manufac- lights, or other glass suspended over
turing purposes. The plant and facili- exposed food in any step of preparation
ties shall: or otherwise protect against food con-
(1) Provide sufficient space for such tamination in case of glass breakage.
placement of equipment and storage of (6) Provide adequate ventilation or
materials as is necessary for the main- control equipment to minimize odors

tenance of sanitary operations and the and vapors (including steam and nox-
production of safe food. ious fumes) in areas where they may
267
§ 110.35 21 CFR Ch. I (4–1–23 Edition)
contaminate food; and locate and oper- (c) Pest control. No pests shall be al-
ate fans and other air-blowing equip- lowed in any area of a food plant.
ment in a manner that minimizes the Guard or guide dogs may be allowed in
potential for contaminating food, food- some areas of a plant if the presence of
packaging materials, and food-contact the dogs is unlikely to result in con-
surfaces. tamination of food, food-contact sur-
(7) Provide, where necessary, ade- faces, or food-packaging materials. Ef-
quate screening or other protection fective measures shall be taken to ex-
against pests. clude pests from the processing areas
and to protect against the contamina-
§ 110.35 Sanitary operations. tion of food on the premises by pests.
(a) General maintenance. Buildings, The use of insecticides or rodenticides
fixtures, and other physical facilities is permitted only under precautions
of the plant shall be maintained in a and restrictions that will protect
sanitary condition and shall be kept in against the contamination of food,
repair sufficient to prevent food from food-contact surfaces, and food-pack-
becoming adulterated within the mean- aging materials.
ing of the act. Cleaning and sanitizing (d) Sanitation of food-contact surfaces.
of utensils and equipment shall be con- All food-contact surfaces, including
ducted in a manner that protects utensils and food-contact surfaces of
against contamination of food, food- equipment, shall be cleaned as fre-
contact surfaces, or food-packaging quently as necessary to protect against
materials. contamination of food.
(b) Substances used in cleaning and (1) Food-contact surfaces used for
sanitizing; storage of toxic materials. (1) manufacturing or holding low-moisture
Cleaning compounds and sanitizing food shall be in a dry, sanitary condi-
agents used in cleaning and sanitizing tion at the time of use. When the sur-
procedures shall be free from undesir- faces are wet-cleaned, they shall, when
able microorganisms and shall be safe necessary, be sanitized and thoroughly
and adequate under the conditions of dried before subsequent use.
use. Compliance with this requirement (2) In wet processing, when cleaning
may be verified by any effective means is necessary to protect against the in-
including purchase of these substances troduction of microorganisms into
under a supplier’s guarantee or certifi- food, all food-contact surfaces shall be
cation, or examination of these sub- cleaned and sanitized before use and
stances for contamination. Only the after any interruption during which
following toxic materials may be used the food-contact surfaces may have be-
or stored in a plant where food is proc- come contaminated. Where equipment
essed or exposed: and utensils are used in a continuous
(i) Those required to maintain clean production operation, the utensils and
and sanitary conditions; food-contact surfaces of the equipment
(ii) Those necessary for use in labora- shall be cleaned and sanitized as nec-
tory testing procedures; essary.
(iii) Those necessary for plant and (3) Non-food-contact surfaces of
equipment maintenance and operation; equipment used in the operation of
and food plants should be cleaned as fre-
(iv) Those necessary for use in the quently as necessary to protect against
plant’s operations. contamination of food.
(2) Toxic cleaning compounds, sani- (4) Single-service articles (such as
tizing agents, and pesticide chemicals utensils intended for one-time use,
shall be identified, held, and stored in a paper cups, and paper towels) should be
manner that protects against contami- stored in appropriate containers and
nation of food, food-contact surfaces, shall be handled, dispensed, used, and
or food-packaging materials. All rel- disposed of in a manner that protects
evant regulations promulgated by against contamination of food or food-
other Federal, State, and local govern- contact surfaces.
ment agencies for the application, use, (5) Sanitizing agents shall be ade-
or holding of these products should be quate and safe under conditions of use.
followed. Any facility, procedure, or machine is
268
acceptable for cleaning and sanitizing (c) Sewage disposal. Sewage disposal
equipment and utensils if it is estab- shall be made into an adequate sewer-
lished that the facility, procedure, or age system or disposed of through
machine will routinely render equip- other adequate means.
ment and utensils clean and provide (d) Toilet facilities. Each plant shall
adequate cleaning and sanitizing treat- provide its employees with adequate,
ment. readily accessible toilet facilities.
(e) Storage and handling of cleaned Compliance with this requirement may
portable equipment and utensils. Cleaned be accomplished by:
and sanitized portable equipment with (1) Maintaining the facilities in a
food-contact surfaces and utensils sanitary condition.
should be stored in a location and man- (2) Keeping the facilities in good re-
ner that protects food-contact surfaces pair at all times.
from contamination.
(3) Providing self-closing doors.
[51 FR 22475, June 19, 1986, as amended at 54 (4) Providing doors that do not open
FR 24892, June 12, 1989] into areas where food is exposed to air-
borne contamination, except where al-
§ 110.37 Sanitary facilities and con-
trols. ternate means have been taken to pro-
tect against such contamination (such
Each plant shall be equipped with as double doors or positive air-flow sys-
adequate sanitary facilities and accom- tems).
modations including, but not limited (e) Hand-washing facilities. Hand-
to: washing facilities shall be adequate
(a) Water supply. The water supply and convenient and be furnished with
shall be sufficient for the operations running water at a suitable tempera-
intended and shall be derived from an ture. Compliance with this require-
adequate source. Any water that con- ment may be accomplished by pro-
tacts food or food-contact surfaces viding:
shall be safe and of adequate sanitary
(1) Hand-washing and, where appro-
quality. Running water at a suitable
priate, hand-sanitizing facilities at
temperature, and under pressure as
each location in the plant where good
needed, shall be provided in all areas
sanitary practices require employees
where required for the processing of
to wash and/or sanitize their hands.
food, for the cleaning of equipment,
utensils, and food-packaging materials, (2) Effective hand-cleaning and sani-
or for employee sanitary facilities. tizing preparations.
(b) Plumbing. Plumbing shall be of (3) Sanitary towel service or suitable
adequate size and design and ade- drying devices.
quately installed and maintained to: (4) Devices or fixtures, such as water
(1) Carry sufficient quantities of control valves, so designed and con-
water to required locations throughout structed to protect against recontami-
the plant. nation of clean, sanitized hands.
(2) Properly convey sewage and liquid (5) Readily understandable signs di-
disposable waste from the plant. recting employees handling unpro-
(3) Avoid constituting a source of tected food, unprotected food-pack-
contamination to food, water supplies, aging materials, of food-contact sur-
equipment, or utensils or creating an faces to wash and, where appropriate,
unsanitary condition. sanitize their hands before they start
(4) Provide adequate floor drainage in work, after each absence from post of
all areas where floors are subject to duty, and when their hands may have
flooding-type cleaning or where normal become soiled or contaminated. These
operations release or discharge water signs may be posted in the processing
or other liquid waste on the floor. room(s) and in all other areas where
(5) Provide that there is not backflow employees may handle such food, ma-
from, or cross-connection between, pip- terials, or surfaces.
ing systems that discharge waste water (6) Refuse receptacles that are con-
or sewage and piping systems that structed and maintained in a manner

carry water for food or food manufac- that protects against contamination of
turing. food.
269
§ 110.40 21 CFR Ch. I (4–1–23 Edition)
(f) Rubbish and offal disposal. Rubbish microorganisms shall be fitted with an
and any offal shall be so conveyed, indicating thermometer, temperature-
stored, and disposed of as to minimize measuring device, or temperature-re-
the development of odor, minimize the cording device so installed as to show
potential for the waste becoming an at- the temperature accurately within the
tractant and harborage or breeding compartment, and should be fitted
place for pests, and protect against with an automatic control for regu-
contamination of food, food-contact lating temperature or with an auto-
surfaces, water supplies, and ground matic alarm system to indicate a sig-
surfaces. nificant temperature change in a man-
ual operation.
Subpart C—Equipment (f) Instruments and controls used for
measuring, regulating, or recording
§ 110.40 Equipment and utensils.
temperatures, pH, acidity, water activ-
(a) All plant equipment and utensils ity, or other conditions that control or
shall be so designed and of such mate- prevent the growth of undesirable
rial and workmanship as to be ade- microorganisms in food shall be accu-
quately cleanable, and shall be prop- rate and adequately maintained, and
erly maintained. The design, construc- adequate in number for their des-
tion, and use of equipment and utensils ignated uses.
shall preclude the adulteration of food
(g) Compressed air or other gases me-
with lubricants, fuel, metal fragments,
chanically introduced into food or used
contaminated water, or any other con-
to clean food-contact surfaces or equip-
taminants. All equipment should be so
installed and maintained as to facili- ment shall be treated in such a way
tate the cleaning of the equipment and that food is not contaminated with un-
of all adjacent spaces. Food-contact lawful indirect food additives.
surfaces shall be corrosion-resistant
when in contact with food. They shall Subpart D [Reserved]
be made of nontoxic materials and de-
signed to withstand the environment of Subpart E—Production and
their intended use and the action of Process Controls
food, and, if applicable, cleaning com-
pounds and sanitizing agents. Food- § 110.80 Processes and controls.
contact surfaces shall be maintained to
protect food from being contaminated All operations in the receiving, in-
by any source, including unlawful indi- specting, transporting, segregating,
rect food additives. preparing, manufacturing, packaging,
(b) Seams on food-contact surfaces and storing of food shall be conducted
shall be smoothly bonded or main- in accordance with adequate sanitation
tained so as to minimize accumulation principles. Appropriate quality control
of food particles, dirt, and organic mat- operations shall be employed to ensure
ter and thus minimize the opportunity that food is suitable for human con-
for growth of microorganisms. sumption and that food-packaging ma-
(c) Equipment that is in the manu- terials are safe and suitable. Overall
facturing or food-handling area and sanitation of the plant shall be under
that does not come into contact with the supervision of one or more com-
food shall be so constructed that it can petent individuals assigned responsi-
be kept in a clean condition. bility for this function. All reasonable
(d) Holding, conveying, and manufac- precautions shall be taken to ensure
turing systems, including gravimetric, that production procedures do not con-
pneumatic, closed, and automated sys- tribute contamination from any
tems, shall be of a design and construc- source. Chemical, microbial, or extra-
tion that enables them to be main- neous-material testing procedures
tained in an appropriate sanitary con- shall be used where necessary to iden-
dition. tify sanitation failures or possible food
(e) Each freezer and cold storage contamination. All food that has be-
compartment used to store and hold come contaminated to the extent that
food capable of supporting growth of it is adulterated within the meaning of
270
the act shall be rejected, or if permis- comply with applicable Food and Drug
sible, treated or processed to eliminate Administration regulations and defect
the contamination. action levels for natural or unavoidable
(a) Raw materials and other ingredi- defects if a manufacturer wishes to use
ents. (1) Raw materials and other ingre- the materials in manufacturing food.
dients shall be inspected and seg- Compliance with this requirement may
regated or otherwise handled as nec- be verified by any effective means, in-
essary to ascertain that they are clean cluding purchasing the materials under
and suitable for processing into food a supplier’s guarantee or certification,
and shall be stored under conditions or examination of these materials for
that will protect against contamina- contamination.
tion and minimize deterioration. Raw (5) Raw materials, other ingredients,
materials shall be washed or cleaned as and rework shall be held in bulk, or in
necessary to remove soil or other con- containers designed and constructed so
tamination. Water used for washing, as to protect against contamination
rinsing, or conveying food shall be safe and shall be held at such temperature
and of adequate sanitary quality. and relative humidity and in such a
Water may be reused for washing, rins- manner as to prevent the food from be-
ing, or conveying food if it does not in- coming adulterated within the mean-
crease the level of contamination of ing of the act. Material scheduled for
the food. Containers and carriers of rework shall be identified as such.
raw materials should be inspected on (6) Frozen raw materials and other
receipt to ensure that their condition ingredients shall be kept frozen. If
has not contributed to the contamina- thawing is required prior to use, it
tion or deterioration of food. shall be done in a manner that pre-
(2) Raw materials and other ingredi- vents the raw materials and other in-
ents shall either not contain levels of gredients from becoming adulterated
microorganisms that may produce food
within the meaning of the act.
poisoning or other disease in humans,
(7) Liquid or dry raw materials and
or they shall be pasteurized or other-
other ingredients received and stored
wise treated during manufacturing op-
erations so that they no longer contain in bulk form shall be held in a manner
levels that would cause the product to that protects against contamination.
be adulterated within the meaning of (b) Manufacturing operations. (1)
the act. Compliance with this require- Equipment and utensils and finished
ment may be verified by any effective food containers shall be maintained in
means, including purchasing raw mate- an acceptable condition through appro-
rials and other ingredients under a sup- priate cleaning and sanitizing, as nec-
plier’s guarantee or certification. essary. Insofar as necessary, equipment
(3) Raw materials and other ingredi- shall be taken apart for thorough
ents susceptible to contamination with cleaning.
aflatoxin or other natural toxins shall (2) All food manufacturing, including
comply with current Food and Drug packaging and storage, shall be con-
Administration regulations and action ducted under such conditions and con-
levels for poisonous or deleterious sub- trols as are necessary to minimize the
stances before these materials or ingre- potential for the growth of microorga-
dients are incorporated into finished nisms, or for the contamination of
food. Compliance with this require- food. One way to comply with this re-
ment may be accomplished by pur- quirement is careful monitoring of
chasing raw materials and other ingre- physical factors such as time, tempera-
dients under a supplier’s guarantee or ture, humidity, aw, pH, pressure, flow
certification, or may be verified by rate, and manufacturing operations
analyzing these materials and ingredi- such as freezing, dehydration, heat
ents for aflatoxins and other natural processing, acidification, and refrigera-
toxins. tion to ensure that mechanical break-
(4) Raw materials, other ingredients, downs, time delays, temperature fluc-
and rework susceptible to contamina- tuations, and other factors do not con-
tion with pests, undesirable microorga- tribute to the decomposition or con-
nisms, or extraneous material shall tamination of food.
271
§ 110.80 21 CFR Ch. I (4–1–23 Edition)
(3) Food that can support the rapid sieves, traps, magnets, electronic
growth of undesirable microorganisms, metal detectors, or other suitable ef-
particularly those of public health sig- fective means.
nificance, shall be held in a manner (9) Food, raw materials, and other in-
that prevents the food from becoming gredients that are adulterated within
adulterated within the meaning of the the meaning of the act shall be dis-
act. Compliance with this requirement posed of in a manner that protects
may be accomplished by any effective against the contamination of other
means, including: food. If the adulterated food is capable
(i) Maintaining refrigerated foods at of being reconditioned, it shall be re-
45 °F (7.2 °C) or below as appropriate for conditioned using a method that has
the particular food involved. been proven to be effective or it shall
(ii) Maintaining frozen foods in a fro- be reexamined and found not to be
zen state. adulterated within the meaning of the
(iii) Maintaining hot foods at 140 °F act before being incorporated into
(60 °C) or above. other food.
(iv) Heat treating acid or acidified (10) Mechanical manufacturing steps
foods to destroy mesophilic microorga- such as washing, peeling, trimming,
nisms when those foods are to be held cutting, sorting and inspecting, mash-
in hermetically sealed containers at ing, dewatering, cooling, shredding, ex-
ambient temperatures. truding, drying, whipping, defatting,
(4) Measures such as sterilizing, irra- and forming shall be performed so as to
diating, pasteurizing, freezing, refrig- protect food against contamination.
erating, controlling pH or controlling Compliance with this requirement may
aw that are taken to destroy or prevent be accomplished by providing adequate
the growth of undesirable microorga- physical protection of food from con-
nisms, particularly those of public taminants that may drip, drain, or be
health significance, shall be adequate
drawn into the food. Protection may be
under the conditions of manufacture,
provided by adequate cleaning and
handling, and distribution to prevent
sanitizing of all food-contact surfaces,
food from being adulterated within the
and by using time and temperature
meaning of the act.
controls at and between each manufac-
(5) Work-in-process shall be handled
turing step.
in a manner that protects against con-
tamination. (11) Heat blanching, when required in
(6) Effective measures shall be taken the preparation of food, should be ef-
to protect finished food from contami- fected by heating the food to the re-
nation by raw materials, other ingredi- quired temperature, holding it at this
ents, or refuse. When raw materials, temperature for the required time, and
other ingredients, or refuse are unpro- then either rapidly cooling the food or
tected, they shall not be handled si- passing it to subsequent manufacturing
multaneously in a receiving, loading, without delay. Thermophilic growth
or shipping area if that handling could and contamination in blanchers should
result in contaminated food. Food be minimized by the use of adequate
transported by conveyor shall be pro- operating temperatures and by periodic
tected against contamination as nec- cleaning. Where the blanched food is
essary. washed prior to filling, water used
(7) Equipment, containers, and uten- shall be safe and of adequate sanitary
sils used to convey, hold, or store raw quality.
materials, work-in-process, rework, or (12) Batters, breading, sauces, gra-
food shall be constructed, handled, and vies, dressings, and other similar prep-
maintained during manufacturing or arations shall be treated or maintained
storage in a manner that protects in such a manner that they are pro-
against contamination. tected against contamination. Compli-
(8) Effective measures shall be taken ance with this requirement may be ac-
to protect against the inclusion of complished by any effective means, in-
metal or other extraneous material in cluding one or more of the following:

food. Compliance with this require- (i) Using ingredients free of contami-
ment may be accomplished by using nation.
272
(ii) Employing adequate heat proc- microorganisms shall be monitored and

esses where applicable. maintained at a pH of 4.6 or below.
(iii) Using adequate time and tem- Compliance with this requirement may
perature controls. be accomplished by any effective
(iv) Providing adequate physical pro- means, including employment of one or
tection of components from contami- more of the following practices:
nants that may drip, drain, or be drawn (i) Monitoring the pH of raw mate-
into them. rials, food in process, and finished food.
(v) Cooling to an adequate tempera- (ii) Controlling the amount of acid or
ture during manufacturing.
acidified food added to low-acid food.
(vi) Disposing of batters at appro-
priate intervals to protect against the (16) When ice is used in contact with
growth of microorganisms. food, it shall be made from water that
(13) Filling, assembling, packaging, is safe and of adequate sanitary qual-
and other operations shall be per- ity, and shall be used only if it has
formed in such a way that the food is been manufactured in accordance with
protected against contamination. Com- current good manufacturing practice
pliance with this requirement may be as outlined in this part.
accomplished by any effective means, (17) Food-manufacturing areas and
including: equipment used for manufacturing
(i) Use of a quality control operation human food should not be used to man-
in which the critical control points are ufacture nonhuman food-grade animal
identified and controlled during manu- feed or inedible products, unless there
facturing. is no reasonable possibility for the con-
(ii) Adequate cleaning and sanitizing tamination of the human food.
of all food-contact surfaces and food
containers. [51 FR 22475, June 19, 1986, as amended at 65
(iii) Using materials for food con- FR 56479, Sept. 19, 2000]
tainers and food- packaging materials
§ 110.93 Warehousing and distribution.
that are safe and suitable, as defined in
§ 130.3(d) of this chapter. Storage and transportation of fin-
(iv) Providing physical protection ished food shall be under conditions
from contamination, particularly air- that will protect food against physical,
borne contamination. chemical, and microbial contamination
(v) Using sanitary handling proce- as well as against deterioration of the
dures. food and the container.
(14) Food such as, but not limited to,
dry mixes, nuts, intermediate moisture
food, and dehydrated food, that relies
Subpart F [Reserved]
on the control of aw for preventing the
growth of undesirable microorganisms Subpart G—Defect Action Levels
shall be processed to and maintained at
a safe moisture level. Compliance with § 110.110 Natural or unavoidable de-
this requirement may be accomplished fects in food for human use that
present no health hazard.
by any effective means, including em-
ployment of one or more of the fol- (a) Some foods, even when produced
lowing practices: under current good manufacturing
(i) Monitoring the aw of food. practice, contain natural or unavoid-
(ii) Controlling the soluble solids- able defects that at low levels are not
water ratio in finished food. hazardous to health. The Food and
(iii) Protecting finished food from Drug Administration establishes max-
moisture pickup, by use of a moisture imum levels for these defects in foods
barrier or by other means, so that the produced under current good manufac-
aw of the food does not increase to an turing practice and uses these levels in
unsafe level. deciding whether to recommend regu-
(15) Food such as, but not limited to, latory action.
acid and acidified food, that relies prin-

cipally on the control of pH for pre-
venting the growth of undesirable
273
(b) Defect action levels are estab- 111.5 Do other statutory provisions and reg-
lished for foods whenever it is nec- ulations apply?
essary and feasible to do so. These lev-
els are subject to change upon the de- Subpart B—Personnel
velopment of new technology or the 111.8 What are the requirements under this
availability of new information. subpart B for written procedures?
(c) Compliance with defect action 111.10 What requirements apply for pre-
levels does not excuse violation of the venting microbial contamination from
requirement in section 402(a)(4) of the sick or infected personnel and for hygien-
act that food not be prepared, packed, ic practices?
111.12 What personnel qualification require-
or held under unsanitary conditions or ments apply?
the requirements in this part that food 111.13 What supervisor requirements apply?
manufacturers, distributors, and hold- 111.14 Under this subpart B, what records
ers shall observe current good manu- must you make and keep?
facturing practice. Evidence indicating
that such a violation exists causes the Subpart C—Physical Plant and Grounds
food to be adulterated within the
111.15 What sanitation requirements apply
meaning of the act, even though the
to your physical plant and grounds?
amounts of natural or unavoidable de- 111.16 What are the requirements under this
fects are lower than the currently es- subpart C for written procedures?
tablished defect action levels. The 111.20 What design and construction re-
manufacturer, distributor, and holder quirements apply to your physical plant?
of food shall at all times utilize quality 111.23 Under this subpart C, what records
control operations that reduce natural must you make and keep?
or unavoidable defects to the lowest
level currently feasible. Subpart D—Equipment and Utensils
(d) The mixing of a food containing 111.25 What are the requirements under this
defects above the current defect action subpart D for written procedures?
level with another lot of food is not 111.27 What requirements apply to the
permitted and renders the final food equipment and utensils that you use?
adulterated within the meaning of the 111.30 What requirements apply to auto-
act, regardless of the defect level of the mated, mechanical, or electronic equip-
final food. ment?
111.35 Under this subpart D, what records
(e) A compilation of the current de-
must you make and keep?
fect action levels for natural or un-
avoidable defects in food for human use Subpart E—Requirement to Establish a
that present no health hazard may be Production and Process Control System
obtained upon request from the Center
for Food Safety and Applied Nutrition 111.55 What are the requirements to imple-
(HFS–565), Food and Drug Administra- ment a production and process control
tion, 5001 Campus Dr., College Park, system?
MD 20740. 111.60 What are the design requirements for
the production and process control sys-
[51 FR 22475, June 19, 1986, as amended at 61 tem?
FR 14480, Apr. 2, 1996; 66 FR 56035, Nov. 6, 111.65 What are the requirements for qual-
2001] ity control operations?
111.70 What specifications must you estab-
lish?
PART 111—CURRENT GOOD MAN- 111.73 What is your responsibility for deter-
UFACTURING PRACTICE IN MAN- mining whether established specifica-
UFACTURING, PACKAGING, LA- tions are met?
BELING, OR HOLDING OPER- 111.75 What must you do to determine
whether specifications are met?
ATIONS FOR DIETARY SUPPLE- 111.77 What must you do if established spec-
MENTS ifications are not met?
111.80 What representative samples must
Subpart A—General Provisions you collect?
111.83 What are the requirements for re-
Sec. serve samples?

111.1 Who is subject to this part? 111.87 Who conducts a material review and
111.3 What definitions apply to this part? makes a disposition decision?
274
111.90 What requirements apply to treat- 111.180 Under this subpart G, what records
ments, in-process adjustments, and re- must you make and keep?
processing when there is a deviation or
unanticipated occurrence or when a spec- Subpart H—Production and Process Con-
ification established in accordance with trol System: Requirements for the Mas-
§ 111.70 is not met? ter Manufacturing Record
111.95 Under this subpart E, what records
must you make and keep? 111.205 What is the requirement to establish
a master manufacturing record?
Subpart F—Production and Process Control 111.210 What must the master manufac-
System: Requirements for Quality Control turing record include?
111.103 What are the requirements under Subpart I—Production and Process Control
this subpart F for written procedures?
111.105 What must quality control personnel
System: Requirements for the Batch
do? Production Record
111.110 What quality control operations are
111.255 What is the requirement to establish
required for laboratory operations asso-
a batch production record?
ciated with the production and process
111.260 What must the batch record include?
control system?
required for a material review and dis- Subpart J—Production and Process Control
position decision? System: Requirements for Laboratory
111.117 What quality control operations are Operations
required for equipment, instruments, and
controls? 111.303 What are the requirements under
111.120 What quality control operations are this subpart J for written procedures?
required for components, packaging, and 111.310 What are the requirements for the
labels before use in the manufacture of a laboratory facilities that you use?
dietary supplement? 111.315 What are the requirements for lab-
111.123 What quality control operations are oratory control processes?
required for the master manufacturing 111.320 What requirements apply to labora-
record, the batch production record, and tory methods for testing and examina-
manufacturing operations? tion?
111.127 What quality control operations are 111.325 Under this subpart J, what records
required for packaging and labeling oper- must you make and keep?
ations?
111.130 What quality control operations are Subpart K—Production and Process Control
required for returned dietary supple- System: Requirements for Manufac-
ments? turing Operations
required for product complaints? 111.353 What are the requirements under
111.140 Under this subpart F, what records this subpart K for written procedures?
must you make and keep? 111.355 What are the design requirements
for manufacturing operations?
Subpart G—Production and Process Con- 111.360 What are the requirements for sani-
trol System: Requirements for Compo- tation?
nents, Packaging, and Labels and for 111.365 What precautions must you take to
Product That You Receive for Pack- prevent contamination?
111.370 What requirements apply to rejected
aging or Labeling as a Dietary Supple-
dietary supplements?
ment 111.375 Under this subpart K, what records
111.153 What are the requirements under must you make and keep?
this subpart G for written procedures?
111.155 What requirements apply to compo- Subpart L—Production and Process Control
nents of dietary supplements? System: Requirements for Packaging
111.160 What requirements apply to pack- and Labeling Operations
aging and labels received?
111.165 What requirements apply to a prod- 111.403 What are the requirements under
uct received for packaging or labeling as this subpart L for written procedures?
a dietary supplement (and for distribu- 111.410 What requirements apply to pack-
tion rather than for return to the sup- aging and labels?
plier)? 111.415 What requirements apply to filling,
111.170 What requirements apply to rejected assembling, packaging, labeling, and re-
components, packaging, and labels, and lated operations?

to rejected products that are received for 111.420 What requirements apply to repack-
packaging or labeling as a dietary sup- aging and relabeling?
plement?
275
§ 111.1 21 CFR Ch. I (4–1–23 Edition)
111.425 What requirements apply to a pack- Subpart A—General Provisions
aged and labeled dietary supplement that
is rejected for distribution? § 111.1 Who is subject to this part?
111.430 Under this subpart L, what records
must you make and keep? (a) Except as provided by paragraph
(b) of this section, you are subject to
Subpart M—Holding and Distributing this part if you manufacture, package,
label, or hold a dietary supplement, in-
111.453 What are the requirements under cluding:
this subpart M for written procedures? (1) A dietary supplement you manu-
111.455 What requirements apply to holding facture but that is packaged or labeled
components, dietary supplements, pack- by another person; and
aging, and labels? (2) A dietary supplement imported or
111.460 What requirements apply to holding offered for import in any State or terri-
in-process material? tory of the United States, the District
111.465 What requirements apply to holding
of Columbia, or the Commonwealth of
reserve samples of dietary supplements?
Puerto Rico.
111.470 What requirements apply to distrib-
(b) The requirements pertaining to
uting dietary supplements?
111.475 Under this subpart M, what records
holding dietary supplements do not
must you make and keep? apply to you if you are holding those
dietary supplements at a retail estab-
Subpart N—Returned Dietary Supplements lishment for the sole purpose of direct
retail sale to individual consumers. A
111.503 What are the requirements under retail establishment does not include a
this subpart N for written procedures? warehouse or other storage facility for
111.510 What requirements apply when a re- a retailer or a warehouse or other stor-
turned dietary supplement is received? age facility that sells directly to indi-
111.515 When must a returned dietary sup- vidual consumers.
plement be destroyed, or otherwise suit-
ably disposed of? § 111.3 What definitions apply to this
111.520 When may a returned dietary supple- part?
ment be salvaged?
111.525 What requirements apply to a re-
The definitions and interpretations
turned dietary supplement that quality of terms in section 201 of the Federal
control personnel approve for reprocess- Food, Drug, and Cosmetic Act (the act)
ing? apply to such terms when used in this
111.530 When must an investigation be con- part. For the purpose of this part, the
ducted of your manufacturing processes following definitions also apply:
and other batches? Actual yield means the quantity that
111.535 Under this subpart N, what records is actually produced at any appropriate
must you make and keep? step of manufacture or packaging of a
particular dietary supplement.
Subpart O—Product Complaints Batch means a specific quantity of a
111.553 What are the requirements under dietary supplement that is uniform,
this subpart O for written procedures? that is intended to meet specifications
111.560 What requirements apply to the re- for identity, purity, strength, and com-
view and investigation of a product composition, and that is produced during a
plaint? specified time period according to a
111.570 Under this subpart O, what records single manufacturing record during the
must you make and keep? same cycle of manufacture.
Batch number, lot number, or control
Subpart P—Records and Recordkeeping number means any distinctive group of
letters, numbers, or symbols, or any
111.605 What requirements apply to the
records that you make and keep?
combination of them, from which the
111.610 What records must be made avail-
complete history of the manufacturing,
able to FDA? packaging, labeling, and/or holding of a
batch or lot of dietary supplements can
AUTHORITY: 21 U.S.C. 321, 342, 343, 371, 374, be determined.
381, 393; 42 U.S.C. 264.
Component means any substance in-

SOURCE: 72 FR 34942, June 25, 2007, unless tended for use in the manufacture of a
otherwise noted. dietary supplement, including those
276
that may not appear in the finished Pest means any objectionable insect
batch of the dietary supplement. Com- or other animal including birds, ro-
ponent includes dietary ingredients (as dents, flies, mites, and larvae.
described in section 201(ff) of the act) Physical plant means all or any part
and other ingredients. of a building or facility used for or in
Contact surface means any surface connection with manufacturing, pack-
that contacts a component or dietary aging, labeling, or holding a dietary
supplement, and those surfaces from supplement.
which drainage onto the component or Product complaint means any commu-
dietary supplement, or onto surfaces
nication that contains any allegation,
that contact the component or dietary
written, electronic, or oral, expressing
supplement, occurs during the normal
course of operations. Examples of con- concern, for any reason, with the qual-
tact surfaces include containers, uten- ity of a dietary supplement, that could
sils, tables, contact surfaces of equip- be related to current good manufac-
ment, and packaging. turing practice. Examples of product
Ingredient means any substance that complaints are: Foul odor, off taste, ill-
is used in the manufacture of a dietary ness or injury, disintegration time,
supplement and that is intended to be color variation, tablet size or size vari-
present in the finished batch of the die- ation, under-filled container, foreign
tary supplement. An ingredient in- material in a dietary supplement con-
cludes, but is not necessarily limited tainer, improper packaging,
to, a dietary ingredient as defined in mislabeling, or dietary supplements
section 201(ff) of the act. that are superpotent, subpotent, or
In-process material means any mate- contain the wrong ingredient, or con-
rial that is fabricated, compounded, tain a drug or other contaminant (e.g.,
blended, ground, extracted, sifted, bacteria, pesticide, mycotoxin, glass,
sterilized, derived by chemical reac- lead).
tion, or processed in any other way for Quality means that the dietary sup-
use in the manufacture of a dietary plement consistently meets the estab-
supplement. lished specifications for identity, pu-
Lot means a batch, or a specific iden-
rity, strength, and composition, and
tified portion of a batch, that is uni-
limits on contaminants, and has been
form and that is intended to meet spec-
manufactured, packaged, labeled, and
ifications for identity, purity,
strength, and composition; or, in the held under conditions to prevent adul-
case of a dietary supplement produced teration under section 402(a)(1), (a)(2),
by continuous process, a specific iden- (a)(3), and (a)(4) of the act.
tified amount produced in a specified Quality control means a planned and
unit of time or quantity in a manner systematic operation or procedure for
that is uniform and that is intended to ensuring the quality of a dietary sup-
meet specifications for identity, pu- plement.
rity, strength, and composition. Quality control personnel means any
Microorganisms means yeasts, molds, person, persons, or group, within or
bacteria, viruses, and other similar mi- outside of your organization, who you
croscopic organisms having public designate to be responsible for your
health or sanitary concern. This defini- quality control operations.
tion includes species that: Representative sample means a sample
(1) May have public health signifi- that consists of an adequate number of
cance; units that are drawn based on rational
(2) May cause a component or dietary criteria, such as random sampling, and
supplement to decompose; that are intended to ensure that the
(3) Indicate that the component or di-
sample accurately portrays the mate-
etary supplement is contaminated with
rial being sampled.
filth; or
(4) Otherwise may cause the compo- Reprocessing means using, in the
manufacture of a dietary supplement,
nent or dietary supplement to be adul-

terated. clean, uncontaminated components or
Must is used to state a requirement. dietary supplements that have been
277
§ 111.5 21 CFR Ch. I (4–1–23 Edition)
previously removed from manufac- § 111.10 What requirements apply for

turing and that have been made suit- preventing microbial contamination
able for use in the manufacture of a di- from sick or infected personnel and
etary supplement. for hygienic practices?
Reserve sample means a representa- (a) Preventing microbial contamination.
tive sample of product that is held for You must take measures to exclude
a designated period of time. from any operations any person who
Sanitize means to adequately treat might be a source of microbial con-
cleaned equipment, containers, uten- tamination, due to a health condition,
sils, or any other cleaned contact sur- where such contamination may occur,
face by a process that is effective in de- of any material, including components,
stroying vegetative cells of microorga- dietary supplements, and contact sur-
nisms of public health significance, and faces used in the manufacture, pack-
in substantially reducing numbers of aging, labeling, or holding of a dietary
other microorganisms, but without ad- supplement. Such measures include the
versely affecting the product or its following:
safety for the consumer. (1) Excluding from working in any
Theoretical yield means the quantity operations that may result in contami-
that would be produced at any appro- nation any person who, by medical ex-
priate step of manufacture or pack- amination, the person’s acknowledge-
aging of a particular dietary supplement, or supervisory observation, is
ment, based upon the quantity of com- shown to have, or appears to have, an
ponents or packaging to be used, in the illness, infection, open lesion, or any
absence of any loss or error in actual other abnormal source of microbial
production. contamination, that could result in mi-
Water activity (aw) is a measure of the crobial contamination of components,
free moisture in a component or die- dietary supplements, or contact sur-
tary supplement and is the quotient of faces, until the health condition no
the water vapor pressure of the sub- longer exists; and
stance divided by the vapor pressure of (2) Instructing your employees to no-
pure water at the same temperature. tify their supervisor(s) if they have or
We means the U.S. Food and Drug if there is a reasonable possibility that
Administration (FDA). they have a health condition described
You means a person who manufac- in paragraph (a)(1) of this section that
tures, packages, labels, or holds die- could result in microbial contamina-
tary supplements. tion of any components, dietary sup-
§ 111.5 Do other statutory provisions plements, or any contact surface.
and regulations apply? (b) Hygienic practices. If you work in
an operation during which adulteration
In addition to this part, you must of the component, dietary supplement,
comply with other applicable statutory or contact surface could occur, you
provisions and regulations under the must use hygienic practices to the ex-
act related to dietary supplements. For tent necessary to protect against such
importers of dietary supplements and contamination of components, dietary
dietary supplement components, the supplements, or contact surfaces.
regulation on foreign supplier These hygienic practices include the
verification programs can be found in following:
subpart L of part 1 of this chapter. (1) Wearing outer garments in a man-
[72 FR 34942, June 25, 2007, as amended at 80 ner that protects against the contami-
FR 74352, Nov. 27, 2015] nation of components, dietary supple-
ments, or any contact surface;
Subpart B—Personnel (2) Maintaining adequate personal
cleanliness;
§ 111.8 What are the requirements (3) Washing hands thoroughly (and
under this subpart B for written sanitizing if necessary to protect
procedures? against contamination with microorga-
You must establish and follow writ- nisms) in an adequate hand-washing fa-
ten procedures for fulfilling the re- cility:
quirements of this subpart. (i) Before starting work; and
278
(ii) At any time when the hands may person otherwise has when not per-
have become soiled or contaminated; forming such operations.
(4) Removing all unsecured jewelry (c) Each person engaged in manufac-
and other objects that might fall into turing, packaging, labeling, or holding,
components, dietary supplements, or in performing any quality control
equipment, or packaging, and removing operations, must have the education,
hand jewelry that cannot be ade- training, or experience to perform the
quately sanitized during periods in person’s assigned functions.
which components or dietary supple-
ments are manipulated by hand. If § 111.13 What supervisor requirements
hand jewelry cannot be removed, it apply?
must be covered by material that is (a) You must assign qualified per-
maintained in an intact, clean, and sonnel to supervise the manufacturing,
sanitary condition and that effectively packaging, labeling, or holding of die-
protects against contamination of tary supplements.
components, dietary supplements, or (b) Each supervisor whom you use
contact surfaces; must be qualified by education, train-
(5) Maintaining gloves used in han- ing, or experience to supervise.
dling components or dietary supple-
ments in an intact, clean, and sanitary § 111.14 Under this subpart B, what
condition. The gloves must be of an im- records must you make and keep?
permeable material; (a) You must make and keep records
(6) Wearing, where appropriate, in an required under this subpart B in ac-
effective manner, hair nets, caps, beard cordance with subpart P of this part.
covers, or other effective hair re- (b) You must make and keep the fol-
straints; lowing records:
(7) Not storing clothing or other per- (1) Written procedures for fulfilling
sonal belongings in areas where compo- the requirements of this subpart B; and
nents, dietary supplements, or any con-
(2) Documentation of training, in-
tact surfaces are exposed or where con-
cluding the date of the training, the
tact surfaces are washed;
type of training, and the person(s)
(8) Not eating food, chewing gum,
trained.
drinking beverages, or using tobacco
products in areas where components,
dietary supplements, or any contact Subpart C—Physical Plant and
surfaces are exposed, or where contact Grounds
surfaces are washed; and
(9) Taking any other precautions nec- § 111.15 What sanitation requirements
essary to protect against the contami- apply to your physical plant and
grounds?
nation of components, dietary supple-
ments, or contact surfaces with micro- (a) Grounds. You must keep the
organisms, filth, or any other extra- grounds of your physical plant in a
neous materials, including perspira- condition that protects against the
tion, hair, cosmetics, tobacco, chemi- contamination of components, dietary
cals, and medicines applied to the skin. supplements, or contact surfaces. The
methods for adequate ground mainte-
§ 111.12 What personnel qualification nance include:
requirements apply? (1) Properly storing equipment, re-
(a) You must have qualified employ- moving litter and waste, and cutting
ees who manufacture, package, label, weeds or grass within the immediate
or hold dietary supplements. vicinity of the physical plant so that it
(b) You must identify who is respon- does not attract pests, harbor pests, or
sible for your quality control oper- provide pests a place for breeding;
ations. Each person who is identified to (2) Maintaining roads, yards, and
perform quality control operations parking lots so that they do not con-
must be qualified to do so and have dis- stitute a source of contamination in
tinct and separate responsibilities re- areas where components, dietary sup-
lated to performing such operations plements, or contact surfaces are ex-
from those responsibilities that the posed;
279
§ 111.15 21 CFR Ch. I (4–1–23 Edition)
(3) Adequately draining areas that your physical plant. Guard or guide
may contribute to the contamination dogs are allowed in some areas of your
of components, dietary supplements, or physical plant if the presence of the
contact surfaces by seepage, filth or dogs will not result in contamination
any other extraneous materials, or by of components, dietary supplements, or
providing a breeding place for pests; contact surfaces;
(4) Adequately operating systems for (2) You must take effective measures
waste treatment and disposal so that to exclude pests from the physical
they do not constitute a source of con- plant and to protect against contami-
tamination in areas where components, nation of components, dietary supple-
dietary supplements, or contact sur- ments, and contact surfaces on the
faces are exposed; and premises by pests; and
(5) If your plant grounds are bordered (3) You must not use insecticides, fu-
by grounds not under your control, and migants, fungicides, or rodenticides,
if those other grounds are not main- unless you take precautions to protect
tained in the manner described in this against the contamination of compo-
section, you must exercise care in the nents, dietary supplements, or contact
plant by inspection, extermination, or surfaces.
other means to exclude pests, dirt, and (e) Water supply. (1) You must provide
filth or any other extraneous materials water that is safe and sanitary, at suit-
that may be a source of contamination. able temperatures, and under pressure
(b) Physical plant facilities. (1) You as needed, for all uses where water does
must maintain your physical plant in a not become a component of the dietary
clean and sanitary condition; and supplement.
(2) You must maintain your physical (2) Water that is used in a manner
plant in repair sufficient to prevent such that the water may become a
components, dietary supplements, or component of the dietary supplement,
contact surfaces from becoming con- e.g., when such water contacts compo-
taminated. nents, dietary supplements, or any con-
(c) Cleaning compounds, sanitizing tact surface, must, at a minimum,
agents, pesticides, and other toxic mate- comply with applicable Federal, State,
rials. (1) You must use cleaning com- and local requirements and not con-
pounds and sanitizing agents that are taminate the dietary supplement.
free from microorganisms of public (f) Plumbing. The plumbing in your
health significance and that are safe physical plant must be of an adequate
and adequate under the conditions of size and design and be adequately in-
use. stalled and maintained to:
(2) You must not use or hold toxic (1) Carry sufficient amounts of water
materials in a physical plant in which to required locations throughout the
components, dietary supplements, or physical plant;
contact surfaces are manufactured or (2) Properly convey sewage and liquid
exposed, unless those materials are disposable waste from your physical
necessary as follows: plant;
(i) To maintain clean and sanitary (3) Avoid being a source of contami-
conditions; nation to components, dietary supple-
(ii) For use in laboratory testing pro- ments, water supplies, or any contact
cedures; surface, or creating an unsanitary con-
(iii) For maintaining or operating the dition;
physical plant or equipment; or (4) Provide adequate floor drainage in
(iv) For use in the plant’s operations. all areas where floors are subject to
(3) You must identify and hold clean- flooding-type cleaning or where normal
ing compounds, sanitizing agents, pes- operations release or discharge water
ticides, pesticide chemicals, and other or other liquid waste on the floor; and
toxic materials in a manner that pro- (5) Not allow backflow from, or cross
tects against contamination of compo- connection between, piping systems
nents, dietary supplements, or contact that discharge waste water or sewage
surfaces. and piping systems that carry water

(d) Pest control. (1) You must not used for manufacturing dietary supple-
allow animals or pests in any area of ments, for cleaning contact surfaces, or
280
for use in bathrooms or hand-washing (a) Be suitable in size, construction,

facilities. and design to facilitate maintenance,
(g) Sewage disposal. You must dispose cleaning, and sanitizing operations;
of sewage into an adequate sewage sys- (b) Have adequate space for the or-
tem or through other adequate means. derly placement of equipment and
(h) Bathrooms. You must provide your holding of materials as is necessary for
employees with adequate, readily ac- maintenance, cleaning, and sanitizing
cessible bathrooms. The bathrooms operations and to prevent contamina-
must be kept clean and must not be a tion and mixups of components and di-
potential source of contamination to etary supplements during manufac-
components, dietary supplements, or turing, packaging, labeling, or holding;
contact surfaces. (c) Permit the use of proper pre-
(i) Hand-washing facilities. You must cautions to reduce the potential for
provide hand-washing facilities that mixups or contamination of compo-
are designed to ensure that an employ- nents, dietary supplements, or contact
ee’s hands are not a source of contami- surfaces, with microorganisms, chemi-
nation of components, dietary supple- cals, filth, or other extraneous mate-
ments, or any contact surface, by pro- rial. Your physical plant must have,
viding facilities that are adequate, con- and you must use, separate or defined
venient, and furnish running water at a areas of adequate size or other control
suitable temperature. systems, such as computerized inven-
(j) Trash disposal. You must convey, tory controls or automated systems of
store, and dispose of trash to: separation, to prevent contamination
and mixups of components and dietary
(1) Minimize the development of
supplements during the following oper-
odors;
ations:
(2) Minimize the potential for the (1) Receiving, identifying, holding,
trash to attract, harbor, or become a and withholding from use, components,
breeding place for pests; dietary supplements, packaging, and
(3) Protect against contamination of labels that will be used in or during the
components, dietary supplements, any manufacturing, packaging, labeling, or
contact surface, water supplies, and holding of dietary supplements;
grounds surrounding your physical (2) Separating, as necessary, compo-
plant; and nents, dietary supplements, packaging,
(4) Control hazardous waste to pre- and labels that are to be used in manu-
vent contamination of components, di- facturing from components, dietary
etary supplements, and contact sur- supplements, packaging, or labels that
faces. are awaiting material review and dis-
(k) Sanitation supervisors. You must position decision, reprocessing, or are
assign one or more employees to super- awaiting disposal after rejection;
vise overall sanitation. Each of these (3) Separating the manufacturing,
supervisors must be qualified by edu- packaging, labeling, and holding of dif-
cation, training, or experience to de- ferent product types including dif-
velop and supervise sanitation proce- ferent types of dietary supplements
dures. and other foods, cosmetics, and phar-
maceutical products;
§ 111.16 What are the requirements (4) Performing laboratory analyses
under this subpart C for written and holding laboratory supplies and
procedures?
samples;
You must establish and follow writ- (5) Cleaning and sanitizing contact
ten procedures for cleaning the phys- surfaces;
ical plant and for pest control. (6) Packaging and label operations;
and
§ 111.20 What design and construction (7) Holding components or dietary
requirements apply to your phys- supplements.
ical plant? (d) Be designed and constructed in a
Any physical plant you use in the manner that prevents contamination of
manufacture, packaging, labeling, or components, dietary supplements, or
holding of dietary supplements must: contact surfaces.
281
§ 111.23 21 CFR Ch. I (4–1–23 Edition)
(1) The design and construction must breakage of glass or glass-like mate-
include: rials.
(i) Floors, walls, and ceilings that (g) Provide effective protection
can be adequately cleaned and kept against contamination of components
clean and in good repair; and dietary supplements in bulk fer-
(ii) Fixtures, ducts, and pipes that do mentation vessels, by, for example:
not contaminate components, dietary (1) Use of protective coverings;
supplements, or contact surfaces by (2) Placement in areas where you can
dripping or other leakage, or conden- eliminate harborages for pests over and
sate; around the vessels;
(iii) Adequate ventilation or environ- (3) Placement in areas where you can
mental control equipment such as air- check regularly for pests, pest infesta-
flow systems, including filters, fans, tion, filth or any other extraneous ma-
and other air-blowing equipment, that terials; and
minimize odors and vapors (including (4) Use of skimming equipment.
steam and noxious fumes) in areas (h) Use adequate screening or other
where they may contaminate compo- protection against pests, where nec-
nents, dietary supplements, or contact essary.
surfaces;
(iv) Equipment that controls tem- § 111.23 Under this subpart C, what
perature and humidity, when such records must you make and keep?
equipment is necessary to ensure the
(a) You must make and keep records
quality of the dietary supplement; and
required under this subpart C in ac-
(v) Aisles or working spaces between cordance with subpart P of this part.
equipment and walls that are ade-
(b) You must make and keep records
quately unobstructed and of adequate
of the written procedures for cleaning
width to permit all persons to perform
the physical plant and for pest control.
their duties and to protect against con-
tamination of components, dietary sup- (c) You must make and keep records
plements, or contact surfaces with that show that water, when used in a
clothing or personal contact. manner such that the water may be-
come a component of the dietary sup-
(2) When fans and other air-blowing
equipment are used, such fans and plement, meets the requirements of
equipment must be located and oper- § 111.15(e)(2).
ated in a manner that minimizes the
potential for microorganisms and par- Subpart D—Equipment and
ticulate matter to contaminate compo- Utensils
nents, dietary supplements, or contact
surfaces; § 111.25 What are the requirements
(e) Provide adequate light in: under this subpart D for written
procedures?
(1) All areas where components or di-
etary supplements are examined, proc- You must establish and follow writ-
essed, or held; ten procedures for fulfilling the re-
(2) All areas where contact surfaces quirements of this subpart D, including
are cleaned; and written procedures for:
(3) Hand-washing areas, dressing and (a) Calibrating instruments and con-
locker rooms, and bathrooms. trols that you use in manufacturing or
(f) Use safety-type light bulbs, fix- testing a component or dietary supple-
tures, skylights, or other glass or ment;
glass-like materials when the light (b) Calibrating, inspecting, and
bulbs, fixtures, skylights or other glass checking automated, mechanical, and
or glass-like materials are suspended electronic equipment; and
over exposed components or dietary (c) Maintaining, cleaning, and sani-
supplements in any step of preparation, tizing, as necessary, all equipment,
unless your physical plant is otherwise utensils, and any other contact sur-
constructed in a manner that will pro- faces that are used to manufacture,
tect against contamination of compo- package, label, or hold components or
nents or dietary supplements in case of dietary supplements.
282
§ 111.27 What requirements apply to (5) Each freezer, refrigerator, and

the equipment and utensils that other cold storage compartment you
you use? use to hold components or dietary sup-
(a) You must use equipment and plements:
utensils that are of appropriate design, (i) Must be fitted with an indicating
construction, and workmanship to en- thermometer, temperature-measuring
able them to be suitable for their in- device, or temperature-recording de-
tended use and to be adequately vice that indicates and records, or al-
cleaned and properly maintained. lows for recording by hand, the tem-
(1) Equipment and utensils include perature accurately within the com-
the following: partment; and
(i) Equipment used to hold or convey; (ii) Must have an automated device
(ii) Equipment used to measure; for regulating temperature or an auto-
(iii) Equipment using compressed air mated alarm system to indicate a sig-
or gas; nificant temperature change in a man-
(iv) Equipment used to carry out ual operation.
processes in closed pipes and vessels; (6) Instruments or controls used in
and the manufacturing, packaging, label-
(v) Equipment used in automated, ing, or holding of a dietary supplement,
mechanical, or electronic systems. and instruments or controls that you
(2) You must use equipment and use to measure, regulate, or record
utensils of appropriate design and con- temperatures, hydrogen-ion concentra-
struction so that use will not result in tion (pH), water activity, or other con-
the contamination of components or ditions, to control or prevent the
dietary supplements with: growth of microorganisms or other
(i) Lubricants; contamination must be:
(ii) Fuel; (i) Accurate and precise;
(iii) Coolants; (ii) Adequately maintained; and
(iv) Metal or glass fragments; (iii) Adequate in number for their
(v) Filth or any other extraneous ma- designated uses.
terial; (7) Compressed air or other gases you
(vi) Contaminated water; or introduce mechanically into or onto a
(vii) Any other contaminants. component, dietary supplement, or
(3) All equipment and utensils you contact surface or that you use to
use must be: clean any contact surface must be
(i) Installed and maintained to facili- treated in such a way that the compo-
tate cleaning the equipment, utensils, nent, dietary supplement, or contact
and all adjacent spaces; surface is not contaminated.
(ii) Corrosion-resistant if the equip- (b) You must calibrate instruments
ment or utensils contact components and controls you use in manufacturing
or dietary supplements; or testing a component or dietary sup-
(iii) Made of nontoxic materials; plement. You must calibrate:
(iv) Designed and constructed to (1) Before first use; and
withstand the environment in which (2) At the frequency specified in writ-
they are used, the action of compo- ing by the manufacturer of the instru-
nents or dietary supplements, and, if ment and control; or
applicable, cleaning compounds and (3) At routine intervals or as other-
sanitizing agents; and wise necessary to ensure the accuracy
(v) Maintained to protect compo- and precision of the instrument and
nents and dietary supplements from control.
being contaminated by any source. (c) You must repair or replace instru-
(4) Equipment and utensils you use ments or controls that cannot be ad-
must have seams that are smoothly justed to agree with the reference
bonded or maintained to minimize ac- standard.
cumulation of dirt, filth, organic mate- (d) You must maintain, clean, and
rial, particles of components or dietary sanitize, as necessary, all equipment,

supplements, or any other extraneous utensils, and any other contact sur-
materials or contaminants. faces used to manufacture, package,
283
§ 111.30 21 CFR Ch. I (4–1–23 Edition)
label, or hold components or dietary § 111.30 What requirements apply to

supplements. automated, mechanical, or elec-
(1) Equipment and utensils must be tronic equipment?
taken apart as necessary for thorough For any automated, mechanical, or
maintenance, cleaning, and sanitizing. electronic equipment that you use to
(2) You must ensure that all contact manufacture, package, label, or hold a
surfaces, used for manufacturing or dietary supplement, you must:
holding low-moisture components or (a) Design or select equipment to en-
dietary supplements, are in a dry and sure that dietary supplement specifica-
sanitary condition when in use. When tions are consistently met;
the surfaces are wet-cleaned, they (b) Determine the suitability of the
must be sanitized, when necessary, and equipment by ensuring that your
thoroughly dried before subsequent equipment is capable of operating sat-
use. isfactorily within the operating limits
(3) If you use wet processing during required by the process;
manufacturing, you must clean and (c) Routinely calibrate, inspect, or
sanitize all contact surfaces, as nec- check the equipment to ensure proper
essary, to protect against the introduc- performance. Your quality control per-
tion of microorganisms into compo- sonnel must periodically review these
nents or dietary supplements. When calibrations, inspections, or checks;
cleaning and sanitizing is necessary, (d) Establish and use appropriate
you must clean and sanitize all contact controls for automated, mechanical,
surfaces before use and after any inter- and electronic equipment (including
ruption during which the contact sur- software for a computer controlled
face may have become contaminated. If process) to ensure that any changes to
you use contact surfaces in a contin- the manufacturing, packaging, label-
uous production operation or in con- ing, holding, or other operations are
secutive operations involving different approved by quality control personnel
batches of the same dietary supple- and instituted only by authorized per-
ment, you must adequately clean and sonnel; and
sanitize the contact surfaces, as nec- (e) Establish and use appropriate con-
essary. trols to ensure that the equipment
(4) You must clean surfaces that do functions in accordance with its in-
not come into direct contact with com- tended use. These controls must be ap-
ponents or dietary supplements as fre- proved by quality control personnel.
quently as necessary to protect against
contaminating components or dietary § 111.35 Under this subpart D, what
supplements. records must you make and keep?
(5) Single-service articles (such as (a) You must make and keep records
utensils intended for one-time use, required under this subpart D in ac-
paper cups, and paper towels) must be: cordance with subpart P of this part.
(i) Stored in appropriate containers; (b) You must make and keep the fol-
and lowing records:
(ii) Handled, dispensed, used, and dis- (1) Written procedures for fulfilling
posed of in a manner that protects the requirements of this subpart, in-
against contamination of components, cluding written procedures for:
dietary supplements, or any contact (i) Calibrating instruments and con-
surface. trols that you use in manufacturing or
(6) Cleaning compounds and sani- testing a component or dietary supple-
tizing agents must be adequate for ment;
their intended use and safe under their (ii) Calibrating, inspecting, and
conditions of use; checking automated, mechanical, and
(7) You must store cleaned and sani- electronic equipment; and
tized portable equipment and utensils (iii) Maintaining, cleaning, and sani-
that have contact surfaces in a loca- tizing, as necessary, all equipment,
tion and manner that protects them utensils, and any other contact sur-
from contamination.
faces that are used to manufacture,

[72 FR 34942, June 25, 2007, as amended at 73 package, label, or hold components or
FR 13124, Mar. 12, 2008] dietary supplements;
284
(2) Documentation, in individual Subpart E—Requirement to Estab-

equipment logs, of the date of the use, lish a Production and Process
maintenance, cleaning, and sanitizing
of equipment, unless such documenta-
Control System
tion is kept with the batch record; § 111.55 What are the requirements to
(3) Documentation of any calibration, implement a production and proc-
each time the calibration is performed, ess control system?
for instruments and controls that you
use in manufacturing or testing a com- You must implement a system of pro-
ponent or dietary supplement. In your duction and process controls that cov-
documentation, you must: ers all stages of manufacturing, pack-
(i) Identify the instrument or control aging, labeling, and holding of the die-
calibrated; tary supplement to ensure the quality
(ii) Provide the date of calibration; of the dietary supplement and that the
(iii) Identify the reference standard dietary supplement is packaged and la-
used including the certification of ac- beled as specified in the master manu-
curacy of the known reference standard facturing record.
and a history of recertification of accu-
racy; § 111.60 What are the design require-
(iv) Identify the calibration method ments for the production and proc-
ess control system?
used, including appropriate limits for
accuracy and precision of instruments (a) Your production and in-process
and controls when calibrating; control system must be designed to en-
(v) Provide the calibration reading or sure that the dietary supplement is
readings found; manufactured, packaged, labeled, and
(vi) Identify the recalibration meth- held in a manner that will ensure the
od used, and reading or readings found, quality of the dietary supplement and
if accuracy or precision or both accu- that the dietary supplement is pack-
racy and precision limits for instru- aged and labeled as specified in the
ments and controls were not met; and master manufacturing record; and
(vii) Include the initials of the person (b) The production and in-process
who performed the calibration and any control system must include all re-
recalibration. quirements of subparts E through L of
(4) Written records of calibrations, this part and must be reviewed and ap-
inspections, and checks of automated, proved by quality control personnel.
mechanical, and electronic equipment;
(5) Backup file(s) of current software § 111.65 What are the requirements for
programs (and of outdated software quality control operations?
that is necessary to retrieve records
You must implement quality control
that you are required to keep in ac-
operations in your manufacturing,
cordance with subpart P of this part,
packaging, labeling, and holding oper-
when current software is not able to re-
ations for producing the dietary sup-
trieve such records) and of data entered
plement to ensure the quality of the di-
into computer systems that you use to
manufacture, package, label, or hold etary supplement and that the dietary
dietary supplements. supplement is packaged and labeled as
(i) Your backup file (e.g., a hard copy specified in the master manufacturing
of data you have entered, diskettes, record.
tapes, microfilm, or compact disks)
§ 111.70 What specifications must you
must be an exact and complete record establish?
of the data you entered.
(ii) You must keep your backup soft- (a) You must establish a specification
ware programs and data secure from al- for any point, step, or stage in the
terations, inadvertent erasures, or loss; manufacturing process where control is
and necessary to ensure the quality of the
(6) Documentation of the controls dietary supplement and that the die-
that you use to ensure that equipment tary supplement is packaged and la-
functions in accordance with its in- beled as specified in the master manu-
tended use. facturing record.
285
§ 111.73 21 CFR Ch. I (4–1–23 Edition)
(b) For each component that you use (e) For each dietary supplement that
in the manufacture of a dietary supple- you manufacture you must establish
ment, you must establish component product specifications for the identity,
specifications as follows: purity, strength, and composition of
(1) You must establish an identity the finished batch of the dietary sup-
specification; plement, and for limits on those types
(2) You must establish component of contamination that may adulterate,
specifications that are necessary to en- or that may lead to adulteration of,
sure that specifications for the purity, the finished batch of the dietary sup-
strength and composition of dietary plement to ensure the quality of the di-
supplements manufactured using the etary supplement.
components are met; and (f) If you receive a product from a
(3) You must establish limits on supplier for packaging or labeling as a
those types of contamination that may dietary supplement (and for distribu-
adulterate or may lead to adulteration tion rather than for return to the sup-
of the finished batch of the dietary supplier), you must establish specifica-
plement to ensure the quality of the ditions to provide sufficient assurance
etary supplement. that the product you receive is ade-
quately identified and is consistent
(c) For the in-process production:
with your purchase order.
(1) You must establish in-process
(g) You must establish specifications
specifications for any point, step, or
for the packaging and labeling of the
stage in the master manufacturing
finished packaged and labeled dietary
record where control is necessary to supplements, including specifications
help ensure that specifications are met that ensure that you used the specified
for the identity, purity, strength, and packaging and that you applied the
composition of the dietary supplements specified label.
and, as necessary, for limits on those
types of contamination that may adul- § 111.73 What is your responsibility for
terate or may lead to adulteration of determining whether established
the finished batch of the dietary sup- specifications are met?
plement; You must determine whether the
(2) You must provide adequate docu- specifications you establish under
mentation of your basis for why meet- § 111.70 are met.
ing the in-process specifications, in
combination with meeting component § 111.75 What must you do to deter-
specifications, will help ensure that the mine whether specifications are
specifications are met for the identity, met?
purity, strength, and composition of (a) Before you use a component, you
the dietary supplements and for limits must:
on those types of contamination that (1)(i) Conduct at least one appro-
may adulterate or may lead to adulter- priate test or examination to verify the
ation of the finished batch of the die- identity of any component that is a di-
tary supplement; and etary ingredient, unless you petition
(3) Quality control personnel must the agency under paragraph (a)(1)(ii) of
review and approve the documentation this section and the agency exempts
that you provide under paragraph (c)(2) you from such testing;
of this section. (ii) You may submit a petition, under
(d) You must establish specifications 21 CFR 10.30, to request an exemption
for dietary supplement labels (label from the testing requirements in para-
specifications) and for packaging that graph (a)(1)(i) of this section. The peti-
may come in contact with dietary sup- tion must set forth the scientific ra-
plements (packaging specifications). tionale, and must be accompanied by
Packaging that may come into contact the supporting data and information,
with dietary supplements must be safe for proposed alternative testing that
and suitable for its intended use and will demonstrate that there is no mate-
must not be reactive or absorptive or rial diminution of assurance, compared

otherwise affect the safety or quality to the assurance provided by 100 per-
of the dietary supplement. cent identity testing, of the identity of
286
the dietary ingredient before use when adulteration of the finished batch of
the dietary ingredient is obtained from the dietary supplement. To do so:
one or more suppliers identified in the (1) You must select one or more es-
petition. If FDA grants the petition, tablished specifications for identity,
you must conduct the tests and exami- purity, strength, composition, and the
nations for the dietary ingredient, oth- limits on those types of contamination
erwise required under § 111.75(a)(1)(i), that may adulterate or that may lead
under the terms specified by FDA when to adulteration of the dietary supple-
the petition is granted; and ment that, if tested or examined on the
(2) Confirm the identity of other finished batches of the dietary supple-
components and determine whether ment, would verify that the production
other applicable component specifica- and process control system is pro-
tions established in accordance with ducing a dietary supplement that
§ 111.70(b) are met. To do so, you must meets all product specifications (or
either: only those product specifications not
(i) Conduct appropriate tests or ex- otherwise exempted from this provision
aminations; or by quality control personnel under
(ii) Rely on a certificate of analysis paragraph (d) of this section);
from the supplier of the component (2) You must conduct appropriate
that you receive, provided that: tests or examinations to determine
(A) You first qualify the supplier by compliance with the specifications se-
establishing the reliability of the sup- lected in paragraph (c)(1) of this sec-
plier’s certificate of analysis through tion;
confirmation of the results of the sup- (3) You must provide adequate docu-
plier’s tests or examinations; mentation of your basis for deter-
(B) The certificate of analysis in- mining that compliance with the speci-
cludes a description of the test or ex- fication(s) selected under paragraph
amination method(s) used, limits of (c)(1) of this section, through the use of
the test or examinations, and actual appropriate tests or examinations con-
results of the tests or examinations; ducted under paragraph (c)(2) of this
(C) You maintain documentation of section, will ensure that your finished
how you qualified the supplier; batch of the dietary supplement meets
(D) You periodically re-confirm the all product specifications for identity,
supplier’s certificate of analysis; and purity, strength, and composition, and
(E) Your quality control personnel the limits on those types of contamina-
review and approve the documentation tion that may adulterate, or that may
setting forth the basis for qualification lead to the adulteration of, the dietary
(and re-qualification) of any supplier. supplement; and
(b) You must monitor the in-process (4) Your quality control personnel
points, steps, or stages where control is must review and approve the docu-
necessary to ensure the quality of the mentation that you provide under
finished batch of dietary supplement paragraph (c)(3) of this section.
to: (d)(1) You may exempt one or more
(1) Determine whether the in-process product specifications from
specifications are met; and verification requirements in paragraph
(2) Detect any deviation or unantici- (c)(1) of this section if you determine
pated occurrence that may result in a and document that the specifications
failure to meet specifications. you select under paragraph (c)(1) of
(c) For a subset of finished dietary this section for determination of com-
supplement batches that you identify pliance with specifications are not able
through a sound statistical sampling to verify that the production and proc-
plan (or for every finished batch), you ess control system is producing a die-
must verify that your finished batch of tary supplement that meets the ex-
the dietary supplement meets product empted product specification and there
specifications for identity, purity, is no scientifically valid method for
strength, composition, and for limits testing or examining such exempted

on those types of contamination that product specification at the finished
may adulterate or that may lead to batch stage. In such a case, you must
287
§ 111.77 21 CFR Ch. I (4–1–23 Edition)
document why, for example, any com- (i) You must establish corrective ac-
ponent and in-process testing, exam- tion plans for use when an established
ination, or monitoring, and any other specification is not met.
information, will ensure that such ex- [72 FR 34942, June 25, 2007, as amended at 72
empted product specification is met FR 34968, June 25, 2007; 73 FR 27727, May 14,
without verification through periodic 2008]
testing of the finished batch; and
(2) Your quality control personnel § 111.77 What must you do if estab-
must review and approve the docu- lished specifications are not met?
mentation that you provide under (a) For specifications established
paragraph (d)(1) of this section. under § 111.70(a), (b)(2), (b)(3), (c), (d),
(e) Before you package or label a (e), and (g) that you do not meet, qual-
product that you receive for packaging ity control personnel, in accordance
or labeling as a dietary supplement with the requirements in subpart F of
(and for distribution rather than for re- this part, must reject the component,
turn to the supplier), you must vis- dietary supplement, package or label
ually examine the product and have unless such personnel approve a treat-
documentation to determine whether ment, an in-process adjustment, or re-
the specifications that you established processing that will ensure the quality
of the finished dietary supplement and
under § 111.70 (f) are met.
that the dietary supplement is pack-
(f)(1) Before you use packaging, you
aged and labeled as specified in the
must, at a minimum, conduct a visual master manufacturing record. No fin-
identification of the containers and ished batch of dietary supplements
closures and review the supplier’s in- may be released for distribution unless
voice, guarantee, or certification to de- it complies with § 111.123(b).
termine whether the packaging speci- (b) For specifications established
fications are met; and under § 111.70(b)(1) that you do not
(2) Before you use labels, you must, meet, quality control personnel must
at a minimum, conduct a visual exam- reject the component and the compo-
ination of the label and review the sup- nent must not be used in manufac-
plier’s invoice, guarantee, or certifi- turing the dietary supplement.
cation to determine whether label (c) For specifications established
specifications are met. under § 111.70(f) that you do not meet,
(g) You must, at a minimum, conduct quality control personnel must reject
a visual examination of the packaging the product and the product may not
and labeling of the finished packaged be packaged or labeled for distribution
and labeled dietary supplements to de- as a dietary supplement.
termine whether you used the specified
packaging and applied the specified § 111.80 What representative samples
must you collect?
label.
(h)(1) You must ensure that the tests The representative samples that you
and examinations that you use to de- must collect include:
termine whether the specifications are (a) Representative samples of each
met are appropriate, scientifically unique lot of components, packaging,
valid methods. and labels that you use to determine
(2) The tests and examinations that whether the components, packaging,
you use must include at least one of and labels meet specifications estab-
lished in accordance with § 111.70(b) and
the following:
(d), and as applicable, § 111.70(a) (and,
(i) Gross organoleptic analysis; when you receive components, pack-
(ii) Macroscopic analysis; aging, or labels from a supplier, rep-
(iii) Microscopic analysis; resentative samples of each unique
(iv) Chemical analysis; or shipment, and of each unique lot with-
(v) Other scientifically valid meth- in each unique shipment);
ods.
(b) Representative samples of in-

process materials for each manufac-
tured batch at points, steps, or stages,
288
in the manufacturing process as speci- (2) Be identified with the batch, lot,
fied in the master manufacturing or control number;
record where control is necessary to (3) Be retained for 1 year past the
ensure the identity, purity, strength, shelf life date (if shelf life dating is
and composition of dietary supple- used), or for 2 years from the date of
ments to determine whether the in- distribution of the last batch of dietary
process materials meet specifications supplements associated with the re-
established in accordance with serve sample, for use in appropriate in-
§ 111.70(c), and as applicable, § 111.70(a); vestigations; and
(c) Representative samples of a sub- (4) Consist of at least twice the quan-
set of finished batches of each dietary tity necessary for all tests or examina-
supplement that you manufacture, tions to determine whether or not the
which you identify through a sound dietary supplement meets product
statistical sampling plan (or otherwise specifications.
every finished batch), before releasing
for distribution to verify that the fin- § 111.87 Who conducts a material re-
ished batch of dietary supplement view and makes a disposition deci-
sion?
meets product specifications estab-
lished in accordance with § 111.70(e), Quality control personnel must con-
and as applicable, § 111.70(a); duct all required material reviews and
(d) Representative samples of each make all required disposition deci-
unique shipment, and of each unique sions.
lot within each unique shipment, of
product that you receive for packaging § 111.90 What requirements apply to
treatments, in-process adjustments,
or labeling as a dietary supplement and reprocessing when there is a
(and for distribution rather than for re- deviation or unanticipated occur-
turn to the supplier) to determine rence or when a specification estab-
whether the received product meets lished in accordance with § 111.70 is
specifications established in accord- not met?
ance with § 111.70(f), and as applicable, (a) You must not reprocess a rejected
§ 111.70(a); and dietary supplement or treat or provide
(e) Representative samples of each an in-process adjustment to a compo-
lot of packaged and labeled dietary nent, packaging, or label to make it
supplements to determine whether the suitable for use in the manufacture of
packaging and labeling of the finished a dietary supplement unless:
packaged and labeled dietary supple- (1) Quality control personnel conduct
ments meet specifications established a material review and make a disposi-
in accordance with § 111.70(g), and as tion decision to approve the reprocess-
applicable, § 111.70(a). ing, treatment, or in-process adjust-
ment; and
§ 111.83 What are the requirements for (2) The reprocessing, treatment, or
reserve samples? in-process adjustment is permitted by
(a) You must collect and hold reserve § 111.77;
samples of each lot of packaged and la- (b) You must not reprocess any die-
beled dietary supplements that you dis- tary supplement or treat or provide an
tribute. in-process adjustment to a component
(b) The reserve samples must: to make it suitable for use in the man-
(1) Be held using the same container- ufacture of a dietary supplement, un-
closure system in which the packaged less:
and labeled dietary supplement is dis- (1) Quality control personnel conduct
tributed, or if distributing dietary sup- a material review and make a disposi-
plements to be packaged and labeled, tion decision that is based on a sci-
using a container-closure system that entifically valid reason and approves
provides essentially the same charac- the reprocessing, treatment, or in-proc-
teristics to protect against contamina- ess adjustment; and
tion or deterioration as the one in (2) The reprocessing, treatment or in-

which it is distributed for packaging process adjustment is permitted by
and labeling elsewhere; § 111.77;
289
§ 111.95 21 CFR Ch. I (4–1–23 Edition)
(c) Any batch of dietary supplement (6) Documentation of FDA’s response

that is reprocessed, that contains com- to a petition submitted under
ponents that you have treated, or to § 111.75(a)(1)(ii) providing for an exemp-
which you have made in-process adjust- tion from the provisions of
ments to make them suitable for use in § 111.75(a)(1)(i).
the manufacture of the dietary supple- [72 FR 34942, June 25, 2007, as amended at 72
ment must be approved by quality con- FR 34968, June 25, 2007]
trol personnel and comply with
§ 111.123(b) before releasing for distribu- Subpart F—Production and Proc-
tion.
ess Control System: Require-
§ 111.95 Under this subpart E, what ments for Quality Control
records must you make and keep?
§ 111.103 What are the requirements
(a) You must make and keep records under this subpart F for written
required under this subpart E in ac- procedures?
cordance with subpart P of this part. You must establish and follow writ-
(b) Under this subpart E, you must ten procedures for the responsibilities
make and keep the following records: of the quality control operations, in-
(1) The specifications established; cluding written procedures for con-
(2) Documentation of your qualifica- ducting a material review and making
tion of a supplier for the purpose of re- a disposition decision, and for approv-
lying on the supplier’s certificate of ing or rejecting any reprocessing.
analysis;
§ 111.105 What must quality control
(3) Documentation for why meeting personnel do?
in-process specifications, in combina-
tion with meeting component speci- Quality control personnel must en-
fications, helps ensure that the dietary sure that your manufacturing, pack-
supplement meets the specifications aging, labeling, and holding operations
ensure the quality of the dietary sup-
for identity, purity, strength, and com-
plement and that the dietary supple-
position; and for limits on those types
ment is packaged and labeled as speci-
of contamination that may adulterate
fied in the master manufacturing
or may lead to adulteration of the fin-
record. To do so, quality control per-
ished batch of the dietary supplement;
sonnel must perform operations that
and include:
(4) Documentation for why the re- (a) Approving or rejecting all proc-
sults of appropriate tests or examina- esses, specifications, written proce-
tions for the product specifications se- dures, controls, tests, and examina-
lected under § 111.75(c)(1) ensure that tions, and deviations from or modifica-
the dietary supplement meets all prod- tions to them, that may affect the
uct specifications; identity, purity, strength, or composi-
(5) Documentation for why any com- tion of a dietary supplement;
ponent and in-process testing, exam- (b) Reviewing and approving the doc-
ination, or monitoring, and any other umentation setting forth the basis for
information, will ensure that a product qualification of any supplier;
specification that is exempted under (c) Reviewing and approving the doc-
§ 111.75(d) is met without verification umentation setting forth the basis for
through periodic testing of the finished why meeting in-process specifications,
batch, including documentation that in combination with meeting compo-
the selected specifications tested or ex- nent specifications, will help ensure
amined under § 111.75 (c)(1) are not able that the identity, purity, strength, and
to verify that the production and proc- composition of the dietary supplement
ess control system is producing a die- are met;
tary supplement that meets the ex- (d) Reviewing and approving the doc-
empted product specification and there umentation setting forth the basis for
is no scientifically valid method for why the results of appropriate tests or
testing or examining such exempted examinations for each product speci-

product specification at the finished fication selected under § 111.75(c)(1) will
batch stage. ensure that the finished batch of the
290
dietary supplement meets product adulteration of the component, dietary

specifications; supplement, or packaging, or could
(e) Reviewing and approving the basis lead to the use of a label not specified
and the documentation for why any in the master manufacturing record;
product specification is exempted from (4) Calibration of an instrument or
the verification requirements in control suggests a problem that may
§ 111.75(c)(1), and for why any compo- have resulted in a failure to ensure the
nent and in-process testing, examina- quality of a batch or batches of a die-
tion, or monitoring, or other methods tary supplement; or
will ensure that such exempted product (5) A dietary supplement is returned.
specification is met without
(b)(1) When there is a deviation or
verification through periodic testing of
unanticipated occurrence during the
the finished batch;
production and in-process control sys-
(f) Ensuring that required representa-
tive samples are collected; tem that results in or could lead to
(g) Ensuring that required reserve adulteration of a component, dietary
samples are collected and held; supplement, or packaging, or could
(h) Determining whether all speci- lead to the use of a label not specified
fications established under § 111.70(a) in the master manufacturing record,
are met; and quality control personnel must reject
(i) Performing other operations re- the component, dietary supplement,
quired under this subpart. packaging, or label unless it approves a
treatment, an in-process adjustment,
§ 111.110 What quality control oper- or reprocessing to correct the applica-
ations are required for laboratory ble deviation or occurrence.
operations associated with the pro- (2) When a specification established
duction and process control sys- in accordance with § 111.70 is not met,
tem?
quality control personnel must reject
Quality control operations for lab- the component, dietary supplement,
oratory operations associated with the package or label, unless quality control
production and process control system personnel approve a treatment, an in-
must include: process adjustment, or reprocessing, as
(a) Reviewing and approving all lab- permitted in § 111.77.
oratory control processes associated (c) The person who conducts a mate-
with the production and process con- rial review and makes the disposition
trol system; decision must, at the time of perform-
(b) Ensuring that all tests and exami- ance, document that material review
nations required under § 111.75 are con- and disposition decision.
ducted; and
(c) Reviewing and approving the re- § 111.117 What quality control oper-
sults of all tests and examinations re- ations are required for equipment,
quired under § 111.75. instruments, and controls?
§ 111.113 What quality control oper- Quality control operations for equip-
ations are required for a material ment, instruments, and controls must
review and disposition decision? include:
(a) Quality control personnel must (a) Reviewing and approving all proc-
conduct a material review and make a esses for calibrating instruments and
disposition decision if: controls;
(1) A specification established in ac- (b) Periodically reviewing all records
cordance with § 111.70 is not met; for calibration of instruments and con-
(2) A batch deviates from the master trols;
manufacturing record, including when (c) Periodically reviewing all records
any step established in the master for calibrations, inspections, and
manufacturing record is not completed checks of automated, mechanical, or
and including any deviation from spec- electronic equipment; and
ifications; (d) Reviewing and approving controls
(3) There is any unanticipated occur- to ensure that automated, mechanical,

rence during the manufacturing oper- or electronic equipment functions in
ations that adulterates or may lead to accordance with its intended use.
291
§ 111.120 21 CFR Ch. I (4–1–23 Edition)
§ 111.120 What quality control oper- (b) Quality control personnel must
ations are required for components, not approve and release for distribu-
packaging, and labels before use in tion:
the manufacture of a dietary sup- (1) Any batch of dietary supplement
plement?
for which any component in the batch
Quality control operations for com- does not meet its identity specifica-
ponents, packaging, and labels before tion;
use in the manufacture of a dietary (2) Any batch of dietary supplement,
supplement must include:
including any reprocessed batch, that
(a) Reviewing all receiving records
does not meet all product specifica-
for components, packaging, and labels;
(b) Determining whether all compo- tions established in accordance with
nents, packaging, and labels conform § 111.70(e);
to specifications established under (3) Any batch of dietary supplement,
§ 111.70 (b) and (d); including any reprocessed batch, that
(c) Conducting any required material has not been manufactured, packaged,
review and making any required dis- labeled, and held under conditions to
position decision; prevent adulteration under section
(d) Approving or rejecting any treat- 402(a)(1), (a)(2), (a)(3), and (a)(4) of the
ment and in-process adjustments of act; and
components, packaging, or labels to (4) Any product received from a sup-
make them suitable for use in the man- plier for packaging or labeling as a die-
ufacture of a dietary supplement; and tary supplement (and for distribution
(e) Approving, and releasing from rather than for return to the supplier)
quarantine, all components, packaging, for which sufficient assurance is not
and labels before they are used. provided to adequately identify the
§ 111.123 What quality control oper- product and to determine that the
ations are required for the master product is consistent with your pur-
manufacturing record, the batch chase order.
production record, and manufac-
turing operations? § 111.127 What quality control oper-
(a) Quality control operations for the ations are required for packaging
and labeling operations?
master manufacturing record, the
batch production record, and manufac- Quality control operations for pack-
turing operations must include: aging and labeling operations must in-
(1) Reviewing and approving all mas- clude:
ter manufacturing records and all (a) Reviewing the results of any vis-
modifications to the master manufac- ual examination and documentation to
turing records; ensure that specifications established
(2) Reviewing and approving all batch under § 111.70(f) are met for all products
production-related records; that you receive for packaging and la-
(3) Reviewing all monitoring required beling as a dietary supplement (and for
under subpart E; distribution rather than for return to
(4) Conducting any required material the supplier);
review and making any required dis-
(b) Approving, and releasing from
position decision;
quarantine, all products that you re-
(5) Approving or rejecting any reproc-
ceive for packaging or labeling as a di-
essing;
(6) Determining whether all in-proc- etary supplement (and for distribution
ess specifications established in ac- rather than for return to the supplier)
cordance with § 111.70(c) are met; before they are used for packaging or
(7) Determining whether each fin- labeling;
ished batch conforms to product speci- (c) Reviewing and approving all
fications established in accordance records for packaging and label oper-
with § 111.70(e); and ations;
(8) Approving and releasing, or re- (d) Determining whether the finished
jecting, each finished batch for dis- packaged and labeled dietary supple-
tribution, including any reprocessed ment conforms to specifications estab-
finished batch. lished in accordance with § 111.70(g);
292
(e) Conducting any required material § 111.140 Under this subpart F, what
review and making any required dis- records must you make and keep?
position decision; (a) You must make and keep the
(f) Approving or rejecting any re- records required under this subpart F
packaging of a packaged dietary sup- in accordance with subpart P of this
plement; part.
(g) Approving or rejecting any re- (b) You must make and keep the fol-
labeling of a packaged and labeled die- lowing records:
tary supplement; and (1) Written procedures for the respon-
(h) Approving for release, or reject- sibilities of the quality control oper-
ing, any packaged and labeled dietary ations, including written procedures
supplement (including a repackaged or for conducting a material review and
relabeled dietary supplement) for dis- making a disposition decision and writ-
tribution. ten procedures for approving or reject-
ing any reprocessing;
§ 111.130 What quality control oper- (2) Written documentation, at the
ations are required for returned di- time of performance, that quality con-
etary supplements? trol personnel performed the review,
Quality control operations for re- approval, or rejection requirements by
turned dietary supplements must in- recording the following:
clude: (i) Date that the review, approval, or
rejection was performed; and
(a) Conducting any required material
(ii) Signature of the person per-
review and making any required dis-
forming the review, approval, or rejec-
position decision; including:
tion; and
(1) Determining whether tests or ex-
(3) Documentation of any material
amination are necessary to determine review and disposition decision and fol-
compliance with product specifications lowup. Such documentation must be
established in accordance with included in the appropriate batch pro-
§ 111.70(e); and duction record and must include:
(2) Reviewing the results of any tests (i) Identification of the specific devi-
or examinations that are conducted to ation or the unanticipated occurrence;
determine compliance with product (ii) Description of your investigation
specifications established in accord- into the cause of the deviation from
ance with § 111.70(e); the specification or the unanticipated
(b) Approving or rejecting any sal- occurrence;
vage and redistribution of any returned (iii) Evaluation of whether or not the
dietary supplement; deviation or unanticipated occurrence
(c) Approving or rejecting any re- has resulted in or could lead to a fail-
processing of any returned dietary sup- ure to ensure the quality of the dietary
plement; and supplement or a failure to package and
(d) Determining whether the reproc- label the dietary supplement as speci-
essed dietary supplement meets prod- fied in the master manufacturing
uct specifications and either approving record;
for release, or rejecting, any returned (iv) Identification of the action(s)
dietary supplement that is reprocessed. taken to correct, and prevent a recur-
rence of, the deviation or the unantici-
§ 111.135 What quality control oper- pated occurrence;
ations are required for product (v) Explanation of what you did with
complaints? the component, dietary supplement,
packaging, or label;
Quality control operations for prod-
(vi) A scientifically valid reason for
uct complaints must include reviewing
any reprocessing of a dietary supple-
and approving decisions about whether ment that is rejected or any treatment
to investigate a product complaint and or in-process adjustment of a compo-
reviewing and approving the findings
nent that is rejected; and

and followup action of any investiga- (vii) The signature of the indi-
tion performed. vidual(s) designated to perform the
293
§ 111.153 21 CFR Ch. I (4–1–23 Edition)
quality control operation, who con- manufacture of a dietary supplement,

ducted the material review and made and releases them from quarantine.
the disposition decision, and of each (d)(1) You must identify each unique
qualified individual who provides infor- lot within each unique shipment of
mation relevant to that material re- components that you receive and any
view and disposition decision. lot of components that you produce in
a manner that allows you to trace the
Subpart G—Production and Proc- lot to the supplier, the date received,
ess Control System: Require- the name of the component, the status
of the component (e.g., quarantined,
ments for Components, Pack- approved, or rejected); and to the die-
aging, and Labels and for tary supplement that you manufac-
Product That You Receive for tured and distributed.
Packaging or Labeling as a (2) You must use this unique identi-
Dietary Supplement fier whenever you record the disposi-
tion of each unique lot within each
§ 111.153 What are the requirements unique shipment of components that
under this subpart G for written you receive and any lot of components
procedures?
that you produce.
You must establish and follow writ- (e) You must hold components under
ten procedures for fulfilling the re- conditions that will protect against
quirements of this subpart G. contamination and deterioration, and
avoid mixups.
§ 111.155 What requirements apply to
components of dietary supple- § 111.160 What requirements apply to
ments? packaging and labels received?
(a) You must visually examine each (a) You must visually examine each
immediate container or grouping of immediate container or grouping of
immediate containers in a shipment immediate containers in a shipment
that you receive for appropriate con- for appropriate content label, con-
tent label, container damage, or bro- tainer damage, or broken seals to de-
ken seals to determine whether the termine whether the container condi-
container condition may have resulted tion may have resulted in contamina-
in contamination or deterioration of tion or deterioration of the packaging
the components; and labels.
(b) You must visually examine the (b) You must visually examine the
supplier’s invoice, guarantee, or cer- supplier’s invoice, guarantee, or cer-
tification in a shipment you receive to tification in a shipment to ensure that
ensure the components are consistent the packaging or labels are consistent
with your purchase order; with your purchase order.
(c) You must quarantine components (c) You must quarantine packaging
before you use them in the manufac- and labels before you use them in the
ture of a dietary supplement until: manufacture of a dietary supplement
(1) You collect representative sam- until:
ples of each unique lot of components (1) You collect representative sam-
(and, for components that you receive, ples of each unique shipment, and of
of each unique shipment, and of each each unique lot within each unique
unique lot within each unique ship- shipment, of packaging and labels and,
ment); at a minimum, conduct a visual identi-
(2) Quality control personnel review fication of the immediate containers
and approve the results of any tests or and closures;
examinations conducted on compo- (2) Quality control personnel review
nents; and and approve the results of any tests or
(3) Quality control personnel approve examinations conducted on the pack-
the components for use in the manufac- aging and labels; and
ture of a dietary supplement, including (3) Quality control personnel approve
approval of any treatment (including the packaging and labels for use in the
in-process adjustments) of components manufacture of a dietary supplement
to make them suitable for use in the and release them from quarantine.
294
(d)(1) You must identify each unique (d)(1) You must identify each unique
lot within each unique shipment of lot within each unique shipment of re-
packaging and labels in a manner that ceived product in a manner that allows
allows you to trace the lot to the sup- you to trace the lot to the supplier, the
plier, the date received, the name of date received, the name of the received
the packaging and label, the status of product, the status of the received
the packaging and label (e.g., quar- product (e.g., quarantined, approved, or
antined, approved, or rejected); and to rejected), and to the product that you
the dietary supplement that you dis- packaged or labeled and distributed as
tributed; and a dietary supplement.
(2) You must use this unique identi- (2) You must use this unique identi-
fier whenever you record the disposi- fier whenever you record the disposi-
tion of each unique lot within each tion of each unique lot within each
unique shipment of packaging and la- unique shipment of the received prod-
bels. uct.
(e) You must hold packaging and la- (e) You must hold the received prod-
bels under conditions that will protect uct under conditions that will protect
against contamination and deteriora- against contamination and deteriora-
tion, and avoid mixups. tion, and avoid mixups.
§ 111.165 What requirements apply to a § 111.170 What requirements apply to

product received for packaging or rejected components, packaging,
labeling as a dietary supplement and labels, and to rejected products
(and for distribution rather than that are received for packaging or
for return to the supplier)? labeling as a dietary supplement?
(a) You must visually examine each You must clearly identify, hold, and
immediate container or grouping of control under a quarantine system for
immediate containers in a shipment of appropriate disposition any compo-
product that you receive for packaging nent, packaging, and label, and any
or labeling as a dietary supplement product that you receive for packaging
(and for distribution rather than for re- or labeling as a dietary supplement
turn to the supplier) for appropriate (and for distribution rather than for re-
content label, container damage, or turn to the supplier), that is rejected
broken seals to determine whether the and unsuitable for use in manufac-
container condition may have resulted turing, packaging, or labeling oper-
in contamination or deterioration of ations.
the received product.
(b) You must visually examine the § 111.180 Under this subpart G, what
supplier’s invoice, guarantee, or cer- records must you make and keep?
tification in a shipment of the received (a) You must make and keep records
product to ensure that the received required under this subpart G in ac-
product is consistent with your pur- cordance with subpart P of this part.
chase order. (b) You must make and keep the fol-
(c) You must quarantine the received lowing records:
product until: (1) Written procedures for fulfilling
(1) You collect representative sam- the requirements of this subpart.
ples of each unique shipment, and of (2) Receiving records (including
each unique lot within each unique records such as certificates of analysis,
shipment, of received product; suppliers’ invoices, and suppliers’ guar-
(2) Quality control personnel review antees) for components, packaging, and
and approve the documentation to de- labels and for products that you re-
termine whether the received product ceive for packaging or labeling as a di-
meets the specifications that you es- etary supplement (and for distribution
tablished under § 111.70(f); and rather than for return to the supplier);
(3) Quality control personnel approve and
the received product for packaging or (3) Documentation that the require-
labeling as a dietary supplement and ments of this subpart were met.

release the received product from quar- (i) The person who performs the re-
antine. quired operation must document, at
295
§ 111.205 21 CFR Ch. I (4–1–23 Edition)
the time of performance, that the re- § 111.210 What must the master manu-
quired operation was performed. facturing record include?
(ii) The documentation must include: The master manufacturing record
(A) The date that the components, must include:
packaging, labels, or products that you (a) The name of the dietary supple-
receive for packaging or labeling as a ment to be manufactured and the
dietary supplement were received; strength, concentration, weight, or
(B) The initials of the person per- measure of each dietary ingredient for
forming the required operation; each batch size;
(C) The results of any tests or exami- (b) A complete list of components to
nations conducted on components, be used;
packaging, or labels, and of any visual (c) An accurate statement of the
examination of product that you re- weight or measure of each component
ceive for packaging or labeling as a di- to be used;
etary supplement; and (d) The identity and weight or meas-
(D) Any material review and disposi- ure of each dietary ingredient that will
tion decision conducted on compo- be declared on the Supplement Facts
nents, packaging, labels, or products label and the identity of each ingre-
that you receive for packaging or la- dient that will be declared on the in-
gredients list of the dietary supple-
beling as a dietary supplement.
ment;
(e) A statement of any intentional
Subpart H—Production and Proc- overage amount of a dietary ingre-
ess Control System: Require- dient;
ments for the Master Manu- (f) A statement of theoretical yield of
facturing Record a manufactured dietary supplement ex-
pected at each point, step, or stage of
§ 111.205 What is the requirement to the manufacturing process where con-
establish a master manufacturing trol is needed to ensure the quality of
record? the dietary supplement, and the ex-
(a) You must prepare and follow a pected yield when you finish manufac-
written master manufacturing record turing the dietary supplement, includ-
for each unique formulation of dietary ing the maximum and minimum per-
supplement that you manufacture, and centages of theoretical yield beyond
which a deviation investigation of a
for each batch size, to ensure uni-
batch is necessary and material review
formity in the finished batch from
is conducted and disposition decision is
batch to batch.
made;
(b) The master manufacturing record (g) A description of packaging and a
must: representative label, or a cross-ref-
(1) Identify specifications for the erence to the physical location of the
points, steps, or stages in the manufac- actual or representative label;
turing process where control is nec- (h) Written instructions, including
essary to ensure the quality of the die- the following:
tary supplement and that the dietary (1) Specifications for each point,
supplement is packaged and labeled as step, or stage in the manufacturing
specified in the master manufacturing process where control is necessary to
record; and ensure the quality of the dietary sup-
(2) Establish controls and procedures plement and that the dietary supple-
to ensure that each batch of dietary ment is packaged and labeled as speci-
supplement that you manufacture fied in the master manufacturing
meets the specifications identified in record;
accordance with paragraph (b)(1) of (2) Procedures for sampling and a
this section. cross-reference to procedures for tests
(c) You must make and keep master or examinations;
manufacturing records in accordance (3) Specific actions necessary to per-

with subpart P of this part. form and verify points, steps, or stages
in the manufacturing process where
296
control is necessary to ensure the qual- (ii) Each lot of dietary supplement,
ity of the dietary supplement and that from the finished batch of dietary sup-
the dietary supplement is packaged plement, that you distribute to an-
and labeled as specified in the master other person for packaging or labeling;
manufacturing record. (b) The identity of equipment and
(i) Such specific actions must include processing lines used in producing the
verifying the weight or measure of any batch;
component and verifying the addition (c) The date and time of the mainte-
of any component; and nance, cleaning, and sanitizing of the
(ii) For manual operations, such spe- equipment and processing lines used in
cific actions must include: producing the batch, or a cross-ref-
(A) One person weighing or meas- erence to records, such as individual
uring a component and another person equipment logs, where this information
verifying the weight or measure; and is retained;
(B) One person adding the component (d) The unique identifier that you as-
and another person verifying the addi- signed to each component (or, when ap-
tion. plicable, to a product that you receive
(4) Special notations and precautions from a supplier for packaging or label-
to be followed; and ing as a dietary supplement), pack-
(5) Corrective action plans for use aging, and label used;
when a specification is not met.
(e) The identity and weight or meas-
ure of each component used;
Subpart I—Production and Process (f) A statement of the actual yield
Control System: Requirements and a statement of the percentage of
for the Batch Production theoretical yield at appropriate phases
Record of processing;
(g) The actual results obtained dur-
§ 111.255 What is the requirement to ing any monitoring operation;
establish a batch production
record? (h) The results of any testing or ex-
amination performed during the batch
(a) You must prepare a batch produc- production, or a cross-reference to such
tion record every time you manufac- results;
ture a batch of a dietary supplement; (i) Documentation that the finished
(b) Your batch production record dietary supplement meets specifica-
must include complete information re- tions established in accordance with
lating to the production and control of § 111.70(e) and (g);
each batch;
(j) Documentation, at the time of
(c) Your batch production record
performance, of the manufacture of the
must accurately follow the appropriate
batch, including:
master manufacturing record and you
must perform each step in the produc- (1) The date on which each step of the
tion of the batch; and master manufacturing record was per-
(d) You must make and keep batch formed; and
production records in accordance with (2) The initials of the persons per-
subpart P of this part. forming each step, including:
(i) The initials of the person respon-
§ 111.260 What must the batch record sible for weighing or measuring each
include? component used in the batch;
The batch production record must in- (ii) The initials of the person respon-
clude the following: sible for verifying the weight or meas-
(a) The batch, lot, or control number: ure of each component used in the
(1) Of the finished batch of dietary batch;
supplement; and (iii) The initials of the person respon-
(2) That you assign in accordance sible for adding the component to the
with § 111.415(f) for the following: batch; and
(i) Each lot of packaged and labeled (iv) The initials of the person respon-
dietary supplement from the finished sible for verifying the addition of com-
batch of dietary supplement; ponents to the batch;
297
§ 111.303 21 CFR Ch. I (4–1–23 Edition)
(k) Documentation, at the time of Subpart J—Production and Proc-

performance, of packaging and labeling ess Control System: Require-
operations, including: ments for Laboratory Oper-
(1) The unique identifier that you as- ations
signed to packaging and labels used,
the quantity of the packaging and la- § 111.303 What are the requirements
bels used, and, when label reconcili- under this subpart J for written
ation is required, reconciliation of any procedures?
discrepancies between issuance and use You must establish and follow writ-
of labels; ten procedures for laboratory oper-
(2) An actual or representative label, ations, including written procedures
or a cross-reference to the physical lo- for the tests and examinations that
cation of the actual or representative you conduct to determine whether
label specified in the master manufac- specifications are met.
turing record; and
(3) The results of any tests or exami- for the laboratory facilities that you
nations conducted on packaged and la- use?
beled dietary supplements (including
repackaged or relabeled dietary supple- You must use adequate laboratory fa-
cilities to perform whatever testing
ments), or a cross-reference to the
and examinations are necessary to de-
physical location of such results;
termine whether:
(l) Documentation at the time of per- (a) Components that you use meet
formance that quality control per- specifications;
sonnel: (b) In-process specifications are met
(1) Reviewed the batch production as specified in the master manufac-
record, including: turing record; and
(i) Review of any monitoring oper- (c) Dietary supplements that you
ation required under subpart E of this manufacture meet specifications.
part; and
(ii) Review of the results of any tests § 111.315 What are the requirements
and examinations, including tests and for laboratory control processes?
examinations conducted on compo- You must establish and follow lab-
nents, in-process materials, finished oratory control processes that are re-
batches of dietary supplements, and viewed and approved by quality control
packaged and labeled dietary supple- personnel, including the following:
ments; (a) Use of criteria for establishing ap-
(2) Approved or rejected any reproc- propriate specifications;
essing or repackaging; and (b) Use of sampling plans for obtain-
(3) Approved and released, or re- ing representative samples, in accord-
jected, the batch for distribution, in- ance with subpart E of this part, of:
cluding any reprocessed batch; and (1) Components, packaging, and la-
bels;
(4) Approved and released, or re-
(2) In-process materials;
jected, the packaged and labeled die-
(3) Finished batches of dietary sup-
tary supplement, including any repack-
plements;
aged or relabeled dietary supplement.
(4) Product that you receive for pack-
(m) Documentation at the time of aging or labeling as a dietary supple-
performance of any required material ment (and for distribution rather than
review and disposition decision. for return to the supplier); and
(n) Documentation at the time of (5) Packaged and labeled dietary sup-
performance of any reprocessing. plements.
(c) Use of criteria for selecting appro-
priate examination and testing meth-
ods;
(d) Use of criteria for selecting stand-

ard reference materials used in per-
forming tests and examinations; and
298
(e) Use of test methods and examina- § 111.355 What are the design require-
tions in accordance with established ments for manufacturing oper-
criteria. ations?
You must design or select manufac-
§ 111.320 What requirements apply to turing processes to ensure that product
laboratory methods for testing and specifications are consistently met.
examination?
(a) You must verify that the labora- § 111.360 What are the requirements
tory examination and testing meth- for sanitation?
odologies are appropriate for their in- You must conduct all manufacturing
tended use. operations in accordance with adequate
(b) You must identify and use an ap- sanitation principles.
propriate scientifically valid method § 111.365 What precautions must you
for each established specification for take to prevent contamination?
which testing or examination is re-
You must take all the necessary pre-
quired to determine whether the speci-
cautions during the manufacture of a
fication is met. dietary supplement to prevent con-
§ 111.325 Under this subpart J, what tamination of components or dietary
records must you make and keep? supplements. These precautions in-
clude:
(a) You must make and keep records (a) Performing manufacturing oper-
required under this subpart J in ac- ations under conditions and controls
cordance with subpart P of this part. that protect against the potential for
(b) You must make and keep the fol- growth of microorganisms and the po-
lowing records: tential for contamination;
(1) Written procedures for laboratory (b) Washing or cleaning components
operations, including written proce- that contain soil or other contami-
dures for the tests and examinations nants;
that you conduct to determine whether (c) Using water that, at a minimum,
specifications are met; complies with the applicable Federal,
(2) Documentation that laboratory State, and local requirements and does
not contaminate the dietary supple-
methodology established in accordance
ment when the water may become a
with this subpart J is followed.
component of the finished batch of die-
(i) The person who conducts the test- tary supplement;
ing and examination must document, (d) Performing chemical, micro-
at the time of performance, that lab- biological, or other testing, as nec-
oratory methodology established in ac- essary to prevent the use of contami-
cordance with this subpart J is fol- nated components;
lowed. (e) Sterilizing, pasteurizing, freezing,
(ii) The documentation for labora- refrigerating, controlling hydrogen-ion
tory tests and examinations must in- concentration (pH), controlling humid-
clude the results of the testing and ex- ity, controlling water activity (aw), or
amination. using any other effective means to re-
move, destroy, or prevent the growth
Subpart K—Production and Proc- of microorganisms and prevent decom-
position;
ess Control System: Require- (f) Holding components and dietary
ments for Manufacturing Op- supplements that can support the rapid
erations growth of microorganisms of public
health significance in a manner that
§ 111.353 What are the requirements prevents the components and dietary
under this subpart K for written supplements from becoming adulter-
procedures? ated;
You must establish and follow writ- (g) Identifying and holding any com-
ten procedures for manufacturing oper- ponents or dietary supplements, for

ations. which a material review and disposi-
tion decision is required, in a manner
299
§ 111.370 21 CFR Ch. I (4–1–23 Edition)
that protects components or dietary Subpart L—Production and Proc-

supplements that are not under a ma- ess Control System: Require-
terial review against contamination ments for Packaging and La-
and mixups with those that are under a beling Operations
material review;
(h) Performing mechanical manufac- § 111.403 What are the requirements
turing steps (such as cutting, sorting, under this subpart L for written
inspecting, shredding, drying, grinding, procedures?
blending, and sifting) by any effective You must establish and follow writ-
means to protect the dietary supple- ten procedures for packaging and label-
ments against contamination, by, for ing operations.
example:
(1) Cleaning and sanitizing contact § 111.410 What requirements apply to
surfaces; packaging and labels?
(2) Using temperature controls; and (a) You must take necessary actions
(3) Using time controls. to determine whether packaging for di-
(i) Using effective measures to pro- etary supplements meets specifications
tect against the inclusion of metal or so that the condition of the packaging
other foreign material in components will ensure the quality of your dietary
or dietary supplements, by, for exam- supplements;
ple: (b) You must control the issuance
(1) Filters or strainers, and use of packaging and labels and
reconciliation of any issuance and use
(2) Traps,
discrepancies. Label reconciliation is
(3) Magnets, or not required for cut or rolled labels if a
(4) Electronic metal detectors. 100-percent examination for correct la-
(j) Segregating and identifying all bels is performed by appropriate elec-
containers for a specific batch of die- tronic or electromechanical equipment
tary supplements to identify their con- during or after completion of finishing
tents and, when necessary, the phase of operations; and
manufacturing; and (c) You must examine, before pack-
(k) Identifying all processing lines aging and labeling operations, pack-
and major equipment used during man- aging and labels for each batch of die-
ufacturing to indicate their contents, tary supplement to determine whether
including the name of the dietary sup- the packaging and labels conform to
plement and the specific batch or lot the master manufacturing record; and
number and, when necessary, the phase (d) You must be able to determine
of manufacturing. the complete manufacturing history
and control of the packaged and la-
§ 111.370 What requirements apply to beled dietary supplement through dis-
rejected dietary supplements? tribution.
You must clearly identify, hold, and
control under a quarantine system for filling, assembling, packaging, la-
appropriate disposition any dietary beling, and related operations?
supplement that is rejected and unsuit-
You must fill, assemble, package,
able for use in manufacturing, pack-
label, and perform other related oper-
aging, or labeling operations. ations in a way that ensures the qual-
ity of the dietary supplement and that
§ 111.375 Under this subpart K, what
records must you make and keep? the dietary supplement is packaged
and labeled as specified in the master
(a) You must make and keep records manufacturing record. You must do
required under this subpart K in ac- this using any effective means, includ-
cordance with subpart P of this part. ing the following:
(b) You must make and keep records (a) Cleaning and sanitizing all filling
of the written procedures for manufac- and packaging equipment, utensils, and
turing operations. dietary supplement packaging, as ap-
propriate;
300
(b) Protecting manufactured dietary appropriate disposition any packaged

supplements from contamination, par- and labeled dietary supplement that is
ticularly airborne contamination; rejected for distribution.
(c) Using sanitary handling proce-
dures; § 111.430 Under this subpart L, what
(d) Establishing physical or spatial records must you make and keep?
separation of packaging and label oper- (a) You must make and keep records
ations from operations on other compo- required under this subpart L in ac-
nents and dietary supplements to pre- cordance with subpart P of this part.
vent mixups; (b) You must make and keep records
(e) Identifying, by any effective of the written procedures for packaging
means, filled dietary supplement con- and labeling operations.
tainers that are set aside and held in
unlabeled condition for future label op- Subpart M—Holding and
erations, to prevent mixups;
(f) Assigning a batch, lot, or control
Distributing
number to: § 111.453 What are the requirements
(1) Each lot of packaged and labeled under this subpart for M written
dietary supplement from a finished procedures?
batch of dietary supplement; and,
You must establish and follow writ-
(2) Each lot of dietary supplement,
ten procedures for holding and distrib-
from a finished batch of dietary supple-
uting operations.
ment, that you distribute to another
person for packaging or labeling. § 111.455 What requirements apply to
(g) Examining a representative sam- holding components, dietary sup-
ple of each batch of the packaged and plements, packaging, and labels?
labeled dietary supplement to deter-
(a) You must hold components and
mine whether the dietary supplement
dietary supplements under appropriate
meets specifications established in ac-
conditions of temperature, humidity,
cordance with § 111.70(g); and
and light so that the identity, purity,
(h) Suitably disposing of labels and
strength, and composition of the com-
packaging for dietary supplements that
ponents and dietary supplements are
are obsolete or incorrect to ensure that
they are not used in any future pack- not affected.
aging and label operations. (b) You must hold packaging and la-
bels under appropriate conditions so
§ 111.420 What requirements apply to that the packaging and labels are not
repackaging and relabeling? adversely affected.
(a) You may repackage or relabel die- (c) You must hold components, die-
tary supplements only after quality tary supplements, packaging, and la-
control personnel have approved such bels under conditions that do not lead
repackaging or relabeling. to the mixup, contamination, or dete-
(b) You must examine a representa- rioration of components, dietary sup-
tive sample of each batch of repack- plements, packaging, and labels.
aged or relabeled dietary supplements
to determine whether the repackaged holding in-process material?
or relabeled dietary supplements meet
all specifications established in accord- (a) You must identify and hold in-
ance with § 111.70(g). process material under conditions that
(c) Quality control personnel must protect against mixup, contamination,
approve or reject each batch of repack- and deterioration.
aged or relabeled dietary supplement (b) You must hold in-process mate-
prior to its release for distribution. rial under appropriate conditions of
temperature, humidity, and light.
§ 111.425 What requirements apply to a
packaged and labeled dietary sup- § 111.465 What requirements apply to
plement that is rejected for dis- holding reserve samples of dietary
tribution? supplements?
You must clearly identify, hold, and (a) You must hold reserve samples of
control under a quarantine system for dietary supplements in a manner that
301
§ 111.470 21 CFR Ch. I (4–1–23 Edition)
protects against contamination and de- § 111.510 What requirements apply

terioration. This includes: when a returned dietary supple-
(1) Holding the reserve samples under ment is received?
conditions consistent with product la- You must identify and quarantine re-
bels or, if no storage conditions are turned dietary supplements until qual-
recommended on the label, under ordi- ity control personnel conduct a mate-
nary storage conditions; and rial review and make a disposition de-
(2) Using the same container-closure cision.
system in which the packaged and la-
beled dietary supplement is distrib- § 111.515 When must a returned die-
uted, or if distributing dietary supple- tary supplement be destroyed, or
ments to be packaged and labeled, otherwise suitably disposed of?
using a container-closure system that You must destroy, or otherwise suit-
provides essentially the same charac- ably dispose of, any returned dietary
teristics to protect against contamina- supplement unless the outcome of a
tion or deterioration as the one in material review and disposition deci-
which you distribute the dietary sup- sion is that quality control personnel
plement for packaging and labeling do the following:
elsewhere. (a) Approve the salvage of the re-
(b) You must retain reserve samples turned dietary supplement for redis-
for 1 year past the shelf life date (if tribution or
shelf life dating is used), or for 2 years (b) Approve the returned dietary sup-
from the date of distribution of the last plement for reprocessing.
batch of dietary supplements associ-
ated with the reserve samples, for use § 111.520 When may a returned dietary
in appropriate investigations. supplement be salvaged?
You may salvage a returned dietary
§ 111.470 What requirements apply to supplement only if quality control per-
distributing dietary supplements?
sonnel conduct a material review and
You must distribute dietary supple- make a disposition decision to allow
ments under conditions that will pro- the salvage.
tect the dietary supplements against
contamination and deterioration. § 111.525 What requirements apply to a
returned dietary supplement that
§ 111.475 Under this subpart M, what quality control personnel approve
records must you make and keep? for reprocessing?
(a) You must make and keep records (a) You must ensure that any re-
required under this subpart M in ac- turned dietary supplements that are
cordance with subpart P of this part. reprocessed meet all product specifica-
(b) You must make and keep the fol- tions established in accordance with
lowing records: § 111.70(e); and
(1) Written procedures for holding (b) Quality control personnel must
and distributing operations; and approve or reject the release for dis-
(2) Records of product distribution. tribution of any returned dietary sup-
plement that is reprocessed.
Subpart N—Returned Dietary § 111.530 When must an investigation
Supplements be conducted of your manufac-
turing processes and other batches?
under this subpart N for written If the reason for a dietary supple-
procedures? ment being returned implicates other
batches, you must conduct an inves-
You must establish and follow writ-
tigation of your manufacturing proc-
ten procedures to fulfill the require-
esses and each of those other batches
ments of this subpart.

to determine compliance with speci-
fications.
302
§ 111.535 Under this subpart N, what ings and followup action of any inves-
records must you make and keep? tigation performed.
(a) You must make and keep records (c) The review and investigation of
required under this subpart N in ac- the product complaint by a qualified
cordance with subpart P of this part. person, and the review by quality con-
(b) You must make and keep the fol- trol personnel about whether to inves-
lowing records: tigate a product complaint, and the
(1) Written procedures for fulfilling findings and followup action of any in-
the requirements of this subpart N. vestigation performed, must extend to
(2) Any material review and disposi- all relevant batches and records.
tion decision on a returned dietary sup-
plement; § 111.570 Under this subpart O, what
(3) The results of any testing or ex- records must you make and keep?
amination conducted to determine (a) You must make and keep the
compliance with product specifications records required under this subpart O
established under § 111.70(e); and, in accordance with subpart P of this
(4) Documentation of the reevalua- part.
tion by quality control personnel of (b) You must make and keep the fol-
any dietary supplement that is reproc- lowing records:
essed and the determination by quality (1) Written procedures for fulfilling
control personnel of whether the re- the requirements of this subpart,
processed dietary supplement meets (2) A written record of every product
product specifications established in complaint that is related to good man-
accordance with § 111.70(e). ufacturing practice,
(i) The person who performs the re-
Subpart O—Product Complaints quirements of this subpart must docu-
ment, at the time of performance, that
§ 111.553 What are the requirements the requirement was performed.
under this subpart O for written (ii) The written record of the product
procedures?
complaint must include the following:
You must establish and follow writ- (A) The name and description of the
ten procedures to fulfill the require- dietary supplement;
ments of this subpart O. (B) The batch, lot, or control number
of the dietary supplement, if available;
the review and investigation of a (C) The date the complaint was re-
product complaint? ceived and the name, address, or tele-
phone number of the complainant, if
(a) A qualified person must:
available;
(1) Review all product complaints to
(D) The nature of the complaint in-
determine whether the product com-
cluding, if known, how the product was
plaint involves a possible failure of a
used;
dietary supplement to meet any of its
(E) The reply to the complainant, if
specifications, or any other require-
any; and
ments of this part 111, including those
specifications and other requirements (F) Findings of the investigation and
that, if not met, may result in a risk of followup action taken when an inves-
illness or injury; and tigation is performed.
(2) Investigate any product complaint
that involves a possible failure of a die- Subpart P—Records and
tary supplement to meet any of its Recordkeeping
specifications, or any other require-
ments of this part, including those § 111.605 What requirements apply to
specifications and other requirements the records that you make and
that, if not met, may result in a risk of keep?
illness or injury. (a) You must keep written records re-
(b) Quality control personnel must quired by this part for 1 year past the
review and approve decisions about shelf life date, if shelf life dating is
whether to investigate a product com- used, or 2 years beyond the date of dis-
plaint and review and approve the find- tribution of the last batch of dietary
303
§ 111.610 21 CFR Ch. I (4–1–23 Edition)
supplements associated with those 112.22 What minimum requirements apply

records. for training personnel who conduct a
(b) Records must be kept as original covered activity?
112.23 What requirements apply regarding
records, as true copies (such as photo-
supervisors?
copies, microfilm, microfiche, or other 112.30 Under this subpart, what require-
accurate reproductions of the original ments apply regarding records?
records), or as electronic records.
(c) All electronic records must com- Subpart D—Health and Hygiene
ply with part 11 of this chapter.
112.31 What measures must I take to pre-
§ 111.610 What records must be made vent ill or infected persons from con-
available to FDA? taminating covered produce with micro-
organisms of public health significance?
(a) You must have all records re- 112.32 What hygienic practices must per-
quired under this part, or copies of sonnel use?
such records, readily available during 112.33 What measures must I take to pre-
the retention period for inspection and vent visitors from contaminating cov-
copying by FDA when requested. ered produce and food contact surfaces
(b) If you use reduction techniques, with microorganisms of public health
significance?
such as microfilming, you must make
suitable reader and photocopying Subpart E—Agricultural Water
equipment readily available to FDA.
112.41 What requirements apply to the qual-
ity of agricultural water?
PART 112—STANDARDS FOR THE 112.42 What requirements apply to my agri-
GROWING, HARVESTING, PACK- cultural water sources, water distribu-
ING, AND HOLDING OF tion system, and pooling of water?
PRODUCE FOR HUMAN CON- 112.43 What requirements apply to treating
agricultural water?
SUMPTION 112.44 What specific microbial quality cri-
teria apply to agricultural water used for
Subpart A—General Provisions certain intended uses?
Sec. 112.45 What measures must I take if my ag-
112.1 What food is covered by this part? ricultural water does not meet the re-
112.2 What produce is not covered by this quirements of § 112.41 or § 112.44?
part? 112.46 How often must I test agricultural
112.3 What definitions apply to this part? water that is subject to the requirements
112.4 Which farms are subject to the re- of § 112.44?
quirements of this part? 112.47 Who must perform the tests required
112.5 Which farms are eligible for a quali- under § 112.46 and what methods must be
fied exemption and associated modified used?
requirements based on average monetary 112.48 What measures must I take for water
value of all food sold and direct farm that I use during harvest, packing, and
marketing? holding activities for covered produce?
112.6 What modified requirements apply to 112.49 What alternatives may I establish
me if my farm is eligible for a qualified and use in lieu of the requirements of
exemption in accordance with § 112.5? this subpart?
112.7 What records must I establish and 112.50 Under this subpart, what require-
keep if my farm is eligible for a qualified ments apply regarding records?
exemption in accordance with § 112.5?
Subpart F—Biological Soil Amendments of
Subpart B—General Requirements Animal Origin and Human Waste
112.11 What general requirements apply to 112.51 What requirements apply for deter-
persons who are subject to this part? mining the status of a biological soil
112.12 Are there any alternatives to the re- amendment of animal origin?
quirements established in this part? 112.52 How must I handle, convey, and store
biological soil amendments of animal or-
Subpart C—Personnel Qualifications and igin?
Training 112.53 What prohibitions apply regarding
use of human waste?
112.21 What requirements apply regarding 112.54 What treatment processes are accept-
qualifications and training for personnel able for a biological soil amendment of
who handle (contact) covered produce or animal origin that I apply in the growing
food contact surfaces? of covered produce?
304
112.55 What microbial standards apply to 112.127 What requirements apply regarding
the treatment processes in § 112.54? domesticated animals in and around a
112.56 What application requirements and fully-enclosed building?
minimum application intervals apply to 112.128 What requirements apply regarding
biological soil amendments of animal or- pest control in buildings?
igin? 112.129 What requirements apply to toilet
112.60 Under this subpart, what require- facilities?
ments apply regarding records? 112.130 What requirements apply for hand-
washing facilities?
Subpart G–H [Reserved] 112.131 What must I do to control and dis-
pose of sewage?
Subpart I—Domesticated and Wild Animals 112.132 What must I do to control and dis-
112.81 How do the requirements of this sub- pose of trash, litter, and waste in areas
part apply to areas where covered activi- used for covered activities?
ties take place? 112.133 What requirements apply to plumb-
112.83 What requirements apply regarding ing?
grazing animals, working animals, and 112.134 What must I do to control animal
animal intrusion? excreta and litter from domesticated ani-
112.84 Does this regulation require covered mals that are under my control?
farms to take actions that would con- 112.140 Under this subpart, what require-
stitute a ‘‘taking’’ of threatened or en- ments apply regarding records?
dangered species; to take measures to ex-
clude animals from outdoor growing Subpart M—Sprouts
areas; or to destroy animal habitat or
otherwise clear farm borders around out- 112.141 What commodities are subject to
door growing areas or drainages? this subpart?
112.142 What requirements apply to seeds or
Subpart J [Reserved] beans used to grow sprouts?
112.143 What measures must I take for
Subpart K—Growing, Harvesting, Packing, growing, harvesting, packing, and hold-
and Holding Activities ing sprouts?
112.144 What testing must I do during grow-
112.111 What measures must I take if I grow, ing, harvesting, packing, and holding
harvest, pack or hold both covered and sprouts?
excluded produce?
112.145 What requirements apply to testing
112.112 What measures must I take imme-
the environment for Listeria species or L.
diately prior to and during harvest ac-
monocytogenes?
tivities?
112.113 How must I handle harvested cov- 112.146 What actions must I take if the
ered produce during covered activities? growing, harvesting, packing, or holding
112.114 What requirements apply to dropped environment tests positive for Listeria
covered produce? species or L. monocytogenes?
112.115 What measures must I take when 112.147 What must I do to collect and test
packaging covered produce? samples of spent sprout irrigation water
112.116 What measures must I take when or sprouts for pathogens?
using food-packing (including food pack- 112.148 What actions must I take if the sam-
aging) material? ples of spent sprout irrigation water or
sprouts test positive for a pathogen?
Subpart L—Equipment, Tools, Buildings, 112.150 Under this subpart, what require-
and Sanitation ments apply regarding records?
112.121 What equipment and tools are sub- Subpart N—Analytical Methods
ject to the requirements of this subpart?
112.122 What buildings are subject to the re- 112.151 What methods must I use to test the
quirements of this subpart? quality of water to satisfy the require-
112.123 What requirements apply regarding ments of § 112.46?
equipment and tools subject to this sub- 112.152 What methods must I use to test the
part? growing, harvesting, packing, and hold-
112.124 What requirements apply to instru- ing environment for Listeria species or L.
ments and controls used to measure, reg- monocytogenes to satisfy the require-
ulate, or record? ments of § 112.144(a)?
112.125 What requirements apply to equip- 112.153 What methods must I use to test
ment that is subject to this subpart used spent sprout irrigation water (or sprouts)
in the transport of covered produce? from each production batch of sprouts

112.126 What requirements apply to my for pathogens to satisfy the requirements
buildings? of § 112.144(b) and (c)?
305
§ 112.1 21 CFR Ch. I (4–1–23 Edition)
Subpart O—Records 112.204 What must I do if I receive an order

to withdraw a qualified exemption appli-
112.161 What general requirements apply to cable to my farm?
records required under this part? 112.205 Can I appeal or request a hearing on
112.162 Where must I store records? an order to withdraw a qualified exemp-
112.163 May I use existing records to satisfy tion applicable to my farm?
the requirements of this part? 112.206 What is the procedure for submitting
112.164 How long must I keep records? an appeal?
112.165 What formats are acceptable for the 112.207 What is the procedure for requesting
records I keep? an informal hearing?
112.166 What requirements apply for making 112.208 What requirements are applicable to
records available and accessible to FDA? an informal hearing?
112.167 Can records that I provide to FDA be 112.209 Who is the presiding officer for an
appeal and for an informal hearing?
disclosed to persons outside of FDA?
112.210 What is the timeframe for issuing a
decision on an appeal?
Subpart P—Variances 112.211 When is an order to withdraw a
112.171 Who may request a variance from qualified exemption applicable to a farm
the requirements of this part? revoked?
112.172 How may a State, tribe, or foreign 112.213 If my qualified exemption is with-
country request a variance from one or drawn, under what circumstances would
more requirements of this part? FDA reinstate my qualified exemption?
112.173 What must be included in the State- AUTHORITY: 21 U.S.C. 321, 331, 342, 350h, 371;
ment of Grounds in a petition requesting 42 U.S.C. 243, 264, 271.
a variance?
SOURCE: 80 FR 74547, Nov. 27, 2015, unless
112.174 What information submitted in a pe-
otherwise noted.
tition requesting a variance or submitted
in comments on such a petition are pub- EDITORIAL NOTE: Nomenclature changes to
licly available? part 112 appear at 81 FR 49896, July 29, 2016.
112.175 Who responds to a petition request-
ing a variance? Subpart A—General Provisions
112.176 What process applies to a petition
requesting a variance? § 112.1 What food is covered by this
112.177 Can an approved variance apply to part?
any person other than those identified in
the petition requesting that variance? (a) Unless it is excluded from this
112.178 Under what circumstances may FDA part under § 112.2, food that is produce
deny a petition requesting a variance? within the meaning of this part and
112.179 When does a variance approved by that is a raw agricultural commodity
FDA become effective? (RAC) is covered by this part. This in-
112.180 Under what circumstances may FDA cludes a produce RAC that is grown do-
modify or revoke an approved variance? mestically and a produce RAC that will
112.181 What procedures apply if FDA deter-
be imported or offered for import in
mines that an approved variance should
be modified or revoked? any State or territory of the United
112.182 What are the permissible types of States, the District of Columbia, or the
variances that may be granted? Commonwealth of Puerto Rico.
(b) For the purpose of this part and
Subpart Q—Compliance and Enforcement subject to the exemptions and qualified
exemptions therein, covered produce
112.192 What is the applicability and status
includes all of the following:
of this part?
112.193 What are the provisions for coordi-
(1) Fruits and vegetables such as al-
nation of education and enforcement? monds, apples, apricots, apriums, Arti-
chokes-globe-type, Asian pears, avoca-
Subpart R—Withdrawal of Qualified dos, babacos, bananas, Belgian endive,
Exemption blackberries, blueberries, boysen-
berries, brazil nuts, broad beans, broc-
112.201 Under what circumstances can FDA coli, Brussels sprouts, burdock, cab-
withdraw a qualified exemption in ac-
bages, Chinese cabbages (Bok Choy,
cordance with the requirements of § 112.5?
112.202 What procedure will FDA use to
mustard, and Napa), cantaloupes,
withdraw an exemption? carambolas, carrots, cauliflower,
112.203 What information must FDA include celeriac, celery, chayote fruit, cherries
in an order to withdraw a qualified ex- (sweet), chestnuts, chicory (roots and
emption? tops), citrus (such as clementine,
306
grapefruit, lemons, limes, mandarin, cept as noted in paragraphs (b)(1), (2),

oranges, tangerines, tangors, and uniq and (3) of this section) under the fol-
fruit), cowpea beans, cress-garden, cu- lowing conditions:
cumbers, curly endive, currants, dan- (1) The produce receives commercial
delion leaves, fennel-Florence, garlic, processing that adequately reduces the
genip, gooseberries, grapes, green presence of microorganisms of public
beans, guavas, herbs (such as basil, health significance. Examples of com-
chives, cilantro, oregano, and parsley), mercial processing that adequately re-
honeydew, huckleberries, Jerusalem duces the presence of microorganisms
artichokes, kale, kiwifruit, kohlrabi, of public health significance are proc-
kumquats, leek, lettuce, lychees, mac-
essing in accordance with the require-
adamia nuts, mangos, other melons
ments of part 113, 114, or 120 of this
(such as Canary, Crenshaw and Per-
sian), mulberries, mushrooms, mustard chapter, treating with a validated proc-
greens, nectarines, onions, papayas, ess to eliminate spore-forming micro-
parsnips, passion fruit, peaches, pears, organisms (such as processing to
peas, peas-pigeon, peppers (such as bell produce tomato paste or shelf-stable
and hot), pine nuts, pineapples, plan- tomatoes), and processing such as re-
tains, plums, plumcots, quince, rad- fining, distilling, or otherwise manu-
ishes, raspberries, rhubarb, rutabagas, facturing/processing produce into prod-
scallions, shallots, snow peas, soursop, ucts such as sugar, oil, spirits, wine,
spinach, sprouts (such as alfalfa and beer or similar products; and
mung bean), strawberries, summer (2) You must disclose in documents
squash (such as patty pan, yellow and accompanying the produce, in accord-
zucchini), sweetsop, Swiss chard, taro, ance with the practice of the trade,
tomatoes, turmeric, turnips (roots and that the food is ‘‘not processed to ade-
tops), walnuts, watercress, water- quately reduce the presence of micro-
melons, and yams; and organisms of public health signifi-
(2) Mixes of intact fruits and vegeta- cance;’’ and
bles (such as fruit baskets). (3) You must either:
§ 112.2 What produce is not covered by (i) Annually obtain written assur-
this part? ance, subject to the requirements of
(a) The following produce is not cov- paragraph (b)(6) of this section, from
ered by this part: the customer that performs the com-
(1) Produce that is rarely consumed mercial processing described in para-
raw, specifically the produce on the graph (b)(1) of this section that the
following exhaustive list: Asparagus; customer has established and is fol-
beans, black; beans, great Northern; lowing procedures (identified in the
beans, kidney; beans, lima; beans, written assurance) that adequately re-
navy; beans, pinto; beets, garden (roots duce the presence of microorganisms of
and tops); beets, sugar; cashews; cher- public health significance; or
ries, sour; chickpeas; cocoa beans; cof- (ii) Annually obtain written assur-
fee beans; collards; corn, sweet; cran- ance, subject to the requirements of
berries; dates; dill (seeds and weed); paragraph (b)(6) of this section, from
eggplants; figs; ginger; hazelnuts; your customer that an entity in the
horseradish; lentils; okra; peanuts; pe- distribution chain subsequent to the
cans; peppermint; potatoes; pumpkins; customer will perform commercial
squash, winter; sweet potatoes; and processing described in paragraph (b)(1)
water chestnuts. of this section and that the customer:
(2) Produce that is produced by an in- (A) Will disclose in documents ac-
dividual for personal consumption or companying the food, in accordance
produced for consumption on the farm
with the practice of the trade, that the
or another farm under the same man-
food is ‘‘not processed to adequately re-
agement; and
(3) Produce that is not a raw agricul- duce the presence of microorganisms of
public health significance’’; and
tural commodity.
(b) Produce is eligible for exemption (B) Will only sell to another entity
from the requirements of this part (ex- that agrees, in writing, it will either:
307
§ 112.3 21 CFR Ch. I (4–1–23 Edition)
(1) Follow procedures (identified in a ganic matter, and soluble chemical

written assurance) that adequately re- components into an aqueous phase. Ag-
duce the presence of microorganisms of ricultural teas are held for longer than
public health significance; or one hour before application. Agricul-
(2) Obtain a similar written assur- tural teas are soil amendments for the
ance from its customer that the purposes of this rule.
produce will receive commercial proc- Agricultural tea additive means a nu-
essing described in paragraph (b)(1) of trient source (such as molasses, yeast
this section, and that there will be dis- extract, or algal powder) added to agri-
closure in documents accompanying cultural tea to increase microbial bio-
the food, in accordance with the prac- mass.
tice of the trade, that the food is ‘‘not Agricultural water means water used
processed to adequately reduce the in covered activities on covered
presence of microorganisms of public produce where water is intended to, or
health significance’’; and is likely to, contact covered produce or
(4) You must establish and maintain food contact surfaces, including water
documentation of your compliance used in growing activities (including
with applicable requirements in para- irrigation water applied using direct
graphs (b)(2) and (3) in accordance with water application methods, water used
the requirements of subpart O of this for preparing crop sprays, and water
part, including: used for growing sprouts) and in har-
(i) Documents containing disclosures vesting, packing, and holding activities
required under paragraph (b)(2) of this (including water used for washing or
section; and cooling harvested produce and water
(ii) Annual written assurances ob- used for preventing dehydration of cov-
tained from customers required under ered produce).
paragraph (b)(3) of this section; and Animal excreta means solid or liquid
(5) The requirements of this subpart animal waste.
and subpart Q of this part apply to Application interval means the time
such produce; and interval between application of an ag-
(6) An entity that provides a written ricultural input (such as a biological
assurance under § 112.2(b)(3)(i) or (ii) soil amendment of animal origin) to a
must act consistently with the assur- growing area and harvest of covered
ance and document its actions taken to produce from the growing area where
satisfy the written assurance. the agricultural input was applied.
Biological soil amendment means any
§ 112.3 What definitions apply to this soil amendment containing biological
part? materials such as stabilized compost,
The definitions and interpretations manure, non-fecal animal byproducts,
of terms in section 201 of the Federal peat moss, pre-consumer vegetative
Food, Drug, and Cosmetic Act apply to waste, sewage sludge biosolids, table
such terms when used in this part. The waste, agricultural tea, or yard trim-
following definitions also apply: mings, alone or in combination.
Adequate means that which is needed Biological soil amendment of animal ori-
to accomplish the intended purpose in gin means a biological soil amendment
keeping with good public health prac- which consists, in whole or in part, of
tice. materials of animal origin, such as ma-
Adequately reduce microorganisms of nure or non-fecal animal byproducts
public health significance means reduce including animal mortalities, or table
the presence of such microorganisms to waste, alone or in combination. The
an extent sufficient to prevent illness. term ‘‘biological soil amendment of
Agricultural tea means a water ex- animal origin’’ does not include any
tract of biological materials (such as form of human waste.
stabilized compost, manure, non-fecal Composting means a process to
animal byproducts, peat moss, pre-con- produce stabilized compost in which or-
sumer vegetative waste, table waste, or ganic material is decomposed by the
yard trimmings), excluding any form of actions of microorganisms under

human waste, produced to transfer mi- thermophilic conditions for a des-
crobial biomass, fine particulate or- ignated period of time (for example, 3
308
days) at a designated temperature (for such activities is either consumed on

example, 131 °F (55 °C)), followed by a that farm or another farm under the
curing stage under cooler conditions. same management, or is processed food
Covered activity means growing, har- identified in paragraph (1)(iii)(B)(1) of
vesting, packing, or holding covered this definition; and
produce on a farm. Covered activity in- (iii) Manufacture/process food, pro-
cludes manufacturing/processing of vided that:
covered produce on a farm, but only to (A) All food used in such activities is
the extent that such activities are per- consumed on that farm or another
formed on raw agricultural commod- farm under the same management; or
ities and only to the extent that such (B) Any manufacturing/processing of
activities are within the meaning of food that is not consumed on that farm
‘‘farm’’ as defined in this chapter. Pro- or another farm under the same man-
viding, acting consistently with, and agement consists only of:
documenting actions taken in compli-
(1) Drying/dehydrating raw agricul-
ance with written assurances as de-
tural commodities to create a distinct
scribed in § 112.2(b) are also covered ac-
commodity (such as drying/dehy-
tivities. This part does not apply to ac-
drating grapes to produce raisins), and
tivities of a facility that are subject to
packaging and labeling such commod-
part 117 of this chapter.
ities, without additional manufac-
Covered produce means produce that
turing/processing (an example of addi-
is subject to the requirements of this
tional manufacturing/processing is
part in accordance with §§ 112.1 and
slicing);
112.2. The term ‘‘covered produce’’ re-
fers to the harvestable or harvested (2) Treatment to manipulate the rip-
part of the crop. ening of raw agricultural commodities
Curing means the final stage of (such as by treating produce with
composting, which is conducted after ethylene gas), and packaging and label-
much of the readily metabolized bio- ing treated raw agricultural commod-
logical material has been decomposed, ities, without additional manufac-
at cooler temperatures than those in turing/processing; and
the thermophilic phase of composting, (3) Packaging and labeling raw agri-
to further reduce pathogens, promote cultural commodities, when these ac-
further decomposition of cellulose and tivities do not involve additional man-
lignin, and stabilize composition. Cur- ufacturing/processing (an example of
ing may or may not involve insulation, additional manufacturing/processing is
depending on environmental condi- irradiation); or
tions. (2) Secondary activities farm. A sec-
Direct water application method means ondary activities farm is an operation,
using agricultural water in a manner not located on a primary production
whereby the water is intended to, or is farm, devoted to harvesting (such as
likely to, contact covered produce or hulling or shelling), packing, and/or
food contact surfaces during use of the holding of raw agricultural commod-
water. ities, provided that the primary pro-
Farm means: duction farm(s) that grows, harvests,
(1) Primary production farm. A pri- and/or raises the majority of the raw
mary production farm is an operation agricultural commodities harvested,
under one management in one general packed, and/or held by the secondary
(but not necessarily contiguous) phys- activities farm owns, or jointly owns, a
ical location devoted to the growing of majority interest in the secondary ac-
crops, the harvesting of crops, the rais- tivities farm. A secondary activities
ing of animals (including seafood), or farm may also conduct those addi-
any combination of these activities. tional activities allowed on a primary
The term ‘‘farm’’ includes operations production farm as described in para-
that, in addition to these activities: graphs (1)(ii) and (iii) of this definition.
(i) Pack or hold raw agricultural Food means food as defined in section
commodities; 201(f) of the Federal Food, Drug, and

(ii) Pack or hold processed food, pro- Cosmetic Act and includes seeds and
vided that all processed food used in beans used to grow sprouts.
309
§ 112.3 21 CFR Ch. I (4–1–23 Edition)
Food contact surfaces means those dental to storage of a food (e.g., activi-
surfaces that contact human food and ties performed for the safe or effective
those surfaces from which drainage, or storage of that food, such as fumigat-
other transfer, onto the food or onto ing food during storage, and drying/de-
surfaces that contact the food ordi- hydrating raw agricultural commod-
narily occurs during the normal course ities when the drying/dehydrating does
of operations. ‘‘Food contact surfaces’’ not create a distinct commodity (such
includes food contact surfaces of equip- as drying/dehydrating hay or alfalfa)).
ment and tools used during harvest, Holding also includes activities per-
packing and holding. formed as a practical necessity for the
Ground water means the supply of distribution of that food (such as
fresh water found beneath the Earth’s blending of the same raw agricultural
surface, usually in aquifers, which sup- commodity and breaking down pallets),
ply wells and springs. Ground water but does not include activities that
does not include any water that meets transform a raw agricultural com-
the definition of surface water. modity into a processed food as defined
Growth media means material that in section 201(gg) of the Federal Food,
acts as a substrate during the growth Drug, and Cosmetic Act. Holding facili-
of covered produce (such as mushrooms ties could include warehouses, cold
and some sprouts) that contains, may storage facilities, storage silos, grain
contain, or consists of components that elevators, and liquid storage tanks.
may include any animal waste (such as Known or reasonably foreseeable haz-
stabilized compost, manure, non-fecal ard means a biological hazard that is
animal byproducts or table waste). known to be, or has the potential to be,
Harvesting applies to farms and farm associated with the farm or the food.
mixed-type facilities and means activi-
Manufacturing/processing means mak-
ties that are traditionally performed
ing food from one or more ingredients,
on farms for the purpose of removing
or synthesizing, preparing, treating,
raw agricultural commodities from the
modifying or manipulating food, in-
place they were grown or raised and
cluding food crops or ingredients. Ex-
preparing them for use as food. Har-
amples of manufacturing/processing ac-
vesting is limited to activities per-
tivities include: Baking, boiling, bot-
formed on raw agricultural commod-
ities, or on processed foods created by tling, canning, cooking, cooling, cut-
drying/dehydrating a raw agricultural ting, distilling, drying/dehydrating raw
commodity without additional manu- agricultural commodities to create a
facturing/processing, on a farm. Har- distinct commodity (such as drying/de-
vesting does not include activities that hydrating grapes to produce raisins),
transform a raw agricultural com- evaporating, eviscerating, extracting
modity into a processed food as defined juice, formulating, freezing, grinding,
in section 201(gg) of the Federal Food, homogenizing, labeling, milling, mix-
Drug, and Cosmetic Act. Examples of ing, packaging (including modified at-
harvesting include cutting (or other- mosphere packaging), pasteurizing,
wise separating) the edible portion of peeling, rendering, treating to manipu-
the raw agricultural commodity from late ripening, trimming, washing, or
the crop plant and removing or trim- waxing. For farms and farm mixed-type
ming part of the raw agricultural com- facilities, manufacturing/processing
modity (e.g., foliage, husks, roots or does not include activities that are
stems). Examples of harvesting also in- part of harvesting, packing, or holding.
clude cooling, field coring, filtering, Manure means animal excreta, alone
gathering, hulling, shelling, sifting, or in combination with litter (such as
threshing, trimming of outer leaves of, straw and feathers used for animal bed-
and washing raw agricultural commod- ding) for use as a soil amendment.
ities grown on a farm. Microorganisms means yeasts, molds,
Hazard means any biological agent bacteria, viruses, protozoa, and micro-
that has the potential to cause illness scopic parasites and includes species
or injury in the absence of its control. having public health significance. The
Holding means storage of food and term ‘‘undesirable microorganisms’’ in-
also includes activities performed inci- cludes those microorganisms that are
310
of public health significance, that sub- with an end user (consumer). Pre-con-
ject food to decomposition, that indi- sumer vegetative waste includes mate-
cate that food is contaminated with rial generated by farms, packing
filth, or that otherwise may cause food houses, canning operations, wholesale
to be adulterated. distribution centers and grocery stores;
Mixed-type facility means an estab- products that have been removed from
lishment that engages in both activi- their packaging (such as out-of-date
ties that are exempt from registration juice, vegetables, condiments, and
under section 415 of the Federal Food, bread); and associated packaging that
Drug, and Cosmetic Act and activities is vegetative in origin (such as paper or
that require the establishment to be corn-starch based products). Pre-con-
registered. An example of such a facil- sumer vegetative waste does not in-
ity is a ‘‘farm mixed-type facility,’’ clude table waste, packaging that has
which is an establishment that is a come in contact with materials (such
farm, but that also conducts activities as meat) that are not vegetative in ori-
outside the farm definition that re- gin, or any waste generated by res-
quire the establishment to be reg- taurants.
istered. Produce means any fruit or vegetable
Monitor means to conduct a planned (including mixes of intact fruits and
sequence of observations or measure- vegetables) and includes mushrooms,
ments to assess whether a process, sprouts (irrespective of seed source),
point or procedure is under control peanuts, tree nuts, and herbs. A fruit is
and, when required, to produce an ac- the edible reproductive body of a seed
curate record of the observation or plant or tree nut (such as apple, or-
measurement. ange, and almond) such that fruit
Non-fecal animal byproduct means means the harvestable or harvested
solid waste (other than manure) that is part of a plant developed from a flower.
animal in origin (such as meat, fat, A vegetable is the edible part of an her-
dairy products, eggs, carcasses, blood baceous plant (such as cabbage or po-
meal, bone meal, fish meal, shellfish tato) or fleshy fruiting body of a fun-
waste (such as crab, shrimp, and lob- gus (such as white button or shiitake)
ster waste), fish emulsions, and offal) grown for an edible part such that veg-
and is generated by commercial, insti- etable means the harvestable or har-
tutional, or agricultural operations. vested part of any plant or fungus
Packing means placing food into a whose fruit, fleshy fruiting bodies,
container other than packaging the seeds, roots, tubers, bulbs, stems,
food and also includes re-packing and leaves, or flower parts are used as food
activities performed incidental to and includes mushrooms, sprouts, and
packing or re-packing a food (e.g., ac- herbs (such as basil or cilantro).
tivities performed for the safe or effec- Produce does not include food grains
tive packing or re-packing of that food meaning the small, hard fruits or seeds
(such as sorting, culling, grading, and of arable crops, or the crops bearing
weighing or conveying incidental to these fruits or seeds, that are primarily
packing or re-packing)), but does not grown and processed for use as meal,
include activities that transform a raw flour, baked goods, cereals and oils
agricultural commodity into a proc- rather than for direct consumption as
essed food as defined in section 201(gg) small, hard fruits or seeds (including
of the Federal Food, Drug, and Cos- cereal grains, pseudo cereals, oilseeds
metic Act. and other plants used in the same fash-
Pest means any objectionable ani- ion). Examples of food grains include
mals or insects, including birds, ro- barley, dent- or flint-corn, sorghum,
dents, flies, and larvae. oats, rice, rye, wheat, amaranth,
Pre-consumer vegetative waste means quinoa, buckwheat, and oilseeds (e.g.,
solid waste that is purely vegetative in cotton seed, flax seed, rapeseed, soy-
origin, not considered yard trash, and bean, and sunflower seed).
derived from commercial, institu- Production batch of sprouts means all
tional, or agricultural operations with- sprouts that are started at the same
out coming in contact with animal time in a single growing unit (e.g., a
products, byproducts or manure or single drum or bin, or a single rack of
311
§ 112.3 21 CFR Ch. I (4–1–23 Edition)
trays that are connected to each substrate during the growth of covered
other), whether or not the sprouts are produce (such as mushrooms and some
grown from a single lot of seed (includ- sprouts).
ing, for example, when multiple types Spent sprout irrigation water means
of seeds are grown in a single growing water that has been used in the grow-
unit). ing of sprouts.
Qualified end-user, with respect to a Stabilized compost means a stabilized
food, means the consumer of the food (i.e., finished) biological soil amend-
(where the term consumer does not in- ment produced through a controlled
clude a business); or a restaurant or re- composting process.
tail food establishment (as those terms Static composting means a process to
are defined in § 1.227) that is located: produce stabilized compost in which air
(1) In the same State or the same In- is introduced into biological material
dian reservation as the farm that pro- (in a pile (or row) that may or may not
duced the food; or be covered with insulating material, or
(2) Not more than 275 miles from such in an enclosed vessel) by a mechanism
farm. that does not include turning. Exam-
Raw agricultural commodity (RAC) ples of structural features for intro-
means ‘‘raw agricultural commodity’’ ducing air include embedded perforated
as defined in section 201(r) of the Fed- pipes and a constructed permanent
eral Food, Drug, and Cosmetic Act. base that includes aeration slots. Ex-
Sanitize means to adequately treat amples of mechanisms for introducing
cleaned surfaces by a process that is ef- air include passive diffusion and me-
fective in destroying vegetative cells of chanical means (such as blowers that
microorganisms of public health sig- suction air from the composting mate-
nificance, and in substantially reduc- rial or blow air into the composting
ing numbers of other undesirable material using positive pressure).
microorganisms, but without adversely Surface water means all water open to
affecting the product or its safety for the atmosphere (rivers, lakes, res-
the consumer. ervoirs, streams, impoundments, seas,
Sewage sludge biosolids means the estuaries, etc.) and all springs, wells,
solid or semi-solid residue generated or other collectors that are directly in-
during the treatment of domestic sew- fluenced by surface water.
age in a treatment works within the Table waste means any post-consumer
meaning of the definition of ‘‘sewage food waste, irrespective of whether the
sludge’’ in 40 CFR 503.9(w). source material is animal or vegetative
Small business means a farm that is in origin, derived from individuals, in-
subject to any of the requirements of stitutions, restaurants, retail oper-
this part and, on a rolling basis, the av- ations, or other sources where the food
erage annual monetary value of has been served to a consumer.
produce (as defined in this section) the Turned composting means a process to
farm sold during the previous 3-year produce stabilized compost in which air
period is no more than $500,000; and the is introduced into biological material
farm is not a very small business as de- (in a pile, row, or enclosed vessel) by
fined in this section. turning on a regular basis. Turning is
Soil amendment means any chemical, the process of mechanically mixing bi-
biological, or physical material (such ological material that is undergoing a
as elemental fertilizers, stabilized com- composting process with the specific
post, manure, non-fecal animal byprod- intention of moving the outer, cooler
ucts, peat moss, perlite, pre-consumer sections of the material being
vegetative waste, sewage sludge bio- composted to the inner, hotter sec-
solids, table waste, agricultural tea tions.
and yard trimmings) intentionally Very small business means a farm that
added to the soil to improve the chem- is subject to any of the requirements of
ical or physical condition of soil in re- this part and, on a rolling basis, the av-
lation to plant growth or to improve erage annual monetary value of
the capacity of the soil to hold water. produce (as defined in this section) the
The term soil amendment also includes farm sold during the previous 3-year
growth media that serve as the entire period is no more than $250,000.
312
Visitor means any person (other than § 112.5 Which farms are eligible for a
personnel) who enters your covered qualified exemption and associated
farm with your permission. modified requirements based on av-
Water distribution system means a sys- erage monetary value of all food
sold and direct farm marketing?
tem to carry water from its primary
source to its point of use, including (a) A farm is eligible for a qualified
pipes, sprinklers, irrigation canals, exemption and associated modified re-
pumps, valves, storage tanks, res- quirements in a calendar year if:
ervoirs, meters, and fittings. (1) During the previous 3-year period
preceding the applicable calendar year,
We means the U.S. Food and Drug
the average annual monetary value of
Administration (FDA).
the food (as defined in § 112.3) the farm
Yard trimmings means purely vegeta- sold directly to qualified end-users (as
tive matter resulting from landscaping defined in § 112.3) during such period ex-
maintenance or land clearing oper- ceeded the average annual monetary
ations, including materials such as tree value of the food the farm sold to all
and shrub trimmings, grass clippings, other buyers during that period; and
palm fronds, trees, tree stumps, un- (2) The average annual monetary
treated lumber, untreated wooden pal- value of all food (as defined in § 112.3)
lets, and associated rocks and soils. the farm sold during the 3-year period
You, for purposes of this part, means preceding the applicable calendar year
the owner, operator, or agent in charge was less than $500,000, adjusted for in-
of a covered farm that is subject to flation.
some or all of the requirements of this (b) For the purpose of determining
part. whether the average annual monetary
value of all food sold during the 3-year
[80 FR 74547, Nov. 27, 2015, as amended at 81 period preceding the applicable cal-
FR 26467, May 3, 2016] endar year was less than $500,000, ad-
justed for inflation, the baseline year
§ 112.4 Which farms are subject to the for calculating the adjustment for in-
requirements of this part?
flation is 2011.
(a) Except as provided in paragraph
(b) of this section, a farm or farm FR 12490, Apr. 2, 2019]
mixed-type facility with an average an-
nual monetary value of produce (as § 112.6 What modified requirements
‘‘produce’’ is defined in § 112.3) sold dur- apply to me if my farm is eligible
ing the previous 3-year period of more for a qualified exemption in accord-
ance with § 112.5?
than $25,000 (on a rolling basis), ad-
justed for inflation using 2011 as the (a) If your farm is eligible for a quali-
baseline year for calculating the ad- fied exemption in accordance with
justment, is a ‘‘covered farm’’ subject § 112.5, you are subject to the require-
to this part. Covered farms subject to ments of:
this part must comply with all applica- (1) This subpart (General Provisions);
ble requirements of this part when con- (2) Subpart O of this part (Records);
(3) Subpart Q of this part (Compli-
ducting a covered activity on covered
ance and Enforcement); and
produce.
(4) Subpart R of this part (With-
(b) A farm is not a covered farm if it drawal of Qualified Exemption).
satisfies the requirements in § 112.5 and (b) In addition, you are subject to the
we have not withdrawn the farm’s ex- following modified requirements:
emption in accordance with the re- (1) When a food packaging label is re-
quirements of subpart R of this part. quired on food that would otherwise be
[80 FR 74547, Nov. 27, 2015, as amended at 84 covered produce under the Federal
FR 12490, Apr. 2, 2019] Food, Drug, and Cosmetic Act or its
implementing regulations, you must
include prominently and conspicuously
on the food packaging label the name

and the complete business address of
the farm where the produce was grown.
313
§ 112.7 21 CFR Ch. I (4–1–23 Edition)
(2) When a food packaging label is necessary to prevent the introduction

not required on food that would other- of known or reasonably foreseeable
wise be covered produce under the Fed- hazards into covered produce, and to
eral Food, Drug, and Cosmetic Act, you provide reasonable assurances that the
must prominently and conspicuously produce is not adulterated under sec-
display, at the point of purchase, the tion 402 of the Federal Food, Drug, and
name and complete business address of Cosmetic Act on account of such haz-
the farm where the produce was grown, ards.
on a label, poster, sign, placard, or doc-
uments delivered contemporaneously § 112.12 Are there any alternatives to
with the produce in the normal course the requirements established in this
of business, or, in the case of Internet part?
sales, in an electronic notice. (a) You may establish alternatives to
(3) The complete business address certain specific requirements of sub-
that you must include in accordance part E of this part, as specified in
with the requirements of paragraph § 112.49, provided that you satisfy the
(b)(1) or (2) of this section must include requirements of paragraphs (b) and (c)
the street address or post office box, of this section.
city, state, and zip code for domestic (b) You may establish and use an al-
farms, and comparable full address in- ternative to any of the requirements
formation for foreign farms. specified in paragraph (a) of this sec-
tion, provided you have adequate sci-
§ 112.7 What records must I establish
and keep if my farm is eligible for a entific data or information to support
qualified exemption in accordance a conclusion that the alternative would
with § 112.5? provide the same level of public health
If your farm is eligible for a qualified protection as the applicable require-
exemption in accordance with § 112.5: ment established in this part, and
(a) You must establish and keep would not increase the likelihood that
records required under this provision in your covered produce will be adulter-
accordance with the requirements of ated under section 402 of the Federal
subpart O of this part, except that the Food, Drug, and Cosmetic Act, in light
requirement in § 112.161(a)(4) for a sig- of your covered produce, practices, and
nature or initial of the person per- conditions.
forming the activity is not required for (c) Scientific data and information
sales receipts kept in the normal used to support an alternative to a re-
course of business. Such receipts must quirement specified in paragraph (a) of
be dated as required under this section may be developed by you,
§ 112.161(a)(4). available in the scientific literature, or
(b) You must establish and keep ade- available to you through a third party.
quate records necessary to dem- You must establish and maintain docu-
onstrate that your farm satisfies the mentation of the scientific data and in-
criteria for a qualified exemption that formation on which you rely in accord-
are described in § 112.5, including a ance with the requirements of subpart
written record reflecting that you have O of this part. You are not required to
performed an annual review and notify or seek prior approval from FDA
verification of your farm’s continued regarding your decision to establish or
eligibility for the qualified exemption. use an alternative under this section.
Subpart B—General Requirements Subpart C—Personnel

Qualifications and Training
§ 112.11 What general requirements
apply to persons who are subject to § 112.21 What requirements apply re-
this part? garding qualifications and training
You must take appropriate measures for personnel who handle (contact)
to minimize the risk of serious adverse covered produce or food contact
surfaces?
health consequences or death from the

use of, or exposure to, covered produce, All of the following requirements
including those measures reasonably apply regarding qualifications and
314
training for personnel who handle (con- (1) Recognizing covered produce that
tact) covered produce or food contact must not be harvested, including cov-
surfaces: ered produce that may be contami-
(a) All personnel (including tem- nated with known or reasonably fore-
porary, part time, seasonal, and con- seeable hazards;
tracted personnel) who handle covered (2) Inspecting harvest containers and
produce or food contact surfaces, or equipment to ensure that they are
who are engaged in the supervision functioning properly, clean, and main-
thereof, must receive adequate train- tained so as not to become a source of
ing, as appropriate to the person’s du- contamination of covered produce with
ties, upon hiring, and periodically known or reasonably foreseeable haz-
thereafter, at least once annually. ards; and
(b) All personnel (including tem- (3) Correcting problems with harvest
porary, part time, seasonal, and con- containers or equipment, or reporting
tracted personnel) who handle covered such problems to the supervisor (or
produce or food contact surfaces, or other responsible party), as appropriate
who are engaged in the supervision to the person’s job responsibilities.
thereof, must have a combination of (c) At least one supervisor or respon-
education, training, and experience sible party for your farm must have
necessary to perform the person’s as- successfully completed food safety
signed duties in a manner that ensures training at least equivalent to that re-
compliance with this part.
ceived under standardized curriculum
(c) Training must be conducted in a
recognized as adequate by the Food and
manner that is easily understood by
Drug Administration.
personnel being trained.
(d) Training must be repeated as nec- § 112.23 What requirements apply re-
essary and appropriate in light of ob- garding supervisors?
servations or information indicating
that personnel are not meeting stand- You must assign or identify per-
ards established by FDA in subparts C sonnel to supervise (or otherwise be re-
through O of this part. sponsible for) your operations to en-
sure compliance with the requirements
§ 112.22 What minimum requirements of this part.
apply for training personnel who
conduct a covered activity? § 112.30 Under this subpart, what re-
quirements apply regarding
(a) At a minimum, all personnel who records?
handle (contact) covered produce dur-
ing covered activities or supervise the (a) You must establish and keep
conduct of such activities must receive records required under this subpart in
training that includes all of the fol- accordance with the requirements of
lowing: subpart O of this part.
(1) Principles of food hygiene and (b) You must establish and keep
food safety; records of training that document re-
(2) The importance of health and per- quired training of personnel, including
sonal hygiene for all personnel and the date of training, topics covered,
visitors, including recognizing symp- and the persons(s) trained.
toms of a health condition that is rea-
sonably likely to result in contamina- Subpart D—Health and Hygiene
tion of covered produce or food contact
surfaces with microorganisms of public § 112.31 What measures must I take to
health significance; and prevent ill or infected persons from
(3) The standards established by FDA contaminating covered produce
in subparts C through O of this part with microorganisms of public
that are applicable to the employee’s health significance?
job responsibilities. (a) You must take measures to pre-
(b) Persons who conduct harvest ac- vent contamination of covered produce
tivities for covered produce must also and food contact surfaces with micro-
receive training that includes all of the organisms of public health significance
following: from any person with an applicable
315
§ 112.32 21 CFR Ch. I (4–1–23 Edition)
health condition (such as commu- § 112.44(a) (as applicable) for water used
nicable illnesses that present a public to wash hands, and drying hands thor-
health risk in the context of normal oughly using single-service towels, san-
work duties, infection, open lesion, itary towel service, electric hand dry-
vomiting, or diarrhea). ers, or other adequate hand drying de-
(b) The measures you must take to vices:
satisfy the requirements of paragraph (i) Before starting work;
(a) of this section must include all of
(ii) Before putting on gloves;
the following measures:
(1) Excluding any person from work- (iii) After using the toilet;
ing in any operations that may result (iv) Upon return to the work station
in contamination of covered produce or after any break or other absence from
food contact surfaces with microorga- the work station;
nisms of public health significance (v) As soon as practical after touch-
when the person (by medical examina- ing animals (including livestock and
tion, the person’s acknowledgement, or working animals), or any waste of ani-
observation) is shown to have, or ap- mal origin; and
pears to have, an applicable health con- (vi) At any other time when the
dition, until the person’s health condi- hands may have become contaminated
tion no longer presents a risk to public in a manner that is reasonably likely
health; and to lead to contamination of covered
(2) Instructing personnel to notify
produce with known or reasonably
their supervisor(s) (or a responsible
foreseeable hazards;
party) if they have, or if there is a rea-
sonable possibility that they have an (4) If you choose to use gloves in han-
applicable health condition. dling covered produce or food contact
surfaces, maintaining gloves in an in-
§ 112.32 What hygienic practices must tact and sanitary condition and replac-
personnel use? ing such gloves when no longer able to
(a) Personnel who work in an oper- do so;
ation in which covered produce or food (5) Removing or covering hand jew-
contact surfaces are at risk of contami- elry that cannot be adequately cleaned
nation with known or reasonably fore- and sanitized during periods in which
seeable hazards must use hygienic covered produce is manipulated by
practices while on duty to the extent hand; and
necessary to protect against such con- (6) Not eating, chewing gum, or using
tamination. tobacco products in an area used for a
(b) The hygienic practices that per- covered activity (however, drinking
sonnel use to satisfy the requirements beverages is permitted in designated
of paragraph (a) of this section when
areas).
handling (contacting) covered produce
or food contact surfaces during a cov- § 112.33 What measures must I take to
ered activity must include all of the prevent visitors from contami-
following practices: nating covered produce and food
(1) Maintaining adequate personal contact surfaces with microorga-
cleanliness to protect against contami- nisms of public health significance?
nation of covered produce and food con-
(a) You must make visitors aware of
tact surfaces;
policies and procedures to protect cov-
(2) Avoiding contact with animals
other than working animals, and tak- ered produce and food contact surfaces
ing appropriate steps to minimize the from contamination by people and take
likelihood of contamination of covered all steps reasonably necessary to en-
produce when in direct contact with sure that visitors comply with such
working animals; policies and procedures.
(3) Washing hands thoroughly, in- (b) You must make toilet and hand-
washing facilities accessible to visi-
cluding scrubbing with soap (or other

effective surfactant) and running water tors.
that satisfies the requirements of
316
Subpart E—Agricultural Water onto covered produce or food contact

surfaces; correcting any significant de-
§ 112.41 What requirements apply to ficiencies (e.g., repairs to well cap, well
the quality of agricultural water? casing, sanitary seals, piping tanks and
All agricultural water must be safe treatment equipment, and control of
and of adequate sanitary quality for its cross-connections); and keeping the
intended use. source free of debris, trash, domes-
ticated animals, and other possible
§ 112.42 What requirements apply to sources of contamination of covered
my agricultural water sources,
water distribution system, and pool- produce to the extent practicable and
ing of water? appropriate under the circumstances.
(d) As necessary and appropriate, you
(a) At the beginning of a growing sea-
son, as appropriate, but at least once must implement measures reasonably
annually, you must inspect all of your necessary to reduce the potential for
agricultural water systems, to the ex- contamination of covered produce with
tent they are under your control (in- known or reasonably foreseeable haz-
cluding water sources, water distribu- ards as a result of contact of covered
tion systems, facilities, and equip- produce with pooled water. For exam-
ment), to identify conditions that are ple, such measures may include using
reasonably likely to introduce known protective barriers or staking to keep
or reasonably foreseeable hazards into covered produce from touching the
or onto covered produce or food con- ground or using an alternative irriga-
tact surfaces in light of your covered tion method.
produce, practices, and conditions, in-
cluding consideration of the following: § 112.43 What requirements apply to
(1) The nature of each agricultural treating agricultural water?
water source (for example, ground (a) When agricultural water is treat-
water or surface water); ed in accordance with § 112.45:
(2) The extent of your control over (1) Any method you use to treat agri-
each agricultural water source; cultural water (such as with physical
(3) The degree of protection of each
treatment, including using a pesticide
agricultural water source;
device as defined by the U.S. Environ-
(4) Use of adjacent and nearby land;
and mental Protection Agency (EPA); EPA-
(5) The likelihood of introduction of registered antimicrobial pesticide
known or reasonably foreseeable haz- product; or other suitable method)
ards to agricultural water by another must be effective to make the water
user of agricultural water before the safe and of adequate sanitary quality
water reaches your covered farm. for its intended use and/or meet the
(b) You must adequately maintain all relevant microbial quality criteria in
agricultural water distribution sys- § 112.44, as applicable.
tems to the extent they are under your (2) You must deliver any treatment
control as necessary and appropriate to of agricultural water in a manner to
prevent the water distribution system ensure that the treated water is con-
from being a source of contamination sistently safe and of adequate sanitary
to covered produce, food contact sur- quality for its intended use and/or con-
faces, areas used for a covered activity, sistently meets the relevant microbial
or water sources, including by regu- quality criteria in § 112.44, as applica-
larly inspecting and adequately storing ble.
all equipment used in the system. (b) You must monitor any treatment
(c) You must adequately maintain all of agricultural water at a frequency
agricultural water sources to the ex- adequate to ensure that the treated
tent they are under your control (such
water is consistently safe and of ade-
as wells). Such maintenance includes
quate sanitary quality for its intended
regularly inspecting each source to
use and/or consistently meets the rel-
identify any conditions that are rea-

sonably likely to introduce known or evant microbial quality criteria in
reasonably foreseeable hazards into or § 112.44, as applicable.
317
§ 112.44 21 CFR Ch. I (4–1–23 Edition)
§ 112.44 What specific microbial qual- sanitary quality for its intended use as
ity criteria apply to agricultural required under § 112.41 and/or if your
water used for certain intended agricultural water does not meet the
uses? microbial quality criterion for the
(a) When you use agricultural water specified purposes as required under
for any one or more of these following § 112.44(a), you must immediately dis-
purposes, you must ensure there is no continue that use(s), and before you
detectable generic Escherichia coli (E. may use the water source and/or dis-
coli) in 100 milliliters (mL) of agricul- tribution system again for the intended
tural water, and you must not use un- use(s), you must either:
treated surface water for any of these (1) Re-inspect the entire affected ag-
purposes: ricultural water system to the extent
(1) Used as sprout irrigation water; it is under your control, identify any
(2) Applied in any manner that di- conditions that are reasonably likely
rectly contacts covered produce during to introduce known or reasonably fore-
or after harvest activities (for example, seeable hazards into or onto covered
water that is applied to covered produce or food contact surfaces, make
produce for washing or cooling activi- necessary changes, and take adequate
ties, and water that is applied to har- measures to determine if your changes
vested crops to prevent dehydration be- were effective and, as applicable, ade-
fore cooling), including when used to quately ensure that your agricultural
make ice that directly contacts cov- water meets the microbial quality cri-
ered produce during or after harvest terion in § 112.44(a); or
activities; (2) Treat the water in accordance
(3) Used to contact food contact sur- with the requirements of § 112.43.
faces, or to make ice that will contact (b) If you have determined that your
food contact surfaces; and agricultural water does not meet the
(4) Used for washing hands during and microbial quality criteria (or any al-
after harvest activities. ternative microbial quality criteria, if
(b) When you use agricultural water applicable) required under § 112.44(b), as
during growing activities for covered soon as practicable and no later than
produce (other than sprouts) using a di- the following year, you must dis-
rect water application method, the fol- continue that use, unless you either:
lowing criteria apply (unless you estab- (1) Apply a time interval(s) (in days)
lish and use alternative criteria in ac- and/or a (calculated) log reduction by:
cordance with § 112.49): (i) Applying a time interval between
(1) A geometric mean (GM) of your last irrigation and harvest using ei-
agricultural water samples of 126 or ther:
less colony forming units (CFU) of ge- (A) A microbial die-off rate of 0.5 log
neric E. coli per 100 mL of water (GM is per day to achieve a (calculated) log re-
a measure of the central tendency of duction of your geometric mean (GM)
your water quality distribution); and and statistical threshold value (STV)
(2) A statistical threshold value to meet the microbial quality criteria
(STV) of your agricultural water sam- in § 112.44(b) (or any alternative micro-
ples of 410 or less CFU of generic E. coli bial criteria, if applicable), but no
per 100 mL of water (STV is a measure greater than a maximum time interval
of variability of your water quality dis- of 4 consecutive days; or
tribution, derived as a model-based cal- (B) An alternative microbial die-off
culation approximating the 90th per- rate and any accompanying maximum
centile using the lognormal distribu- time interval, in accordance with
tion). § 112.49; and/or
(ii) Applying a time interval between
§ 112.45 What measures must I take if harvest and end of storage using an ap-
my agricultural water does not propriate microbial die-off rate be-
meet the requirements of § 112.41 or tween harvest and end of storage, and/
§ 112.44? or applying a (calculated) log reduction
(a) If you have determined or have using appropriate microbial removal

reason to believe that your agricul- rates during activities such as commer-
tural water is not safe or of adequate cial washing, to meet the microbial
318
quality criteria in § 112.44(b) (or any al- (1) Conduct an initial survey to de-
ternative microbial criteria, if applica- velop a microbial water quality profile
ble), and any accompanying maximum of the agricultural water source.
time interval or log reduction, pro- (i) The initial survey must be con-
vided you have adequate supporting ducted:
scientific data and information; (A) For an untreated surface water
(2) Re-inspect the entire affected ag- source, by taking a minimum total of
ricultural water system to the extent 20 samples of agricultural water (or an
it is under your control, identify any alternative testing frequency that you
conditions that are reasonably likely establish and use, in accordance with
to introduce known or reasonably fore- § 112.49) over a minimum period of 2
seeable hazards into or onto covered years, but not greater than 4 years.
(B) For an untreated ground water
produce or food contact surfaces, make
source, by taking a minimum total of
necessary changes, and take adequate
four samples of agricultural water dur-
measures to determine if your changes
ing the growing season or over a period
were effective and adequately ensure
of 1 year.
that your agricultural water meets the (ii) The samples of agricultural water
microbial quality criteria in § 112.44(b) must be representative of your use of
(or any alternative microbial criteria, the water and must be collected as
if applicable); or close in time as practicable to, but
(3) Treat the water in accordance prior to, harvest. The microbial water
with the requirements of § 112.43. quality profile initially consists of the
geometric mean (GM) and the statis-
§ 112.46 How often must I test agricul- tical threshold value (STV) of generic
tural water that is subject to the re- Escherichia coli (E. coli) (colony forming
quirements of § 112.44?
units (CFU) per 100 milliliter (mL)) cal-
(a) There is no requirement to test culated using this data set. You must
any agricultural water that is subject determine the appropriate way(s) in
to the requirements of § 112.44 when: which the water may be used based on
(1) You receive water from a Public your microbial water quality profile in
Water System, as defined under the accordance with § 112.45(b).
Safe Drinking Water Act (SDWA) regu- (iii) You must update the microbial
lations, 40 CFR part 141, that furnishes water quality profile annually as re-
water that meets the microbial required under paragraph (b)(2) of this
quirements under those regulations or section, and otherwise required under
under the regulations of a State (as de- paragraph (b)(3) of this section.
fined in 40 CFR 141.2) approved to ad- (2) Conduct an annual survey to up-
minister the SDWA public water sup- date the microbial water quality pro-
ply program, and you have Public file of your agricultural water.
Water System results or certificates of (i) After the initial survey described
in paragraph (b)(1)(i) of this section,
compliance that demonstrate that the
you must test the water annually to
water meets that requirement;
update your existing microbial water
(2) You receive water from a public quality profile to confirm that the
water supply that furnishes water that way(s) in which the water is used con-
meets the microbial quality require- tinues to be appropriate. You must
ment described in § 112.44(a), and you analyze:
have public water system results or (A) For an untreated surface water
certificates of compliance that dem- source, a minimum number of five
onstrate that the water meets that re- samples per year (or an alternative
quirement; or testing frequency that you establish
(3) You treat water in accordance and use, in accordance with § 112.49).
with the requirements of § 112.43. (B) For an untreated ground water
(b) Except as provided in paragraph source, a minimum of one sample per
(a) of this section, you must take the year.
following steps for each source of water (ii) The samples of agricultural water
used for purposes that are subject to must be representative of your use of
the requirements of § 112.44(b): the water and must be collected as
319
§ 112.47 21 CFR Ch. I (4–1–23 Edition)
close in time as practicable to, but you may test once annually thereafter,
prior to, harvest. using a minimum of one sample col-
(iii) To update the microbial water lected to be representative of the in-
quality profile, you must calculate re- tended use(s). You must resume testing
vised GM and STV values using your at least four times per growing season
current annual survey data, combined or year if any annual test fails to meet
with your most recent initial or annual the microbial quality criteria in
survey data from within the previous 4 § 112.44(a).
years, to make up a rolling data set of:
(A) At least 20 samples for untreated § 112.47 Who must perform the tests
required under § 112.46 and what
surface water sources; and methods must be used?
(B) At least 4 samples for untreated
ground water sources. (a) You may meet the requirements
(iv) You must modify your water use, related to agricultural water testing
as appropriate, based on the revised required under § 112.46 using:
GM and STV values in your updated (1) Test results from your agricul-
microbial water quality profile in ac- tural water source(s) performed by you,
cordance with § 112.45(b). or by a person or entity acting on your
(3) If you have determined or have behalf; or
reason to believe that your microbial (2) Data collected by a third party or
water quality profile no longer rep- parties, provided the water source(s)
resents the quality of your water (for sampled by the third party or parties
example, if there are significant adequately represent your agricultural
changes in adjacent land use that are water source(s) and all other applicable
reasonably likely to adversely affect requirements of this part are met.
the quality of your water source), you (b) Agricultural water samples must
must develop a new microbial water be aseptically collected and tested
using a method as set forth in § 112.151.
quality profile reflective of the time
period at which you believe your mi- § 112.48 What measures must I take for
crobial water quality profile changed. water that I use during harvest,
(i) To develop a new microbial water packing, and holding activities for
quality profile, you must calculate new covered produce?
GM and STV values using your current (a) You must manage the water as
annual survey data (if taken after the necessary, including by establishing
time of the change), combined with and following water-change schedules
new data, to make up a data set of: for re-circulated water, to maintain its
(A) At least 20 samples for untreated safety and adequate sanitary quality
surface water sources; and and minimize the potential for con-
(B) At least 4 samples for untreated tamination of covered produce and food
ground water sources. contact surfaces with known or reason-
(ii) You must modify your water use ably foreseeable hazards (for example,
based on the new GM and STV values hazards that may be introduced into
in your new microbial water quality the water from soil adhering to the
profile in accordance with § 112.45(b). covered produce).
(c) If you use untreated ground water (b) You must visually monitor the
for the purposes that are subject to the quality of water that you use during
requirements of § 112.44(a), you must harvest, packing, and holding activi-
initially test the microbial quality of ties for covered produce (for example,
each source of the untreated ground water used for washing covered produce
water at least four times during the in dump tanks, flumes, or wash tanks,
growing season or over a period of 1 and water used for cooling covered
year, using a minimum total of four produce in hydrocoolers) for buildup of
samples collected to be representative organic material (such as soil and
of the intended use(s). Based on these plant debris).
results, you must determine whether (c) You must maintain and monitor
the water can be used for that purpose, the temperature of water at a tempera-
in accordance with § 112.45(a). If your ture that is appropriate for the com-
four initial sample results meet the modity and operation (considering the
microbial quality criteria of § 112.44(a), time and depth of submersion) and is
320
adequate to minimize the potential for or removal rate(s) that you used to de-
infiltration of microorganisms of pub- termine the time interval (in days) be-
lic health significance into covered tween harvest and end of storage, in-
produce. cluding other activities such as com-
mercial washing, as applicable, used to
§ 112.49 What alternatives may I estab- achieve the calculated log reduction of
lish and use in lieu of the require-
ments of this subpart? generic Escherichia coli (E. coli), in ac-
cordance with § 112.45(b)(1)(ii);
Provided you satisfy the require- (6) Documentation of actions you
ments of § 112.12, you may establish and take in accordance with § 112.45. With
use one or more of the following alter- respect to any time interval or (cal-
natives: culated) log reduction applied in ac-
(a) An alternative microbial quality cordance with § 112.45(b)(1)(i) and/or (ii),
criterion (or criteria) using an appro- such documentation must include the
priate indicator of fecal contamina- specific time interval or log reduction
tion, in lieu of the microbial quality
applied, how the time interval or log
criteria in § 112.44(b);
reduction was determined, and the
(b) An alternative microbial die-off
dates of corresponding activities such
rate and an accompanying maximum
as the dates of last irrigation and har-
time interval, in lieu of the microbial
vest, the dates of harvest and end of
die-off rate and maximum time inter-
storage, and/or the dates of activities
val in § 112.45(b)(1)(i);
such as commercial washing);
(c) An alternative minimum number
of samples used in the initial survey (7) Annual documentation of the re-
for an untreated surface water source, sults or certificates of compliance from
in lieu of the minimum number of sam- a public water system required under
ples required under § 112.46(b)(1)(i)(A); § 112.46(a)(1) or (2), if applicable;
and (8) Scientific data or information you
(d) An alternative minimum number rely on to support any alternative that
of samples used in the annual survey you establish and use in accordance
for an untreated surface water source, with § 112.49; and
in lieu of the minimum number of sam- (9) Any analytical methods you use
ples required under § 112.46(b)(2)(i)(A). in lieu of the method that is incor-
porated by reference in § 112.151(a).
§ 112.50 Under this subpart, what re-
quirements apply regarding
records? Subpart F—Biological Soil Amend-
(a) You must establish and keep
ments of Animal Origin and
records required under this subpart in Human Waste
accordance with the requirements of
subpart O of this part. § 112.51 What requirements apply for
determining the status of a biologi-
(b) You must establish and keep the cal soil amendment of animal ori-
following records: gin?
(1) The findings of the inspection of
your agricultural water system in ac- (a) A biological soil amendment of
cordance with the requirements of animal origin is treated if it has been
§ 112.42(a); processed to completion to adequately
(2) Documentation of the results of reduce microorganisms of public health
all analytical tests conducted on agri- significance in accordance with the re-
cultural water for purposes of compli- quirements of § 112.54, or, in the case of
ance with this subpart; an agricultural tea, the biological ma-
(3) Scientific data or information you terials of animal origin used to make
rely on to support the adequacy of a the tea have been so processed, the
method used to satisfy the require- water used to make the tea is not un-
ments of § 112.43(a)(1) and (2); treated surface water, and the water
(4) Documentation of the results of used to make the tea has no detectable
water treatment monitoring under generic Escherichia coli (E. coli) in 100
§ 112.43(b); milliliters (mL) of water.

(5) Scientific data or information you (b) A biological soil amendment of
rely on to support the microbial die-off animal origin is untreated if it:
321
§ 112.52 21 CFR Ch. I (4–1–23 Edition)
(1) Has not been processed to comple- age sludge biosolids used in accordance
tion in accordance with the require- with the requirements of 40 CFR part
ments of § 112.54, or in the case of an 503, subpart D, or equivalent regu-
agricultural tea, the biological mate- latory requirements.
rials of animal origin used to make the
tea have not been so processed, or the § 112.54 What treatment processes are
water used to make the tea is unacceptable for a biological soil
treated surface water, or the water amendment of animal origin that I
apply in the growing of covered
used to make the tea has detectable ge- produce?
neric E. coli in 100 mL of water;
(2) Has become contaminated after Each of the following treatment
treatment; processes are acceptable for a biologi-
(3) Has been recombined with an un- cal soil amendment of animal origin
treated biological soil amendment of that you apply in the growing of cov-
animal origin; ered produce, provided that the result-
(4) Is or contains a component that is ing biological soil amendments are ap-
untreated waste that you know or have plied in accordance with the applicable
reason to believe is contaminated with requirements of § 112.56:
a hazard or has been associated with (a) A scientifically valid controlled
foodborne illness; or physical process (e.g., thermal), chem-
(5) Is an agricultural tea made with ical process (e.g., high alkaline pH), bi-
biological materials of animal origin ological process (e.g., composting), or a
that contains an agricultural tea addi- combination of scientifically valid con-
tive. trolled physical, chemical and/or bio-
logical processes that has been vali-
§ 112.52 How must I handle, convey, dated to satisfy the microbial standard
and store biological soil amend- in § 112.55(a) for Listeria monocytogenes
ments of animal origin? (L. monocytogenes), Salmonella species,
(a) You must handle, convey and and E. coli O157:H7; or
store any biological soil amendment of (b) A scientifically valid controlled
animal origin in a manner and location physical, chemical, or biological proc-
such that it does not become a poten- ess, or a combination of scientifically
tial source of contamination to covered valid controlled physical, chemical,
produce, food contact surfaces, areas and/or biological processes, that has
used for a covered activity, water been validated to satisfy the microbial
sources, water distribution systems, standard in § 112.55(b) for Salmonella
and other soil amendments. Agricul- species and fecal coliforms. Examples
tural teas that are biological soil of scientifically valid controlled bio-
amendments of animal origin may be logical (e.g., composting) processes
used in water distribution systems pro- that meet the microbial standard in
vided that all other requirements of § 112.55(b) include:
this rule are met. (1) Static composting that maintains
(b) You must handle, convey and aerobic (i.e., oxygenated) conditions at
store any treated biological soil a minimum of 131 °F (55 °C) for 3 con-
amendment of animal origin in a man- secutive days and is followed by ade-
ner and location that minimizes the quate curing; and
risk of it becoming contaminated by an (2) Turned composting that main-
untreated or in-process biological soil tains aerobic conditions at a minimum
amendment of animal origin. of 131 °F (55 °C) for 15 days (which do
(c) You must handle, convey, and not have to be consecutive), with a
store any biological soil amendment of minimum of five turnings, and is fol-
animal origin that you know or have lowed by adequate curing.
reason to believe may have become
contaminated as if it was untreated. § 112.55 What microbial standards
apply to the treatment processes in
§ 112.53 What prohibitions apply re- § 112.54?
garding use of human waste?
The following microbial standards

You may not use human waste for apply to the treatment processes in
growing covered produce, except sew- § 112.54 as set forth in that section.
322
(a) For L. monocytogenes, Salmonella evant standards in the table in this

species, and E. coli O157:H7, the rel- paragraph (a); or
For the microorganism— The microbial standard is—
(1) L. monocytogenes .................................................................. Not detected using a method that can detect one colony form-
ing unit (CFU) per 5 gram (or milliliter, if liquid is being sam-
pled) analytical portion.
(2) Salmonella species ................................................................ Not detected using a method that can detect three most prob-
able numbers (MPN) per 4 grams (or milliliter, if liquid is
being sampled) of total solids.
(3) E. coli O157:H7 ...................................................................... Not detected using a method that can detect 0.3 MPN per 1
gram (or milliliter, if liquid is being sampled) analytical por-
tion.
(b) Salmonella species are not de- § 112.56 What application require-
tected using a method that can detect ments and minimum application in-
three MPN Salmonella species per 4 tervals apply to biological soil
grams (or milliliter, if liquid is being amendments of animal origin?
sampled) of total solids; and less than (a) You must apply the biological soil
1,000 MPN fecal coliforms per gram (or amendments of animal origin specified
milliliter, if liquid is being sampled) of in the first column of the table in this
total solids. paragraph (a) in accordance with the
application requirements specified in
[80 FR 74547, Nov. 27, 2015, as amended at 81 the second column of the table in this
FR 26468, May 3, 2016] paragraph (a) and the minimum appli-
cation intervals specified in the third
column of the table in this paragraph
(a).
And then the
If the biological soil amendment of animal origin Then the biological soil amendment of animal or- minimum application in-
is— igin must be applied— terval is—
(1)(i) Untreated ....................................................... In a manner that does not contact covered [Reserved].
produce during application and minimizes the
potential for contact with covered produce
after application.
(ii) Untreated ........................................................... In a manner that does not contact covered 0 days.
produce during or after application.
(2) Treated by a scientifically valid controlled In a manner that minimizes the potential for con- 0 days.
physical, chemical, or biological process, or tact with covered produce during and after ap-
combination of scientifically valid controlled plication.
physical, chemical, and/or biological processes,
in accordance with the requirements of
§ 112.54(b) to meet the microbial standard in
§ 112.55(b).
(3) Treated by a scientifically valid controlled In any manner (i.e., no restrictions) ..................... 0 days.
physical, chemical, or biological process, or
combination of scientifically valid controlled
physical, chemical, or biological processes, in
accordance with the requirements of § 112.54(a)
to meet the microbial standard in § 112.55(a).
(b) [Reserved] (b) For any biological soil amend-

ment of animal origin you use, you
§ 112.60 Under this subpart, what re- must establish and keep the following
quirements apply regarding records:
records?
(1) For a treated biological soil
(a) You must establish and keep amendment of animal origin you re-
records required under this subpart in ceive from a third party, documenta-
tion (such as a Certificate of Conform-

subpart O of this part. ance) at least annually that:
323
§ 112.81 21 CFR Ch. I (4–1–23 Edition)
(i) The process used to treat the bio- (2) If significant evidence of potential
logical soil amendment of animal ori- contamination is found (such as obser-
gin is a scientifically valid process that vation of animals, animal excreta or
has been carried out with appropriate crop destruction), you must evaluate
process monitoring; and whether the covered produce can be
(ii) The biological soil amendment of harvested in accordance with the re-
animal origin has been handled, con- quirements of § 112.112 and take meas-
veyed and stored in a manner and loca- ures reasonably necessary during grow-
tion to minimize the risk of contami- ing to assist you later during harvest
nation by an untreated or in process bi- when you must identify, and not har-
ological soil amendment of animal ori- vest, covered produce that is reason-
gin; and ably likely to be contaminated with a
(2) For a treated biological soil known or reasonably foreseeable haz-
amendment of animal origin you ard.
produce for your own covered farm(s),
documentation that process controls § 112.84 Does this regulation require
(for example, time, temperature, and covered farms to take actions that
would constitute a ‘‘taking’’ of
turnings) were achieved. threatened or endangered species;
to take measures to exclude ani-
Subpart G–H [Reserved] mals from outdoor growing areas;
or to destroy animal habitat or oth-
erwise clear farm borders around
Subpart I—Domesticated and Wild outdoor growing areas or drain-
Animals ages?
§ 112.81 How do the requirements of No. Nothing in this regulation au-
this subpart apply to areas where thorizes the ‘‘taking’’ of threatened or
covered activities take place? endangered species as that term is de-
fined by the Endangered Species Act
(a) The requirements of this subpart
(16 U.S.C. 1531–1544) (i.e., to harass,
apply when a covered activity takes
harm, pursue, hunt, shoot, wound, kill,
place in an outdoor area or a partially-
trap, capture, or collect, or to attempt
enclosed building and when, under the
to engage in any such conduct), in vio-
circumstances, there is a reasonable
lation of the Endangered Species Act.
probability that animals will contami-
This regulation does not require cov-
nate covered produce.
ered farms to take measures to exclude
(b) The requirements of this subpart animals from outdoor growing areas, or
do not apply: to destroy animal habitat or otherwise
(1) When a covered activity takes clear farm borders around outdoor
place in a fully-enclosed building; or growing areas or drainages.
(2) To fish used in aquaculture oper-
ations.
Subpart J [Reserved]
§ 112.83 What requirements apply re-
garding grazing animals, working Subpart K—Growing, Harvesting,
animals, and animal intrusion? Packing, and Holding Activities
(a) You must take the steps set forth
in paragraph (b) of this section if under § 112.111 What measures must I take if
the circumstances there is a reasonable I grow, harvest, pack or hold both
probability that grazing animals, covered and excluded produce?
working animals, or animal intrusion If you grow, harvest, pack or hold
will contaminate covered produce. produce that is not covered in this part
(b) You must: (i.e., excluded produce in accordance
(1) Assess the relevant areas used for with § 112.2) and also conduct such ac-
a covered activity for evidence of po- tivities on covered produce, and the ex-
tential contamination of covered cluded produce is not grown, harvested,
produce as needed during the growing packed or held in accordance with this
season (based on your covered produce; part, you must take measures during
your practices and conditions; and these covered activities, as applicable,
your observations and experience); and to:
324
(a) Keep covered produce separate § 112.115 What measures must I take
from excluded produce (except when when packaging covered produce?
covered produce and excluded produce You must package covered produce in
are placed in the same container for a manner that prevents the formation
distribution); and of Clostridium botulinum toxin if such
(b) Adequately clean and sanitize, as toxin is a known or reasonably foresee-
necessary, any food contact surfaces able hazard (such as for mushrooms).
that contact excluded produce before
using such food contact surfaces for § 112.116 What measures must I take
when using food-packing (including
covered activities on covered produce. food packaging) material?
§ 112.112 What measures must I take (a) You must use food-packing mate-
immediately prior to and during rial that is adequate for its intended
harvest activities? use, which includes being:
(1) Cleanable or designed for single
You must take all measures reason- use; and
ably necessary to identify, and not har- (2) Unlikely to support growth or
vest, covered produce that is reason- transfer of bacteria.
ably likely to be contaminated with a (b) If you reuse food-packing mate-
known or reasonably foreseeable haz- rial, you must take adequate steps to
ard, including steps to identify and not ensure that food contact surfaces are
harvest covered produce that is visibly clean, such as by cleaning food-packing
contaminated with animal excreta. At containers or using a clean liner.
a minimum, identifying and not har-
vesting covered produce that is reason- Subpart L—Equipment, Tools,
ably likely to be contaminated with Buildings, and Sanitation
animal excreta or that is visibly con-
taminated with animal excreta re- § 112.121 What equipment and tools
quires a visual assessment of the grow- are subject to the requirements of
this subpart?
ing area and all covered produce to be
harvested, regardless of the harvest Equipment and tools subject to the
method used. requirements of this subpart are those
that are intended to, or likely to, con-
§ 112.113 How must I handle harvested tact covered produce; and those instru-
covered produce during covered ac- ments or controls used to measure, reg-
tivities? ulate, or record conditions to control
You must handle harvested covered or prevent the growth of microorga-
nisms of public health significance. Ex-
produce during covered activities in a
amples include knives, implements,
manner that protects against contami-
mechanical harvesters, waxing machin-
nation with known or reasonably fore-
ery, cooling equipment (including
seeable hazards—for example, by avoid- hydrocoolers), grading belts, sizing
ing, to the degree practicable, contact equipment, palletizing equipment, and
of cut surfaces of harvested produce equipment used to store or convey har-
with soil. vested covered produce (such as con-
tainers, bins, food-packing material,
§ 112.114 What requirements apply to dump tanks, flumes, and vehicles or
dropped covered produce?
other equipment used for transport
You must not distribute dropped cov- that are intended to, or likely to, con-
ered produce. Dropped covered produce tact covered produce).
is covered produce that drops to the
ground before harvest. Dropped covered § 112.122 What buildings are subject to
the requirements of this subpart?
produce does not include root crops
that grow underground (such as car- Buildings subject to the require-
rots), crops that grow on the ground ments of this subpart include:
(such as cantaloupe), or produce that is (a) Any fully- or partially-enclosed
intentionally dropped to the ground as building used for covered activities, in-
part of harvesting (such as almonds). cluding minimal structures that have a
roof but do not have any walls; and
325
§ 112.123 21 CFR Ch. I (4–1–23 Edition)
(b) Storage sheds, buildings, or other § 112.124 What requirements apply to

structures used to store food contact instruments and controls used to
surfaces (such as harvest containers measure, regulate, or record?
and food-packing materials). Instruments or controls you use to
measure, regulate, or record tempera-
§ 112.123 What general requirements tures, hydrogen-ion concentration
apply regarding equipment and
tools subject to this subpart? (pH), sanitizer efficacy or other condi-
tions, in order to control or prevent
All of the following requirements the growth of microorganisms of public
apply regarding equipment and tools health significance, must be:
subject to this subpart: (a) Accurate and precise as necessary
(a) You must use equipment and and appropriate in keeping with their
tools that are of adequate design, con- purpose;
struction, and workmanship to enable (b) Adequately maintained; and
them to be adequately cleaned and (c) Adequate in number for their des-
properly maintained; and ignated uses.
(b) Equipment and tools must be:
(1) Installed and maintained as to fa- § 112.125 What requirements apply to
cilitate cleaning of the equipment and equipment that is subject to this
of all adjacent spaces; and subpart used in the transport of
(2) Stored and maintained to protect covered produce?
covered produce from being contami- Equipment that is subject to this
nated with known or reasonably fore- subpart that you use to transport cov-
seeable hazards and to prevent the ered produce must be:
equipment and tools from attracting (a) Adequately clean before use in
and harboring pests. transporting covered produce; and
(c) Seams on food contact surfaces of (b) Adequate for use in transporting
equipment and tools that you use must covered produce.
be either smoothly bonded, or main-
tained to minimize accumulation of § 112.126 What requirements apply to
dirt, filth, food particles, and organic my buildings?
material and thus minimize the oppor- (a) All of the following requirements
tunity for harborage or growth of apply regarding buildings:
microorganisms. (1) Buildings must be suitable in size,
(d)(1) You must inspect, maintain, construction, and design to facilitate
and clean and, when necessary and ap- maintenance and sanitary operations
propriate, sanitize all food contact sur- for covered activities to reduce the po-
faces of equipment and tools used in tential for contamination of covered
covered activities as frequently as rea- produce or food contact surfaces with
sonably necessary to protect against known or reasonably foreseeable haz-
contamination of covered produce. ards. Buildings must:
(2) You must maintain and clean all (i) Provide sufficient space for place-
non-food-contact surfaces of equipment ment of equipment and storage of ma-
and tools subject to this subpart used terials;
during harvesting, packing, and hold- (ii) Permit proper precautions to be
ing as frequently as reasonably nec- taken to reduce the potential for con-
essary to protect against contamina- tamination of covered produce, food
tion of covered produce. contact surfaces, or packing materials
(e) If you use equipment such as pal- with known or reasonably foreseeable
lets, forklifts, tractors, and vehicles hazards. The potential for contamina-
such that they are intended to, or like- tion must be reduced by effective de-
ly to, contact covered produce, you sign including the separation of oper-
must do so in a manner that minimizes ations in which contamination is likely
the potential for contamination of cov- to occur, by one or more of the fol-
ered produce or food contact surfaces lowing means: Location, time, parti-
with known or reasonably foreseeable tion, enclosed systems, or other effec-
hazards. tive means; and
326
(2) You must provide adequate drain- ence of pests and removing them when
age in all areas where normal oper- present).
ations release or discharge water or
other liquid waste on the ground or § 112.129 What requirements apply to
floor of the building. toilet facilities?
(b) You must implement measures to All of the following requirements
prevent contamination of your covered apply to toilet facilities:
produce and food contact surfaces in (a) You must provide personnel with
your buildings, as appropriate, consid- adequate, readily accessible toilet fa-
ering the potential for such contamina- cilities, including toilet facilities read-
tion through: ily accessible to growing areas during
(1) Floors, walls, ceilings, fixtures, harvesting activities.
ducts, or pipes; and (b) Your toilet facilities must be de-
(2) Drip or condensate. signed, located, and maintained to:
(1) Prevent contamination of covered
§ 112.127 What requirements apply re- produce, food contact surfaces, areas
garding domesticated animals in used for a covered activity, water
and around a fully-enclosed build- sources, and water distribution sys-
ing?
tems with human waste;
(a) You must take reasonable pre- (2) Be directly accessible for serv-
cautions to prevent contamination of icing, be serviced and cleaned at a fre-
covered produce, food contact surfaces, quency sufficient to ensure suitability
and food-packing materials in fully-en- of use, and be kept supplied with toilet
closed buildings with known or reason- paper; and
ably foreseeable hazards from domes- (3) Provide for the sanitary disposal
ticated animals by: of waste and toilet paper.
(1) Excluding domesticated animals (c) During growing activities that
from fully-enclosed buildings where take place in a fully-enclosed building,
covered produce, food contact surfaces, and during covered harvesting, pack-
or food-packing material is exposed; or ing, or holding activities, you must
(2) Separating domesticated animals provide a hand-washing station in suf-
in a fully enclosed building from an ficiently close proximity to toilet fa-
area where a covered activity is con- cilities to make it practical for persons
ducted on covered produce by location, who use the toilet facility to wash
time, or partition. their hands.
(b) Guard or guide dogs may be al-
lowed in some areas of a fully enclosed § 112.130 What requirements apply for
building if the presence of the dogs is hand-washing facilities?
unlikely to result in contamination of All of the following requirements
produce, food contact surfaces, or food- apply to hand-washing facilities:
packing materials. (a) You must provide personnel with
adequate, readily accessible hand-
§ 112.128 What requirements apply re- washing facilities during growing ac-
garding pest control in buildings? tivities that take place in a fully-en-
(a) You must take those measures closed building, and during covered
reasonably necessary to protect cov- harvest, packing, or holding activities.
ered produce, food contact surfaces, (b) Your hand-washing facilities must
and food-packing materials from con- be furnished with:
tamination by pests in buildings, in- (1) Soap (or other effective surfac-
cluding routine monitoring for pests as tant);
necessary and appropriate. (2) Running water that satisfies the
(b) For fully-enclosed buildings, you requirements of § 112.44(a) for water
must take measures to exclude pests used to wash hands; and
from your buildings. (3) Adequate drying devices (such as
(c) For partially-enclosed buildings, single service towels, sanitary towel
you must take measures to prevent service, or electric hand dryers).
pests from becoming established in (c) You must provide for appropriate
your buildings (such as by use of disposal of waste (for example, waste
screens or by monitoring for the pres- water and used single-service towels)
327
§ 112.131 21 CFR Ch. I (4–1–23 Edition)
associated with a hand-washing facility (1) Minimize the potential for trash,
and take appropriate measures to pre- litter, or waste to attract or harbor
vent waste water from a hand-washing pests; and
facility from contaminating covered (2) Protect against contamination of
produce, food contact surfaces, areas covered produce, food contact surfaces,
used for a covered activity, agricul- areas used for a covered activity, agri-
tural water sources, and agricultural cultural water sources, and agricul-
water distribution systems with known tural water distribution systems with
or reasonably foreseeable hazards. known or reasonably foreseeable haz-
(d) You may not use antiseptic hand ards.
rubs as a substitute for soap (or other
(b) You must adequately operate sys-
effective surfactant) and water.
tems for waste treatment and disposal
§ 112.131 What must I do to control so that they do not constitute a poten-
and dispose of sewage? tial source of contamination in areas
All of the following requirements used for a covered activity.
apply for the control and disposal of
sewage: plumbing?
(a) You must dispose of sewage into
an adequate sewage or septic system or The plumbing must be of an adequate
through other adequate means. size and design and be adequately in-
(b) You must maintain sewage and stalled and maintained to:
septic systems in a manner that pre- (a) Distribute water under pressure
vents contamination of covered as needed, in sufficient quantities, in
produce, food contact surfaces, areas all areas where used for covered activi-
used for a covered activity, agricul- ties, for sanitary operations, or for
tural water sources, and agricultural hand-washing and toilet facilities;
water distribution systems with known (b) Properly convey sewage and liq-
or reasonably foreseeable hazards. uid disposable waste;
(c) You must manage and dispose of (c) Avoid being a source of contami-
leakages or spills of human waste in a nation to covered produce, food contact
manner that prevents contamination of
surfaces, areas used for a covered activ-
covered produce, and prevents or mini-
ity, or agricultural water sources; and
mizes contamination of food contact
surfaces, areas used for a covered activ- (d) Not allow backflow from, or cross
ity, agricultural water sources, or agri- connection between, piping systems
cultural water distribution systems. that discharge waste water or sewage
(d) After a significant event (such as and piping systems that carry water
flooding or an earthquake) that could used for a covered activity, for sani-
negatively impact a sewage or septic tary operations, or for use in hand-
system, you must take appropriate washing facilities.
steps to ensure that sewage and septic
systems continue to operate in a man- § 112.134 What must I do to control
ner that does not contaminate covered animal excreta and litter from do-
produce, food contact surfaces, areas mesticated animals that are under
my control?
used for a covered activity, agricul-
tural water sources, or agricultural (a) If you have domesticated animals,
water distribution systems. to prevent contamination of covered
produce, food contact surfaces, areas
§ 112.132 What must I do to control used for a covered activity, agricul-
and dispose of trash, litter, and tural water sources, or agricultural
waste in areas used for covered ac-
tivities? water distribution systems with ani-
mal waste, you must:
All of the following requirements
(1) Adequately control their excreta
apply to the control and disposal of
and litter; and
trash, litter, and waste in areas used
(2) Maintain a system for control of
for covered activities:

(a) You must convey, store, and dis- animal excreta and litter.
pose of trash, litter and waste to: (b) [Reserved]
328
§ 112.140 Under this subpart, what re- (c) If your reason to believe that a lot
quirements apply regarding of seeds or beans may be contaminated
records? was based only on microbial test re-
(a) You must establish and keep sults:
records required under this subpart in (1) You are not required to take the
accordance with the requirements of steps set forth in paragraph (b)(1) of
subpart O of this part. this section if you treat your lot of
(b) You must establish and keep doc- seeds or beans with a process that is
umentation of the date and method of reasonably certain to achieve destruc-
cleaning and sanitizing of equipment tion or elimination in the seeds or
subject to this subpart used in: beans of the most resistant microorga-
(1) Growing operations for sprouts; nisms of public health significance
and that are likely to occur in the seeds or
(2) Covered harvesting, packing, or beans; or
holding activities. (2) You are not required to take the
steps set forth in paragraphs (b)(1) and
Subpart M—Sprouts (2) of this section if you later reason-
ably determine, through appropriate
§ 112.141 What commodities are sub- followup actions, that the lot of seeds
ject to this subpart?
or beans is not the source of contami-
The requirements of this subpart nation (e.g., the lot of seeds or beans is
apply to growing, harvesting, packing, not the source of a pathogen found in
and holding of all sprouts, except soil- spent sprout irrigation water or
or substrate-grown sprouts harvested sprouts).
without their roots. (d) You must visually examine seeds
§ 112.142 What requirements apply to and beans, and packaging used to ship
seeds or beans used to grow seeds or beans, for signs of potential
sprouts? contamination with known or reason-
In addition to the requirements of ably foreseeable hazards.
this part, all of the following require- (e) You must either:
ments apply to seeds or beans used to (1) Treat seeds or beans that will be
grow sprouts. used to grow sprouts using a scientif-
(a) You must take measures reason- ically valid method to reduce micro-
ably necessary to prevent the introduc- organisms of public health signifi-
tion of known or reasonably foresee- cance; or
able hazards into or onto seeds or (2) Rely on prior treatment of seeds
beans that you will use for sprouting. or beans conducted by a grower, dis-
(b) Except as provided in paragraph tributor, or supplier of the seeds or
(c) of this section, if you know or have beans (whether to fulfill this require-
reason to believe that a lot of seeds or ment completely or for the purpose of
beans may be contaminated with a considering such prior treatment when
pathogen (either because it has been applying appropriate additional treat-
associated with foodborne illness; or ment of the seeds or beans at the cov-
based on microbial test results, includ- ered farm immediately before sprout-
ing a positive finding of a pathogen in ing), provided that you obtain docu-
tests required under § 112.144(b)), you mentation (such as a Certificate of
must: Conformance) from the grower, dis-
(1) Discontinue use of all seeds or tributor, or supplier that:
beans from that lot for sprout produc-
(i) The prior treatment was con-
tion and ensure that sprouts grown
ducted using a scientifically valid
from that lot of seeds or beans do not
enter commerce; and method to reduce microorganisms of
(2) Report the information (associa- public health significance; and
tion with illness and/or findings of mi- (ii) The treated seeds or beans were
handled and packaged following the
crobial testing) to the seed grower, dis-

tributor, supplier, or other entity from treatment in a manner that minimizes
whom you received the seeds or beans. the potential for contamination.
329
§ 112.143 21 CFR Ch. I (4–1–23 Edition)
§ 112.143 What measures must I take in-process stage (i.e., while sprouts are
for growing, harvesting, packing, still growing) for E. coli O157:H7, Sal-
and holding sprouts? monella species, and any pathogens
You must take all of the following meeting the criteria in paragraph (c) of
measures for growing, harvesting, this section, in accordance with the re-
packing, and holding sprouts: quirements of § 112.147.
(a) You must grow, harvest, pack, (c) In addition to E. coli O157:H7 and
and hold sprouts in a fully-enclosed Salmonella species, you must conduct
building. tests as provided in paragraph (b) of
(b) Any food contact surfaces you use this section for additional pathogens
to grow, harvest, pack, or hold sprouts when the following conditions are met:
must be cleaned and sanitized before (1) Testing for the pathogen is rea-
contact with sprouts or seeds or beans sonably necessary to minimize the risk
used to grow sprouts. of serious adverse health consequences
(c) You must conduct testing during or death from use of, or exposure to,
growing, harvesting, packing, and hold- sprouts; and
ing sprouts, as specified in § 112.144. (2) A scientifically valid test method
(d) You must establish and imple- for the pathogen is available to detect
ment a written environmental moni- the pathogen in spent sprout irrigation
toring plan as specified in § 112.145. water (or sprouts).
(e) You must take certain actions if
you detect Listeria species or L. § 112.145 What requirements apply to
testing the environment for Listeria
monocytogenes in the growing, har- species or L. monocytogenes?
vesting, packing, or holding environ-
ment, as specified in § 112.146. All of the following testing require-
(f) You must establish and implement ments apply for the growing, har-
a written sampling plan to test spent vesting, packing, and holding environ-
sprout irrigation water or sprouts for ment for Listeria species or L.
pathogens as specified in § 112.147. monocytogenes.
(g) You must take certain actions if (a) You must establish and imple-
the samples of spent sprout irrigation ment a written environmental moni-
water or sprouts test positive for a toring plan that is designed to identify
pathogen as specified in § 112.148. L. monocytogenes if it is present in the
growing, harvesting, packing, or hold-
§ 112.144 What testing must I do during environment.
ing growing, harvesting, packing, (b) Your written environmental mon-
and holding sprouts? itoring plan must be directed to sam-
All of the following testing must be pling and testing for either Listeria spe-
done during growing, harvesting, pack- cies or L. monocytogenes.
ing, and holding sprouts: (c) Your written environmental mon-
(a) You must test the growing, har- itoring plan must include a sampling
vesting, packing, and holding environ- plan that specifies:
ment for Listeria species or L. (1) What you will test collected sam-
monocytogenes in accordance with the ples for (i.e., Listeria species or L.
requirements of § 112.145. monocytogenes);
(b) You must either: (2) How often you will collect envi-
(1) Test spent sprout irrigation water ronmental samples, which must be no
from each production batch of sprouts less than monthly, and at what point
for E. coli O157:H7, Salmonella species, during production you will collect the
and any pathogens meeting the criteria samples; and
in paragraph (c) of this section, in ac- (3) Sample collection sites; the num-
cordance with the requirements of ber and location of sampling sites must
§ 112.147; or be sufficient to determine whether
(2) If testing spent sprout irrigation measures are effective and must in-
water is not practicable (for example, clude appropriate food contact surfaces
soil-grown sprouts harvested with and non-food-contact surfaces of equip-
roots or for hydroponically grown ment, and other surfaces within the
sprouts that use very little water), test growing, harvesting, packing, and hold-
each production batch of sprouts at the ing environment.
330
(d) You must aseptically collect envi- identifies the number and location of
ronmental samples and test them for samples (of spent sprout irrigation
Listeria species or L. monocytogenes water or sprouts) to be collected for
using a method as set forth in § 112.152. each production batch of sprouts to en-
(e) Your written environmental mon- sure that the collected samples are rep-
itoring plan must include a corrective resentative of the production batch
action plan that, at a minimum, re- when testing for contamination.
quires you to take the actions in (b) In accordance with the written
§ 112.146, and details when and how you sampling plan required under para-
will accomplish those actions, if the graph (a) of this section, you must
growing, harvesting, packing, or hold- aseptically collect samples of spent
ing environment tests positive for Lis- sprout irrigation water or sprouts, and
teria species or L. monocytogenes. test the collected samples for patho-
§ 112.146 What actions must I take if gens using a method as set forth in
the growing, harvesting, packing, § 112.153. You must not allow the pro-
or holding environment tests posi- duction batch of sprouts to enter into
tive for Listeria species or L. commerce unless the results of the
monocytogenes? testing of spent sprout irrigation water
You must, at a minimum, take the or sprouts are negative for E. coli
following actions if you detect Listeria O157:H7, Salmonella species, and, if ap-
species or L. monocytogenes in the grow- plicable, a pathogen meeting the cri-
ing, harvesting, packing, or holding en- teria in § 112.144(c).
vironment: (c) Your written sampling plan must
(a) Conduct additional testing of sur- include a corrective action plan that at
faces and areas surrounding the area a minimum, requires you to take the
where Listeria species or L. actions in § 112.148, and details when
monocytogenes was detected to evaluate and how you will accomplish those ac-
the extent of the problem, including tions, if the samples of spent sprout ir-
the potential for Listeria species or L. rigation water or sprouts test positive
monocytogenes to have become estab- for E. coli O157:H7, Salmonella species,
lished in a niche; or a pathogen meeting the criteria in
(b) Clean and sanitize the affected § 112.144(c).
surfaces and surrounding areas;
(c) Conduct additional sampling and § 112.148 What actions must I take if
testing to determine whether the Lis- the samples of spent sprout irriga-
teria species or L. monocytogenes has tion water or sprouts test positive
been eliminated; for a pathogen?
(d) Conduct finished product testing You must, at a minimum, take the
when appropriate; following actions if the samples of
(e) Perform any other actions nec- spent sprout irrigation water or
essary to prevent recurrence of the sprouts test positive for E. coli O157:H7,
contamination; and Salmonella species, or a pathogen meet-
(f) Take appropriate action to pre- ing the criteria in § 112.144(c):
vent any food that is adulterated under (a) Take appropriate action to pre-
section 402 of the Federal Food, Drug, vent any food that is adulterated under
and Cosmetic Act from entering into section 402 of the Federal Food, Drug,
commerce. and Cosmetic Act from entering into
§ 112.147 What must I do to collect and commerce;
test samples of spent sprout irriga- (b) Take the steps required in
tion water or sprouts for patho- § 112.142(b) with respect to the lot of
gens? seeds or beans used to grow the af-
All of the following requirements fected production batch of sprouts (ex-
apply for collecting and testing sam- cept as allowed under § 112.142(c));
ples of spent sprout irrigation water or (c) Clean and sanitize the affected
sprouts for pathogens as required in surfaces and surrounding areas; and
§ 112.144(b): (d) Perform any other actions nec-

(a) You must establish and imple- essary to prevent reoccurrence of the
ment a written sampling plan that contamination.
331
§ 112.150 21 CFR Ch. I (4–1–23 Edition)
§ 112.150 Under this subpart, what re- Avenue NW., Washington, DC 20460.
quirements apply regarding You may inspect a copy at FDA’s Main
records? Library, 10903 New Hampshire Ave.,
(a) You must establish and keep Bldg. 2, Third Floor, Silver Spring, MD
records required under this subpart in 20993, 301–796–2039, or at the National
accordance with the requirements of Archives and Records Administration
subpart O of this part. (NARA). For information on the avail-
(b) You must establish and keep the ability of this material at NARA, call
following records: 202–741–6030, or go to: http://
(1) Documentation of your treatment www.archives.gov/federal_register/
of seeds or beans to reduce microorga- code_of_federal_regulations/
nisms of public health significance in ibr_locations.html; or
the seeds or beans, at your farm; or al- (b)(1) A scientifically valid method
ternatively, documentation (such as a that is at least equivalent to the meth-
Certificate of Conformance) from your od of analysis in § 112.151(a) in accu-
seed supplier that seeds or beans are racy, precision, and sensitivity; or
treated to reduce microorganisms of (2) For any other indicator of fecal
public health significance and are ap- contamination you may test for pursu-
propriately handled and packaged fol- ant to § 112.49(a), a scientifically valid
lowing the treatment, in accordance method.
with the requirements of § 112.142(e);
(2) Your written environmental mon- § 112.152 What methods must I use to
itoring plan in accordance with the retest the growing, harvesting, pack-
quirements of § 112.145; ing, and holding environment for
(3) Your written sampling plan for Listeria species or L.
monocytogenes to satisfy the re-
each production batch of sprouts in ac- quirements of § 112.144(a)?
cordance with the requirements of
§ 112.147(a) and (c); You must test the growing, har-
(4) Documentation of the results of vesting, packing, and holding environ-
all analytical tests conducted for pur- ment for Listeria species or L.
poses of compliance with this subpart; monocytogenes using:
(5) Any analytical methods you use (a) The method of analysis described
in lieu of the methods that are incor- in ‘‘Testing Methodology for Listeria
porated by reference in §§ 112.152 and species or L. monocytogenes in Environ-
112.153; and mental Samples,’’ Version 1, October
(6) Documentation of actions you 2015, U.S. Food and Drug Administra-
take in accordance with §§ 112.142(b) tion. The Director of the Federal Reg-
and (c), 112.146, and 112.148. ister approves this incorporation by
reference in accordance with 5 U.S.C.
Subpart N—Analytical Methods 552(a) and 1 CFR part 5. You may ob-
tain a copy from, and/or inspect a copy
§ 112.151 What methods must I use to at, the Division of Produce Safety,
test the quality of water to satisfy Center for Food Safety and Applied Nu-
the requirements of § 112.46? trition (CFSAN), U.S. Food and Drug
You must test the quality of water Administration, 5001 Campus Dr., Col-
using: lege Park, MD 20740, 240–402–1600;
(a) The method of analysis published FDA’s Main Library, 10903 New Hamp-
by the U.S. Environmental Protection shire Ave., Bldg. 2, Third Floor, Silver
Agency (EPA), ‘‘Method 1603: Esch- Spring, MD 20993, 301–796–2039; http://
erichia coli (E. coli) in Water by Mem- www.fda.gov/fsma; or at the National
brane Filtration Using Modified mem- Archives and Records Administration
brane-Thermotolerant Escherichia coli (NARA). For information on the avail-
Agar (Modified mTEC), EPA–821–R–09– ability of this material at NARA, call
007),’’ December, 2009. The Director of 202–741–6030, or go to: http://
the Federal Register approves this in- www.archives.gov/federal_register/
corporation by reference in accordance code_of_federal_regulations/
with 5 U.S.C. 552(a) and 1 CFR part 51. ibr_locations.html; or

You may obtain a copy from EPA, Of- (b) A scientifically valid method that
fice of Water (4303T), 1200 Pennsylvania is at least equivalent to the method of
332
analysis in § 112.152(a) in accuracy, pre- (iii) An adequate description (such as

cision, and sensitivity. the commodity name, or the specific
variety or brand name of a commodity,
§ 112.153 What methods must I use to and, when available, any lot number or
test spent sprout irrigation water other identifier) of covered produce ap-
(or sprouts) from each production
batch of sprouts for pathogens to plicable to the record;
satisfy the requirements of (iv) The location of a growing area
§ 112.144(b) and (c)? (for example, a specific field) or other
area (for example, a specific packing
You must test spent sprout irrigation
shed) applicable to the record; and
water (or sprouts) from each produc-
(v) The date and time of the activity
tion batch for pathogens using:
documented;
(a) For E. coli O157:H7, Salmonella spe-
(2) Be created at the time an activity
cies:
is performed or observed;
(1) The method of analysis described
(3) Be accurate, legible, and indelible;
in ‘‘Testing Methodologies for E. coli
and
O157:H7 and Salmonella species in Spent
(4) Be dated, and signed or initialed
Sprout Irrigation Water (or Sprouts),’’
by the person who performed the activ-
Version 1, October 2015, U.S. Food and
ity documented.
Drug Administration. The Director of
(b) Records required under §§ 112.7(b),
the Federal Register approves this in-
112.30(b), 112.50(b)(2), (4), and (6),
corporation by reference in accordance
112.60(b)(2), 112.140(b)(1) and (2), and
with 5 U.S.C. 552(a) and 1 CFR part 5.
112.150(b)(1), (4), and (6), must be re-
You may obtain a copy from, and/or in-
spect a copy at, the Division of viewed, dated, and signed, within a rea-
Produce Safety, Center for Food Safety sonable time after the records are
and Applied Nutrition (CFSAN), Food made, by a supervisor or responsible
and Drug Administration, 5001 Campus party.
Dr., College Park, MD 20740, 240–402– [80 FR 74547, Nov. 27, 2015, as amended at 84
1600; FDA’s Main Library, 10903 New FR 12491, Apr. 2, 2019]
Hampshire Ave., Bldg. 2, Third Floor,
Silver Spring, MD 20993, 301–796–2039; § 112.162 Where must I store records?
http://www.fda.gov/fsma; or at the Na- (a) Offsite storage of records is per-
tional Archives and Records Adminis- mitted if such records can be retrieved
tration (NARA). For information on and provided onsite within 24 hours of
the availability of this material at request for official review.
NARA, call 202–741–6030, or go to: http:// (b) Electronic records are considered
www.archives.gov/federal_register/ to be onsite at your farm if they are
code_of_federal_regulations/ accessible from an onsite location at
ibr_locations.html; or your farm.
(2) A scientifically valid method that
is at least equivalent to the method of § 112.163 May I use existing records to
analysis in § 112.153(a)(1) in accuracy, satisfy the requirements of this
precision, and sensitivity; and part?
(b) For any other pathogen(s) meet- (a) Existing records (e.g., records that
ing the criteria in § 112.144(c), a sci- are kept to comply with other Federal,
entifically valid method. State, or local regulations, or for any
other reason) do not need to be dupli-
Subpart O—Records cated if they contain all of the required
information and satisfy the require-
§ 112.161 What general requirements ments of this part. Existing records
apply to records required under may be supplemented as necessary to
this part? include all of the required information
(a) Except as otherwise specified, all and satisfy the requirements of this
records required under this part must: part.
(1) Include, as applicable: (b) The information required by this
(i) The name and location of your part does not need to be kept in one set
farm; of records. If existing records contain

(ii) Actual values and observations some of the required information, any
obtained during monitoring; new information required by this part
333
§ 112.164 21 CFR Ch. I (4–1–23 Edition)
may be kept either separately or com- them available and accessible to FDA
bined with the existing records. for inspection and copying.
(b) If you use electronic techniques
§ 112.164 How long must I keep to keep records, or to keep true copies
records?
of records, or if you use reduction tech-
(a)(1) You must keep records required niques such as microfilm to keep true
by this part for at least 2 years past copies of records, you must provide the
the date the record was created. records to FDA in a format in which
(2) Records that a farm relies on dur- they are accessible and legible.
ing the 3-year period preceding the ap- (c) If your farm is closed for a pro-
plicable calendar year to satisfy the longed period, the records may be
criteria for a qualified exemption, in
transferred to some other reasonably
accordance with §§ 112.5 and 112.7, must
accessible location but must be re-
be retained as long as necessary to sup-
turned to your farm within 24 hours for
port the farm’s status during the appli-
official review upon request.
cable calendar year.
(b) Records that relate to the general § 112.167 Can records that I provide to
adequacy of the equipment or processes FDA be disclosed to persons outside
or records that relate to analyses, sam- of FDA?
pling, or action plans being used by a
farm, including the results of scientific Records obtained by FDA in accord-
studies, tests, and evaluations, must be ance with this part are subject to the
retained at the farm for at least 2 years disclosure requirements under part 20
after the use of such equipment or of this chapter.
processes, or records related to anal-
yses, sampling, or action plans, is dis- Subpart P—Variances
continued.
§ 112.171 Who may request a variance
§ 112.165 What formats are acceptable from the requirements of this part?
for the records I keep?
A State, Federally-recognized tribe
You must keep records as: (or ‘‘tribe’’), or a foreign country from
(a) Original records; which food is imported into the United
(b) True copies (such as photocopies, States may request a variance from
pictures, scanned copies, microfilm, one or more requirements of this part,
microfiche, or other accurate reproduc- where the State, tribe, or foreign coun-
tions of the original records); or try determines that:
(c) Electronic records. Records that
(a) The variance is necessary in light
are established or maintained to sat-
of local growing conditions; and
isfy the requirements of this part and
that meet the definition of electronic (b) The procedures, processes, and
records in § 11.3(b)(6) of this chapter are practices to be followed under the vari-
exempt from the requirements of part ance are reasonably likely to ensure
11 of this chapter. Records that satisfy that the produce is not adulterated
the requirements of this part, but that under section 402 of the Federal Food,
also are required under other applica- Drug, and Cosmetic Act and to provide
ble statutory provisions or regulations, the same level of public health protec-
remain subject to part 11 of this chap- tion as the requirements of this part.
ter.
§ 112.172 How may a State, tribe, or
§ 112.166 What requirements apply for foreign country request a variance
making records available and ac- from one or more requirements of
cessible to FDA? this part?
(a) You must have all records re- To request a variance from one or
quired under this part readily available more requirements of this part, the
and accessible during the retention pe- competent authority (i.e., the regu-
riod for inspection and copying by FDA latory authority for food safety) for a
upon oral or written request, except State, tribe, or a foreign country must
that you have 24 hours to obtain submit a petition under § 10.30 of this
records you keep offsite and make chapter.
334
§ 112.173 What must be included in the § 112.176 What process applies to a pe-
Statement of Grounds in a petition tition requesting a variance?
requesting a variance? (a) In general, the procedures set
In addition to the requirements set forth in § 10.30 of this chapter govern
forth in § 10.30 of this chapter, the our response to a petition requesting a
Statement of Grounds in a petition re- variance.
questing a variance must: (b) Under § 10.30(h)(3) of this chapter,
(a) Provide a statement that the ap- we will publish a notice in the FEDERAL
plicable State, tribe, or foreign country REGISTER, requesting information and
has determined that the variance is views on a filed petition, including in-
necessary in light of local growing con- formation and views from persons who
ditions and that the procedures, proc- could be affected by the variance if the
esses, and practices to be followed petition were to be granted (e.g., be-
under the variance are reasonably like- cause their farm is covered by the peti-
ly to ensure that the produce is not tion or as a person similarly situated
adulterated under section 402 of the to persons covered by the petition).
Federal Food, Drug and Cosmetic Act (c) Under § 10.30(e)(3) of this chapter,
and to provide the same level of public we will respond to the petitioner in
health protection as the requirements writing and will also make public a no-
of this part; tice on FDA’s Web site announcing our
(b) Describe with particularity the decision to either grant or deny the pe-
variance requested, including the per- tition.
sons to whom the variance would apply (1) If we grant the petition, either in
and the provision(s) of this part to whole or in part, we will specify the
persons to whom the variance applies
which the variance would apply;
and the provision(s) of this part to
(c) Present information dem-
which the variance applies.
onstrating that the procedures, proc- (2) If we deny the petition (including
esses, and practices to be followed partial denials), our written response
under the variance are reasonably like- to the petitioner and our public notice
ly to ensure that the produce is not announcing our decision to deny the
adulterated under section 402 of the petition will explain the reason(s) for
Federal Food, Drug, and Cosmetic Act the denial.
(21 U.S.C. 342) and to provide the same (d) We will make readily accessible
level of public health protection as the to the public, and periodically update,
requirements of this part. a list of filed petitions requesting
variances, including the status of each
§ 112.174 What information submitted
in a petition requesting a variance petition (for example, pending, grant-
or submitted in comments on such ed, or denied).
a petition are publicly available?
§ 112.177 Can an approved variance
We will presume that information apply to any person other than
submitted in a petition requesting a those identified in the petition re-
variance and comments submitted on questing that variance?
such a petition, including a request (a) A State, tribe, or a foreign coun-
that a variance be applied to its simi- try that believes that a variance re-
larly situated persons, does not contain quested by a petition submitted by an-
information exempt from public disclo- other State, tribe, or foreign country
sure under part 20 of this chapter and should also apply to similarly situated
will be made public as part of the dock- persons in its jurisdiction may request
et associated with this request. that the variance be applied to its
similarly situated persons by submit-
§ 112.175 Who responds to a petition ting comments in accordance with
requesting a variance? § 10.30 of this chapter. These comments
The Director or Deputy Directors of must include the information required
the Center for Food Safety and Applied in § 112.173. If FDA determines that
Nutrition (CFSAN), or the Director, Of- these comments should instead be

fice of Compliance, CFSAN, responds treated as a separate request for a vari-
to a request for a variance. ance, FDA will notify the State, tribe,
335
§ 112.178 21 CFR Ch. I (4–1–23 Edition)
or foreign country that submitted § 112.181 What procedures apply if

these comments that a separate re- FDA determines that an approved
quest must be submitted in accordance variance should be modified or re-
with §§ 112.172 and 112.173. voked?
(b) If we grant a petition requesting a (a) We will provide the following no-
variance, in whole or in part, we may tifications:
specify that the variance also applies (1) We will notify a State, tribe, or a
to persons in a specific location who foreign country directly, in writing at
are similarly situated to those identi- the address identified in its petition, if
fied in the petition. we determine that a variance granted
in response to its petition should be
(c) If we specify that the variance
modified or revoked. Our direct, writ-
also applies to persons in a specific lo-
ten notification will provide the State,
cation who are similarly situated to
tribe, or foreign country with an oppor-
those identified in the petition, we will tunity to request an informal hearing
inform the applicable State, tribe, or under part 16 of this chapter.
foreign country where the similarly (2) We will publish a notice of our de-
situated persons are located of our determination that a variance should be
cision in writing and will publish a no- modified or revoked in the FEDERAL
tice on our Web site announcing our REGISTER. This notice will establish a
decision to apply the variance to simi- public docket so that interested parties
larly situated persons in that par- may submit written comments on our
ticular location. determination.
(3) When applicable, we will:
§ 112.178 Under what circumstances (i) Notify in writing any States,
may FDA deny a petition request- tribes, or foreign countries where a
ing a variance? variance applies to similarly situated
We may deny a variance request if it persons of our determination that the
does not provide the information re- variance should be modified or re-
quired under § 112.173 (including the revoked;
quirements of § 10.30 of this chapter), or (ii) Provide those States, tribes, or
if we determine that the variance is foreign countries with an opportunity
not reasonably likely to ensure that to request an informal hearing under
the produce is not adulterated under part 16 of this chapter; and
(iii) Include in the FEDERAL REGISTER
section 402 of the Federal Food, Drug
notice described in paragraph (a)(2) of
and Cosmetic Act and to provide the
this section public notification of our
same level of public health protection
decision to modify or revoke the vari-
as the requirements of this part. ance granted to States, tribes, or for-
eign countries in which similarly situ-
§ 112.179 When does a variance ap-
proved by FDA become effective? ated persons are located.
(b) We will consider submissions from
A variance approved by FDA becomes affected States, tribes, or foreign coun-
effective on the date of our written de- tries and from other interested parties
cision on the petition. as follows:
(1) We will consider requests for hear-
§ 112.180 Under what circumstances ings by affected States, tribes, or for-
may FDA modify or revoke an ap- eign countries under part 16 of this
proved variance? chapter.
We may modify or revoke a variance (i) If FDA grants a hearing, we will
if we determine that such variance is provide the State, tribe, or foreign
not reasonably likely to ensure that country with an opportunity to make
the produce is not adulterated under an oral submission. We will provide no-
section 402 of the Federal Food, Drug, tice on our Web site of the hearing, in-
and Cosmetic Act and to provide the cluding the time, date, and place of the
same level of public health protection hearing.
as the requirements of this part. (ii) If more than one State, tribe, or
foreign country requests an informal
hearing under part 16 of this chapter
336
about our determination that a par- (1) Adulterated within the meaning
ticular variance should be modified or of:
revoked, we may consolidate such re- (i) Section 402(a)(3) of the Federal
quests (for example, into a single hear- Food, Drug, and Cosmetic Act in that
ing). the food has been grown, harvested,
(2) We will consider written submis- packed, or held under such conditions
sions submitted to the public docket that it is unfit for food; or
from interested parties. (ii) Section 402(a)(4) of the Federal
(c) We will provide notice of our final Food, Drug, and Cosmetic Act in that
decision as follows: the food has been prepared, packed, or
(1) On the basis of the administrative held under insanitary conditions
record, FDA will issue a written deci- whereby it may have become contami-
sion, as provided for under part 16 of nated with filth, or whereby it may
this chapter. have been rendered injurious to health;
(2) We will publish a notice of our de- or
cision in the FEDERAL REGISTER. The (2) In violation of section 361 of the
effective date of the decision will be Public Health Service Act (42 U.S.C.
the date of publication of the notice. 264).
§ 112.182 What are the permissible § 112.193 What are the provisions for
types of variances that may be coordination of education and en-
granted? forcement?
A variance(s) may be requested for Under section 419(b)(2)(A) of the Fed-
one or more requirements in subparts eral Food, Drug, and Cosmetic Act,
A through O of this part. Examples of FDA coordinates education and en-
permissible types of variances include: forcement activities by State, terri-
(a) Variance from the microbial qual- torial, tribal, and local officials by
ity criteria when agricultural water is helping develop education, training,
used during growing activities for cov- and enforcement approaches.
ered produce (other than sprouts) using
a direct water application method, es- Subpart R—Withdrawal of
tablished in § 112.44(b); Qualified Exemption
(b) Variance from the microbial die-
off rate that is used to determine the § 112.201 Under what circumstances
time interval between last irrigation can FDA withdraw a qualified ex-
and harvest, and/or the accompanying emption in accordance with the re-
maximum time interval, established in quirements of § 112.5?
§ 112.45(b)(1)(i); and (a) We may withdraw your qualified
(c) Variance from the approach or exemption under § 112.5:
frequency for testing water used for (1) In the event of an active inves-
purposes that are subject to the re- tigation of a foodborne illness outbreak
quirements of § 112.44(b), established in that is directly linked to your farm; or
§ 112.46(b). (2) If we determine that it is nec-
essary to protect the public health and
Subpart Q—Compliance and prevent or mitigate a foodborne illness
Enforcement outbreak based on conduct or condi-
tions associated with your farm that
§ 112.192 What is the applicability and are material to the safety of the food
status of this part? that would otherwise be covered
(a) The failure to comply with the re- produce grown, harvested, packed or
quirements of this part, issued under held at your farm.
section 419 of the Federal Food, Drug, (b) Before FDA issues an order to
and Cosmetic Act, is a prohibited act withdraw your qualified exemption,
under section 301(vv) of the Federal FDA:
Food, Drug, and Cosmetic Act. (1) May consider one or more other
(b) The criteria and definitions in actions to protect the public health
this part apply in determining whether and prevent or mitigate a foodborne
a food is: illness outbreak, including a warning
337
§ 112.202 21 CFR Ch. I (4–1–23 Edition)
letter, recall, administrative deten- following circumstances that leads

tion, refusal of food offered for import, FDA to issue the order:
seizure, and injunction; (1) An active investigation of a
(2) Must notify the owner, operator, foodborne illness outbreak that is di-
or agent in charge of the farm, in writ- rectly linked to the farm; or
ing, of circumstances that may lead (2) Conduct or conditions associated
FDA to withdraw the exemption, and with a farm that are material to the
provide an opportunity for the owner, safety of the food that would otherwise
operator, or agent in charge of the be covered produce grown, harvested,
farm to respond in writing, within 15 packed and held at such farm.
calendar days of the date of receipt of (d) A statement that the farm must
the notification, to FDA’s notification; either:
and (1) Comply with subparts B through O
(3) Must consider the actions taken of this part on the date that is 120 cal-
by the farm to address the cir- endar days from the date of receipt of
cumstances that may lead FDA to the order, or within a reasonable time-
withdraw the exemption. frame, agreed to by FDA, based on a
written justification, submitted to
§ 112.202 What procedure will FDA use FDA, for a timeframe that exceeds 120
to withdraw an exemption? calendar days from the date of receipt
(a) An FDA Division Director in of the order; or
whose division the farm is located (or, (2) Appeal the order within 15 cal-
in the case of a foreign farm, the Direc- endar days of the date of receipt of the
tor of the Office of Compliance in the order in accordance with the require-
Center for Food Safety and Applied Nu- ments of § 112.206.
trition), or an FDA official senior to ei- (e) A statement that a farm may re-
ther such Director, must approve an quest that FDA reinstate an exemption
order to withdraw the exemption be- that was withdrawn by following the
fore the order is issued. procedures in § 112.213;
(b) Any officer or qualified employee (f) The text of section 419(f) of the
of FDA may issue an order to withdraw Federal Food, Drug, and Cosmetic Act
the exemption after it has been ap- and of this subpart;
proved in accordance with paragraph (g) A statement that any informal
(a) of this section. hearing on an appeal of the order must
(c) FDA must issue an order to with- be conducted as a regulatory hearing
draw the exemption to the owner, oper- under part 16 of this chapter, with cer-
ator, or agent in charge of the farm. tain exceptions described in § 112.208;
(d) FDA must issue an order to with- (h) The mailing address, telephone
draw the exemption in writing, signed number, email address, fax number,
and dated by the officer or qualified and name of the FDA Division Director
employee of FDA who is issuing the in whose division the farm is located
order. (or for foreign farms, the same infor-
[80 FR 74547, Nov. 27, 2015, as amended at 85 mation for the Director of the Office of
FR 16552, Mar. 24, 2020] Compliance in the Center for Food
Safety and Applied Nutrition); and
§ 112.203 What information must FDA (i) The name and the title of the FDA
include in an order to withdraw a representative who approved the order.
qualified exemption?
An order to withdraw a qualified ex- FR 16552, Mar. 24, 2020]
emption applicable to a farm under
§ 112.5 must include the following infor- § 112.204 What must I do if I receive an
mation: order to withdraw a qualified ex-
(a) The date of the order; emption applicable to my farm?
(b) The name, address and location of The owner, operator, or agent in
the farm; charge of a farm that receives an order
(c) A brief, general statement of the to withdraw a qualified exemption ap-

reasons for the order, including infor- plicable to that farm under § 112.5 must
mation relevant to one or both of the either:
338
(a) Comply with applicable require- (1) Submit the appeal in writing to
ments of this part within 120 calendar the FDA Division Director in whose di-
days of the date from receipt of the vision the farm is located (or in the
order or, if operations have ceased and case of a foreign farm, the Director of
will not resume within 120 calendar the Office of Compliance in the Center
days, before the beginning of oper- for Food Safety and Applied Nutrition),
ations in the next growing season, or at the mailing address, email address,
within a reasonable timeframe, agreed or fax number identified in the order
to by FDA, based on a written jus- within 15 calendar days of the date of
tification, submitted to FDA, for a receipt of the order; and
timeframe that exceeds 120 calendar (2) Respond with particularity to the
days from the date of receipt of the facts and issues contained in the order,
order; or including any supporting documenta-
(b) Appeal the order within 15 cal- tion upon which the owner, operator or
endar days of the date of receipt of the agent in charge of the farm relies.
order in accordance with the require- (b) In a written appeal of the order
ments of § 112.206. withdrawing an exemption provided
under § 112.5, the owner, operator, or
§ 112.205 Can I appeal or request a agent in charge of the farm may in-
hearing on an order to withdraw a clude a written request for an informal
qualified exemption applicable to hearing as provided in § 112.207.
my farm?
(a) Submission of an appeal, includ- FR 16552, Mar. 24, 2020]
ing submission of a request for an in-
formal hearing, will not operate to § 112.207 What is the procedure for re-
delay or stay any administrative ac- questing an informal hearing?
tion, including enforcement action by (a) If the owner, operator, or agent in
FDA, unless the Commissioner of Food charge of the farm appeals the order,
and Drugs, as a matter of discretion, the owner, operator, or agent in charge
determines that delay or a stay is in of the farm:
the public interest. (1) May request an informal hearing;
(b) If the owner, operator, or agent in and
charge of the farm appeals the order, (2) Must submit any request for an
and FDA confirms the order: informal hearing together with its
(1) The owner, operator, or agent in written appeal submitted in accordance
charge of the farm must comply with with § 112.206 within 15 calendar days of
applicable requirements of this part the date of receipt of the order.
within 120 calendar days from the date (b) A request for an informal hearing
of receipt of the order, or, if operations may be denied, in whole or in part, if
have ceased and will not resume within the presiding officer determines that
120 calendar days, before the beginning no genuine and substantial issue of ma-
of operations in the next growing sea- terial fact has been raised by the mate-
son, or within a reasonable timeframe, rial submitted. If the presiding officer
agreed to by FDA, based on a written determines that a hearing is not justi-
justification, submitted to FDA, for a fied, a written notice of the determina-
timeframe that exceeds 120 calendar tion will be given to the owner, oper-
days from the date of receipt of the ator, or agent in charge of the farm ex-
order; and plaining the reason for the denial.
(2) The owner, operator, or agent in
charge of the farm is no longer subject § 112.208 What requirements are appli-
to the modified requirements in §§ 112.6 cable to an informal hearing?
and 112.7. If the owner, operator, or agent in
charge of the farm requests an infor-
§ 112.206 What is the procedure for mal hearing, and FDA grants the re-
submitting an appeal? quest:
(a) To appeal an order to withdraw a (a) The hearing will be held within 15
qualified exemption applicable to a calendar days after the date the appeal
farm under § 112.5, the owner, operator, is filed or, if applicable, within a time-
or agent in charge of the farm must: frame agreed upon in writing by the
339
§ 112.209 21 CFR Ch. I (4–1–23 Edition)
owner, operator, or agent in charge of for reconsideration or a stay of the pre-

the farm and FDA. siding officer’s final decision.
(b) The presiding officer may require (7) If FDA grants a request for an in-
that a hearing conducted under this formal hearing on an appeal of an order
subpart be completed within 1 calendar withdrawing an exemption, the hearing
day, as appropriate. must be conducted as a regulatory
(c) FDA must conduct the hearing in hearing under a regulation in accord-
accordance with part 16 of this chapter, ance with part 16 of this chapter, ex-
except that: cept that § 16.95(b) does not apply to a
hearing under this subpart. With re-
(1) The order withdrawing an exemp-
spect to a regulatory hearing under
tion under § 112.5, rather than the no-
this subpart, the administrative record
tice under § 16.22(a) of this chapter, pro-
of the hearing specified in §§ 16.80(a)(1),
vides notice of the opportunity for a
(2), (3), and (5) of this chapter and
hearing under this section and is part
112.208(c)(5) constitutes the exclusive
of the administrative record of the reg- record for the presiding officer’s final
ulatory hearing under § 16.80(a) of this decision. For purposes of judicial re-
chapter. view under § 10.45 of this chapter, the
(2) A request for a hearing under this record of the administrative pro-
subpart must be addressed to the FDA ceeding consists of the record of the
Division Director (or, in the case of a hearing and the presiding officer’s final
foreign farm, the Director of the Office decision.
of Compliance in the Center for Food
Safety and Applied Nutrition) as pro- [80 FR 74547, Nov. 27, 2015, as amended at 85
FR 16552, Mar. 24, 2020]
vided in the order withdrawing an ex-
emption. § 112.209 Who is the presiding officer
(3) Section 112.209, rather than for an appeal and for an informal
§ 16.42(a) of this chapter, describes the hearing?
FDA employees who preside at hear- The presiding officer for an appeal,
ings under this subpart. and for an informal hearing, must be
(4) Section 16.60(e) and (f) of this an Office of Regulatory Affairs Pro-
chapter does not apply to a hearing gram Director or another FDA official
under this subpart. The presiding offi- senior to an FDA Division Director.
cer must prepare a written report of [85 FR 16552, Mar. 24, 2020]
the hearing. All written material pre-
sented at the hearing will be attached § 112.210 What is the timeframe for
to the report. The presiding officer issuing a decision on an appeal?
must include as part of the report of (a) If the owner, operator, or agent in
the hearing a finding on the credibility charge of a farm appeals the order
of witnesses (other than expert wit- without requesting a hearing, the pre-
nesses) whenever credibility is a mate- siding officer must issue a written re-
rial issue, and must include a proposed port that includes a final decision con-
decision, with a statement of reasons. firming or revoking the withdrawal by
The hearing participant may review the 10th calendar day after the appeal
and comment on the presiding officer’s is filed.
report within 2 calendar days of (b) If the owner, operator, or agent in
issuance of the report. The presiding charge of a farm appeals the order and
officer will then issue the final deci- requests an informal hearing:
sion. (1) If FDA grants the request for a
(5) Section 16.80(a)(4) of this chapter hearing and the hearing is held, the
does not apply to a regulatory hearing presiding officer must provide a 2 cal-
under this subpart. The presiding offi- endar day opportunity for the hearing
cer’s report of the hearing and any participants to review and submit com-
comments on the report by the hearing ments on the report of the hearing
participant under § 112.208(c)(4) are part under § 112.208(c)(4), and must issue a
of the administrative record. final decision within 10 calendar days
(6) No party shall have the right, after the hearing is held; or
under § 16.119 of this chapter to petition (2) If FDA denies the request for a
the Commissioner of Food and Drugs hearing, the presiding officer must
340
issue a final decision on the appeal Division Director in whose division

confirming or revoking the withdrawal your farm is located (or, in the case of
within 10 calendar days after the date a foreign farm, the Director of the Of-
the appeal is filed. fice of Compliance in the Center for
Food Safety and Applied Nutrition)
§ 112.211 When is an order to with-
will, on his or her own initiative or at
draw a qualified exemption applica-
ble to a farm revoked? the request of a farm, reinstate the
qualified exemption.
An order to withdraw a qualified ex-
(b) You may ask FDA to reinstate a
emption applicable to a farm under
qualified exemption that has been
§ 112.5 is revoked if:
(a) The owner, operator, or agent in withdrawn under the procedures of this
charge of the farm appeals the order subpart as follows:
and requests an informal hearing, FDA (1) Submit a request, in writing, to
grants the request for an informal the FDA Division Director in whose di-
hearing, and the presiding officer does vision your farm is located (or, in the
not confirm the order within the 10 cal- case of a foreign farm, the Director of
endar days after the hearing, or issues the Office of Compliance in the Center
a decision revoking the order within for Food Safety and Applied Nutrition);
that time; or and
(b) The owner, operator, or agent in (2) Present, in writing, data and in-
charge of the farm appeals the order formation to demonstrate that you
and requests an informal hearing, FDA have adequately resolved any problems
denies the request for an informal with the conduct and conditions that
hearing, and FDA does not confirm the are material to the safety of the food
order within the 10 calendar days after produced and harvested at your farm,
the appeal is filed, or issues a decision such that continued withdrawal of the
revoking the order within that time; or exemption is not necessary to protect
(c) The owner, operator, or agent in
the public health and prevent or miti-
charge of the farm appeals the order
gate a foodborne illness outbreak.
without requesting an informal hear-
ing, and FDA does not confirm the (c) If your qualified exemption was
order within the 10 calendar days after withdrawn under § 112.201(a)(1) and FDA
the appeal is filed, or issues a decision later determines, after finishing the
revoking the order within that time. active investigation of a foodborne ill-
(d) Confirmation of a withdrawal ness outbreak, that the outbreak is not
order by the presiding officer is consid- directly linked to your farm, FDA will
ered a final Agency action for purposes reinstate your qualified exemption
of 5 U.S.C. 702. under § 112.5, and FDA will notify you
in writing that your exempt status has
§ 112.213 If my qualified exemption is been reinstated.
withdrawn, under what cir- (d) If your qualified exemption was
cumstances would FDA reinstate
my qualified exemption? withdrawn under § 112.201(a)(1) and (2)
and FDA later determines, after fin-
(a) If the FDA Division Director in ishing the active investigation of a
whose division your farm is located (or,
foodborne illness outbreak, that the
in the case of a foreign farm, the Direc-
outbreak is not directly linked to your
tor of the Office of Compliance in the
farm, FDA will inform you of this find-
Center for Food Safety and Applied Nu-
trition) determines that the farm has ing, and you may ask FDA to reinstate
adequately resolved any problems with your qualified exemption under § 112.5,
the conduct and conditions that are in accordance with the requirements of
material to the safety of the food pro- paragraph (b) of this section.
duced or harvested at such farm, and [80 FR 74547, Nov. 27, 2015, as amended at 85
that continued withdrawal of the ex- FR 16552, Mar. 24, 2020]
emption is not necessary to protect the

public health or prevent or mitigate a
foodborne illness outbreak, the FDA
341
PART 113—THERMALLY PROCESSED (c) Come-up-time means the time

LOW-ACID FOODS PACKAGED which elapses between the introduction
IN HERMETICALLY SEALED CON- of steam into the closed retort and the
time when the retort reaches the re-
TAINERS quired processing temperature.
(d) Commercial processor includes any
person engaged in commercial, custom,
Sec. or institutional (church, school, penal,
113.3 Definitions. or other organization) processing of
113.5 Current good manufacturing practice. food, including pet food. Persons en-
113.10 Personnel. gaged in the production of foods that
are to be used in market or consumer
Subpart B [Reserved] tests are also included.
Subpart C—Equipment (e) Commercial sterility: (1) ‘‘Commer-
cial sterility’’ of thermally processed
113.40 Equipment and procedures. food means the condition achieved—
(i) By the application of heat which
Subpart D—Control of Components, Food renders the food free of—
Product Containers, Closures, and In-
(a) Microorganisms capable of repro-
Process Material
ducing in the food under normal non-
113.60 Containers. refrigerated conditions of storage and
distribution; and
Subpart E—Production and Process (b) Viable microorganisms (including
Controls spores) of public health significance; or
113.81 Product preparation. (ii) By the control of water activity
113.83 Establishing scheduled processes. and the application of heat, which ren-
113.87 Operations in the thermal processing ders the food free of microorganisms
room. capable of reproducing in the food
113.89 Deviations in processing, venting, or under normal nonrefrigerated condi-
control of critical factors. tions of storage and distribution.
(2) ‘‘Commercial sterility’’ of equip-
Subpart F—Records and Reports ment and containers used for aseptic
113.100 Processing and production records. processing and packaging of food
means the condition achieved by appli-
AUTHORITY: 21 U.S.C. 342, 371, 374; 42 U.S.C.
264.
cation of heat, chemical sterilant(s), or
other appropriate treatment that ren-
SOURCE: 44 FR 16215, Mar. 16, 1979, unless ders the equipment and containers free
otherwise noted. of viable microorganisms having public
health significance, as well as micro-
Subpart A—General Provisions organisms of nonhealth significance,
capable of reproducing in the food
§ 113.3 Definitions. under normal nonrefrigerated condi-
For the purposes of this part, the fol- tions of storage and distribution.
lowing definitions apply: (f) Critical factor means any property,
(a) Aseptic processing and packaging characteristic, condition, aspect, or
means the filling of a commercially other parameter, variation of which
sterilized cooled product into may affect the scheduled process and
presterilized containers, followed by the attainment of commercial ste-
aseptic hermetical sealing, with a rility.
presterilized closure, in an atmosphere (g) Flame sterilizer means an appa-
free of microorganisms. ratus in which hermetically sealed con-
(b) Bleeders means openings used to tainers are agitated at atmospheric
remove air that enters with steam pressure, by either continuous, dis-
from retorts and steam chambers and continuous, or reciprocating move-
to promote circulation of steam in ment, with impinging gas flames to
such retorts and steam chambers. achieve sterilization temperatures. A

Bleeders may serve as a means of re- holding period in a heated section may
moving condensate. follow the initial heating period.
342
(h) Headspace, gross is the vertical quate under the conditions of manufac-
distance between the level of the prod- ture for a given product to achieve
uct (generally the liquid surface) in an commercial sterility. This process may
upright rigid container and the top be in excess of that necessary to ensure
edge of the container (the top of the destruction of microorganisms of pub-
double seam of a can or the top edge of lic health significance, and shall be at
a glass jar). least equivalent to the process estab-
(i) Headspace, net of a container is the lished by a competent processing au-
vertical distance between the level of thority to achieve commercial ste-
the product (generally the liquid sur- rility.
face) in the upright rigid container and (s) Shall is used to state mandatory
the inside surface of the lid. requirements.
(j) Hermetically sealed container means
(t) Should is used to state rec-
a container that is designed and in-
ommended or advisory procedures or to
tended to be secure against the entry
identify recommended equipment.
of microorganisms and thereby to
maintain the commercial sterility of (u) Vacuum-packed products means
its contents after processing. those products that are sealed in a con-
(k) Incubation means the holding of a tainer under the vacuum specified in
sample(s) at a specified temperature the scheduled process, the maintenance
for a specified period of time for the of which vacuum is critical to the ade-
purpose of permitting or stimulating quacy of the scheduled process.
the growth of microorganisms. (v) Vents means openings through the
(l) Initial temperature means the aver- retort shell, controlled by gate, plug
age temperature of the contents of the cock, or other adequate valves used for
coldest container to be processed at the the elimination of air during the vent-
time the thermal processing cycle being period.
gins, as determined after thorough stir- (w) Water activity (aw) is a measure of
ring or shaking of the filled and sealed the free moisture in a product and is
container. the quotient of the water vapor pres-
(m) Lot means that amount of a prod- sure of the substance divided by the
uct produced during a period of time vapor pressure of pure water at the
indicated by a specific code. same temperature.
(n) Low-acid foods means any foods,
other than alcoholic beverages, with a § 113.5 Current good manufacturing
finished equilibrium pH greater than practice.
4.6 and a water activity (aw) greater The criteria in §§ 113.10, 113.40, 113.60,
than 0.85. Tomatoes and tomato prod- 113.81, 113.83, 113.87, 113.89, and 113.100
ucts having a finished equilibrium pH shall apply in determining whether the
less than 4.7 are not classed as low-acid facilities, methods, practices, and con-
foods. trols used by the commercial processor
(o) Minimum thermal process means in the manufacture, processing, or
the application of heat to food, either packing of low-acid foods in hermeti-
before or after sealing in a hermeti-
cally sealed containers are operated or
cally sealed container, for a period of
administered in a manner adequate to
time and at a temperature scientif-
protect the public health.
ically determined to be adequate to en-
sure destruction of microorganisms of § 113.10 Personnel.
public health significance.
(p) Operating process means the proc- The operators of processing systems,
ess selected by the processor that retorts, aseptic processing and pack-
equals or exceeds the minimum re- aging systems and product formulating
quirements set forth in the scheduled systems (including systems wherein
process. water activity is used in conjunction
(q) Retort means any closed vessel or with thermal processing) and container
other equipment used for the thermal closure inspectors shall be under the
processing of foods. operating supervision of a person who

(r) Scheduled process means the proc- has attended a school approved by the
ess selected by the processor as ade- Commissioner for giving instruction
343
§ 113.40 21 CFR Ch. I (4–1–23 Edition)
appropriate to the preservation tech- glass thermometer shall not exceed 17

nology involved and who has been iden- °F per inch (4 °C per centimeter) of
tified by that school as having satisfac- graduated scale. A mercury-in-glass
torily completed the prescribed course thermometer that has a divided mer-
of instruction. This person shall super- cury column shall be considered defec-
vise only in those areas for which a tive.
school approved by the Commissioner (v) Each temperature-indicating de-
identifies the person as having satisfac- vice shall be installed where it can be
torily completed training. accurately and easily read. The tem-
perature-indicating device sensor shall
Subpart B [Reserved] be installed either within the retort
shell or in external wells attached to
Subpart C—Equipment the retort. External wells or pipes shall
be connected to the retort through at
§ 113.40 Equipment and procedures. least a 3⁄4-inch (2 centimeters) diameter
(a) Equipment and procedures for pres- opening and equipped with a 1⁄16-inch
sure processing in steam in still retorts— (1.5 millimeters) or larger bleeder open-
(1) Temperature-indicating device. Each ing so located as to provide a full flow
retort shall be equipped with at least of steam past the length of the tem-
one temperature-indicating device that perature-indicating device sensor. The
accurately indicates the temperature bleeders for external wells shall emit
during processing. Each temperature- steam continuously during the entire
indicating device shall have a sensor processing period. The temperature-in-
and a display. Each temperature-indi- dicating device—not the temperature
cating device and each reference device recording device—shall be the ref-
that is maintained by the processor erence instrument for indicating the
shall be tested for accuracy against a processing temperature.
reference device for which the accuracy (2) Temperature-recording device. Each
is traceable to a National Institute of retort shall have an accurate tempera-
Standards and Technology (NIST), or ture-recording device. Each tempera-
other national metrology institute, ture-recording device shall have a sen-
standard reference device by appro- sor and a mechanism for recording
priate standard procedures, upon in- temperatures to a permanent record,
stallation and at least once a year such as a temperature-recording chart.
thereafter, or more frequently if nec- The temperature-recording device sen-
essary, to ensure accuracy during proc- sor shall be installed either within the
essing. Each temperature-indicating retort shell or in a well attached to the
device and each reference device that is shell. Each temperature-recording de-
maintained by the processor shall have vice sensor well shall have a 1⁄16-inch
a tag, seal, or other means of identity. (1.5 millimeters) or larger bleeder that
(i) The design of the temperature-in- emits steam continuously during the
dicating device shall ensure that the processing period.
accuracy of the device is not affected (i) Analog or graphical recordings.
by electromagnetic interference and Temperature-recording devices that
environmental conditions. create analog or graphical recordings
(ii) Records of the accuracy of the may be used. Temperature-recording
temperature-indicating device and of a devices that record to charts shall be
reference device that is maintained by used only with the appropriate chart.
the processor shall be established and Each chart shall have a working scale
maintained in accordance with of not more than 55 °F per inch (12 °C
§ 113.100(c) and (d). per centimeter) within a range of 20 °F
(iii) A temperature-indicating device (10 °C) of the process temperature.
that is defective or cannot be adjusted Chart graduations shall not exceed 2 °F
to the accurate calibrated reference de- (1 °C) within a range of 10 °F (5 °C) of
vice shall be repaired before further the process temperature. Temperature-
use or replaced. recording devices that create
(iv) A temperature-indicating device multipoint plottings of temperature

shall be accurate to 1 °F (0.5 °C). The readings shall record the temperature
temperature range of a mercury-in- at intervals that will assure that the
344
parameters of the process time and steam inlet in bottom portion and vent
process temperature have been met. in top portion.
(ii) Digital recordings. Temperature- (6) Crate supports. A bottom crate
recording devices, such as data loggers, support shall be used in vertical still
that record numbers or create other retorts. Baffle plates shall not be used
digital records may be used. Such a de- in the bottom of still retorts.
vice shall record the temperature at in- (7) Steam spreaders. Steam spreaders
tervals that will assure that the pa- are continuations of the steam inlet
rameters of the process time and proc- line inside the retort. Horizontal still
ess temperature have been met. retorts shall be equipped with steam
(iii) Adjustments. The temperature-re- spreaders that extend the length of the
cording device shall be adjusted with retort. For steam spreaders along the
sufficient frequency to ensure agree- bottom of the retort, the perforations
ment as nearly as possible with, but to should be along the top 90° of the pipe,
be in no event higher than, the tem- that is, within 45° on either side of the
perature-indicating device during proc- top center. Horizontal still retorts over
essing. A means of preventing unau- 30 feet (9.1 meters) long should have
thorized changes in adjustment shall two steam inlets connected to the
be provided. A lock or a notice from spreader. In vertical still retorts, the
management posted at or near the tem- steam spreaders, if used, should be per-
perature-recording device that provides forated along the center line of the
a warning that only authorized persons pipe facing the interior of the retort or
are permitted to make adjustments is a along the sides of the pipe. The number
satisfactory means of preventing unau- of perforations should be such that the
thorized changes. total cross-sectional area of the per-
forations is equal to 1.5 to 2 times the
(iv) Temperature controller. The tem-
cross-sectional area of the smallest re-
perature-recording device may be com-
striction in the steam inlet line.
bined with the steam controller and
(8) Bleeders. Bleeders, except those for
may be a recorder-controller.
temperature-indicating device wells,
(3) Pressure gages. Each retort should shall be 1/8-inch (3 millimeters) or larg-
be equipped with a pressure gage that er and shall be wide open during the
is accurate to 2 pounds per square inch entire process, including the come-up
(13.8 kilopascals) or less. time. For horizontal still retorts,
(4) Steam controller. Each retort shall bleeders shall be located within ap-
be equipped with an automatic steam proximately 1 foot (30.5 centimeters) of
controller to maintain the retort tem- the outermost locations of containers
perature. This may be a recorder-con- at each end along the top of the retort.
troller when combined with a tempera- Additional bleeders shall be located
ture-recording device. The steam con- not more than 8 feet (2.4 meters) apart
troller may be air-operated and actu- along the top. Bleeders may be in-
ated by a temperature sensor posi- stalled at positions other than those
tioned near the temperature-indicating specified in this paragraph, as long as
device in the retort. Air-operated tem- there is evidence in the form of heat
perature controllers should have ade- distribution data that they accomplish
quate filter systems to ensure a supply adequate removal of air and circula-
of clean, dry air. A steam controller action of steam within the retort.
tivated by the steam pressure of the re- Vertical retorts shall have at least one
tort is acceptable if it is carefully bleeder opening located in that portion
maintained mechanically so that it op- of the retort opposite the steam inlet.
erates satisfactorily. In retorts having top steam inlet and
(5) Steam inlet. The steam inlet to bottom venting, a bleeder shall be in-
each still retort shall be large enough stalled in the bottom of the retort to
to provide sufficient steam for proper remove condensate. All bleeders shall
operation of the retort. Steam may be arranged so that the operator can
enter either the top portion or the bot- observe that they are functioning prop-
tom portion of the retort but, in any erly.

case, shall enter the portion of the re- (9) Stacking equipment and position of
tort opposite the vent; for example, containers. Crates, trays, gondolas, etc.,
345
§ 113.40 21 CFR Ch. I (4–1–23 Edition)
for holding containers shall be made of opposite the steam inlet; for example,
strap iron, adequately perforated sheet steam inlet in bottom portion and vent
metal, or other suitable material. in top portion. Where a retort manifold
When perforated sheet metal is used for connects several vent pipes from a sin-
the bottoms, the perforations should be gle still retort, it shall be controlled by
approximately the equivalent of 1-inch a gate, plug cock, or other adequate
(2.5 centimeters) holes on 2-inch (5.1 type of valve. The retort manifold shall
centimeters) centers. If dividers are be of a size that the cross-sectional
used between the layers of containers, area of the pipe is larger than the total
they should be perforated as stated in cross-sectional area of all connecting
this paragraph. The positioning of con- vents. The discharge shall not be di-
tainers in the retort, when specified in rectly connected to a closed drain
the scheduled process, shall be in ac- without an atmospheric break in the
cordance with that process. line. A manifold header connecting
(10) Air valves. Retorts using air for vents or manifolds from several still
pressure cooling shall be equipped with retorts shall lead to the atmosphere.
a suitable valve to prevent air leakage The manifold header shall not be con-
into the retort during processing. trolled by a valve and shall be of a size
(11) Water valves. Retorts using water that the cross-sectional area is at least
for cooling shall be equipped with a equal to the total cross-sectional area
suitable valve to prevent leakage of of all connecting retort manifold pipes
water into the retort during proc- from all retorts venting simulta-
essing. neously. Timing of the process shall
(12) Vents. Vents shall be installed in not begin until the retort has been
such a way that air is removed from properly vented and the processing
the retort before timing of the process temperature has been reached. Some
is started. Vents shall be controlled by typical installations and operating pro-
gate, plug cock, or other adequate type cedures reflecting the requirements of
valves which shall be fully open to per- this section for venting still retorts
mit rapid discharge of air from the re- without divider plates are given in
tort during the venting period. Vents paragraphs (a)(12)(i)(A) through
shall not be connected directly to a (a)(12)(i)(D) and (a)(12)(ii)(A) and
closed drain system. If the overflow is (a)(12)(ii)(B) of this section.
used as a vent, there shall be an atmos- (i) Venting horizontal retorts. (A) Vent-
pheric break in the line before it con- ing through multiple 1-inch (2.5 centi-
nects to a closed drain. The vent shall meters) vents discharging directly to
be located in that portion of the retort atmosphere.
346
ER03MR11.000</GPH>
(1) Specifications. One 1-inch (2.5 cen- (2) Venting method. Vent valves
timeters) vent for every 5 feet (1.5 me- should be wide open for at least 5 min-
ters) of retort length equipped with a utes and to at least 225 °F (107 °C), or at
gate or plug cock valve and discharging least 7 minutes and to at least 220 °F
to atmosphere; end vents not more (104.5 °C).
than 2.5 feet (76 centimeters) from ends (B) Venting through multiple 1-inch
of retort. (2.5 centimeters) vents discharging
through a manifold to atmosphere.
(1) Specifications. One 1-inch (2.5 cen- (2) Venting method. Manifold vent
timeters) vent for every 5 feet (1.5 me- gate or plug cock valve should be wide
ters) of retort length; and vents not open for at least 6 minutes and to at
over 2.5 feet (76 centimeters) from ends least 225 °F (107 °C), or for at least 8
of retort. Size of manifold—for retorts minutes and to at least 220 °F (104.5 °C).
less than 15 feet (4.6 meters) in length, (C) Venting through water spreaders.
2.5 inches (6.4 centimeters); for retorts
15 feet (4.6 meters) and over in length,
3 inches (7.6 centimeters).
347
ER03MR11.001</GPH>
§ 113.40 21 CFR Ch. I (4–1–23 Edition)
(1) Size of vent and vent valve. For re- equal to the cross-sectional area of the
torts less than 15 feet (4.6 meters) in vent pipe inlet.
length, 2 inches (5.1 centimeters); for (3) Venting method. Water spreader
retorts 15 feet (4.6 meters) and over in vent gate or plug cock valve should be
length, 2.5 inches (6.4 centimeters). wide open for at least 5 minutes and to
(2) Size of water spreader. For retorts at least 225 °F (107 °C), or for at least 7
less than 15 feet (4.6 meters) in length, minutes and to at least 220 °F (104.5 °C).
1.5 inches (3.8 centimeters); for retorts
(D) Venting through a single 2.5-inch
15 feet (4.6 meters) and over in length,
(6.4 centimeters) top vent (for retorts
2 inches (5.1 centimeters). The number
of holes should be such that their total not exceeding 15 feet (4.6 meters) in
cross-sectional area is approximately length).
ER03MR11.003</GPH>
348
ER03MR11.002</GPH>
(1) Specifications. A 2.5-inch (6.4 centi- least 4 minutes and to at least 220 °F
meters) vent equipped with a 2.5-inch (104.5 °C).
(6.4 centimeters) gate or plug cock (ii) Venting vertical retorts. (A) Vent-
valve and located within 2 feet (61 cen- ing through a 1.5-inch (3.8 centimeters)
timeters) of the center of the retort. overflow.
(2) Venting method. Vent gate or plug
cock valve should be wide open for at
(1) Specifications. A 1.5-inch (3.8 centi- (2) Venting method. Vent gate or plug
meters) overflow pipe equipped with a cock valve should be wide open for at
1.5-inch (3.8 centimeters) gate or plug least 4 minutes and to at least 218 °F
cock valve and with not more than 6 (103.5 °C), or for at least 5 minutes and
feet (1.8 meters) of 1.5-inch (3.8 centi- to at least 215 °F (102 °C).
meters) pipe beyond the valve before (B) Venting through a single 1-inch
break to the atmosphere or to a mani- (2.5 centimeters) side or top vent.
fold header.
349
ER03MR11.004</GPH>
§ 113.40 21 CFR Ch. I (4–1–23 Edition)
(1) Specifications. A 1-inch (2.5 centi- essing record at intervals of sufficient

meters) vent in lid or top side, frequency to ensure that the factors
equipped with a 1-inch (2.5 centimeters) are within the limits specified in the
gate or plug cock valve and discharging scheduled process.
directly into the atmosphere or to a (i) When maximum fill-in or drained
manifold header. weight is specified in the scheduled
(2) Venting method. Vent gate or plug process, it shall be measured and re-
cock valve should be wide open for at corded at intervals of sufficient fre-
least 5 minutes and to at least 230 °F
quency to ensure that the weight of the
(110 °C), or for at least 7 minutes and to
at least 220 °F (104.5 °C). product does not exceed the maximum
(iii) Other procedures. Other installa- for the given container size specified in
tions and operating procedures that de- the scheduled process.
viate from the requirements in para- (ii) Closing machine vacuum in vacu-
graph (a)(12) of this section may be um-packed products shall be observed
used if there is evidence in the form of and recorded at intervals of sufficient
heat distribution data, which shall be frequency to ensure that the vacuum is
kept on file, that they accomplish ade- as specified in the scheduled process.
quate venting of air. (iii) Such measurements and record-
(13) Critical factors. Critical factors ings should be made at intervals not to
specified in the scheduled process shall exceed 15 minutes.
be measured and recorded on the proc-
350
ER03MR11.005</GPH>
(iv) When the product style results in izontal and vertical retorts, the tem-
stratification or layering of the pri- perature-indicating device sensor shall
mary product in the containers, the po- be inserted directly into the retort
sitioning of containers in the retort shell or in a separate well or sleeve at-
shall be according to the scheduled tached to the retort. The temperature-
process. indicating device sensor shall be lo-
(b) Equipment and procedures for pres- cated so that it is beneath the surface
sure processing in water in still retorts— of the water throughout the process
(1) Temperature-indicating device. Each and where there is adequate circulation
retort shall be equipped with at least to ensure accurate temperature meas-
one temperature-indicating device that urement. On horizontal retorts, the
accurately indicates the temperature
temperature-indicating device sensor
during processing. Each temperature-
should be located in the side at the
indicating device shall have a sensor
and a display. Each temperature-indi- center of the retort. The temperature-
cating device and each reference device indicating device—not the tempera-
that is maintained by the processor ture-recording device—shall be the ref-
shall be tested for accuracy against a erence instrument for indicating the
reference device for which the accuracy processing temperature.
is traceable to a National Institute of (2) Temperature-recording device. Each
Standards and Technology (NIST), or retort shall have an accurate tempera-
other national metrology institute, ture-recording device. Each tempera-
standard reference device by appro- ture-recording device shall have a sen-
priate standard procedures, upon in- sor and a mechanism for recording
stallation and at least once a year temperatures to a permanent record,
thereafter, or more frequently if nec- such as a temperature-recording chart.
essary, to ensure accuracy during proc- (i) Analog or graphical recordings.
essing. Each temperature-indicating Temperature-recording devices that
device and each reference device that is create analog or graphical recordings
maintained by the processor shall have may be used. Temperature-recording
a tag, seal, or other means of identity. devices that record to charts shall be
(i) The design of the temperature-in- used only with the appropriate chart.
dicating device shall ensure that the
Each chart shall have a working scale
accuracy of the device is not affected
of not more than 55 °F per inch (12 °C
by electromagnetic interference and
per centimeter) within a range of 20 °F
environmental conditions.
(ii) Records of the accuracy of the (10 °C) of the process temperature.
temperature-indicating device and of a Chart graduations shall not exceed 2 °F
reference device that is maintained by (1 °C) within a range of 10 °F (5 °C) of
the processor shall be established and the process temperature. Temperature-
maintained in accordance with recording devices that create
§ 113.100(c) and (d). multipoint plottings of temperature
(iii) A temperature-indicating device readings shall record the temperature
that is defective or cannot be adjusted at intervals that will assure that the
to the accurate calibrated reference de- parameters of the process time and
vice shall be repaired before further process temperature have been met.
use or replaced. (ii) Digital recordings. Temperature-
(iv) A temperature-indicating device recording devices, such as data loggers,
shall be accurate to 1 °F (0.5 °C). The that record numbers or create other
temperature range of a mercury-in- digital records may be used. Such a de-
glass thermometer shall not exceed 17 vice shall record the temperature at in-
°F per inch (4 °C per centimeter) of tervals that will assure that the pa-
graduated scale. A mercury-in-glass rameters of the process time and proc-
thermometer that has a divided mer- ess temperature have been met.
cury column shall be considered defec-
(iii) Adjustments. The temperature-re-
tive.
cording device shall be adjusted with
(v) Each temperature-indicating de-

vice shall be installed where it can be sufficient frequency to ensure agree-
accurately and easily read. In both hor- ment as nearly as possible with, but to
351
§ 113.40 21 CFR Ch. I (4–1–23 Edition)
be in no event higher than, the tem- (5) Steam introduction. Steam shall be
perature-indicating device during proc- distributed in the bottom of the retort
essing. A means of preventing unau- in a manner adequate to provide uni-
thorized changes in adjustment shall form heat distribution throughout the
be provided. A lock or a notice from retort. In vertical retorts, uniform
management posted at or near the tem- steam distribution can be achieved by
perature-recording device that provides any of several methods. In horizontal
a warning that only authorized persons retorts, the steam distributor shall run
are permitted to make adjustments is a the length of the bottom of the retort
satisfactory means of preventing unau- with perforations distributed uni-
thorized changes. formly along the upper part of the pipe.
(iv) Temperature controller. The tem- (6) Crate supports. A bottom crate
perature-recording device may be com- support shall be used in vertical still
bined with the steam controller and retorts. Baffle plates shall not be used
may be a combination recorder-con- in the bottom of the retort. Centering
troller. For a vertical retort equipped guides should be installed so as to en-
with a combination recorder-con- sure that there is about a 1.5-inch (3.8
troller, the temperature recorder-con- centimeters) clearance between the
troller sensor shall be located at the side wall of the crate and the retort
bottom of the retort below the lowest wall.
crate rest in such a position that the (7) Stacking equipment and position of
steam does not strike it directly. For a containers. Crates, trays, gondolas, etc.,
horizontal retort equipped with a com- for holding containers shall be made of
bination recorder-controller, the tem- strap iron, adequately perforated sheet
perature recorder-controller sensor metal, or other suitable material.
shall be located between the water sur- When perforated sheet metal is used for
face and the horizontal plane passing the bottoms, the perforations should be
through the center of the retort so that approximately the equivalent of 1-inch
there is no opportunity for direct (2.5 centimeters) holes on 2-inch (5.1
steam impingement on the sensor. For centimeters) centers. If divider plates
all still retort systems that pressure are used between the layers of con-
process in water and are equipped with tainers, they should be perforated as
combination recorder-controllers, the stated in this paragraph. The posi-
temperature recorder-controller sen- tioning of containers in the retort,
sors shall be located where the re- when specified in the scheduled proc-
corded temperature is an accurate ess, shall be in accordance with that
measurement of the scheduled process process. Dividers, racks, trays, or other
temperature and is not affected by the means of positioning of flexible con-
heating media. tainers shall be designed and employed
(3) Pressure gages. (i) Each retort to ensure even circulation of heating
should be equipped with a pressure medium around all containers in the
gage that is accurate to 2 pounds per retort.
square inch (13.8 kilopascals) or less. (8) Drain valve. A nonclogging, water-
(ii) Each retort should have an ad- tight valve shall be used. A screen shall
justable pressure relief or control valve be installed or other suitable means
of a capacity sufficient to prevent an shall be used on all drain openings to
undesired increase in retort pressure prevent clogging.
when the water valve is wide open and (9) Air supply and controls. In both
should be installed in the overflow line. horizontal and vertical still retorts for
(4) Steam controller. Each retort shall pressure processing in water, a means
be equipped with an automatic steam shall be provided for introducing com-
controller to maintain the retort tem- pressed air at the proper pressure and
perature. The steam controller may be rate. The proper pressure shall be con-
combined with a temperature-record- trolled by an automatic pressure con-
ing device and, thus, may be a com- trol unit. A check valve shall be pro-
bination recorder-controller. Air-oper- vided in the air supply line to prevent
ated temperature controllers should water from entering the system. Air or
have adequate filter systems to ensure water circulation shall be maintained
a supply of clean, dry air. continuously during the come-up time
352
and during processing and cooling peri- lating system. The pump shall be de-
ods. The adequacy of the air or water signed to provide proper flow on start-
circulation for uniform heat distribu- up and during operation, such as with a
tion within the retort shall be estab- bleeder or other suitable means to re-
lished in accordance with procedures move air during startup and with an
recognized by a competent processing appropriate device or design to prevent
authority and records shall be kept on pump cavitation during operation. The
file. If air is used to promote circula- pump shall be equipped with a sig-
tion, it shall be introduced into the naling device to warn the operator
steam line at a point between the re- when it is not running. Alternative
tort and the steam control valve at the methods for circulation of water in the
bottom of the retort. retort may be used when established by
(10) Water level indicator. There shall a competent authority as adequate for
be a means of determining the water even heat distribution.
level in the retort during operation, (12) Cooling water supply. In vertical
e.g., by using a sensor, gage, water retorts, the cooling water should be in-
glass, or petcock(s). Water shall cover troduced at the top of the retort be-
the top layer of containers during the
tween the water and container levels.
entire come-up time and processing pe-
In horizontal retorts the cooling water
riods and should cover the top layer of
should be introduced into the suction
containers during the cooling periods.
side of the pump. A check valve should
The operator shall check and record
be included in the cooling water line.
the water level at intervals sufficient
to ensure its adequacy. (13) Retort headspace. The headspace
(11) Water circulation. When a water necessary to control the air pressure
circulating system is used for heat dis- should be maintained between the
tribution, it shall be installed in such a water level and the top of the retort
manner that water will be drawn from shell.
the bottom of the retort through a suc- (14) Vertical and horizontal still retorts.
tion manifold and discharged through a Vertical and horizontal still retorts
spreader which extends the length of should follow the arrangements in the
the top of the retort. The holes in the diagrams in this paragraph. Other in-
water spreader shall be uniformly dis- stallation and operating procedures
tributed and should have an aggregate that deviate from these arrangements
area not greater than the cross-sec- may be used, as long as there is evi-
tional area of the outlet line from the dence in the form of heat distribution
pump. The suction outlets shall be pro- data or other suitable information,
tected with nonclogging screens or which shall be kept on file, which dem-
other suitable means shall be used to onstrates that the heat distribution is
keep debris from entering the circu- adequate.
353
§ 113.40 21 CFR Ch. I (4–1–23 Edition)
LEGEND FOR VERTICAL AND HORIZONTAL C—Temperature control.

STILL RETORTS D—Overflow line.
E1—Drain line.
A—Water line. E2—Screens.
B—Steam line. F—Check valves.
354
ER03MR11.006</GPH>
G—Line from hot water storage. device shall have a sensor and a dis-
H—Suction line and manifold. play. Each temperature-indicating de-
I—Circulating pump. vice and each reference device that is
J—Petcocks.
K—Recirculating line. maintained by the processor shall be
L—Steam distributor. tested for accuracy against a reference
M—Temperature-controller sensor. device for which the accuracy is trace-
N—Temperature-indicating device sensor. able to a National Institute of Stand-
O—Water spreader. ards and Technology (NIST), or other
P—Safety valve. national metrology institute, standard
Q—Vent valve for steam processing.
R—Pressure gage.
reference device by appropriate stand-
S—Inlet air control. ard procedures, upon installation and
T—Pressure control. at least once a year thereafter, or more
U—Air line. frequently if necessary, to ensure accu-
V—To pressure control instrument. racy during processing. Each tempera-
W—To temperature control instrument. ture-indicating device and each ref-
X—Wing nuts. erence device that is maintained by the
Y1—Crate support.
Y2—Crate guides. processor shall have a tag, seal, or
Z—Constant flow orifice valve. other means of identity.
Z1—Constant flow orifice valve used during (i) The design of the temperature-in-
come-up. dicating device shall ensure that the
Z2—Constant flow orifice valve used during accuracy of the device is not affected
cook. by electromagnetic interference and
(15) Critical factors. Critical factors environmental conditions.
specified in the scheduled process shall (ii) Records of the accuracy of the
be measured and recorded on the proc- temperature-indicating device and of a
essing record at intervals of sufficient reference device that is maintained by
frequency to ensure that the factors the processor shall be established and
are within the limits specified in the maintained in accordance with
scheduled process. § 113.100(c) and (d).
(i) When maximum fill-in or drained (iii) A temperature-indicating device
weight is specified in the scheduled that is defective or cannot be adjusted
process, it shall be measured and re- to the accurate calibrated reference de-
corded at intervals of sufficient fre- vice shall be repaired before further
quency to ensure that the weight of the use or replaced.
product does not exceed the maximum (iv) A temperature-indicating device
for the given container size specified in shall be accurate to 1 °F (0.5 °C). The
the scheduled process. temperature range of a mercury-in-
(ii) Closing machine vacuum in vacu- glass thermometer shall not exceed 17
um-packed products shall be observed °F per inch (4 °C per centimeter) of
and recorded at intervals of sufficient graduated scale. A mercury-in-glass
frequency to ensure that the vacuum is thermometer that has a divided mer-
as specified in the scheduled process. cury column shall be considered defec-
(iii) Such measurements and record- tive.
ings should be made at intervals not to (v) Each temperature-indicating de-
exceed 15 minutes. vice shall be installed where it can be
(iv) When the product style results in accurately and easily read. The tem-
stratification or layering of the pri- perature-indicating device sensor shall
mary product in the containers, the po- be installed either within the retort
sitioning of containers in the retort shell or in external wells attached to
shall be according to the scheduled the retort. External wells or pipes shall
process. be connected to the retort through at
(c) Equipment and procedures for pres- least a 3⁄4-inch (2 centimeters) diameter
sure processing in steam in continuous opening and equipped with a 1⁄16-inch
agitating retorts—(1) Temperature-indi- (1.5 millimeters) or larger bleeder open-
cating device. Each retort shall be ing so located as to provide a full flow
equipped with at least one tempera- of steam past the length of the tem-
ture-indicating device that accurately perature-indicating device sensor. The

indicates the temperature during proc- bleeders for external wells shall emit
essing. Each temperature-indicating steam continuously during the entire
355
§ 113.40 21 CFR Ch. I (4–1–23 Edition)
processing period. The temperature-in- are permitted to make adjustments is a

dicating device—not the temperature- satisfactory means of preventing unau-
recording device—shall be the ref- thorized changes.
erence instrument for indicating the (iv) Temperature controller. The tem-
processing temperature. perature-recording device may be com-
(2) Temperature-recording device. Each bined with the steam controller and
retort shall have an accurate tempera- may be a recorder-controller.
ture-recording device. Each tempera- (3) Pressure gages. Each retort should
ture-recording device shall have a sen- be equipped with a pressure gage that
sor and a mechanism for recording is accurate to 2 pounds per square inch
temperatures to a permanent record, (13.8 kilopascals) or less.
such as a temperature-recording chart. (4) Steam controller. Each retort shall
The temperature-recording device sen- be equipped with an automatic steam
sor shall be installed either within the controller to maintain the retort tem-
retort shell or in a well attached to the perature. This may be a recorder-con-
shell. Each temperature-recording de- troller when combined with a tempera-
vice sensor well shall have a 1⁄16-inch ture-recording device. A steam con-
(1.5 millimeters) or larger bleeder that troller activated by the steam pressure
emits steam continuously during the of the retort is acceptable if it is care-
processing period. fully maintained mechanically so that
(i) Analog or graphical recordings. it operates satisfactorily. Air-operated
Temperature-recording devices that temperature controllers should have
create analog or graphical recordings adequate filter systems to ensure a
may be used. Temperature-recording supply of clean, dry air.
devices that record to charts shall be (5) Bleeders. Bleeders, except those for
used only with the appropriate chart. temperature-indicating device wells,
Each chart shall have a working scale shall be 1⁄8-inch (3 millimeters) or larg-
of not more than 55 °F per inch (12 °C er and shall be wide open during the
per centimeter) within a range of 20 °F entire process, including the come-up
(10 °C) of the process temperature. time. Bleeders shall be located within
Chart graduations shall not exceed 2 °F approximately 1 foot (30.5 centimeters)
(1 °C) within a range of 10 °F (5 °C) of of the outermost location of containers
the process temperature. Temperature- at each end along the top of the retort.
recording devices that create Additional bleeders shall be located
multipoint plottings of temperature not more than 8 feet (2.4 meters) apart
readings shall record the temperature along the top of the retort. All bleeders
at intervals that will assure that the shall be arranged so that the operator
parameters of the process time and can observe that they are functioning
process temperature have been met. properly. The condensate bleeder shall
(ii) Digital recordings. Temperature- be checked with sufficient frequency to
recording devices, such as data loggers, ensure adequate removal of condensate
that record numbers or create other or shall be equipped with an automatic
digital records may be used. Such a de- alarm system(s) that would serve as a
vice shall record the temperature at in- continuous monitor of condensate-
tervals that will assure that the pa- bleeder functioning. Visual checks
rameters of the process time and proc- should be done at intervals of not more
ess temperature have been met. than 15 minutes. A record of such
(iii) Adjustments. The temperature-re- checks should be kept to show that the
cording device shall be adjusted with bleeder is functioning properly.
sufficient frequency to ensure agree- (6) Venting and condensate removal.
ment as nearly as possible with, but to Vents shall be located in that portion
be in no event higher than, the tem- of the retort opposite the steam inlet.
perature-indicating device during proc- Air shall be removed before processing
essing. A means of preventing unau- is started. Heat distribution data or
thorized changes in adjustment shall documentary proof from the manufac-
be provided. A lock or a notice from turer or from a competent processing
management posted at or near the tem- authority, demonstrating that ade-

perature-recording device that provides quate venting is achieved, shall be kept
a warning that only authorized persons on file. At the time steam is turned on,
356
the drain should be opened for a time records required in this chapter. If the
sufficient to remove steam condensate alternative procedure of prompt cool-
from the retort, and provision shall be ing is followed, the subsequent han-
made for continuing drainage of con- dling methods used for the containers
densate during the retort operation. in the retort at the time of stopping
The condensate bleeder in the bottom and cooling shall be entered on the pro-
of the shell serves as an indicator of duction records.
continuous condensate removal. (9) Temperature drop. If the tempera-
(7) Retort speed timing. The rotational ture of the continuous retort drops
speed of the retort shall be specified in below the temperature specified in the
the scheduled process. The speed shall scheduled process while containers are
be adjusted and recorded when the rein the retort, the retort reel shall be
tort is started, at any time a speed stopped promptly. An automatic device
change is made, and at intervals of suf- should be used to stop the reel when
ficient frequency to ensure that the re- the temperature drops below the speci-
tort speed is maintained as specified in fied process temperature. Before the
the scheduled process. These adjust- reel is restarted, all containers in the
ments and recordings should be made retort shall be given a complete sched-
every 4 hours or less. Alternatively, a uled still retort process if the tempera-
recording tachometer may be used to ture drop was 10 °F (5 °C) or more below
provide a continuous record of the the specified temperature, or alter-
speed. A means of preventing unau- natively, container entry to the retort
thorized speed changes on retorts shall shall be stopped and the reel restarted
be provided. A lock or a notice from to empty the retort. The discharged
management posted at or near the containers shall be either reprocessed,
speed adjustment device that provides repacked and reprocessed, or discarded.
a warning that only authorized persons Both the time at which the reel
are permitted to make adjustments is a stopped and the time the retort was
satisfactory means of preventing unau- used for a still retort process, if so
thorized changes. used, shall be indicated on the tem-
(8) Emergency stops. If a retort jams perature-recording device record and
or breaks down during processing oper- entered on the other production
ations, necessitating cooling the retort records required in this chapter. If the
for repairs, the retort shall be operated alternative procedure of emptying the
in such a way that ensures that the retort is followed, the subsequent han-
product is commercially sterile, or the dling methods used for the containers
retort is to be cooled promptly and all in the retort at the time of the tem-
containers either reprocessed, repacked perature drop shall be entered on the
and reprocessed, or discarded. When op- production records. If the temperature
erated as a still retort, all containers drop was less than 10 °F (5 °C), a sched-
shall be given a full still retort process uled authorized emergency still process
before the retort is cooled. If, in such approved by a qualified person(s) hav-
an emergency, a scheduled still process ing expert knowledge of thermal proc-
or another process established to en- essing requirements may be used before
sure commercial sterility is to be used, restarting the retort reel. Alter-
it shall be made readily available to natively, container entry to the retort
the retort operator. shall be stopped and an authorized
(i) Any containers in the retort in- emergency agitating process may be
take valve or in transfer valves be- used before container entry to the re-
tween cooker shells of a continuous retort is restarted. When emergency pro-
tort at the time of breakdown shall ei- cedures are used, no containers may
ther be reprocessed, repacked and re- enter the retort and the process and
processed, or discarded. procedures used shall be noted on the
(ii) Both the time at which the reel production records.
stopped and the time the retort was (10) Critical factors. Critical factors
used for a still retort process, if so specified in the scheduled process shall
used, shall be indicated on the tem- be measured and recorded on the proc-
perature-recording device record and essing record at intervals of sufficient
entered on the other production frequency to ensure that the factors
357
§ 113.40 21 CFR Ch. I (4–1–23 Edition)
are within the limits specified in the frequently if necessary, to ensure accu-
scheduled process. The minimum racy during processing. Each tempera-
headspace of containers, if specified in ture-indicating device and each ref-
the scheduled process, shall be meas- erence device that is maintained by the
ured and recorded at intervals of suffi- processor shall have a tag, seal, or
cient frequency to ensure that the other means of identity.
headspace is as specified in the sched- (i) The design of the temperature-in-
uled process. The headspace of solder- dicating device shall ensure that the
tipped, lapseam (vent hole) cans may accuracy of the device is not affected
be measured by net weight determina- by electromagnetic interference and
tions. The headspace of double seamed environmental conditions.
cans may also be measured by net (ii) Records of the accuracy of the
weight determinations for homogenous temperature-indicating device and of a
liquids, taking into account the spe- reference device that is maintained by
cific can end profile and other factors the processor shall be established and
which affect the headspace, if proof of maintained in accordance with
the accuracy of such measurements is § 113.100(c) and (d).
maintained and the procedure and re- (iii) A temperature-indicating device
sultant headspace is in accordance that is defective or cannot be adjusted
with the scheduled process. When the to the accurate calibrated reference de-
product consistency is specified in the vice shall be repaired before further
scheduled process, the consistency of use or replaced.
the product shall be determined by ob- (iv) A temperature-indicating device
jective measurements on the product shall be accurate to 1 °F (0.5 °C). The
taken from the filler before processing temperature range of a mercury-in-
and recorded at intervals of sufficient glass thermometer shall not exceed 17
frequency to ensure that the consist- °F per inch (4 °C per centimeter) of
ency is as specified in the scheduled graduated scale. A mercury-in-glass
process. Minimum closing machine thermometer that has a divided mer-
vacuum in vacuum-packed products, cury column shall be considered defec-
maximum fill-in or drained weight, tive.
minimum net weight, and percent sol- (v) Each temperature-indicating de-
ids shall be as specified in the sched- vice shall be installed where it can be
uled process for all products when devi- accurately and easily read. The tem-
ations from such specifications may af- perature-indicating device sensor shall
fect the scheduled process. All meas- be installed either within the retort
urements and recordings of critical fac- shell or in external wells attached to
tors should be made at intervals not to the retort. External wells or pipes shall
exceed 15 minutes. be connected to the retort through at
(d) Equipment and procedures for pres- least a 3⁄4-inch (2 centimeters) diameter
sure processing in steam in discontinuous opening and equipped with a 1⁄16-inch
agitating retorts—(1) Temperature-indi- (1.5 millimeters) or larger bleeder open-
cating device. Each retort shall be ing so located as to provide a full flow
equipped with at least one tempera- of steam past the length of the tem-
ture-indicating device that accurately perature-indicating device sensor. The
indicates the temperature during proc- bleeders for external wells shall emit
essing. Each temperature-indicating steam continuously during the entire
device shall have a sensor and a dis- processing period. The temperature-in-
play. Each temperature-indicating de- dicating device—not the temperature-
vice and each reference device that is recording device—shall be the ref-
maintained by the processor shall be erence instrument for indicating the
tested for accuracy against a reference processing temperature.
device for which the accuracy is trace- (2) Temperature-recording device. Each
able to a National Institute of Stand- retort shall have an accurate tempera-
ards and Technology (NIST), or other ture-recording device. Each tempera-
national metrology institute, standard ture-recording device shall have a sen-
reference device by appropriate stand- sor and a mechanism for recording

ard procedures, upon installation and temperatures to a permanent record,
at least once a year thereafter, or more such as a temperature-recording chart.
358
The temperature-recording device sen- (4) Steam controller. Each retort shall
sor shall be installed either within the be equipped with an automatic steam
retort shell or in a well attached to the controller to maintain the retort tem-
shell. Each temperature-recording de- perature. This may be a recorder-con-
vice sensor well shall have a 1⁄16-inch troller when combined with a tempera-
(1.5 millimeters) or larger bleeder that ture-recording device. A steam con-
emits steam continuously during the troller activated by the steam pressure
processing period. of the retort is acceptable if it is me-
(i) Analog or graphical recordings. chanically maintained so that it oper-
Temperature-recording devices that ates satisfactorily. Air-operated tem-
create analog or graphical recordings perature controllers should have ade-
may be used. Temperature-recording quate filter systems to ensure a supply
devices that record to charts shall be of clean, dry air.
used only with the appropriate chart. (5) Bleeders. Bleeders, except those for
Each chart shall have a working scale temperature-indicating device wells,
of not more than 55 °F per inch (12 °C shall be 1⁄8-inch (3 millimeters) or larg-
per centimeter) within a range of 20 °F er and shall be wide open during the
(10 °C) of the process temperature. entire process, including the come-up
Chart graduations shall not exceed 2 °F time. Bleeders shall be located within
(1 °C) within a range of 10 °F (5 °C) of approximately 1 foot (30.5 centimeters)
the process temperature. Temperature- of the outermost location of con-
recording devices that create tainers, at each end along the top of
multipoint plottings of temperature the retort; additional bleeders shall be
readings shall record the temperature located not more than 8 feet (2.4 me-
at intervals that will assure that the ters) apart along the top. Bleeders may
parameters of the process time and be installed at positions other than
process temperature have been met. those specified in this paragraph, as
(ii) Digital recordings. Temperature- long as there is evidence in the form of
recording devices, such as data loggers, heat distribution data that they ac-
that record numbers or create other complish adequate removal of air and
digital records may be used. Such a de- circulation of heat within the retort.
vice shall record the temperature at in- In retorts having top steam inlet and
tervals that will assure that the pa- bottom venting, a bleeder shall be in-
rameters of the process time and proc- stalled in the bottom of the retort to
ess temperature have been met. remove condensate. All bleeders shall
(iii) Adjustments. The temperature-re- be arranged in a way that enables the
cording device shall be adjusted with operator to observe that they are func-
sufficient frequency to ensure agree- tioning properly.
ment as nearly as possible with, but to (6) Venting and condensate removal.
be in no event higher than, the tem- The air in each retort shall be removed
perature-indicating device during proc- before processing is started. Heat dis-
essing. A means of preventing unau- tribution data or documentary proof
thorized changes in adjustment shall from the manufacturer or from a com-
be provided. A lock or a notice from petent processing authority, dem-
management posted at or near the tem- onstrating that adequate venting is
perature-recording device that provides achieved, shall be kept on file. At the
a warning that only authorized persons time steam is turned on, the drain
are permitted to make adjustments is a should be opened for a time sufficient
satisfactory means of preventing unau- to remove steam condensate from the
thorized changes. retort and provision should be made for
(iv) Temperature controller. The tem- continuing drainage of condensate dur-
perature-recording device may be coming the retort operation.
bined with the steam controller and (7) Retort speed timing. The rotational
may be a recorder-controller. speed of the retort shall be specified in
(3) Pressure gages. Each retort should the scheduled process. The speed shall
be equipped with a pressure gage that be adjusted, as necessary, to ensure

is accurate to 2 pounds per square inch that the speed is as specified in the
(13.8 kilopascals) or less. scheduled process. The rotational speed
359
§ 113.40 21 CFR Ch. I (4–1–23 Edition)
as well as the process time shall be re- maintained by the processor shall be
corded for each retort load processed. tested for accuracy against a reference
Alternatively, a recording tachometer device for which the accuracy is trace-
may be used to provide a continuous able to a National Institute of Stand-
record of the speed. A means of pre- ards and Technology (NIST), or other
venting unauthorized speed changes on national metrology institute, standard
retorts shall be provided. A lock or a reference device by appropriate stand-
notice from management posted at or ard procedures, upon installation and
near the speed-adjustment device that at least once a year thereafter, or more
provides a warning that only author- frequently if necessary, to ensure accu-
ized persons are permitted to make ad- racy during processing. Each tempera-
justments is a satisfactory means of ture-indicating device and each ref-
preventing unauthorized changes. erence device that is maintained by the
(8) Critical factors. Critical factors processor shall have a tag, seal, or
specified in the scheduled process shall
other means of identity.
(i) The design of the temperature-in-
essing record at intervals of sufficient
frequency to ensure that the factors dicating device shall ensure that the
are within the limits specified in the accuracy of the device is not affected
scheduled process. The minimum by electromagnetic interference and
headspace of containers in each retort environmental conditions.
load to be processed, if specified in the (ii) Records of the accuracy of the
scheduled process, shall be measured temperature-indicating device and of a
and recorded at intervals of sufficient reference device that is maintained by
frequency to ensure that the headspace the processor shall be established and
is as specified in the scheduled process. maintained in accordance with
The headspace of solder-tipped, lap § 113.100(c) and (d).
seam (vent hole) cans may be measured (iii) A temperature-indicating device
by net weight determinations. When that is defective or cannot be adjusted
the product consistency is specified in to the accurate calibrated reference de-
the scheduled process, the consistency vice shall be repaired before further
of the product shall be determined by use or replaced.
objective measurements on the product (iv) A temperature-indicating device
taken from the filler before processing shall be accurate to 1 °F (0.5 °C). The
and recorded at intervals of sufficient temperature range of a mercury-in-
frequency to ensure that the consist- glass thermometer shall not exceed 17
ency is as specified in the scheduled °F per inch (4 °C per centimeter) of
process. Minimum closing machine graduated scale. A mercury-in-glass
vacuum in vacuum-packed products,
thermometer that has a divided mer-
maximum fill-in or drained weight,
cury column shall be considered defec-
minimum net weight, and percent sol-
tive.
ids shall be as specified in the sched-
uled process for all products for which (v) Each temperature-indicating de-
deviations from such specifications vice shall be installed where it can be
may affect the scheduled process. All accurately and easily read. In both hor-
measurements and recordings of crit- izontal and vertical retorts, the tem-
ical factors should be made at intervals perature-indicating device sensor shall
not to exceed 15 minutes. be inserted directly into the retort
(e) Equipment and procedures for pres- shell or in a separate well or sleeve at-
sure processing in water in discontinuous tached to the retort. The temperature-
agitating retorts—(1) Temperature-indi- indicating device sensor shall be lo-
cating device. Each retort shall be cated so that it is beneath the surface
equipped with at least one tempera- of the water throughout the process
ture-indicating device that accurately and where there is adequate circulation
indicates the temperature during proc- to ensure accurate temperature meas-
essing. Each temperature-indicating urement. On horizontal retorts, the
device shall have a sensor and a dis- temperature-indicating device sensor

play. Each temperature-indicating de- should be located in the side at the
vice and each reference device that is center of the retort. The temperature-
360
indicating device—not the tempera- bined with the steam controller and
ture-recording device—shall be the ref- may be a recorder-controller. Air-oper-
erence instrument for indicating the ated temperature controllers should
processing temperature. have adequate filter systems to ensure
(2) Temperature-recording device. Each a supply of clean, dry air.
retort shall have an accurate tempera- (3) Pressure gages. Each retort should
ture-recording device. Each tempera- be equipped with a pressure gage that
ture-recording device shall have a sen- is accurate to 2 pounds per square inch
sor and a mechanism for recording (13.8 kilopascals) or less.
temperatures to a permanent record, (4) Steam controller. Each retort shall
such as a temperature-recording chart. be equipped with an automatic steam
The temperature-recording device sen- controller to maintain the retort tem-
sor shall be installed either within the perature. This may be a recorder-con-
retort shell or in a well attached to the troller when combined with a tempera-
shell. ture-recording device. Air-operated
(i) Analog or graphical recordings. temperature controllers should have
Temperature-recording devices that adequate filter systems to ensure a
create analog or graphical recordings supply of clean, dry air.
may be used. Temperature-recording (5) Retort speed timing. The rotational
devices that record to charts shall be speed of the retort shall be specified in
used only with the appropriate chart. the scheduled process. The speed shall
Each chart shall have a working scale be adjusted, as necessary, to ensure
of not more than 55 °F per inch (12 °C that the speed is as specified in the
per centimeter) within a range of 20 °F scheduled process. The rotational speed
(10 °C) of the process temperature. as well as the process time shall be re-
Chart graduations shall not exceed 2 °F corded for each retort load processed.
(1 °C) within a range of 10 °F (5 °C) of Alternatively, a recording tachometer
the process temperature. Temperature- may be used to provide a continuous
recording devices that create record of the speed. A means of pre-
multipoint plottings of temperature venting unauthorized speed changes
readings shall record the temperature shall be provided. A lock or a notice
at intervals that will assure that the from management posted at or near
parameters of the process time and the speed adjustment device that pro-
process temperature have been met. vides a warning that only authorized
(ii) Digital recordings. Temperature- persons are permitted to make adjust-
recording devices, such as data loggers, ment is a satisfactory means of pre-
that record numbers or create other venting unauthorized changes.
digital records may be used. Such a de- (6) Air supply and controls. When air is
vice shall record the temperature at in- used to provide overpressure:
tervals that will assure that the pa- (i) A means shall be provided for in-
rameters of the process time and proc- troducing compressed air at the proper
ess temperature have been met. pressure and rate. The proper pressure
(iii) Adjustments. The temperature-re- shall be controlled by an automatic
cording device shall be adjusted with pressure control unit. A check valve
sufficient frequency to ensure agree- shall be provided in the air supply line
ment as nearly as possible with, but to to prevent water from entering the sys-
be in no event higher than, the tem- tem.
perature-indicating device during proc- (ii) A water level indicator, e.g., sen-
essing. A means of preventing unau- sor, gage, water glass, or petcock(s),
thorized changes in adjustment shall shall be used for determining the water
be provided. A lock or a notice from level in the retort during operation.
management posted at or near the tem- Water shall cover the top layer of con-
perature-recording device that provides tainers during the entire come-up time
a warning that only authorized persons and processing periods and should also
are permitted to make adjustments is a cover the top layer of containers dur-
satisfactory means of preventing unau- ing the cooling periods. The operator
thorized changes. shall check and record the water level

(iv) Temperature controller. The tem- at intervals sufficient to ensure its
perature-recording device may be com- adequacy.
361
§ 113.40 21 CFR Ch. I (4–1–23 Edition)
(7) Water circulation. When a water ing machine vacuum in vacuum-packed

circulating system is used for heat dis- products, maximum fill-in or drained
tribution, it shall be installed in such a weight, minimum net weight, and per-
manner that water will be drawn from cent solids shall be as specified in the
the bottom of the retort through a suc- scheduled process for all products when
tion manifold and discharged through a deviations from such specifications
spreader which extends the length of may affect the scheduled process. All
the top of the retort. The holes in the measurements and recordings of crit-
water spreader shall be uniformly dis- ical factors should be made at intervals
tributed and should have an aggregate not to exceed 15 minutes.
area not greater than the cross-sec- (f) Equipment and procedures for pres-
tional area of the outlet line from the sure processing in steam in hydrostatic re-
pump. The suction outlets shall be pro-
torts—(1) Temperature-indicating device.
tected with nonclogging screens or
Each retort shall be equipped with at
other suitable means shall be used to
least one temperature-indicating de-
keep debris from entering the circu-
vice that accurately indicates the tem-
lating system. The pump shall be de-
signed to provide proper flow on start- perature during processing. Each tem-
up and during operation, such as with a perature-indicating device shall have a
bleeder or other suitable means to re- sensor and a display. Each tempera-
move air during startup and with an ture-indicating device and each ref-
appropriate device or design to prevent erence device that is maintained by the
pump cavitation during operation. The processor shall be tested for accuracy
pump shall be equipped with a sig- against a reference device for which
naling device to warn the operator the accuracy is traceable to a National
when it is not running. Alternative Institute of Standards and Technology
methods for circulation of water in the (NIST), or other national metrology in-
retort may be used when established by stitute, standard reference device by
a competent authority as adequate for appropriate standard procedures, upon
even heat distribution. installation and at least once a year
(8) Drain valve. A nonclogging, water- thereafter, or more frequently if nec-
tight valve shall be used. A screen shall essary, to ensure accuracy during proc-
be installed or other suitable means essing. Each temperature-indicating
shall be used on all drain openings to device and each reference device that is
prevent clogging. maintained by the processor shall have
(9) Critical factors. Critical factors a tag, seal, or other means of identity.
specified in the scheduled process shall (i) The design of the temperature-in-
be measured and recorded on the proc- dicating device shall ensure that the
essing record at intervals of sufficient accuracy of the device is not affected
frequency to ensure that the factors by electromagnetic interference and
are within the limits specified in the environmental conditions.
scheduled process. The minimum
(ii) Records of the accuracy of the
headspace of containers, if specified in
temperature-indicating device and of a
the scheduled process, shall be meas-
ured and recorded at intervals of suffi- reference device that is maintained by
cient frequency to ensure that the the processor shall be established and
headspace is as specified in the sched- maintained in accordance with
uled process. The headspace of solder- § 113.100(c) and (d).
tipped, lap seam (vent hole) cans may (iii) A temperature-indicating device
be measured by net weight determina- that is defective or cannot be adjusted
tions. When the product consistency is to the accurate calibrated reference de-
specified in the scheduled process, the vice shall be repaired before further
consistency of the product shall be de- use or replaced.
termined by objective measurements (iv) A temperature-indicating device
on the product taken from the filler be- shall be accurate to 1 °F (0.5 °C). The
fore processing and recorded at inter- temperature range of a mercury-in-
vals of sufficient frequency to ensure glass thermometer shall not exceed 17

that the consistency is as specified in °F per inch (4 °C per centimeter) of
the scheduled process. Minimum clos- graduated scale. A mercury-in-glass
362
thermometer that has a divided mer- parameters of the process time and
cury column shall be considered defec- process temperature have been met.
tive. (ii) Digital recordings. Temperature-
(v) Each temperature-indicating de- recording devices, such as data loggers,
vice shall be installed where it can be that record numbers or create other
accurately and easily read. The tem- digital recordings may be used. Such a
perature-indicating device sensor shall device shall record the temperature at
be located in the steam dome near the intervals that will assure that the pa-
steam-water interface. When the sched- rameters of the process time and proc-
uled process specifies maintenance of ess temperature have been met.
particular temperatures in the hydro- (iii) Adjustments. The temperature-re-
static water legs, a temperature-indi- cording device shall be adjusted with
cating device sensor shall be located in sufficient frequency to ensure agree-
each hydrostatic water leg in a posi- ment as nearly as possible with, but to
tion near the bottom temperature-re- be in no event higher than, the tem-
cording device sensor. The tempera- perature-indicating device during proc-
ture-indicating device—not the tem- essing. A means of preventing unau-
perature-recording device—shall be the thorized changes in adjustment shall
reference instrument for indicating the be provided. A lock or a notice from
processing temperature. management posted at or near the tem-
perature-recording device that provides
(2) Temperature-recording device. Each
a warning that only authorized persons
retort shall have an accurate tempera-
are permitted to make adjustments is a
ture-recording device. Each tempera-
satisfactory means of preventing unau-
ture-recording device shall have a sen-
thorized changes.
sor and a mechanism for recording (iv) Temperature controller. The tem-
temperatures to a permanent record, perature-recording device may be com-
such as a temperature-recording chart. bined with the steam controller and
The temperature-recording device sen- may be a recorder-controller.
sor shall be installed either within the (3) Pressure gages. Each retort should
steam dome or in a well attached to be equipped with a pressure gage that
the dome. Each temperature-recording is accurate to 2 pounds per square inch
device sensor well shall have a 1⁄16-inch (13.8 kilopascals) or less.
(1.5 millimeters) or larger bleeder that (4) Recording of temperatures. Tem-
emits steam continuously during the peratures indicated by the tempera-
processing period. Additional temperature-indicating device or devices shall
ture-recording device sensors shall be be entered on a suitable form during
installed in the hydrostatic water legs processing operations. Temperatures
in situations where the scheduled proc- shall be recorded by an accurate tem-
ess specifies maintenance of particular perature-recording device or devices at
temperatures in the hydrostatic water the following points:
legs. (i) In the steam chamber between the
(i) Analog or graphical recordings. steam-water interface and the lowest
Temperature-recording devices that container position.
create analog or graphical recordings (ii) Near the top and the bottom of
may be used. Temperature-recording each hydrostatic water leg if the sched-
devices that record to charts shall be uled process specifies maintenance of
used only with the appropriate chart. particular temperatures in the legs.
Each chart shall have a working scale (5) Steam controller. Each retort shall
of not more than 55 °F per inch (12 °C be equipped with an automatic steam
per centimeter) within a range of 20 °F controller to maintain the retort tem-
(10 °C) of the process temperature. perature. This may be a recorder-con-
Chart graduations shall not exceed 2 °F troller when combined with a tempera-
(1 °C) within a range of 10 °F (5 °C) of ture-recording device. A steam con-
the process temperature. Temperature- troller activated by the steam pressure
recording devices that create of the retort is acceptable if it is care-
multipoint plottings of temperature fully mechanically maintained so that

readings shall record the temperature it operates satisfactorily. Air-operated
at intervals that will assure that the temperature controllers should have
363
§ 113.40 21 CFR Ch. I (4–1–23 Edition)
adequate filter systems to ensure a (iii) Such measurements and record-

supply of clean, dry air. ings should be made at intervals not to
(6) Venting. Before the start of proc- exceed 15 minutes.
essing operations, the retort steam (g) Aseptic processing and packaging
chamber or chambers shall be vented systems—(1) Product sterilizer—(i) Equip-
to ensure removal of air. ment—(A) Temperature-indicating device.
(7) Bleeders. Bleeder openings 1⁄4-inch Each product sterilizer shall be
(6 millimeters) or larger shall be lo- equipped with at least one tempera-
cated at the top of the steam chamber ture-indicating device that accurately
or chambers opposite the point of indicates the temperature during proc-
essing. Each temperature-indicating
steam entry. Bleeders shall be wide
device shall have a sensor and a dis-
open and shall emit steam continu-
play. Each temperature-indicating de-
ously during the entire process, includ-
vice and each reference device that is
ing the come-up time. All bleeders
maintained by the processor shall be
shall be arranged in such a way that tested for accuracy against a reference
the operator can observe that they are device for which the accuracy is trace-
functioning properly. able to a National Institute of Stand-
(8) Retort speed. The speed of the con- ards and Technology (NIST), or other
tainer-conveyor chain shall be speci- national metrology institute, standard
fied in the scheduled process and shall reference device by appropriate stand-
be determined and recorded at the ard procedures, upon installation and
start of processing and at intervals of at least once a year thereafter, or more
sufficient frequency to ensure that the frequently if necessary, to ensure accu-
retort speed is maintained as specified. racy during processing. Each tempera-
The speed should be determined and re- ture-indicating device and each ref-
corded every 4 hours. An automatic de- erence device that is maintained by the
vice should be used to stop the chain processor shall have a tag, seal, or
when the temperature drops below that other means of identity.
specified in the scheduled process. A (1) The design of the temperature-in-
means of preventing unauthorized dicating device shall ensure that the
speed changes shall be provided. A lock accuracy of the device is not affected
or a notice from management posted at by electromagnetic interference and
or near the speed-adjusting device that environmental conditions.
provides a warning that only author- (2) Records of the accuracy of the
ized persons are permitted to make ad- temperature-indicating device and of a
justments is a satisfactory means of reference device that is maintained by
preventing unauthorized changes. the processor shall be established and
maintained in accordance with
(9) Critical factors. Critical factors
§ 113.100(c) and (d).
specified in the scheduled process shall
(3) A temperature-indicating device
that is defective or cannot be adjusted
essing record at intervals of sufficient
to the accurate calibrated reference de-
frequency to ensure that the factors
vice shall be repaired before further
are within the limits specified in the use or replaced.
scheduled process. (4) A temperature-indicating device
(i) When maximum fill-in or drained shall be accurate to 1 °F (0.5 °C). The
weight is specified in the scheduled temperature range of a mercury-in-
process, it shall be measured and re- glass thermometer shall not exceed 17
corded at intervals of sufficient fre- °F per inch (4 °C per centimeter) of
quency to ensure that the weight of the graduated scale. A mercury-in-glass
product does not exceed the maximum thermometer that has a divided mer-
for the given container size specified in cury column shall be considered defec-
the scheduled process. tive.
(ii) Closing machine vacuum in vacu- (5) Each temperature-indicating de-
um-packed products shall be observed vice shall be installed where it can be
and recorded at intervals of sufficient accurately and easily read. The tem-
frequency to ensure that the vacuum is perature-indicating device—not the
as specified in the scheduled process. temperature-recording device—shall be
364
the reference instrument for indicating satisfactory means of preventing unau-

the processing temperature. thorized changes.
(B) Temperature-recording device. Each (C) Temperature controller. An accu-
product sterilizer shall have an accurate temperature controller shall be in-
rate temperature-recording device. stalled and capable of ensuring that
Each temperature-recording device the desired product sterilization tem-
shall have a sensor and a mechanism perature is maintained. Air-operated
for recording temperatures to a perma- temperature controllers should have
nent record, such as a temperature-re- adequate filter systems to ensure a
cording chart. A temperature-recording supply of clean, dry air.
device sensor shall be installed in the (D) Product-to-product regenerators.
product at the holding-tube outlet be- When a product-to-product regenerator
tween the holding tube and the inlet to is used to heat the cold unsterilized
the cooler. Additional temperature-re- product entering the sterilizer by
cording device sensors shall be located means of a heat exchange system, it
at each point where temperature is shall be designed, operated, and con-
specified as a critical factor in the trolled so that the pressure of the
scheduled process. sterilized product in the regenerator is
(1) Analog or graphical recordings. greater than the pressure of any
Temperature-recording devices that unsterilized product in the regenerator
create analog or graphical recordings to ensure that any leakage in the re-
may be used. Temperature-recording generator is from the sterilized product
devices that record to charts shall be into the unsterilized product.
used only with the appropriate chart. (E) Differential pressure recorder-con-
Each chart shall have a working scale troller. When a product-to-product re-
of not more than 55 °F per inch (12 °C generator is used, it shall be equipped
per centimeter) within a range of 20 °F with an accurate differential pressure
(10 °C) of the desired product steriliza- recorder-controller. The differential
tion temperature. Chart graduations pressure recorder-controller shall be
shall not exceed 2 °F (1 °C) within a accurate to within 2 pounds per square
range of 10 °F (5 °C) of the process tem- inch (13.8 kilopascals). One pressure
perature. Temperature-recording de- sensor shall be installed at the steri-
vices that create multipoint plottings lized product regenerator outlet and
of temperature readings shall record the other pressure sensor shall be in-
the temperature at intervals that will stalled at the unsterilized product re-
assure that the parameters of the proc- generator inlet. The sensor and re-
ess time and process temperature have corder of the differential pressure re-
been met. corder-controller shall be tested for ac-
(2) Digital recordings. Temperature-re- curacy against an accurate reference
cording devices, such as data loggers, device upon installation and at least
that record numbers or create other once every 3 months of operation
digital recordings may be used. Such a thereafter, or more frequently if nec-
device shall record the temperature at essary, to ensure its accuracy.
intervals that will assure that the pa- (1) Analog or graphical recordings. Dif-
rameters of the process time and proc- ferential pressure recorder-controllers
ess temperature have been met. that create analog or graphical record-
(3) Adjustments. The temperature-re- ings may be used. Differential pressure
cording device shall be adjusted with recorder-controllers that record to
sufficient frequency to ensure agree- charts shall be used only with the ap-
ment as nearly as possible with, but to propriate chart. The scale divisions of
be in no event higher than, the tem- the chart shall not exceed 2 pounds per
perature-indicating device during proc- square inch (13.8 kilopascals) on a
essing. A means of preventing unau- working scale of not more than 20
thorized changes in adjustment shall pounds per square inch per inch of
be provided. A lock or a notice from scale (55 kilopascals per centimeter).
management posted at or near the tem- (2) Digital recordings. Differential
perature-recording device that provides pressure recorder-controllers, such as

a warning that only authorized persons data loggers, that record numbers or
are permitted to make adjustments is a create other digital recordings may be
365
§ 113.40 21 CFR Ch. I (4–1–23 Edition)
used. Such differential pressure re- seals or other effective barriers at the
corder-controllers shall record the dif- potential access points. Appropriate
ferential pressure at intervals that will means should be provided to permit the
assure that the minimum differential operator to monitor the performance of
pressure is maintained. the seals or barriers during operations.
(F) Flow control. A flow control de- (ii) Operation—(A) Startup. Before the
vice shall be located upstream from the start of aseptic processing operations
holding tube and shall be operated to the product sterilizer and all product-
maintain the required rate of product contact surfaces downstream shall be
flow. A means of preventing unauthor- brought to a condition of commercial
ized flow adjustments shall be pro- sterility.
vided. A lock or a notice from manage- (B) Temperature drop in product-steri-
ment posted at or near the flow con- lizing holding tube. When product tem-
trolling device that provides a warning perature in the holding tube drops
that only authorized persons are per- below the temperature specified in the
mitted to make adjustments is a satis- scheduled process, product flow should
factory means of preventing unauthor- be diverted away from the filler or
ized changes. aseptic surge tank by means of a flow-
(G) Product holding tube. The product- diversion system. If for any reason
sterilizing holding tube shall be de- product subjected to a temperature
signed to give continuous holding of drop below the scheduled process is
every particle of food for at least the filled into containers, the product shall
minimum holding time specified in the
be segregated from product that re-
scheduled process. The holding tube
ceived the scheduled process. The proc-
shall be designed so that no portion of
essing deviation shall be handled in ac-
the tube between the product inlet and
cordance with § 113.89. The product
the product outlet can be heated, and
holding tube and any further system
it must be sloped upward at least 1⁄4-
portions affected shall be returned to a
inch per foot (2.1 centimeters per
condition of commercial sterility be-
meter).
fore product flow is resumed to the
(H) Flow-diversion systems. If a proc-
filler or to the aseptic surge tank.
essor elects to install a flow-diversion
system, it should be installed in the (C) Loss of proper pressures in the re-
product piping located between the generator. When a regenerator is used,
product cooler and the product filler or the product may lose sterility when-
aseptic surge tank and should be de- ever the pressure of sterilized product
signed to divert flow away from the in the regenerator is less than 1 pound
filler or aseptic surge tank automati- per square inch (6.9 kilopascals) greater
cally. Controls and/or warning systems than the pressure of unsterilized prod-
should be designed and installed with uct in the regenerator. In this case,
necessary sensors and actuators to op- product flow should be diverted away
erate whenever the sterilizing tempera- from the filler or aseptic surge tank by
ture in the holding tube or pressure dif- means of the flow-diversion system. If
ferential in the product regenerator for any reason the product is filled into
drops below specified limits. Flow-di- containers, the product shall be seg-
version systems should be designed and regated from product that received the
operated in accordance with rec- scheduled process. The processing devi-
ommendations of an aseptic processing ation shall be handled in accordance
and packaging authority. with § 113.89. Product flow to the filler
(I) Equipment downstream from the or to the aseptic surge tank shall not
holding tube. Product coolers, aseptic be resumed until the cause of the im-
surge tanks, or any other equipment proper pressure relationships in the re-
downstream from the holding tube, generator has been corrected and the
with rotating or reciprocating shafts, affected system(s) has been returned to
valve stems, instrument connections, a condition of commercial sterility.
or other such points, are subject to po- (D) Loss of sterile air pressure or other
tential entry of microorganisms into protection level in the aseptic surge tank.
the product. Such locations in the sys- When an aseptic surge tank is used,
tem should be equipped with steam conditions of commercial sterility may
366
be lost when the sterile air over- factory means of preventing unauthor-
pressure or other means of protection ized changes.
drops below the scheduled process (ii) Operation—(A) Startup. Before the
value. Product flow to and/or from the start of packaging operations, both the
aseptic surge tank shall not be re- container and closure sterilizing sys-
sumed until the potentially contami- tem and the product filling and closing
nated product in the tank is removed, system shall be brought to a condition
and the aseptic surge tank has been re- of commercial sterility.
turned to a condition of commercial (B) Loss of sterility. A system shall be
sterility. provided to stop packaging operations,
(E) Records. Readings at the following or alternatively to ensure segregation
points shall be observed and recorded of any product packaged when the
at the start of aseptic packaging oper- packaging conditions fall below sched-
ations and at intervals of sufficient fre- uled processes. Compliance with this
quency to ensure that these values are requirement may be accomplished by
as specified in the scheduled process: diverting product away from the filler,
Temperature-indicating device in hold- by preventing containers from entering
ing tube outlet; temperature-recording the filler, or by other suitable means.
device in holding tube outlet; differen- In the event product is packaged under
tial pressure recorder-controller, if a conditions below those specified in the
product-to-product regenerator is used; scheduled process, all such product
product flow rate as established by the shall be segregated from product that
flow control device or as determined by received the scheduled process. The
filling and closing rates and, if an asep- processing deviation shall be handled
tic surge tank is used, sterile air pres- in accordance with § 113.89. In the event
sure or other protection means; and of loss of sterility, the system(s) shall
proper performance of steam seals or be returned to a condition of commer-
other similar devices. The measure-
cial sterility before resuming pack-
ments and recordings should be made
aging operations.
at intervals not to exceed 1 hour.
(C) Records. Observations and meas-
(2) Container sterilizing, filling, and
closing operation—(i) Equipment—(A) Re- urements of operating conditions shall
cording device. The container and clo- be made and recorded at intervals of
sure sterilization system and product sufficient frequency to ensure that
filling and closing system shall be in- commercial sterility of the food prod-
strumented to demonstrate that the re- uct is being achieved; such measure-
quired sterilization is being accom- ments shall include the sterilization
plished continuously. Recording de- media flow rates, temperatures, the
vices shall be used to record, when ap- container and closure rates (if applica-
plicable, the sterilization media flow ble) through the sterilizing system, and
rates, temperature, concentration, or the sterilization conditions if a batch
other factors. When a batch system is system is used for container steriliza-
used for container sterilization, the tion. The measurements and recordings
sterilization conditions shall be re- should be made at intervals not to ex-
corded. ceed 1 hour.
(B) Timing method(s). A method(s) (3) Incubation. Incubation tests
shall be used either to give the reten- should be conducted on a representa-
tion time of containers, and closures if tive sample of containers of product
applicable, in the sterilizing environ- from each code; records of the test re-
ment specified in the scheduled proc- sults should be maintained.
ess, or to control the sterilization cycle (4) Critical factors. Critical factors
at the rate specified in the scheduled specified in the scheduled process shall
process. A means of preventing unau- be measured and recorded on the proc-
thorized speed changes must be pro- essing record at intervals of sufficient
vided. A lock or a notice from manage- frequency to ensure that the factors
ment posted at or near the speed ad- are within the limits specified in the
justing device that provides a warning scheduled process. Such measurements

that only authorized persons are per- and recordings should be done at inter-
mitted to make adjustments is a satis- vals not to exceed 15 minutes.
367
§ 113.60 21 CFR Ch. I (4–1–23 Edition)
(h) Equipment and procedures for flame specified in the scheduled process shall
sterilizers. The container conveyor be measured with instruments having
speed shall be specified in the sched- the accuracy and dependability ade-
uled process. The container conveyor quate to ensure that the requirements
speed shall be measured and recorded of the scheduled process are met. All
at the start of operations and at inter- measurements shall be made and re-
vals of sufficient frequency to ensure corded at intervals of sufficient fre-
that the conveyor speed is as specified quency to ensure that the critical fac-
in the scheduled process. Such meas- tors are within the limits specified in
urements and recordings should be the scheduled process.
done at 1-hour intervals. Alternatively, (j) Other systems. All systems, wheth-
a recording tachometer may be used to er or not specifically mentioned in this
provide a continuous record of the part, for the thermal processing of low-
speed. A means of preventing changes acid foods in hermetically sealed con-
in flame intensity and unauthorized tainers shall conform to the applicable
speed changes on the conveyor shall be requirements of this part and the
provided. A lock or a notice from man- methods and controls used for the man-
agement posted at or near the speed ufacture, processing, and packing of
adjusting device that provides a warn- these foods shall be as established in
ing that only authorized persons are the scheduled process. These systems
permitted to make adjustments is a shall be operated or administered in a
satisfactory means of preventing unau- manner adequate to ensure that com-
thorized changes. The surface tempera- mercial sterility is achieved. Critical
ture of at least one container from factors specified in the scheduled proc-
each conveyor channel shall be meas- ess shall be measured and recorded at
ured and recorded at the entry and at intervals of sufficient frequency to en-
the end of the holding period at inter- sure that the critical factors are within
vals of sufficient frequency to ensure the limits specified in the scheduled
that the temperatures specified in the process.
scheduled process are maintained. Such [76 FR 11906, Mar. 3, 2011; 76 FR 81363, Dec. 28,
measurements and recordings should 2011]
be done at intervals not to exceed 15
minutes.
(1) Process interruption. In the event Subpart D—Control of Compo-
of process interruption wherein the nents, Food Product Con-
temperature of the product may have tainers, Closures, and In-Proc-
dropped, an authorized, scheduled ess Materials
emergency plan approved by a qualified
person having expert knowledge of the § 113.60 Containers.
process requirements may be used. (a) Closures. Regular observations
(2) Critical factors. Critical factors shall be maintained during production
specified in the scheduled process shall runs for gross closure defects. Any such
be measured and recorded on the proc- defects shall be recorded and corrective
essing record at intervals of sufficient action taken and recorded. At intervals
frequency to ensure that the factors of sufficient frequency to ensure proper
are within the limits specified in the closure, the operator, closure super-
scheduled process. visor, or other qualified container clo-
(i) Equipment and procedures for ther- sure inspection person shall visually
mal processing of foods wherein critical examine either the top seam of a can
factors such as water activity are used in randomly selected from each seaming
conjunction with thermal processing. The head or the closure of any other type of
methods and controls used for the man- container being used and shall record
ufacture, processing, and packing of the observations made. For double-
such foods shall be as established in seam cans, each can should be exam-
the scheduled process and shall be op- ined for cutover or sharpness, skidding
erated or administered in a manner or deadheading, false seam, droop at
adequate to ensure that the product is the crossover or lap, and condition of
safe. The time and temperature of inside of countersink wall for evidence
processing and other critical factors of broken chuck. Such measurements
368
and recordings should be made at inter- down examinations shall be recorded

vals not to exceed 30 minutes. Addi- and the corrective action taken, if any,
tional visual closure inspections shall shall be noted.
be made immediately following a jam (i) Required and optional can seam
in a closing machine, after closing ma- measurements:
chine adjustment, or after startup of a (a) Micrometer measurement system:
machine following a prolonged shut- Required Optional
down. All pertinent observations shall
be recorded. When irregularities are Cover hook Overlap (by calculation).
Body hook Countersink.
found, the corrective action shall be re- Width (length, height)
corded. Tightness (observation for wrinkle)
(1) Teardown examinations for dou- Thickness
ble-seam cans shall be performed by a
qualified individual and the results (b) Seam scope or projector:
therefrom shall be recorded at inter- Required Optional
vals of sufficient frequency on enough
containers from each seaming station Body hook Width (length, height).
Overlap Cover hook.
to ensure maintenance of seam integ- Tightness (observation for wrinkle) Countersink.
rity. Such examinations and recordings Thickness by micrometer
should be made at intervals not to ex-
ceed 4 hours. The results of the tear- (c) Can double seam terminology:
369
§ 113.60 21 CFR Ch. I (4–1–23 Edition)
(1) ‘‘Crossover’’: The portion of a dou- (2) ‘‘Cutover’’: A fracture, sharp bend,
ble seam at the lap. or break in the metal at the top of the
inside portion of the double seam.
370
ER01JA93.376</GPH>
(3) ‘‘Deadhead’’: A seam which is in- ibly perforated or otherwise marked, if

complete due to chuck spinning in the the label is securely affixed to the
countersink. product container. The required identi-
(4) ‘‘Droop’’: Smooth projection of fication shall identify in code the es-
double seam below bottom of normal tablishment where packed, the product
seam. contained therein, the year packed, the
(5) ‘‘False seam’’: A small seam day packed, and the period during
breakdown where the cover hook and which packed. The packing period code
the body hook are not overlapped. shall be changed with sufficient fre-
(6) ‘‘Lap’’: Two thicknesses of mate- quency to enable ready identification
rial bonded together. of lots during their sale and distribu-
(ii) Two measurements at different tion. Codes may be changed on the
locations, excluding the side seam, basis of one of the following: intervals
shall be made for each double seam of 4 to 5 hours; personnel shift changes;
characteristic if a seam scope or seam or batches, as long as the containers
projector is used. When a micrometer that constitute the batch do not extend
is used, three measurements shall be over a period of more than one per-
made at points approximately 120° sonnel shift.
apart, excluding the side seam. (d) Postprocess handling. Container
(iii) Overlap length can be calculated handling equipment used in handling
by the following formula: filled containers shall be designed, con-
structed, and operated to preserve the
The theoretical overlap length = CH + can seam or other container closure in-
BH + T ¥ W, where tegrity. Container handling equipment,
CH = cover hook including automated and non-auto-
BH = body hook mated equipment, shall be checked
T = cover thickness, and with sufficient frequency and repaired
W = seam width (height, length)
or replaced as necessary to prevent
(2) For glass containers with vacuum damage to containers and container
closures, capper efficiency must be closures. When cans are handled on
checked by a measurement of the cold belt conveyors, the conveyors should
water vacuum. This shall be done be- be constructed to minimize contact by
fore actual filling operations, and the the belt with the double seam, i.e., cans
results shall be recorded. should not be rolled on the double
(3) For closures other than double seam. All worn and frayed belting, can
seams and glass containers, appro- retarders, cushions, etc. should be re-
priate detailed inspections and tests placed with new nonporous material.
shall be conducted by qualified per- All tracks and belts that come into
sonnel at intervals of sufficient fre- contact with the can seams should be
quency to ensure proper closing ma- thoroughly scrubbed and sanitized at
chine performance and consistently re- intervals of sufficient frequency to
liable hermetic seal production. avoid product contamination.
Records of such tests shall be main-
tained. FR 11922, Mar. 3, 2011]
(b) Cooling water. Container cooling
water shall be chlorinated or otherwise
sanitized as necessary for cooling ca- Subpart E—Production and
nals and for recirculated water sup- Process Controls
plies. There should be a measurable re-
sidual of the sanitizer employed at the § 113.81 Product preparation.
water discharge point of the container (a) Before using raw materials and
cooler. ingredients susceptible to micro-
(c) Coding. Each hermetically sealed biological contamination, the proc-
container of low-acid processed food essor shall ensure that those materials
shall be marked with an identifying and ingredients are suitable for use in
code that shall be permanently visible processing low-acid food. Compliance
to the naked eye. When the container with this requirement may be accom-
does not permit the code to be em- plished by receiving the raw materials
bossed or inked, the label may be leg- and ingredients under a supplier’s
371
§ 113.83 21 CFR Ch. I (4–1–23 Edition)
guarantee that they are suitable for the food free of microorganisms capa-
use, by examining them for their ble of reproducing in the food under
microbiological condition, or by other normal nonrefrigerated conditions of
acceptable means. storage and distribution.
(b) Blanching by heat, when required
in the preparation of food for canning, § 113.83 Establishing scheduled proc-
should be effected by heating the food esses.
to the required temperature, holding it Scheduled processes for low-acid
at this temperature for the required foods shall be established by qualified
time, and then either rapidly cooling persons having expert knowledge of
the food or passing it to subsequent thermal processing requirements for
processing without delay. low-acid foods in hermetically sealed
Thermophilic growth and contamina- containers and having adequate facili-
tion in blanchers should be minimized ties for making such determinations.
by the use of adequate operating tem- The type, range, and combination of
peratures and by cleaning. If the variations encountered in commercial
blanched food product is washed before
production shall be adequately pro-
filling, potable water should be used.
vided for in establishing the scheduled
(c) The filling of containers, either
process. Variations include those that
mechanically or by hand, shall be con-
occur due to seasonal or growing fluc-
trolled so as to ensure that the filling
tuations, variety differences, supplier
requirements specified in the scheduled
process are met. processes, reprocessing, and mixing a
(d) The exhausting of containers for batch of processed product with the
the removal of air shall be controlled same unprocessed product before it is
so as to meet the conditions for which processed. Critical factors, e.g., min-
the process was designed. Compliance imum headspace, consistency, max-
with the requirement may be accom- imum fill-in or drained weight, aw, etc.,
plished by heat exhausting, mechanical that may affect the scheduled process,
exhausting, hot brining, or steam in- shall be specified in the scheduled proc-
jection. ess. Acceptable scientific methods of
(e) When the maintenance of pH establishing heat sterilization proc-
(above 4.6) of a normally low-acid food esses shall include, when necessary,
is a basis for a scheduled process, there but shall not be limited to, the use of
shall be careful supervision to ensure microbial thermal death time data,
that the equilibrium pH of the finished process calculations based on product
product meets that of the scheduled heat penetration data, and inoculated
process. The methodology described in packs. Calculation shall be performed
§ 114.90 of this chapter should be used. according to procedures recognized by
(f) When the scheduled process sets competent processing authorities. If in-
forth critical factors to prevent the cubation tests are necessary for proc-
growth of microorganisms not de- ess confirmation, they shall include
stroyed by the thermal process, the containers from test trials and from
factors shall be carefully controlled to actual commercial production runs
ensure that the limits established in during the period of instituting the
the scheduled process are not exceeded. process. The incubation tests for con-
When normally low-acid foods require firmation of the scheduled processes
sufficient solute to permit safe proc- should include the containers from the
essing at low temperatures, such as in test trials and a number of containers
boiling water, there shall be careful su- from each of four or more actual com-
pervision to ensure that the equi- mercial production runs. The number
librium water activity (aw) of the fin- of containers from actual commercial
ished product meets that of the sched- production runs should be determined
uled process. The scheduled thermal on the basis of recognized scientific
processes for foods having an aw great- methods to be of a size sufficient to en-
er than 0.85 and less than the aw that sure the adequacy of the process. Com-
would allow the growth of spores of plete records covering all aspects of
microorganisms of public health sig- the establishment of the process and
nificance shall be sufficient to render associated incubation tests shall be
372
prepared and shall be permanently re- mine the initial temperature shall be
tained by the person or organization tested for accuracy against a reference
making the determination. device for which the accuracy is trace-
[76 FR 11922, Mar. 3, 2011]
able to a National Institute of Stand-
ards and Technology (NIST), or other
§ 113.87 Operations in the thermal national metrology institute, standard
processing room. reference device, by appropriate stand-
(a) Operating processes and retort ard procedures, with sufficient fre-
venting procedures to be used for each quency to ensure that initial tempera-
product and container size being ture measurements are accurate.
packed shall either be posted in a con- Records of the accuracy of the tem-
spicuous place near the processing perature-indicating device and of a ref-
equipment or be made readily available erence device that is maintained by the
to the retort or processing system op- processor shall be established and
erator and any duly authorized em- maintained in accordance with
ployee of the Food and Drug Adminis- § 113.100(c) and (d).
tration. Scheduled processes must be (d) Timing devices used in recording
made readily available to the super- thermal process time information shall
visor and any duly authorized em- be accurate to the extent needed to en-
ployee of the Food and Drug Adminis- sure that the processing time and vent-
tration. ing time specified in the scheduled
(b) A system for product traffic con- process are achieved. Pocket or wrist
trol in the retort room shall be estab- watches are not considered satisfactory
lished to prevent unretorted product for timing purposes. Digital clocks
from bypassing the retort process. may be used if the operating process
Each retort basket, truck, car, or crate and the venting schedule have a 1-
used to hold containers in a retort, or minute or greater safety factor over
one or more containers therein, shall, the scheduled process.
if it contains any retorted food prod- (e) Clock times on temperature-re-
uct, be plainly and conspicuously cording device records shall reasonably
marked with a heat-sensitive indicator, correspond to the time of day on the
or by other effective means that will processing records to provide correla-
indicate visually, to thermal proc- tion of these records.
essing personnel, those units that have (f) The steam supply to the thermal
been retorted. A visual check shall be processing system shall be adequate to
performed to determine whether or not the extent needed to ensure that suffi-
the appropriate change has occurred in cient steam pressure is maintained
the heat-sensitive indicator as a result during thermal processing, regardless
of retorting for all retort baskets, of other demands of steam by the
trucks, cars, or crates, to ensure that plant.
each unit of product has been retorted. (g) If mufflers are used on bleeders or
A record of these checks should be vent systems, evidence that the bleed-
made. ers or vents are operated in a manner
(c) The initial temperature of the that does not significantly impede the
contents of the containers to be proc- removal of air shall be kept on file.
essed shall be accurately determined This evidence may be in the form of
and recorded with sufficient frequency heat distribution data or other satis-
to ensure that the temperature of the factory evidence such as a letter from
product is no lower than the minimum the manufacturer, the designer, or a
initial temperature specified in the competent processing authority.
scheduled process. For those operations [44 FR 16215, Mar. 16, 1979, as amended at 76
that use water during the filling of the FR 11923, Mar. 3, 2011]
retort or during processing, provision
shall be made to ensure that the water § 113.89 Deviations in processing, vent-
will not, before the start of each ther- ing, or control of critical factors.
mal process, lower the initial tempera- Whenever any process is less than the
ture of the product below that specified scheduled process or when critical fac-
in the scheduled process. The tempera- tors are out of control for any low-acid
ture-indicating device used to deter- food or container system as disclosed
373
§ 113.100 21 CFR Ch. I (4–1–23 Edition)
from records by processor check or oth- cating device and temperature-record-

erwise, the commercial processor of ing device readings, and other appro-
that low-acid food shall either fully re- priate processing data. Closing ma-
process that portion of the production chine vacuum in vacuum-packed prod-
involved, keeping full records of the re- ucts, maximum fill-in or drained
processing conditions or, alternatively, weight, or other critical factors speci-
must set aside that portion of the prod- fied in the scheduled process shall also
uct involved for further evaluation as be recorded. In addition, the following
to any potential public health signifi- records shall be maintained:
cance. Such evaluation shall be made (1) Still retorts. Time steam on; time
by a competent processing authority temperature up to processing tempera-
and shall be in accordance with proce- ture; time steam off; venting time and
dures recognized by competent proc- temperature to which vented.
essing authorities as being adequate to (2) Agitating retorts. Functioning of
detect any potential hazard to public condensate bleeder; retort speed; and,
health. Unless this evaluation dem- when specified in the scheduled proc-
onstrates that the product had been ess, headspace, consistency, maximum
given a thermal process that rendered drained weight, minimum net weight,
it free of microorganisms of potential and percent solids.
public health significance, the product (3) Hydrostatic retorts. The tempera-
set aside shall be either fully reproc- ture in the steam chamber between the
essed to render it commercially sterile steam-water interface and the lowest
or destroyed. A record shall be made of container position; speed of the con-
the evaluation procedures used and the tainer conveyor chain; and, when the
results. Either upon completion of full scheduled process specifies mainte-
reprocessing and the attainment of nance of particular temperatures in the
commercial sterility or after the deter- hydrostatic water legs, the tempera-
mination that no significant potential tures near the top and the bottom of
for public health hazard exists, that each hydrostatic water leg.
portion of the product involved may be (4) Aseptic processing and packaging
shipped in normal distribution. Other- systems. Product temperature in the
wise, the portion of the product in- holding tube outlet as indicated by the
volved shall be destroyed. All process temperature-indicating device and the
deviations involving a failure to satisfy temperature-recording device; differen-
the minimum requirements of the tial pressure as indicated by the dif-
scheduled process, including emer- ferential pressure recorder-controller,
gencies arising from a jam or break- if a product-to-product regenerator is
down of a continuous agitating retort used; product flow rate, as determined
necessitating cooling the retort for re- by the flow controlling device or by
pairs, shall be recorded and made the filling and closing rates; sterilization
subject of a separate file (or a log iden- media flow rate or temperature or
tifying the appropriate data) detailing both; retention time of containers, and
those deviations and the actions taken. closures when applicable, in the steri-
lizing environment; and, when a batch
Subpart F—Records and Reports system is used for container and/or clo-
sure sterilization, sterilization cycle
§ 113.100 Processing and production times and temperatures.
records. (5) Flame sterilizers. Container con-
(a) Processing and production infor- veyor speed; surface temperature at
mation shall be entered at the time it the beginning and at the end of the
is observed by the retort or processing holding period; nature of container.
system operator, or other designated (6) Food preservation methods wherein
person, on forms that include the prod- critical factors such as water activity are
uct, the code number, the date, the reused in conjunction with thermal proc-
tort or processing system number, the essing. Product formulation and sched-
size of container, the approximate uled processes used, including the ther-
number of containers per coding inter- mal process, its associated critical fac-
val, the initial temperature, the actual tors, as well as other critical factors,
processing time, the temperature-indi- and results of aw determinations.
374
(7) Other systems. Critical factors (5) The date and results of each accu-
specified in the formulation of the racy test, including the amount of cali-
product or in the scheduled process. bration adjustment; and
(b) Temperature-recording device (6) The date on or before which the
records shall be identified by date, re- next accuracy test must be performed.
tort number, and other data as nec- (d) Records of the accuracy of a ref-
essary, so they can be correlated with erence device maintained by the proc-
the record of lots processed. Each entry essor shall include:
on the processing and production (1) A reference to the tag, seal, or
records shall be made by the retort or other means of identity used by the
processing system operator, or other processor to identify the reference de-
designated person, at the time the spe- vice;
cific retort or processing system condi- (2) The name of the manufacturer of
tion or operation occurs, and this re- the reference device;
tort or processing system operator or (3) The identity of the equipment and
other designated person shall sign or reference to procedures used for the ac-
initial each record form. Not later than curacy test and to adjust or calibrate
1 working day after the actual process, the reference device or, if an outside
and before shipment or release for dis- facility is used to conduct the accuracy
tribution, a representative of plant test for the reference device, a guar-
management who is qualified by suit- antee, certificate of accuracy, certifi-
able training or experience shall review cate of calibration, or other document
all processing and production records from the facility that includes a state-
for completeness and to ensure that ment or other documentation regard-
the product received the scheduled ing the traceability of the accuracy to
process. The records, including tem- a NIST or other national metrology in-
stitute standard;
perature-recording device records,
shall be signed or initialed and dated (4) The identity of the person or facil-
by the reviewer. ity that performed the accuracy test
and adjusted or calibrated the ref-
(c) Records of the accuracy of a tem-
erence device;
perature-indicating device shall in-
(5) The date and results of each accu-
clude:
racy test, including the amount of cali-
(1) A reference to the tag, seal, or bration adjustment; and
other means of identity used by the
(6) The date on or before which the
processor to identify the temperature- next accuracy test must be performed.
indicating device;
(e) Records of all container closure
(2) The name of the manufacturer of examinations shall specify the product
the temperature-indicating device; code, the date and time of container
(3) The identity of the reference de- closure inspections, the measurements
vice, equipment, and procedures used obtained, and all corrective actions
for the accuracy test and to adjust the taken. Records shall be signed or ini-
temperature-indicating device or, if an tialed by the container closure inspec-
outside facility is used to conduct the tor and reviewed by management with
accuracy test for the temperature-indi- sufficient frequency to ensure that the
cating device, a guarantee, certificate containers are hermetically sealed.
of accuracy, certificate of calibration, The records shall be signed or initialed
or other document from the facility and dated by the reviewer.
that includes a statement or other doc- (f) Records shall be maintained to
umentation regarding the traceability identify the initial distribution of the
of the accuracy to a National Institute finished product to facilitate, when
of Standards and Technology (NIST) or necessary, the segregation of specific
other national metrology institute food lots that may have become con-
standard; taminated or otherwise rendered unfit
(4) The identity of the person or facil- for their intended use.
ity that performed the accuracy test (g) Copies of all records provided for
and adjusted or calibrated the tempera- in this part, except those required
ture-indicating device; under § 113.83 establishing scheduled
375
processes, shall be retained at the proc- dings, peppers, tropical fruits, and fish,
essing plant for a period of not less singly or in any combination. They
than 1 year from the date of manufac- have a water activity (aw) greater than
ture, and at the processing plant or 0.85 and have a finished equilibrium pH
other reasonably accessible location of 4.6 or below. These foods may be
for an additional 2 years. If, during the called, or may purport to be, ‘‘pickles’’
first year of the 3-year record-retention or ‘‘pickled ______.’’ Carbonated bev-
period, the processing plant is closed erages, jams, jellies, preserves, acid
for a prolonged period between sea- foods (including such foods as stand-
sonal packs, the records may be trans- ardized and nonstandardized food
ferred to some other reasonably acces- dressings and condiment sauces) that
sible location at the end of the sea-
contain small amounts of low-acid
sonal pack.
food(s) and have a resultant finished
(h) Records of this part may be main-
tained electronically, provided they equilibrium pH that does not signifi-
are in compliance with part 11 of this cantly differ from that of the predomi-
chapter. nant acid or acid food, and foods that
are stored, distributed, and retailed
[44 FR 16215, Mar. 16, 1979, as amended at 76 under refrigeration are excluded from
FR 11923, Mar. 3, 2011]
the coverage of this part.
(c) Lot means the product produced
PART 114—ACIDIFIED FOODS during a period indicated by a specific
code.
(d) Low-acid foods means any foods,
Sec. other than alcoholic beverages, with a
114.3 Definitions. finished equilibrium pH greater than
114.5 Current good manufacturing practices.
4.6 and a water activity (aw) greater
114.10 Personnel.
than 0.85. Tomatoes and tomato prod-
Subparts B–D [Reserved] ucts having a finished equilibrium pH
less than 4.7 are not classed as low-acid
Subpart E—Production and Process foods.
Controls (e) Scheduled process means the proc-
114.80 Processes and controls. ess selected by a processor as adequate
114.83 Establishing scheduled processes. for use under the conditions of manu-
114.89 Deviations from scheduled proce- facture for a food in achieving and
dures. maintaining a food that will not per-
114.90 Methodology.
mit the growth of microorganisms hav-
Subpart F—Records and Reports ing public health significance. It in-
cludes control of pH and other critical
114.100 Records. factors equivalent to the process estab-
AUTHORITY: 21 U.S.C. 342, 371, 374; 42 U.S.C. lished by a competent processing au-
264. thority.
SOURCE: 44 FR 16235, Mar. 16, 1979, unless (f) Shall is used to state mandatory
otherwise noted. requirements.
(g) Should is used to state rec-
Subpart A—General Provisions ommended or advisory procedures or to
identify recommended equipment.
§ 114.3 Definitions. (h) Water activity (aw) is a measure of
For the purposes of this part, the fol- the free moisture in a product and is
lowing definitions apply. the quotient of the water vapor pres-
(a) Acid foods means foods that have sure of the substance divided by the
a natural pH of 4.6 or below. vapor pressure of pure water at the
(b) Acidified foods means low-acid same temperature.
foods to which acid(s) or acid food(s)
are added; these foods include, but are

not limited to, beans, cucumbers, cab- FR 14245, Apr. 1, 1996]
bage, artichokes, cauliflower, pud-
376
§ 114.5 Current good manufacturing designated in the scheduled process and

practice. maintained in all finished foods. Manu-
The criteria in §§ 114.10, 114.80, 114.83, facturing shall be in accordance with
114.89, and 114.100, as well as the cri- the scheduled process. Acidified foods
teria in parts 110 and 117 of this chap- shall be thermally processed to an ex-
ter, apply in determining whether an tent that is sufficient to destroy the
article of acidified food is adulterated: vegetative cells of microorganisms of
(a) Within the meaning of section public health significance and those of
402(a)(3) of the Federal Food, Drug, and nonhealth significance capable of re-
Cosmetic Act in that it has been manu- producing in the food under the condi-
factured under such conditions that it tions in which the food is stored, dis-
is unfit for food; or tributed, retailed and held by the user.
(b) Within the meaning of section Permitted preservatives may be used
402(a)(4) of the Federal Food, Drug, and to inhibit reproduction of microorga-
Cosmetic Act in that it has been pre- nisms of nonhealth significance (in lieu
pared, packed, or held under insanitary of thermal processing).
conditions whereby it may have be- (2) Sufficient control, including fre-
come contaminated with filth, or quent testing and recording of results,
whereby it may have been rendered in- shall be exercised so that the finished
jurious to health. equilibrium pH values for acidified
foods are not higher than 4.6. Measure-
[80 FR 56144, Sept. 17, 2015]
ment of acidity of foods in-process may
§ 114.10 Personnel. be made by potentiometric methods,
titratable acidity, or colorimetric
All operators of processing and pack- methods. If the finished equilibrium pH
aging systems shall be under the oper- of the food is above 4.0, the measure-
ating supervisions of a person who has ment of the finished equilibrium pH
attended a school approved by the
shall be by a potentiometric method,
Commissioner for giving instruction in
and the in-process measurements by ti-
food-handling techniques, food-protec-
tration or colorimetry shall be related
tion principles, personal hygiene and
to the finished equilibrium pH. If the
plant sanitation practices, pH controls
finished equilibrium pH is 4.0 or below,
and critical factors in acidification,
then the measurement of acidity of the
and who has been identified by that
final product may be made by any suit-
school as having satisfactorily com-
able method. Special care should be
pleted the prescribed course of instruc-
taken when food ingredients have been
tion. The Commissioner will consider
subjected to lye, lime, or similar high
students who have satisfactorily com-
pH materials.
pleted the required portions of the
(3) Procedures for acidification to at-
courses presented under § 108.35 and
tain acceptable equilibrium pH levels
part 113 of this chapter before March
in the final food include, but are not
16, 1979, to be in compliance with the
limited to, the following:
requirement of this section.
(i) Blanching of the food ingredients
in acidified aqueous solutions.
Subparts B–D [Reserved] (ii) Immersion of the blanched food
in acid solutions. Although immersion
Subpart E—Production and of food in an acid solution is a satisfac-
Process Controls tory method for acidification, care
must be taken to ensure that the acid
§ 114.80 Processes and controls. concentration is properly maintained.
(a) Processing operations. The manu- (iii) Direct batch acidification, which
facturer shall employ appropriate qual- can be achieved by adding a known
ity control procedures to ensure that amount of an acid solution to a speci-
finished foods do not present a health fied amount of food during acidifica-
hazard. tion.
(1) Acidified foods shall be so manu- (iv) Direct addition of a predeter-
factured, processed, and packaged that mined amount of acid to individual

a finished equilibrium pH value of 4.6 containers during production. Liquid
or lower is achieved within the time acids are generally more effective than
377
§ 114.83 21 CFR Ch. I (4–1–23 Edition)
solid or pelleted acids. Care must be of this chapter; or (c) set aside that
taken to ensure that the proper portion of the food involved for further
amount of acid is added to each con- evaluation as to any potential public
tainer. health significance. The evaluation
(v) Addition of acid foods to low-acid shall be made by a competent proc-
foods in controlled proportions to con- essing authority and shall be in accord-
form to specific formulations. ance with procedures recognized by
(4) Testing and examinations of con- competent processing authorities as
tainers shall occur often enough to en- being adequate to detect any potential
sure that the container suitably pro- hazard to public health. Unless the
tects the food from leakage or con- evaluation demonstrates that the food
tamination. has undergone a process that has ren-
(b) Coding. Each container or product dered it safe, the food set aside shall ei-
shall be marked with an identifying ther be fully reprocessed to render it
code permanently visible to the naked safe, or be destroyed. A record shall be
eye. If the container does not permit made of the procedures used in the
the code to be embossed or inked, the evaluation and the results. Either upon
label may be legibly perforated or oth- completion of full reprocessing and the
erwise marked, as long as the label is attainment of a safe food, or after the
securely affixed to the product con- determination that no significant po-
tainer. The required identification tential for public health hazard exists,
shall specify in code the establishment that portion of the food involved may
where the product was packed, the be shipped in normal distribution. Oth-
product contained therein, and the erwise, the portion of the food involved
year, day, and period during which it shall be destroyed.
was packed. The packing period code
shall be changed often enough to en- § 114.90 Methodology.
able ready identification of lots during Methods that may be used to deter-
their sale and distribution. Codes may mine pH or acidity for acidified foods
be changed periodically on one of the include, but are not limited to, the fol-
following bases: intervals of 4 to 5 lowing:
hours; personnel shift changes; or (a) Potentiometric method for the deter-
batches, as long as the containers con- mination of pH—(1) Principles. The term
stituting the batch do not represent ‘‘pH’’ is used to designate the intensity
those processed during more than one or degree of acidity. The value of pH,
personnel shift. the logarithm of the reciprocal of the
hydrogen ion concentration in solu-
§ 114.83 Establishing scheduled proc- tion, is determined by measuring the
esses. difference in potential between two
The scheduled process shall be estab- electrodes immersed in a sample solu-
lished by a qualified person who has ex- tion. A suitable system consists of a
pert knowledge acquired through ap- potentiometer, a glass electrode, and a
propriate training and experience in reference electrode. A precise pH deter-
the acidification and processing of mination can be made by making an
acidified foods. electromotive force (emf) measurement
of a standard buffer solution whose pH
§ 114.89 Deviations from scheduled is known, and then comparing that
processes. measurement to an emf measurement
Whenever any process operation devi- of a sample of the solution to be tested.
ates from the scheduled process for any (2) Instruments. The primary instru-
acidified food and/or the equilibrium ment for use in pH determination is
pH of the finished product is higher the pH meter or potentiometer. For
than 4.6, the commercial processor of most work, an instrument with a di-
the acidified food shall either: (a) Fully rect-reading pH scale is necessary. Bat-
reprocess that portion of the food by a tery and line-operated instruments are
process established by a competent available commercially. If the line
processing authority as adequate to en- voltage is unstable, line-operated in-

sure a safe product; (b) thermally proc- struments should be fitted with voltage
ess it as a low-acid food under part 113 regulators to eliminate drifting of
378
meter-scale readings. Batteries should automatic temperature compensator

be checked frequently to ensure proper may be used.
operation of battery operated instru- (iii) Accuracy. The accuracy of most
ments. An instrument using an ex- pH meters is stated to be approxi-
panded unit scale or a digital readout mately 0.1 pH unit, and reproducibility
system is preferred since it allows is usually ±0.05 pH unit or less. Some
more precise measurements. meters permit the expansion of any pH
(3) Electrodes. The typical pH meter is unit range to cover the entire scale and
equipped with a glass membrane elec- have an accuracy of approximately
trode and a reference electrode or a ±0.01 pH unit and a reproducibility of
single probe combination electrode. ±0.005 pH units.
Various types of electrodes designed (4) General procedure for determining
for specific uses are available. The pH. When operating an instrument, the
most commonly used reference elec- operator should use the manufacturer’s
trode is the calomel electrode, which instructions and should observe the fol-
incorporates a salt bridge filled with lowing techniques for pH determina-
saturated potassium chloride solution. tions:
(i) Care and use of electrodes. Calomel (i) Switch the instrument on and
electrodes should be kept filled with allow the electronic components to
saturated potassium chloride solution warm up and stabilize before pro-
or other solution specified by the man- ceeding.
ufacturer because they may become (ii) Standardize the instrument and
damaged if they are allowed to dry out. electrodes with commercially prepared
For best results, electrodes should be standard 4.0 pH buffer or with freshly
soaked in buffer solution, distilled or prepared 0.05 molar potassium acid
deionized water, or other liquid speci- phthalate buffer solution prepared as
fied by the manufacturer for several outlined in ‘‘Official Methods of Anal-
hours before using and kept ready by ysis of the Association of Official Ana-
storing with tips immersed in distilled lytical Chemists’’ (AOAC), 13th Ed.
water or in buffer solution used for (1980), section 50.007(c), under ‘‘Buffer
standardization. Electrodes should be Solutions for Calibration of pH Equip-
rinsed with water before immersing in ment—Official Final Action,’’ which is
the standard buffers and rinsed with incorporated by reference. Copies may
water or the solution to be measured be obtained from the AOAC INTER-
next between sample determinations. A NATIONAL, 481 North Frederick Ave.,
lag in meter response may indicate suite 500, Gaithersburg, MD 20877, or
aging effects or fouling of the elec- may be examined at the National Ar-
trodes, and cleaning and rejuvenation chives and Records Administration
of the electrodes may be necessary and (NARA). For information on the avail-
may be accomplished by placing the ability of this material at NARA, call
electrodes in 0.1 molar sodium hydrox- 202–741–6030, or go to: http://
ide solution for 1 minute and then www.archives.gov/federal_register/
transferring them to 0.1 molar hydro- code_of_federal_regulations/
chloric acid solution for 1 minute. The ibr_locations.html. Note the temperature
cycle should be repeated two times, of the buffer solution and set the tem-
ending with the electrodes in the acid perature compensator control at the
solution. The electrodes should then be observed temperature (room tempera-
thoroughly rinsed with water and blot- ture is near 25 °C).
ted with soft tissue before proceeding (iii) Rinse the electrodes with water
with the standardization. and blot, but do not wipe, with soft tis-
(ii) Temperature. To obtain accurate sue.
results, a uniform temperature should (iv) Immerse the tips in the buffer so-
be maintained for the electrodes, the lution and take the pH reading, allow-
standard buffer solutions, and the sam- ing about 1 minute for the meter to
ples. Tests should be made at a tem- stabilize. Adjust the standardization
perature between 20° and 30 °C, the op- control so that the meter reading cor-
timum being 25 °C. Any temperature
responds to the pH of the known buffer

determinations made without meter (for example, 4.0) for the temperature
compensation may affect pH values. An observed. Rinse the electrodes with
379
§ 114.90 21 CFR Ch. I (4–1–23 Edition)
water and blot with soft tissue. Repeat the temperature of the buffer solution
procedure with fresh portions of buffer used for the standardization.
solution until the instrument remains (ii) Rinse and blot the electrodes. Im-
in balance on two successive trials. To merse the electrodes in the sample and
check the operation of the pH meter, take the pH reading, allowing 1 minute
check the pH reading using another for the meter to stabilize. Rinse and
standard buffer such as one having a blot the electrodes and repeat on a
pH of 7.0, or check it with freshly pre- fresh portion of sample. Oil and grease
pared 0.025 molar phosphate solution from the samples may coat the elec-
prepared as outlined in the AOAC, 13th trodes; therefore, it is advisable to
Ed. (1980), section 50.007(e), which is in- clean and standardize the instrument
corporated by reference. The avail- frequently. When oily samples cause
ability of this incorporation by ref- fouling problems, it may become nec-
erence is given in paragraph (a)(4)(ii) of essary to rinse the electrodes with
this section. Expanded scale pH meters ethyl ether.
may be checked with pH 3.0 or pH 5.0 (iii) Determine two pH values on the
standard buffers. Buffers and instru- well-mixed sample. These readings
ments can be further checked by com- should agree with one another to indi-
parison with values obtained with a cate that the sample is homogeneous.
second properly standardized instru- Report values to the nearest 0.05 pH
ment. unit.
(v) Indicating electrodes may be (6) Preparation of samples. Some food
checked for proper operation by first products may consist of a mixture of
using an acid buffer and then a base liquid and solid components that differ
buffer. First standardize the electrodes in acidity. Other food products may be
using a pH 4.0 buffer at or near 25 °C. semisolid in character. The following
Standardization control should be ad- are examples of preparation procedures
justed so that the meter reads exactly for pH testing for each of these cat-
4.0. Electrodes should be rinsed with egories:
water, then blotted and immersed in a (i) Liquid and solid component mix-
pH 9.18 borax buffer prepared as out- tures. Drain the contents of the con-
lined in the AOAC, 13th Ed. (1980), sec- tainer for 2 minutes on a U.S. standard
tion 50.007(f), which is incorporated by No. 8 sieve (preferably stainless steel)
reference. The availability of this in- inclined at a 17- to 20-degree angle.
corporation by reference is given in Record weight of the liquid and solid
paragraph (a)(4)(ii) of this section. The portions and retain each portion sepa-
pH reading should be within ±0.3 units rately.
of the 9.18 value. (a) If the liquid contains sufficient
(vi) The pH meter can be tested for oil to cause electrode fouling, separate
proper operation by shorting the glass the layers with a separatory funnel and
and reference electrode inputs, thereby retain the aqueous layer. The oil layer
reducing the voltage to zero. In some may be discarded. Adjust the tempera-
meters this shorting is done by switch- ture of the aqueous layer to 25 °C and
ing the instrument to standby, and in determine its pH.
other instruments by use of a shorting (b) Remove the drained solids from
strap. With the instrument shorted the sieve, blend to a uniform paste, ad-
out, standardization control should be just the temperature of the paste to 25
turned from one extreme to another. °C and determine its pH.
This operation should produce a deflec- (c) Mix aliquots of solid and liquid
tion greater than ±1.5 pH unit from fractions in the same ratio as found in
center scale. the original container and blend to a
(5) Determining pH on samples. (i) Ad- uniform consistency. Adjust the tem-
just the temperature of the sample to perature of the blend to 25 °C and de-
room temperature (25 °C), and set the termine the equilibriated pH. Alter-
temperature compensator control to natively, blend the entire contents of
the observed temperature. With some the container to a uniform paste, ad-
expanded scale instruments, the sam- just the temperature of the paste to 25
ple temperature must be the same as °C, and determine the equilibriated pH.
380
(ii) Marinated oil products. Separate (b) Colorimetric methods for the deter-
the oil from the solid product. Blend mination of pH. This method may be
the solid in a blender to a paste con- used in lieu of the potentiometric
sistency; it may become necessary to method if the pH is 4.0 or lower.
add a small amount of distilled water (1) Principle. The colorimetric method
to some samples to facilitate the for pH involves the use of indicator
blending. A small amount of added dyes in solutions that gradually change
water will not alter the pH of most color over limited pH ranges. An indi-
food products, but caution must be ex- cator that has the greatest color
ercised concerning poorly buffered
change at approximately the pH of the
foods. No more than 20 milliliters of
sample being tested is selected. The pH
distilled water should be added to each
is determined by the color of the indi-
100 grams of product. Determine the pH
by immersing electrodes in the pre- cator when exposed to the sample
pared paste after adjusting the tem- under test.
perature to 25 °C. (2) Indicator solutions. Most indicator
(iii) Semisolid products. Food products solutions are prepared as a 0.04 percent
of a semisolid consistency, such as pud- solution of the indicator dye in alco-
dings, potato salad, etc., may be blend- hol. In testing, a few drops of indicator
ed to a paste consistency, and the pH solution are added to 10-milliliter por-
may be determined on the prepared tions of the sample solution. Colors
paste. If more fluidity is required, 10 to should be compared using a bright
20 milliliters of distilled water may be background. Approximate determina-
added to 100 grams of product. Adjust tions can be made on white porcelain
the temperature of the prepared paste spot plates, the test colors being com-
to 25 °C and determine its pH. pared thereon with a set of color stand-
(iv) Special product mixtures. For spe- ards. More accurate colorimetric tests
cial product mixtures such as anti- can be made using a comparator block
pasto, pour off the oil, blend the re- fitted with sets of tubes of standard in-
maining product to a paste, and deter- dicator solutions of known pH.
mine the pH of the blended paste. If (3) Indicator paper. A paper tape
more fluidity is required, add 10 to 20 treated with indicator dye is dipped
milliliters of distilled water to each 100 into the sample solution. Depending
grams of product and blend. Adjust the
upon the pH of the solution, the tape
temperature of the prepared paste to 25
will change color and an approximate
°C and determine its pH.
pH can be determined by comparison
(7) Process pH determination. Obtain
with a standard color chart.
sample portions of material for pH de-
termination. (c) Titratable acidity. Acceptable
(i) For process liquids, adjust the methods for determining titratable
temperature of the liquid to 25 °C and acidity are described in the AOAC, 13th
determine the pH by immersing the Ed. (1980), section 22.060, under ‘‘Ti-
electrodes in the liquid. tratable Acidity—Official Final Ac-
(ii) Drain solid materials on a sieve tion,’’ for ‘‘Indicator Method,’’ and sec-
and blend to a workable paste. Adjust tion 22.061 for ‘‘Glass Electrode Meth-
the temperature of the prepared paste od—Official Final Action,’’ which is in-
to 25 °C and determine its pH. corporated by reference. The avail-
(iii) If enough solid materials are ability of this incorporation by ref-
available to make a paste, blend rep- erence is given in paragraph (a)(4)(ii) of
resentative aliquots of liquid and solid this section. The procedure for pre-
materials to a workable paste. Adjust paring and standardizing the sodium
the temperature of the prepared paste hydroxide solution is described in the
to 25 °C and determine the equilibrated AOAC, 13th Ed. (1980), sections 50.032–
pH. Alternatively, blend the entire con- 50.035, under ‘‘Sodium Hydroxide—Offi-
tents of the container to a uniform cial Final Action’’ by the ‘‘Standard
paste, adjust the temperature of the

paste to 25 °C, and determine the
equilibrated pH.
381
§ 114.100 21 CFR Ch. I (4–1–23 Edition)
Potassium Hydroxide Phthalate Meth- PART 115—SHELL EGGS

od,’’ which is also incorporated by ref-
erence and available as set forth in
paragraph (a)(4)(ii) of this section. AUTHORITY: 21 U.S.C. 342, 371; 42 U.S.C. 243,
264, 271.
FR 11822, Mar. 19, 1982; 49 FR 5609, Feb. 14, § 115.50 Refrigeration of shell eggs
1984; 54 FR 24892, June 12, 1989; 63 FR 14035, held for retail distribution.
Mar. 24, 1998]
(a) For purposes of this section a
‘‘retail establishment’’ is an operation
Subpart F—Records and Reports that stores, prepares, packages, serves,
vends, or otherwise provides food for
§ 114.100 Records.
human consumption directly to con-
(a) Records shall be maintained of ex- sumers.
aminations of raw materials, pack- (b) Except as provided in paragraph
aging materials, and finished products, (c) of this section, all shell eggs,
and of suppliers’ guarantees or certifi- whether in intrastate or interstate
cations that verify compliance with commerce, held for retail distribution:
Food and Drug Administration regula- (1) Shall promptly be placed under re-
tions and guidance documents or ac- frigeration as specified in paragraph
tion levels. (b)(2) of this section upon receipt at a
(b) Processing and production records retail establishment, except that, when
showing adherence to scheduled proc- short delays are unavoidable, the eggs
esses, including records of pH measure- shall be placed under refrigeration, as
ments and other critical factors in- soon as reasonably possible; and
tended to ensure a safe product, shall (2) Shall be stored and displayed
be maintained and shall contain suffi- under refrigeration at an ambient tem-
cient additional information such as perature not greater than 7.2 °C (45 °F)
product code, date, container size, and while held at a retail establishment.
product, to permit a public health haz- (c) Shell eggs that have been specifi-
ard evaluation of the processes applied cally processed to destroy all viable
to each lot, batch, or other portion of Salmonella shall be exempt from the re-
production. quirements of paragraph (b) of this sec-
(c) All departures from scheduled tion.
processes having a possible bearing on (d) Under sections 311 and 361 of the
public health or the safety of the food Public Health Service Act (PHS Act),
shall be noted and the affected portion any State or locality that is willing
of the product identified; these depar- and able to assist the agency in the en-
tures shall be recorded and made the forcement of paragraph (b) of this sec-
subject of a separate file (or log identi- tion, and is authorized to inspect or
fying the appropriate data) delineating regulate retail establishments, may, in
them, the action taken to rectify them, its own jurisdiction, enforce paragraph
and the disposition of the portion of (b) of this section through inspections
the product involved. under paragraph (f) of this section and
(d) Records shall be maintained iden- through administrative enforcement
tifying initial distribution of the fin- remedies identified in paragraph (e) of
ished product to facilitate, when nec- this section until FDA notifies the
essary, the segregation of specific food State or locality in writing that such
lots that may have become contami- assistance is no longer needed. When
nated or otherwise unfit for their in- providing assistance under paragraph
tended use. (e) of this section, a State or locality
(e) Copies of all records provided for may follow the hearing procedures set
in paragraphs (b), (c), and (d) of this out in paragraphs (e)(2)(iii) through
section shall be retained at the proc- (e)(2)(iv) of this section, substituting,
essing plant or other reasonably acces- where necessary, appropriate State or
sible location for a period of 3 years local officials for designated FDA offi-
from the date of manufacture.
cials or may utilize State or local hear-

[44 FR 16235, Mar. 16, 1979, as amended at 65 ing procedures if such procedures sat-
FR 56479, Sept. 19, 2000] isfy due process.
382
(e) This section is established under (E) Identification or description of

authority of both the Federal Food, the eggs;
Drug, and Cosmetic Act (the act) and (F) The order number;
the PHS Act. Under the act, the agency (G) The date of the order;
can enforce the food adulteration pro- (H) The text of this entire section;
visions under 21 U.S.C. 331, 332, 333, and (I) A statement that the order may
334. However, 42 U.S.C. 264 provides for be appealed by written appeal or by re-
the issuance of implementing enforce- questing an informal hearing;
ment regulations; therefore, FDA has (J) The name and phone number of
established the following administra- the person issuing the order; and
tive enforcement procedures for the di- (K) The location and telephone num-
version or destruction of shell eggs and ber of the office or agency and the
for informal hearings under the PHS name of its director.
Act: (iii) Approval of Division Director. An
(1) Upon finding that any shell eggs order, before issuance, shall be ap-
have been held in violation of this sec- proved by the FDA Division Director in
tion, an authorized FDA representative whose division the shell eggs are lo-
or a State or local representative in ac- cated. If prior written approval is not
cordance with paragraph (d) of this sec- feasible, prior oral approval shall be
tion may order such eggs to be di- obtained and confirmed by written
verted, under the supervision of said memorandum as soon as possible.
representative, for processing in ac- (iv) Labeling or marking of shell eggs
cordance with the Egg Products Inspec- under order. An FDA, State, or local
tion Act (EPIA) (21 U.S.C. 1031 et seq.) agency representative issuing an order
or destroyed by or under the super- under paragraph (e)(1) of this section
vision of an officer or employee of the shall label or mark the shell eggs with
FDA, or, if applicable, of the State or official tags that include the following
locality in accordance with the fol- information:
lowing procedures: (A) A statement that the shell eggs
(i) Order for diversion or destruction. are detained in accordance with regula-
Any division office of FDA or any tions issued under section 361(a) of the
State or local agency acting under PHS Act (42 U.S.C. 264(a)).
paragraph (d) of this section, upon find- (B) A statement that the shell eggs
ing shell eggs held in violation of this shall not be sold, distributed or other-
section, may serve upon the person in wise disposed of or moved except, after
whose possession such eggs are found a notifying the issuing entity in writing,
written order that such eggs be di- to:
verted, under the supervision of an offi- (1) Divert them for processing in ac-
cer or employee of the issuing entity, cordance with the EPIA or destroy
for processing in accordance with the them; or
EPIA (21 U.S.C. 1031 et seq.) or de- (2) Move them to an another location
stroyed by or under the supervision of for holding pending appeal.
said division office, within 10 working (C) A statement that the violation of
days from the date of receipt of the the order or the removal or alteration
order. of the tag is punishable by fine or im-
(ii) Issuance of order. The order shall prisonment or both (section 368 of the
include the following information: PHS Act, 42 U.S.C. 271).
(A) A statement that the shell eggs (D) The order number and the date of
identified in the order are subject to di- the order, and the name of the govern-
version for processing in accordance ment representative who issued the
with the EPIA or destruction; order.
(B) A detailed description of the facts (v) Sale or other disposition of shell eggs
that justify the issuance of the order; under order. After service of the order,
(C) The location of the eggs; the person in possession of the shell
(D) A statement that these eggs shall eggs that are the subject of the order
not be sold, distributed, or otherwise shall not sell, distribute, or otherwise
disposed of or moved except as pro- dispose of or move any eggs subject to

vided in paragraph (e)(1)(v) of this sec- the order unless and until the notice is
tion; withdrawn after an appeal except, after
383
§ 115.50 21 CFR Ch. I (4–1–23 Edition)
notifying FDA’s division office or, if (A) The presiding FDA official may
applicable, the State or local agency in direct that the hearing be conducted in
writing, to: any suitable manner permitted by law
(A) Divert or destroy them as speci- and this section. The presiding FDA of-
fied in paragraph (e)(1)(i) of this sec- ficial has the power to take such ac-
tion; or tions and make such rulings as are nec-
(B) Move them to another location essary or appropriate to maintain
for holding pending appeal. order and to conduct an informal, fair,
(2) The person on whom the order for expeditious, and impartial hearing, and
diversion or destruction is served may to enforce the requirements concerning
either comply with the order or appeal the conduct of hearings.
the order to an Office of Regulatory Af- (B) Employees of FDA will first give
fairs Program Director in accordance a full and complete statement of the
with the following procedures: action which is the subject of the hear-
(i) Appeal of a detention order. Any ap- ing, together with the information and
peal shall be submitted in writing to reasons supporting it, and may present
FDA’s Division Director in whose divi- oral or written information relevant to
sion the shell eggs are located within 5 the hearing. The party requesting the
working days of the issuance of the hearing may then present oral or writ-
shall be held within 5 working days able examination of any person (except
shall not be later than 20 calendar days on the matter at the hearing.
after the issuance of the order. The (C) The hearing shall be informal in
The appellant of an order shall state but any party may comment upon or
(ii) Summary decision. A request for a (D) The party requesting the hearing
issue of fact has been raised by the ma- (E) The presiding FDA official shall
(iii) Informal hearing. Appearance by (F) The presiding FDA official shall
any appellant at the hearing may be by include as part of the report of the
mail or in person, with or without hearing a finding on the credibility of
counsel. The informal hearing shall be witnesses (other than expert witnesses)
conducted by the Office of Regulatory whenever credibility is a material
Affairs Program Director or another issue, and shall include a recommended
FDA official senior to an FDA Division decision, with a statement of reasons.
Director, and a written summary of the (iv) Written appeal. If the appellant
proceedings shall be prepared by the appeals the detention order but does
presiding FDA official. not request a hearing, the presiding
384
FDA official shall render a decision on tion. Inspections may be made with or
the appeal affirming or revoking the without notice and will ordinarily be
detention within 5-working days after made during regular business hours.
the receipt of the appeal. (g) Preemption. No State or local gov-
(v) Presiding FDA official’s decision. If, erning entity shall establish or con-
based on the evidence presented at the tinue in effect any law, rule, regula-
hearing or by the appellant in a writ- tion, or other requirement allowing re-
ten appeal, the presiding FDA official frigeration of unpasteurized shell eggs
finds that the shell eggs were held in at retail establishments at any tem-
violation of this section, he shall af- perature greater than 7.2 °C (45 °F).
firm the order that they be diverted, [65 FR 76112, Dec. 5, 2000, as amended at 82
under the supervision of an officer or FR 14145, Mar. 17, 2017; 85 FR 16552, Mar. 24,
employee of FDA for processing under 2020]
the EPIA or destroyed by or under the
supervision of an officer or employee of PART 117—CURRENT GOOD MAN-
FDA; otherwise, the presiding FDA of- UFACTURING PRACTICE, HAZARD
ficial shall issue a written notice that
the prior order is withdrawn. If the pre- ANALYSIS, AND RISK–BASED PRE-
siding FDA official affirms the order, VENTIVE CONTROLS FOR HUMAN
he shall order that the diversion or de- FOOD
struction be accomplished within 10-
working days from the date of the Subpart A—General Provisions
issuance of his decision. The presiding Sec.
FDA official’s decision shall be accom- 117.1 Applicability and status.
panied by a statement of the reasons 117.3 Definitions.
for the decision. The decision of the 117.4 Qualifications of individuals who man-
presiding FDA official shall constitute ufacture, process, pack, or hold food.
final agency action, reviewable in the 117.5 Exemptions.
117.7 Applicability of subparts C, D, and G
courts. of this part to a facility solely engaged
(vi) No appeal. If there is no appeal of in the storage of unexposed packaged
the order and the person in possession food.
of the shell eggs that are subject to the 117.8 Applicability of subpart B of this part
order fails to divert or destroy them to the off-farm packing and holding of
within 10 working days, or if the de- raw agricultural commodities
mand is affirmed by the presiding FDA 117.9 Records required for this subpart.
official after an appeal and the person Subpart B—Current Good Manufacturing
in possession of such eggs fails to di- Practice
vert or destroy them within 10 working
days, FDA’s division office or appro- 117.10 Personnel.
priate State or local agency may des- 117.20 Plant and grounds.
ignate an officer or employee to divert 117.35 Sanitary operations.
117.37 Sanitary facilities and controls.
or destroy such eggs. It shall be unlaw-
117.40 Equipment and utensils.
ful to prevent or to attempt to prevent 117.80 Processes and controls.
such diversion or destruction of the 117.93 Warehousing and distribution.
shell eggs by the designated officer or 117.95 Holding and distribution of human
employee. food by-products for use as animal food.
(f) Inspection. Persons engaged in re- 117.110 Defect action levels.
tail distribution of shell eggs shall per-
Subpart C—Hazard Analysis and Risk-
mit authorized representatives of FDA
Based Preventive Controls
to make at any reasonable time such
inspection of the retail establishment 117.126 Food safety plan.
in which shell eggs are being held, in- 117.130 Hazard analysis.
cluding inspection and sampling of 117.135 Preventive controls.
such eggs and the equipment in which 117.136 Circumstances in which the owner,
operator, or agent in charge of a manu-
shell eggs are held and any records re-
facturing/processing facility is not re-
lating to such equipment or eggs, as quired to implement a preventive con-
may be necessary in the judgement of trol.

such representatives to determine com- 117.137 Provision of assurances required
pliance with the provisions of this sec- under § 117.136(a)(2), (3), and (4).
385
§ 117.1 21 CFR Ch. I (4–1–23 Edition)
117.139 Recall plan. 117.335 Special requirements applicable to a
117.140 Preventive control management written assurance.
components.
117.145 Monitoring. Subpart G—Supply-Chain Program
117.150 Corrective actions and corrections.
117.155 Verification. 117.405 Requirement to establish and imple-
117.160 Validation. ment a supply-chain program.
117.410 General requirements applicable to a
117.165 Verification of implementation and
supply-chain program.
effectiveness.
117.415 Responsibilities of the receiving fa-
117.170 Reanalysis.
cility.
117.180 Requirements applicable to a pre- 117.420 Using approved suppliers.
ventive controls qualified individual and 117.425 Determining appropriate supplier
a qualified auditor. verification activities (including deter-
117.190 Implementation records required for mining the frequency of conducting the
this subpart. activity).
117.430 Conducting supplier verification ac-
Subpart D—Modified Requirements tivities for raw materials and other in-
gredients.
117.201 Modified requirements that apply to
117.435 Onsite audit.
a qualified facility.
117.475 Records documenting the supply-
117.206 Modified requirements that apply to
chain program.
a facility solely engaged in the storage of
unexposed packaged food. AUTHORITY: 21 U.S.C. 331, 342, 343, 350d note,
350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271.
Subpart E—Withdrawal of a Qualified SOURCE: 80 FR 56145, Sept. 17, 2015, unless
Facility Exemption otherwise noted.
117.251 Circumstances that may lead FDA EDITORIAL NOTE: Nomenclature changes to
to withdraw a qualified facility exemp- part 117 appear at 81 FR 49896, July 29, 2016.
tion.
117.254 Issuance of an order to withdraw a
qualified facility exemption.
117.257 Contents of an order to withdraw a § 117.1 Applicability and status.
qualified facility exemption.
117.260 Compliance with, or appeal of, an (a) The criteria and definitions in
order to withdraw a qualified facility ex- this part apply in determining whether
emption. a food is:
117.264 Procedure for submitting an appeal. (1) Adulterated within the meaning
117.267 Procedure for requesting an informal of:
hearing. (i) Section 402(a)(3) of the Federal
117.270 Requirements applicable to an infor-
mal hearing.
Food, Drug, and Cosmetic Act in that
117.274 Presiding officer for an appeal and the food has been manufactured under
for an informal hearing. such conditions that it is unfit for
117.277 Timeframe for issuing a decision on food; or
an appeal. (ii) Section 402(a)(4) of the Federal
117.280 Revocation of an order to withdraw Food, Drug, and Cosmetic Act in that
a qualified facility exemption. the food has been prepared, packed, or
117.284 Final agency action. held under insanitary conditions
117.287 Reinstatement of a qualified facility whereby it may have become contami-
exemption that was withdrawn.
nated with filth, or whereby it may
Subpart F—Requirements Applying to have been rendered injurious to health;
Records That Must Be Established and and
Maintained (2) In violation of section 361 of the
Public Health Service Act (42 U.S.C.
117.301 Records subject to the requirements 264).
of this subpart. (b) The operation of a facility that
117.305 General requirements applying to manufactures, processes, packs, or
records. holds food for sale in the United States
117.310 Additional requirements applying to
the food safety plan.
if the owner, operator, or agent in
117.315 Requirements for record retention. charge of such facility is required to
117.320 Requirements for official review. comply with, and is not in compliance
117.325 Public disclosure. with, section 418 of the Federal Food,
117.330 Use of existing records. Drug, and Cosmetic Act or subpart C,
386
D, E, F, or G of this part is a prohibited the problem will recur, evaluate all af-
act under section 301(uu) of the Federal fected food for safety, and prevent af-
Food, Drug, and Cosmetic Act. fected food from entering commerce).
(c) Food covered by specific current Critical control point means a point,
good manufacturing practice regula- step, or procedure in a food process at
tions also is subject to the require- which control can be applied and is es-
ments of those regulations. sential to prevent or eliminate a food
[80 FR 56145, Sept. 17, 2015, as amended at 81 safety hazard or reduce such hazard to
FR 3715, Jan. 22, 2016] an acceptable level.
Defect action level means a level of a
§ 117.3 Definitions.
non-hazardous, naturally occurring,
The definitions and interpretations unavoidable defect at which FDA may
of terms in section 201 of the Federal regard a food product ‘‘adulterated’’
Food, Drug, and Cosmetic Act apply to and subject to enforcement action
such terms when used in this part. The under section 402(a)(3) of the Federal
following definitions also apply: Food, Drug, and Cosmetic Act.
Acid foods or acidified foods means
Environmental pathogen means a
foods that have an equilibrium pH of
pathogen capable of surviving and per-
4.6 or below.
Adequate means that which is needed sisting within the manufacturing, proc-
to accomplish the intended purpose in essing, packing, or holding environ-
keeping with good public health prac- ment such that food may be contami-
tice. nated and may result in foodborne ill-
Affiliate means any facility that con- ness if that food is consumed without
trols, is controlled by, or is under com- treatment to significantly minimize
mon control with another facility. the environmental pathogen. Examples
Allergen cross-contact means the unin- of environmental pathogens for the
tentional incorporation of a food aller- purposes of this part include Listeria
gen into a food. monocytogenes and Salmonella spp. but
Audit means the systematic, inde- do not include the spores of pathogenic
pendent, and documented examination sporeforming bacteria.
(through observation, investigation, Facility means a domestic facility or
records review, discussions with em- a foreign facility that is required to
ployees of the audited entity, and, as register under section 415 of the Fed-
appropriate, sampling and laboratory eral Food, Drug, and Cosmetic Act, in
analysis) to assess an audited entity’s accordance with the requirements of
food safety processes and procedures. part 1, subpart H of this chapter.
Batter means a semifluid substance, Farm means farm as defined in § 1.227
usually composed of flour and other in- of this chapter.
gredients, into which principal compo- FDA means the Food and Drug Ad-
nents of food are dipped or with which ministration.
they are coated, or which may be used Food means food as defined in section
directly to form bakery foods.
201(f) of the Federal Food, Drug, and
Blanching, except for tree nuts and
Cosmetic Act and includes raw mate-
peanuts, means a prepackaging heat
rials and ingredients.
treatment of foodstuffs for an adequate
time and at an adequate temperature Food allergen means a major food al-
to partially or completely inactivate lergen as defined in section 201(qq) of
the naturally occurring enzymes and to the Federal Food, Drug, and Cosmetic
effect other physical or biochemical Act.
changes in the food. Food-contact surfaces are those sur-
Calendar day means every day shown faces that contact human food and
on the calendar. those surfaces from which drainage, or
Correction means an action to iden- other transfer, onto the food or onto
tify and correct a problem that oc- surfaces that contact the food ordi-
curred during the production of food, narily occurs during the normal course
without other actions associated with of operations. ‘‘Food-contact surfaces’’

a corrective action procedure (such as includes utensils and food-contact sur-
actions to reduce the likelihood that faces of equipment.
387
§ 117.3 21 CFR Ch. I (4–1–23 Edition)
Full-time equivalent employee is a term occur in the absence of preventive con-

used to represent the number of em- trols), establish one or more preventive
ployees of a business entity for the pur- controls to significantly minimize or
pose of determining whether the busi- prevent the hazard in a food and com-
ness qualifies for the small business ex- ponents to manage those controls (such
emption. The number of full-time as monitoring, corrections or correc-
equivalent employees is determined by tive actions, verification, and records)
dividing the total number of hours of as appropriate to the food, the facility,
salary or wages paid directly to em- and the nature of the preventive con-
ployees of the business entity and of all trol and its role in the facility’s food
of its affiliates and subsidiaries by the safety system.
number of hours of work in 1 year, 2,080 Holding means storage of food and
hours (i.e., 40 hours × 52 weeks). If the also includes activities performed inci-
result is not a whole number, round dental to storage of a food (e.g., activi-
down to the next lowest whole number. ties performed for the safe or effective
Harvesting applies to farms and farm storage of that food, such as fumigat-
mixed-type facilities and means activi- ing food during storage, and drying/de-
ties that are traditionally performed hydrating raw agricultural commod-
on farms for the purpose of removing ities when the drying/dehydrating does
raw agricultural commodities from the not create a distinct commodity (such
place they were grown or raised and as drying/dehydrating hay or alfalfa)).
preparing them for use as food. Har- Holding also includes activities per-
vesting is limited to activities performed as a practical necessity for the
formed on raw agricultural commod- distribution of that food (such as
ities, or on processed foods created by blending of the same raw agricultural
drying/dehydrating a raw agricultural commodity and breaking down pallets),
commodity without additional manu- but does not include activities that
facturing/processing, on a farm. Har- transform a raw agricultural com-
vesting does not include activities that modity into a processed food as defined
transform a raw agricultural com- in section 201(gg) of the Federal Food,
modity into a processed food as defined Drug, and Cosmetic Act. Holding facili-
in section 201(gg) of the Federal Food, ties could include warehouses, cold
Drug, and Cosmetic Act. Examples of storage facilities, storage silos, grain
harvesting include cutting (or other- elevators, and liquid storage tanks.
wise separating) the edible portion of Known or reasonably foreseeable haz-
the raw agricultural commodity from ard means a biological, chemical (in-
the crop plant and removing or trim- cluding radiological), or physical haz-
ming part of the raw agricultural com- ard that is known to be, or has the po-
modity (e.g., foliage, husks, roots or tential to be, associated with the facil-
stems). Examples of harvesting also in- ity or the food.
clude cooling, field coring, filtering, Lot means the food produced during a
gathering, hulling, shelling, sifting, period of time and identified by an es-
threshing, trimming of outer leaves of, tablishment’s specific code.
and washing raw agricultural commod- Manufacturing/processing means mak-
ities grown on a farm. ing food from one or more ingredients,
Hazard means any biological, chem- or synthesizing, preparing, treating,
ical (including radiological), or phys- modifying or manipulating food, in-
ical agent that has the potential to cluding food crops or ingredients. Ex-
cause illness or injury. amples of manufacturing/processing ac-
Hazard requiring a preventive control tivities include: Baking, boiling, bot-
means a known or reasonably foresee- tling, canning, cooking, cooling, cut-
able hazard for which a person knowl- ting, distilling, drying/dehydrating raw
edgeable about the safe manufacturing, agricultural commodities to create a
processing, packing, or holding of food distinct commodity (such as drying/de-
would, based on the outcome of a haz- hydrating grapes to produce raisins),
ard analysis (which includes an assess- evaporating, eviscerating, extracting
ment of the severity of the illness or juice, formulating, freezing, grinding,

injury if the hazard were to occur and homogenizing, irradiating, labeling,
the probability that the hazard will milling, mixing, packaging (including
388
modified atmosphere packaging), pas- Preventive controls means those risk-

teurizing, peeling, rendering, treating based, reasonably appropriate proce-
to manipulate ripening, trimming, dures, practices, and processes that a
washing, or waxing. For farms and person knowledgeable about the safe
farm mixed-type facilities, manufac- manufacturing, processing, packing, or
turing/processing does not include ac- holding of food would employ to sig-
tivities that are part of harvesting, nificantly minimize or prevent the haz-
packing, or holding. ards identified under the hazard anal-
Microorganisms means yeasts, molds, ysis that are consistent with the cur-
bacteria, viruses, protozoa, and micro- rent scientific understanding of safe
scopic parasites and includes species food manufacturing, processing, pack-
that are pathogens. The term ‘‘unde-
ing, or holding at the time of the anal-
sirable microorganisms’’ includes those
ysis.
microorganisms that are pathogens,
that subject food to decomposition, Preventive controls qualified individual
that indicate that food is contaminated means a qualified individual who has
with filth, or that otherwise may cause successfully completed training in the
food to be adulterated. development and application of risk-
Mixed-type facility means an estab- based preventive controls at least
lishment that engages in both activi- equivalent to that received under a
ties that are exempt from registration standardized curriculum recognized as
under section 415 of the Federal Food, adequate by FDA or is otherwise quali-
Drug, and Cosmetic Act and activities fied through job experience to develop
that require the establishment to be and apply a food safety system.
registered. An example of such a facil- Qualified auditor means a person who
ity is a ‘‘farm mixed-type facility,’’ is a qualified individual as defined in
which is an establishment that is a this part and has technical expertise
farm, but also conducts activities out- obtained through education, training,
side the farm definition that require or experience (or a combination there-
the establishment to be registered. of) necessary to perform the auditing
Monitor means to conduct a planned function as required by § 117.180(c)(2).
sequence of observations or measure- Examples of potential qualified audi-
ments to assess whether control meas-
tors include:
ures are operating as intended.
Packing means placing food into a (1) A government employee, includ-
container other than packaging the ing a foreign government employee;
food and also includes re-packing and and
activities performed incidental to (2) An audit agent of a certification
packing or re-packing a food (e.g., ac- body that is accredited in accordance
tivities performed for the safe or effec- with regulations in part 1, subpart M of
tive packing or re-packing of that food this chapter.
(such as sorting, culling, grading, and Qualified end-user, with respect to a
weighing or conveying incidental to food, means the consumer of the food
packing or re-packing)), but does not (where the term consumer does not in-
include activities that transform a raw clude a business); or a restaurant or re-
agricultural commodity into a proc- tail food establishment (as those terms
essed food as defined in section 201(gg) are defined in § 1.227 of this chapter)
of the Federal Food, Drug, and Cos- that:
metic Act. (1) Is located:
Pathogen means a microorganism of (i) In the same State or the same In-
public health significance. dian reservation as the qualified facil-
Pest refers to any objectionable ani-
ity that sold the food to such res-
mals or insects including birds, ro-
taurant or establishment; or
dents, flies, and larvae.
Plant means the building or structure (ii) Not more than 275 miles from
or parts thereof, used for or in connec- such facility; and
(2) Is purchasing the food for sale di-
tion with the manufacturing, proc-

essing, packing, or holding of human rectly to consumers at such restaurant
food. or retail food establishment.
389
§ 117.3 21 CFR Ch. I (4–1–23 Edition)
Qualified facility means (when includ- cessfully reconditioned by reprocessing

ing the sales by any subsidiary; affil- and that is suitable for use as food.
iate; or subsidiaries or affiliates, col- Safe-moisture level is a level of mois-
lectively, of any entity of which the fa- ture low enough to prevent the growth
cility is a subsidiary or affiliate) a fa- of undesirable microorganisms in the
cility that is a very small business as finished product under the intended
defined in this part, or a facility to conditions of manufacturing, proc-
which both of the following apply: essing, packing, and holding. The safe
(1) During the 3-year period preceding moisture level for a food is related to
the applicable calendar year, the aver- its water activity (aw). An aw will be
age annual monetary value of the food considered safe for a food if adequate
manufactured, processed, packed or data are available that demonstrate
held at such facility that is sold di- that the food at or below the given aw
rectly to qualified end-users (as defined will not support the growth of undesir-
in this part) during such period exceed- able microorganisms.
ed the average annual monetary value Sanitize means to adequately treat
of the food sold by such facility to all cleaned surfaces by a process that is ef-
other purchasers; and fective in destroying vegetative cells of
(2) The average annual monetary pathogens, and in substantially reduc-
value of all food sold during the 3-year ing numbers of other undesirable
period preceding the applicable cal- microorganisms, but without adversely
endar year was less than $500,000, ad- affecting the product or its safety for
justed for inflation. the consumer.
Qualified facility exemption means an
Significantly minimize means to reduce
exemption applicable to a qualified fa-
to an acceptable level, including to
cility under § 117.5(a).
eliminate.
Qualified individual means a person
Small business means, for purposes of
who has the education, training, or ex-
this part, a business (including any
perience (or a combination thereof)
subsidiaries and affiliates) employing
necessary to manufacture, process,
fewer than 500 full-time equivalent em-
pack, or hold clean and safe food as ap-
ployees.
propriate to the individual’s assigned
duties. A qualified individual may be, Subsidiary means any company which
but is not required to be, an employee is owned or controlled directly or indi-
of the establishment. rectly by another company.
Quality control operation means a Supplier means the establishment
planned and systematic procedure for that manufactures/processes the food,
taking all actions necessary to prevent raises the animal, or grows the food
food from being adulterated. that is provided to a receiving facility
Raw agricultural commodity has the without further manufacturing/proc-
meaning given in section 201(r) of the essing by another establishment, ex-
Federal Food, Drug, and Cosmetic Act. cept for further manufacturing/proc-
Ready-to-eat food (RTE food) means essing that consists solely of the addi-
any food that is normally eaten in its tion of labeling or similar activity of a
raw state or any other food, including de minimis nature.
a processed food, for which it is reason- Supply-chain-applied control means a
ably foreseeable that the food will be preventive control for a hazard in a
eaten without further processing that raw material or other ingredient when
would significantly minimize biologi- the hazard in the raw material or other
cal hazards. ingredient is controlled before its re-
Receiving facility means a facility ceipt.
that is subject to subparts C and G of Unexposed packaged food means pack-
this part and that manufactures/proc- aged food that is not exposed to the en-
esses a raw material or other ingre- vironment.
dient that it receives from a supplier. Validation means obtaining and eval-
Rework means clean, unadulterated uating scientific and technical evi-
food that has been removed from proc- dence that a control measure, combina-
essing for reasons other than insani- tion of control measures, or the food
tary conditions or that has been suc- safety plan as a whole, when properly
390
implemented, is capable of effectively (b) Qualifications of all individuals en-

controlling the identified hazards. gaged in manufacturing, processing,
Verification means the application of packing, or holding food. Each indi-
methods, procedures, tests and other vidual engaged in manufacturing, proc-
evaluations, in addition to monitoring, essing, packing, or holding food (in-
to determine whether a control meas- cluding temporary and seasonal per-
ure or combination of control measures sonnel) or in the supervision thereof
is or has been operating as intended must:
and to establish the validity of the food (1) Be a qualified individual as that
safety plan. term is defined in § 117.3—i.e., have the
Very small business means, for pur- education, training, or experience (or a
poses of this part, a business (including combination thereof) necessary to
any subsidiaries and affiliates) aver- manufacture, process, pack, or hold
aging less than $1,000,000, adjusted for clean and safe food as appropriate to
inflation, per year, during the 3-year the individual’s assigned duties; and
period preceding the applicable cal- (2) Receive training in the principles
endar year in sales of human food plus of food hygiene and food safety, includ-
the market value of human food manu- ing the importance of employee health
factured, processed, packed, or held and personal hygiene, as appropriate to
without sale (e.g., held for a fee). the food, the facility and the individ-
Water activity (aw) is a measure of the ual’s assigned duties.
free moisture in a food and is the
(c) Additional qualifications of super-
quotient of the water vapor pressure of
visory personnel. Responsibility for en-
the substance divided by the vapor
suring compliance by individuals with
pressure of pure water at the same
the requirements of this part must be
temperature.
clearly assigned to supervisory per-
Written procedures for receiving raw
sonnel who have the education, train-
materials and other ingredients means
ing, or experience (or a combination
written procedures to ensure that raw
thereof) necessary to supervise the pro-
materials and other ingredients are re-
duction of clean and safe food.
ceived only from suppliers approved by
the receiving facility (or, when nec- (d) Records. Records that document
essary and appropriate, on a temporary training required by paragraph (b)(2) of
basis from unapproved suppliers whose this section must be established and
raw materials or other ingredients are maintained.
subjected to adequate verification ac-
§ 117.5 Exemptions.
tivities before acceptance for use).
You means, for purposes of this part, (a) Except as provided by subpart E
the owner, operator, or agent in charge of this part, subparts C and G of this
of a facility. part do not apply to a qualified facil-
ity. Qualified facilities are subject to
FR 3715, Jan. 22, 2016] the modified requirements in § 117.201.
(b) Subparts C and G of this part do
§ 117.4 Qualifications of individuals not apply with respect to activities
who manufacture, process, pack, or that are subject to part 123 of this
hold food. chapter (Fish and Fishery Products) at
(a) Applicability. (1) The management a facility if you are required to comply
of an establishment must ensure that with, and are in compliance with, part
all individuals who manufacture, proc- 123 of this chapter with respect to such
ess, pack, or hold food subject to sub- activities.
parts B and F of this part are qualified (c) Subparts C and G of this part do
to perform their assigned duties. not apply with respect to activities
(2) The owner, operator, or agent in that are subject to part 120 of this
charge of a facility must ensure that chapter (Hazard Analysis and Critical
all individuals who manufacture, proc- Control Point (HACCP) Systems) at a
ess, pack, or hold food subject to sub- facility if you are required to comply
part C, D, E, F, or G of this part are with, and are in compliance with, part
qualified to perform their assigned du- 120 of this chapter with respect to such
ties. activities.
391
§ 117.5 21 CFR Ch. I (4–1–23 Edition)
(d)(1) Subparts C and G of this part vegetables are separately considered

do not apply with respect to activities for the purposes of these activity/food
that are subject to part 113 of this combinations (i.e., coffee beans, cocoa
chapter (Thermally Processed Low- beans, fresh herbs, peanuts, sugarcane,
Acid Foods Packaged in Hermetically sugar beets, tree nuts, seeds for direct
Sealed Containers) at a facility if you consumption) to appropriately address
are required to comply with, and are in specific hazards associated with these
compliance with, part 113 of this chap- foods and/or processing activities con-
ter with respect to such activities. ducted on these foods.
(2) The exemption in paragraph (d)(1) (i) Dried/dehydrated fruit and vegetable
of this section is applicable only with products includes only those processed
respect to the microbiological hazards food products such as raisins and dried
that are regulated under part 113 of legumes made without additional man-
this chapter. ufacturing/processing beyond drying/
(e) Subparts C and G do not apply to dehydrating, packaging, and/or label-
any facility with regard to the manu- ing.
facturing, processing, packaging, or (ii) Other fruit and vegetable products
holding of a dietary supplement that is includes those processed food products
in compliance with the requirements of that have undergone one or more of the
part 111 of this chapter (Current Good following processes: acidification, boil-
Manufacturing Practice in Manufac- ing, canning, coating with things other
turing, Packaging, Labeling, or Hold- than wax/oil/resin, cooking, cutting,
ing Operations for Dietary Supple- chopping, grinding, peeling, shredding,
ments) and section 761 of the Federal slicing, or trimming. Examples include
Food, Drug, and Cosmetic Act (Serious flours made from legumes (such as
Adverse Event Reporting for Dietary chickpea flour), pickles, and snack
Supplements). chips made from potatoes or plantains.
(f) Subparts C and G of this part do Examples also include dried fruit and
not apply to activities of a facility that vegetable products made with addi-
are subject to section 419 of the Federal tional manufacturing/processing (such
Food, Drug, and Cosmetic Act (Stand- as dried apple slices; pitted, dried
ards for Produce Safety). plums, cherries, and apricots; and
(g)(1) The exemption in paragraph sulfited raisins). This category does
(g)(3) of this section applies to packing not include dried/dehydrated fruit and
or holding of processed foods on a farm vegetable products made without addi-
mixed-type facility, except for proc- tional manufacturing/processing as de-
essed foods produced by drying/dehy- scribed in paragraph (g)(2)(i) of this
drating raw agricultural commodities section. This category also does not in-
to create a distinct commodity (such clude products that require time/tem-
as drying/dehydrating grapes to perature control for safety (such as
produce raisins, and drying/dehy- fresh-cut fruits and vegetables).
drating fresh herbs to produce dried (iii) Peanut and tree nut products in-
herbs), and packaging and labeling cludes processed food products such as
such commodities, without additional roasted peanuts and tree nuts, sea-
manufacturing/processing (such as soned peanuts and tree nuts, and pea-
chopping and slicing), the packing and nut and tree nut flours.
holding of which are within the ‘‘farm’’ (iv) Processed seeds for direct consump-
definition in § 1.227 of this chapter. Ac- tion include processed food products
tivities that are within the ‘‘farm’’ def- such as roasted pumpkin seeds, roasted
inition, when conducted on a farm sunflower seeds, and roasted flax seeds.
mixed-type facility, are not subject to (v) Dried/dehydrated herb and spice
the requirements of subparts C and G products includes only processed food
of this part and therefore do not need products such as dried intact herbs
to be specified in the exemption. made without additional manufac-
(2) For the purposes of paragraphs turing/processing beyond drying/dehy-
(g)(3) and (h)(3) of this section, the fol- drating, packaging, and/or labeling.
lowing terms describe the foods associ- (vi) Other herb and spice products in-
ated with the activity/food combina- cludes those processed food products
tions. Several foods that are fruits or such as chopped fresh herbs, chopped or
392
ground dried herbs (including tea), (i) Baked goods (e.g., bread and cook-
herbal extracts (e.g., essential oils, ex- ies);
tracts containing more than 20 percent (ii) Candy (e.g., hard candy, fudge,
ethanol, extracts containing more than maple candy, maple cream, nut
35 percent glycerin), dried herb- or brittles, taffy, and toffee);
spice-infused honey, and dried herb- or (iii) Cocoa beans (roasted);
spice-infused oils and/or vinegars. This (iv) Cocoa products;
category does not include dried/dehy- (v) Coffee beans (roasted);
drated herb and spice products made (vi) Game meat jerky;
without additional manufacturing/ (vii) Gums, latexes, and resins that
processing beyond drying/dehydrating, are processed foods;
packaging, and/or labeling as described
(viii) Honey (pasteurized);
in paragraph (g)(2)(v) of this section.
This category also does not include (ix) Jams, jellies, and preserves;
products that require time/temperature (x) Milled grain products (e.g., flour,
control for safety, such as fresh herb- bran, and corn meal);
infused oils. (xi) Molasses and treacle;
(vii) Grains include barley, dent- or (xii) Oils (e.g., olive oil and sunflower
flint-corn, sorghum, oats, rice, rye, seed oil);
wheat, amaranth, quinoa, buckwheat (xiii) Other fruit and vegetable prod-
and oilseeds for oil extraction (such as ucts (e.g., flours made from legumes;
cotton seed, flax seed, rapeseed, soy- pitted, dried fruits; sliced, dried apples;
beans, and sunflower seed). snack chips);
(viii) Milled grain products include (xiv) Other grain products (e.g., dried
processed food products such as flour, pasta, oat flakes, and popcorn);
bran, and corn meal. (xv) Other herb and spice products
(ix) Baked goods include processed (e.g., chopped or ground dried herbs,
food products such as breads, brownies, herbal extracts);
cakes, cookies, and crackers. This cat- (xvi) Peanut and tree nut products
egory does not include products that (e.g., roasted peanuts and tree nut
require time/temperature control for flours);
safety, such as cream-filled pastries. (xvii) Processed seeds for direct con-
(x) Other grain products include proc- sumption (e.g., roasted pumpkin seeds);
essed food products such as dried ce- (xviii) Soft drinks and carbonated
real, dried pasta, oat flakes, and pop- water;
corn. This category does not include (xix) Sugar;
milled grain products as described in (xx) Syrups (e.g., maple syrup and
paragraph (g)(2)(viii) of this section or agave syrup);
baked goods as described in paragraph (xxi) Trail mix and granola;
(g)(2)(ix) of this section. (xxii) Vinegar; and
(3) Subparts C and G of this part do (xxiii) Any other processed food that
not apply to on-farm packing or hold- does not require time/temperature con-
ing of food by a small or very small trol for safety (e.g., vitamins, minerals,
business, and § 117.201 does not apply to and dietary ingredients (e.g., bone
on-farm packing or holding of food by a meal) in powdered, granular, or other
very small business, if the only pack- solid form).
ing and holding activities subject to (h)(1) The exemption in paragraph
section 418 of the Federal Food, Drug, (h)(3) of this section applies to manu-
and Cosmetic Act that the business facturing/processing of foods on a farm
conducts are the following low-risk mixed-type facility, except for manu-
packing or holding activity/food com- facturing/processing that is within the
binations—i.e., packing (or re-packing) ‘‘farm’’ definition in § 1.227 of this chap-
(including weighing or conveying inci- ter. Drying/dehydrating raw agricul-
dental to packing or re-packing); sort- tural commodities to create a distinct
ing, culling, or grading incidental to commodity (such as drying/dehy-
packing or storing; and storing (ambi- drating grapes to produce raisins, and
ent, cold and controlled atmosphere) drying/dehydrating fresh herbs to
of: produce dried herbs), and packaging
393
§ 117.5 21 CFR Ch. I (4–1–23 Edition)
and labeling such commodities, with- raisins with chocolate), other fruit and
out additional manufacturing/proc- vegetable products except for non-
essing (such as chopping and slicing), dried, non-intact fruits and vegetables
are within the ‘‘farm’’ definition in (e.g., coating dried plum pieces, dried
§ 1.227 of this chapter. In addition, pitted cherries, and dried pitted apri-
treatment to manipulate ripening of cots with chocolate are low-risk activ-
raw agricultural commodities (such as ity/food combinations but coating ap-
by treating produce with ethylene gas), ples on a stick with caramel is not a
and packaging and labeling the treated low-risk activity/food combination),
raw agricultural commodities, without other grain products (e.g., adding car-
additional manufacturing/processing, amel to popcorn or adding seasonings
is within the ‘‘farm’’ definition. In ad- to popcorn provided that the
dition, coating intact fruits and vege- seasonings have been treated to signifi-
tables with wax, oil, or resin used for cantly minimize pathogens, peanuts
the purpose of storage or transpor- and tree nuts (e.g., adding seasonings
tation is within the ‘‘farm’’ definition. provided that the seasonings have been
Activities that are within the ‘‘farm’’ treated to significantly minimize
definition, when conducted on a farm pathogens), and peanut and tree nut
mixed-type facility, are not subject to products (e.g., adding seasonings pro-
the requirements of subparts C and G vided that the seasonings have been
of this part and therefore do not need treated to significantly minimize
to be specified in the exemption. pathogens));
(2) The terms in paragraph (g)(2) of (iv) Drying/dehydrating (that in-
this section describe certain foods asso- cludes additional manufacturing or is
ciated with the activity/food combina- performed on processed foods) other
tions in paragraph (h)(3) of this sec- fruit and vegetable products with pH
tion. less than 4.2 (e.g., drying cut fruit and
(3) Subparts C and G of this part do vegetables with pH less than 4.2), and
not apply to on-farm manufacturing/ other herb and spice products (e.g., dry-
processing activities conducted by a ing chopped fresh herbs, including tea);
small or very small business for dis- (v) Extracting (including by pressing,
tribution into commerce, and § 117.201 by distilling, and by solvent extrac-
does not apply to on-farm manufac- tion) dried/dehydrated herb and spice
turing/processing activities conducted products (e.g., dried mint), fresh herbs
by a very small business for distribu- (e.g., fresh mint), fruits and vegetables
tion into commerce, if the only manu- (e.g., olives, avocados), grains (e.g., oil-
facturing/processing activities subject seeds), and other herb and spice prod-
to section 418 of the Federal Food, ucts (e.g., chopped fresh mint, chopped
Drug, and Cosmetic Act that the busi- dried mint);
ness conducts are the following low- (vi) Freezing acid fruits and vegeta-
risk manufacturing/processing activ- bles with pH less than 4.2 and other
ity/food combinations: fruit and vegetable products with pH
(i) Boiling gums, latexes, and resins; less than 4.2 (e.g., cut fruits and vegeta-
(ii) Chopping, coring, cutting, peel- bles);
ing, pitting, shredding, and slicing acid (vii) Grinding/cracking/crushing/mill-
fruits and vegetables that have a pH ing baked goods (e.g., crackers), cocoa
less than 4.2 (e.g., cutting lemons and beans (roasted), coffee beans (roasted),
limes), baked goods (e.g., slicing bread), dried/dehydrated fruit and vegetable
dried/dehydrated fruit and vegetable products (e.g., raisins and dried leg-
products (e.g., pitting dried plums), umes), dried/dehydrated herb and spice
dried herbs and other spices (e.g., chop- products (e.g., intact dried basil),
ping intact, dried basil), game meat grains (e.g., oats, rice, rye, wheat),
jerky, gums/latexes/resins, other grain other fruit and vegetable products (e.g.,
products (e.g., shredding dried cereal), dried, pitted dates), other grain prod-
peanuts and tree nuts, and peanut and ucts (e.g., dried cereal), other herb and
tree nut products (e.g., chopping roast- spice products (e.g., chopped dried
ed peanuts); herbs), peanuts and tree nuts, and pea-

(iii) Coating dried/dehydrated fruit nut and tree nut products (e.g., roasted
and vegetable products (e.g., coating peanuts);
394
(viii) Labeling baked goods that do (xvi) Making popcorn from grains;
not contain food allergens, candy that (xvii) Making snack chips from fruits
does not contain food allergens, cocoa and vegetables (e.g., making plantain
beans (roasted), cocoa products that do and potato chips);
not contain food allergens), coffee (xviii) Making soft drinks and car-
beans (roasted), game meat jerky, bonated water from sugar, syrups, and
gums/latexes/resins that are processed water;
foods, honey (pasteurized), jams/jellies/ (xix) Making sugars and syrups from
preserves, milled grain products that fruits and vegetables (e.g., dates),
do not contain food allergens (e.g., corn grains (e.g., rice, sorghum), other grain
meal) or that are single-ingredient products (e.g., malted grains such as
foods (e.g., wheat flour, wheat bran), barley), saps (e.g., agave, birch, maple,
molasses and treacle, oils, other fruit palm), sugar beets, and sugarcane;
and vegetable products that do not (xx) Making trail mix and granola
contain food allergens (e.g., snack chips from cocoa products (e.g., chocolate),
made from potatoes or plantains), dried/dehydrated fruit and vegetable
other grain products that do not con- products (e.g., raisins), other fruit and
tain food allergens (e.g., popcorn), vegetable products (e.g., chopped dried
other herb and spice products (e.g., fruits), other grain products (e.g., oat
chopped or ground dried herbs), peanut flakes), peanut and tree nut products,
or tree nut products, (provided that and processed seeds for direct consump-
they are single-ingredient, or are in tion, provided that peanuts, tree nuts,
forms in which the consumer can rea- and processed seeds are treated to sig-
sonably be expected to recognize the nificantly minimize pathogens;
food allergen(s) without label declara- (xxi) Making vinegar from fruits and
tion, or both (e.g., roasted or seasoned vegetables, other fruit and vegetable
whole nuts, single-ingredient peanut or products (e.g., fruit wines, apple cider),
tree nut flours)), processed seeds for di- and other grain products (e.g., malt);
rect consumption, soft drinks and car- (xxii) Mixing baked goods (e.g., types
bonated water, sugar, syrups, trail mix of cookies), candy (e.g., varieties of
and granola (other than those con- taffy), cocoa beans (roasted), coffee
taining milk chocolate and provided beans (roasted), dried/dehydrated fruit
that peanuts and/or tree nuts are in and vegetable products (e.g., dried blue-
forms in which the consumer can rea- berries, dried currants, and raisins),
sonably be expected to recognize the dried/dehydrated herb and spice prod-
food allergen(s) without label declara- ucts (e.g., dried, intact basil and dried,
tion), vinegar, and any other processed intact oregano), honey (pasteurized),
food that does not require time/tem- milled grain products (e.g., flour, bran,
perature control for safety and that and corn meal), other fruit and vege-
does not contain food allergens (e.g., vi- table products (e.g., dried, sliced apples
tamins, minerals, and dietary ingredi- and dried, sliced peaches), other grain
ents (e.g., bone meal) in powdered, products (e.g., different types of dried
granular, or other solid form); pasta), other herb and spice products
(ix) Making baked goods from milled (e.g., chopped or ground dried herbs,
grain products (e.g., breads and cook- dried herb- or spice-infused honey, and
ies); dried herb- or spice-infused oils and/or
(x) Making candy from peanuts and vinegars), peanut and tree nut prod-
tree nuts (e.g., nut brittles), sugar/syr- ucts, sugar, syrups, vinegar, and any
ups (e.g., taffy, toffee), and saps (e.g., other processed food that does not re-
maple candy, maple cream); quire time/temperature control for
(xi) Making cocoa products from safety (e.g., vitamins, minerals, and di-
roasted cocoa beans; etary ingredients (e.g., bone meal) in
(xii) Making dried pasta from grains; powdered, granular, or other solid
(xiii) Making jams, jellies, and pre- form);
serves from acid fruits and vegetables (xxiii) Packaging baked goods (e.g.,
with a pH of 4.6 or below; bread and cookies), candy, cocoa beans
(xiv) Making molasses and treacle (roasted), cocoa products, coffee beans
from sugar beets and sugarcane; (roasted), game meat jerky, gums/
(xv) Making oat flakes from grains; latexes/resins that are processed foods,
395
§ 117.5 21 CFR Ch. I (4–1–23 Edition)
honey (pasteurized), jams/jellies/pre- described in paragraph (i)(1) of this sec-

serves, milled grain products (e.g., tion, provided such food:
flour, bran, corn meal), molasses and (i) Is in prepackaged form that pre-
treacle, oils, other fruit and vegetable vents any direct human contact with
products (e.g., pitted, dried fruits; such food; and
sliced, dried apples; snack chips), other (ii) Constitutes not more than 5 per-
grain products (e.g., popcorn), other cent of the overall sales of the facility,
herb and spice products (e.g., chopped as determined by the Secretary of the
or ground dried herbs), peanut and tree
Treasury.
nut products, processed seeds for direct
consumption, soft drinks and carbon- (j) Subparts C and G of this part do
ated water, sugar, syrups, trail mix and not apply to facilities that are solely
granola, vinegar, and any other proc- engaged in the storage of raw agricul-
essed food that does not require time/ tural commodities (other than fruits
temperature control for safety (e.g., vi- and vegetables) intended for further
tamins, minerals, and dietary ingredi- distribution or processing.
ents (e.g., bone meal) in powdered, (k)(1) Except as provided by para-
granular, or other solid form); graph (k)(2) of this section, subpart B
(xxiv) Pasteurizing honey; of this part does not apply to any of
(xxv) Roasting and toasting baked the following:
goods (e.g., toasting bread for crou- (i) ‘‘Farms’’ (as defined in § 1.227 of
tons); this chapter);
(xxvi) Salting other grain products (ii) Fishing vessels that are not sub-
(e.g., soy nuts), peanut and tree nut ject to the registration requirements of
products, and processed seeds for direct part 1, subpart H of this chapter in ac-
consumption; and cordance with § 1.226(f) of this chapter;
(xxvii) Sifting milled grain products (iii) Establishments solely engaged in
(e.g., flour, bran, corn meal), other the holding and/or transportation of
fruit and vegetable products (e.g., one or more raw agricultural commod-
chickpea flour), and peanut and tree ities;
nut products (e.g., peanut flour, almond
(iv) Activities of ‘‘farm mixed-type
flour).
facilities’’ (as defined in § 1.227 of this
(i)(1) Subparts C and G of this part do
not apply with respect to alcoholic bev- chapter) that fall within the definition
erages at a facility that meets the fol- of ‘‘farm’’; or
lowing two conditions: (v) Establishments solely engaged in
(i) Under the Federal Alcohol Admin- hulling, shelling, drying, packing, and/
istration Act (27 U.S.C. 201 et seq.) or or holding nuts (without additional
chapter 51 of subtitle E of the Internal manufacturing/processing, such as
Revenue Code of 1986 (26 U.S.C. 5001 et roasting nuts).
seq.) the facility is required to obtain a (2) If a ‘‘farm’’ or ‘‘farm mixed-type
permit from, register with, or obtain facility’’ dries/dehydrates raw agricul-
approval of a notice or application tural commodities that are produce as
from the Secretary of the Treasury as defined in part 112 of this chapter to
a condition of doing business in the create a distinct commodity, subpart B
United States, or is a foreign facility of of this part applies to the packaging,
a type that would require such a per- packing, and holding of the dried com-
mit, registration, or approval if it were modities. Compliance with this re-
a domestic facility; and quirement may be achieved by com-
(ii) Under section 415 of the Federal plying with subpart B of this part or
Food, Drug, and Cosmetic Act the fa- with the applicable requirements for
cility is required to register as a facil- packing and holding in part 112 of this
ity because it is engaged in manufac- chapter.
turing, processing, packing, or holding
one or more alcoholic beverages. [80 FR 56145, Sept. 17, 2015, as amended at 81
(2) Subparts C and G of this part do FR 3716, Jan. 22, 2016]

not apply with respect to food that is
not an alcoholic beverage at a facility
396
§ 117.7 Applicability of subparts C, D, (a) Disease control. Any person who,

and G of this part to a facility solely by medical examination or supervisory
engaged in the storage of unex- observation, is shown to have, or ap-
posed packaged food. pears to have, an illness, open lesion,
(a) Applicability of subparts C and G. including boils, sores, or infected
Subparts C and G of this part do not wounds, or any other abnormal source
apply to a facility solely engaged in of microbial contamination by which
the storage of unexposed packaged there is a reasonable possibility of
food. food, food-contact surfaces, or food-
(b) Applicability of subpart D. A facil- packaging materials becoming con-
ity solely engaged in the storage of un- taminated, must be excluded from any
exposed packaged food, including unex- operations which may be expected to
posed packaged food that requires result in such contamination until the
time/temperature control to signifi- condition is corrected, unless condi-
cantly minimize or prevent the growth tions such as open lesions, boils, and
of, or toxin production by, pathogens is infected wounds are adequately cov-
subject to the modified requirements ered (e.g., by an impermeable cover).
in § 117.206 for any unexposed packaged Personnel must be instructed to report
food that requires time/temperature such health conditions to their super-
control to significantly minimize or visors.
prevent the growth of, or toxin produc- (b) Cleanliness. All persons working in
tion by, pathogens. direct contact with food, food-contact
surfaces, and food-packaging materials
§ 117.8 Applicability of subpart B of must conform to hygienic practices
this part to the off-farm packing
and holding of raw agricultural while on duty to the extent necessary
commodities. to protect against allergen cross-con-
tact and against contamination of
Except as provided by § 117.5(k)(1), food. The methods for maintaining
subpart B of this part applies to the cleanliness include:
off-farm packaging, packing, and hold-
(1) Wearing outer garments suitable
ing of raw agricultural commodities.
to the operation in a manner that pro-
Compliance with this requirement for
tects against allergen cross-contact
raw agricultural commodities that are
and against the contamination of food,
produce as defined in part 112 of this
food-contact surfaces, or food-pack-
chapter may be achieved by complying
with subpart B of this part or with the aging materials.
applicable requirements for packing (2) Maintaining adequate personal
and holding in part 112 of this chapter. cleanliness.
(3) Washing hands thoroughly (and
[81 FR 3956, Jan. 25, 2016] sanitizing if necessary to protect
against contamination with undesir-
§ 117.9 Records required for this sub-
part. able microorganisms) in an adequate
hand-washing facility before starting
(a) Records that document training work, after each absence from the work
required by § 117.4(b)(2) must be estab- station, and at any other time when
lished and maintained. the hands may have become soiled or
(b) The records that must be estab- contaminated.
lished and maintained are subject to (4) Removing all unsecured jewelry
the requirements of subpart F of this and other objects that might fall into
part. food, equipment, or containers, and re-
moving hand jewelry that cannot be
Subpart B—Current Good adequately sanitized during periods in
Manufacturing Practice which food is manipulated by hand. If
such hand jewelry cannot be removed,
§ 117.10 Personnel. it may be covered by material which
The management of the establish- can be maintained in an intact, clean,
ment must take reasonable measures and sanitary condition and which effec-
and precautions to ensure the fol- tively protects against the contamina-
lowing: tion by these objects of the food, food-
397
§ 117.20 21 CFR Ch. I (4–1–23 Edition)
contact surfaces, or food-packaging be exercised in the plant by inspection,

materials. extermination, or other means to ex-
(5) Maintaining gloves, if they are clude pests, dirt, and filth that may be
used in food handling, in an intact, a source of food contamination.
clean, and sanitary condition. (b) Plant construction and design. The
(6) Wearing, where appropriate, in an plant must be suitable in size, con-
effective manner, hair nets, headbands, struction, and design to facilitate
caps, beard covers, or other effective maintenance and sanitary operations
hair restraints. for food-production purposes (i.e., man-
(7) Storing clothing or other personal ufacturing, processing, packing, and
belongings in areas other than where holding). The plant must:
food is exposed or where equipment or (1) Provide adequate space for such
utensils are washed. placement of equipment and storage of
(8) Confining the following to areas materials as is necessary for mainte-
other than where food may be exposed nance, sanitary operations, and the
or where equipment or utensils are production of safe food.
washed: eating food, chewing gum, (2) Permit the taking of adequate
drinking beverages, or using tobacco. precautions to reduce the potential for
(9) Taking any other necessary pre- allergen cross-contact and for contami-
cautions to protect against allergen nation of food, food-contact surfaces,
cross-contact and against contamina- or food-packaging materials with
tion of food, food-contact surfaces, or microorganisms, chemicals, filth, and
food-packaging materials with micro- other extraneous material. The poten-
organisms or foreign substances (in- tial for allergen cross-contact and for
cluding perspiration, hair, cosmetics, contamination may be reduced by ade-
tobacco, chemicals, and medicines ap- quate food safety controls and oper-
plied to the skin). ating practices or effective design, in-
cluding the separation of operations in
§ 117.20 Plant and grounds. which allergen cross-contact and con-
(a) Grounds. The grounds about a food tamination are likely to occur, by one
plant under the control of the operator or more of the following means: loca-
must be kept in a condition that will tion, time, partition, air flow systems,
protect against the contamination of dust control systems, enclosed sys-
food. The methods for adequate main- tems, or other effective means.
tenance of grounds must include: (3) Permit the taking of adequate
(1) Properly storing equipment, re- precautions to protect food in installed
moving litter and waste, and cutting outdoor bulk vessels by any effective
weeds or grass within the immediate means, including:
vicinity of the plant that may con- (i) Using protective coverings.
stitute an attractant, breeding place, (ii) Controlling areas over and around
or harborage for pests. the vessels to eliminate harborages for
(2) Maintaining roads, yards, and pests.
parking lots so that they do not con- (iii) Checking on a regular basis for
stitute a source of contamination in pests and pest infestation.
areas where food is exposed. (iv) Skimming fermentation vessels,
(3) Adequately draining areas that as necessary.
may contribute contamination to food (4) Be constructed in such a manner
by seepage, foot-borne filth, or pro- that floors, walls, and ceilings may be
viding a breeding place for pests. adequately cleaned and kept clean and
(4) Operating systems for waste kept in good repair; that drip or con-
treatment and disposal in an adequate densate from fixtures, ducts and pipes
manner so that they do not constitute does not contaminate food, food-con-
a source of contamination in areas tact surfaces, or food-packaging mate-
where food is exposed. rials; and that aisles or working spaces
(5) If the plant grounds are bordered are provided between equipment and
by grounds not under the operator’s walls and are adequately unobstructed
control and not maintained in the and of adequate width to permit em-
manner described in paragraphs (a)(1) ployees to perform their duties and to
through (4) of this section, care must protect against contaminating food,
398
food-contact surfaces, or food-pack- (i) Those required to maintain clean

aging materials with clothing or per- and sanitary conditions;
sonal contact. (ii) Those necessary for use in labora-
(5) Provide adequate lighting in tory testing procedures;
hand-washing areas, dressing and lock- (iii) Those necessary for plant and
er rooms, and toilet rooms and in all equipment maintenance and operation;
areas where food is examined, manu- and
factured, processed, packed, or held (iv) Those necessary for use in the
and where equipment or utensils are plant’s operations.
cleaned; and provide shatter-resistant (2) Toxic cleaning compounds, sani-
light bulbs, fixtures, skylights, or tizing agents, and pesticide chemicals
other glass suspended over exposed must be identified, held, and stored in
food in any step of preparation or oth- a manner that protects against con-
erwise protect against food contamina- tamination of food, food-contact sur-
tion in case of glass breakage. faces, or food-packaging materials.
(6) Provide adequate ventilation or (c) Pest control. Pests must not be al-
control equipment to minimize dust, lowed in any area of a food plant.
odors and vapors (including steam and Guard, guide, or pest-detecting dogs
noxious fumes) in areas where they may be allowed in some areas of a
may cause allergen cross-contact or plant if the presence of the dogs is un-
contaminate food; and locate and oper- likely to result in contamination of
ate fans and other air-blowing equip- food, food-contact surfaces, or food-
ment in a manner that minimizes the packaging materials. Effective meas-
potential for allergen cross-contact and ures must be taken to exclude pests
for contaminating food, food-packaging from the manufacturing, processing,
materials, and food-contact surfaces. packing, and holding areas and to pro-
(7) Provide, where necessary, ade- tect against the contamination of food
quate screening or other protection on the premises by pests. The use of
against pests. pesticides to control pests in the plant
is permitted only under precautions
§ 117.35 Sanitary operations. and restrictions that will protect
(a) General maintenance. Buildings, against the contamination of food,
fixtures, and other physical facilities food-contact surfaces, and food-pack-
of the plant must be maintained in a aging materials.
clean and sanitary condition and must (d) Sanitation of food-contact surfaces.
be kept in repair adequate to prevent All food-contact surfaces, including
food from becoming adulterated. Clean- utensils and food-contact surfaces of
ing and sanitizing of utensils and equipment, must be cleaned as fre-
equipment must be conducted in a quently as necessary to protect against
manner that protects against allergen allergen cross-contact and against con-
cross-contact and against contamina- tamination of food.
tion of food, food-contact surfaces, or (1) Food-contact surfaces used for
food-packaging materials. manufacturing/processing, packing, or
(b) Substances used in cleaning and holding low-moisture food must be in a
sanitizing; storage of toxic materials. (1) clean, dry, sanitary condition before
Cleaning compounds and sanitizing use. When the surfaces are wet-cleaned,
agents used in cleaning and sanitizing they must, when necessary, be sani-
procedures must be free from undesir- tized and thoroughly dried before sub-
able microorganisms and must be safe sequent use.
and adequate under the conditions of (2) In wet processing, when cleaning
use. Compliance with this requirement is necessary to protect against allergen
must be verified by any effective cross-contact or the introduction of
means, including purchase of these sub- microorganisms into food, all food-con-
stances under a letter of guarantee or tact surfaces must be cleaned and sani-
certification or examination of these tized before use and after any interrup-
substances for contamination. Only the tion during which the food-contact sur-
following toxic materials may be used faces may have become contaminated.
or stored in a plant where food is proc- Where equipment and utensils are used
essed or exposed: in a continuous production operation,
399
§ 117.37 21 CFR Ch. I (4–1–23 Edition)
the utensils and food-contact surfaces equipment, or utensils or creating an

of the equipment must be cleaned and unsanitary condition.
sanitized as necessary. (4) Provide adequate floor drainage in
(3) Single-service articles (such as all areas where floors are subject to
utensils intended for one-time use, flooding-type cleaning or where normal
paper cups, and paper towels) must be operations release or discharge water
stored, handled, and disposed of in a or other liquid waste on the floor.
manner that protects against allergen (5) Provide that there is not backflow
cross-contact and against contamina- from, or cross-connection between, pip-
tion of food, food-contact surfaces, or ing systems that discharge waste water
food-packaging materials. or sewage and piping systems that
(e) Sanitation of non-food-contact sur- carry water for food or food manufac-
faces. Non-food-contact surfaces of turing.
equipment used in the operation of a (c) Sewage disposal. Sewage must be
food plant must be cleaned in a manner disposed of into an adequate sewerage
and as frequently as necessary to pro- system or disposed of through other
tect against allergen cross-contact and adequate means.
against contamination of food, food- (d) Toilet facilities. Each plant must
contact surfaces, and food-packaging provide employees with adequate, read-
materials. ily accessible toilet facilities. Toilet
(f) Storage and handling of cleaned facilities must be kept clean and must
portable equipment and utensils. Cleaned not be a potential source of contamina-
and sanitized portable equipment with tion of food, food-contact surfaces, or
food-contact surfaces and utensils food-packaging materials.
(e) Hand-washing facilities. Each plant
must be stored in a location and man-
must provide hand-washing facilities
ner that protects food-contact surfaces
designed to ensure that an employee’s
from allergen cross-contact and from
hands are not a source of contamina-
contamination.
tion of food, food-contact surfaces, or
§ 117.37 Sanitary facilities and con- food-packaging materials, by providing
trols. facilities that are adequate, conven-
ient, and furnish running water at a
Each plant must be equipped with suitable temperature.
adequate sanitary facilities and accom- (f) Rubbish and offal disposal. Rubbish
modations including: and any offal must be so conveyed,
(a) Water supply. The water supply stored, and disposed of as to minimize
must be adequate for the operations in- the development of odor, minimize the
tended and must be derived from an potential for the waste becoming an at-
adequate source. Any water that con- tractant and harborage or breeding
tacts food, food-contact surfaces, or place for pests, and protect against
food-packaging materials must be safe contamination of food, food-contact
and of adequate sanitary quality. Run- surfaces, food-packaging materials,
ning water at a suitable temperature, water supplies, and ground surfaces.
and under pressure as needed, must be
provided in all areas where required for § 117.40 Equipment and utensils.
the processing of food, for the cleaning (a)(1) All plant equipment and uten-
of equipment, utensils, and food-pack- sils used in manufacturing, processing,
aging materials, or for employee sani- packing, or holding food must be so de-
tary facilities. signed and of such material and work-
(b) Plumbing. Plumbing must be of manship as to be adequately cleanable,
adequate size and design and ade- and must be adequately maintained to
quately installed and maintained to: protect against allergen cross-contact
(1) Carry adequate quantities of and contamination.
water to required locations throughout (2) Equipment and utensils must be
the plant. designed, constructed, and used appro-
(2) Properly convey sewage and liquid priately to avoid the adulteration of
disposable waste from the plant. food with lubricants, fuel, metal frag-
(3) Avoid constituting a source of ments, contaminated water, or any
contamination to food, water supplies, other contaminants.
400
(3) Equipment must be installed so as to clean food-contact surfaces or equip-

to facilitate the cleaning and mainte- ment must be treated in such a way
nance of the equipment and of adjacent that food is not contaminated with un-
spaces. lawful indirect food additives.
(4) Food-contact surfaces must be
corrosion-resistant when in contact § 117.80 Processes and controls.
with food. (a) General. (1) All operations in the
(5) Food-contact surfaces must be manufacturing, processing, packing,
made of nontoxic materials and de- and holding of food (including oper-
signed to withstand the environment of ations directed to receiving, inspect-
their intended use and the action of ing, transporting, and segregating)
food, and, if applicable, cleaning com- must be conducted in accordance with
pounds, sanitizing agents, and cleaning adequate sanitation principles.
procedures.
(2) Appropriate quality control oper-
(6) Food-contact surfaces must be
ations must be employed to ensure
maintained to protect food from aller-
that food is suitable for human con-
gen cross-contact and from being con-
sumption and that food-packaging ma-
taminated by any source, including un-
terials are safe and suitable.
lawful indirect food additives.
(b) Seams on food-contact surfaces (3) Overall sanitation of the plant
must be smoothly bonded or main- must be under the supervision of one or
tained so as to minimize accumulation more competent individuals assigned
of food particles, dirt, and organic mat- responsibility for this function.
ter and thus minimize the opportunity (4) Adequate precautions must be
for growth of microorganisms and al- taken to ensure that production proce-
lergen cross-contact. dures do not contribute to allergen
(c) Equipment that is in areas where cross-contact and to contamination
food is manufactured, processed, from any source.
packed, or held and that does not come (5) Chemical, microbial, or extra-
into contact with food must be so con- neous-material testing procedures
structed that it can be kept in a clean must be used where necessary to iden-
and sanitary condition. tify sanitation failures or possible al-
(d) Holding, conveying, and manufac- lergen cross-contact and food contami-
turing systems, including gravimetric, nation.
pneumatic, closed, and automated sys- (6) All food that has become contami-
tems, must be of a design and construc- nated to the extent that it is adulter-
tion that enables them to be main- ated must be rejected, or if appro-
tained in an appropriate clean and san- priate, treated or processed to elimi-
itary condition. nate the contamination.
(e) Each freezer and cold storage (b) Raw materials and other ingredi-
compartment used to store and hold ents. (1) Raw materials and other ingre-
food capable of supporting growth of dients must be inspected and seg-
microorganisms must be fitted with an regated or otherwise handled as nec-
indicating thermometer, temperature- essary to ascertain that they are clean
measuring device, or temperature-re- and suitable for processing into food
cording device so installed as to show and must be stored under conditions
the temperature accurately within the that will protect against allergen
compartment. cross-contact and against contamina-
(f) Instruments and controls used for tion and minimize deterioration. Raw
measuring, regulating, or recording materials must be washed or cleaned as
temperatures, pH, acidity, water activ- necessary to remove soil or other con-
ity, or other conditions that control or tamination. Water used for washing,
prevent the growth of undesirable rinsing, or conveying food must be safe
microorganisms in food must be accu- and of adequate sanitary quality.
rate and precise and adequately main- Water may be reused for washing, rins-
tained, and adequate in number for ing, or conveying food if it does not
their designated uses. cause allergen cross-contact or in-

(g) Compressed air or other gases me- crease the level of contamination of
chanically introduced into food or used the food.
401
§ 117.80 21 CFR Ch. I (4–1–23 Edition)
(2) Raw materials and other ingredi- (2) All food manufacturing, proc-
ents must either not contain levels of essing, packing, and holding must be
microorganisms that may render the conducted under such conditions and
food injurious to the health of humans, controls as are necessary to minimize
or they must be pasteurized or other- the potential for the growth of micro-
wise treated during manufacturing op- organisms, allergen cross-contact, con-
erations so that they no longer contain tamination of food, and deterioration
levels that would cause the product to of food.
be adulterated. (3) Food that can support the rapid
(3) Raw materials and other ingredi- growth of undesirable microorganisms
ents susceptible to contamination with must be held at temperatures that will
aflatoxin or other natural toxins must prevent the food from becoming adul-
comply with FDA regulations for poi- terated during manufacturing, proc-
sonous or deleterious substances before essing, packing, and holding.
these raw materials or other ingredi- (4) Measures such as sterilizing, irra-
ents are incorporated into finished diating, pasteurizing, cooking, freez-
food. ing, refrigerating, controlling pH, or
(4) Raw materials, other ingredients, controlling aw that are taken to de-
and rework susceptible to contamina- stroy or prevent the growth of undesir-
tion with pests, undesirable microorga- able microorganisms must be adequate
nisms, or extraneous material must under the conditions of manufacture,
comply with applicable FDA regula- handling, and distribution to prevent
tions for natural or unavoidable defects food from being adulterated.
if a manufacturer wishes to use the
(5) Work-in-process and rework must
materials in manufacturing food.
be handled in a manner that protects
(5) Raw materials, other ingredients,
against allergen cross-contact, con-
and rework must be held in bulk, or in
tamination, and growth of undesirable
containers designed and constructed so
microorganisms.
as to protect against allergen cross-
contact and against contamination and (6) Effective measures must be taken
must be held at such temperature and to protect finished food from allergen
relative humidity and in such a man- cross-contact and from contamination
ner as to prevent the food from becom- by raw materials, other ingredients, or
ing adulterated. Material scheduled for refuse. When raw materials, other in-
rework must be identified as such. gredients, or refuse are unprotected,
(6) Frozen raw materials and other they must not be handled simulta-
ingredients must be kept frozen. If neously in a receiving, loading, or ship-
thawing is required prior to use, it ping area if that handling could result
must be done in a manner that pre- in allergen cross-contact or contami-
vents the raw materials and other in- nated food. Food transported by con-
gredients from becoming adulterated. veyor must be protected against aller-
(7) Liquid or dry raw materials and gen cross-contact and against contami-
other ingredients received and stored nation as necessary.
in bulk form must be held in a manner (7) Equipment, containers, and uten-
that protects against allergen cross- sils used to convey, hold, or store raw
contact and against contamination. materials and other ingredients, work-
(8) Raw materials and other ingredi- in-process, rework, or other food must
ents that are food allergens, and re- be constructed, handled, and main-
work that contains food allergens, tained during manufacturing, proc-
must be identified and held in a man- essing, packing, and holding in a man-
ner that prevents allergen cross-con- ner that protects against allergen
tact. cross-contact and against contamina-
(c) Manufacturing operations. (1) tion.
Equipment and utensils and food con- (8) Adequate measures must be taken
tainers must be maintained in an ade- to protect against the inclusion of
quate condition through appropriate metal or other extraneous material in
cleaning and sanitizing, as necessary. food.

Insofar as necessary, equipment must (9) Food, raw materials, and other in-
be taken apart for thorough cleaning. gredients that are adulterated:
402
(i) Must be disposed of in a manner must be processed to and maintained

that protects against the contamina- at a safe moisture level.
tion of other food; or (15) Food, such as acid and acidified
(ii) If the adulterated food is capable food, that relies principally on the con-
of being reconditioned, it must be: trol of pH for preventing the growth of
(A) Reconditioned (if appropriate) undesirable microorganisms must be
using a method that has been proven to monitored and maintained at a pH of
be effective; or 4.6 or below.
(B) Reconditioned (if appropriate) (16) When ice is used in contact with
and reexamined and subsequently food, it must be made from water that
found not to be adulterated within the is safe and of adequate sanitary quality
meaning of the Federal Food, Drug, in accordance with § 117.37(a), and must
and Cosmetic Act before being incor- be used only if it has been manufac-
porated into other food. tured in accordance with current good
(10) Steps such as washing, peeling, manufacturing practice as outlined in
trimming, cutting, sorting and inspect- this part.
ing, mashing, dewatering, cooling,
shredding, extruding, drying, whipping, § 117.93 Warehousing and distribution.
defatting, and forming must be per- Storage and transportation of food
formed so as to protect food against al- must be under conditions that will pro-
lergen cross-contact and against con- tect against allergen cross-contact and
tamination. Food must be protected against biological, chemical (including
from contaminants that may drip, radiological), and physical contamina-
drain, or be drawn into the food. tion of food, as well as against deterio-
(11) Heat blanching, when required in ration of the food and the container.
the preparation of food capable of sup-
porting microbial growth, must be ef- § 117.95 Holding and distribution of
fected by heating the food to the re- human food by-products for use as
quired temperature, holding it at this animal food.
temperature for the required time, and (a) Human food by-products held for
then either rapidly cooling the food or distribution as animal food without ad-
passing it to subsequent manufacturing ditional manufacturing or processing
without delay. Growth and contamina- by the human food processor, as identi-
tion by thermophilic microorganisms fied in § 507.12 of this chapter, must be
in blanchers must be minimized by the held under conditions that will protect
use of adequate operating temperatures against contamination, including the
and by periodic cleaning and sanitizing following:
as necessary. (1) Containers and equipment used to
(12) Batters, breading, sauces, gra- convey or hold human food by-products
vies, dressings, dipping solutions, and for use as animal food before distribu-
other similar preparations that are tion must be designed, constructed of
held and used repeatedly over time appropriate material, cleaned as nec-
must be treated or maintained in such essary, and maintained to protect
a manner that they are protected against the contamination of human
against allergen cross-contact and food by-products for use as animal
against contamination, and mini- food;
mizing the potential for the growth of (2) Human food by-products for use as
undesirable microorganisms. animal food held for distribution must
(13) Filling, assembling, packaging, be held in a way to protect against con-
and other operations must be per- tamination from sources such as trash;
formed in such a way that the food is and
protected against allergen cross-con- (3) During holding, human food by-
tact, contamination and growth of un- products for use as animal food must
desirable microorganisms. be accurately identified.
(14) Food, such as dry mixes, nuts, in- (b) Labeling that identifies the by-
termediate moisture food, and dehy- product by the common or usual name
drated food, that relies principally on must be affixed to or accompany

the control of aw for preventing the human food by-products for use as ani-
growth of undesirable microorganisms mal food when distributed.
403
§ 117.110 21 CFR Ch. I (4–1–23 Edition)
(c) Shipping containers (e.g., totes, ventive controls as required by

drums, and tubs) and bulk vehicles § 117.145(a);
used to distribute human food by-prod- (6) The written corrective action pro-
ucts for use as animal food must be ex- cedures as required by § 117.150(a)(1);
amined prior to use to protect against and
contamination of the human food by- (7) The written verification proce-
products for use as animal food from dures as required by § 117.165(b).
the container or vehicle when the facil- (c) Records. The food safety plan re-
ity is responsible for transporting the quired by this section is a record that
human food by-products for use as ani- is subject to the requirements of sub-
mal food itself or arranges with a third part F of this part.
party to transport the human food by-
products for use as animal food. [80 FR 56145, Sept. 17, 2015, as amended at 84
FR 12491, Apr. 2, 2019]
[80 FR 56337, Sept. 17, 2015]
§ 117.130 Hazard analysis.
§ 117.110 Defect action levels.
(a) Requirement for a hazard analysis.
(a) The manufacturer, processor,
(1) You must conduct a hazard analysis
packer, and holder of food must at all
to identify and evaluate, based on expe-
times utilize quality control operations
rience, illness data, scientific reports,
that reduce natural or unavoidable de-
and other information, known or rea-
fects to the lowest level currently fea-
sonably foreseeable hazards for each
sible.
type of food manufactured, processed,
(b) The mixing of a food containing
packed, or held at your facility to de-
defects at levels that render that food
termine whether there are any hazards
adulterated with another lot of food is
requiring a preventive control.
not permitted and renders the final
(2) The hazard analysis must be writ-
food adulterated, regardless of the de-
ten regardless of its outcome.
fect level of the final food. For exam-
ples of defect action levels that may (b) Hazard identification. The hazard
render food adulterated, see the Defect identification must consider:
Levels Handbook, which is accessible (1) Known or reasonably foreseeable
athttp://www.fda.gov/pchfrule and hazards that include:
athttp://www.fda.gov. (i) Biological hazards, including
microbiological hazards such as
Subpart C—Hazard Analysis and parasites, environmental pathogens,
and other pathogens;
Risk-Based Preventive Controls
(ii) Chemical hazards, including radi-
§ 117.126 Food safety plan. ological hazards, substances such as
pesticide and drug residues, natural
(a) Requirement for a food safety plan.
toxins, decomposition, unapproved food
(1) You must prepare, or have prepared,
or color additives, and food allergens;
and implement a written food safety
and
plan.
(iii) Physical hazards (such as stones,
(2) The food safety plan must be pre-
glass, and metal fragments); and
pared, or its preparation overseen, by
one or more preventive controls quali- (2) Known or reasonably foreseeable
fied individuals. hazards that may be present in the
(b) Contents of a food safety plan. The food for any of the following reasons:
written food safety plan must include: (i) The hazard occurs naturally;
(1) The written hazard analysis as re- (ii) The hazard may be unintention-
quired by § 117.130(a)(2); ally introduced; or
(2) The written preventive controls as (iii) The hazard may be intentionally
required by § 117.135(b); introduced for purposes of economic
(3) The written supply-chain program gain.
as required by subpart G of this part; (c) Hazard evaluation. (1)(i) The haz-
(4) The written recall plan as re- ard analysis must include an evalua-
quired by § 117.139(a); and tion of the hazards identified in para-

(5) The written procedures for moni- graph (b) of this section to assess the
toring the implementation of the pre- severity of the illness or injury if the
404
hazard were to occur and the prob- (c) Preventive controls include, as
ability that the hazard will occur in appropriate to the facility and the
the absence of preventive controls. food:
(ii) The hazard evaluation required (1) Process controls. Process controls
by paragraph (c)(1)(i) of this section include procedures, practices, and proc-
must include an evaluation of environ- esses to ensure the control of param-
mental pathogens whenever a ready-to- eters during operations such as heat
eat food is exposed to the environment processing, acidifying, irradiating, and
prior to packaging and the packaged refrigerating foods. Process controls
food does not receive a treatment or must include, as appropriate to the na-
otherwise include a control measure ture of the applicable control and its
(such as a formulation lethal to the role in the facility’s food safety sys-
pathogen) that would significantly tem:
minimize the pathogen. (i) Parameters associated with the
(2) The hazard evaluation must con- control of the hazard; and
sider the effect of the following on the (ii) The maximum or minimum
safety of the finished food for the in- value, or combination of values, to
tended consumer: which any biological, chemical, or
(i) The formulation of the food; physical parameter must be controlled
(ii) The condition, function, and de- to significantly minimize or prevent a
sign of the facility and equipment; hazard requiring a process control.
(iii) Raw materials and other ingredi-
(2) Food allergen controls. Food aller-
ents;
gen controls include procedures, prac-
(iv) Transportation practices;
tices, and processes to control food al-
(v) Manufacturing/processing proce-
lergens. Food allergen controls must
dures;
include those procedures, practices,
(vi) Packaging activities and labeling
and processes employed for:
activities;
(vii) Storage and distribution; (i) Ensuring protection of food from
(viii) Intended or reasonably foresee- allergen cross-contact, including dur-
able use; ing storage, handling, and use; and
(ix) Sanitation, including employee (ii) Labeling the finished food, in-
hygiene; and cluding ensuring that the finished food
(x) Any other relevant factors, such is not misbranded under section 403(w)
as the temporal (e.g., weather-related) of the Federal Food, Drug, and Cos-
nature of some hazards (e.g., levels of metic Act.
some natural toxins). (3) Sanitation controls. Sanitation con-
trols include procedures, practices, and
§ 117.135 Preventive controls. processes to ensure that the facility is
(a)(1) You must identify and imple- maintained in a sanitary condition
ment preventive controls to provide as- adequate to significantly minimize or
surances that any hazards requiring a prevent hazards such as environmental
preventive control will be significantly pathogens, biological hazards due to
minimized or prevented and the food employee handling, and food allergen
manufactured, processed, packed, or hazards. Sanitation controls must in-
held by your facility will not be adul- clude, as appropriate to the facility
terated under section 402 of the Federal and the food, procedures, practices, and
Food, Drug, and Cosmetic Act or mis- processes for the:
branded under section 403(w) of the (i) Cleanliness of food-contact sur-
Federal Food, Drug, and Cosmetic Act. faces, including food-contact surfaces
(2) Preventive controls required by of utensils and equipment;
paragraph (a)(1) of this section include: (ii) Prevention of allergen cross-con-
(i) Controls at critical control points tact and cross-contamination from in-
(CCPs), if there are any CCPs; and sanitary objects and from personnel to
(ii) Controls, other than those at food, food packaging material, and
CCPs, that are also appropriate for other food-contact surfaces and from
food safety. raw product to processed product.

(b) Preventive controls must be writ- (4) Supply-chain controls. Supply-
ten. chain controls include the supply-chain
405
§ 117.136 21 CFR Ch. I (4–1–23 Edition)
program as required by subpart G of is ‘‘not processed to control [identified

this part. hazard]’’; and
(5) Recall plan. Recall plan as re- (ii) Annually obtain from your cus-
quired by § 117.139. tomer written assurance that it is
(6) Other controls. Preventive controls manufacturing, processing, or pre-
include any other procedures, prac- paring the food in accordance with ap-
tices, and processes necessary to sat- plicable food safety requirements.
isfy the requirements of paragraph (a) (4) You rely on your customer to pro-
of this section. Examples of other con- vide assurance that the food will be
trols include hygiene training and processed to control the identified haz-
other current good manufacturing ard by an entity in the distribution
practices. chain subsequent to the customer and
you:
§ 117.136 Circumstances in which the (i) Disclose in documents accom-
owner, operator, or agent in charge
of a manufacturing/processing facil- panying the food, in accordance with
ity is not required to implement a the practice of the trade, that the food
preventive control. is ‘‘not processed to control [identified
(a) Circumstances. If you are a manu- hazard]’’; and
facturer/processor, you are not re- (ii) Annually obtain from your cus-
quired to implement a preventive con- tomer written assurance, subject to the
trol when you identify a hazard requir- requirements of § 117.137, that your cus-
ing a preventive control (identified tomer:
hazard) and any of the following cir- (A) Will disclose in documents ac-
cumstances apply: companying the food, in accordance
(1) You determine and document that with the practice of the trade, that the
the type of food (e.g., raw agricultural food is ‘‘not processed to control [iden-
commodities such as cocoa beans, cof- tified hazard]’’; and
fee beans, and grains) could not be con- (B) Will only sell to another entity
sumed without application of an appro- that agrees, in writing, it will:
priate control. (1) Follow procedures (identified in a
(2) You rely on your customer who is written assurance) that will signifi-
subject to the requirements for hazard cantly minimize or prevent the identi-
analysis and risk-based preventive con- fied hazard (if the entity is subject to
trols in this subpart to ensure that the the requirements for hazard analysis
identified hazard will be significantly and risk-based preventive controls in
minimized or prevented and you: this subpart) or manufacture, process,
(i) Disclose in documents accom- or prepare the food in accordance with
panying the food, in accordance with applicable food safety requirements (if
the practice of the trade, that the food the entity is not subject to the require-
is ‘‘not processed to control [identified ments for hazard analysis and risk-
hazard]’’; and based preventive controls in this sub-
(ii) Annually obtain from your cus- part); or
tomer written assurance, subject to the (2) Obtain a similar written assur-
requirements of § 117.137, that the cus- ance from the entity’s customer, sub-
tomer has established and is following ject to the requirements of § 117.137, as
procedures (identified in the written in paragraphs (a)(4)(ii)(A) and (B) of
assurance) that will significantly mini- this section, as appropriate; or
mize or prevent the identified hazard. (5) You have established, docu-
(3) You rely on your customer who is mented, and implemented a system
not subject to the requirements for that ensures control, at a subsequent
hazard analysis and risk-based preven- distribution step, of the hazards in the
tive controls in this subpart to provide food you distribute and you document
assurance it is manufacturing, proc- the implementation of that system.
essing, or preparing the food in accord- (b) Records. You must document any
ance with applicable food safety re- circumstance, specified in paragraph
quirements and you: (a) of this section, that applies to you,
(i) Disclose in documents accom- including:

panying the food, in accordance with (1) A determination, in accordance
the practice of the trade, that the food with paragraph (a) of this section, that
406
the type of food could not be consumed § 117.140 Preventive control manage-
without application of an appropriate ment components.
control; (a) Except as provided by paragraphs
(2) The annual written assurance (b) and (c) of this section, the preven-
from your customer in accordance with tive controls required under § 117.135
paragraph (a)(2) of this section; are subject to the following preventive
(3) The annual written assurance control management components as
from your customer in accordance with appropriate to ensure the effectiveness
paragraph (a)(3) of this section; of the preventive controls, taking into
(4) The annual written assurance account the nature of the preventive
from your customer in accordance with control and its role in the facility’s
paragraph (a)(4) of this section; and food safety system:
(5) Your system, in accordance with (1) Monitoring in accordance with
paragraph (a)(5) of this section, that § 117.145;
ensures control, at a subsequent dis- (2) Corrective actions and corrections
tribution step, of the hazards in the in accordance with § 117.150; and
food you distribute. (3) Verification in accordance with
§ 117.155.
[80 FR 56145, Sept. 17, 2015, as amended at 81 (b) The supply-chain program estab-
FR 3716, Jan. 22, 2016] lished in subpart G of this part is sub-
ject to the following preventive control
§ 117.137 Provision of assurances re- management components as appro-
quired under § 117.136(a)(2), (3), and priate to ensure the effectiveness of the
(4).
supply-chain program, taking into ac-
A facility that provides a written as- count the nature of the hazard con-
surance under § 117.136(a)(2), (3), or (4) trolled before receipt of the raw mate-
must act consistently with the assur- rial or other ingredient:
ance and document its actions taken to (1) Corrective actions and corrections
satisfy the written assurance. in accordance with § 117.150, taking into
account the nature of any supplier non-
§ 117.139 Recall plan. conformance;
For food with a hazard requiring a (2) Review of records in accordance
preventive control: with § 117.165(a)(4); and
(a) You must establish a written re- (3) Reanalysis in accordance with
§ 117.170.
call plan for the food.
(c) The recall plan established in
(b) The written recall plan must in-
§ 117.139 is not subject to the require-
clude procedures that describe the ments of paragraph (a) of this section.
steps to be taken, and assign responsi-
bility for taking those steps, to per- § 117.145 Monitoring.
form the following actions as appro-
As appropriate to the nature of the
priate to the facility: preventive control and its role in the
(1) Directly notify the direct con- facility’s food safety system:
signees of the food being recalled, in- (a) Written procedures. You must es-
cluding how to return or dispose of the tablish and implement written proce-
affected food; dures, including the frequency with
(2) Notify the public about any haz- which they are to be performed, for
ard presented by the food when appro- monitoring the preventive control; and
priate to protect public health; (b) Monitoring. You must monitor the
(3) Conduct effectiveness checks to preventive controls with adequate fre-
verify that the recall is carried out; quency to provide assurance that they
and are consistently performed.
(4) Appropriately dispose of recalled (c) Records. (1) Requirement to docu-
food—e.g., through reprocessing, re- ment monitoring. You must document
working, diverting to a use that does the monitoring of preventive controls
not present a safety concern, or de- in accordance with this section in

stroying the food. records that are subject to verification
in accordance with § 117.155(a)(2) and
407
§ 117.150 21 CFR Ch. I (4–1–23 Edition)
records review in accordance with the Federal Food, Drug, and Cosmetic
§ 117.165(a)(4)(i). Act.
(2) Exception records. (i) Records of re- (b) Corrective action in the event of an
frigeration temperature during storage unanticipated food safety problem. (1) Ex-
of food that requires time/temperature cept as provided by paragraph (c) of
control to significantly minimize or this section, you are subject to the re-
prevent the growth of, or toxin produc- quirements of paragraphs (b)(2) of this
tion by, pathogens may be affirmative section if any of the following cir-
records demonstrating temperature is cumstances apply:
controlled or exception records dem- (i) A preventive control is not prop-
onstrating loss of temperature control. erly implemented and a corrective ac-
(ii) Exception records may be ade- tion procedure has not been estab-
quate in circumstances other than lished;
monitoring of refrigeration tempera- (ii) A preventive control, combina-
ture. tion of preventive controls, or the food
[80 FR 56145, Sept. 17, 2015, as amended at 81 safety plan as a whole is found to be in-
FR 3716, Jan. 22, 2016] effective; or
(iii) A review of records in accord-
§ 117.150 Corrective actions and cor- ance with § 117.165(a)(4) finds that the
rections. records are not complete, the activities
(a) Corrective action procedures. As ap- conducted did not occur in accordance
propriate to the nature of the hazard with the food safety plan, or appro-
and the nature of the preventive con- priate decisions were not made about
trol, except as provided by paragraph corrective actions.
(c) of this section: (2) If any of the circumstances listed
(1) You must establish and imple- in paragraph (b)(1) of this section
ment written corrective action proce- apply, you must:
dures that must be taken if preventive (i) Take corrective action to identify
controls are not properly implemented, and correct the problem, reduce the
including procedures to address, as ap- likelihood that the problem will recur,
propriate: evaluate all affected food for safety,
(i) The presence of a pathogen or ap- and, as necessary, prevent affected food
propriate indicator organism in a from entering commerce as would be
ready-to-eat product detected as a re- done following a corrective action pro-
sult of product testing conducted in ac- cedure under paragraphs (a)(2)(i)
cordance with § 117.165(a)(2); and through (iv) of this section; and
(ii) The presence of an environmental (ii) When appropriate, reanalyze the
pathogen or appropriate indicator or- food safety plan in accordance with
ganism detected through the environ- § 117.170 to determine whether modi-
mental monitoring conducted in ac- fication of the food safety plan is re-
cordance with § 117.165(a)(3). quired.
(2) The corrective action procedures (c) Corrections. You do not need to
must describe the steps to be taken to comply with the requirements of para-
ensure that: graphs (a) and (b) of this section if:
(i) Appropriate action is taken to (1) You take action, in a timely man-
identify and correct a problem that has ner, to identify and correct conditions
occurred with implementation of a pre- and practices that are not consistent
ventive control; with the food allergen controls in
(ii) Appropriate action is taken, when § 117.135(c)(2)(i) or the sanitation con-
necessary, to reduce the likelihood trols in § 117.135(c)(3)(i) or (ii); or
that the problem will recur; (2) You take action, in a timely man-
(iii) All affected food is evaluated for ner, to identify and correct a minor
safety; and and isolated problem that does not di-
(iv) All affected food is prevented rectly impact product safety.
from entering into commerce, if you (d) Records. All corrective actions
cannot ensure that the affected food is (and, when appropriate, corrections)
not adulterated under section 402 of the taken in accordance with this section
Federal Food, Drug, and Cosmetic Act must be documented in records. These
or misbranded under section 403(w) of records are subject to verification in
408
accordance with § 117.155(a)(3) and measures could impact whether the

records review in accordance with control measure or combination of con-
§ 117.165(a)(4)(i). trol measures, when properly imple-
mented, will effectively control the
§ 117.155 Verification. hazards; and
(a) Verification activities. Verification (iii) Whenever a reanalysis of the
activities must include, as appropriate food safety plan reveals the need to do
to the nature of the preventive control so;
and its role in the facility’s food safety (2) Must include obtaining and evalu-
system: ating scientific and technical evidence
(1) Validation in accordance with (or, when such evidence is not available
§ 117.160. or is inadequate, conducting studies) to
(2) Verification that monitoring is determine whether the preventive con-
being conducted as required by § 117.140 trols, when properly implemented, will
(and in accordance with § 117.145). effectively control the hazards; and
(3) Verification that appropriate de- (c) You do not need to validate:
cisions about corrective actions are (1) The food allergen controls in
being made as required by § 117.140 (and § 117.135(c)(2);
in accordance with § 117.150). (2) The sanitation controls in
(4) Verification of implementation § 117.135(c)(3);
and effectiveness in accordance with (3) The recall plan in § 117.139;
§ 117.165; and (4) The supply-chain program in sub-
(5) Reanalysis in accordance with part G of this part; and
§ 117.170. (5) Other preventive controls, if the
(b) Documentation. All verification preventive controls qualified individual
activities conducted in accordance prepares (or oversees the preparation
with this section must be documented of) a written justification that valida-
in records. tion is not applicable based on factors
such as the nature of the hazard, and
§ 117.160 Validation. the nature of the preventive control
(a) You must validate that the pre- and its role in the facility’s food safety
ventive controls identified and imple- system.
mented in accordance with § 117.135 are
adequate to control the hazard as ap- § 117.165 Verification of implementa-
propriate to the nature of the prevention and effectiveness.
tive control and its role in the facili- (a) Verification activities. You must
ty’s food safety system. verify that the preventive controls are
(b) The validation of the preventive consistently implemented and are ef-
controls: fectively and significantly minimizing
(1) Must be performed (or overseen) or preventing the hazards. To do so you
by a preventive controls qualified indi- must conduct activities that include
vidual: the following, as appropriate to the fa-
(i)(A) Prior to implementation of the cility, the food, and the nature of the
food safety plan; or preventive control and its role in the
(B) When necessary to demonstrate facility’s food safety system:
the control measures can be imple- (1) Calibration of process monitoring
mented as designed: instruments and verification instru-
(1) Within 90 calendar days after pro- ments (or checking them for accuracy);
duction of the applicable food first be- (2) Product testing, for a pathogen
gins; or (or appropriate indicator organism) or
(2) Within a reasonable timeframe, other hazard;
provided that the preventive controls (3) Environmental monitoring, for an
qualified individual prepares (or over- environmental pathogen or for an ap-
sees the preparation of) a written jus- propriate indicator organism, if con-
tification for a timeframe that exceeds tamination of a ready-to-eat food with
90 calendar days after production of the an environmental pathogen is a hazard
applicable food first begins; requiring a preventive control, by col-

(ii) Whenever a change to a control lecting and testing environmental sam-
measure or combination of control ples; and
409
§ 117.170 21 CFR Ch. I (4–1–23 Edition)
(4) Review of the following records (vii) Include the corrective action
within the specified timeframes, by (or procedures required by § 117.150(a)(1).
under the oversight of) a preventive (3) Environmental monitoring as re-
controls qualified individual, to ensure quired by paragraph (a)(3) of this sec-
that the records are complete, the action. Procedures for environmental
tivities reflected in the records oc- monitoring must:
curred in accordance with the food (i) Be scientifically valid;
safety plan, the preventive controls are (ii) Identify the test microorga-
effective, and appropriate decisions nism(s);
were made about corrective actions: (iii) Identify the locations from
(i) Records of monitoring and correc- which samples will be collected and the
tive action records within 7 working number of sites to be tested during rou-
days after the records are created or tine environmental monitoring. The
within a reasonable timeframe, pro- number and location of sampling sites
vided that the preventive controls must be adequate to determine wheth-
qualified individual prepares (or over- er preventive controls are effective;
sees the preparation of) a written jus- (iv) Identify the timing and fre-
tification for a timeframe that exceeds quency for collecting and testing sam-
7 working days; and ples. The timing and frequency for col-
(ii) Records of calibration, testing lecting and testing samples must be
(e.g., product testing, environmental adequate to determine whether preven-
monitoring), supplier and supply-chain tive controls are effective;
verification activities, and other (v) Identify the test(s) conducted, in-
verification activities within a reason- cluding the analytical method(s) used;
able time after the records are created; (vi) Identify the laboratory con-
and ducting the testing; and
(5) Other activities appropriate for (vii) Include the corrective action
verification of implementation and ef- procedures required by § 117.150(a)(1).
fectiveness.
(b) Written procedures. As appropriate § 117.170 Reanalysis.
to the facility, the food, the nature of (a) You must conduct a reanalysis of
the preventive control, and the role of the food safety plan as a whole at least
the preventive control in the facility’s once every 3 years;
food safety system, you must establish (b) You must conduct a reanalysis of
and implement written procedures for the food safety plan as a whole, or the
the following activities: applicable portion of the food safety
(1) The method and frequency of cali- plan:
brating process monitoring instru- (1) Whenever a significant change in
ments and verification instruments (or the activities conducted at your facil-
checking them for accuracy) as re- ity creates a reasonable potential for a
quired by paragraph (a)(1) of this sec- new hazard or creates a significant in-
tion. crease in a previously identified haz-
(2) Product testing as required by ard;
paragraph (a)(2) of this section. Proce- (2) Whenever you become aware of
dures for product testing must: new information about potential haz-
(i) Be scientifically valid; ards associated with the food;
(ii) Identify the test microorga- (3) Whenever appropriate after an un-
nism(s) or other analyte(s); anticipated food safety problem in ac-
(iii) Specify the procedures for iden- cordance with § 117.150(b); and
tifying samples, including their rela- (4) Whenever you find that a preven-
tionship to specific lots of product; tive control, combination of preventive
(iv) Include the procedures for sam- controls, or the food safety plan as a
pling, including the number of samples whole is ineffective.
and the sampling frequency; (c) You must complete the reanalysis
(v) Identify the test(s) conducted, in- required by paragraphs (a) and (b) of
cluding the analytical method(s) used; this section and validate, as appro-
(vi) Identify the laboratory con- priate to the nature of the preventive
ducting the testing; and control and its role in the facility’s
410
food safety system, any additional pre- (8) Determination that reanalysis can
ventive controls needed to address the be completed, and additional preven-
hazard identified: tive controls validated, as appropriate
(1) Before any change in activities to the nature of the preventive control
(including any change in preventive and its role in the facility’s food safety
control) at the facility is operative; or system, in a timeframe that exceeds
(2) When necessary to demonstrate the first 90 calendar days of production
the control measures can be imple- of the applicable food.
mented as designed: (b) A qualified auditor must conduct
(i) Within 90 calendar days after pro- an onsite audit (§ 117.435(a)).
duction of the applicable food first be- (c)(1) To be a preventive controls
gins; or qualified individual, the individual
(ii) Within a reasonable timeframe, must have successfully completed
provided that the preventive controls training in the development and appli-
qualified individual prepares (or over- cation of risk-based preventive con-
sees the preparation of) a written jus- trols at least equivalent to that re-
tification for a timeframe that exceeds ceived under a standardized curriculum
90-calendar days after production of recognized as adequate by FDA or be
the applicable food first begins. otherwise qualified through job experi-
(d) You must revise the written food ence to develop and apply a food safety
safety plan if a significant change in system. Job experience may qualify an
the activities conducted at your facil- individual to perform these functions if
ity creates a reasonable potential for a such experience has provided an indi-
new hazard or a significant increase in vidual with knowledge at least equiva-
a previously identified hazard or docu- lent to that provided through the
ment the basis for the conclusion that standardized curriculum. This indi-
no revisions are needed. vidual may be, but is not required to
(e) A preventive controls qualified in- be, an employee of the facility.
dividual must perform (or oversee) the (2) To be a qualified auditor, a quali-
reanalysis. fied individual must have technical ex-
(f) You must conduct a reanalysis of pertise obtained through education,
the food safety plan when FDA deter- training, or experience (or a combina-
mines it is necessary to respond to new tion thereof) necessary to perform the
hazards and developments in scientific auditing function.
understanding. (d) All applicable training in the de-
velopment and application of risk-
§ 117.180 Requirements applicable to a based preventive controls must be doc-
preventive controls qualified indi- umented in records, including the date
vidual and a qualified auditor. of the training, the type of training,
(a) One or more preventive controls and the person(s) trained.
qualified individuals must do or over-
see the following: § 117.190 Implementation records re-
(1) Preparation of the food safety quired for this subpart.
plan (§ 117.126(a)(2)); (a) You must establish and maintain
(2) Validation of the preventive con- the following records documenting im-
trols (§ 117.160(b)(1)); plementation of the food safety plan:
(3) Written justification for valida- (1) Documentation, as required by
tion to be performed in a timeframe § 117.136(b), of the basis for not estab-
that exceeds the first 90 calendar days lishing a preventive control in accord-
of production of the applicable food; ance with § 117.136(a);
(4) Determination that validation is (2) Records that document the moni-
not required (§ 117.160(c)(5)); toring of preventive controls;
(5) Review of records (§ 117.165(a)(4)); (3) Records that document corrective
(6) Written justification for review of actions;
records of monitoring and corrective (4) Records that document
actions within a timeframe that ex- verification, including, as applicable,
ceeds 7 working days; those related to:

(7) Reanalysis of the food safety plan (i) Validation;
(§ 117.170(d)); and (ii) Verification of monitoring;
411
§ 117.201 21 CFR Ch. I (4–1–23 Edition)
(iii) Verification of corrective ac- Web site is available from wherever the
tions; Internet is accessible, including librar-
(iv) Calibration of process moni- ies, copy centers, schools, and Internet
toring and verification instruments; cafes. FDA encourages electronic sub-
(v) Product testing; mission.
(vi) Environmental monitoring; (2) Submission by mail. (i) You must
(vii) Records review; and use Form FDA 3942a. You may obtain a
(viii) Reanalysis; copy of this form by any of the fol-
(5) Records that document the sup- lowing mechanisms:
ply-chain program; and
(A) Download it from http://
(6) Records that document applicable
www.fda.gov/pchfrule;
training for the preventive controls
qualified individual and the qualified (B) Write to the U.S. Food and Drug
auditor. Administration (HFS–681), 5001 Campus
(b) The records that you must estab- Dr., College Park, MD 20740; or
lish and maintain are subject to the re- (C) Request a copy of this form by
quirements of subpart F of this part. phone at 1–800–216–7331 or 301–575–0156.
(ii) Send a paper Form FDA 3942a to
Subpart D—Modified the U.S. Food and Drug Administration
Requirements (HFS–681), 5001 Campus Dr., College
Park, MD 20740. We recommend that
§ 117.201 Modified requirements that you submit a paper copy only if your
apply to a qualified facility. facility does not have reasonable ac-
(a) Attestations to be submitted. A cess to the Internet.
qualified facility must submit the fol- (c) Frequency of determination of status
lowing attestations to FDA: and submission. (1) A facility must de-
(1) An attestation that the facility is termine and document its status as a
a qualified facility as defined in § 117.3. qualified facility on an annual basis no
For the purpose of determining wheth- later than July 1 of each calendar year.
er a facility satisfies the definition of (2) The attestations required by para-
qualified facility, the baseline year for graph (a) of this section must be:
calculating the adjustment for infla- (i) Submitted to FDA initially:
tion is 2011; and (A) By December 17, 2018, for a facil-
(2)(i) An attestation that you have ity that begins manufacturing, proc-
identified the potential hazards associ- essing, packing, or holding food before
ated with the food being produced, are September 17, 2018;
implementing preventive controls to (B) Before beginning operations, for a
address the hazards, and are moni- facility that begins manufacturing,
toring the performance of the preven- processing, packing, or holding food
tive controls to ensure that such con-
after September 17, 2018; or
trols are effective; or
(ii) An attestation that the facility is (C) By July 31 of the applicable cal-
in compliance with State, local, coun- endar year, when the status of a facil-
ty, tribal, or other applicable non-Fed- ity changes from ‘‘not a qualified facil-
eral food safety law, including relevant ity’’ to ‘‘qualified facility’’ based on
laws and regulations of foreign coun- the annual determination required by
tries, including an attestation based on paragraph (c)(1) of this section; and
licenses, inspection reports, certifi- (ii) Beginning in 2020, submitted to
cates, permits, credentials, certifi- FDA every 2 years during the period
cation by an appropriate agency (such beginning on October 1 and ending on
as a State department of agriculture), December 31.
or other evidence of oversight. (3) When the status of a facility
(b) Procedure for submission. The at- changes from ‘‘qualified facility’’ to
testations required by paragraph (a) of ‘‘not a qualified facility’’ based on the
this section must be submitted to FDA annual determination required by para-
by one of the following means: graph (c)(1) of this section, the facility
(1) Electronic submission. To submit must notify FDA of that change in sta-
electronically, go to http://www.fda.gov/ tus using Form 3942a by July 31 of the
furls and follow the instructions. This applicable calendar year.
412
(d) Timeframe for compliance with sub- duction by pathogens, the facility must
parts C and G of this part when the facil- conduct the following activities as ap-
ity status changes to ‘‘not a qualified fa- propriate to ensure the effectiveness of
cility.’’ When the status of a facility the temperature controls:
changes from ‘‘qualified facility’’ to (1) Establish and implement tempera-
‘‘not a qualified facility,’’ the facility ture controls adequate to significantly
must comply with subparts C and G of minimize or prevent the growth of, or
this part no later than December 31 of toxin production by, pathogens;
the applicable calendar year unless (2) Monitor the temperature controls
otherwise agreed to by FDA and the fa- with adequate frequency to provide as-
cility. surance that the temperature controls
(e) Notification to consumers. A quali- are consistently performed;
fied facility that does not submit attes- (3) If there is a loss of temperature
tations under paragraph (a)(2)(i) of this control that may impact the safety of
section must provide notification to such refrigerated packaged food, take
consumers as to the name and com- appropriate corrective actions to:
plete business address of the facility (i) Correct the problem and reduce
where the food was manufactured or the likelihood that the problem will
processed (including the street address recur;
or P.O. box, city, state, and zip code for (ii) Evaluate all affected food for
domestic facilities, and comparable full safety; and
address information for foreign facili-
(iii) Prevent the food from entering
ties), as follows:
commerce, if you cannot ensure the af-
(1) If a food packaging label is re-
fected food is not adulterated under
quired, the notification required by
section 402 of the Federal Food, Drug,
paragraph (e) of this section must ap-
and Cosmetic Act;
pear prominently and conspicuously on
the label of the food. (4) Verify that temperature controls
(2) If a food packaging label is not re- are consistently implemented by:
quired, the notification required by (i) Calibrating temperature moni-
paragraph (e) of this section must ap- toring and recording devices (or check-
pear prominently and conspicuously, at ing them for accuracy);
the point of purchase, on a label, post- (ii) Reviewing records of calibration
er, sign, placard, or documents deliv- within a reasonable time after the
ered contemporaneously with the food records are created; and
in the normal course of business, or in (iii) Reviewing records of monitoring
an electronic notice, in the case of and corrective actions taken to correct
Internet sales. a problem with the control of tempera-
(f) Records. (1) A qualified facility ture within 7 working days after the
must maintain those records relied records are created or within a reason-
upon to support the attestations that able timeframe, provided that the pre-
are required by paragraph (a) of this ventive controls qualified individual
section. prepares (or oversees the preparation
(2) The records that a qualified facil- of) a written justification for a time-
ity must maintain are subject to the frame that exceeds 7 working days;
requirements of subpart F of this part. (5) Establish and maintain the fol-
lowing records:
FR 3716, Jan. 22, 2016] (i) Records (whether affirmative
records demonstrating temperature is
§ 117.206 Modified requirements that controlled or exception records dem-
apply to a facility solely engaged in onstrating loss of temperature control)
the storage of unexposed packaged documenting the monitoring of tem-
food. perature controls for any such refrig-
(a) If a facility that is solely engaged erated packaged food;
in the storage of unexposed packaged (ii) Records of corrective actions
food stores any such refrigerated pack- taken when there is a loss of tempera-
aged food that requires time/temperature control that may impact the safe-
ture control to significantly minimize ty of any such refrigerated packaged
or prevent the growth of, or toxin pro- food; and
413
§ 117.251 21 CFR Ch. I (4–1–23 Edition)
(iii) Records documenting Compliance in the Center for Food

verification activities. Safety and Applied Nutrition), or an
(b) The records that a facility must FDA official senior to either such Di-
establish and maintain under para- rector, must approve an order to with-
graph (a)(5) of this section are subject draw the exemption before the order is
to the requirements of subpart F of issued.
this part. (b) Any officer or qualified employee
of FDA may issue an order to withdraw
Subpart E—Withdrawal of a the exemption after it has been ap-
Qualified Facility Exemption proved in accordance with paragraph
(a) of this section.
§ 117.251 Circumstances that may lead (c) FDA must issue an order to with-
FDA to withdraw a qualified facil- draw the exemption to the owner, oper-
ity exemption. ator, or agent in charge of the facility.
(a) FDA may withdraw a qualified fa- (d) FDA must issue an order to with-
cility exemption under § 117.5(a): draw the exemption in writing, signed
(1) In the event of an active inves- and dated by the officer or qualified
tigation of a foodborne illness outbreak employee of FDA who is issuing the
that is directly linked to the qualified order.
facility; or
(2) If FDA determines that it is nec-
FR 16553, Mar. 24, 2020]
essary to protect the public health and
prevent or mitigate a foodborne illness § 117.257 Contents of an order to with-
outbreak based on conditions or con- draw a qualified facility exemption.
duct associated with the qualified fa-
An order to withdraw a qualified fa-
cility that are material to the safety of
cility exemption under § 117.5(a) must
the food manufactured, processed,
include the following information:
packed, or held at such facility.
(b) Before FDA issues an order to (a) The date of the order;
withdraw a qualified facility exemp- (b) The name, address, and location
tion, FDA: of the qualified facility;
(1) May consider one or more other (c) A brief, general statement of the
actions to protect the public health or reasons for the order, including infor-
mitigate a foodborne illness outbreak, mation relevant to one or both of the
including a warning letter, recall, ad- following circumstances that leads
ministrative detention, suspension of FDA to issue the order:
registration, refusal of food offered for (1) An active investigation of a
import, seizure, and injunction; foodborne illness outbreak that is di-
(2) Must notify the owner, operator, rectly linked to the facility; or
or agent in charge of the facility, in (2) Conditions or conduct associated
writing, of circumstances that may with a qualified facility that are mate-
lead FDA to withdraw the exemption, rial to the safety of the food manufac-
and provide an opportunity for the tured, processed, packed, or held at
owner, operator, or agent in charge of such facility.
the facility to respond in writing, with- (d) A statement that the facility
in 15 calendar days of the date of re- must either:
ceipt of the notification, to FDA’s noti- (1) Comply with subparts C and G of
fication; and this part on the date that is 120 cal-
(3) Must consider the actions taken endar days after the date of receipt of
by the facility to address the cir- the order, or within a reasonable time-
cumstances that may lead FDA to frame, agreed to by FDA, based on a
withdraw the exemption. written justification, submitted to
FDA, for a timeframe that exceeds 120
§ 117.254 Issuance of an order to with- calendar days from the date of receipt
draw a qualified facility exemption. of the order; or
(a) An FDA Division Director in (2) Appeal the order within 15 cal-
whose division the qualified facility is endar days of the date of receipt of the
located (or, in the case of a foreign fa- order in accordance with the require-
cility, the Director of the Office of ments of § 117.264.
414
(e) A statement that a facility may calendar days of the date of receipt of
request that FDA reinstate an exemp- the order, or within a reasonable time-
tion that was withdrawn by following frame, agreed to by FDA, based on a
the procedures in § 117.287; written justification, submitted to
(f) The text of section 418(l) of the FDA, for a timeframe that exceeds 120
Federal Food, Drug, and Cosmetic Act calendar days from the date of receipt
and of this subpart; of the order; and
(g) A statement that any informal (2) You are no longer subject to the
hearing on an appeal of the order must modified requirements in § 117.201.
be conducted as a regulatory hearing
under part 16 of this chapter, with cer- § 117.264 Procedure for submitting an
tain exceptions described in § 117.270; appeal.
(h) The mailing address, telephone (a) To appeal an order to withdraw a
number, email address, fax number, qualified facility exemption, you must:
and name of the FDA Division Director (1) Submit the appeal in writing to
in whose division the facility is located the FDA Division Director in whose di-
(or, in the case of a foreign facility, the vision the facility is located (or, in the
same information for the Director of case of a foreign facility, the Director
the Office of Compliance in the Center of the Office of Compliance in the Cen-
for Food Safety and Applied Nutrition); ter for Food Safety and Applied Nutri-
and tion), at the mailing address, email ad-
(i) The name and the title of the FDA dress, or fax number identified in the
representative who approved the order. order within 15 calendar days of the
[80 FR 56145, Sept. 17, 2015, as amended at 81 date of receipt of confirmation of the
FR 3716, Jan. 22, 2016; 85 FR 16553, Mar. 24, order; and
2020] (2) Respond with particularity to the
facts and issues contained in the order,
§ 117.260 Compliance with, or appeal including any supporting documenta-
of, an order to withdraw a qualified
facility exemption. tion upon which you rely.
(b) In a written appeal of the order
(a) If you receive an order under withdrawing an exemption provided
§ 117.254 to withdraw a qualified facility under § 117.5(a), you may include a
exemption, you must either: written request for an informal hearing
(1) Comply with applicable require- as provided in § 117.267.
ments of this part within 120 calendar
days of the date of receipt of the order, [80 FR 56145, Sept. 17, 2015, as amended at 81
or within a reasonable timeframe, FR 3716, Jan. 22, 2016; 85 FR 16553, Mar. 24,
agreed to by FDA, based on a written 2020]
justification, submitted to FDA, for a
§ 117.267 Procedure for requesting an
timeframe that exceeds 120 calendar informal hearing.
days from the date of receipt of the
order; or (a) If you appeal the order, you:
(2) Appeal the order within 15 cal- (1) May request an informal hearing;
endar days of the date of receipt of the and
order in accordance with the require- (2) Must submit any request for an
ments of § 117.264. informal hearing together with your
(b) Submission of an appeal, includ- written appeal submitted in accordance
ing submission of a request for an in- with § 117.264 within 15 calendar days of
formal hearing, will not operate to the date of receipt of the order.
delay or stay any administrative ac- (b) A request for an informal hearing
tion, including enforcement action by may be denied, in whole or in part, if
FDA, unless the Commissioner of Food the presiding officer determines that
and Drugs, as a matter of discretion, no genuine and substantial issue of ma-
determines that delay or a stay is in terial fact has been raised by the mate-
the public interest. rial submitted. If the presiding officer
(c) If you appeal the order, and FDA determines that a hearing is not justi-
confirms the order: fied, written notice of the determina-

(1) You must comply with applicable tion will be given to you explaining the
requirements of this part within 120 reason for the denial.
415
§ 117.270 21 CFR Ch. I (4–1–23 Edition)
§ 117.270 Requirements applicable to comments on the report by the hearing

an informal hearing. participant under § 117.270(c)(4) are part
If you request an informal hearing, of the administrative record.
and FDA grants the request: (6) No party shall have the right,
(a) The hearing will be held within 15 under § 16.119 of this chapter to petition
calendar days after the date the appeal the Commissioner of Food and Drugs
is filed or, if applicable, within a time- for reconsideration or a stay of the pre-
frame agreed upon in writing by you siding officer’s final decision.
and FDA. (7) If FDA grants a request for an in-
(b) The presiding officer may require formal hearing on an appeal of an order
that a hearing conducted under this withdrawing an exemption, the hearing
subpart be completed within 1-calendar must be conducted as a regulatory
day, as appropriate. hearing under a regulation in accord-
(c) FDA must conduct the hearing in ance with part 16 of this chapter, ex-
accordance with part 16 of this chapter, cept that § 16.95(b) of this chapter does
except that: not apply to a hearing under this sub-
(1) The order withdrawing an exemp- part. With respect to a regulatory
tion under §§ 117.254 and 117.257, rather hearing under this subpart, the admin-
than the notice under § 16.22(a) of this istrative record of the hearing specified
chapter, provides notice of opportunity in §§ 16.80(a)(1) through (3) and (a)(5) of
for a hearing under this section and is this chapter and 117.270(c)(5) con-
part of the administrative record of the stitutes the exclusive record for the
regulatory hearing under § 16.80(a) of presiding officer’s final decision. For
this chapter. purposes of judicial review under § 10.45
(2) A request for a hearing under this of this chapter, the record of the ad-
subpart must be addressed to the FDA ministrative proceeding consists of the
Division Director (or, in the case of a record of the hearing and the presiding
foreign facility, the Director of the Of- officer’s final decision.
fice of Compliance in the Center for
Food Safety and Applied Nutrition) as [80 FR 56145, Sept. 17, 2015, as amended at 85
provided in the order withdrawing an FR 16553, Mar. 24, 2020]
exemption.
(3) Section 117.274, rather than § 117.274 Presiding officer for an ap-
§ 16.42(a) of this chapter, describes the peal and for an informal hearing.
FDA employees who preside at hear- The presiding officer for an appeal,
ings under this subpart. and for an informal hearing, must be
(4) Section 16.60(e) and (f) of this an Office of Regulatory Affairs Pro-
chapter does not apply to a hearing gram Director or another FDA official
under this subpart. The presiding offi- senior to an FDA Division Director.
cer must prepare a written report of
the hearing. All written material pre- [85 FR 16553, Mar. 24, 2020]
sented at the hearing will be attached
§ 117.277 Timeframe for issuing a deci-
to the report. The presiding officer sion on an appeal.
must include as part of the report of
the hearing a finding on the credibility (a) If you appeal the order without
of witnesses (other than expert wit- requesting a hearing, the presiding offi-
nesses) whenever credibility is a mate- cer must issue a written report that in-
rial issue, and must include a proposed cludes a final decision confirming or
decision, with a statement of reasons. revoking the withdrawal by the 10th
The hearing participant may review calendar day after the appeal is filed.
and comment on the presiding officer’s (b) If you appeal the order and re-
report within 2-calendar days of quest an informal hearing:
issuance of the report. The presiding (1) If FDA grants the request for a
officer will then issue the final deci- hearing and the hearing is held, the
sion. presiding officer must provide a 2-cal-
(5) Section 16.80(a)(4) of this chapter endar day opportunity for the hearing
does not apply to a regulatory hearing participants to review and submit com-
under this subpart. The presiding offi- ments on the report of the hearing
cer’s report of the hearing and any under § 117.270(c)(4), and must issue a
416
final decision within 10-calendar days outbreak, the FDA Division Director in
after the hearing is held; or whose division your facility is located
(2) If FDA denies the request for a (or, in the case of a foreign facility, the
hearing, the presiding officer must Director of the Office of Compliance in
issue a final decision on the appeal the Center for Food Safety and Applied
confirming or revoking the withdrawal Nutrition) will, on his or her own ini-
within 10 calendar days after the date tiative or on the request of a facility,
the appeal is filed. reinstate the exemption.
§ 117.280 Revocation of an order to (b) You may ask FDA to reinstate an
withdraw a qualified facility ex- exemption that has been withdrawn
emption. under the procedures of this subpart as
An order to withdraw a qualified fa- follows:
cility exemption is revoked if: (1) Submit a request, in writing, to
(a) You appeal the order and request the FDA Division Director in whose di-
an informal hearing, FDA grants the vision your facility is located (or, in
request for an informal hearing, and the case of a foreign facility, the Direc-
the presiding officer does not confirm tor of the Office of Compliance in the
the order within the 10-calendar days Center for Food Safety and Applied Nu-
after the hearing, or issues a decision trition); and
revoking the order within that time; or (2) Present data and information to
(b) You appeal the order and request demonstrate that you have adequately
an informal hearing, FDA denies the resolved any problems with the condi-
request for an informal hearing, and tions and conduct that are material to
FDA does not confirm the order within the safety of the food manufactured,
the 10-calendar days after the appeal is
processed, packed, or held at your fa-
filed, or issues a decision revoking the
cility, such that continued withdrawal
order within that time; or
of the exemption is not necessary to
(c) You appeal the order without re-
questing an informal hearing, and FDA protect public health and prevent or
does not confirm the order within the mitigate a foodborne illness outbreak.
10-calendar days after the appeal is (c) If your exemption was withdrawn
filed, or issues a decision revoking the under § 117.251(a)(1) and FDA later de-
order within that time. termines, after finishing the active in-
vestigation of a foodborne illness out-
§ 117.284 Final agency action. break, that the outbreak is not di-
Confirmation of a withdrawal order rectly linked to your facility, FDA will
by the presiding officer is considered a reinstate your exemption under
final agency action for purposes of 5 § 117.5(a), and FDA will notify you in
U.S.C. 702. writing that your exempt status has
been reinstated.
§ 117.287 Reinstatement of a qualified (d) If your exemption was withdrawn
facility exemption that was with-
drawn. under both § 117.251(a)(1) and (2) and
FDA later determines, after finishing
(a) If the FDA Division Director in the active investigation of a foodborne
whose division your facility is located
illness outbreak, that the outbreak is
(or, in the case of a foreign facility, the
not directly linked to your facility,
Director of the Office of Compliance in
FDA will inform you of this finding,
the Center for Food Safety and Applied
Nutrition) determines that a facility and you may ask FDA to reinstate
has adequately resolved any problems your exemption under § 117.5(a) in ac-
with the conditions and conduct that cordance with the requirements of
are material to the safety of the food paragraph (b) of this section.
manufactured, processed, packed, or [80 FR 56145, Sept. 17, 2015, as amended at 85
held at the facility and that continued FR 16553, Mar. 24, 2020]
withdrawal of the exemption is not

necessary to protect public health and
prevent or mitigate a foodborne illness
417
§ 117.301 21 CFR Ch. I (4–1–23 Edition)
Subpart F—Requirements Apply- § 117.310 Additional requirements ap-

ing to Records That Must Be plying to the food safety plan.
Established and Maintained The owner, operator, or agent in
charge of the facility must sign and
§ 117.301 Records subject to the re- date the food safety plan:
quirements of this subpart. (a) Upon initial completion; and
(a) Except as provided by paragraphs (b) Upon any modification.
(b) and (c) of this section, all records
§ 117.315 Requirements for record re-
required by this part are subject to all tention.
requirements of this subpart.
(b) The requirements of § 117.310 apply (a)(1) All records required by this
only to the written food safety plan. part must be retained at the plant or
facility for at least 2 years after the
(c) The requirements of § 117.305(b),
date they were prepared.
(d), (e), and (f) do not apply to the
(2) Records that a facility relies on
records required by § 117.201.
during the 3-year period preceding the
§ 117.305 General requirements apply- applicable calendar year to support its
ing to records. status as a qualified facility must be
retained at the facility as long as nec-
Records must: essary to support the status of a facil-
(a) Be kept as original records, true ity as a qualified facility during the
copies (such as photocopies, pictures, applicable calendar year.
scanned copies, microfilm, microfiche, (b) Records that relate to the general
or other accurate reproductions of the adequacy of the equipment or processes
original records), or electronic records; being used by a facility, including the
(b) Contain the actual values and ob- results of scientific studies and evalua-
servations obtained during monitoring tions, must be retained by the facility
and, as appropriate, during verification for at least 2 years after their use is
activities; discontinued (e.g., because the facility
(c) Be accurate, indelible, and legible; has updated the written food safety
(d) Be created concurrently with per- plan (§ 117.126) or records that docu-
formance of the activity documented; ment validation of the written food
safety plan (§ 117.155(b)));
(e) Be as detailed as necessary to pro-
vide history of work performed; and (c) Except for the food safety plan,
offsite storage of records is permitted
(f) Include:
if such records can be retrieved and
(1) Information adequate to identify provided onsite within 24 hours of re-
the plant or facility (e.g., the name, quest for official review. The food safe-
and when necessary, the location of the ty plan must remain onsite. Electronic
plant or facility); records are considered to be onsite if
(2) The date and, when appropriate, they are accessible from an onsite loca-
the time of the activity documented; tion.
(3) The signature or initials of the (d) If the plant or facility is closed
person performing the activity; and for a prolonged period, the food safety
(4) Where appropriate, the identity of plan may be transferred to some other
the product and the lot code, if any. reasonably accessible location but
(g) Records that are established or must be returned to the plant or facil-
maintained to satisfy the requirements ity within 24 hours for official review
of this part and that meet the defini- upon request.
tion of electronic records in § 11.3(b)(6)
§ 117.320 Requirements for official re-
of this chapter are exempt from the review.
quirements of part 11 of this chapter.
Records that satisfy the requirements All records required by this part
of this part, but that also are required must be made promptly available to a
under other applicable statutory provi- duly authorized representative of the
Secretary of Health and Human Serv-

sions or regulations, remain subject to
ices for official review and copying
upon oral or written request.
418
§ 117.325 Public disclosure. Subpart G—Supply-Chain

Records obtained by FDA in accord- Program
ance with this part are subject to the
disclosure requirements under part 20 § 117.405 Requirement to establish and
implement a supply-chain program.
of this chapter.
(a)(1) Except as provided by para-
§ 117.330 Use of existing records. graphs (a)(2) and (3) of this section, the
receiving facility must establish and
(a) Existing records (e.g., records that
implement a risk-based supply-chain
are kept to comply with other Federal,
program for those raw materials and
State, or local regulations, or for any
other ingredients for which the receiv-
ing facility has identified a hazard re-
cated if they contain all of the required quiring a supply-chain-applied control.
(2) A receiving facility that is an im-
ments of this subpart. Existing records porter, is in compliance with the for-
may be supplemented as necessary to eign supplier verification program re-
include all of the required information quirements under part 1, subpart L of
and satisfy the requirements of this this chapter, and has documentation of
subpart. verification activities conducted under
(b) The information required by this § 1.506(e) of this chapter (which provides
part does not need to be kept in one set assurance that the hazards requiring a
of records. If existing records contain supply-chain-applied control for the
some of the required information, any raw material or other ingredient have
new information required by this part been significantly minimized or pre-
may be kept either separately or com- vented) need not conduct supplier
bined with the existing records. verification activities for that raw ma-
terial or other ingredient.
§ 117.335 Special requirements appli- (3) The requirements in this subpart
cable to a written assurance. do not apply to food that is supplied for
(a) Any written assurance required research or evaluation use, provided
by this part must contain the following that such food:
elements: (i) Is not intended for retail sale and
(1) Effective date; is not sold or distributed to the public;
(2) Printed names and signatures of (ii) Is labeled with the statement
authorized officials; ‘‘Food for research or evaluation use’’;
(3) The applicable assurance under: (iii) Is supplied in a small quantity
(i) Section 117.136(a)(2); that is consistent with a research,
(ii) Section 117.136(a)(3); analysis, or quality assurance purpose,
(iii) Section 117.136(a)(4); the food is used only for this purpose,
and any unused quantity is properly
(iv) Section 117.430(c)(2);
disposed of; and
(v) Section 117.430(d)(2); or
(iv) Is accompanied with documents,
(vi) Section 117.430(e)(2); in accordance with the practice of the
(b) A written assurance required trade, stating that the food will be
under § 117.136(a)(2), (3), or (4) must in- used for research or evaluation pur-
clude: poses and cannot be sold or distributed
(1) Acknowledgement that the facil- to the public.
ity that provides the written assurance (b) The supply-chain program must
assumes legal responsibility to act con- be written.
sistently with the assurance and docu- (c) When a supply-chain-applied con-
ment its actions taken to satisfy the trol is applied by an entity other than
written assurance; and the receiving facility’s supplier (e.g.,
(2) Provision that if the assurance is when a non-supplier applies controls to
terminated in writing by either entity, certain produce (i.e., produce covered
responsibility for compliance with the by part 112 of this chapter), because
applicable provisions of this part re- growing, harvesting, and packing ac-
verts to the manufacturer/processor as tivities are under different manage-
of the date of termination. ment), the receiving facility must:
419
§ 117.410 21 CFR Ch. I (4–1–23 Edition)
(1) Verify the supply-chain-applied are conducted, the following must be

control; or considered:
(2) Obtain documentation of an ap- (i) The hazard analysis of the food,
propriate verification activity from an- including the nature of the hazard con-
other entity, review and assess the en- trolled before receipt of the raw mate-
tity’s applicable documentation, and rial or other ingredient, applicable to
document that review and assessment. the raw material and other ingredients;
[80 FR 56145, Sept. 17, 2015; 81 FR 3956, Jan.
(ii) The entity or entities that will be
25, 2016] applying controls for the hazards re-
quiring a supply-chain-applied control;
§ 117.410 General requirements appli- (iii) Supplier performance, including:
cable to a supply-chain program. (A) The supplier’s procedures, proc-
(a) The supply-chain program must esses, and practices related to the safe-
include: ty of the raw material and other ingre-
(1) Using approved suppliers as re- dients;
quired by § 117.420; (B) Applicable FDA food safety regu-
(2) Determining appropriate supplier lations and information relevant to the
verification activities (including deter- supplier’s compliance with those regu-
mining the frequency of conducting the lations, including an FDA warning let-
activity) as required by § 117.425; ter or import alert relating to the safe-
(3) Conducting supplier verification ty of food and other FDA compliance
activities as required by §§ 117.430 and actions related to food safety (or, when
117.435; applicable, relevant laws and regula-
(4) Documenting supplier verification tions of a country whose food safety
activities as required by § 117.475; and system FDA has officially recognized
(5) When applicable, verifying a sup- as comparable or has determined to be
ply-chain-applied control applied by an equivalent to that of the United
entity other than the receiving facili- States, and information relevant to the
ty’s supplier and documenting that supplier’s compliance with those laws
verification as required by § 117.475, or and regulations); and
obtaining documentation of an appro- (C) The supplier’s food safety history
priate verification activity from an- relevant to the raw materials or other
other entity, reviewing and assessing ingredients that the receiving facility
that documentation, and documenting receives from the supplier, including
the review and assessment as required available information about results
by § 117.475. from testing raw materials or other in-
(b) The following are appropriate sup- gredients for hazards, audit results re-
plier verification activities for raw ma- lating to the safety of the food, and re-
terials and other ingredients: sponsiveness of the supplier in cor-
(1) Onsite audits; recting problems; and
(2) Sampling and testing of the raw (iv) Any other factors as appropriate
material or other ingredient; and necessary, such as storage and
(3) Review of the supplier’s relevant transportation practices.
food safety records; and (2) Considering supplier performance
(4) Other appropriate supplier can be limited to the supplier’s compli-
verification activities based on sup- ance history as required by paragraph
plier performance and the risk associ- (d)(1)(iii)(B) of this section, if the sup-
ated with the raw material or other in- plier is:
gredient. (i) A qualified facility as defined by
(c) The supply-chain program must § 117.3;
provide assurance that a hazard requir- (ii) A farm that grows produce and is
ing a supply-chain-applied control has not a covered farm under part 112 of
been significantly minimized or pre- this chapter in accordance with
vented. § 112.4(a), or in accordance with
(d)(1) Except as provided by para- §§ 112.4(b) and 112.5; or
graph (d)(2) of this section, in approv- (iii) A shell egg producer that is not
ing suppliers and determining the ap- subject to the requirements of part 118
propriate supplier verification activi- of this chapter because it has less than
ties and the frequency with which they 3,000 laying hens.
420
(e) If the owner, operator, or agent in (b) For the purposes of this subpart, a
charge of a receiving facility deter- receiving facility may not accept any
mines through auditing, verification of the following as a supplier
testing, document review, relevant verification activity:
consumer, customer or other com- (1) A determination by its supplier of
plaints, or otherwise that the supplier the appropriate supplier verification
is not controlling hazards that the re- activities for that supplier;
ceiving facility has identified as re- (2) An audit conducted by its sup-
quiring a supply-chain-applied control, plier;
the receiving facility must take and
(3) A review by its supplier of that
document prompt action in accordance
supplier’s own relevant food safety
with § 117.150 to ensure that raw mate-
records; or
rials or other ingredients from the sup-
plier do not cause food that is manu- (4) The conduct by its supplier of
factured or processed by the receiving other appropriate supplier verification
facility to be adulterated under section activities for that supplier within the
402 of the Federal Food, Drug, and Cos- meaning of § 117.410(b)(4).
metic Act or misbranded under section (c) The requirements of this section
403(w) of the Federal Food, Drug, and do not prohibit a receiving facility
Cosmetic Act. from relying on an audit provided by
its supplier when the audit of the sup-
§ 117.415 Responsibilities of the receiv- plier was conducted by a third-party
ing facility. qualified auditor in accordance with
(a)(1) The receiving facility must ap- §§ 117.430(f) and 117.435.
prove suppliers.
(2) Except as provided by paragraphs § 117.420 Using approved suppliers.
(a)(3) and (4) of this section, the receiv- (a) Approval of suppliers. The receiv-
ing facility must determine and con- ing facility must approve suppliers in
duct appropriate supplier verification accordance with the requirements of
activities, and satisfy all documenta- § 117.410(d), and document that ap-
tion requirements of this subpart. proval, before receiving raw materials
(3) An entity other than the receiving and other ingredients received from
facility may do any of the following, those suppliers;
provided that the receiving facility re- (b) Written procedures for receiving raw
views and assesses the entity’s applica-
materials and other ingredients. (1) Writ-
ble documentation, and documents
ten procedures for receiving raw mate-
that review and assessment:
rials and other ingredients must be es-
(i) Establish written procedures for
tablished and followed;
receiving raw materials and other in-
gredients by the entity; (2) The written procedures for receiv-
(ii) Document that written proce- ing raw materials and other ingredi-
dures for receiving raw materials and ents must ensure that raw materials
other ingredients are being followed by and other ingredients are received only
the entity; and from approved suppliers (or, when nec-
(iii) Determine, conduct, or both de- essary and appropriate, on a temporary
termine and conduct the appropriate basis from unapproved suppliers whose
supplier verification activities, with raw materials or other ingredients are
appropriate documentation. subjected to adequate verification ac-
(4) The supplier may conduct and tivities before acceptance for use); and
document sampling and testing of raw (3) Use of the written procedures for
materials and other ingredients, for receiving raw materials and other in-
the hazard controlled by the supplier, gredients must be documented.
as a supplier verification activity for a
particular lot of product and provide § 117.425 Determining appropriate
such documentation to the receiving supplier verification activities (in-
facility, provided that the receiving fa- cluding determining the frequency
of conducting the activity).
cility reviews and assesses that docu-

mentation, and documents that review Appropriate supplier verification ac-
and assessment. tivities (including the frequency of
421
§ 117.430 21 CFR Ch. I (4–1–23 Edition)
conducting the activity) must be deter- system FDA has officially recognized
mined in accordance with the require- as comparable or has determined to be
ments of § 117.410(d). equivalent to that of the United
States). The written assurance must
§ 117.430 Conducting supplier include either:
verification activities for raw mate- (i) A brief description of the preven-
rials and other ingredients. tive controls that the supplier is imple-
(a) Except as provided by paragraph menting to control the applicable haz-
(c), (d), or (e) of this section, one or ard in the food; or
more of the supplier verification ac- (ii) A statement that the facility is
tivities specified in § 117.410(b), as de- in compliance with State, local, coun-
termined under § 117.410(d), must be ty, tribal, or other applicable non-Fed-
conducted for each supplier before eral food safety law, including relevant
using the raw material or other ingre- laws and regulations of foreign coun-
dient from that supplier and periodi- tries.
cally thereafter. (d) If a supplier is a farm that grows
(b)(1) Except as provided by para- produce and is not a covered farm
graph (b)(2) of this section, when a haz- under part 112 of this chapter in ac-
ard in a raw material or other ingre- cordance with § 112.4(a), or in accord-
dient will be controlled by the supplier ance with §§ 112.4(b) and 112.5, the re-
and is one for which there is a reason- ceiving facility does not need to com-
able probability that exposure to the ply with paragraphs (a) and (b) of this
hazard will result in serious adverse section for produce that the receiving
health consequences or death to hu- facility receives from the farm as a raw
mans: material or other ingredient if the re-
(i) The appropriate supplier ceiving facility:
verification activity is an onsite audit (1) Obtains written assurance that
of the supplier; and the raw material or other ingredient
(ii) The audit must be conducted be- provided by the supplier is not subject
fore using the raw material or other in- to part 112 of this chapter in accord-
gredient from the supplier and at least ance with § 112.4(a), or in accordance
annually thereafter. with §§ 112.4(b) and 112.5:
(2) The requirements of paragraph (i) Before first approving the supplier
(b)(1) of this section do not apply if for an applicable calendar year; and
there is a written determination that (ii) On an annual basis thereafter, by
other verification activities and/or less December 31 of each calendar year, for
frequent onsite auditing of the supplier the following calendar year; and
provide adequate assurance that the (2) Obtains written assurance, at
hazards are controlled. least every 2 years, that the farm ac-
(c) If a supplier is a qualified facility knowledges that its food is subject to
as defined by § 117.3, the receiving facil- section 402 of the Federal Food, Drug,
ity does not need to comply with para- and Cosmetic Act (or, when applicable,
graphs (a) and (b) of this section if the that its food is subject to relevant laws
receiving facility: and regulations of a country whose
(1) Obtains written assurance that food safety system FDA has officially
the supplier is a qualified facility as recognized as comparable or has deter-
defined by § 117.3: mined to be equivalent to that of the
(i) Before first approving the supplier United States).
for an applicable calendar year; and (e) If a supplier is a shell egg pro-
(ii) On an annual basis thereafter, by ducer that is not subject to the re-
December 31 of each calendar year, for quirements of part 118 of this chapter
the following calendar year; and because it has less than 3,000 laying
(2) Obtains written assurance, at hens, the receiving facility does not
least every 2 years, that the supplier is need to comply with paragraphs (a) and
producing the raw material or other in- (b) of this section if the receiving facil-
gredient in compliance with applicable ity:
FDA food safety regulations (or, when (1) Obtains written assurance that
applicable, relevant laws and regula- the shell eggs produced by the supplier
tions of a country whose food safety are not subject to part 118 because the
422
shell egg producer has less than 3,000 (ii) For a foreign supplier, the writ-
laying hens: ten results of an inspection by FDA or
(i) Before first approving the supplier the food safety authority of a country
for an applicable calendar year; and whose food safety system FDA has offi-
(ii) On an annual basis thereafter, by cially recognized as comparable or has
December 31 of each calendar year, for determined to be equivalent to that of
the following calendar year; and the United States.
(2) Obtains written assurance, at (2) For inspections conducted by the
least every 2 years, that the shell egg food safety authority of a country
producer acknowledges that its food is whose food safety system FDA has offi-
subject to section 402 of the Federal cially recognized as comparable or de-
Food, Drug, and Cosmetic Act (or, termined to be equivalent, the food
when applicable, that its food is sub- that is the subject of the onsite audit
ject to relevant laws and regulations of must be within the scope of the official
a country whose food safety system recognition or equivalence determina-
FDA has officially recognized as com- tion, and the foreign supplier must be
parable or has determined to be equiva- in, and under the regulatory oversight
lent to that of the United States). of, such country.
(f) There must not be any financial (d) If the onsite audit is solely con-
conflicts of interests that influence the ducted to meet the requirements of
results of the verification activities this subpart by an audit agent of a cer-
listed in § 117.410(b) and payment must tification body that is accredited in ac-
not be related to the results of the accordance with regulations in part 1,
tivity. subpart M of this chapter, the audit is
not subject to the requirements in
§ 117.435 Onsite audit. those regulations.
(a) An onsite audit of a supplier must [80 FR 56145, Sept. 17, 2015]
be performed by a qualified auditor.
(b) If the raw material or other ingre- § 117.475 Records documenting the
dient at the supplier is subject to one supply-chain program.
or more FDA food safety regulations, (a) The records documenting the sup-
an onsite audit must consider such reg- ply-chain program are subject to the
ulations and include a review of the requirements of subpart F of this part.
supplier’s written plan (e.g., Hazard (b) The receiving facility must re-
Analysis and Critical Control Point view the records listed in paragraph (c)
(HACCP) plan or other food safety of this section in accordance with
plan), if any, and its implementation, § 117.165(a)(4).
for the hazard being controlled (or, (c) The receiving facility must docu-
when applicable, an onsite audit may ment the following in records as appli-
consider relevant laws and regulations cable to its supply-chain program:
of a country whose food safety system (1) The written supply-chain pro-
FDA has officially recognized as com- gram;
parable or has determined to be equiva- (2) Documentation that a receiving
lent to that of the United States). facility that is an importer is in com-
(c)(1) The following may be sub- pliance with the foreign supplier
stituted for an onsite audit, provided verification program requirements
that the inspection was conducted under part 1, subpart L of this chapter,
within 1 year of the date that the on- including documentation of
site audit would have been required to verification activities conducted under
be conducted: § 1.506(e) of this chapter;
(i) The written results of an appro- (3) Documentation of the approval of
priate inspection of the supplier for a supplier;
compliance with applicable FDA food (4) Written procedures for receiving
safety regulations by FDA, by rep- raw materials and other ingredients;
resentatives of other Federal Agencies (5) Documentation demonstrating use
(such as the United States Department of the written procedures for receiving
of Agriculture), or by representatives raw materials and other ingredients;

of State, local, tribal, or territorial (6) Documentation of the determina-
agencies; or tion of the appropriate supplier
423
§ 117.475 21 CFR Ch. I (4–1–23 Edition)
verification activities for raw mate- provide adequate assurance that the
rials and other ingredients; hazards are controlled when a hazard
(7) Documentation of the conduct of in a raw material or other ingredient
an onsite audit. This documentation will be controlled by the supplier and is
must include: one for which there is a reasonable
(i) The name of the supplier subject probability that exposure to the hazard
to the onsite audit; will result in serious adverse health
(ii) Documentation of audit proce- consequences or death to humans;
dures; (12) The following documentation of
(iii) The dates the audit was con- an alternative verification activity for
ducted; a supplier that is a qualified facility:
(iv) The conclusions of the audit; (i) The written assurance that the
(v) Corrective actions taken in re- supplier is a qualified facility as de-
sponse to significant deficiencies iden- fined by § 117.3, before approving the
tified during the audit; and supplier and on an annual basis there-
(vi) Documentation that the audit after; and
was conducted by a qualified auditor; (ii) The written assurance that the
(8) Documentation of sampling and supplier is producing the raw material
testing conducted as a supplier or other ingredient in compliance with
verification activity. This documenta- applicable FDA food safety regulations
tion must include: (or, when applicable, relevant laws and
(i) Identification of the raw material regulations of a country whose food
or other ingredient tested (including safety system FDA has officially recog-
lot number, as appropriate) and the nized as comparable or has determined
number of samples tested; to be equivalent to that of the United
(ii) Identification of the test(s) con- States);
ducted, including the analytical meth- (13) The following documentation of
od(s) used; an alternative verification activity for
(iii) The date(s) on which the test(s) a supplier that is a farm that supplies
were conducted and the date of the re- a raw material or other ingredient and
port; is not a covered farm under part 112 of
(iv) The results of the testing; this chapter:
(v) Corrective actions taken in re- (i) The written assurance that sup-
sponse to detection of hazards; and plier is not a covered farm under part
(vi) Information identifying the lab- 112 of this chapter in accordance with
oratory conducting the testing; § 112.4(a), or in accordance with
(9) Documentation of the review of §§ 112.4(b) and 112.5, before approving
the supplier’s relevant food safety the supplier and on an annual basis
records. This documentation must in- thereafter; and
clude: (ii) The written assurance that the
(i) The name of the supplier whose farm acknowledges that its food is sub-
records were reviewed; ject to section 402 of the Federal Food,
(ii) The date(s) of review; Drug, and Cosmetic Act (or, when ap-
(iii) The general nature of the records plicable, that its food is subject to rel-
reviewed; evant laws and regulations of a coun-
(iv) The conclusions of the review; try whose food safety system FDA has
and officially recognized as comparable or
(v) Corrective actions taken in re- has determined to be equivalent to
sponse to significant deficiencies iden- that of the United States);
tified during the review; (14) The following documentation of
(10) Documentation of other appro- an alternative verification activity for
priate supplier verification activities a supplier that is a shell egg producer
based on the supplier performance and that is not subject to the requirements
the risk associated with the raw mate- established in part 118 of this chapter
rial or other ingredient; because it has less than 3,000 laying
(11) Documentation of any deter- hens:
mination that verification activities (i) The written assurance that the
other than an onsite audit, and/or less shell eggs provided by the supplier are
frequent onsite auditing of a supplier, not subject to part 118 of this chapter
424
because the supplier has less than 3,000 accordance with §§ 117.430(f) and 117.435;
laying hens, before approving the sup- and
plier and on an annual basis thereafter; (v) Applicable documentation, from
and an entity other than the receiving fa-
(ii) The written assurance that the cility, of verification activities when a
shell egg producer acknowledges that supply-chain-applied control is applied
its food is subject to section 402 of the by an entity other than the receiving
Federal Food, Drug, and Cosmetic Act facility’s supplier.
(or, when applicable, that its food is [80 FR 56145, Sept. 17, 2015]
subject to relevant laws and regula-
tions of a country whose safety system
FDA has officially recognized as com-
PART 118—PRODUCTION, STOR-
parable or has determined to be equiva- AGE, AND TRANSPORTATION OF
lent to that of the United States); SHELL EGGS
(15) The written results of an appro-
priate inspection of the supplier for Sec.
118.1 Persons covered by the requirements
compliance with applicable FDA food in this part.
safety regulations by FDA, by rep- 118.3 Definitions.
resentatives of other Federal Agencies 118.4 Salmonella Enteritidis (SE) prevention
(such as the United States Department measures.
of Agriculture), or by representatives 118.5 Environmental testing for Salmonella
from State, local, tribal, or territorial Enteritidis (SE).
agencies, or the food safety authority 118.6 Egg testing for Salmonella Enteritidis
(SE).
of another country when the results of
118.7 Sampling methodology for Salmonella
such an inspection is substituted for an Enteritidis (SE).
onsite audit; 118.8 Testing methodology for Salmonella
(16) Documentation of actions taken Enteritidis (SE).
with respect to supplier non-conform- 118.9 Administration of the Salmonella
ance; Enteritidis (SE) prevention plan.
(17) Documentation of verification of 118.10 Recordkeeping requirements for the
Salmonella Enteritidis (SE) prevention
a supply-chain-applied control applied plan.
by an entity other than the receiving 118.11 Registration requirements for shell
facility’s supplier; and egg producers covered by the require-
(18) When applicable, documentation ments of this part.
of the receiving facility’s review and 118.12 Enforcement and compliance.
assessment of: AUTHORITY: 21 U.S.C. 321, 331–334, 342, 371,
(i) Applicable documentation from an 381, 393; 42 U.S.C. 243, 264, 271.
entity other than the receiving facility SOURCE: 74 FR 33095, July 9, 2009, unless
that written procedures for receiving otherwise noted.
raw materials and other ingredients
EDITORIAL NOTE: Nomenclature changes to
are being followed;
(ii) Applicable documentation, from
an entity other than the receiving fa- § 118.1 Persons covered by the require-
cility, of the determination of the ap- ments in this part.
propriate supplier verification activi- (a) If you are a shell egg producer
ties for raw materials and other ingre- with 3,000 or more laying hens at a par-
dients; ticular farm that does not sell all of
(iii) Applicable documentation, from your eggs directly to consumers and
an entity other than the receiving fa- that produces shell eggs for the table
cility, of conducting the appropriate market, you are covered by some or all
supplier verification activities for raw of the requirements in this part, as fol-
materials and other ingredients; lows:
(iv) Applicable documentation, from (1) If any of your eggs that are pro-
its supplier, of: duced at a particular farm do not re-
(A) The results of sampling and test- ceive a treatment as defined in § 118.3,
ing conducted by the supplier; or you must comply with all of the re-
(B) The results of an audit conducted quirements of this part for egg produc-
by a third-party qualified auditor in tion on that farm.
425
§ 118.3 21 CFR Ch. I (4–1–23 Edition)
(2) If all of your eggs that are pro- and the time that the hen is perma-
duced at the particular farm receive a nently taken out of production.
treatment as defined in § 118.3, you Molting means a life stage during
must comply only with the refrigera- which hens stop laying eggs and shed
tion requirements in § 118.4(e) for pro- their feathers.
duction of eggs on that farm and with Pest means any objectionable animal
the registration requirements in including, but not limited to, rodents,
§ 118.11. flies, and larvae.
(b) If you transport or hold shell eggs Positive flock means a flock that has
for shell egg processing or egg products had an egg test that was positive for
facilities, you must comply with the SE. A flock is considered positive until
refrigeration requirements in § 118.4(e). that flock meets the egg testing re-
This section applies only to eggs from quirements in § 118.6(c) to return to
farms with 3,000 or more laying hens. table egg production.
Positive poultry house means a poultry
§ 118.3 Definitions. house from which there has been an en-
The definitions and interpretations vironmental test that was positive for
of terms in section 201 of the Federal SE at any time during the life of a
Food, Drug, and Cosmetic Act (the group in the poultry house until that
FFDCA) (21 U.S.C. 321) are applicable house is cleaned and disinfected ac-
to such terms when used in this part, cording to § 118.4(d).
except where they are redefined in this Poultry house means a building, other
part. The following definitions also structure, or separate section within a
apply: structure used to house poultry. For
structures comprising more than one
Biosecurity means a program, includ-
section containing poultry, each sec-
ing the limiting of visitors on the farm
tion that is separated from the other
and in poultry houses, maintaining
sections is considered a separate house.
personnel and equipment practices that
Producer means a person who owns
will protect against cross contamina-
and/or operates a poultry house con-
tion from one poultry house to an-
taining laying hens which produce
other, preventing stray poultry, wild
shell eggs for human consumption.
birds, cats, and other animals from en-
Shell egg (or egg) means the egg of
tering poultry houses, and not allowing
the domesticated chicken.
employees to keep birds at home, to
Shell egg processing facility means a
ensure that there is no introduction or
facility that processes (e.g., washes,
transfer of Salmonella Enteritidis (SE)
grades, packs) shell eggs for the table
onto a farm or among poultry houses.
egg market.
Egg products facility means a USDA-
Treatment (or treated) means a tech-
inspected egg products plant where liq-
nology or process that achieves at least
uid, frozen, and/or dried egg products
a 5-log destruction of SE for shell eggs,
are produced.
or the processing of egg products in ac-
Farm means all poultry houses and cordance with the Egg Products Inspec-
grounds immediately surrounding the tion Act.
poultry houses covered under a single
biosecurity program. § 118.4 Salmonella Enteritidis (SE) pre-
Flock means all laying hens within vention measures.
one poultry house. You must follow the SE prevention
Group means all laying hens of the measures set forth in this section. In
same age within one poultry house. addition, you must have and imple-
Induced molting means molting that ment a written SE prevention plan
is artificially initiated. that is specific to each farm where you
Laying cycle means the period of time produce eggs and that includes, at a
that a hen begins to produce eggs until minimum, the following SE prevention
it undergoes induced molting or is per- measures:
manently taken out of production and (a) Pullets. You must procure pullets
the period of time that a hen produces that are SE monitored or raise pullets
eggs between successive induced molt- under SE monitored conditions. ‘‘SE
ing periods or between induced molting monitored’’ means the pullets are
426
raised under SE control conditions (1) Monitor for rodents by visual in-
that prevent SE, including: spection and mechanical traps or
(1) Procurement of chicks. Chicks are glueboards or another appropriate
procured from SE-monitored breeder monitoring method and, when moni-
flocks that meet the National Poultry toring indicates unacceptable rodent
Improvement Plan’s standards for activity within a poultry house, use ap-
‘‘U.S. S. Enteritidis Clean’’ status (9 propriate methods to achieve satisfac-
CFR 145.23(d)) or equivalent standard; tory rodent control;
(2) Environmental testing. (i) The pul- (2) Monitor for flies by spot cards,
let environment is tested for SE when Scudder grills, or sticky traps or an-
pullets are 14 to 16 weeks of age; other appropriate monitoring method
(ii) If the environmental test re- and, when monitoring indicates unac-
quired in paragraph (a)(2)(i) of this sec- ceptable fly activity within a poultry
tion is negative, you do not need to house, use appropriate methods to
perform any additional testing of those achieve satisfactory fly control.
birds or their environment until the (3) Remove debris within a poultry
environmental test at 40 to 45 weeks of house and vegetation and debris out-
age specified in § 118.5(a); and side a poultry house that may provide
(iii) If the environmental test re- harborage for pests.
quired in paragraph (a)(2)(i) of this sec- (d) Cleaning and disinfection. You
tion is positive, you must begin egg must clean and disinfect the poultry
testing, as specified in § 118.6, within 2 house according to these procedures be-
weeks of the start of egg laying. fore new laying hens are added to the
(3) Cleaning and disinfection. If the en- house, if you have had an environ-
vironmental test required in paragraph mental test or an egg test that was
(a)(2) of this section is positive, the positive for SE at any point during the
pullet environment is cleaned and dis- life of a flock that was housed in the
infected, to include: poultry house prior to depopulation. As
(i) Removal of all visible manure; part of the cleaning and disinfection
(ii) Dry cleaning the positive pullet procedures, you must:
house to remove dust, feathers, and old (1) Remove all visible manure;
feed; and (2) Dry clean the positive poultry
(iii) Following cleaning, disinfection house to remove dust, feathers, and old
of the positive pullet house with spray, feed; and
aerosol, fumigation, or another appro- (3) Following cleaning, disinfect the
priate disinfection method. positive poultry house with spray, aer-
(b) Biosecurity. As part of this pro- osol, fumigation, or another appro-
gram, you must take steps to ensure priate disinfection method.
that there is no introduction or trans- (e) Refrigeration. You must hold and
fer of SE into or among poultry houses. transport eggs at or below 45 °F ambi-
Among such biosecurity measures you ent temperature beginning 36 hours
must, at a minimum: after time of lay. If the eggs are to be
(1) Limit visitors on the farm and in processed as table eggs and are not
the poultry houses; processed for the ultimate consumer
(2) Maintain practices that will pro- within 36 hours from the time of lay
tect against cross contamination when and, therefore, are held and trans-
equipment is moved among poultry ported as required at or below 45 °F
houses; ambient temperature, then you may
(3) Maintain practices that will pro- then hold them at room temperature
tect against cross contamination when for no more than 36 hours just prior to
persons move between poultry houses; processing to allow an equilibration
(4) Prevent stray poultry, wild birds, step to temper the eggs.
cats, and other animals from entering
poultry houses; and § 118.5 Environmental testing for Sal-
(5) Not allow employees to keep birds monella Enteritidis (SE).
at home. (a) Environmental testing when laying

(c) Rodents, flies, and other pest con- hens are 40 to 45 weeks of age. As one in-
trol. As part of this program, you must: dicator of the effectiveness of your SE
427
§ 118.6 21 CFR Ch. I (4–1–23 Edition)
prevention plan, you must perform en- (ii) Begin egg testing (described in
vironmental testing for SE (as de- § 118.6), unless you divert eggs to treat-
scribed in §§ 118.7 and 118.8) in a poultry ment as defined in § 118.3 for the life of
house when any group of laying hens the flock in that poultry house. Re-
constituting the flock within the poul- sults of egg testing, when conducted,
try house is 40 to 45 weeks of age. must be available within 10-calendar
(1) If an environmental test at 40 to days of receiving notification of the
45 weeks is negative and your laying positive environmental test.
hens do not undergo induced molting,
then you do not need to perform any § 118.6 Egg testing for Salmonella
additional environmental testing with- Enteritidis (SE).
in that poultry house, unless the poul- (a)(1) If the environmental test for
try house contains more than one pullets at 14 to 16 weeks of age required
group of laying hens. If the poultry by § 118.4(a) is positive, you must divert
house contains more than one group of eggs to treatment (defined in § 118.3) for
laying hens, then you must perform en- the life of any flock or conduct egg
vironmental testing on the poultry testing within 2 weeks of the start of
house when each group of laying hens egg laying, as specified in paragraphs
is 40 to 45 weeks of age. (b) through (e) of this section.
(2) If the environmental test at 40 to (2) If you have an SE-positive envi-
45 weeks is positive, then you must: ronmental test at any time during the
(i) Review and make any necessary life of a flock, you must divert eggs to
adjustments to your SE prevention treatment (defined in § 118.3) for the
plan to ensure that all measures are life of the flock in that positive poultry
being properly implemented and house or conduct egg testing as speci-
(ii) Begin egg testing (described in fied in paragraphs (b) through (e) of
§ 118.6), unless you divert eggs to treat- this section.
ment as defined in § 118.3 for the life of (b) Eggs must be sampled as de-
the flock in that poultry house. Re- scribed in § 118.7 and tested using meth-
sults of egg testing must be obtained odology as described in § 118.8.
within 10-calendar days of receiving no- (c) You must conduct four egg tests,
tification of the positive environ- using sampling and methodology in
mental test. §§ 118.7 and 118.8, on the flock in the
(b) Environmental testing after an in- positive poultry house at 2-week inter-
duced molting period. If you induce a vals. If all four tests are negative for
molt in a flock or a group in a flock, SE, you are not required to do further
you must perform environmental test- egg testing.
ing for SE in the poultry house at 4 to (d) If any of the four egg tests is posi-
6 weeks after the end of any molting tive for SE, you must divert, upon re-
process. ceiving notification of an SE-positive
(1) If an environmental test at 4 to 6 egg test, all eggs from that flock to
weeks after the end of the molting treatment (defined in § 118.3) until the
process is negative and none of your conditions of paragraph (c) of this sec-
laying hens in that poultry house is tion are met.
molted again, then you do not need to (e) If you have a positive egg test in
perform any additional environmental a flock and divert eggs from that flock
testing in that poultry house. Each and later meet the negative test result
time a flock or group within the flock requirements described in paragraph
is molted, you must perform environ- (c) of this section and return to table
mental testing in the poultry house at egg production, you must conduct one
4 to 6 weeks after the end of the molt- egg test per month on that flock, using
ing process. sampling and methodology in §§ 118.7
(2) If the environmental test at 4 to 6 and 118.8, for the life of the flock.
weeks after the end of a molting proc- (1) If all the monthly egg tests in
ess is positive, then you must: paragraph (e) of this section are nega-
(i) Review and make any necessary tive for SE, you may continue to sup-
adjustments to your SE prevention ply eggs to the table market.

plan to ensure that all measures are (2) If any of the monthly egg tests in
being properly implemented; and paragraph (e) of this section is positive
428
for SE, you must divert eggs from the pling and Detection of Salmonella Web
positive flock to treatment for the life site is located at http://www.fda.gov/
of the flock or until the conditions of Food/ScienceResearch/
paragraph (c) of this section are met. LaboratoryMethods/ucm114716.htm, cur-
(f) If you are diverting eggs, the pal- rent as of June 26, 2009. The Director of
let, case, or other shipping container the Federal Register approves the in-
must be labeled and all documents ac- corporation by reference of ‘‘Environ-
companying the shipment must con- mental Sampling and Detection of Sal-
tain the following statement: ‘‘Federal monella in Poultry Houses,’’ April 2008,
law requires that these eggs must be in accordance with 5 U.S.C. 552(a) and 1
treated to achieve at least a 5-log de- CFR part 51. FDA will request approval
struction of Salmonella Enteritidis or to incorporate by reference any up-
processed as egg products in accord- dates to this Web site. FDA will change
ance with the Egg Products Inspection the date of the Web site in this para-
Act, 21 CFR 118.6(f).’’ The statement graph with each update. You may ob-
must be legible and conspicuous. tain a copy from Division of Microbi-
ology (HFS–710), Center for Food Safe-
§ 118.7 Sampling methodology for Sal- ty and Applied Nutrition, Food and
monella Enteritidis (SE). Drug Administration, 5001 Campus Dr.,
(a) Environmental sampling. An envi- College Park, MD 20740, 301–436–2364, or
ronmental test must be done for each you may examine a copy at the Food
poultry house in accordance with § 118.5 and Drug Administration’s Main Li-
(a) and (b). Within each poultry house, brary, 10903 New Hampshire Ave., Bldg.
you must sample the environment 2, Third Floor, Silver Spring, MD 20993,
using a sampling plan appropriate to 301–796–2039, or at the National Ar-
the poultry house layout. chives and Records Administration
(b) Egg sampling. When you conduct (NARA). For information on the avail-
an egg test required under § 118.6, you ability of this material at NARA, call
must collect and test the following 202–741–6030, or go to: http://
number of eggs from the positive poul- www.archives.gov/federal_register/
try house: code_of_federal_regulations/
(1) To meet the egg testing require- ibr_locations.html.
ments of § 118.6(c), you must collect and (b) Testing of egg samples for SE. Test-
deliver for testing a minimum of 1,000 ing to detect SE in egg samples must
intact eggs representative of a day’s be conducted according to Chapter 5 of
production. The 1,000-egg sample must FDA’s Bacteriological Analytical Man-
be tested according to § 118.8. You must ual (BAM), December 2007 Edition, or
collect and test four 1,000-egg samples an equivalent method in accuracy, pre-
at 2-week intervals for a total of 4,000 cision, and sensitivity in detecting SE.
eggs. Chapter 5 of FDA’s Bacteriological An-
(2) To meet the monthly egg testing alytical Manual, December 2007 Edi-
requirement of § 118.6(e), you must col- tion, is located at http://www.fda.gov/
lect and deliver for testing a minimum Food/ScienceResearch/
of 1,000 intact eggs representative of a LaboratoryMethods/
day’s production per month for the life BacteriologicalAnalyticalManualBAM/
of the flock. Eggs must be tested ac- ucm070149.htm, current as of June 26,
cording to § 118.8. 2009. The method is incorporated by
reference in accordance with 5 U.S.C.
§ 118.8 Testing methodology for Sal- 552(a) and 1 CFR part 51. FDA will re-
monella Enteritidis (SE). quest approval to incorporate by ref-
(a) Testing of environmental samples for erence any updates to this Web site.
SE. Testing to detect SE in environ- FDA will change the date of the Web
mental samples must be conducted by site in this paragraph with each up-
the method entitled ‘‘Environmental date. You may obtain a copy from Divi-
Sampling and Detection of Salmonella sion of Microbiology (HFS–710), Center
in Poultry Houses,’’ April 2008, or an for Food Safety and Applied Nutrition,
equivalent method in accuracy, preci- Food and Drug Administration, 5001

sion, and sensitivity in detecting SE. Campus Dr., College Park, MD 20740,
The April 2008 Environmental Sam- 301–436–2364, or you may examine a
429
§ 118.9 21 CFR Ch. I (4–1–23 Edition)
copy at the Food and Drug Administra- ‘‘SE monitored’’ conditions, including
tion’s Main Library, 10903 New Hamp- environmental testing records for pul-
shire Ave., Bldg. 2, Third Floor, Silver lets, as required by § 118.4(a)(2);
Spring, MD 20993, 301–796–2039, or at the (3) Records documenting compliance
National Archives and Records Admin- with the SE prevention measures, as
istration (NARA). For information on follows:
the availability of this material at (i) Biosecurity measures;
NARA, call 202–741–6030, or go to: http:// (ii) Rodent and other pest control
www.archives.gov/federal_register/ measures;
code_of_federal_regulations/ (iii) Cleaning and disinfection proce-
ibr_locations.html. dures performed at depopulation, when
[74 FR 33095, July 9, 2009, as amended at 81
applicable;
FR 5590, Feb. 3, 2016] (iv) Refrigeration requirements;
(v) Environmental and egg sampling
§ 118.9 Administration of the Sal- procedures, when applicable, performed
monella Enteritidis (SE) prevention under § 118.7;
plan. (vi) Results of SE testing, when ap-
You must have one or more super- plicable, performed under § 118.8 as re-
visory personnel, who do not have to be quired in §§ 118.4(a)(2), 118.5, and 118.6;
on-site employees, to be responsible for (vii) Diversion of eggs, if applicable,
ensuring compliance with each farm’s as required in § 118.6; and
SE prevention plan. This person must (viii) Eggs at a particular farm being
have successfully completed training given a treatment as defined in § 118.3,
on SE prevention measures for egg pro- if you are a producer complying with
duction that is equivalent to that re- the requirements of this section as de-
ceived under a standardized curriculum scribed in § 118.1(a)(2).
recognized by the Food and Drug Ad- (4) Records of review and of modifica-
ministration or must be otherwise tions of the SE prevention plan and
qualified through job experience to ad- corrective actions taken.
minister the SE prevention measures. (b) General requirements for records
Job experience will qualify this person maintained by shell egg producers. All
to perform these functions if it has pro- records required by § 118.10(a) must in-
vided knowledge at least equivalent to clude:
that provided through the standardized (1) Your name and the location of
curriculum. This person is responsible your farm,
for: (2) The date and time of the activity
(a) Development and implementation that the record reflects,
of an SE prevention plan that is appro- (3) The signature or initials of the
priate for your specific farm and meets person performing the operation or cre-
the requirements of § 118.4; ating the record. The written SE pre-
(b) Reassessing and modifying the SE vention plan must be dated and carry
prevention plan as necessary to ensure the signature(s) (not initials) of the
that the requirements in § 118.4 are person(s) who administers the plan as
met; and described in § 118.9, and
(c) Review of records created under (4) Data and information reflecting
§ 118.10. This person does not need to compliance activities must be entered
have performed the monitoring or cre- on records at the time the activity is
ated the records. performed or observed, and the records
must contain the actual values ob-
§ 118.10 Recordkeeping requirements served, if applicable.
for the Salmonella Enteritidis (SE) (c) Length of time records must be re-
prevention plan. tained. You must retain all records re-
(a) Records: You must maintain the quired by this part at your place of
following records documenting your SE business, unless stored offsite under
prevention measures: § 118.10(d), for 1 year after the flock to
(1) A written SE prevention plan re- which they pertain has been taken per-
quired by § 118.4; manently out of production.

(2) Documentation that pullets were (d) Offsite storage of records. You may
‘‘SE monitored’’ or were raised under store the records required by this part,
430
except for the written SE prevention thorized by the owner or operator of a

plan, offsite. You must be able to re- farm, such as an agent in charge, may
trieve and provide the records at your register by mail or fax.
place of business within 24 hours of re- (i) You must register using FDA
quest for official review. Electronic Form No. 3733. You may obtain a copy
records are considered to be onsite if of this form by writing to the U.S.
they are accessible from an onsite loca- Food and Drug Administration, 5600
tion. Fishers Lane (HFS–681), Rockville, MD
(e) Official review of records. You must 20857, or by requesting the form by
have all records required by this part phone at 1–800–216–7331 or 301–575–0156.
available for official review and copy- (ii) When you receive the form, you
ing at reasonable times. must fill it out completely and legibly
(f) Public disclosure of records. Records and either mail it to the address in
required by this part are subject to the paragraph (b)(2)(i) of this section or fax
disclosure requirements under part 20 it to the number on the form.
of this chapter. (iii) If any required information on
§ 118.11 Registration requirements for the form is incomplete or illegible
shell egg producers covered by the when FDA receives it, FDA will return
requirements of this part. the form to you for revision, provided
that your mailing address or fax num-
(a) Shell egg producers covered under
ber is legible and valid. When returning
§ 118.1(a) are required to register their
a registration form for revision, FDA
farms with FDA within 30 days of be-
will use the means by which the form
coming an egg producer or, if already
was received by the agency (i.e., by
an egg producer, by each farm’s appli-
cable compliance date. mail or fax).
(b) Shell egg producers may register (iv) FDA will enter complete and leg-
their farms by any of the following ible mailed and faxed registration sub-
means: missions into its registration system,
(1) Electronic registration. To register along with CD–ROM submissions, as
electronically, you must register at soon as practicable, in the order FDA
http://www.access.fda.gov, which will be receives them.
available for registration 24 hours a (v) FDA will then mail to the address
day, 7 days a week beginning May 10, or fax to the fax number on the reg-
2010. This Web site is available from istration form a copy of the registra-
wherever the Internet is accessible, in- tion as entered, confirmation of reg-
cluding libraries, copy centers, schools, istration, and your registration num-
and Internet cafes. ber. When responding to a registration
(i) An individual authorized by the submission, FDA will use the means by
owner or operator of a farm, such as an which the registration was received by
agent in charge, may also register a the agency (i.e., by mail or fax).
farm electronically. (vi) If any information you pre-
(ii) FDA strongly encourages elec- viously submitted was incorrect at the
tronic registration for the benefit of time of submission, you must imme-
both FDA and the registrant. diately update your facility’s registra-
(iii) Once you complete your elec- tion. If any information you previously
tronic registration, FDA will auto- submitted that was correct at the time
matically provide you with an elec- of submission subsequently changes,
tronic confirmation of registration and you must update your facility’s reg-
a permanent registration number. istration within 60 calendar days.
(iv) You will be considered registered (vii) Your facility is considered reg-
once FDA electronically transmits istered once FDA enters your facility’s
your confirmation and registration registration data into the registration
number. system and the system generates a reg-
(2) Registration by mail or by fax. If, istration number.
for example, you do not have reason- (3) Registration by CD–ROM for mul-
able access to the Internet through any tiple submissions. If, for example, you do
of the methods described in paragraph not have reasonable access to the
(b)(1) of this section, an individual au- Internet through any of the methods
431
§ 118.12 21 CFR Ch. I (4–1–23 Edition)
provided under paragraph (b)(1) of this (c) No registration fee is required.

section, you may register by CD–ROM. (d) You must submit all registration
(i) Registrants submitting their reg- information in the English language.
istrations in CD–ROM format must use All information must be submitted
ISO 9660 (CD–R or CD–RW) data format. using the Latin (Roman) alphabet.
(ii) These files must be submitted on (e) Each registrant must submit the
a portable document format (PDF) ren- following information through one of
dition of the registration form (FDA the methods described in paragraph (b)
Form No. 3733) and be accompanied by of this section:
one signed copy of the certification (1) The name, full address, and phone
statement that appears on the registra- number of the farm; and
tion form. (2) The average or usual number of
(iii) Each submission on the CD–ROM layers of each house and number of
must contain the same preferred mail- poultry houses on the farm.
ing address in the appropriate block on (3) A statement in which the shell
FDA Form No. 3733. egg producer certifies that the infor-
(iv) A CD–ROM may contain registra- mation submitted is true and accurate.
tions for as many facilities as needed If the individual submitting the form is
up to the CD–ROM’s capacity. not the shell egg producer in charge of
(v) The registration on the CD–ROM the farm, the registration must also in-
for each separate facility must have a clude a statement in which the indi-
unique file name up to 32 characters vidual certifies that the information
long, the first part of which may be submitted is true and accurate, cer-
used to identify the parent company. tifies that he/she is authorized to sub-
(vi) You must mail the CD–ROM to mit registration, and identifies by
the U.S. Food and Drug Administra- name, address, and telephone number,
tion, 5600 Fishers Lane (HFS–681), the individual who authorized submis-
Rockville, MD 20857. sion of the registration. Each registra-
(vii) If FDA receives a CD–ROM that tion must include the name of the indi-
does not comply with these specifica- vidual registering the farm submitting
tions, it will return the CD–ROM to the the registration, and the individual’s
submitter unprocessed. signature (for paper and CD–ROM op-
(viii) FDA will enter CD–ROM sub- tions).
missions that comply with these speci- (f) Registered egg producers must
fications into its registration system, submit an update to a registration
along with the complete and legible within 60-calendar days of any change
mailed and faxed submissions, as soon to any of the information previously
as practicable, in the order FDA re- submitted by any of the means as pro-
ceives them. vided in § 118.11(b).
(ix) For each facility on the CD– (g) Registered egg producers must no-
ROM, FDA will mail to the preferred tify FDA within 120 days of ceasing egg
mailing address a copy of the registra- production by completing sections 1b,
tion(s) as entered, confirmation of reg- 1c, and 2 of Form 3733. This notifica-
istration, and each facility’s assigned tion is not required if you are a sea-
registration number. sonal egg producer or you temporarily
(x) If any information you previously cease operation due to labor disputes,
submitted was incorrect at the time of fire, natural disasters, or other tem-
submission, you must immediately up- porary conditions.
date your facility’s registration. If any [74 FR 33095, July 9, 2009, as amended at 75
information you previously submitted FR 18751, Apr. 13, 2010]
that was correct at the time of submis-
sion subsequently changes, you must § 118.12 Enforcement and compliance.
update your facility’s registration (a) Authority. This part is established
within 60 calendar days. under authority of the Public Health
(xi) Your facility is considered reg- Service Act (the PHS Act). Under the
istered once FDA enters your facility’s FFDCA, the Food and Drug Adminis-
registration data into the registration tration (FDA) can enforce the food
system and the system generates a reg- adulteration provisions under 21 U.S.C.
istration number. 331 through 334 and 342. Under the PHS
432
Act (42 U.S.C. 264), FDA has the au- (B) A detailed description of the facts
thority to make and enforce regula- that justify the issuance of the order;
tions for the control of communicable (C) The location of the eggs;
diseases. FDA has established the fol- (D) A statement that these eggs must
lowing administrative enforcement not be sold, distributed, or otherwise
procedures for the diversion or destruc- disposed of or moved except as pro-
tion of shell eggs and for informal vided in paragraph (a)(1)(iv) of this sec-
hearings under the PHS Act: tion;
(1) Upon a finding that any shell eggs (E) Identification or description of
have been produced or held in violation the eggs;
of this part, an authorized FDA rep- (F) The order number;
resentative or a State or local rep- (G) The date of the order;
resentative in accordance with para- (H) The text of this entire section;
graph (c) of this section may order (I) A statement that the order may
such eggs to be diverted, under the su- be appealed by written appeal or by re-
pervision of said representative, for questing an informal hearing;
processing in accordance with the Egg (J) The name and phone number of
Products Inspection Act (EPIA) (21 the person issuing the order; and
U.S.C. 1031 et seq.) or by a treatment (K) The location and telephone num-
that achieves at least a 5-log destruc- ber of the office or agency issuing the
tion of SE or destroyed by or under the order and the name of its Director.
supervision of an officer or employee of (ii) Approval of Division Director. An
FDA, or, if applicable, of the State or order, before issuance, must be ap-
locality in accordance with the fol- proved by FDA’s Division Director. If
lowing procedures: prior written approval is not feasible,
(i) Order for diversion or destruction prior oral approval must be obtained
under the PHS Act. Any division office and confirmed by written memo-
of FDA or any State or locality acting randum as soon as possible.
under paragraph (c) of this section, (iii) Labeling or marking of shell eggs
upon finding shell eggs that have been under order. An FDA, State, or local
produced or held in violation of this representative issuing an order under
part, may serve a written order upon paragraph (a)(1)(i) of this section must
the person in whose possession the eggs label or mark the shell eggs with offi-
are found requiring that the eggs be dicial tags that include the following in-
verted, under the supervision of an offi- formation:
cer or employee of the issuing entity, (A) A statement that the shell eggs
for processing in accordance with the are detained in accordance with regula-
EPIA (21 U.S.C. 1031 et seq.) or by a tions issued under section 361(a) of the
treatment that achieves at least a 5-log PHS Act (42 U.S.C. 264(a)).
destruction of SE or destroyed by or (B) A statement that the shell eggs
under the supervision of the issuing en- must not be sold, distributed or other-
tity, within 10 working days from the wise disposed of or moved except, after
date of receipt of the order, unless, notifying the issuing entity in writing,
under paragraph (a)(2)(iii) of this sec- to:
tion, a hearing is held, in which case (1) Divert them for processing in ac-
the eggs must be diverted or destroyed cordance with the EPIA or by a treat-
consistent with the decision of the Of- ment that achieves at least a 5-log de-
fice of Regulatory Affairs Program Di- struction of SE or destroy them or
rector or another FDA official senior (2) Move them to another location for
to an FDA Division Director under holding pending appeal.
paragraph (a)(2)(v) of this section. The (C) A statement that the violation of
order must include the following infor- the order or the removal or alteration
mation: of the tag is punishable by fine or im-
(A) A statement that the shell eggs prisonment or both (section 368 of the
identified in the order are subject to di- PHS Act (42 U.S.C. 271)).
version for processing in accordance (D) The order number and the date of
with the EPIA or by a treatment that the order, and the name of the govern-
achieves at least a 5-log destruction of ment representative who issued the
SE or destruction; order.
433
§ 118.12 21 CFR Ch. I (4–1–23 Edition)
(iv) Sale or other disposition of shell (iii) Informal hearing. Appearance by

eggs under order. After service of the any appellant at the hearing may be by
order, the person in possession of the mail or in person, with or without
shell eggs that are the subject of the counsel. The informal hearing must be
order must not sell, distribute, or oth- conducted by the Office of Regulatory
erwise dispose of or move any eggs sub- Affairs Program Director or another
ject to the order unless and until re- FDA official senior to an FDA Division
ceiving a notice that the order is with- Director, and a written summary of the
drawn after an appeal except, after no- proceedings must be prepared by the
tifying FDA’s division office or, if ap- presiding FDA official.
plicable, the State or local representa- (A) The presiding FDA official may
tive, in writing, to: direct that the hearing be conducted in
(A) Divert or destroy them as speci- any suitable manner permitted by law
fied in paragraph (a)(1)(i) of this sec- and by this section. The presiding FDA
tion, or official has the power to take such ac-
(B) Move them to another location tions and make such rulings as are nec-
for holding pending appeal. essary or appropriate to maintain
(2) The person on whom the order for order and to conduct an informal, fair,
diversion or destruction is served may expeditious, and impartial hearing, and
either comply with the order or appeal to enforce the requirements concerning
the conduct of hearings.
the order to an Office of Regulatory Af-
(B) Employees of FDA will first give
fairs Program Director in accordance
a full and complete statement of the
with the following procedures:
action that is the subject of the hear-
(i) Appeal of a detention order. Any ap- ing, together with the information and
peal must be submitted in writing to reasons supporting it, and may present
FDA’s Division Director in whose divi- oral or written information relevant to
sion the shell eggs are located within 5 the hearing. The party requesting the
working days of the issuance of the hearing may then present oral or writ-
must be held within 5 working days able examination of any person (except
must not be later than 20 calendar days on the matter at the hearing.
after the issuance of the order. The (C) The hearing shall be informal in
The appellant of an order must state but any party may comment upon or
(ii) Summary decision. A request for a (D) The party requesting the hearing
issue of fact has been raised by the ma- (E) The presiding FDA official must
434
(F) The presiding FDA official must (b) Inspection. Persons engaged in
include as part of the report of the production of shell eggs must permit
hearing a finding on the credibility of authorized representatives of FDA to
witnesses (other than expert witnesses) make, at any reasonable time, an in-
whenever credibility is a material spection of the egg production estab-
issue, and must include a recommended lishment in which shell eggs are being
decision, with a statement of reasons. produced. Such inspection includes the
(iv) Written appeal. If the appellant inspection and sampling of shell eggs
appeals the detention order but does and the environment, the equipment
not request a hearing, the presiding related to production of shell eggs, the
FDA official must render a decision on equipment in which shell eggs are held,
the appeal affirming or revoking the and examination and copying of any
detention order within 5-working days records relating to such equipment or
after the receipt of the appeal. eggs, as may be necessary in the judg-
(v) Presiding FDA official’s decision. If, ment of such representatives to deter-
based on the evidence presented at the mine compliance with the provisions of
hearing or by the appellant in a writ- this section. Inspections may be made
ten appeal, the presiding FDA official with or without notice and will ordi-
finds that the shell eggs were produced narily be made during regular business
or held in violation of this section, he hours.
must affirm the order that they be di- (c) State and local cooperation. Under
verted, under the supervision of an offi- sections 311 and 361 of the Public
cer or employee of FDA for processing Health Service Act, any State or local-
under the EPIA or by a treatment that ity that is willing and able to assist
achieves at least a 5-log destruction of the agency in the enforcement of
SE or destroyed by or under the super- §§ 118.4 through 118.10, and is authorized
vision of an officer or employee of to inspect or regulate egg production
FDA; otherwise, the presiding FDA of- establishments, may, in its own juris-
ficial must issue a written notice that diction, enforce §§ 118.4 through 118.10
the prior order is withdrawn. If the pre- through inspections under paragraph
siding FDA official affirms the order, (b) of this section and through adminis-
he must order that the diversion or de- trative enforcement remedies specified
struction be accomplished within 10- in paragraph (a) of this section unless
working days from the date of the FDA notifies the State or locality in
issuance of his decision. The presiding writing that such assistance is no
FDA official’s decision must be accom- longer needed. A state or locality may
panied by a statement of the reasons substitute, where necessary, appro-
for the decision. The decision of the priate State or local officials for des-
presiding FDA official constitutes final ignated FDA officials in this section.
agency action, subject to judicial re- When providing assistance under para-
view. graph (a) of this section, a State or lo-
(vi) No appeal. If there is no appeal of cality may follow the hearing proce-
the order and the person in possession dures set out in paragraphs (a)(2)(iii)
of the shell eggs that are subject to the through (a)(2)(v) of this section, or may
order fails to divert or destroy them utilize comparable State or local hear-
within 10 working days, or if the de- ing procedures if such procedures sat-
mand is affirmed by the presiding FDA isfy due process.
official after an appeal and the person (d) Preemption. No State or local gov-
in possession of such eggs fails to di- erning entity shall establish, or con-
vert or destroy them within 10 working tinue in effect any law, rule, regula-
days, FDA’s division office or, if appli- tion, or other requirement regarding
cable, the State or local representative prevention of SE in shell eggs during
may designate an officer or employee production, storage, or transportation
to divert or destroy such eggs. It shall that is less stringent than those re-
be unlawful to prevent or to attempt to quired by this part.
prevent such diversion or destruction [74 FR 33095, July 9, 2009, as amended at 82

of the shell eggs by the designated offi- FR 14146, Mar. 17, 2017; 85 FR 16554, Mar. 24,
cer or employee. 2020]
435
PART 119—DIETARY SUPPLEMENTS Subpart A—General Provisions

THAT PRESENT A SIGNIFICANT OR
§ 120.1 Applicability.
UNREASONABLE RISK
(a) Any juice sold as such or used as
an ingredient in beverages shall be
AUTHORITY: 21 U.S.C. 321, 342, 343, 371. processed in accordance with the re-
quirements of this part. Juice means
§ 119.1 Dietary supplements con- the aqueous liquid expressed or ex-
taining ephedrine alkaloids. tracted from one or more fruits or
Dietary supplements containing vegetables, purees of the edible por-
ephedrine alkaloids present an unrea- tions of one or more fruits or vegeta-
sonable risk of illness or injury under bles, or any concentrates of such liquid
conditions of use recommended or sug- or puree. The requirements of this part
gested in the labeling, or if no condi- shall apply to any juice regardless of
tions of use are recommended or sug- whether the juice, or any of its ingredi-
gested in the labeling, under ordinary ents, is or has been shipped in inter-
state commerce (as defined in section
conditions of use. Therefore, dietary
201(b) of the Federal Food, Drug, and
supplements containing ephedrine
Cosmetic Act, 21 U.S.C. 321(b)). Raw ag-
alkaloids are adulterated under section ricultural ingredients of juice are not
402(f)(1)(A) of the Federal Food, Drug, subject to the requirements of this
and Cosmetic Act. part. Processors should apply existing
[69 FR 6853, Feb. 11, 2004] agency guidance to minimize microbial
food safety hazards for fresh fruits and
vegetables in handling raw agricultural
PART 120—HAZARD ANALYSIS AND products.
CRITICAL CONTROL POINT (b) The regulations in this part shall
(HACCP) SYSTEMS be effective January 22, 2002. However,
by its terms, this part is not binding on
Subpart A—General Provisions small and very small businesses until
the dates listed in paragraphs (b)(1) and
Sec. (b)(2) of this section.
120.1 Applicability. (1) For small businesses employing
120.3 Definitions. fewer than 500 persons the regulations
120.5 Current good manufacturing practice. in this part are binding on January 21,
120.6 Sanitation standard operating proce- 2003.
dures.
(2) For very small businesses that
120.7 Hazard analysis.
have either total annual sales of less
120.8 Hazard Analysis and Critical Control
than $500,000, or if their total annual
Point (HACCP) plan.
120.9 Legal basis.
sales are greater than $500,000 but their
120.10 Corrective actions.
total food sales are less than $50,000; or
120.11 Verification and validation.
the person claiming this exemption
120.12 Records. employed fewer than an average of 100
120.13 Training. full-time equivalent employees and
120.14 Application of requirements to im- fewer than 100,000 units of juice were
ported products. sold in the United States, the regula-
tions are binding on January 20, 2004.
Subpart B—Pathogen Reduction
§ 120.3 Definitions.
120.20 General. The definitions of terms in section
120.24 Process controls. 201 of the Federal Food, Drug, and Cos-
120.25 Process verification for certain proc- metic Act, § 101.9(j)(18)(vi) of this chap-
essors.
ter, and parts 110 and 117 of this chap-
AUTHORITY: 21 U.S.C. 321, 342, 343, 346, 348, ter are applicable to such terms when
371, 374, 379e, 381, 393; 42 U.S.C. 241, 242l, 264. used in this part, except that the defi-
SOURCE: 66 FR 6197, Jan. 19, 2001, unless nitions and terms in parts 110 and 117
otherwise noted. do not govern such terms where such

terms are redefined in this part and ex-
cept that the terms facility, hazard,
436
and manufacturing/processing in parts (2) For purposes of this part, proc-

110 and 117 do not govern such terms essing does not include:
where used in this part. The following (i) Harvesting, picking, or trans-
definitions shall also apply: porting raw agricultural ingredients of
(a) Cleaned means washed with water juice products, without otherwise en-
of adequate sanitary quality. gaging in processing; and
(b) Control means to prevent, elimi- (ii) The operation of a retail estab-
nate, or reduce. lishment.
(c) Control measure means any action (k) Processor means any person en-
or activity to prevent, reduce to ac- gaged in commercial, custom, or insti-
ceptable levels, or eliminate a hazard. tutional processing of juice products,
(d) Critical control point means a either in the United States or in a for-
point, step, or procedure in a food proc- eign country, including any person en-
ess at which a control measure can be gaged in the processing of juice prod-
applied and at which control is essen- ucts that are intended for use in mar-
tial to reduce an identified food hazard ket or consumer tests.
to an acceptable level. (l) Retail establishment is an operation
(e) Critical limit means the maximum that provides juice directly to the con-
or minimum value to which a physical, sumers and does not include an estab-
biological, or chemical parameter must lishment that sells or distributes juice
be controlled at a critical control point to other business entities as well as di-
to prevent, eliminate, or reduce to an rectly to consumers. ‘‘Provides’’ in-
acceptable level the occurrence of the cludes storing, preparing, packaging,
identified food hazard. serving, and vending.
(f) Culled means separation of dam- (m) Shall is used to state mandatory
aged fruit from undamaged fruit. For requirements.
processors of citrus juices using treat- (n) Shelf-stable product means a prod-
ments to fruit surfaces to comply with uct that is hermetically sealed and,
§ 120.24, culled means undamaged, tree- when stored at room temperature,
picked fruit that is U.S. Department of should not demonstrate any microbial
Agriculture choice or higher quality. growth.
(g) Food hazard means any biological, (o) Should is used to state rec-
chemical, or physical agent that is rea- ommended or advisory procedures or to
sonably likely to cause illness or in- identify recommended equipment.
(p) Validation means that element of
jury in the absence of its control.
verification focused on collecting and
(h) Importer means either the U.S.
evaluating scientific and technical in-
owner or consignee at the time of entry
formation to determine whether the
of a food product into the United
HACCP plan, when properly imple-
States, or the U.S. agent or representa-
mented, will effectively control the
tive of the foreign owner or consignee
identified food hazards.
at the time of entry into the United (q) Verification means those activi-
States. The importer is responsible for ties, other than monitoring, that es-
ensuring that goods being offered for tablish the validity of the HACCP plan
entry into the United States are in and that the system is operating ac-
compliance with all applicable laws. cording to the plan.
For the purposes of this definition, the
importer is ordinarily not the custom [66 FR 6197, Jan. 19, 2001, as amended at 80
house broker, the freight forwarder, FR 56167, Sept. 17, 2015]
the carrier, or the steamship represent-
§ 120.5 Current good manufacturing
ative. practice.
(i) Monitor means to conduct a
planned sequence of observations or Except as provided by § 117.5(c), parts
measurements to assess whether a 110 and 117 of this chapter apply in de-
process, point, or procedure is under termining whether the facilities, meth-
control and to produce an accurate ods, practices, and controls used to
record for use in verification. process juice are safe, and whether the
food has been processed under sanitary
(j)(1) Processing means activities that

are directly related to the production conditions.
of juice products. [80 FR 56167, Sept. 17, 2015]
437
§ 120.6 21 CFR Ch. I (4–1–23 Edition)
§ 120.6 Sanitation standard operating (d) Relationship to Hazard Analysis

procedures. and Critical Control Point (HACCP) plan.
(a) Sanitation controls. Each processor Sanitation standard operating proce-
shall have and implement a sanitation dure controls may be included in the
standard operating procedure (SSOP) HACCP plan required under § 120.8(b).
that addresses sanitation conditions However, to the extent that they are
and practices before, during, and after implemented in accordance with this
processing. The SSOP shall address: section, they need not be included in
the HACCP plan.
(1) Safety of the water that comes
into contact with food or food contact [66 FR 6197, Jan. 19, 2001, as amended at 80
surfaces or that is used in the manufac- FR 56167, Sept. 17, 2015]
ture of ice;
(2) Condition and cleanliness of food § 120.7 Hazard analysis.
contact surfaces, including utensils, (a) Each processor shall develop, or
gloves, and outer garments; have developed for it, a written hazard
(3) Prevention of cross contamination analysis to determine whether there
from insanitary objects to food, food are food hazards that are reasonably
packaging material, and other food likely to occur for each type of juice
contact surfaces, including utensils, processed by that processor and to
gloves, and outer garments, and from identify control measures that the
raw product to processed product; processor can apply to control those
(4) Maintenance of hand washing, hazards. The written hazard analysis
hand sanitizing, and toilet facilities; shall consist of at least the following:
(5) Protection of food, food packaging (1) Identification of food hazards;
material, and food contact surfaces (2) An evaluation of each food hazard
from adulteration with lubricants, fuel, identified to determine if the hazard is
pesticides, cleaning compounds, sani- reasonably likely to occur and thus,
tizing agents, condensate, and other constitutes a food hazard that must be
chemical, physical, and biological con- addressed in the HACCP plan. A food
taminants; hazard that is reasonably likely to
(6) Proper labeling, storage, and use occur is one for which a prudent proc-
of toxic compounds; essor would establish controls because
(7) Control of employee health condi- experience, illness data, scientific re-
tions that could result in the micro- ports, or other information provide a
biological contamination of food, food basis to conclude that there is a rea-
packaging materials, and food contact sonable possibility that, in the absence
surfaces; and of those controls, the food hazard will
(8) Exclusion of pests from the food occur in the particular type of product
plant. being processed. This evaluation shall
(b) Monitoring. The processor shall include an assessment of the severity
monitor the conditions and practices of the illness or injury if the food haz-
during processing with sufficient fre- ard occurs;
quency to ensure, at a minimum, con- (3) Identification of the control meas-
formance with those conditions and ures that the processor can apply to
practices specified in part 110 of this control the food hazards identified as
chapter and in subpart B of part 117 of reasonably likely to occur in paragraph
this chapter that are appropriate both (a)(2) of this section;
to the plant and to the food being proc- (4) Review of the current process to
essed. Each processor shall correct, in determine whether modifications are
a timely manner, those conditions and necessary; and
practices that are not met. (5) Identification of critical control
(c) Records. Each processor shall points.
maintain SSOP records that, at a min- (b) The hazard analysis shall include
imum, document the monitoring and food hazards that can be introduced
corrections prescribed by paragraph (b) both within and outside the processing
of this section. These records are sub- plant environment, including food haz-
ject to the recordkeeping requirements ards that can occur before, during, and
of § 120.12. after harvest. The hazard analysis shall
438
be developed by an individual or indi- types of juice products together, or

viduals who have been trained in ac- group types of production methods to-
cordance with § 120.13 and shall be sub- gether, if the food hazards, critical con-
ject to the recordkeeping requirements trol points, critical limits, and proce-
of § 120.12. dures required to be identified and per-
(c) In evaluating what food hazards formed by paragraph (b) of this section
are reasonably likely to occur, consid- are essentially identical, provided that
eration should be given, at a minimum, any required features of the plan that
to the following: are unique to a specific product or
(1) Microbiological contamination; method are clearly delineated in the
(2) Parasites; plan and are observed in practice.
(3) Chemical contamination; (b) The contents of the HACCP plan.
(4) Unlawful pesticides residues; The HACCP plan shall, at a minimum:
(5) Decomposition in food where a (1) List all food hazards that are rea-
food hazard has been associated with sonably likely to occur as identified in
decomposition; accordance with § 120.7, and that thus
(6) Natural toxins; must be controlled for each type of
(7) Unapproved use of food or color product;
additives; (2) List the critical control points for
(8) Presence of undeclared ingredi- each of the identified food hazards that
ents that may be allergens; and is reasonably likely to occur, including
(9) Physical hazards. as appropriate:
(d) Processors should evaluate prod-
(i) Critical control points designed to
uct ingredients, processing procedures,
control food hazards that are reason-
packaging, storage, and intended use;
ably likely to occur and could be intro-
facility and equipment function and
duced inside the processing plant envi-
design; and plant sanitation, including
ronment; and
employee hygiene, to determine the po-
(ii) Critical control points designed
tential effect of each on the safety of
to control food hazards introduced out-
the finished food for the intended con-
side the processing plant environment,
sumer.
including food hazards that occur be-
(e) HACCP plans for juice need not
fore, during, and after harvest;
address the food hazards associated
with microorganisms and microbial (3) List the critical limits that shall
toxins that are controlled by the re- be met at each of the critical control
quirements of part 113 or part 114 of points;
this chapter. A HACCP plan for such (4) List the procedures, and the fre-
juice shall address any other food haz- quency with which they are to be per-
ards that are reasonably likely to formed, that will be used to monitor
occur. each of the critical control points to
ensure compliance with the critical
§ 120.8 Hazard Analysis and Critical limits;
Control Point (HACCP) plan. (5) Include any corrective action
(a) HACCP plan. Each processor shall plans that have been developed in ac-
have and implement a written HACCP cordance with § 120.10(a), and that are
plan whenever a hazard analysis re- to be followed in response to deviations
veals one or more food hazards that are from critical limits at critical control
reasonably likely to occur during proc- points;
essing, as described in § 120.7. The (6) List the validation and
HACCP plan shall be developed by an verification procedures, and the fre-
individual or individuals who have quency with which they are to be per-
been trained in accordance with § 120.13 formed, that the processor will use in
and shall be subject to the record- accordance with § 120.11; and
keeping requirements of § 120.12. A (7) Provide for a recordkeeping sys-
HACCP plan shall be specific to: tem that documents the monitoring of
(1) Each location where juice is proc- the critical control points in accord-
essed by that processor; and ance with § 120.12. The records shall
(2) Each type of juice processed by contain the actual values and observa-
the processor. The plan may group tions obtained during monitoring.
439
§ 120.9 21 CFR Ch. I (4–1–23 Edition)
(c) Sanitation. Sanitation controls fected product for distribution. The re-
may be included in the HACCP plan. view shall be performed by an indi-
However, to the extent that they are vidual or individuals who have ade-
monitored in accordance with § 120.6, quate training or experience to perform
they are not required to be included in such review;
the HACCP plan. (3) Take corrective action, when nec-
essary, with respect to the affected
§ 120.9 Legal basis. product to ensure that no product en-
Failure of a processor to have and to ters commerce that is either injurious
implement a Hazard Analysis and Crit- to health or is otherwise adulterated as
ical Control Point (HACCP) system a result of the deviation;
that complies with §§ 120.6, 120.7, and (4) Take corrective action, when nec-
120.8, or otherwise to operate in accord- essary, to correct the cause of the devi-
ance with the requirements of this ation; and
part, shall render the juice products of (5) Perform or obtain timely
that processor adulterated under sec- verification in accordance with § 120.11,
tion 402(a)(4) of the Federal Food, by an individual or individuals who
Drug, and Cosmetic Act. Whether a have been trained in accordance with
processor’s actions are consistent with § 120.13, to determine whether modifica-
ensuring the safety of juice will be de- tion of the HACCP plan is required to
termined through an evaluation of the reduce the risk of recurrence of the de-
processor’s overall implementation of viation, and to modify the HACCP plan
its HACCP system. as necessary.
(c) All corrective actions taken in ac-
§ 120.10 Corrective actions. cordance with this section shall be
Whenever a deviation from a critical fully documented in records that are
limit occurs, a processor shall take subject to verification in accordance
corrective action by following the pro- with § 120.11(a)(1)(iv)(B) and the record-
cedures set forth in paragraph (a) or keeping requirements of § 120.12.
paragraph (b) of this section.
(a) Processors may develop written § 120.11 Verification and validation.
corrective action plans, which become (a) Verification. Each processor shall
part of their HACCP plans in accord- verify that the Hazard Analysis and
ance with § 120.8(b)(5), by which proc- Critical Control Point (HACCP) system
essors predetermine the corrective ac- is being implemented according to de-
tions that they will take whenever sign.
there is a deviation from a critical (1) Verification activities shall in-
limit. A corrective action plan that is clude:
appropriate for a particular deviation (i) A review of any consumer com-
is one that describes the steps to be plaints that have been received by the
taken and assigns responsibility for processor to determine whether such
taking those steps, to ensure that: complaints relate to the performance
(1) No product enters commerce that of the HACCP plan or reveal previously
is either injurious to health or is other- unidentified critical control points;
wise adulterated as a result of the devi- (ii) The calibration of process moni-
ation; and toring instruments;
(2) The cause of the deviation is cor- (iii) At the option of the processor,
rected. the performance of periodic end-prod-
(b) When a deviation from a critical uct or in-process testing; except that
limit occurs, and the processor does processors of citrus juice that rely in
not have a corrective action plan that whole or in part on surface treatment
is appropriate for that deviation, the of fruit shall perform end-product test-
processor shall: ing in accordance with § 120.25.
(1) Segregate and hold the affected (iv) A review, including signing and
product, at least until the require- dating, by an individual who has been
ments of paragraphs (b)(2) and (b)(3) of trained in accordance with § 120.13, of
this section are met; the records that document:

(2) Perform or obtain a review to de- (A) The monitoring of critical con-
termine the acceptability of the af- trol points. The purpose of this review
440
shall be, at a minimum, to ensure that product distribution systems; or the in-
the records are complete and to verify tended use or consumers of the finished
that the records document values that product. The validation shall be per-
are within the critical limits. This re- formed by an individual or individuals
view shall occur within 1 week (7 days) who have been trained in accordance
of the day that the records are made; with § 120.13 and shall be subject to the
(B) The taking of corrective actions. recordkeeping requirements of § 120.12.
The purpose of this review shall be, at The HACCP plan shall be modified im-
a minimum, to ensure that the records mediately whenever a validation re-
are complete and to verify that appro- veals that the plan is no longer ade-
priate corrective actions were taken in quate to fully meet the requirements of
accordance with § 120.10. This review this part.
shall occur within 1 week (7 days) of (c) Validation of the hazard analysis.
the day that the records are made; and Whenever a juice processor has no
(C) The calibrating of any process HACCP plan because a hazard analysis
monitoring instruments used at crit- has revealed no food hazards that are
ical control points and the performance reasonably likely to occur, the proc-
of any periodic end-product or in-processor shall reassess the adequacy of
ess testing that is part of the proc- that hazard analysis whenever there
essor’s verification activities. The pur- are any changes in the process that
pose of these reviews shall be, at a min- could reasonably affect whether a food
imum, to ensure that the records are hazard exists. Such changes may in-
complete and that these activities oc- clude changes in the following: Raw
curred in accordance with the proc- materials or source of raw materials;
essor’s written procedures. These re- product formulation; processing meth-
views shall occur within a reasonable ods or systems, including computers
time after the records are made; and and their software; packaging; finished
(v) The following of procedures in product distribution systems; or the in-
§ 120.10 whenever any verification pro- tended use or intended consumers of
cedure, including the review of con- the finished product. The validation of
sumer complaints, establishes the need the hazard analysis shall be performed
to take a corrective action; and by an individual or individuals who
(vi) Additional process verification if have been trained in accordance with
required by § 120.25. § 120.13, and, records documenting the
(2) Records that document the cali- validation shall be subject to the rec-
bration of process monitoring instru- ordkeeping requirements of § 120.12.
ments, in accordance with paragraph
(a)(1)(iv)(B) of this section, and the per- § 120.12 Records.
formance of any periodic end-product (a) Required records. Each processor
and in-process testing, in accordance shall maintain the following records
with paragraph (a)(1)(iv)(C) of this sec- documenting the processor’s Hazard
tion, are subject to the recordkeeping Analysis and Critical Control Point
requirements of § 120.12. (HACCP) system:
(b) Validation of the HACCP plan. (1) Records documenting the imple-
Each processor shall validate that the mentation of the sanitation standard
HACCP plan is adequate to control operating procedures (SSOP’s) (see
food hazards that are reasonably likely § 120.6);
to occur; this validation shall occur at (2) The written hazard analysis re-
least once within 12 months after im- quired by § 120.7;
plementation and at least annually (3) The written HACCP plan required
thereafter or whenever any changes in by § 120.8;
the process occur that could affect the (4) Records documenting the ongoing
hazard analysis or alter the HACCP application of the HACCP plan that in-
plan in any way. Such changes may include:
clude changes in the following: Raw (i) Monitoring of critical control
materials or source of raw materials; points and their critical limits, includ-
product formulation; processing meth- ing the recording of actual times, tem-
ods or systems, including computers peratures, or other measurements, as
and their software; packaging; finished prescribed in the HACCP plan; and
441
§ 120.13 21 CFR Ch. I (4–1–23 Edition)
(ii) Corrective actions, including all the monitoring occurred, if such

actions taken in response to a devi- records can be retrieved and provided
ation; and onsite within 24 hours of request for of-
(5) Records documenting verification ficial review. Electronic records are
of the HACCP system and validation of considered to be onsite if they are ac-
the HACCP plan or hazard analysis, as cessible from an onsite location and
appropriate. comply with paragraph (g) of this sec-
(b) General requirements. All records tion.
required by this part shall include: (3) If the processing facility is closed
(1) The name of the processor or im- for a prolonged period between sea-
porter and the location of the processor sonal packs, the records may be trans-
or importer, if the processor or im- ferred to some other reasonably acces-
porter has more than one location; sible location at the end of the sea-
(2) The date and time of the activity sonal pack but shall be immediately
that the record reflects, except that returned to the processing facility for
records required by paragraphs (a)(2), official review upon request.
(a)(3), and (a)(5) of this section need not (e) Official review. All records re-
include the time; quired by this part shall be available
(3) The signature or initials of the for review and copying at reasonable
person performing the operation or cre- times.
ating the record; and (f) Public disclosure. (1) All records re-
(4) Where appropriate, the identity of quired by this part are not available
the product and the production code, if for public disclosure unless they have
any. Processing and other information been previously disclosed to the public,
shall be entered on records at the time as defined in § 20.81 of this chapter, or
that it is observed. The records shall unless they relate to a product or in-
contain the actual values and observa- gredient that has been abandoned and
tions obtained during monitoring. no longer represent a trade secret or
(c) Documentation. (1) The records in confidential commercial or financial
paragraphs (a)(2) and (a)(3) of this sec- information as defined in § 20.61 of this
tion shall be signed and dated by the chapter.
most responsible individual onsite at (2) Records required to be maintained
the processing facility or by a higher by this part are subject to disclosure to
level official of the processor. These the extent that they are otherwise pub-
signatures shall signify that these licly available, or that disclosure could
records have been accepted by the firm. not reasonably be expected to cause a
(2) The records in paragraphs (a)(2) competitive hardship, such as generic
and (a)(3) of this section shall be signed type HACCP plans that reflect stand-
and dated: ard industry practices.
(i) Upon initial acceptance; (g) Records maintained on computers.
(ii) Upon any modification; and The maintenance of computerized
(iii) Upon verification and validation records, in accordance with part 11 of
in accordance with § 120.11. this chapter, is acceptable.
(d) Record retention. (1) All records re-
quired by this part shall be retained at § 120.13 Training.
the processing facility or at the im- (a) Only an individual who has met
porter’s place of business in the United the requirements of paragraph (b) of
States for, in the case of perishable or this section shall be responsible for the
refrigerated juices, at least 1 year after following functions:
the date that such products were pre- (1) Developing the hazard analysis,
pared, and for, in the case of frozen, including delineating control meas-
preserved, or shelf stable products, 2 ures, as required by § 120.7.
years or the shelf life of the product, (2) Developing a Hazard Analysis and
whichever is greater, after the date Critical Control Point (HACCP) plan
that the products were prepared. that is appropriate for a specific proc-
(2) Offsite storage of processing essor, in order to meet the require-
records required by paragraphs (a)(1) ments of § 120.8;

and (a)(4) of this section is permitted (3) Verifying and modifying the
after 6 months following the date that HACCP plan in accordance with the
442
corrective action procedures specified were processed under controls that

in § 120.10(b)(5) and the validation ac- meet the requirements of this part.
tivities specified in §§ 120.11(b) and (c); These steps may include any of the fol-
and 120.7; lowing:
(4) Performing the record review re- (A) Obtaining from the foreign proc-
quired by § 120.11(a)(1)(iv). essor the Hazard Analysis and Critical
(b) The individual performing the Control Point (HACCP) plan and pre-
functions listed in paragraph (a) of this requisite program of the standard oper-
section shall have successfully com- ating procedure records required by
pleted training in the application of this part that relate to the specific lot
HACCP principles to juice processing of food being offered for import;
at least equivalent to that received (B) Obtaining either a continuing or
under standardized curriculum recog- lot specific certificate from an appro-
nized as adequate by the Food and priate foreign government inspection
Drug Administration, or shall be other- authority or competent third party
wise qualified through job experience certifying that the imported food has
to perform these functions. Job experi- been processed in accordance with the
ence may qualify an individual to per- requirements of this part;
form these functions if such experience (C) Regularly inspecting the foreign
has provided knowledge at least equiv- processor’s facilities to ensure that the
alent to that provided through the imported food is being processed in ac-
standardized curriculum. The trained cordance with the requirements of this
individual need not be an employee of part;
the processor. (D) Maintaining on file a copy, in
English, of the foreign processor’s haz-
§ 120.14 Application of requirements to ard analysis and HACCP plan, and a
imported products. written guarantee from the foreign
This section sets forth specific re- processor that the imported food is
quirements for imported juice. processed in accordance with the re-
(a) Importer requirements. Every im- quirements of this part;
porter of juice shall either: (E) Periodically testing the imported
(1) Obtain the juice from a country food, and maintaining on file a copy, in
that has an active memorandum of un- English, of a written guarantee from
derstanding (MOU) or similar agree- the foreign processor that the imported
ment with the Food and Drug Adminis- food is processed in accordance with
tration, that covers the food and docu- the requirements of this part; or
ments the equivalency or compliance (F) Other such verification measures
of the inspection system of the foreign as appropriate that provide an equiva-
country with the U.S. system, accu- lent level of assurance of compliance
rately reflects the relationship be- with the requirements of this part.
tween the signing parties, and is func- (b) Competent third party. An importer
tioning and enforceable in its entirety; may hire a competent third party to
or assist with or perform any or all of the
(2) Have and implement written pro- verification activities specified in para-
cedures for ensuring that the juice that graph (a)(2) of this section, including
such importer receives for import into writing the importer’s verification pro-
the United States was processed in ac- cedures on the importer’s behalf.
cordance with the requirements of this (c) Records. The importer shall main-
part. The procedures shall provide, at a tain records, in English, that document
minimum: the performance and results of the af-
(i) Product specifications that are de- firmative steps specified in paragraph
signed to ensure that the juice is not (a)(2)(ii) of this section. These records
adulterated under section 402 of the shall be subject to the applicable provi-
Federal Food, Drug, and Cosmetic Act sions of § 120.12.
because it may be injurious to health (d) Determination of compliance. The
or because it may have been processed importer shall provide evidence that
under insanitary conditions; and all juice offered for entry into the
(ii) Affirmative steps to ensure that United States has been processed under
the products being offered for entry conditions that comply with this part.
443
§ 120.20 21 CFR Ch. I (4–1–23 Edition)
If assurances do not exist that an im- of this section and perform final prod-
ported juice has been processed under uct packaging within a single produc-
conditions that are equivalent to those tion facility operating under current
required of domestic processors under good manufacturing practices. Proc-
this part, the product will appear to be essors claiming an exemption under
adulterated and will be denied entry. paragraph (a)(1) or (a)(2) of this section
shall also process and perform final
Subpart B—Pathogen Reduction product packaging of all juice subject
to the claimed exemption within a sin-
§ 120.20 General. gle production facility operating under
This subpart augments subpart A of current good manufacturing practices.
this part by setting forth specific re-
quirements for process controls. § 120.25 Process verification for cer-
tain processors.
§ 120.24 Process controls. Each juice processor that relies on
(a) In order to meet the requirements treatments that do not come into di-
of subpart A of this part, processors of rect contact with all parts of the juice
juice products shall include in their to achieve the requirements of § 120.24
Hazard Analysis and Critical Control shall analyze the finished product for
Point (HACCP) plans control measures biotype I Escherichia coli as follows:
that will consistently produce, at a (a) One 20 milliliter (mL) sample
minimum, a 5 log (i.e., 105) reduction, (consisting of two 10 mL subsamples)
for a period at least as long as the shelf for each 1,000 gallons of juice produced
life of the product when stored under shall be sampled each production day.
normal and moderate abuse conditions, If less than 1,000 gallons of juice is pro-
in the pertinent microorganism. For duced per day, the sample must be
the purposes of this regulation, the taken for each 1,000 gallons produced
‘‘pertinent microorganism’’ is the most but not less than once every 5 working
resistant microorganism of public days that the facility is producing that
health significance that is likely to juice. Each subsample shall be taken
occur in the juice. The following juice
by randomly selecting a package of
processors are exempt from this para-
juice ready for distribution to con-
graph:
sumers.
(1) A juice processor that is subject
to the requirements of part 113 or part (b) If the facility is producing more
114 of this chapter; and than one type of juice covered by this
(2) A juice processor using a single section, processors shall take subsam-
thermal processing step sufficient to ples according to paragraph (a) of this
achieve shelf-stability of the juice or a section for each of the covered juice
thermal concentration process that in- products produced.
cludes thermal treatment of all ingre- (c) Processors shall analyze each sub-
dients, provided that the processor in- sample for the presence of E. coli by the
cludes a copy of the thermal process method entitled ‘‘Analysis for Esch-
used to achieve shelf-stability or con- erichia coli in Citrus Juices—Modifica-
centration in its written hazard anal- tion of AOAC Official Method 992.30’’ or
ysis required by § 120.7. another method that is at least equiva-
(b) All juice processors shall meet lent to this method in terms of accu-
the requirements of paragraph (a) of racy, precision, and sensitivity in de-
this section through treatments that tecting E. coli. This method is designed
are applied directly to the juice, except to detect the presence or absence of E.
that citrus juice processors may use coli in a 20 mL sample of juice (con-
treatments to fruit surfaces, provided sisting of two 10 mL subsamples). The
that the 5-log reduction process begins method is as follows:
after culling and cleaning as defined in (1) Sample size. Total-20 mL of juice;
§ 120.3(a) and (f) and the reduction is ac- perform analysis using two 10 mL
complished within a single production aliquots.
facility. (2) Media. Universal Preenrichment

(c) All juice processors shall meet the Broth (Difco, Detroit, MI), EC Broth
requirements of paragraphs (a) and (b) (various manufacturers).
444
(3) Method. ColiComplete (AOAC Offi- sive to determine that there are no
cial Method 992.30—modified). trends towards loss of control;
(4) Procedure. Perform the following (i) If the conditions and practices are
procedure two times: not being met, correct those that do
(i) Aseptically inoculate 10 mL of not conform to the HACCP plan; or
juice into 90 mL of Universal (ii) If the conditions and practices
Preenrichment Broth (Difco) and incu- are being met, the processor shall vali-
bate at 35 °C for 18 to 24 hours. date the HACCP plan in relation to the
(ii) Next day, transfer 1 mL of 5-log reduction standard; and
preenriched sample into 10 mL of EC (3) Take corrective action as set
Broth, without durham gas vials. After forth in § 120.10. Corrective actions
inoculation, aseptically add a shall include ensuring no product en-
ColiComplete SSD disc into each tube. ters commerce that is injurious to
(iii) Incubate at 44.5 °C for 18 to 24 health as set forth in § 120.10(a)(1).
hours.
(iv) Examine the tubes under PART 121—MITIGATION STRATEGIES
longwave ultra violet light (366 nm). TO PROTECT FOOD AGAINST IN-
Fluorescent tubes indicate presence of
E. coli.
TENTIONAL ADULTERATION
(v) MUG positive and negative con-
trols should be used as reference in in-
terpreting fluorescence reactions. Use Sec.
an E. coli for positive control and 2 neg- 121.1 Applicability.
ative controls—a MUG negative strain 121.3 Definitions.
and an uninoculated tube media. 121.4 Qualifications of individuals who per-
(d) If either 10 mL subsample is posi- form activities under subpart C of this
part.
tive for E. coli, the 20 mL sample is re- 121.5 Exemptions.
corded as positive and the processor
shall: Subpart B [Reserved]
(1) Review monitoring records for the
control measures to attain the 5-log re- Subpart C—Food Defense Measures
duction standard and correct those
121.126 Food defense plan.
conditions and practices that are not
121.130 Vulnerability assessment to identify
met. In addition, the processor may significant vulnerabilities and actionable
choose to test the sample for the pres- process steps.
ence of pathogens of concern. 121.135 Mitigation strategies for actionable
(2) If the review of monitoring process steps.
records or the additional testing indi- 121.138 Mitigation strategies management
cates that the 5-log reduction standard components.
was not achieved (e.g., a sample is 121.140 Food defense monitoring.
121.145 Food defense corrective actions.
found to be positive for the presence of
121.150 Food defense verification.
a pathogen or a deviation in the proc- 121.157 Reanalysis.
ess or its delivery is identified), the
processor shall take corrective action Subpart D—Requirements Applying to
as set forth in § 120.10. Records That Must Be Established and
(e) If two samples in a series of seven Maintained
tests are positive for E. coli, the control
measures to attain the 5-log reduction 121.301 Records subject to the requirements
of this subpart.
standard shall be deemed to be inad-
121.305 General requirements applying to
equate and the processor shall imme- records.
diately: 121.310 Additional requirements applying to
(1) Until corrective actions are com- the food defense plan.
pleted, use an alternative process or 121.315 Requirements for record retention.
processes that achieve the 5-log reduc- 121.320 Requirements for official review.
tion after the juice has been expressed; 121.325 Public disclosure.
(2) Perform a review of the moni- 121.330 Use of existing records.
toring records for control measures to

Subpart E—Compliance
attain the 5-log reduction standard.
The review shall be sufficiently exten- 121.401 Compliance.
445
§ 121.1 21 CFR Ch. I (4–1–23 Edition)
AUTHORITY: 21 U.S.C. 331, 342, 350g, 350(i), Cosmetic Act and includes raw mate-
371, 374. rials and ingredients.
SOURCE: 81 FR 34219, May 27, 2016, unless Food defense means, for purposes of
otherwise noted. this part, the effort to protect food
from intentional acts of adulteration
Subpart A—General Provisions where there is an intent to cause wide
scale public health harm.
§ 121.1 Applicability. Food defense monitoring means to con-
This part applies to the owner, oper- duct a planned sequence of observa-
ator or agent in charge of a domestic tions or measurements to assess
or foreign food facility that manufac- whether mitigation strategies are oper-
tures/processes, packs, or holds food for ating as intended.
consumption in the United States and Food defense verification means the
is required to register under section 415 application of methods, procedures,
of the Federal Food, Drug, and Cos- and other evaluations, in addition to
metic Act, unless one of the exemp- food defense monitoring, to determine
tions in § 121.5 applies. whether a mitigation strategy or com-
bination of mitigation strategies is or
§ 121.3 Definitions. has been operating as intended accord-
The definitions and interpretations ing to the food defense plan.
of terms in section 201 of the Federal Full-time equivalent employee is a term
Food, Drug, and Cosmetic Act are ap- used to represent the number of em-
plicable to such terms when used in ployees of a business entity for the pur-
this part. The following definitions pose of determining whether the busi-
also apply: ness qualifies as a small business. The
Actionable process step means a point, number of full-time equivalent employ-
step, or procedure in a food process ees is determined by dividing the total
where a significant vulnerability exists number of hours of salary or wages
and at which mitigation strategies can paid directly to employees of the busi-
be applied and are essential to signifi- ness entity and of all of its affiliates
cantly minimize or prevent the signifi- and subsidiaries by the number of
cant vulnerability. hours of work in 1 year, 2,080 hours
Adequate means that which is needed (i.e., 40 hours × 52 weeks). If the result
to accomplish the intended purpose in is not a whole number, round down to
keeping with good public health prac- the next lowest whole number.
tices. Holding means storage of food and
Affiliate means any facility that con- also includes activities performed inci-
trols, is controlled by, or is under com- dental to storage of food (e.g., activi-
mon control with another facility. ties performed for the safe or effective
Calendar day means every day as storage of that food, such as fumigat-
shown on the calendar. ing food during storage, and drying/de-
Contaminant means, for purposes of hydrating raw agricultural commod-
this part, any biological, chemical, ities when the drying/dehydrating does
physical, or radiological agent that not create a distinct commodity (such
may be added to food to intentionally as drying/dehydrating hay or alfalfa)).
cause illness, injury, or death. Holding also includes activities per-
Facility means a domestic facility or formed as a practical necessity for the
a foreign facility that is required to distribution of that food (such as
register under section 415 of the Fed- blending of the same raw agricultural
eral Food, Drug, and Cosmetic Act, in commodity and breaking down pallets),
accordance with the requirements of but does not include activities that
part 1, subpart H of this chapter. transform a raw agricultural com-
Farm means farm as defined in § 1.227 modity into a processed food as defined
of this chapter. in section 201(gg) of the Federal Food,
FDA means the Food and Drug Ad- Drug, and Cosmetic Act. Holding facili-
ministration. ties could include warehouses, cold

Food means food as defined in section storage facilities, storage silos, grain
201(f) of the Federal Food, Drug, and elevators, and liquid storage tanks.
446
Manufacturing/processing means mak- of the Federal Food, Drug, and Cos-

ing food from one or more ingredients, metic Act.
or synthesizing, preparing, treating, Qualified individual means a person
modifying or manipulating food, in- who has the education, training, or ex-
cluding food crops or ingredients. Ex- perience (or a combination thereof)
amples of manufacturing/processing ac- necessary to perform an activity re-
tivities include: Baking, boiling, bot- quired under subpart C of this part, as
tling, canning, cooking, cooling, cut- appropriate to the individual’s assigned
ting, distilling, drying/dehydrating raw duties. A qualified individual may be,
agricultural commodities to create a but is not required to be, an employee
distinct commodity (such as drying/de-
of the establishment.
hydrating grapes to produce raisins),
evaporating, eviscerating, extracting Significant vulnerability means a vul-
juice, formulating, freezing, grinding, nerability that, if exploited, could rea-
homogenizing, irradiating, labeling, sonably be expected to cause wide scale
milling, mixing, packaging (including public health harm. A significant vul-
modified atmosphere packaging), pas- nerability is identified by a vulner-
teurizing, peeling, rendering, treating ability assessment conducted by a
to manipulate ripening, trimming, qualified individual, that includes con-
washing, or waxing. For farms and sideration of the following: (1) Poten-
farm mixed-type facilities, manufac- tial public health impact (e.g., severity
turing/processing does not include ac- and scale) if a contaminant were added,
tivities that are part of harvesting, (2) degree of physical access to the
packing, or holding. product, and (3) ability of an attacker
Mitigation strategies mean those risk- to successfully contaminate the prod-
based, reasonably appropriate meas- uct. The assessment must consider the
ures that a person knowledgeable possibility of an inside attacker.
about food defense would employ to Significantly minimize means to reduce
significantly minimize or prevent sig- to an acceptable level, including to
nificant vulnerabilities identified at eliminate.
actionable process steps, and that are
Small business means, for purposes of
consistent with the current scientific
this part, a business (including any
understanding of food defense at the
time of the analysis. subsidiaries and affiliates) employing
Mixed-type facility means an estab- fewer than 500 full-time equivalent em-
lishment that engages in both activi- ployees.
ties that are exempt from registration Subsidiary means any company which
under section 415 of the Federal Food, is owned or controlled directly or indi-
Drug, and Cosmetic Act and activities rectly by another company.
that require the establishment to be Very small business means, for pur-
registered. An example of such a facil- poses of this part, a business (including
ity is a ‘‘farm mixed-type facility,’’ any subsidiaries and affiliates) aver-
which is an establishment that is a aging less than $10,000,000, adjusted for
farm, but also conducts activities out- inflation, per year, during the 3-year
side the farm definition that require period preceding the applicable cal-
the establishment to be registered. endar year in sales of human food plus
Packing means placing food into a the market value of human food manu-
container other than packaging the factured, processed, packed, or held
food and also includes re-packing and without sale (e.g., held for a fee).
activities performed incidental to Vulnerability means the susceptibility
packing or re-packing a food (e.g., ac- of a point, step, or procedure in a fa-
tivities performed for the safe or effec-
cility’s food process to intentional
tive packing or re-packing of that food
adulteration.
(such as sorting, culling, grading, and
weighing or conveying incidental to You means, for purposes of this part,
packing or re-packing)), but does not the owner, operator, or agent in charge
of a facility.
include activities that transform a raw

agricultural commodity into a proc-
essed food as defined in section 201(gg)
447
§ 121.4 21 CFR Ch. I (4–1–23 Edition)
§ 121.4 Qualifications of individuals (iv) Reanalysis as required in

who perform activities under sub- § 121.157.
part C of this part. (d) Additional qualifications of super-
(a) Applicability. You must ensure visory personnel. Responsibility for en-
that each individual who performs ac- suring compliance by individuals with
tivities required under subpart C of the requirements of this part must be
this part is a qualified individual as clearly assigned to supervisory per-
that term is defined in § 121.3. sonnel with a combination of edu-
(b) Qualifications of individuals as- cation, training, and experience nec-
signed to an actionable process step. Each essary to supervise the activities under
individual assigned to an actionable this subpart.
process step (including temporary and (e) Records. Training required by
seasonal personnel) or in the super- paragraphs (b)(2) and (c)(2) of this sec-
vision thereof must: tion must be documented in records,
(1) Be a qualified individual as that and must:
term is defined in § 121.3—i.e., have the (1) Include the date of training, the
appropriate education, training, or ex- type of training, and the persons
perience (or a combination thereof) trained; and
necessary to properly implement the
(2) Be established and maintained in
mitigation strategy or combination of
mitigation strategies at the actionable
subpart D of this part.
process step; and
(2) Receive training in food defense
§ 121.5 Exemptions.
awareness.
(c) Qualifications of individuals for cer- (a) This part does not apply to a very
tain activities described in paragraph small business, except that a very
(c)(3) of this section. Each individual as- small business must, upon request, pro-
signed to certain activities described in vide for official review documentation
paragraph (c)(3) of this section must: sufficient to show that the facility
(1) Be a qualified individual as that meets this exemption. Such docu-
term is defined in § 121.3—i.e., have the mentation must be retained for 2 years.
appropriate education, training, or ex- (b) This part does not apply to the
perience (or a combination thereof) holding of food, except the holding of
necessary to properly perform the ac- food in liquid storage tanks.
tivities; and (c) This part does not apply to the
(2) Have successfully completed packing, re-packing, labeling, or re-la-
training for the specific function at beling of food where the container that
least equivalent to that received under directly contacts the food remains in-
a standardized curriculum recognized tact.
as adequate by FDA or be otherwise
(d) This part does not apply to activi-
qualified through job experience to
ties of a farm that are subject to sec-
conduct the activities. Job experience
tion 419 of the Federal Food, Drug, and
may qualify an individual to perform
Cosmetic Act (Standards for Produce
these functions if such experience has
Safety).
provided an individual with knowledge
at least equivalent to that provided (e)(1) This part does not apply with
through the standardized curriculum. respect to alcoholic beverages at a fa-
This individual may be, but is not re- cility that meets the following two
quired to be, an employee of the facil- conditions:
ity. (i) Under the Federal Alcohol Admin-
(3) One or more qualified individuals istration Act (27 U.S.C. 201 et seq.) or
must do or oversee: chapter 51 of subtitle E of the Internal
(i) The preparation of the food de- Revenue Code of 1986 (26 U.S.C. 5001 et
fense plan as required in § 121.126; seq.) the facility is required to obtain a
(ii) The conduct of a vulnerability as- permit from, register with, or obtain
sessment as required in § 121.130; approval of a notice or application
(iii) The identification and expla- from the Secretary of the Treasury as
nation of the mitigation strategies as a condition of doing business in the
required in § 121.135; and United States, or is a foreign facility of
448
a type that would require such a per- (2) The written mitigation strategies,
mit, registration, or approval if it were including required explanations, as re-
a domestic facility; and quired by § 121.135(b);
(ii) Under section 415 of the Federal (3) The written procedures for the
Food, Drug, and Cosmetic Act the fa- food defense monitoring of the imple-
cility is required to register as a facil- mentation of the mitigation strategies
ity because it is engaged in manufac- as required by § 121.140(a);
turing, processing, packing, or holding (4) The written procedures for food
one or more alcoholic beverages. defense corrective actions as required
(2) This part does not apply with re- by § 121.145(a)(1); and
spect to food that is not an alcoholic (5) The written procedures for food
beverage at a facility described in defense verification as required by
paragraph (e)(1) of this section, pro- § 121.150(b).
vided such food:
(c) Records. The food defense plan re-
(i) Is in prepackaged form that pre-
quired by this section is a record that
vents any direct human contact with
such food; and is subject to the requirements of sub-
part D of this part.
(ii) Constitutes not more than 5 per-
cent of the overall sales of the facility, § 121.130 Vulnerability assessment to
as determined by the Secretary of the identify significant vulnerabilities
Treasury. and actionable process steps.
(f) This part does not apply to the
manufacturing, processing, packing, or (a) Requirement for a vulnerability as-
holding of food for animals other than sessment. You must conduct or have
man. conducted a vulnerability assessment
(g) This part does not apply to on- for each type of food manufactured,
farm manufacturing, processing, pack- processed, packed, or held at your fa-
ing, or holding of the following foods cility using appropriate methods to
on a farm mixed-type facility, when evaluate each point, step, or procedure
conducted by a small or very small in your food operation to identify sig-
business if such activities are the only nificant vulnerabilities and actionable
activities conducted by the business process steps. Appropriate methods
subject to section 418 of the Federal must include, at a minimum, an eval-
Food, Drug, and Cosmetic Act. uation of:
(1) Eggs (in-shell, other than raw ag- (1) The potential public health im-
ricultural commodities, e.g., pasteur- pact (e.g., severity and scale) if a con-
ized); and taminant were added;
(2) Game meats (whole or cut, not (2) The degree of physical access to
ground or shredded, without secondary the product; and
ingredients). (3) The ability of an attacker to suc-
cessfully contaminate the product.
Subpart B—Reserved (b) Inside attacker. The assessment
must consider the possibility of an in-
Subpart C—Food Defense side attacker.
Measures (c) Written vulnerability assessment.
Regardless of the outcome, the vulner-
§ 121.126 Food defense plan. ability assessment must be written and
(a) Requirement for a food defense plan. must include an explanation as to why
You must prepare, or have prepared, each point, step, or procedure either
and implement a written food defense was or was not identified as an action-
plan. able process step.
(b) Contents of a food defense plan. The
written food defense plan must include: § 121.135 Mitigation strategies for ac-
tionable process steps.
(1) The written vulnerability assess-
ment, including required explanations, (a) You must identify and implement
to identify significant vulnerabilities mitigation strategies at each action-

and actionable process steps as re- able process step to provide assurances
quired by § 121.130(c); that the significant vulnerability at
449
§ 121.138 21 CFR Ch. I (4–1–23 Edition)
each step will be significantly mini- mitigation strategy is functioning as

mized or prevented and the food manu- intended. Exception records dem-
factured, processed, packed, or held by onstrating the mitigation strategy is
your facility will not be adulterated not functioning as intended may be
under section 402 of the Federal Food, adequate in some circumstances.
Drug, and Cosmetic Act. For each miti-
gation strategy implemented at each § 121.145 Food defense corrective ac-
actionable process step, you must in- tions.
clude a written explanation of how the (a) Food defense corrective action proce-
mitigation strategy sufficiently mini- dures. As appropriate to the nature of
mizes or prevents the significant vul- the actionable process step and the na-
nerability associated with the action- ture of the mitigation strategy:
able process step. (1) You must establish and imple-
(b) Mitigation strategies and accom- ment written food defense corrective
panying explanations must be written. action procedures that must be taken
if mitigation strategies are not prop-
§ 121.138 Mitigation strategies man-
agement components. erly implemented.
(2) The food defense corrective action
Mitigation strategies required procedures must describe the steps to
under§ 121.135 are subject to the fol- be taken to ensure that:
lowing mitigation strategies manage- (i) Appropriate action is taken to
ment components as appropriate to en- identify and correct a problem that has
sure the proper implementation of the occurred with implementation of a
mitigation strategies, taking into ac- mitigation strategy; and
count the nature of each such mitiga-
(ii) Appropriate action is taken, when
tion strategy and its role in the facili-
necessary, to reduce the likelihood
ty’s food defense system:
that the problem will recur.
(a) Food defense monitoring in ac-
cordance with § 121.140; (b) Records. All food defense correc-
(b) Food defense corrective actions in tive actions taken in accordance with
accordance with § 121.145; and this section must be documented in
(c) Food defense verification in ac- records that are subject to food defense
cordance with § 121.150. verification in accordance with
§ 121.150(a)(2) and records review in ac-
§ 121.140 Food defense monitoring. cordance with § 121.150(a)(3)(i).
As appropriate to the nature of the § 121.150 Food defense verification.
mitigation strategy and its role in the
facility’s food defense system: (a) Food defense verification activities.
(a) Written procedures. You must es- Food defense verification activities
tablish and implement written proce- must include, as appropriate to the na-
dures, including the frequency with ture of the mitigation strategy and its
which they are to be performed, for role in the facility’s food defense sys-
food defense monitoring of the mitiga- tem:
tion strategies. (1) Verification that food defense
(b) Food defense monitoring. You must monitoring is being conducted as re-
monitor the mitigation strategies with quired by § 121.138 (and in accordance
adequate frequency to provide assur- with § 121.140);
ances that they are consistently per- (2) Verification that appropriate de-
formed. cisions about food defense corrective
(c) Records—(1) Requirement to docu- actions are being made as required by
ment food defense monitoring. You must § 121.138 (and in accordance with
document the monitoring of mitigation § 121.145);
strategies in accordance with this sec- (3) Verification that mitigation
tion in records that are subject to strategies are properly implemented
verification in accordance with and are significantly minimizing or
§ 121.150(a)(1) and records review in ac- preventing the significant
cordance with § 121.150(a)(3)(i). vulnerabilities. To do so, you must

(2) Exception records. Records may be conduct activities that include the fol-
affirmative records demonstrating the lowing, as appropriate to the facility,
450
the food, and the nature of the mitiga- biological, chemical, radiological, or
tion strategy and its role in the facili- other terrorism risk assessment.
ty’s food defense system: (c) You must complete such reanaly-
(i) Review of the food defense moni- sis required by paragraphs (a) and (b) of
toring and food defense corrective ac- this section and implement any addi-
tions records within appropriate time- tional mitigation strategies needed to
frames to ensure that the records are address the significant vulnerabilities
complete, the activities reflected in identified, if any:
the records occurred in accordance (1) Before any change in activities
with the food defense plan, the mitiga- (including any change in mitigation
tion strategies are properly imple- strategy) at the facility is operative;
mented, and appropriate decisions were (2) When necessary within 90-cal-
made about food defense corrective ac- endar days after production; and
tions; and (3) Within a reasonable timeframe,
(ii) Other activities appropriate for providing a written justification is pre-
verification of proper implementation pared for a timeframe that exceeds 90
of mitigation strategies; and days after production of the applicable
(4) Verification of reanalysis in ac- food first begins.
cordance with § 121.157. (d) You must revise the written food
(b) Written procedures. You must es- defense plan if a significant change in
tablish and implement written proce- the activities conducted at your facil-
dures, including the frequency for ity creates a reasonable potential for a
which they are to be performed, for new vulnerability or a significant in-
verification activities conducted ac- crease in a previously identified vul-
cording to § 121.150(a)(3)(ii). nerability or document the basis for
(c) Documentation. All verification ac- the conclusion that no revisions are
tivities conducted in accordance with needed.
this section must be documented in
records.
Subpart D—Requirements Apply-
§ 121.157 Reanalysis. ing to Records That Must Be
(a) You must conduct a reanalysis of Established and Maintained
the food defense plan, as a whole at § 121.301 Records subject to the re-
least once every 3 years; quirements of this subpart.
(b) You must conduct a reanalysis of
the food defense plan as a whole, or the (a) Except as provided by paragraph
applicable portion of the food defense (b) of this section, all records required
plan: by subpart C of this part are subject to
(1) Whenever a significant change all requirements of this subpart.
made in the activities conducted at (b) The requirements of § 121.310 apply
your facility creates a reasonable po- only to the written food defense plan.
tential for a new vulnerability or a sig-
§ 121.305 General requirements apply-
nificant increase in a previously identi- ing to records.
fied vulnerability;
(2) Whenever you become aware of Records must:
new information about potential (a) Be kept as original records, true
vulnerabilities associated with the food copies (such as photocopies, pictures,
operation or facility; scanned copies, microfilm, microfiche,
(3) Whenever you find that a mitiga- or other accurate reproductions of the
tion strategy, a combination of mitiga- original records), or electronic records;
tion strategies, or the food defense plan (b) Contain the actual values and ob-
as a whole is not properly imple- servations obtained during food defense
mented; and monitoring;
(4) Whenever FDA requires reanalysis (c) Be accurate, indelible, and legible;
to respond to new vulnerabilities, cred- (d) Be created concurrently with per-
ible threats to the food supply, and de- formance of the activity documented;
velopments in scientific understanding (e) Be as detailed as necessary to pro-

including, as appropriate, results from vide history of work performed; and
the Department of Homeland Security (f) Include:
451
§ 121.310 21 CFR Ch. I (4–1–23 Edition)
(1) Information adequate to identify returned to the facility within 24 hours

the facility (e.g., the name, and when for official review upon request.
necessary, the location of the facility);
(2) The date and, when appropriate, § 121.320 Requirements for official re-
the time of the activity documented; view.
(3) The signature or initials of the All records required by this part
person performing the activity; and must be made promptly available to a
(4) Where appropriate, the identity of duly authorized representative of the
the product and the lot code, if any. Secretary of Health and Human Serv-
(g) Records that are established or ices for official review and copying
maintained to satisfy the requirements upon oral or written request.
of this part and that meet the defini-
tion of electronic records in § 11.3(b)(6) § 121.325 Public disclosure.
of this chapter are exempt from the re- Records required by this part will be
quirements of part 11 of this chapter. protected from public disclosure to the
Records that satisfy the requirements extent allowable under part 20 of this
of this part, but that also are required chapter.
under other applicable statutory provi-
sions or regulations, remain subject to § 121.330 Use of existing records.
(a) Existing records (e.g., records that
§ 121.310 Additional requirements ap- are kept to comply with other Federal,
plying to the food defense plan. State, or local regulations, or for any
The owner, operator, or agent in
cated if they contain all of the required
charge of the facility must sign and
date the food defense plan:
ments of this subpart. Existing records
(a) Upon initial completion; and
may be supplemented as necessary to
(b) Upon any modification.
include all of the required information
§ 121.315 Requirements for record re- and satisfy the requirements of this
tention. subpart.
(b) The information required by this
(a)(1) All records required by this
part does not need to be kept in one set
part must be retained at the facility
of records. If existing records contain
for at least 2 years after the date they
some of the required information, any
were prepared.
new information required by this part
(2) Records that a facility relies on
may be kept either separately or com-
during the 3-year period preceding the
bined with the existing records.
applicable calendar year to support its
status as exempt as a very small busi-
ness must be retained at the facility as Subpart E—Compliance
long as necessary to support the status
of a facility as a very small business § 121.401 Compliance.
during the applicable calendar year. (a) The operation of a facility that
(b) The food defense plan must be re- manufactures, processes, packs, or
tained for at least 2 years after its use holds food for sale in the United States
is discontinued. if the owner, operator, or agent in
(c) Except for the food defense plan, charge of such facility is required to
offsite storage of records is permitted comply with, and is not in compliance
if such records can be retrieved and with, section 418 of the Federal Food,
provided onsite within 24 hours of re- Drug, and Cosmetic Act or subparts C
quest for official review. The food de- or D of this part is a prohibited act
fense plan must remain onsite. Elec- under section 301(uu) of the Federal
tronic records are considered to be on- Food, Drug, and Cosmetic Act.
site if they are accessible from an on- (b) The failure to comply with sec-
site location. tion 420 of the Federal Food, Drug, and
(d) If the facility is closed for a pro- Cosmetic Act or subparts C or D of this
longed period, the food defense plan part is a prohibited act under section
may be transferred to some other rea- 301(ww) of the Federal Food, Drug, and
sonably accessible location but must be Cosmetic Act.
452
PART 123—FISH AND FISHERY (c) Critical limit means the maximum
PRODUCTS or minimum value to which a physical,
biological, or chemical parameter must
Subpart A—General Provisions be controlled at a critical control point
to prevent, eliminate, or reduce to an
Sec. acceptable level the occurrence of the
123.3 Definitions. identified food safety hazard.
123.5 Current good manufacturing practice.
(d) Fish means fresh or saltwater
123.6 Hazard analysis and Hazard Analysis
Critical Control Point (HACCP) plan. finfish, crustaceans, other forms of
123.7 Corrective actions. aquatic animal life (including, but not
123.8 Verification. limited to, alligator, frog, aquatic tur-
123.9 Records. tle, jellyfish, sea cucumber, and sea ur-
123.10 Training. chin and the roe of such animals) other
123.11 Sanitation control procedures. than birds or mammals, and all mol-
123.12 Special requirements for imported lusks, where such animal life is in-
products.
tended for human consumption.
Subpart B—Smoked and Smoke-Flavored (e) Fishery product means any human
Fishery Products food product in which fish is a charac-
terizing ingredient.
123.15 General. (f) Food safety hazard means any bio-
123.16 Process controls.
logical, chemical, or physical property
Subpart C—Raw Molluscan Shellfish that may cause a food to be unsafe for
human consumption.
123.20 General. (g) Importer means either the U.S.
123.28 Source controls. owner or consignee at the time of entry
AUTHORITY: 21 U.S.C. 321, 342, 343, 346, 348, into the United States, or the U.S.
371, 374, 379e, 381, 393; 42 U.S.C. 241, 241l, 264. agent or representative of the foreign
SOURCE: 60 FR 65197, Dec. 18, 1995, unless owner or consignee at the time of entry
otherwise noted. into the United States, who is respon-
sible for ensuring that goods being of-
Subpart A—General Provisions fered for entry into the United States
are in compliance with all laws affect-
§ 123.3 Definitions. ing the importation. For the purposes
The definitions and interpretations of this definition, ordinarily the im-
of terms in section 201 of the Federal porter is not the custom house broker,
Food, Drug, and Cosmetic Act (the act) the freight forwarder, the carrier, or
and in parts 110 and 117 of this chapter the steamship representative.
are applicable to such terms when used (h) Molluscan shellfish means any edi-
in this part, except that the definitions ble species of fresh or frozen oysters,
and terms in parts 110 and 117 do not clams, mussels, or scallops, or edible
govern such terms where such terms portions of such species, except when
are redefined in this part and except the product consists entirely of the
that the terms facility, hazard, and shucked adductor muscle.
manufacturing/processing in parts 110 (i) Preventive measure means physical,
and 117 do not govern such terms where chemical, or other factors that can be
used in this part. The following defini- used to control an identified food safe-
tions shall also apply: ty hazard.
(a) Certification number means a (j) Process-monitoring instrument
unique combination of letters and means an instrument or device used to
numbers assigned by a shellfish control indicate conditions during processing
authority to a molluscan shellfish at a critical control point.
processor. (k)(1) Processing means, with respect
(b) Critical control point means a to fish or fishery products: Handling,
point, step, or procedure in a food proc- storing, preparing, heading, evis-
ess at which control can be applied, cerating, shucking, freezing, changing
and a food safety hazard can as a result into different market forms, manufac-
be prevented, eliminated, or reduced to turing, preserving, packing, labeling,
acceptable levels. dockside unloading, or holding.
453
§ 123.5 21 CFR Ch. I (4–1–23 Edition)
(2) The regulations in this part do as immersing it in a solution of wood

not apply to: smoke.
(i) Harvesting or transporting fish or (t) Tag means a record of harvesting
fishery products, without otherwise en- information attached to a container of
gaging in processing. shellstock by the harvester or proc-
(ii) Practices such as heading, evis- essor.
cerating, or freezing intended solely to [60 FR 65197, Dec. 18, 1995, as amended at 80
prepare a fish for holding on board a FR 56167, Sept. 17, 2015]
harvest vessel.
(iii) The operation of a retail estab- § 123.5 Current good manufacturing
lishment. practice.
(l) Processor means any person en- (a) Except as provided by § 117.5(b),
gaged in commercial, custom, or insti- parts 110 and 117 of this chapter apply
tutional processing of fish or fishery in determining whether the facilities,
products, either in the United States or methods, practices, and controls used
in a foreign country. A processing in- to process fish and fishery products are
cludes any person engaged in the pro- safe, and whether these products have
duction of foods that are to be used in been processed under sanitary condi-
market or consumer tests. tions.
(m) Scombroid toxin-forming species (b) The purpose of this part is to set
means tuna, bluefish, mahi mahi, and forth requirements specific to the proc-
other species, whether or not in the essing of fish and fishery products.
family Scombridae, in which signifi-
cant levels of histamine may be pro- [60 FR 65197, Dec. 18, 1995, as amended at 80
FR 56167, Sept. 17, 2015]
duced in the fish flesh by
decarboxylation of free histidine as a § 123.6 Hazard analysis and Hazard
result of exposure of the fish after cap- Analysis Critical Control Point
ture to temperatures that permit the (HACCP) plan.
growth of mesophilic bacteria.
(a) Hazard analysis. Every processor
(n) Shall is used to state mandatory
shall conduct, or have conducted for it,
requirements.
a hazard analysis to determine whether
(o) Shellfish control authority means a there are food safety hazards that are
Federal, State, or foreign agency, or reasonably likely to occur for each
sovereign tribal government, legally kind of fish and fishery product proc-
responsible for the administration of a essed by that processor and to identify
program that includes activities such the preventive measures that the proc-
as classification of molluscan shellfish essor can apply to control those haz-
growing areas, enforcement of ards. Such food safety hazards can be
molluscan shellfish harvesting con- introduced both within and outside the
trols, and certification of molluscan processing plant environment, includ-
shellfish processors. ing food safety hazards that can occur
(p) Shellstock means raw, in-shell before, during, and after harvest. A
molluscan shellfish. food safety hazard that is reasonably
(q) Should is used to state rec- likely to occur is one for which a pru-
ommended or advisory procedures or to dent processor would establish controls
identify recommended equipment. because experience, illness data, sci-
(r) Shucked shellfish means molluscan entific reports, or other information
shellfish that have one or both shells provide a basis to conclude that there
removed. is a reasonable possibility that it will
(s) Smoked or smoke-flavored fishery occur in the particular type of fish or
products means the finished food pre- fishery product being processed in the
pared by: absence of those controls.
(1) Treating fish with salt (sodium (b) The HACCP plan. Every processor
chloride), and shall have and implement a written
(2) Subjecting it to the direct action HACCP plan whenever a hazard anal-
of smoke from burning wood, sawdust, ysis reveals one or more food safety
or similar material and/or imparting to hazards that are reasonably likely to
it the flavor of smoke by a means such occur, as described in paragraph (a) of
454
this section. A HACCP plan shall be ards that occur before, during, and
specific to: after harvest;
(1) Each location where fish and fish- (3) List the critical limits that must
ery products are processed by that be met at each of the critical control
processor; and points;
(2) Each kind of fish and fishery prod- (4) List the procedures, and frequency
uct processed by the processor. The thereof, that will be used to monitor
plan may group kinds of fish and fish- each of the critical control points to
ery products together, or group kinds ensure compliance with the critical
of production methods together, if the limits;
food safety hazards, critical control (5) Include any corrective action
points, critical limits, and procedures plans that have been developed in ac-
required to be identified and performed cordance with § 123.7(b), to be followed
in paragraph (c) of this section are in response to deviations from critical
identical for all fish and fishery prod- limits at critical control points;
ucts so grouped or for all production (6) List the verification procedures,
methods so grouped. and frequency thereof, that the proc-
(c) The contents of the HACCP plan. essor will use in accordance with
The HACCP plan shall, at a minimum: § 123.8(a);
(1) List the food safety hazards that (7) Provide for a recordkeeping sys-
are reasonably likely to occur, as iden- tem that documents the monitoring of
tified in accordance with paragraph (a) the critical control points. The records
of this section, and that thus must be shall contain the actual values and ob-
controlled for each fish and fishery servations obtained during monitoring.
product. Consideration should be given
(d) Signing and dating the HACCP
to whether any food safety hazards are
plan. (1) The HACCP plan shall be
reasonably likely to occur as a result
signed and dated, either by the most
of the following:
responsible individual onsite at the
(i) Natural toxins;
processing facility or by a higher level
(ii) Microbiological contamination;
official of the processor. This signature
(iii) Chemical contamination;
shall signify that the HACCP plan has
(iv) Pesticides;
been accepted for implementation by
(v) Drug residues;
the firm.
(vi) Decomposition in scombroid
toxin-forming species or in any other (2) The HACCP plan shall be dated
species where a food safety hazard has and signed:
been associated with decomposition; (i) Upon initial acceptance;
(vii) Parasites, where the processor (ii) Upon any modification; and
has knowledge or has reason to know (iii) Upon verification of the plan in
that the parasite-containing fish or accordance with § 123.8(a)(1).
fishery product will be consumed with- (e) Products subject to other regula-
out a process sufficient to kill the tions. For fish and fishery products
parasites, or where the processor rep- that are subject to the requirements of
resents, labels, or intends for the prod- part 113 or 114 of this chapter, the
uct to be so consumed; HACCP plan need not list the food safe-
(viii) Unapproved use of direct or in- ty hazard associated with the forma-
direct food or color additives; and tion of Clostridium botulinum toxin in
(ix) Physical hazards; the finished, hermetically sealed con-
(2) List the critical control points for tainer, nor list the controls to prevent
each of the identified food safety haz- that food safety hazard. A HACCP plan
ards, including as appropriate: for such fish and fishery products shall
(i) Critical control points designed to address any other food safety hazards
control food safety hazards that could that are reasonably likely to occur.
be introduced in the processing plant (f) Sanitation. Sanitation controls
environment; and may be included in the HACCP plan.
(ii) Critical control points designed However, to the extent that they are
to control food safety hazards intro- monitored in accordance with § 123.11(b)

duced outside the processing plant en- they need not be included in the
vironment, including food safety haz- HACCP plan, and vice versa.
455
§ 123.7 21 CFR Ch. I (4–1–23 Edition)
(g) Legal basis. Failure of a processor or may not include training in accord-
to have and implement a HACCP plan ance with § 123.10;
that complies with this section when- (3) Take corrective action, when nec-
ever a HACCP plan is necessary, other- essary, with respect to the affected
wise operate in accordance with the re- product to ensure that no product en-
quirements of this part, shall render ters commerce that is either injurious
the fish or fishery products of that to health or is otherwise adulterated as
processor adulterated under section a result of the deviation;
402(a)(4) of the act. Whether a proc- (4) Take corrective action, when nec-
essor’s actions are consistent with en- essary, to correct the cause of the devi-
suring the safety of food will be deter- ation;
mined through an evaluation of the (5) Perform or obtain timely reassess-
processors overall implementation of ment by an individual or individuals
its HACCP plan, if one is required. who have been trained in accordance
with § 123.10, to determine whether the
§ 123.7 Corrective actions. HACCP plan needs to be modified to re-
(a) Whenever a deviation from a crit- duce the risk of recurrence of the devi-
ical limit occurs, a processor shall take ation, and modify the HACCP plan as
corrective action either by: necessary.
(1) Following a corrective action plan (d) All corrective actions taken in ac-
that is appropriate for the particular cordance with this section shall be
deviation, or fully documented in records that are
subject to verification in accordance
(2) Following the procedures in para-
with § 123.8(a)(3)(ii) and the record-
graph (c) of this section.
keeping requirements of § 123.9.
(b) Processors may develop written
corrective action plans, which become § 123.8 Verification.
part of their HACCP plans in accord-
(a) Overall verification. Every proc-
ance with § 123.6(c)(5), by which they
essor shall verify that the HACCP plan
predetermine the corrective actions
is adequate to control food safety haz-
that they will take whenever there is a
ards that are reasonably likely to
deviation from a critical limit. A cor-
occur, and that the plan is being effec-
rective action plan that is appropriate
tively implemented. Verification shall
for a particular deviation is one that
include, at a minimum:
describes the steps to be taken and as-
(1) Reassessment of the HACCP plan. A
signs responsibility for taking those
reassessment of the adequacy of the
steps, to ensure that:
HACCP plan whenever any changes
(1) No product enters commerce that occur that could affect the hazard anal-
is either injurious to health or is other- ysis or alter the HACCP plan in any
wise adulterated as a result of the devi- way or at least annually. Such changes
ation; and may include changes in the following:
(2) The cause of the deviation is cor- Raw materials or source of raw mate-
rected. rials, product formulation, processing
(c) When a deviation from a critical methods or systems, finished product
limit occurs and the processor does not distribution systems, or the intended
have a corrective action plan that is use or consumers of the finished prod-
appropriate for that deviation, the uct. The reassessment shall be per-
processor shall: formed by an individual or individuals
(1) Segregate and hold the affected who have been trained in accordance
product, at least until the require- with § 123.10. The HACCP plan shall be
ments of paragraphs (c)(2) and (c)(3) of modified immediately whenever a reas-
this section are met; sessment reveals that the plan is no
(2) Perform or obtain a review to de- longer adequate to fully meet the re-
termine the acceptability of the af- quirements of § 123.6(c).
fected product for distribution. The re- (2) Ongoing verification activities. On-
view shall be performed by an indi- going verification activities including:
vidual or individuals who have ade- (i) A review of any consumer com-
quate training or experience to perform plaints that have been received by the
such a review. Adequate training may processor to determine whether they
456
relate to the performance of critical materials or source of raw materials,

control points or reveal the existence product formulation, processing meth-
of unidentified critical control points; ods or systems, finished product dis-
(ii) The calibration of process-moni- tribution systems, or the intended use
toring instruments; and, or consumers of the finished product.
(iii) At the option of the processor, The reassessment shall be performed
the performing of periodic end-product by an individual or individuals who
or in-process testing. have been trained in accordance with
(3) Records review. A review, including § 123.10.
signing and dating, by an individual (d) Recordkeeping. The calibration of
who has been trained in accordance process-monitoring instruments, and
with § 123.10, of the records that docu- the performing of any periodic end-
ment: product and in-process testing, in ac-
(i) The monitoring of critical control cordance with paragraphs (a)(2)(ii)
points. The purpose of this review shall through (iii) of this section shall be
be, at a minimum, to ensure that the documented in records that are subject
records are complete and to verify that to the recordkeeping requirements of
they document values that are within § 123.9.
the critical limits. This review shall
occur within 1 week of the day that the § 123.9 Records.
records are made; (a) General requirements. All records
(ii) The taking of corrective actions. required by this part shall include:
The purpose of this review shall be, at
(1) The name and location of the
a minimum, to ensure that the records
processor or importer;
are complete and to verify that appro-
priate corrective actions were taken in (2) The date and time of the activity
accordance with § 123.7. This review that the record reflects;
shall occur within 1 week of the day (3) The signature or initials of the
that the records are made; and person performing the operation; and
(iii) The calibrating of any process (4) Where appropriate, the identity of
control instruments used at critical the product and the production code, if
control points and the performing of any. Processing and other information
any periodic end-product or in-process shall be entered on records at the time
testing that is part of the processor’s that it is observed.
verification activities. The purpose of (b) Record retention. (1) All records re-
these reviews shall be, at a minimum, quired by this part shall be retained at
to ensure that the records are com- the processing facility or importer’s
plete, and that these activities oc- place of business in the United States
curred in accordance with the proc- for at least 1 year after the date they
essor’s written procedures. These re- were prepared in the case of refrig-
views shall occur within a reasonable erated products and for at least 2 years
time after the records are made. after the date they were prepared in
(b) Corrective actions. Processors shall the case of frozen, preserved, or shelf-
immediately follow the procedures in stable products.
§ 123.7 whenever any verification proce- (2) Records that relate to the general
dure, including the review of a con- adequacy of equipment or processes
sumer complaint, reveals the need to being used by a processor, including
take a corrective action. the results of scientific studies and
(c) Reassessment of the hazard analysis. evaluations, shall be retained at the
Whenever a processor does not have a processing facility or the importer’s
HACCP plan because a hazard analysis place of business in the United States
has revealed no food safety hazards for at least 2 years after their applica-
that are reasonably likely to occur, the bility to the product being produced at
processor shall reassess the adequacy the facility.
of that hazard analysis whenever there (3) If the processing facility is closed
are any changes that could reasonably for a prolonged period between sea-
affect whether a food safety hazard sonal packs, or if record storage capac-
now exists. Such changes may include, ity is limited on a processing vessel or
but are not limited to changes in: Raw at a remote processing site, the records
457
§ 123.10 21 CFR Ch. I (4–1–23 Edition)
may be transferred to some other rea- (a) Developing a HACCP plan, which
sonably accessible location at the end could include adapting a model or ge-
of the seasonal pack but shall be imme- neric-type HACCP plan, that is appro-
diately returned for official review priate for a specific processor, in order
upon demand. to meet the requirements of § 123.6(b);
(c) Official review. All records re- (b) Reassessing and modifying the
quired by this part and all plans and HACCP plan in accordance with the
procedures required by this part shall corrective action procedures specified
be available for official review and in § 123.7(c)(5), the HACCP plan in ac-
copying at reasonable times. cordance with the verification activi-
(d) Public disclosure. (1) Subject to the ties specified in § 123.8(a)(1), and the
limitations in paragraph (d)(2) of this hazard analysis in accordance with the
section, all plans and records required verification activities specified in
by this part are not available for public § 123.8(c); and
disclosure unless they have been pre- (c) Performing the record review re-
viously disclosed to the public as de- quired by § 123.8(a)(3); The trained indi-
fined in § 20.81 of this chapter or they vidual need not be an employee of the
relate to a product or ingredient that processor.
has been abandoned and they no longer § 123.11 Sanitation control procedures.
represent a trade secret or confidential
commercial or financial information as (a) Sanitation SOP. Each processor
defined in § 20.61 of this chapter. should have and implement a written
(2) However, these records and plans sanitation standard operating proce-
may be subject to disclosure to the ex- dure (herein referred to as SSOP) or
tent that they are otherwise publicly similar document that is specific to
available, or that disclosure could not each location where fish and fishery
products are produced. The SSOP
reasonably be expected to cause a com-
should specify how the processor will
petitive hardship, such as generic-type
meet those sanitation conditions and
HACCP plans that reflect standard in-
practices that are to be monitored in
dustry practices.
accordance with paragraph (b) of this
(e) Tags. Tags as defined in § 123.3(t)
section.
are not subject to the requirements of (b) Sanitation monitoring. Each proc-
this section unless they are used to ful- essor shall monitor the conditions and
fill the requirements of § 123.28(c). practices during processing with suffi-
(f) Records maintained on computers. cient frequency to ensure, at a min-
The maintenance of records on com- imum, conformance with those condi-
puters is acceptable, provided that ap- tions and practices specified in part 110
propriate controls are implemented to of this chapter and in subpart B of part
ensure the integrity of the electronic 117 of this chapter that are both appro-
data and signatures. priate to the plant and the food being
processed and relate to the following:
§ 123.10 Training.
(1) Safety of the water that comes
At a minimum, the following func- into contact with food or food contact
tions shall be performed by an indi- surfaces, or is used in the manufacture
vidual who has successfully completed of ice;
training in the application of HACCP (2) Condition and cleanliness of food
principles to fish and fishery product contact surfaces, including utensils,
processing at least equivalent to that gloves, and outer garments;
received under standardized cur- (3) Prevention of cross-contamina-
riculum recognized as adequate by the tion from insanitary objects to food,
U.S. Food and Drug Administration or food packaging material, and other
who is otherwise qualified through job food contact surfaces, including uten-
experience to perform these functions. sils, gloves, and outer garments, and
Job experience will qualify an indi- from raw product to cooked product;
vidual to perform these functions if it (4) Maintenance of hand washing,
has provided knowledge at least equiv- hand sanitizing, and toilet facilities;
alent to that provided through the (5) Protection of food, food packaging
standardized curriculum. material, and food contact surfaces
458
from adulteration with lubricants, fuel, they offer for import into the United
pesticides, cleaning compounds, sani- States were processed in accordance
tizing agents, condensate, and other with the requirements of this part. The
chemical, physical, and biological con- procedures shall list at a minimum:
taminants; (i) Product specifications that are de-
(6) Proper labeling, storage, and use signed to ensure that the product is not
of toxic compounds; adulterated under section 402 of the
(7) Control of employee health condi- Federal Food, Drug, and Cosmetic Act
tions that could result in the micro- because it may be injurious to health
biological contamination of food, food or have been processed under insani-
packaging materials, and food contact tary conditions, and,
surfaces; and (ii) Affirmative steps that may in-
(8) Exclusion of pests from the food clude any of the following:
plant. (A) Obtaining from the foreign proc-
The processor shall correct in a time- essor the HACCP and sanitation moni-
ly manner, those conditions and prac- toring records required by this part
tices that are not met. that relate to the specific lot of fish or
(c) Sanitation control records. Each fishery products being offered for im-
processor shall maintain sanitation port;
control records that, at a minimum, (B) Obtaining either a continuing or
document the monitoring and correc- lot-by-lot certificate from an appro-
tions prescribed by paragraph (b) of priate foreign government inspection
this section. These records are subject authority or competent third party
to the requirements of § 123.9. certifying that the imported fish or
(d) Relationship to HACCP plan. Sani- fishery product is or was processed in
tation controls may be included in the accordance with the requirements of
HACCP plan, required by § 123.6(b). this part;
However, to the extent that they are (C) Regularly inspecting the foreign
monitored in accordance with para- processor’s facilities to ensure that the
graph (b) of this section they need not imported fish or fishery product is
be included in the HACCP plan, and being processed in accordance with the
vice versa. requirements of this part;
[60 FR 65197, Dec. 18, 1995, as amended at 80 (D) Maintaining on file a copy, in
FR 56167, Sept. 17, 2015] English, of the foreign processor’s
HACCP plan, and a written guarantee
§ 123.12 Special requirements for im- from the foreign processor that the im-
ported products. ported fish or fishery product is proc-
This section sets forth specific re- essed in accordance with the require-
quirements for imported fish and fish- ments of the part;
ery products. (E) Periodically testing the imported
(a) Importer verification. Every im- fish or fishery product, and maintain-
porter of fish or fishery products shall ing on file a copy, in English, of a writ-
either: ten guarantee from the foreign proc-
(1) Obtain the fish or fishery product essor that the imported fish or fishery
from a country that has an active product is processed in accordance with
memorandum of understanding (MOU) the requirements of this part or,
or similar agreement with the Food (F) Other such verification measures
and Drug Administration, that covers as appropriate that provide an equiva-
the fish or fishery product and docu- lent level of assurance of compliance
ments the equivalency or compliance with the requirements of this part.
of the inspection system of the foreign (b) Competent third party. An importer
country with the U.S. system, accu- may hire a competent third party to
rately reflects the current situation be- assist with or perform any or all of the
tween the signing parties, and is func- verification activities specified in para-
tioning and enforceable in its entirety; graph (a)(2) of this section, including
or writing the importer’s verification pro-
(2) Have and implement written cedures on the importer’s behalf.

verification procedures for ensuring (c) Records. The importer shall main-
that the fish and fishery products that tain records, in English, that document
459
§ 123.15 21 CFR Ch. I (4–1–23 Edition)
the performance and results of the af- chemical contamination, natural tox-
firmative steps specified in paragraph ins, and related food safety hazards,
(a)(2)(ii) of this section. These records processors shall include in their
shall be subject to the applicable provi- HACCP plans how they are controlling
sions of § 123.9. the origin of the molluscan shellfish
(d) Determination of compliance. There they process to ensure that the condi-
must be evidence that all fish and fish- tions of paragraphs (b), (c), and (d) of
ery products offered for entry into the this section are met.
United States have been processed (b) Processors shall only process
under conditions that comply with this molluscan shellfish harvested from
part. If assurances do not exist that the growing waters approved for harvesting
imported fish or fishery product has by a shellfish control authority. In the
been processed under conditions that case of molluscan shellfish harvested
are equivalent to those required of do- from U.S. Federal waters, the require-
mestic processors under this part, the ments of this paragraph will be met so
product will appear to be adulterated long as the shellfish have not been har-
and will be denied entry. vested from waters that have been
closed to harvesting by an agency of
Subpart B—Smoked and Smoke- the Federal government.
Flavored Fishery Products (c) To meet the requirements of para-
graph (b) of this section, processors
§ 123.15 General. who receive shellstock shall accept
This subpart augments subpart A of only shellstock from a harvester that
this part by setting forth specific re- is in compliance with such licensure
quirements for processing smoked and requirements as may apply to the har-
smoke-flavored fishery products. vesting of molluscan shellfish or from
a processor that is certified by a shell-
§ 123.16 Process controls. fish control authority, and that has a
tag affixed to each container of
In order to meet the requirements of
shellstock. The tag shall bear, at a
subpart A of this part, processors of
minimum, the information required in
smoked and smoke-flavored fishery
§ 1240.60(b) of this chapter. In place of
products, except those subject to the
the tag, bulk shellstock shipments may
requirements of part 113 or 114 of this
be accompanied by a bill of lading or
chapter, shall include in their HACCP
similar shipping document that con-
plans how they are controlling the food
tains the information required in
safety hazard associated with the for-
§ 1240.60(b) of this chapter. Processors
mation of toxin by Clostridium botu-
shall maintain records that document
linum for at least as long as the shelf
that all shellstock have met the re-
life of the product under normal and
quirements of this section. These
moderate abuse conditions.
records shall document:
(1) The date of harvest;
Subpart C—Raw Molluscan (2) The location of harvest by State
Shellfish and site;
(3) The quantity and type of shellfish;
§ 123.20 General. (4) The date of receipt by the proc-
This subpart augments subpart A of essor; and
this part by setting forth specific re- (5) The name of the harvester, the
quirements for processing fresh or fro- name or registration number of the
zen molluscan shellfish, where such harvester’s vessel, or an identification
processing does not include a treat- number issued to the harvester by the
ment that ensures the destruction of shellfish control authority.
vegetative cells of microorganisms of (d) To meet the requirements of para-
public health concern. graph (b) of this section, processors
who receive shucked molluscan shell-
§ 123.28 Source controls. fish shall accept only containers of
(a) In order to meet the requirements shucked molluscan shellfish that bear
of subpart A of this part as they apply a label that complies with § 1240.60(c) of
to microbiological contamination, this chapter. Processors shall maintain
460
records that document that all shucked and transported under sanitary condi-
molluscan shellfish have met the re- tions.
quirements of this section. These [80 FR 56167, Sept. 17, 2015]
records shall document:
(1) The date of receipt; § 129.3 Definitions.
(2) The quantity and type of shellfish; For the purposes of this part, the fol-
and lowing definitions apply:
(3) The name and certification num- (a) Approved source when used in ref-
ber of the packer or repacker of the erence to a plant’s product water or op-
product. erations water means a source of water
and the water therefrom, whether it be
PART 129—PROCESSING AND BOT- from a spring, artesian well, drilled
TLING OF BOTTLED DRINKING well, municipal water supply, or any
other source, that has been inspected
WATER and the water sampled, analyzed, and
found to be of a safe and sanitary qual-
Subpart A—General Provisions ity according to applicable laws and
Sec. regulations of State and local govern-
129.1 Current good manufacturing practice. ment agencies having jurisdiction. The
129.3 Definitions. presence in the plant of current certifi-
cates or notifications of approval from
Subpart B—Buildings and Facilities the government agency or agencies
having jurisdiction constitutes ap-
129.20 Plant construction and design. proval of the source and the water sup-
129.35 Sanitary facilities. ply.
129.37 Sanitary operations. (b) Bottled drinking water means all
water which is sealed in bottles, pack-
Subpart C—Equipment ages, or other containers and offered
129.40 Equipment and procedures. for sale for human consumption, in-
cluding bottled mineral water.
Subpart D [Reserved] (c) Lot means a collection of primary
containers or unit packages of the
Subpart E—Production and Process same size, type, and style produced
Controls under conditions as nearly uniform as
possible and designated by a common
129.80 Processes and controls. container code or marking.
AUTHORITY: 21 U.S.C. 342, 348, 350k, 371, 374, (d) Multiservice containers means con-
42 U.S.C. 264. tainers intended for use more than one
time.
(e) Nontoxic materials means mate-
otherwise noted.
rials for product water contact surfaces
utilized in the transporting, proc-
Subpart A—General Provisions essing, storing, and packaging of bot-
tled drinking water, which are free of
§ 129.1 Current good manufacturing substances which may render the water
practice.
injurious to health or which may ad-
The applicable criteria in parts 110 versely affect the flavor, color, odor, or
and 117 of this chapter, as well as the bacteriological quality of the water.
criteria in §§ 129.20, 129.35, 129.37, 129.40, (f) Operations water means water
and 129.80 shall apply in determining which is delivered under pressure to a
whether the facilities, methods, prac- plant for container washing, hand
tices, and controls used in the proc- washing, plant and equipment cleanup
essing, bottling, holding, and shipping and for other sanitary purposes.
of bottled drinking water are in con- (g) Primary container means the im-
formance with or are operated or ad- mediate container in which the product
ministered in conformity with good water is packaged.
manufacturing practice to assure that (h) Product water means processed

bottled drinking water is safe and that water used by a plant for bottled drink-
it has been processed, bottled, held, ing water.
461
§ 129.20 21 CFR Ch. I (4–1–23 Edition)
(i) Shall and should. ‘‘Shall’’ refers to water supply for each plant shall be
mandatory requirements and ‘‘should’’ from an approved source properly lo-
refers to recommended or advisory pro- cated, protected, and operated and
cedures or equipment. shall be easily accessible, adequate,
(j) Shipping case means a container in and of a safe, sanitary quality which
which one or more primary containers shall be in conformance at all times
of the product are held. with the applicable laws and regula-
(k) Single-service container means a tions of the government agency or
container intended for one time usage agencies having jurisdiction.
only. (2) Operations water. If different from
(l) Unit package means a standard the product water supply, the oper-
commercial package of bottled drink- ations water supply shall be obtained
ing water, which may consist of one or from an approved source properly lo-
more containers. cated, protected, and operated and
shall be easily accessible, adequate,
FR 12175, Mar. 6, 1979]
and of a safe, sanitary quality which
shall be in conformance at all times
with the applicable laws and regula-
Subpart B—Buildings and Facilities tions of the government agency or
agencies having jurisdiction.
§ 129.20 Plant construction and design.
(3) Product water and operations water
(a) The bottling room shall be sepa- from approved sources. (i) Samples of
rated from other plant operations or source water from each source in use
storage areas by tight walls, ceilings, by the plant are to be taken and ana-
and self-closing doors to protect lyzed by the plant as often as nec-
against contamination. Conveyor open- essary, but at a minimum frequency of
ings shall not exceed the size required once each year for chemical contami-
to permit passage of containers. nants and once every 4 years for radio-
(b) If processing operations are con- logical contaminants. Additionally,
ducted in other than a sealed system source water obtained from other than
under pressure, adequate protection a public water system is to be sampled
shall be provided to preclude contami- and analyzed for total coliform at least
nation of the water and the system. once each week. If any coliform orga-
(c) Adequate ventilation shall be pro- nisms are detected, follow-up testing
vided to minimize condensation in must be conducted to determine wheth-
processing rooms, bottling rooms, and er any of the coliform organisms are
in container washing and sanitizing Escherichia coli. This sampling is in ad-
areas. dition to any performed by government
(d) The washing and sanitizing of agencies having jurisdiction. Source
containers for bottled drinking water water found to contain E. coli is not
shall be performed in an enclosed room. considered water of a safe, sanitary
The washing and sanitizing operation quality as required for use in bottled
shall be positioned within the room so water by paragraph (a)(1) of this sec-
as to minimize any possible post-sani- tion. Before a bottler can use source
tizing contamination of the containers water from a source that has tested
before they enter the bottling room. positive for E. coli, the bottler must
(e) Rooms in which product water is take appropriate measures to rectify or
handled, processed, or held or in which otherwise eliminate the cause of E. coli
containers, utensils, or equipment are contamination of that source in a man-
washed or held shall not open directly ner sufficient to prevent its reoccur-
into any room used for domestic house- rence. A source previously found to
hold purposes. contain E. coli will be considered nega-
tive for E. coli after five samples col-
§ 129.35 Sanitary facilities. lected over a 24-hour period from the
Each plant shall provide adequate same sampling site that originally
sanitary facilities including, but not tested positive for E. coli are tested and
limited to, the following: found to be E. coli negative. Records of

(a) Product water and operations approval of the source water by govern-
water—(1) Product water. The product ment agencies having jurisdiction,
462
records of sampling and analyses for that are likely to result from such
which the plant is responsible, and treatment.
records describing corrective measures (iv) The finished bottled water must
taken in response to a finding of E. coli comply with bottled water quality
are to be maintained on file at the standards (§ 165.110(b) of this chapter)
plant. and section 402(a)(1) and (a)(3) of the
(ii) Test and sample methods shall be Federal Food, Drug, and Cosmetic Act
those recognized and approved by the dealing with adulterated foods.
government agency or agencies having (b) Air under pressure. Whenever air
jurisdiction over the approval of the under pressure is directed at product
water source, and shall be consistent water or a product water-contact sur-
with the minimum requirements set face, it shall be free of oil, dust, rust,
forth in § 165.110(b) of this chapter. excessive moisture, and extraneous ma-
(iii) Analysis of the sample may be terials; shall not affect the bacterio-
performed for the plant by competent logical quality of the water; and should
commercial laboratories (e.g., Environ- not adversely affect the flavor, color,
mental Protection Agency (EPA) and or odor of the water.
State-certified laboratories), except (c) Locker and lunchrooms. When em-
that the analysis of the five samples ployee locker and lunchrooms are pro-
from the same sampling site that origi- vided, they shall be separate from
nally tested positive for E. coli, as re- plant operations and storage areas and
quired by paragraph (a)(3) of this sec- shall be equipped with self-closing
tion, must be conducted under part 1, doors. The rooms shall be maintained
subpart R of this chapter. in a clean and sanitary condition and
(4) Source water testing exemptions. (i) refuse containers should be provided.
Firms that use a public water system Packaging or wrapping material or
for source water may substitute public other processing supplies shall not be
water system testing results, or certifi- stored in locker or lunchrooms.
cates showing full compliance with all [42 FR 14355, Mar. 15, 1977, as amended at 44
provisions of EPA National Primary FR 12175, Mar. 6, 1979; 60 FR 57123, Nov. 13,
and Secondary Drinking Water Regula- 1995; 66 FR 16865, Mar. 28, 2001; 74 FR 25664,
tions pertaining to chemical contami- May 29, 2009; 86 FR 68831, Dec. 3, 2021]
nants (40 CFR parts 141 and 143), for the
testing requirements of § 129.35(a)(3). § 129.37 Sanitary operations.
(ii) Firms that do not use a public (a) The product water-contact sur-
water system as the source of their faces of all multiservice containers,
water may reduce the frequency of utensils, pipes, and equipment used in
their testing of that source, as well as the transportation, processing, han-
the number of chemical contaminants dling, and storage of product water
for which they test the source water, if shall be clean and adequately sanitized.
they can document that such reduction All product water-contact surfaces
is consistent with a State-issued waiv- shall be inspected by plant personnel as
er under EPA regulations (40 CFR parts often as necessary to maintain the san-
141 and 143). itary condition of such surfaces and to
(iii) Firms that do not use a public assure they are kept free of scale, evi-
water system as the source of their dence of oxidation, and other residue.
water and whose source water has not The presence of any unsanitary condi-
been treated with a chlorine-based dis- tion, scale, residue, or oxidation shall
infectant or ozone do not have to test be immediately remedied by adequate
their source water for the residual dis- cleaning and sanitizing of that product
infectants and DBP’s listed in water-contact surface prior to use.
§ 165.110(b)(4)(iii)(H) of this chapter. (b) After cleaning, all multiservice
Firms that do not use a public water containers, utensils, and disassembled
system as the source of their water but piping and equipment shall be trans-
whose source water has been treated ported and stored in such a manner as
with a chlorine-based disinfectant or to assure drainage and shall be pro-
ozone must test their source water for tected from contamination.
the residual disinfectants and the (c) Single-service containers and caps
DBP’s listed in § 165.110(b)(4)(iii)(H) or seals shall be purchased and stored
463
§ 129.40 21 CFR Ch. I (4–1–23 Edition)
in sanitary closures and kept clean uct water samples shall be taken after
therein in a clean, dry place until used. processing and prior to bottling by the
Prior to use they shall be examined, plant and analyzed as often as is nec-
and as necessary, washed, rinsed, and essary to assure uniformity and effec-
sanitized and shall be handled in a san- tiveness of the processes performed by
itary manner. the plant. The methods of analysis
(d) Filling, capping, closing, sealing, shall be those approved by the govern-
and packaging of containers shall be ment agency or agencies having juris-
done in a sanitary manner so as to pre- diction.
clude contamination of the bottled (b) Containers. (1) Multiservice pri-
drinking water. mary containers shall be adequately
cleaned, sanitized, and inspected just
Subpart C—Equipment prior to being filled, capped, and
sealed. Containers found to be unsani-
§ 129.40 Equipment and procedures.
tary or defective by the inspection
(a) Suitability. (1) All plant equipment shall be reprocessed or discarded. All
and utensils shall be suitable for their multiservice primary containers shall
intended use. This includes all collec- be washed, rinsed, and sanitized by me-
tion and storage tanks, piping, fittings, chanical washers or by any other meth-
connections, bottle washers, fillers, od giving adequate sanitary results.
cappers, and other equipment which Mechanical washers shall be inspected
may be used to store, handle, process, as often as is necessary to assure ade-
package, or transport product water.
quate performance. Records of physical
(2) All product water contact surfaces
maintenance, inspections and condi-
shall be constructed of nontoxic and
tions found, and performance of the
nonabsorbant material which can be
adequately cleaned and sanitized and is mechanical washer shall be maintained
in compliance with section 409 of the by the plant.
act. (2) Multiservice shipping cases shall
(b) Design. Storage tanks shall be of be maintained in such condition as to
the type that can be closed to exclude assure they will not contaminate the
all foreign matter and shall be ade- primary container or the product
quately vented. water. Adequate dry or wet cleaning
procedures shall be performed as often
Subpart D [Reserved] as necessary to maintain the cases in
satisfactory condition.
Subpart E—Production and (c) Cleaning and sanitizing solutions.
Cleaning and sanitizing solutions uti-
Process Controls lized by the plant shall be sampled and
§ 129.80 Processes and controls. tested by the plant as often as is nec-
essary to assure adequate performance
(a) Treatment of product water. All
in the cleaning and sanitizing oper-
treatment of product water by distilla-
ations. Records of these tests shall be
tion, ion-exchanging, filtration, ultra-
violet treatment, reverse osmosis, maintained by the plant.
carbonation, mineral addition, or any (d) Sanitizing operations. Sanitizing
other process shall be done in a manner operations, including those performed
so as to be effective in accomplishing by chemical means or by any other
its intended purpose and in accordance means such as circulation of live steam
with section 409 of the Federal Food, or hot water, shall be adequate to ef-
Drug, and Cosmetic Act. All such proc- fect sanitization of the intended prod-
esses shall be performed in and by uct water-contact surfaces and any
equipment and with substances which other critical area. The plant should
will not adulterate the bottled product. maintain a record of the intensity of
A record of the type and date of phys- the sanitizing agent and the time dura-
ical inspections of such equipment, tion that the agent was in contact with
conditions found, and the performance the surface being sanitized. The fol-
and effectiveness of such equipment lowing times and intensities shall be
shall be maintained by the plant. Prod- considered a minimum:
464
(1) Steam in enclosed system: At certain that they are free from con-
least 170 °F for at least 15 minutes or at tamination. At least once each 3
least 200 °F for at least 5 minutes. months, a bacteriological swab and/or
(2) Hot water in enclosed system: At rinse count should be made from at
least 170 °F for at least 15 minutes or at least four containers and closures se-
least 200 °F for at least 5 minutes. lected just prior to filling and sealing.
(3) Chemical sanitizers shall be No more than one of the four samples
equivalent in bactericidal action to a 2- may exceed more than one bacteria per
minute exposure of 50 parts per million milliliter of capacity or one colony per
of available chlorine at 57 °F when used square centimeter of surface area. All
as an immersion or circulating solu- samples shall be free of coliform orga-
tion. Chemical sanitizers applied as a nisms. The procedure and apparatus for
spray or fog shall have as a minimum these bacteriological tests shall be in
100 parts per million of available chlo- conformance with those recognized by
rine at 57 °F or its equivalent in bac- the government agency or agencies
tericidal action. having jurisdiction. Tests shall be per-
(4) 0.1 part per million ozone water formed either by qualified plant per-
solution in an enclosed system for at sonnel or a competent commercial lab-
least 5 minutes. oratory.
(5) When containers are sanitized (g) Compliance procedures. A quality
using a substance other than one pro- standard for bottled drinking water is
vided for in § 178.1010 of this chapter, established in § 165.110(b) of this chap-
such substance shall be removed from ter. To assure that the plant’s produc-
the surface of the container by a rins- tion of bottled drinking water complies
ing procedure. The final rinse, prior to with the applicable standards, laws,
filling the container with product and regulations of the government
water, shall be performed with a dis- agency or agencies having jurisdiction,
infected water rinse free of pathogenic the plant will analyze product samples
bacteria or by an additional sanitizing as follows:
procedure equivalent in bactericidal
(1) For bacteriological purposes, take
action to that required in paragraph
and analyze at least once a week for
(d)(3) of this section.
total coliform a representative sample
(e) Unit package production code. Each
unit package from a batch or segment from a batch or segment of a contin-
of a continuous production run of bot- uous production run for each type of
tled drinking water shall be identified bottled drinking water produced during
by a production code. The production a day’s production. The representative
code shall identify a particular batch sample shall consist of primary con-
or segment of a continuous production tainers of product or unit packages of
run and the day produced. The plant product. If any coliform organisms are
shall record and maintain information detected, follow-up testing must be
as to the kind of product, volume pro- conducted to determine whether any of
duced, date produced, lot code used, the coliform organisms are E. coli.
and the distribution of the finished (2) For chemical, physical, and radio-
product to wholesale and retail outlets. logical purposes, take and analyze at
(f) Filling, capping, or sealing. During least annually a representative sample
the process of filling, capping or seal- from a batch or segment of a contin-
ing either single-service or multi- uous production run for each type of
service containers, the performance of bottled drinking water produced during
the filler, capper or sealer shall be a day’s production. The representative
monitored and the filled containers sample(s) consists of primary con-
visually or electronically inspected to tainers of product of unit packages of
assure they are sound, properly capped product.
or sealed, and coded and labeled. Con- (3) Analyze such samples by methods
tainers which are not satisfactory shall approved by the government agency or
be reprocessed or rejected. Only agencies having jurisdiction. The plant
nontoxic containers and closures shall shall maintain records of date of sam-
be used. All containers and closures pling, type of product sampled, produc-
shall be sampled and inspected to as- tion code, and results of the analysis.
465
(h) Record retention. All records re- (b) If a regulation prescribing a defi-
quired by §§ 129.1, 129.20, 129.35, 129.37, nition and standard of identity for a
129.40, and 129.80 shall be maintained at food has been promulgated under sec-
the plant for not less than 2 years. tion 401 of the act and the name there-
Plants shall also retain, on file at the in specified for the food is used in any
plant, current certificates or notifica- other regulation under section 401 or
tions of approval issued by the govern- any other provision of the act, such
ment agency or agencies approving the name means the food which conforms
plant’s source and supply of product to such definition and standard, except
water and operations water. All re-
as otherwise specifically provided in
quired documents shall be available for
official review at reasonable times. such other regulation.
(c) No provision of any regulation
[42 FR 14355, Mar. 15, 1977, as amended at 44 prescribing a definition and standard of
FR 12175, Mar. 6, 1979; 60 FR 57124, Nov. 13,
1995; 74 FR 25665, May 29, 2009]
identity or standard of quality or fill of
container under section 401 of the act
shall be construed as in any way affect-
PART 130—FOOD STANDARDS: ing the concurrent applicability of the
GENERAL general provisions of the act and the
regulations thereunder relating to
adulteration and misbranding. For ex-
Sec. ample, all regulations under section 401
130.3 Definitions and interpretations. contemplate that the food and all arti-
130.5 Procedure for establishing a food
cles used as components or ingredients
standard.
130.6 Review of Codex Alimentarius food thereof shall not be poisonous or dele-
standards. terious and shall be clean, sound, and
130.8 Conformity to definitions and stand- fit for food. A provision in such regula-
ards of identity. tions for the use of coloring or fla-
130.9 Sulfites in standardized food.
voring does not authorize such use
130.10 Requirements for foods named by use
of a nutrient content claim and a stand- under circumstances or in a manner
ardized term. whereby damage or inferiority is con-
130.11 Label designations of ingredients for cealed or whereby the food is made to
standardized foods. appear better or of greater value than
130.12 General methods for water capacity
it is.
and fill of containers.
130.14 General statements of substandard (d) Safe and suitable means that the
quality and substandard fill of container. ingredient:
130.17 Temporary permits for interstate (1) Performs an appropriate function
shipment of experimental packs of food in the food in which it is used.
varying from the requirements of defini-
tions and standards of identity. (2) Is used at a level no higher than
necessary to achieve its intended pur-
Subpart B—Food Additives in Standardized pose in that food.
Foods (3) Is not a food additive or color ad-
130.20 Food additives proposed for use in
ditive as defined in section 201 (s) or (t)
foods for which definitions and standards of the Federal Food, Drug, and Cos-
of identity are established. metic Act as used in that food, or is a
AUTHORITY: 21 U.S.C. 321, 336, 341, 343, 371. food additive or color additive as so de-
fined and is used in conformity with
EDITORIAL NOTE: Nomenclature changes to
regulations established pursuant to
section 409 or 721 of the act.
(e) Section 403(i) of the act requires
Subpart A—General Provisions the listing of all ingredients in stand-
§ 130.3 Definitions and interpretations. ardized foods. All ingredients must be
listed in accordance with the require-
(a) The definitions and interpreta-
tions of terms contained in section 201 ments of part 101 of this chapter, ex-
cept that where a definition and stand-
of the act shall be applicable also to

such terms when used in regulations ard of identity has specific labeling
promulgated under the act.
466
provisions for optional ingredients, op- tunity for comment, if reasonable

tional ingredients may be declared in grounds are provided in the petition.
accordance with those provisions. Any published proposal shall state any
[42 FR 14357, Mar. 15, 1977, as amended at 58 deviations from the Codex standard
FR 2876, Jan. 6, 1993] and the stated reasons therefor.
(2) The Commissioner may on his
§ 130.5 Procedure for establishing a own initiative propose by publication
food standard. in the FEDERAL REGISTER the adoption
(a) The procedure for establishing a of a Codex standard, with or without
food standard under section 401 of the change, through a new standard or an
act shall be governed by part 10 of this appropriate amendment to an existing
chapter. standard, pursuant to section 401 of the
(b) Any petition for a food standard act. Any such proposal shall specify
shall show that the proposal, if adopt-
any deviations from the Codex stand-
ed, would promote honesty and fair
ard, and the reasons for any such devi-
dealing in the interest of consumers.
(c) Any petition for a food standard ations.
shall assert that the petitioner com- (3) Any Codex standard not handled
mits himself to substantiate the infor- under paragraph (b) (1) or (2) of this
mation in the petition by evidence in a section may be published in the FED-
public hearing, if such a hearing be- ERAL REGISTER for review and informal
comes necessary. comment. Interested persons shall be
(d) If a petitioner fails to appear, or requested to comment on the desir-
to substantiate the information in his ability and need for the standard, on
petition, at a public hearing on the the specific provisions of the standard,
matter, the Commissioner may either on additional or different provisions
(1) withdraw the regulation and termi- that should be included in the stand-
nate the proceeding or (2) if he con- ard, and on any other pertinent points.
cludes that it is in accordance with the After reviewing all such comments, the
requirements of section 401 of the act, Commissioner either shall publish a
continue the proceeding and introduce proposal to establish a food standard
evidence to substantiate such informa-
pursuant to section 401 of the act cov-
tion.
ering the food involved, or shall pub-
[42 FR 14357, Mar. 15, 1977, as amended at 42 lish a notice terminating consideration
FR 15673, Mar. 22, 1977] of such a standard.
§ 130.6 Review of Codex Alimentarius (c) All interested persons are encour-
food standards. aged to confer with different interest
(a) All food standards adopted by the groups (consumers, industry, the aca-
Codex Alimentarius Commission will demic community, professional organi-
be reviewed by the Food and Drug Ad- zations, and others) in formulating pe-
ministration and will be accepted with- titions or comments pursuant to para-
out change, accepted with change, or graph (b) of this section. All such peti-
not accepted. tions or comments are requested to in-
(b) Review of Codex standards will be clude a statement of any meetings and
accomplished in one of the following discussions that have been held with
three ways: other interest groups. Appropriate
(1) Any interested person may peti- weight will be given by the Commis-
tion the Commissioner to adopt a sioner to petitions or comments that
Codex standard, with or without reflect a consensus of different interest
change, by proposing a new standard or groups.
an appropriate amendment of an exist-
ing standard, pursuant to section 401 of § 130.8 Conformity to definitions and
the act. Any such petition shall specify standards of identity.
any deviations from the Codex stand-
In the following conditions, among
ard, and the reasons for any such devi-
others, a food does not conform to the
ations. The Commissioner shall publish

such a petition in the FEDERAL REG- definition and standard of identity
ISTER as a proposal, with an oppor-
therefor:
467
§ 130.9 21 CFR Ch. I (4–1–23 Edition)
(a) If it contains an ingredient for All approved material is available for

which no provision is made in such def- inspection at the Food and Drug Ad-
inition and standard, unless such ingre- ministration, Dockets Management
dient is an incidental additive intro- Staff, 5630 Fishers Lane, Rm. 1061,
duced at a nonfunctional and insignifi- Rockville, MD 20852, 240–402–7500, and
cant level as a result of its deliberate available from AOAC International,
and purposeful addition to another in- 2275 Research Blvd., Ste. 300, Rockville,
gredient permitted by the terms of the MD 20850–3250. It is also available for
applicable standard and the presence of inspection at the National Archives
such incidental additive in and Records Administration (NARA).
unstandardized foods has been exempt- For information on the availability of
ed from label declaration as provided this material at NARA, email
in § 101.100 of this chapter. fedreg.legal@nara.gov or go to
(b) If it fails to contain any one or www.archives.gov/federal-register/cfr/ibr-
more ingredients required by such defi- locations.html.
nition and standard; (1) AOAC Official Method 990.28, Sul-
(c) If the quantity of any ingredient fites in Foods, Optimized Monier-Wil-
or component fails to conform to the liams Method, Section 47.3.43, Official
limitation, if any, prescribed therefor Methods of Analysis, 21st edition, 2019.
by such definition and standard. (2) Determination of Sulfite in Food
by Liquid Chromatography Tandem
§ 130.9 Sulfites in standardized food. Mass Spectrometry: Collaborative
(a) Any standardized food that con- Study, Katherine S. Carlos and Lowri
tains a sulfiting agent or combination S. De Jager; Journal of AOAC Inter-
of sulfiting agents that is functional national, Vol. 100, No. 6, 2017, pp. 1785–
and provided for in the applicable 1794.
standard or that is present in the fin- [58 FR 2876, Jan. 6, 1993, as amended at 63 FR
ished food at a detectable concentra- 14035, Mar. 24, 1998; 87 FR 2547, Jan. 18, 2022]
tion is misbranded unless the presence
of the sulfiting agent or agents is de- § 130.10 Requirements for foods named
clared on the label of the food. A de- by use of a nutrient content claim
tectable amount of sulfiting agent is 10 and a standardized term.
parts per million (ppm or mg/kg) or (a) Description. The foods prescribed
more of the sulfite in the finished food. by this general definition and standard
The concentration of sulfite in the fin- of identity are those foods that sub-
ished food will be determined using ei- stitute (see § 101.13(d) of this chapter)
ther: for a standardized food defined in parts
(1) Determination of Sulfite in Food 131 through 169 of this chapter and that
by Liquid Chromatography Tandem use the name of that standardized food
Mass Spectrometry; or in their statement of identity but that
(2) AOAC Official Method 990.28. do not comply with the standard of
(b) Any standardized food that, as a identity because of a deviation that is
result of actions that are consistent described by an expressed nutrient con-
with current good manufacturing prac- tent claim that has been defined by
tice, contains an indirectly added FDA regulation. The nutrient content
sulfiting agent that has no functional claim shall comply with the require-
effect in the food and that would, in ments of § 101.13 of this chapter and
the absence of § 101.100(a)(4) of this with the requirements of the regula-
chapter, be considered to be an inci- tions in part 101 of this chapter that
dental additive for purposes of § 130.8, define the particular nutrient content
conforms to the applicable definition claim that is used. The food shall com-
and standard of identity if the presence ply with the relevant standard in all
of the sulfiting agent is declared on the other respects except as provided in
label of the food. paragraphs (b), (c), and (d) of this sec-
(c) The standards required in this tion.
section are incorporated by reference (b) Nutrient addition. (1) Nutrients
into this section with the approval of shall be added to the food to restore
the Director of the Federal Register nutrient levels so that the product is
under 5 U.S.C. 552(a) and 1 CFR part 51. not nutritionally inferior, as defined in
468
§ 101.3(e)(4) of this chapter, to the characteristics to the standardized

standardized food as defined in parts food defined in parts 131 through 169 of
131 through 169 of this chapter. The ad- this chapter.
dition of nutrients shall be reflected in (2) An ingredient or component of an
the ingredient statement. ingredient that is specifically required
(2) Yogurt containing less than 3.25 by the standard (i.e., a mandatory in-
percent milkfat is exempt from compli- gredient) as defined in parts 131
ance with paragraph (b)(1) of this sec- through 169 of this chapter, shall not be
tion with respect to vitamin A for- replaced or exchanged with a similar
tification provided the product com- ingredient from another source unless
plies with all other requirements. the standard, as defined in parts 131
(c) Performance characteristics. Devi- through 169 of this chapter, provides
ations from noningredient provisions of for the addition of such ingredient
the standard of identity (e.g., moisture (e.g., vegetable oil shall not replace
content, food solids content require- milkfat in light sour cream).
ments, or processing conditions) are (3) An ingredient or component of an
permitted in order that the substitute ingredient that is specifically prohib-
food possesses performance character- ited by the standard as defined in parts
istics similar to those of the standard- 131 through 169 of this chapter, shall
ized food. Deviations from ingredient not be added to a substitute food under
and noningredient provisions of the this section.
standard must be the minimum nec-
(4) An ingredient that is specifically
essary to qualify for the nutrient con-
required by the standard as defined in
tent claim while maintaining similar
parts 131 through 169 of this chapter,
performance characteristics as the
shall be present in the product in a sig-
standardized food, or the food will be
nificant amount. A significant amount
deemed to be adulterated under section
of an ingredient or component of an in-
402(b) of the act. The performance char-
gredient is at least that amount that is
acteristics (e.g., physical properties,
required to achieve the technical effect
flavor characteristics, functional prop-
of that ingredient in the food.
erties, shelf life) of the food shall be
similar to those of the standardized (5) Water and fat analogs may be
food as produced under parts 131 added to replace fat and calories in ac-
through 169 of this chapter, except that cordance with § 130.10(c), (d)(1), and
if there is a significant difference in (d)(2).
performance characteristics that mate- (e) Yogurt with modified milkfat and
rially limits the uses of the food com- fat-containing flavoring ingredients. Fat-
pared to the uses of the standardized containing flavoring ingredients may
food, the label shall include a state- be added to yogurt for which the
ment informing the consumer of such milkfat content has been modified in
difference (e.g., if appropriate, ‘‘not accordance with the expressed nutrient
recommended for cooking’’). Such content claim regulations in § 101.62(b)
statement shall comply with the re- of this chapter. The name of the food
quirements of § 101.13(d) of this chapter. includes the term ‘‘ll yogurt,’’ the
The modified product shall perform at blank being filled in with the nutrient
least one of the principal functions of content claim in § 101.62(b)(1)(i),
the standardized product substantially (b)(2)(i), or (b)(4)(i) of this chapter cor-
as well as the standardized product. responding to the milkfat content, and
(d) Other ingredients. (1) Ingredients a descriptor of the fat-containing fla-
used in the product shall be those in- voring ingredient(s).
gredients provided for by the standard (f) Nomenclature. The name of a sub-
as defined in parts 131 through 169 of stitute food that complies with all
this chapter and in paragraph (b) of parts of this regulation is the appro-
this section, except that safe and suit- priate expressed nutrient content
able ingredients may be used to im- claim and the applicable standardized
prove texture, add flavor, prevent syn- term.
eresis, extend shelf life, improve ap- (g) Label declaration. (1) Each of the
pearance, or add sweetness so that the ingredients used in the food shall be de-
product is not inferior in performance clared on the label as required by the
469
§ 130.11 21 CFR Ch. I (4–1–23 Edition)
applicable sections of part 101 of this (1) In the case of a container with lid
chapter and part 130. attached by double seam, cut out the
(2) Ingredients not provided for, and lid without removing or altering the
ingredients used in excess of those lev- height of the double seam.
els provided for, by the standard as de- (2) Wash, dry, and weigh the empty
fined in parts 131 through 169 of this container.
chapter, shall be identified as such (3) Fill the container with distilled
with an asterisk in the ingredient water at 68 °F to 3⁄16 inch vertical dis-
statement, except that ingredients tance below the top level of the con-
added to restore nutrients to the prod- tainer, and weigh the container thus
uct as required in paragraph (b) of this filled.
section shall not be identified with an (4) Subtract the weight found in
asterisk. The statement paragraph (a)(2) of this section from
‘‘*Ingredient(s) not in regular ______’’ the weight found in paragraph (a)(3) of
(fill in name of the traditional stand- this section. The difference shall be
ardized food) or ‘‘*Ingredient(s) in ex- considered to be the weight of water re-
cess of amount permitted in regular quired to fill the container.
______’’ (fill in name of the traditional In the case of a container with lid at-
standardized food) or both as appro- tached otherwise than by double seam,
priate shall immediately follow the in- remove the lid and proceed as directed
gredient statement in the same type in paragraphs (a) (2) to (4) of this sec-
size. tion, except that under paragraph (a)(3)
[58 FR 2446, Jan. 6, 1993, as amended at 86 FR of this section, fill the container to the
31137, June 11, 2021; 87 FR 76568, Dec. 15, 2022] level of the top thereof.
(b) The term general method for fill of
§ 130.11 Label designations of ingredi- containers means the following method:
ents for standardized foods. (1) In the case of a container with lid
Some definitions and standards of attached by double seam, cut out the
identity for foods set forth below re- lid without removing or altering the
quire that designated optional ingredi- height of the double seam.
ents such as spices, flavorings, color- (2) Measure the vertical distance
ings, emulsifiers, flavor enhancers, sta- from the top level of the container to
bilizers, preservatives, and sweeteners the top level of the food.
be declared in a specified manner on (3) Remove the food from the con-
the label wherever the name of the tainer; wash, dry, and weigh the con-
standardized food appears on the label tainer.
so conspicuously as to be easily seen (4) Fill the container with water to
3⁄16 inch vertical distance below the top
under customary conditions of pur-
chase. Such requirements shall apply level of the container. Record the tem-
to a manufacturer, packer, or dis- perature of the water, weigh the con-
tributor of a standardized food only if tainer thus filled, and determine the
the words or statements on the label of weight of the water by subtracting the
the standardized food significantly dif- weight of the container found in para-
ferentiate between two or more foods graph (b)(3) of this section.
(5) Maintaining the water at the tem-
that comply with the same standard by
perature recorded in paragraph (b)(4) of
describing the optional forms or vari-
this section, draw off water from the
eties, the packing medium, or signifi-
container as filled in paragraph (b)(4)
cant characterizing ingredients present
of this section to the level of the food
in the food.
found in paragraph (b)(2) of this sec-
[58 FR 2876, Jan. 6, 1993] tion, weigh the container with remain-
ing water, and determine the weight of
§ 130.12 General methods for water ca- the remaining water by subtracting the
pacity and fill of containers. weight of the container found in para-
For the purposes of regulations pro- graph (b)(3) of this section.
mulgated under section 401 of the act: (6) Divide the weight of water found
(a) The term general method for water in paragraph (b)(5) of this section by
capacity of containers means the fol- the weight of water found in paragraph
lowing method: (b)(4) of this section, and multiply by
470
100. The result shall be considered to be on a strongly contrasting, uniform

the percent of the total capacity of the background, and are so placed as to be
container occupied by the food. easily seen when the name of the food
In the case of a container with lid at- or any pictorial representation thereof
tached otherwise than by double seam, is viewed, wherever such name or rep-
remove the lid and proceed as directed resentation appears so conspicuously
in paragraphs (b) (2) to (6) of this sec- as to be easily seen under customary
tion, except that under paragraph (b)(4) conditions of purchase.
of this section, fill the container to the § 130.17 Temporary permits for inter-
level of the top thereof. state shipment of experimental
packs of food varying from the re-
§ 130.14 General statements of sub- quirements of definitions and
standard quality and substandard standards of identity.
fill of container.
(a) The Food and Drug Administra-
For the purposes of regulations pro- tion recognizes that before petitions to
mulgated under section 401 of the act: amend food standards can be sub-
(a) The term general statement of submitted, appropriate investigations of
standard quality means the statement potential advances in food technology
‘‘Below Standard in Quality Good sometimes require tests in interstate
Food—Not High Grade’’ printed in two markets of the advantages to and ac-
lines of Cheltenham bold condensed ceptance by consumers of experimental
caps. The words ‘‘Below Standard in packs of food varying from applicable
Quality’’ constitute the first line, and definitions and standards of identity
the second immediately follows. If the prescribed under section 401 of the act.
quantity of the contents of the con- (b) It is the purpose of the Food and
tainer is less than 1 pound, the type of Drug Administration to permit such
the first line is 12-point, and of the sec- tests when it can be ascertained that
ond, 8-point. If such quantity is 1 pound the sole purpose of the tests is to ob-
or more, the type of the first line is 14- tain data necessary for reasonable
point, and of the second, 10-point. Such grounds in support of a petition to
statement is enclosed within lines, not amend food standards, that the tests
less than 6 points in width, forming a are necessary to the completion or con-
rectangle. Such statement, with en- clusiveness of an otherwise adequate
closing lines, is on a strongly con- investigation, and that the interests of
trasting, uniform background, and is so consumers are adequately safeguarded;
placed as to be easily seen when the permits for such tests shall normally
name of the food or any pictorial rep- be for a period not to exceed 15 months.
resentation thereof is viewed, wherever The Food and Drug Administration, or
such name or representation appears so good cause shown by the applicant,
conspicuously as to be easily seen may provide for a longer test market
under customary conditions of pur- period. The Food and Drug Administra-
chase. tion will therefore refrain from recom-
(b) The term general statement of sub- mending regulatory proceedings under
standard fill means the statement the act on the charge that a food does
‘‘Below Standard in Fill’’ printed in not conform to an applicable standard,
Cheltenham bold condensed caps. If the if the person who introduces or causes
quantity of the contents of the con- the introduction of the food into inter-
tainer is less than 1 pound, the state- state commerce holds an effective per-
ment is in 12-point type; if such quan- mit from the Food and Drug Adminis-
tity is 1 pound or more, the statement tration providing specifically for those
is in 14-point type. Such statement is variations in respect to which the food
enclosed within lines, not less than 6 fails to conform to the applicable defi-
points in width, forming a rectangle; nition and standard of identity. The
but if the statement specified in para- test period will begin on the date the
graph (a) of this section is also used, person holding an effective permit
both statements (one following the from the Food and Drug Administra-
other) may be enclosed within the tion introduces or causes the introduc-
same rectangle. Such statement or tion of the food covered by the permit
statements, with enclosing lines, are into interstate commerce but not later
471
§ 130.17 21 CFR Ch. I (4–1–23 Edition)
than 3 months after notice of the tinguish between the food being tested
issuance of the permit is published in and such food complying with the
the FEDERAL REGISTER. The Food and standard.
Drug Administration shall be notified (10) The period during which the ap-
in writing of the date on which the test plicant desires to introduce such food
period begins as soon as it is deter- into interstate commerce, with a state-
mined. ment of the reasons supporting the
(c) Any person desiring a permit may need for such period. If a period longer
file with the Team Leader, Conven- than 15 months is requested, a detailed
tional Foods Team, Division of Stand- explanation of why a 15-month period
ards and Labeling Regulations, Office is inadequate shall be provided.
of Nutritional Products, Labeling and (11) The probable amount of such
Dietary Supplements, Center for Food food that will be distributed. The
Safety and Applied Nutrition (HFS– amount distributed should be limited
822), 5001 Campus Dr., College Park, to the smallest number of units reason-
MD 20740, a written application in trip- ably required for a bona fide market
licate containing as part thereof the test. Justification for the amount re-
following: quested shall be included.
(1) Name and address of the appli- (12) The areas of distribution.
cant.
(13) The address at which such food
(2) A statement of whether or not the
will be manufactured.
applicant is regularly engaged in pro-
(14) A statement of whether or not
ducing the food involved.
such food has been or is to be distrib-
(3) A reference to the applicable defi-
uted in the State in which it was man-
nition and standard of identity (citing
ufactured.
applicable section of regulations).
(4) A full description of the proposed (15) If it has not been or is not to be
variation from the standard. so distributed, a statement showing
(5) The basis upon which the food so why.
varying is believed to be wholesome (16) If it has been or is to be so dis-
and nondeleterious. tributed, a statement of why it is
(6) The amount of any new ingredient deemed necessary to distribute such
to be added; the amount of any ingre- food in other States.
dient, required by the standard, to be (d) The Food and Drug Administra-
eliminated; any change of concentration may require the applicant to fur-
tion not contemplated by the standard; nish samples of the food varying from
or any change in name that would the standard and to furnish such addi-
more appropriately describe the new tional information as may be deemed
product under test. If such new ingre- necessary for action on the application.
dient is not a commonly known food (e) If the Food and Drug Administra-
ingredient, a description of its prop- tion concludes that the variation may
erties and basis for concluding that it be advantageous to consumers and will
is not a deleterious substance. not result in failure of the food to con-
(7) The purpose of effecting the vari- form to any provision of the act except
ation. section 403(g), a permit shall be issued
(8) A statement of how the variation to the applicant for interstate ship-
is of potential advantage to consumers. ment of such food. The terms and con-
The statement shall include the rea- ditions of the permit shall be those set
sons why the applicant does not con- forth in the application with such
sider the data obtained in any prior in- modifications, restrictions, or quali-
vestigations which may have been con- fications as the Food and Drug Admin-
ducted sufficient to support a petition istration may deem necessary and
to amend the standard. state in the permit.
(9) The proposed label (or an accurate (f) The terms and conditions of the
draft) to be used on the food to be mar- permit may be modified at the discre-
ket tested. The label shall conform in tion of the Food and Drug Administra-
all respects to the general require- tion or upon application of the per-
ments of the act and shall provide a mittee during the effective period of
means whereby the consumer can dis- the permit.
472
(g) The Food and Drug Administra- tion, he shall submit the labeling under
tion may revoke a permit for cause, which the food is to be distributed.
which shall include but not be limited (j) Notice of the granting or revoca-
to the following: tion of any permit shall be published in
(1) That the permittee has introduced the FEDERAL REGISTER.
a food into interstate commerce con- (k) All applications for a temporary
trary to the terms and conditions of permit, applications for an extension of
the permit. a temporary permit, and related
(2) That the application for a permit records are available for public disclo-
contains an untrue statement of a ma- sure when the notice of a permit or ex-
terial fact. tension thereof is published in the FED-
(3) That the need therefor no longer ERAL REGISTER. Such disclosure shall
exists. be in accordance with the rules estab-
(h) During the period within which lished in part 20 of this chapter.
any permit is effective, it shall be (l) Any person who contests denial,
deemed to be included within the terms modification, or revocation of a tem-
of any guaranty or undertaking other- porary permit shall have an oppor-
wise effective pursuant to the provi- tunity for a regulatory hearing before
sions of section 303(c) of the act. the Food and Drug Administration pur-
(i) If an application is made for an suant to part 16 of this chapter.
extension of the permit, it shall be ac- [42 FR 14357, Mar. 15, 1977, as amended at 42
companied by a description of experi- FR 15673, Mar. 22, 1977; 46 FR 37500, July 21,
ments conducted under the permit, 1981; 54 FR 24892, June 12, 1989; 59 FR 15051,
tentative conclusions reached, and rea- Mar. 31, 1994; 66 FR 17359, Mar. 30, 2001; 66 FR
sons why further experimental ship- 56035, Nov. 6, 2001]
ments are considered necessary. The
application for an extension shall be Subpart B—Food Additives in
filed not later than 3 months prior to Standardized Foods
the expiration date of the permit and
shall be accompanied by a petition to § 130.20 Food additives proposed for
amend the affected food standard. If use in foods for which definitions
the Food and Drug Administration con- and standards of identity are estab-
cludes that it will be in the interest of lished.
consumers to issue an extension of the (a) Where a petition is received for
time period for the market test, a no- the issuance or amendment of a regula-
tice will be published in the FEDERAL tion establishing a definition and
REGISTER stating that fact. The notice standard of identity for a food under
will include an invitation to all inter- section 401 of the act, which proposes
ested persons to participate in the mar- the inclusion of a food additive in such
ket test under the same conditions definition and standard of identity, the
that applied to the initial permit hold- provisions of the regulations in part 171
er, including labeling and the amount of this chapter shall apply with respect
to be distributed, except that the des- to the information that must be sub-
ignated area of distribution shall not mitted with respect to the food addi-
apply. The extended market test period tive. Since section 409(b)(5) of the act
shall not begin prior to the publication requires that the Commissioner publish
of a notice in the FEDERAL REGISTER notice of a petition for the establish-
granting the extension and shall termi- ment of a food additive regulation
nate either on the effective date of an within 30 days after filing, notice of a
affirmative order ruling on the pro- petition relating to a definition and
posal or 30 days after a negative order standard of identity shall also be pub-
ruling on the proposal, whichever the lished within that time limitation if it
case may be. Any interested person includes a request, so designated, for
who accepts the invitation to partici- the establishment of a regulation per-
pate in the extended market test shall taining to a food additive.
notify the Food and Drug Administra- (b) If a petition for a definition and
tion in writing of that fact, the amount standard of identity contains a pro-
to be distributed, and the area of disposal for a food additive regulation,
tribution; and along with such notifica- and the petitioner fails to designate it
473
as such, the Commissioner, upon deter- the table of this paragraph and held
mining that the petition includes a continuously at or above that tempera-
proposal for a food additive regulation, ture for the specified time (or other
shall so notify the petitioner and shall time/temperature relationship which
thereafter proceed in accordance with has been demonstrated to be equivalent
the regulations in part 171 of this chap- thereto in microbial destruction):
ter.
Temperature Time
PART 131—MILK AND CREAM 145 °F 1 ..................................................... 30 minutes

161 °F 1 ..................................................... 15 seconds
191 °F ....................................................... 1 second
Subpart A—General Provisions 204 °F ....................................................... 0.05 second
212 °F ....................................................... 0.01 second
Sec.
131.3 Definitions. 1 If the dairy ingredient has a fat content of 10 percent or
131.25 Whipped cream products containing more, or if it contains added sweeteners, the specified tem-
perature shall be increased by 5 °F.
flavoring or sweetening.
(c) Ultra-pasteurized when used to de-
Subpart B—Requirements for Specific scribe a dairy product means that such
Standardized Milk and Cream product shall have been thermally
131.110 Milk. processed at or above 280 °F for at least
131.111 Acidified milk. 2 seconds, either before or after pack-
131.112 Cultured milk. aging, so as to produce a product which
131.115 Concentrated milk. has an extended shelf life under refrig-
131.120 Sweetened condensed milk. erated conditions.
131.125 Nonfat dry milk.
131.127 Nonfat dry milk fortified with vita-
§ 131.25 Whipped cream products con-
mins A and D.
taining flavoring or sweetening.
131.130 Evaporated milk.
131.147 Dry whole milk. The unqualified name ‘‘whipped
131.149 Dry cream. cream’’ should not be applied to any
131.150 Heavy cream. product other than one made by whip-
131.155 Light cream.
ping the cream that complies with the
131.157 Light whipping cream.
131.160 Sour cream. standards of identity for whipping
131.162 Acidified sour cream. cream (§§ 131.150 and 131.157 of this
131.170 Eggnog. chapter). If flavoring and/or sweetening
131.180 Half-and-half. is added, the resulting product is a fla-
131.200 Yogurt. vored and/or sweetened whipped cream,
AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, and should be so identified.
379e.
SOURCE: 42 FR 14360, Mar. 15, 1977, unless Subpart B—Requirements for Spe-
otherwise noted. cific Standardized Milk and
EDITORIAL NOTE: Nomenclature changes to Cream
part 131 appear at 63 FR 14035, Mar. 24, 1998.
§ 131.110 Milk.
Subpart A—General Provisions (a) Description. Milk is the lacteal se-
cretion, practically free from colos-
§ 131.3 Definitions. trum, obtained by the complete milk-
(a) Cream means the liquid milk prod- ing of one or more healthy cows. Milk
uct high in fat separated from milk, that is in final package form for bev-
which may have been adjusted by add- erage use shall have been pasteurized
ing thereto: Milk, concentrated milk, or ultrapasteurized, and shall contain
dry whole milk, skim milk, con- not less than 81⁄4 percent milk solids
centrated skim milk, or nonfat dry not fat and not less than 31⁄4 percent
milk. Cream contains not less than 18 milkfat. Milk may have been adjusted
percent milkfat. by separating part of the milkfat
(b) Pasteurized when used to describe therefrom, or by adding thereto cream,
a dairy product means that every par- concentrated milk, dry whole milk,
ticle of such product shall have been skim milk, concentrated skim milk, or
heated in properly operated equipment nonfat dry milk. Milk may be homog-
to one of the temperatures specified in enized.
474
(b) Vitamin addition (Optional). (1) If appears on the principal display panel
added, vitamin A shall be present in or panels of the label in letters not less
such quantity that each quart of the than one-half the height of the letters
food contains not less than 2000 Inter- used in such name:
national Units thereof within limits of (i) If vitamins are added, the phrase
good manufacturing practice. ‘‘vitamin A’’ or ‘‘vitamin A added’’, or
(2) If added, vitamin D shall be ‘‘vitamin D’’ or ‘‘vitamin D added’’, or
present in such quantity that each ‘‘vitamin A and D’’ or ‘‘vitamins A and
quart of the food contains 400 Inter- D added’’, as is appropriate. The word
national Units thereof within limits of ‘‘vitamin’’ may be abbreviated ‘‘vit.’’.
good manufacturing practice. (ii) The word ‘‘ultra-pasteurized’’ if
(c) Optional ingredients. The following the food has been ultra-pasteurized.
safe and suitable ingredients may be (2) The following terms may appear
used: on the label:
(1) Carriers for vitamins A and D. (i) The word ‘‘pasteurized’’ if the food
(2) Characterizing flavoring ingredi- has been pasteurized.
ents (with or without coloring, nutri- (ii) The word ‘‘homogenized’’ if the
tive sweetener, emulsifiers, and stabi- food has been homogenized.
lizers) as follows: (f) Label declaration. Each of the in-
(i) Fruit and fruit juice (including gredients used in the food shall be de-
concentrated fruit and fruit juice). clared on the label as required by the
(ii) Natural and artificial food applicable sections of parts 101 and 130
flavorings. of this chapter.
(d) Methods of analysis. Referenced [42 FR 14360, Mar. 15, 1977, as amended at 47
methods are from ‘‘Official Methods of FR 11822, Mar. 19, 1982; 49 FR 10090, Mar. 19,
Analysis of the Association of Official 1984; 54 FR 24892, June 12, 1989; 58 FR 2890,
Analytical Chemists,’’ 13th Ed. (1980), Jan. 6, 1993]
which is incorporated by reference.
Copies may be obtained from the AOAC § 131.111 Acidified milk.
INTERNATIONAL, 481 North Frederick (a) Description. Acidified milk is the
Ave., suite 500, Gaithersburg, MD 20877, food produced by souring one or more
or may be examined at the National of the optional dairy ingredients speci-
Archives and Records Administration fied in paragraph (c) of this section
(NARA). For information on the avail- with one or more of the acidifying in-
ability of this material at NARA, call gredients specified in paragraph (d) of
202–741–6030, or go to: http:// this section, with or without the addi-
www.archives.gov/federal_register/ tion of characterizing microbial orga-
code_of_federal_regulations/ nisms. One or more of the other op-
ibr_locations.html. tional ingredients specified in para-
(1) Milkfat content—‘‘Fat, Roese- graphs (b) and (e) of this section may
Gottlieb Method—Official Final Ac- also be added. When one or more of the
tion,’’ section 16.059. ingredients specified in paragraph (e)(1)
(2) Milk solids not fat content—Cal- of this section are used, they shall be
culated by subtracting the milk fat included in the souring process. All in-
content from the total solids content gredients used are safe and suitable.
as determined by the method ‘‘Total Acidified milk contains not less than
Solids, Method I—Official Final Ac- 3.25 percent milkfat and not less than
tion,’’ section 16.032. 8.25 percent milk solids not fat and has
(3) Vitamin D content—‘‘Vitamin D— a titratable acidity of not less than 0.5
Official Final Action,’’ sections 43.195– percent, expressed as lactic acid. The
43.208. food may be homogenized and shall be
(e) Nomenclature. The name of the pasteurized or ultra-pasteurized prior
food is ‘‘milk’’. The name of the food to the addition of the microbial culture
shall be accompanied on the label by a and, when applicable, the addition of
declaration indicating the presence of flakes or granules of butterfat or
any characterizing flavoring, as speci- milkfat.
fied in § 101.22 of this chapter. (b) Vitamin addition (optional). (1) If

(1) The following terms shall accom- added, vitamin A shall be present in
pany the name of the food wherever it such quantity that each 946 milliliters
475
§ 131.111 21 CFR Ch. I (4–1–23 Edition)
(quart) of the food contains not less from ‘‘Official Methods of Analysis of
than 2,000 International Units thereof, the Association of Official Analytical
within limits of good manufacturing Chemists,’’ 13th Ed. (1980), which is in-
practice. corporated by reference. Copies are
(2) If added, vitamin D shall be available from the AOAC INTER-
present in such quantity that each 946 NATIONAL, 481 North Frederick Ave.,
milliliters (quart) of the food contains suite 500, Gaithersburg, MD 20877, or
400 International Units thereof, within available for inspection at the National
limits of good manufacturing practice. Archives and Records Administration
(c) Optional dairy ingredients. Cream, (NARA). For information on the avail-
milk, partially skimmed milk, or skim ability of this material at NARA, call
milk, used alone or in combination. 202–741–6030, or go to: http://
(d) Optional acidifying ingredients. www.archives.gov/federal_register/
Acetic acid, adipic acid, citric acid, fu- code_of_federal_regulations/
maric acid, glucono-delta- lactone, hy- ibr_locations.html.
drochloric acid, lactic acid, malic acid, (1) Milkfat content—As determined
phosphoric acid, succinic acid, and tar- by the method prescribed in section
taric acid. 16.059, ‘‘Roese-Gottlieb Method (Ref-
(e) Other optional ingredients. (1) Con- erence Method) (11)—Official Final Ac-
centrated skim milk, nonfat dry milk, tion,’’ under the heading ‘‘Fat.’’
buttermilk, whey, lactose, (2) Milk solids not fat content—Cal-
lactalbumins, lactoglobulins, or whey culated by subtracting the milkfat con-
modified by partial or complete re- tent from the total solids content as
moval of lactose and/or minerals, to in- determined by the method prescribed
crease the nonfat solids content of the in section 16.032, ‘‘Method I—Official
food: Provided, That the ratio of pro- Final Action,’’ under the heading
tein to total nonfat solids of the food, ‘‘Total Solids.’’
and the protein efficiency ratio of all (3) Titratable acidity—As determined
protein present, shall not be decreased by the method prescribed in section
as a result of adding such ingredients. 16.023, ‘‘Acidity (2)—Official Final Ac-
(2) Nutritive carbohydrate sweet- tion,’’ or by an equivalent potentio-
eners. Sugar (sucrose), beet or cane; in- metric method.
vert sugar (in paste or sirup form); (g) Nomenclature. The name of the
brown sugar; refiner’s sirup; molasses food is ‘‘acidified milk’’. The full name
(other than blackstrap); high fructose of the food shall appear on the prin-
corn sirup; fructose; fructose sirup; cipal display panel of the label in type
maltose; maltose sirup, dried maltose of uniform size, style, and color. The
sirup; malt extract, dried malt extract; name of the food shall be accompanied
malt sirup, dried malt sirup; honey; by a declaration indicating the pres-
maple sugar; or any of the sweeteners ence of any characterizing flavoring as
listed in part 168 of this chapter, except specified in § 101.22 of this chapter, and
table sirup. may be accompanied by a declaration
(3) Flavoring ingredients. such as a traditional name of the food
(4) Color additives that do not impart or the generic name of the organisms
a color simulating that of milkfat or used, thereby indicating the presence
butterfat. of the characterizing microbial orga-
(5) Stabilizers. nisms or ingredients when used, e.g.,
(6) Butterfat or milkfat, which may ‘‘acidified kefir milk’’, ‘‘acidified aci-
or may not contain color additives, in dophilus milk’’, or when characterizing
the form of flakes or granules. ingredients such as those in paragraphs
(7) Aroma- and flavor-producing mi- (e) (6), (7), (8), and (9) of this section are
crobial culture. used, the food may be named ‘‘acidified
(8) Salt. buttermilk’’.
(9) Citric acid, in a maximum amount (1) The following terms shall accom-
of 0.15 percent by weight of the milk pany the name of the food wherever it
used, or an equivalent amount of so- appears on the principal display panel
dium citrate, as a flavor precursor. or panels of the label in letters not less
(f) Methods of analysis. The following than one-half of the height of the let-
referenced methods of analysis are ters used in such name:
476
(i) The phrase ‘‘vitamin A’’ or ‘‘vita- (c) Optional dairy ingredients. Cream,
min A added’’, or ‘‘vitamin D’’ or ‘‘vi- milk, partially skimmed milk, or skim
tamin D added’’, or ‘‘vitamins A and D milk, used alone or in combination.
added’’, as appropriate. The word ‘‘vi- (d) Other optional ingredients. (1) Con-
tamin’’ may be abbreviated ‘‘vit.’’. centrated skim milk, nonfat dry milk,
(ii) The word ‘‘sweetened’’ if nutri- buttermilk, whey, lactose, lactalbum-
tive carbohydrate sweetener is added ins, lactoglobulins, or whey modified
without the addition of characterizing by partial or complete removal of lac-
flavoring. tose and/or minerals, to increase the
(2) The term ‘‘homogenized’’ may ap- nonfat solids content of the food: Pro-
pear on the label if the dairy ingredi- vided, That the ratio of protein to total
ents used are homogenized. nonfat solids of the food, and the pro-
(h) Label declaration. Each of the in- tein efficiency ratio of all protein
gredients used in the food shall be de- present, shall not be decreased as a re-
clared on the label as required by the sult of adding such ingredients.
applicable sections of parts 101 and 130 (2) Nutritive carbohydrate sweet-
of this chapter. eners. Sugar (sucrose), beet or cane; in-
[46 FR 9934, Jan. 30, 1981, as amended at 47 vert sugar (in paste or sirup form);
FR 11822, Mar. 19, 1982; 47 FR 41523, Sept. 21, brown sugar; refiner’s sirup; molasses
1982; 48 FR 24869, June 3, 1983; 54 FR 24892, (other than blackstrap); high fructose
June 12, 1989; 58 FR 2890, Jan. 6, 1993] corn sirup; fructose; fructose sirup;
maltose; maltose sirup, dried maltose
§ 131.112 Cultured milk. sirup; malt extract, dried malt extract;
(a) Description. Cultured milk is the malt sirup, dried malt sirup; honey;
food produced by culturing one or more maple sugar; or any of the sweeteners
of the optional dairy ingredients speci- listed in part 168 of this chapter, except
fied in paragraph (c) of this section table sirup.
with characterizing microbial orga- (3) Flavoring ingredients.
nisms. One or more of the other op- (4) Color additives that do not impart
tional ingredients specified in para- a color simulating that of milkfat or
graphs (b) and (d) of this section may butterfat.
also be added. When one or more of the (5) Stabilizers.
ingredients specified in paragraph (6) Butterfat or milkfat, which may
(d)(1) of this section are used, they or may not contain color additives, in
shall be included in the culturing proc- the form of flakes or granules.
ess. All ingredients used are safe and (7) Aroma- and flavor-producing mi-
suitable. Cultured milk contains not crobial culture.
less than 3.25 percent milkfat and not (8) Salt.
less than 8.25 percent milk solids not (9) Citric acid, in a maximum amount
fat and has a titratable acidity of not of 0.15 percent by weight of the milk
less than 0.5 percent, expressed as lac- used, or an equivalent amount of so-
tic acid. The food may be homogenized dium citrate, as a flavor precursor.
and shall be pasteurized or ultra-pas- (e) Methods of analysis. The following
teurized prior to the addition to the referenced methods of analysis are
microbial culture, and when applicable, from ‘‘Official Methods of Analysis of
the addition of flakes or granules of the Association of Official Analytical
butterfat or milkfat. Chemists,’’ 13th Ed. (1980), which is in-
(b) Vitamin addition (optional). (1) If corporated by reference. Copies may be
added, vitamin A shall be present in obtained from the AOAC INTER-
such quantity that each 946 milliliters NATIONAL, 481 North Frederick Ave.,
(quart) of the food contains not less suite 500, Gaithersburg, MD 20877, or
than 2,000 International Units thereof, available for inspection at the National
within limits of good manufacturing Archives and Records Administration
practice. (NARA). For information on the avail-
(2) If added, vitamin D shall be ability of this material at NARA, call
present in such quantity that each 946 202–741–6030, or go to: http://
milliliters (quart) of the food contains www.archives.gov/federal_register/

400 International Units thereof, within code_of_federal_regulations/
limits of good manufacturing practice. ibr_locations.html.
477
§ 131.115 21 CFR Ch. I (4–1–23 Edition)
(1) Milkfat content—section 16.059, applicable sections of parts 101 and 130
‘‘Roese-Gottlieb Method (Reference of this chapter.
Method) (11)—Official Final Action,’’
[46 FR 9934, Jan. 30, 1981, as amended at 47
under the heading ‘‘Fat.’’ FR 11822, Mar. 19, 1982; 47 FR 41523, Sept. 21,
(2) Milk solids not fat content—Cal- 1982; 48 FR 24869, June 3, 1983; 54 FR 24892,
culated by subtracting the milkfat con- June 12, 1989; 58 FR 2890, Jan. 6, 1993]
tent from the total solids content as
determined by the method prescribed § 131.115 Concentrated milk.
in section 16.032, ‘‘Method I—Official (a) Description. Concentrated milk is
Final Action,’’ under the heading the liquid food obtained by partial re-
‘‘Total Solids.’’ moval of water from milk. The milkfat
(3) Titratable acidity—As determined and total milk solids contents of the
by the methods prescribed in section food are not less than 7.5 and 25.5 per-
16.023 ‘‘Acidity (2)—Official Final Ac- cent, respectively. It is pasteurized,
tion,’’ or by an equivalent potentio- but is not processed by heat so as to
metric method. prevent spoilage. It may be homog-
(f) Nomenclature. The name of the enized.
food is ‘‘cultured milk’’. The full name (b) Vitamin addition (Optional). If
of the food shall appear on the prin- added, vitamin D shall be present in
cipal display panel in type of uniform
such quantity that each fluid ounce of
size, style, and color. The name of the
the food contains 25 International
food shall be accompanied by a declara-
Units thereof, within limits of good
tion indicating the presence of any manufacturing practice.
characterizing flavoring as specified in
(c) Optional ingredients. The following
§ 101.22 of this chapter, and may be ac-
safe and suitable optional ingredients
companied by a declaration such as a
may be used:
traditional name of the food or the ge-
neric name of the organisms used, (1) Carrier for vitamin D.
thereby indicating the presence of the (2) Characterizing flavoring ingredi-
characterizing microbial organisms or ents, with or without coloring, as fol-
ingredients, e.g., ‘‘kefir cultured lows:
milk’’, ‘‘acidophilus cultured milk’’, or (i) Fruit and fruit juice, including
when characterizing ingredients such concentrated fruit and fruit juice.
as those in paragraphs (d) (6), (7), (8), (ii) Natural and artificial food fla-
and (9) of this section, and lactic acid- voring.
producing organisms are used the food (d) Methods of analysis. Referenced
may be named ‘‘cultured buttermilk’’. methods are from ‘‘Official Methods of
(1) The following terms shall accom- Analysis of the Association of Official
pany the name of the food wherever it Analytical Chemists,’’ 13th Ed. (1980),
appears on the principal display panel which is incorporated by reference.
or panels of the label in letters not less Copies may be obtained from the AOAC
than one-half of the height of the let- INTERNATIONAL, 481 North Frederick
ters used in such name: Ave., suite 500, Gaithersburg, MD 20877,
(i) The phrase ‘‘vitamin A’’ or ‘‘vita- or may be examined at the National
min A added’’, or ‘‘vitamin D’’ or ‘‘vi- Archives and Records Administration
tamin D added’’, or ‘‘vitamin A and D (NARA). For information on the avail-
added’’, as appropriate. The word ‘‘vi- ability of this material at NARA, call
tamin’’ may be abbreviated ‘‘vit.’’. 202–741–6030, or go to: http://
(ii) The word ‘‘sweetened’’ if nutri- www.archives.gov/federal_register/
tive carbohydrate sweetener is added code_of_federal_regulations/
without the addition of characterizing ibr_locations.html.
flavoring. (1) Milkfat content—‘‘Fat—Official
(2) The term ‘‘homogenized’’ may ap- Final Action,’’ section 16.172.
pear on the label if the dairy ingredi- (2) Total milk solids—‘‘Total Solids—
ents used are homogenized. Official Final Action,’’ section 16.169.
(g) Label declaration. Each of the in- (3) Vitamin D content—‘‘Vitamin D

gredients used in the food shall be de- in Milk—Official Final Action,’’ sec-
clared on the label as required by the tions 43.195–43.208.
478
(e) Nomenclature. The name of the ined at the National Archives and
food is ‘‘Concentrated milk’’ or alter- Records Administration (NARA). For
natively ‘‘Condensed milk’’. If the food information on the availability of this
contains added vitamin D, the phrase material at NARA, call 202–741–6030, or
‘‘vitamin D’’ or ‘‘vitamin D added’’ go to: http://www.archives.gov/fed-
shall accompany the name of the food eral_register/code_of_federal_regulations/
wherever it appears on the principal ibr_locations.html.
display panel or panels of the label in (d) Nomenclature. The name of the
letters not less than one-half the food is ‘‘Sweetened condensed milk.’’
height of the letters used in such name. The word ‘‘homogenized’’ may appear
The word ‘‘homogenized’’ may appear on the label if the food has been ho-
on the label if the food has been homogenized. The name of the food shall
mogenized. The name of the food shall include a declaration of the presence of
include a declaration of the presence of any characterizing flavoring, as speci-
any characterizing flavoring, as specified in § 101.22 of this chapter.
fied in § 101.22 of this chapter. (e) Label declaration. Each of the in-
(f) Label declaration. Each of the ingredients used in the food shall be de-
gredients used in the food shall be declared on the label as required by the
clared on the label as required by the applicable sections of parts 101 and 130
applicable sections of parts 101 and 130 of this chapter.
of this chapter. [43 FR 21670, May 19, 1978, as amended at 47
[42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11823, Mar. 19, 1982; 49 FR 10091, Mar. 19,
FR 11822, Mar. 19, 1982; 48 FR 13024, Mar. 29, 1984; 54 FR 24892, June 12, 1989; 58 FR 2890,
1983; 49 FR 10090, Mar. 19, 1984; 54 FR 24892, Jan. 6, 1993]
June 12, 1989; 58 FR 2890, Jan. 6, 1993]
§ 131.125 Nonfat dry milk.
§ 131.120 Sweetened condensed milk. (a) Description. Nonfat dry milk is the
(a) Description. Sweetened condensed product obtained by removal of water
milk is the food obtained by partial re- only from pasteurized skim milk. It
moval of water only from a mixture of contains not more than 5 percent by
milk and safe and suitable nutritive weight of moisture, and not more than
carbohydrate sweeteners. The finished 11⁄2 percent by weight of milkfat unless
food contains not less than 8 percent otherwise indicated.
by weight of milkfat, and not less than (b) Optional ingredients. Safe and suit-
28 percent by weight of total milk sol- able characterizing flavoring ingredi-
ids. The quantity of nutritive carbo- ents (with or without coloring and nu-
hydrate sweetener used is sufficient to tritive carbohydrate sweetener) as fol-
prevent spoilage. The food is pasteur- lows:
ized and may be homogenized. (1) Fruit and fruit juice, including
(b) Optional ingredients. The following concentrated fruit and fruit juice.
safe and suitable characterizing fla- (2) Natural and artificial food
voring ingredients, with or without flavorings.
coloring and nutritive carbohydrate (c) Methods of analysis. The following
sweeteners, may be used: referenced methods of analysis are
(1) Fruit and fruit juice, including from ‘‘Official Methods of Analysis of
concentrated fruit and fruit juice. the Association of Official Analytical
(2) Natural and artificial food fla- Chemists,’’ 13th Ed. (1980), which is in-
voring. corporated by reference. Copies may be
(c) Methods of analysis. The milkfat obtained from the AOAC INTER-
content is determined by the method NATIONAL, 481 North Frederick Ave.,
prescribed in ‘‘Official Methods of suite 500, Gaithersburg, MD 20877, or
Analysis of the Association of Official may be examined at the National Ar-
Analytical Chemists,’’ 13th Ed. (1980), chives and Records Administration
section 16.185, under ‘‘Fat—Official (NARA). For information on the avail-
Final Action,’’ which is incorporated ability of this material at NARA, call
by reference. Copies may be obtained 202–741–6030, or go to: http://
from the AOAC INTERNATIONAL, 481 www.archives.gov/federal_register/

North Frederick Ave., suite 500, Gai- code_of_federal_regulations/
thersburg, MD 20877, or may be exam- ibr_locations.html.
479
§ 131.127 21 CFR Ch. I (4–1–23 Edition)
(1) Milkfat content—‘‘Fat in Dried (c) Optional ingredients. The following

Milk—Official Final Action,’’ sections safe and suitable optional ingredients
16.199–16.200. may be used:
(2) Moisture content—‘‘Moisture—Of- (1) Carriers for vitamins A and D.
ficial Final Action,’’ section 16.192. (2) Characterizing flavoring ingredi-
(d) Nomenclature. The name of the ents, with or without coloring and nu-
food is ‘‘Nonfat dry milk’’. If the fat tritive carbohydrate sweetener, as fol-
content is over 11⁄2 percent by weight, lows:
the name of the food on the principal (i) Fruit and fruit juice, including
display panel or panels shall be accom- concentrated fruit and fruit juice.
panied by the statement ‘‘Contains __% (ii) Natural and artificial food
milkfat’’, the blank to be filled in with flavorings.
the percentage to the nearest one- (d) Methods of analysis. The following
tenth of 1 percent of fat contained, referenced methods of analysis are
within limits of good manufacturing from ‘‘Official Methods of Analysis of
practice. The name of the food shall in- the Association of Official Analytical
clude a declaration of the presence of Chemists,’’ 13th Ed. (1980), which is in-
any characterizing flavoring, as speci- corporated by reference. Copies may be
fied in § 101.22 of this chapter. obtained from the AOAC INTER-
(e) Label declaration. Each of the in- NATIONAL, 481 North Frederick Ave.,
gredients used in the food shall be de- suite 500, Gaithersburg, MD 20877, or
clared on the label as required by the may be examined at the National Ar-
applicable sections of parts 101 and 130 chives and Records Administration
of this chapter.
(NARA). For information on the avail-
[42 FR 14360, Mar. 15, 1977, as amended at 43 ability of this material at NARA, call
FR 19836, May 9, 1978; 47 FR 11823, Mar. 19, 202–741–6030, or go to: http://
1982; 49 FR 10091, Mar. 19, 1984; 54 FR 24892, www.archives.gov/federal_register/
June 12, 1989; 58 FR 2890, Jan. 6, 1993] code_of_federal_regulations/
ibr_locations.html.
§ 131.127 Nonfat dry milk fortified
with vitamins A and D. (1) Milkfat content—‘‘Fat in Dried
Milk—Official Final Action,’’ sections
(a) Description. Nonfat dry milk for- 16.199–16.200.
tified with vitamins A and D conforms
(2) Moisture content—‘‘Moisture—Of-
to the standard of identity for nonfat
ficial Final Action,’’ section 16.192.
dry milk, except that vitamins A and D
(3) Vitamin D content—‘‘Vitamin D—
are added as prescribed by paragraph
Official Final Action,’’ sections 43.195–
(b) of this section.
43.208.
(b) Vitamin addition. (1) Vitamin A is
added in such quantity that, when pre- (e) Nomenclature. The name of the
pared according to label directions, food is ‘‘Nonfat dry milk fortified with
each quart of the reconstituted product vitamins A and D’’. If the fat content is
contains 2000 International Units over 11⁄2 percent by weight, the name of
thereof. the food on the principal display panel
(2) Vitamin D is added in such quan- or panels shall be accompanied by the
tity that, when prepared according to statement ‘‘Contains __% milkfat’’, the
label directions, each quart of the re- blank to be filled in to the nearest one-
constituted product contains 400 Inter- tenth of 1 percent with the percentage
national Units thereof. of fat contained within limits of good
(3) The requirements of this para- manufacturing practice. The name of
graph will be deemed to have been met the food shall include a declaration of
if reasonable overages, within limits of the presence of any characterizing fla-
good manufacturing practice, are voring, as specified in § 101.22 of this
present to ensure that the required lev- chapter.
els of vitamins are maintained (f) Label declaration. Each of the in-
gredients used in the food shall be de-
throughout the expected shelf life of

the food under customary conditions of clared on the label as required by the
distribution.
480
applicable sections of parts 101 and 130 NATIONAL, 481 North Frederick Ave.,
of this chapter. suite 500, Gaithersburg, MD 20877, or
may be examined at the National Ar-
FR 19836, May 9, 1978; 43 FR 29769, July 11, chives and Records Administration
1978; 43 FR 36622, Aug. 18, 1978; 47 FR 11823, (NARA). For information on the avail-
Mar. 19, 1982; 49 FR 10091, Mar. 19, 1984; 54 FR ability of this material at NARA, call
24892, June 12, 1989; 58 FR 2890, Jan. 6, 1993] 202–741–6030, or go to: http://
www.archives.gov/federal_register/
§ 131.130 Evaporated milk. code_of_federal_regulations/
(a) Description. Evaporated milk is ibr_locations.html.
the liquid food obtained by partial re- (1) Milkfat content—‘‘Fat—Official
moval of water only from milk. It con- Final Action,’’ section 16.172.
tains not less than 6.5 percent by (2) Total milk solids—‘‘Total Solids—
weight of milkfat, not less than 16.5 Official Final Action,’’ section 16.169.
percent by weight of milk solids not (3) Vitamin D content—‘‘Vitamin D
fat, and not less than 23 percent by in Milk—Official Final Action,’’ sec-
weight of total milk solids. Evaporated tions 43.195–43.208.
milk contains added vitamin D as pre- (e) Nomenclature. The name of the
scribed by paragraph (b) of this section. food is ‘‘Evaporated milk.’’ The phrase
It is homogenized. It is sealed in a con- ‘‘vitamin D’’ or ‘‘vitamin D added’’, or
tainer and so processed by heat, either ‘‘vitamins A and D’’ or ‘‘vitamins A
before or after sealing, as to prevent and D added’’, as is appropriate, shall
spoilage. immediately precede or follow the
(b) Vitamin addition. (1) Vitamin D name of the food wherever it appears
shall be present in such quantity that on the principal display panel or panels
each fluid ounce of the food contains 25 of the label in letters not less than one-
International Units thereof within lim- half the height of the letters used in
its of good manufacturing practice. such name. The name of the food shall
(2) Addition of vitamin A is optional, include a declaration of a the presence
If added, vitamin A shall be present in of any characterizing flavoring, as
such quantity that each fluid ounce of specified in § 101.22 of this chapter.
the food contains not less than 125 (f) Label declaration. Each of the in-
International Units thereof within lim- gredients used in the food shall be de-
its of good maufacturing practice. clared on the label as required by the
(c) Optional ingredients. The following applicable sections of parts 101 and 130
safe and suitable ingredients may be of this chapter.
used: [43 FR 21670, May 19, 1978, as amended at 47
(1) Carriers for vitamins A and D. FR 11823, Mar. 19, 1982; 49 FR 10091, Mar. 19,
(2) Emulsifiers. 1984; 54 FR 24892, June 12, 1989; 58 FR 2890,
(3) Stabilizers, with or without Jan. 6, 1993; 59 FR 17691, Apr. 14, 1994]
dioctyl sodium sulfosuccinate (when
permitted by and complying with the § 131.147 Dry whole milk.
provisions of § 172.810 of this chapter) as (a) Description. Dry whole milk is the
a solubilizing agent. product obtained by removal of water
(4) Characterizing flavoring ingredi- only from pasteurized milk, as defined
ents, with or without coloring and nu- in § 131.110(a), which may have been ho-
tritive carbohydrate sweeteners, as fol- mogenized. Alternatively, dry whole
lows: milk may be obtained by blending
(i) Fruit and fruit juice, including fluid, condensed, or dried nonfat milk
concentrated fruit and fruit juice. with liquid or dried cream or with
(ii) Natural and artificial food fla- fluid, condensed, or dried milk, as ap-
voring. propriate, provided the resulting dry
(d) Methods of analysis. The following whole milk is equivalent in composi-
referenced methods of analysis are tion to that obtained by the method
from ‘‘Official Methods of Analysis of described in the first sentence of this
the Association of Official Analytical paragraph. It contains the lactose,
Chemists,’’ 13th Ed. (1980), which is in- milk proteins, milkfat, and milk min-
corporated by reference. Copies may be erals in the same relative proportions
obtained from the AOAC INTER- as the milk from which it was made. It
481
§ 131.149 21 CFR Ch. I (4–1–23 Edition)
contains not less than 26 percent but (1) Milkfat content—‘‘Fat in Dried
less than 40 percent by weight of Milk—Official Final Action,’’ sections
milkfat on an as is basis. It contains 16.199–16.200.
not more than 5 percent by weight of (2) Moisture content—‘‘Moisture—Of-
moisture on a milk solids not fat basis. ficial Final Action,’’ section 16.192.
(b) Vitamin addition. (1) Addition of (3) Vitamin D content—‘‘Vitamin D—
vitamin A is optional. If added, vita- Official Final Action,’’ sections 43.195–
min A shall be present in such quantity 43.208.
that, when prepared according to label (e) Nomenclature. The name of the
directions, each quart of the reconsti- food is ‘‘Dry whole milk.’’ The name of
tuted product shall contain not less the food shall appear on the principal
than 2,000 International Units thereof. display panel of the label in type of
(2) Addition of vitamin D is optional. uniform size, style, and color. The
If added, vitamin D shall be present in name of the food shall be accompanied
such quantity that, when prepared ac- by a declaration indicating the pres-
cording to label directions, each quart ence of any characterizing flavoring as
of the reconstituted product shall con- specified in § 101.22 of this chapter. The
tain 400 International Units thereof. following phrases in type size not less
(3) The requirements of this para- than one-half the height of the type
graph will be met if reasonable over- size used in such name shall accom-
ages, within limits of good manufac- pany the name of the food wherever it
turing practice, are present to ensure appears on the principal display panel
that the required levels of vitamins are or panels.
maintained throughout the expected (1) The phrase ‘‘Contains __%
shelf life of the food under customary milkfat’’, the blank to be filled in with
conditions of distribution. the whole number closest to the actual
(c) Optional ingredients. The following fat content of the food.
safe and suitable optional ingredients (2) If vitamins are ‘‘added’’, the
may be used: phrase ‘‘vitamin A’’, or ‘‘vitamin A
(1) Carriers for vitamins A and D. added’’, or ‘‘vitamin D’’, or ‘‘vitamin D
(2) Emulsifiers. added’’, or ‘‘vitamins A and D’’, or ‘‘vi-
(3) Stabilizers. tamins A and D added’’, as appropriate.
(4) Anticaking agents. The word ‘‘vitamin’’ may be abbre-
(5) Antioxidants. viated ‘‘vit.’’
(6) Characterizing flavoring ingredi- (f) Label declaration. Each of the in-
ents (with or without coloring and nu- gredients used in the food shall be de-
tritive carbohydrate sweetener) as fol- clared on the label as required by the
lows: applicable sections of parts 101 and 130
(i) Fruit and fruit juice, including of this chapter.
concentrated fruit and fruit juice. [43 FR 19836, May 9, 1978, as amended at 47
(ii) Natural and artificial food fla- FR 11824, Mar. 19, 1982; 49 FR 10092, Mar. 19,
voring. 1984; 54 FR 24893, June 12, 1989; 58 FR 2891,
(d) Methods of analysis. The following Jan. 6, 1993]
referenced methods of analysis are
from ‘‘Official Methods of Analysis of § 131.149 Dry cream.
the Association of Official Analytical (a) Description. Dry cream is the prod-
Chemists,’’ 13th Ed. (1980), which is in- uct obtained by removal of water only
corporated by reference. Copies may be from pasteurized milk or cream or a
obtained from the AOAC INTER- mixture thereof, which may have been
NATIONAL, 481 North Frederick Ave., homogenized. Alternatively, dry cream
suite 500, Gaithersburg, MD 20877, or may be obtained by blending dry milks
may be examined at the National Ar- as defined in §§ 131.125(a) and 131.147(a)
chives and Records Administration with dry cream as appropriate: Pro-
(NARA). For information on the avail- vided, That the resulting product is
ability of this material at NARA, call equivalent in composition to that ob-
202–741–6030, or go to: http:// tained by the method described in the
www.archives.gov/federal_register/ first sentence of this paragraph. It con-

code_of_federal_regulations/ tains not less than 40 percent but less
ibr_locations.html. than 75 percent by weight of milkfat on
482
an as is basis. It contains not more the whole number closest to the actual
than 5 percent by weight of moisture fat content of the food.
on a milk solids not fat basis. (2) The word ‘‘sweetened’’ if no char-
(b) Optional ingredients. The following acterizing flavoring ingredients are
safe and suitable optional ingredients used but nutritive carbohydrate sweet-
may be used: ener is added.
(1) Emulsifiers. (e) Label declaration. Each of the in-
(2) Stabilizers. gredients used in the food shall be de-
(3) Anticaking agents. clared on the label as required by the
(4) Antioxidants. applicable sections of parts 101 and 130
of this chapter.
(5) Nutritive carbohydrate sweet-
eners. [43 FR 19836, May 9, 1978, as amended at 44
(6) Characterizing flavoring ingredi- FR 3965, Jan. 19, 1979; 47 FR 11824, Mar. 19,
ents, with or without coloring, as fol- 1982; 48 FR 13024, Mar. 29, 1983; 49 FR 10092,
Mar. 19, 1984; 54 FR 24893, June 12, 1989; 58 FR
lows: 2891, Jan. 6, 1993; 61 FR 59002, Nov. 20, 1996]
(i) Fruit and fruit juice, including
concentrated fruit and fruit juice. § 131.150 Heavy cream.
(ii) Natural and artificial food fla- (a) Description. Heavy cream is cream
voring. which contains not less than 36 percent
(c) Methods of analysis. The following milkfat. It is pasteurized or ultra-pas-
referenced methods of analysis are teurized, and may be homogenized.
from ‘‘Official Methods of Analysis of (b) Optional ingredients. The following
the Association of Official Analytical safe and suitable optional ingredients
Chemists,’’ 13th Ed. (1980), which is in- may be used:
corporated by reference. Copies may be (1) Emulsifiers.
obtained from the AOAC INTER- (2) Stabilizers.
NATIONAL, 481 North Frederick Ave., (3) Nutritive sweeteners.
suite 500, Gaithersburg, MD 20877, or (4) Characterizing flavoring ingredi-
may be examined at the National Ar- ents (with or without coloring) as fol-
chives and Records Administration lows:
(NARA). For information on the avail- (i) Fruit and fruit juice (including
ability of this material at NARA, call concentrated fruit and fruit juice).
202–741–6030, or go to: http:// (ii) Natural and artificial food fla-
www.archives.gov/federal_register/ voring.
code_of_federal_regulations/ (c) Methods of analysis. The milkfat
ibr_locations.html. content is determined by the method
(1) Milkfat content—‘‘Fat in Dried prescribed in ‘‘Official Methods of
Milk—Official Final Action,’’ sections Analysis of the Association of Official
16.199–16.200. Analytical Chemists,’’ 13th Ed. (1980),
(2) Moisture content—‘‘Moisture—Of- sections 16.156 and 16.059, under ‘‘Fat,
ficial Final Action,’’ section 16.192. Roese-Gottlieb Method—Official Final
(d) Nomenclature. The name of the Action,’’ which is incorporated by ref-
food is ‘‘Dry cream.’’ The name of the erence. Copies may be obtained from
food shall appear on the principal dis- the AOAC INTERNATIONAL, 481 North
play panel of the label in type of uni- Frederick Ave., suite 500, Gaithersburg,
form size, style, and color. The name of MD 20877, or may be examined at the
the food shall be accompanied by a dec- National Archives and Records Admin-
laration indicating the presence of any istration (NARA). For information on
characterizing flavoring as specified in the availability of this material at
§ 101.22 of this chapter. The following NARA, call 202–741–6030, or go to: http://
terms shall accompany the name of the www.archives.gov/federal_register/
food wherever it appears on the prin- code_of_federal_regulations/
cipal display panel or panels of the ibr_locations.html.
label, in letters not less than one-half (d) Nomenclature. (1) The name of the
of the height of the letters used in such food is ‘‘Heavy cream’’ or alternatively
name: ‘‘Heavy whipping cream’’. The name of

(1) The phrase ‘‘Contains __% the food shall be accompanied on the
milkfat’’, the blank to be filled in with label by a declaration indicating the
483
§ 131.155 21 CFR Ch. I (4–1–23 Edition)
presence of any characterizing fla- MD 20877, or may be examined at the

voring, as specified in § 101.22 of this National Archives and Records Admin-
chapter. The following terms shall ac- istration (NARA). For information on
company the name of the food wher- the availability of this material at
ever it appears on the principal display NARA, call 202–741–6030, or go to: http://
panel or panels of the label in letters www.archives.gov/federal_register/
not less than one-half the height of the code_of_federal_regulations/
letters used in such name: ibr_locations.html.
(i) The word ‘‘ultra-pasteurized’’ if (d) Nomenclature. The name of the
the food has been ultra-pasteurized. food is ‘‘Light cream’’, or alternatively
(ii) The word ‘‘sweetened’’ if no char- ‘‘Coffee cream’’ or ‘‘Table cream’’. The
acterizing flavoring ingredients are name of the food shall be accompanied
used, but nutritive sweetener is added. on the label by a declaration indicating
(2) The following terms may appear the presence of any characterizing fla-
on the label: voring, as specified in § 101.22 of this
(i) The word ‘‘pasteurized’’ if the food chapter.
has been pasteurized. (1) The following terms shall accom-
(ii) The word ‘‘homogenized’’ if the pany the name of the food wherever it
food has been homogenized. appears on the principal display panel
(e) Label declaration. Each of the in- or panels of the label in letters not less
gredients used in the food shall be de- than one-half the height of the letters
clared on the label as required by the used in such name:
applicable sections of parts 101 and 130 (i) The word ‘‘ultra-pasteurized’’ if
of this chapter. the food has been ultra-pasteurized.
[42 FR 14360, Mar. 15, 1977, as amended at 47 (ii) The word ‘‘sweetened’’ if no char-
FR 11824, Mar. 19, 1982; 49 FR 10092, Mar. 19, acterizing flavoring ingredients are
1984; 54 FR 24893, June 12, 1989; 58 FR 2891, used, but nutritive sweetener is added.
Jan. 6, 1993] (2) The following terms may appear
on the label:
§ 131.155 Light cream.
(i) The word ‘‘pasteurized’’ if the food
(a) Description. Light cream is cream has been pasteurized.
which contains not less than 18 percent (ii) The word ‘‘homogenized’’ if the
but less than 30 percent milkfat. It is food has been homogenized.
pasteurized or ultra-pasteurized, and (e) Label declaration. Each of the in-
may be homogenized. gredients used in the food shall be de-
(b) Optional ingredients. The following clared on the label as required by the
safe and suitable ingredients may be applicable sections of parts 101 and 130
used: of this chapter.
(1) Stabilizers.
(2) Emulsifiers. [42 FR 14360, Mar. 15, 1977, as amended at 47
(3) Nutritive sweeteners. FR 11824, Mar. 19, 1982; 49 FR 10092, Mar. 1,
(4) Characterizing flavoring ingredi- 1984; 54 FR 24893, June 12, 1989; 58 FR 2891,
Jan. 6, 1993]
ents (with or without coloring) as fol-
lows: § 131.157 Light whipping cream.
(i) Fruit and fruit juice (including
concentrated fruit and fruit juice). (a) Description. Light whipping cream
(ii) Natural and artificial food fla- is cream which contains not less than
voring. 30 percent but less than 36 percent
(c) Methods of analysis. The milkfat milkfat. It is pasteurized or ultra-pas-
content is determined by the method teurized, and may be homogenized.
prescribed in ‘‘Official Methods of (b) Optional ingredients. The following
Analysis of the Association of Official safe and suitable optional ingredients
Analytical Chemists,’’ 13th Ed. (1980), may be used:
sections 16.156 and 16.059, under ‘‘Fat, (1) Emulsifiers.
Roese-Gottlieb Method—Official Final (2) Stabilizers.
Action,’’ which is incorporated by ref- (3) Nutritive sweeteners.
erence. Copies may be obtained from (4) Characterizing flavoring ingredi-

the AOAC INTERNATIONAL, 481 North ents (with or without coloring) as fol-
Frederick Ave., suite 500, Gaithersburg, lows:
484
(i) Fruit and fruit juice (including § 131.160 Sour cream.

concentrated fruit and fruit juice). (a) Description. Sour cream results
(ii) Natural and artificial food fla- from the souring, by lactic acid pro-
voring. ducing bacteria, of pasteurized cream.
(c) Methods of analysis. The milkfat Sour cream contains not less than 18
content is determined by the method percent milkfat; except that when the
prescribed in ‘‘Official Methods of food is characterized by the addition of
Analysis of the Association of Official nutritive sweeteners or bulky flavoring
Analytical Chemists,’’ 13th Ed. (1980), ingredients, the weight of the milkfat
sections 16.156 and 16.059, under ‘‘Fat, is not less than 18 percent of the re-
Roese-Gottlieb Method—Official Final mainder obtained by subtracting the
Action,’’ which is incorporated by ref- weight of such optional ingredients
erence. Copies may be obtained from from the weight of the food; but in no
the AOAC INTERNATIONAL, 481 North case does the food contain less than
Frederick Ave., suite 500, Gaithersburg, 14.4 percent milkfat. Sour cream has a
MD 20877, or may be examined at the titratable acidity of not less than 0.5
National Archives and Records Admin- percent, calculated as lactic acid.
istration (NARA). For information on (b) Optional ingredients. (1) Safe and
the availability of this material at suitable ingredients that improve tex-
NARA, call 202–741–6030, or go to: http:// ture, prevent syneresis, or extend the
www.archives.gov/federal_register/ shelf life of the product.
code_of_federal_regulations/ (2) Sodium citrate in an amount not
ibr_locations.html. more than 0.1 percent may be added
prior to culturing as a flavor precursor.
(d) Nomenclature. The name of the
(3) Rennet.
food is ‘‘Light whipping cream’’ or al-
(4) Safe and suitable nutritive sweet-
ternatively ‘‘Whipping cream’’. The eners.
name of the food shall be accompanied (5) Salt.
on the label by a declaration indicating (6) Flavoring ingredients, with or
the presence of any characterizing fla- without safe and suitable coloring, as
voring, as specified in § 101.22 of this follows:
chapter. (i) Fruit and fruit juice (including
(1) The following terms shall accom- concentrated fruit and fruit juice).
pany the name of the food wherever it (ii) Safe and suitable natural and ar-
appears on the principal display panel tificial food flavoring.
or panels of the label in letters not less (c) Methods of analysis. Referenced
than one-half the height of the letters methods in paragraph (c) (1) and (2) of
used in such name: this section are from ‘‘Official Methods
(i) The word ‘‘ultra-pasteurized’’ if of Analysis of the Association of Offi-
the food has been ultra-pasteurized. cial Analytical Chemists,’’ 13th Ed.
(ii) The word ‘‘sweetened’’ if no char- (1980), which is incorporated by ref-
acterizing flavoring ingredients are erence. Copies may be obtained from
used, but nutritive sweetener is added. the AOAC INTERNATIONAL, 481 North
(2) The following terms may appear Frederick Ave., suite 500, Gaithersburg,
on the label: MD 20877, or may be examined at the
(i) The word ‘‘pasteurized’’ if the food National Archives and Records Admin-
istration (NARA). For information on
has been pasteurized.
the availability of this material at
(ii) The word ‘‘homogenized’’ if the
NARA, call 202–741–6030, or go to: http://
food has been homogenized. www.archives.gov/federal_register/
(e) Label declaration. Each of the in- code_of_federal_regulations/
gredients used in the food shall be de- ibr_locations.html.
clared on the label as required by the (1) Milkfat content—‘‘Fat—Official
applicable sections of parts 101 and 130 Final Action,’’ section 16.172.
of this chapter. (2) Titratable acidity—‘‘Acidity—Of-
[42 FR 14360, Mar. 15, 1977, as amended at 47 ficial Final Action,’’ section 16.023.
FR 11824, Mar. 19, 1982; 49 FR 10092, Mar. 19, (d) Nomenclature. The name of the
1984; 54 FR 24893, June 12, 1989; 58 FR 2891, food is ‘‘Sour cream’’ or alternatively
Jan. 6, 1993] ‘‘Cultured sour cream’’. The full name
485
§ 131.162 21 CFR Ch. I (4–1–23 Edition)
of the food shall appear on the prin- this section are from ‘‘Official Methods
cipal display panel of the label in type of Analysis of the Association of Offi-
of uniform size, style, and color. The cial Analytical Chemists,’’ 13th Ed.
name of the food shall be accompanied (1980), which is incorporated by ref-
by a declaration indicating the pres- erence. Copies may be obtained from
ence of any flavoring that character- the AOAC INTERNATIONAL, 481 North
izes the product, as specified in § 101.22 Frederick Ave., suite 500, Gaithersburg,
of this chapter. If nutritive sweetener MD 20877, or may be examined at the
in an amount sufficient to characterize National Archives and Records Admin-
the food is added without addition of istration (NARA). For information on
characterizing flavoring, the name of the availability of this material at
the food shall be preceded by the word NARA, call 202–741–6030, or go to: http://
‘‘sweetened’’. www.archives.gov/federal_register/
(e) Label declaration. Each of the in- code_of_federal_regulations/
gredients used in the food shall be de- ibr_locations.html.
clared on the label as required by the (1) Milkfat content—‘‘Fat—Official
applicable sections of parts 101 and 130 Final Action,’’ section 16.172.
of this chapter. (2) Titratable acidity—‘‘Acidity—Of-
ficial Final Action,’’ section 16.023.
FR 11824, Mar. 19, 1982; 49 FR 10092, Mar. 19,
(d) Nomenclature. The name of the
1984; 54 FR 24893, June 12, 1989; 58 FR 2891, food is ‘‘Acidified sour cream’’. The full
Jan. 6, 1993] name of the food shall appear on the
principal display panel of the label in
§ 131.162 Acidified sour cream. type of uniform size, style, and color.
(a) Description. Acidified sour cream The name of the food shall be accom-
results from the souring of pasteurized panied by a declaration indicating the
cream with safe and suitable acidifiers, presence of any flavoring that charac-
with or without addition of lactic acid terizes the product, as specified in
producing bacteria. Acidified sour § 101.22 of this chapter. If nutritive
cream contains not less than 18 percent sweetener in an amount sufficient to
milkfat; except that when the food is characterize the food is added without
characterized by the addition of nutri- addition of characterizing flavoring,
tive sweeteners or bulky flavoring in- the name of the food shall be preceded
gredients, the weight of milkfat is not by the word ‘‘sweetened’’.
less than 18 percent of the remainder (e) Label declaration. Each of the in-
obtained by subtracting the weight of gredients used in the food shall be de-
such optional ingredients from the clared on the label as required by the
weight of the food; but in no case does applicable sections of parts 101 and 130
the food contain less than 14.4 percent of this chapter.
milkfat. Acidified sour cream has a ti- [42 FR 14360, Mar. 15, 1977, as amended at 47
tratable acidity of not less than 0.5 per- FR 11825, Mar. 19, 1982; 49 FR 10092, Mar. 19,
cent, calculated as lactic acid. 1984; 54 FR 24893, June 12, 1989; 58 FR 2891,
(b) Optional ingredients. (1) Safe and Jan. 6, 1993]
suitable ingredients that improve tex-
ture, prevent syneresis, or extend the § 131.170 Eggnog.
shelf life of the product. (a) Description. Eggnog is the food
(2) Rennet. containing one or more of the optional
(3) Safe and suitable nutritive sweet- dairy ingredients specified in para-
eners. graph (b), one or more of the optional
(4) Salt. egg yolk-containing ingredients speci-
(5) Flavoring ingredients, with or fied in paragraph (c) of this section,
without safe and suitable coloring, as and one or more of the optional nutri-
follows: tive carbohydrate sweeteners specified
(i) Fruit and fruit juice, including in paragraph (d) of this section. One or
concentrated fruit and fruit juice. more of the optional ingredients speci-
(ii) Safe and suitable natural and ar- fied in paragraph (e) of this section
tificial food flavoring. may also be added. All ingredients used

(c) Methods of analysis. Referenced are safe and suitable. Eggnog contains
methods in paragraphs (c) (1) and (2) of not less than 6 percent milkfat and not
486
less than 8.25 percent milk solids not Archives and Records Administration
fat. The egg yolk solids content is not (NARA). For information on the avail-
less than 1 percent by weight of the fin- ability of this material at NARA, call
ished food. The food shall be pasteur- 202–741–6030, or go to: http://
ized or ultra-pasteurized and may be www.archives.gov/federal_register/
homogenized. Flavoring ingredients code_of_federal_regulations/
and color additives may be added after ibr_locations.html.
the food is pasteurized or ultra-pas- (1) Milkfat content—As determined
teurized. by the method prescribed in section
(b) Optional dairy ingredients. Cream, 16.059, ‘‘Roese-Gottlieb Method (Ref-
milk, partially skimmed milk, or skim erence Method) (11)—Official Final Ac-
milk, used alone or in combination. tion,’’ under the heading ‘‘Fat.’’
(c) Egg yolk-containing ingredients. (2) Milk solids not fat content—Cal-
Liquid egg yolk, frozen egg yolk, dried culated by subtracting the milkfat con-
egg yolk, liquid whole eggs, frozen tent from the total solids content as
whole eggs, dried whole eggs, or any determined by the method prescribed
one or more of the foregoing ingredi- in section 16.032, ‘‘Method I—Official
ents with liquid egg white or frozen egg Final Action,’’ under the heading
white. ‘‘Total Solids.’’
(d) Nutritive carbohydrate sweeteners. (g) Nomenclature. The name of the
Sugar (sucrose), beet or cane; invert food is ‘‘eggnog’’. The name of the food
sugar (in paste or sirup form); brown shall be accompanied by a declaration
sugar; refiner’s sirup; molasses (other indicating the presence of any charac-
than blackstrap); high fructose corn terizing flavoring as specified in § 101.22
sirup; fructose; fructose sirup; maltose; of this chapter. If the food is ultra-pas-
maltose sirup, dried maltose sirup; teurized, the phrase ‘‘ultra-pasteur-
malt extract, dried malt extract; malt ized’’ shall accompany the name of the
sirup, dried malt sirup; honey; maple food wherever it appears on the label in
sugar; or any of the sweeteners listed letters not less than one-half of the
in part 168 of this chapter, except table height of the letters used in the name.
sirup. The following terms may accompany
(e) Other optional ingredients. (1) Con- the name of the food on the label:
centrated skim milk, nonfat dry milk, (1) The word ‘‘pasteurized’’ if the food
buttermilk, whey, lactose, has been pasteurized.
lactalbumins, lactoglobulins, or whey (2) The word ‘‘homogenized’’ if the
modified by partial or complete re- food has been homogenized.
moval of lactose and/or minerals, to in- (h) Label declaration. Each of the in-
crease the nonfat solids content of the gredients used in the food shall be de-
food: Provided, That the ratio of pro- clared on the label as required by the
tein to total nonfat solids of the food, applicable sections of parts 101 and 130
and the protein efficiency ratio of all of this chapter.
protein present shall not be decreased [46 FR 9938, Jan. 30, 1981, as amended at 47
as a result of adding such ingredients. FR 11825, Mar. 19, 1982; 47 FR 41524, Sept. 21,
(2) Salt. 1982; 47 FR 49638, Nov. 2, 1982; 48 FR 24869,
(3) Flavoring ingredients. June 3, 1983; 54 FR 24893, June 12, 1989; 58 FR
(4) Color additives that do not impart 2891, Jan. 6, 1993]
a color simulating that of egg yolk,
milkfat, or butterfat. § 131.180 Half-and-half.
(5) Stabilizers. (a) Description. Half-and-half is the
(f) Methods of analysis. The following food consisting of a mixture of milk
referenced methods of analysis are and cream which contains not less than
from ‘‘Official Methods of Analysis of 10.5 percent but less than 18 percent
the Association of Official Analytical milkfat. It is pasteurized or ultra-pas-
Chemists,’’ 13th Ed. (1980), which is in- teurized, and may be homogenized.
corporated by reference. Copies are (b) Optional ingredients. The following
available from the AOAC INTER- safe and suitable optional ingredients
NATIONAL, 481 North Frederick Ave., may be used:

suite 500, Gaithersburg, MD 20877, or (1) Emulsifiers.
available for inspection at the National (2) Stabilizers.
487
§ 131.200 21 CFR Ch. I (4–1–23 Edition)
(3) Nutritive sweeteners. applicable sections of parts 101 and 130

(4) Characterizing flavoring ingredi- of this chapter.
ents (with or without coloring) as fol- [42 FR 14360, Mar. 15, 1977, as amended at 47
lows: FR 11825, Mar. 19, 1982; 49 FR 10092, Mar. 19,
(i) Fruit and fruit juice (including 1984; 54 FR 24893, June 12, 1989; 58 FR 2891,
concentrated fruit and fruit juice). Jan. 6, 1993]
(ii) Natural and artificial food fla- § 131.200 Yogurt.
voring.
(c) Methods of analysis. The milkfat (a) Description. Yogurt is the food
produced by culturing one or more of
content is determined by the method
the basic dairy ingredients specified in
prescribed in ‘‘Official Methods of
paragraph (b) of this section and any of
Analysis of the Association of Official the optional dairy ingredients specified
Analytical Chemists,’’ 13th Ed. (1980), in paragraph (c) of this section with a
in sections 16.156 and 16.059, under characterizing bacterial culture that
‘‘Fat, Roese-Gottlieb Method—Official contains the lactic acid-producing bac-
Final Action,’’ which is incorporated teria, Lactobacillus delbrueckii subsp.
by reference. Copies may be obtained bulgaricus and Streptococcus
from the AOAC INTERNATIONAL, 481 thermophilus. The ingredients specified
North Frederick Ave., suite 500, Gai- in paragraphs (b) and (c) of this section
thersburg, MD 20877, at the National may be homogenized and must be pas-
Archives and Records Administration teurized or ultra-pasteurized before the
(NARA). For information on the avail- addition of the characterizing bacterial
ability of this material at NARA, call culture. One or more of the other op-
202–741–6030, or go to: http:// tional ingredients specified in para-
www.archives.gov/federal_register/ graph (d) of this section may also be
code_of_federal_regulations/ added. Yogurt, before the addition of
ibr_locations.html. bulky flavoring ingredients, contains
(d) Nomenclature. The name of the not less than 3.25 percent milkfat and
food is ‘‘Half-and-half’’. The name of not less than 8.25 percent milk solids
the food shall be accompanied on the not fat and has either a titratable acid-
ity of not less than 0.7 percent, ex-
label by a declaration indicating the
pressed as lactic acid, or a pH of 4.6 or
presence of any characterizing fla-
lower. To extend the shelf life of the
voring, as specified in § 101.22 of this
food, yogurt may be treated after cul-
chapter. turing to inactivate viable microorga-
(1) The following terms shall accom- nisms.
pany the name of the food wherever it (b) Basic dairy ingredients. Cream,
appears on the principal display panel milk, partially skimmed milk, skim
or panels of the label in letters not less milk, or the reconstituted versions of
than one-half the height of the letters these ingredients may be used alone or
used in such name: in combination.
(i) The word ‘‘ultra-pasteurized’’ if (c) Optional dairy ingredients. Other
the food has been ultra-pasteurized. safe and suitable milk-derived ingredi-
(ii) The word ‘‘sweetened’’ if no char- ents may be used to increase the milk
acterizing flavor ingredients are used, solids not fat content of the food above
but nutritive sweetener is added. the minimum of 8.25 percent required
(2) The following terms may appear in paragraph (a) of this section, pro-
on the label: vided that the ratio of protein to total
nonfat solids of the food, and the pro-
(i) The word ‘‘pasteurized’’ if the food
tein efficiency ratio of all protein
has been pasteurized.
present must not be decreased as a re-
(ii) The word ‘‘homogenized’’ if the sult of adding such ingredients.
food has been homogenized. (d) Other optional ingredients. The fol-
(e) Label declaration. Each of the in- lowing safe and suitable ingredients
gredients used in the food shall be de- may be used:
clared on the label as required by the
(1) Cultures, in addition to the char-

acterizing bacterial culture specified in
paragraph (a) of this section.
488
(2) Sweeteners. (i) The word ‘‘sweetened’’ if a nutri-

(3) Flavoring ingredients. tive carbohydrate sweetener is added
(4) Color additives. without the addition of characterizing
(5) Stabilizers. flavor.
(6) Emulsifiers. (ii) The phrase ‘‘does not contain live
(7) Preservatives. and active cultures’’ if the dairy ingre-
(8) Vitamin addition (optional). dients have been treated after cul-
(i) If added, vitamin A must be turing to inactivate viable microorga-
present in such quantity that the food nisms.
contains not less than 10 percent Daily (iii) The phrase ‘‘vitamin A’’ or ‘‘vi-
Value per Reference Amount Com- tamin A added’’, or ‘‘vitamin D’’ or
monly Consumed (RACC) thereof, with- ‘‘vitamin D added’’, or ‘‘vitamins A and
in limits of current good manufac- D added’’, as appropriate. The word
turing practice. ‘‘vitamin’’ may be abbreviated ‘‘vit’’.
(ii) If added, vitamin D must be (2) The name of the food may be ac-
present in such quantity that the food companied by the phrase ‘‘contains live
contains not less than 10 percent Daily and active cultures’’ or another appro-
Value per Reference Amount Com- priate descriptor if the food contains a
monly Consumed (RACC) thereof, with- minimum level of live and active cul-
in limits of current good manufactures of 107 colony forming units per
turing practices. gram (CFU/g) at the time of manufac-
(e) Methods of analysis—(1) Milk—(i) ture with a reasonable expectation of
Milkfat content. As determined by the 106 CFU/g through the manufacturer’s
method prescribed in section 33.2.26, assigned shelf life of the product.
AOAC Official Method 989.05, Fat in (3) The term ‘‘homogenized’’ may ap-
Milk Modified Mojonnier Ether Extrac- pear on the label if the dairy ingredi-
tion Method. ents used are homogenized.
(ii) Milk solids not fat. Calculated by (g) Yogurt containing less than 3.25 per-
subtracting the milkfat content from cent milkfat. (1) Yogurt may contain
the total solids content using the less than 3.25 percent milkfat and at
method prescribed in section 33.2.45, least 2.44 percent milkfat. If the
AOAC Official Method 990.21, Solids- milkfat content is below 2.44 percent,
Not-Fat in Milk by Difference between the product is considered a modified
Total Solids and Fat Contents. food and is covered under § 130.10 of this
(iii) Titratable acidity. As determined chapter.
by the method prescribed in section (2) Yogurt with milkfat content less
33.2.06, AOAC Official Method 947.05, than 3.25 percent and at least 2.44 per-
Acidity of Milk Titrimetric Method. cent milkfat, must be labeled with the
(2) pH. As determined by the poten- following two phrases in the statement
tiometric method described in of identity, which must appear to-
§ 114.90(a) of this chapter. gether:
(3) Live and active cultures. As deter- (i) The word ‘‘yogurt’’ in type of the
mined by the method described in ISO same size and style.
7889:2003(E)/IDF 117:2003(E), Yogurt— (ii) The statement ‘‘ll percent
Enumeration of Characteristic Micro- milkfat,’’ the blank being filled in with
organisms—Colony-Count Technique at the nearest half percent to the actual
37 °C. milkfat content of the product. This
(f) Nomenclature. The name of the statement of milkfat content must ap-
food is ‘‘yogurt.’’ The name of the food pear in letters not less than one-half of
must be accompanied by a declaration the height of the letters in the phrase
indicating the presence of any charac- specified in paragraph (g)(2)(i) of this
terizing flavoring as specified in § 101.22 section, but in no case less than one-
of this chapter. eighth of an inch in height.
(1) The following term(s) must ac- (3) Yogurt with milkfat less than 3.25
company the name of the food wher- percent and at least 2.44 percent
ever it appears on the principal display milkfat must comply with this stand-
panel or panels of the label in letters ard, except that it may deviate as de-
not less than one-half of the height of scribed in § 130.10 (b), (c), and (d) of this
the letters used in such name: chapter.
489
(h) Label declaration. Each of the in- PART 133—CHEESES AND RELATED
gredients used in the food must be de- CHEESE PRODUCTS
clared on the label as required by the
applicable sections of parts 101 and 130 Subpart A—General Provisions
of this chapter.
(i) Incorporation by reference. The Sec.
standards required in this section are 133.3 Definitions.
133.5 Methods of analysis.
incorporated by reference into this sec- 133.10 Notice to manufacturers, packers,
tion with the approval of the Director and distributors of pasteurized blended
of the Federal Register under 5 U.S.C. cheese, pasteurized process cheese,
552(a) and 1 CFR part 51. To enforce cheese food, cheese spread, and related
any edition other than that specified in foods.
this section, FDA must publish a docu-
ment in the FEDERAL REGISTER, and Subpart B—Requirements for Specific
the material must be available to the Standardized Cheese and Related
public. All approved material is avail- Products
able for inspection at the Food and 133.102 Asiago fresh and asiago soft cheese.
Drug Administration’s Dockets Man- 133.103 Asiago medium cheese.
agement Staff, 5630 Fishers Lane, Rm. 133.104 Asiago old cheese.
1061, Rockville, MD 20852, 240–402–7500, 133.106 Blue cheese.
and is available from the sources indi- 133.108 Brick cheese.
cated in this paragraph (i). It is also 133.109 Brick cheese for manufacturing.
133.111 Caciocavallo siciliano cheese.
available for inspection at the National 133.113 Cheddar cheese.
Archives and Records Administration 133.114 Cheddar cheese for manufacturing.
(NARA). For information on the avail- 133.116 Low sodium cheddar cheese.
ability of this material at NARA, email 133.118 Colby cheese.
fedreg.legal@nara.gov or go to 133.119 Colby cheese for manufacturing.
www.archives.gov/federal-register/cfr/ibr- 133.121 Low sodium colby cheese.
locations.html. 133.123 Cold-pack and club cheese.
133.124 Cold-pack cheese food.
(1) AOAC INTERNATIONAL, 2275 Re- 133.125 Cold-pack cheese food with fruits,
search Blvd., Suite 300, Rockville, MD vegetables, or meats.
20850–3250: 133.127 Cook cheese, koch kaese.
(i) AOAC Official Method 947.05, Acid- 133.128 Cottage cheese.
ity of Milk Titrimetric Method, Sec- 133.129 Dry curd cottage cheese.
tion 33.2.06, Official Methods of Anal- 133.133 Cream cheese.
ysis, 21st edition, 2019, Vol. 1. 133.134 Cream cheese with other foods.
133.136 Washed curd and soaked curd cheese.
(ii) AOAC Official Method 989.05, Fat 133.137 Washed curd cheese for manufac-
in Milk Modified Mojonnier Ether Ex- turing.
traction Method, Section 33.2.26, Offi- 133.138 Edam cheese.
cial Methods of Analysis, 21st edition, 133.140 Gammelost cheese.
2019, Vol. 1. 133.141 Gorgonzola cheese.
(iii) AOAC Official Method 990.21, 133.142 Gouda cheese.
Solids-Not-Fat in Milk by Difference 133.144 Granular and stirred curd cheese.
133.145 Granular cheese for manufacturing.
between Total Solids and Fat Contents, 133.146 Grated cheeses.
Section 33.2.45, Official Methods of 133.147 Grated American cheese food.
Analysis, 21st edition, 2019, Vol. 1. 133.148 Hard grating cheeses.
(2) ISO, ISO Central Secretariat, Che- 133.149 Gruyere cheese.
min de Blandonnet 8, CP 401, 1214 133.150 Hard cheeses.
Vernier, Geneva, Switzerland. 133.152 Limburger cheese.
133.153 Monterey cheese and monterey jack
(i) ISO 7889:2003(E), Yogurt—Enu-
cheese.
meration of Characteristic Microorga- 133.154 High-moisture jack cheese.
nisms—Colony-Count Technique at 37 133.155 Mozzarella cheese and scamorza
°C, First edition, 2003–02–01. cheese.
NOTE 1 TO PARAGRAPH (h)(2)(i): ISO 133.156 Low-moisture mozzarella and
7889:2003(E) is co-published as IDF 117:2003(E). scamorza cheese.
(ii) [Reserved] 133.157 Part-skim mozzarella and scamorza
cheese.
[86 FR 31137, June 11, 2021, as amended at 87 133.158 Low-moisture part-skim mozzarella
FR 76568, Dec. 15, 2022] and scamorza cheese.
490
133.160 Muenster and munster cheese. (c) Cream means cream, reconstituted
133.161 Muenster and munster cheese for cream, dry cream, and plastic cream.
manufacturing. Water, in a sufficient quantity to re-
133.162 Neufchatel cheese.
133.164 Nuworld cheese. constitute concentrated and dry forms,
133.165 Parmesan and reggiano cheese. may be added.
133.167 Pasteurized blended cheese. (d) Pasteurized when used to describe
133.168 Pasteurized blended cheese with a dairy ingredient means that every
fruits, vegetables, or meats. particle of such ingredient shall have
133.169 Pasteurized process cheese. been heated in properly operated equip-
133.170 Pasteurized process cheese with
fruits, vegetables, or meats. ment to one of the temperatures speci-
133.171 Pasteurized process pimento cheese. fied in the table of this paragraph and
133.173 Pasteurized process cheese food. held continuously at or above that
133.174 Pasteurized process cheese food with temperature for the specified time (or
fruits, vegetables, or meats. other time/temperature relationship
133.175 Pasteurized cheese spread. which has been demonstrated to be
133.176 Pasteurized cheese spread with
equivalent thereto in microbial de-
fruits, vegetables, or meats.
133.178 Pasteurized neufchatel cheese spread struction):
with other foods.
Temperature Time
133.179 Pasteurized process cheese spread.
133.180 Pasteurized process cheese spread 145 °F1 ................................................................ 30 min.
with fruits, vegetables, or meats. 161 °F1 ................................................................ 15 s.
133.181 Provolone cheese. 191 °F .................................................................. 1 s.
133.182 Soft ripened cheeses. 204 °F .................................................................. 0.05 s.
133.183 Romano cheese. 212 °F .................................................................. 0.01 s.
133.184 Roquefort cheese, sheep’s milk blue-
1 If the dairy ingredient has a fat content of 10 percent or
mold, and blue-mold cheese from sheep’s
more, the specified temperature shall be increased by 5 °F.
milk.
133.185 Samsoe cheese. (e) Ultrapasteurized when used to de-
133.186 Sap sago cheese. scribe a dairy ingredient means that
133.187 Semisoft cheeses.
133.188 Semisoft part-skim cheeses.
such ingredient shall have been ther-
133.189 Skim milk cheese for manufac- mally processed at or above 280 °F for
turing. at least 2 seconds.
133.190 Spiced cheeses.
133.191 Part-skim spiced cheeses. [48 FR 2742, Jan. 21, 1983; 48 FR 11426, Mar. 18,
133.193 Spiced, flavored standardized 1983]
cheeses.
133.195 Swiss and emmentaler cheese. § 133.5 Methods of analysis.
133.196 Swiss cheese for manufacturing. Moisture, milkfat, and phosphatase
AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, levels in cheeses will be determined by
379e. the following methods of analysis from
‘‘Official Methods of Analysis of the
Subpart A—General Provisions Association of Official Analytical
Chemists,’’ 13th ed., 1980, which is in-
§ 133.3 Definitions. corporated by reference (copies are
(a) Milk means the lacteal secretion, available from the AOAC INTER-
practically free from colostrum, ob- NATIONAL, 481 North Frederick Ave.,
tained by the complete milking of one suite 500, Gaithersburg, MD 20877, or
or more healthy cows, which may be available for inspection at the National
clarified and may be adjusted by sepa- Archives and Records Administration
rating part of the fat therefrom; con- (NARA). For information on the avail-
centrated milk, reconstituted milk, ability of this material at NARA, call
and dry whole milk. Water, in a suffi- 202–741–6030, or go to: http://
cient quantity to reconstitute con- www.archives.gov/federal_register/
centrated and dry forms, may be added. code_of_federal_regulations/
(b) Nonfat milk means skim milk, ibr_locations.html):
concentrated skim milk, reconstituted (a) Moisture content—section 16.233
skim milk, and nonfat dry milk. Water, ‘‘Method I (52)—Official Final Action’’,
under the heading ‘‘Moisture’’.
in a sufficient quantity to reconstitute

concentrated and dry forms, may be (b) Milkfat content—section 16.255
added. ‘‘Fat (60)—Official Final Action’’.
491
§ 133.10 21 CFR Ch. I (4–1–23 Edition)
(c) Phenol equivalent value—section nence. The names of the optional ingre-
16.275 ‘‘Reagents’’, section 16.276 dients should appear prominently and
‘‘Sampling’’, and section 16.277 ‘‘Deter- conspicuously but should not be dis-
mination’’, under the heading ‘‘Resid- played with greater prominence than
ual Phosphatase (27) Official Final Ac- the name of the food. The word ‘‘con-
tion’’. tains’’ may precede the names of the
(d) Milkfat in solids (fat on a dry optional ingredients, and when so used
basis)—Subtract the percent of mois- will not be considered as intervening
ture found from 100; divide the remain- printed matter between name of food
der into the percent milkfat found. The and name of optional ingredients re-
quotient, multiplied by 100, shall be quired to be placed on the label.
considered to be the percent of milkfat (d) Where a manufacturer elects to
contained in the solids. include a label statement of fat and
moisture content, the declaration
[48 FR 2742, Jan. 21, 1983; 48 FR 11426, Mar. 18, should be on the basis of the food as
1983, as amended at 54 FR 24893, June 12, 1989;
marketed. A fat declaration on a mois-
63 FR 14035, Mar. 24, 1998]
ture-free basis is likely to be mis-
§ 133.10 Notice to manufacturers, leading, and should not be used in la-
packers, and distributors of pas- beling.
teurized blended cheese, pasteur-
ized process cheese, cheese food, Subpart B—Requirements for Spe-
cheese spread, and related foods.
cific Standardized Cheese
(a) Definitions and standards of iden- and Related Products
tity have recently been promulgated
under the authority of the Federal § 133.102 Asiago fresh and asiago soft
Food, Drug, and Cosmetic Act for a cheese.
number of foods made in part from (a) Asiago fresh cheese, asiago soft
cheese, including pasteurized process cheese, is the food prepared from milk
cheese; pasteurized process cheese with and other ingredients specified in this
fruits, vegetables, or meats; pasteur- section, by the procedure set forth in
ized blended cheese; pasteurized proc- paragraph (b) of this section, or by an-
ess cheese food; pasteurized process other procedure which produces a fin-
cheese spread, and related foods. These ished cheese having the same physical
standards prescribe the name for each and chemical properties as the cheese
such food. The act requires that this produced when the procedure set forth
name appear on the label. Many of in paragraph (b) of this section is used.
these names consist of several words. It contains not more than 45 percent of
In the past it has been the practice of moisture, and its solids contain not
some manufacturers to subordinate the less than 50 percent of milkfat, as de-
words ‘‘pasteurized,’’ ‘‘blended,’’ termined by the methods prescribed in
‘‘process,’’ ‘‘food,’’ and ‘‘spread’’ to § 133.5 (a), (b), and (d). It is cured for
give undue prominence to the word not less than 60 days.
‘‘cheese’’ and to words naming the va- (b) Milk which may be pasteurized or
riety of cheese involved. clarified or both, and which may be
(b) When placing the names of these warmed, is subjected to the action of
foods on labels so as to comply with harmless lactic-acid producing bac-
the requirements of section 403 (a), (f), teria, present in such milk or added
and (g) of the act, all the words form- thereto. Harmless artificial blue or
ing the name specified by a definition green coloring in a quantity which neu-
and standard of identity should be tralizes any natural yellow coloring in
given equal prominence. This can read- the curd may be added. Sufficient
ily be accomplished by printing the rennet, or other safe and suitable milk-
specified name of the food in letters of clotting enzyme that produces equiva-
the same size, color, and style of type, lent curd formation, or both, with or
and with the same background. without purified calcium chloride in a
(c) Where the names of optional in- quantity not more than 0.02 percent
gredients are required to appear on the (calculated as anhydrous calcium chlo-

label, the designations of all such in- ride) of the weight of the milk, is added
gredients should be given equal promi- to set the milk to a semisolid mass.
492
The mass is cut, stirred, and heated to animal, plant, or microbial origin may
promote and regulate separation of the be declared as ‘‘enzymes’’.
whey from the curd. The whey is [42 FR 14366, Mar. 15, 1977, as amended at 48
drained off. When the curd is suffi- FR 49013, Oct. 24, 1983; 49 FR 10093, Mar. 19,
ciently firm it is removed from the 1984; 58 FR 2891, Jan. 6, 1993]
kettle or vat, further drained for a
short time, packed into hoops, and § 133.103 Asiago medium cheese.
pressed. The pressed curd is salted in Asiago medium cheese conforms to
brine and cured in a well-ventilated the definition and standard of identity
room. During curing the surface of the and is subject to the requirements for
cheese is occasionally rubbed with a label statement of ingredients pre-
vegetable oil. A harmless preparation scribed by § 133.102 for asiago fresh
of enzymes of animal or plant origin cheese, except that it contains not
capable of aiding in the curing or de- more than 35 percent moisture, its sol-
velopment of flavor of asiago fresh ids contain not less than 45 percent of
cheese may be added during the proce- milkfat, and it is cured for not less
dure in such quantity that the weight than 6 months.
of the solids of such preparation is not [58 FR 2892, Jan. 6, 1993]
more than 0.1 percent of the weight of
the milk used. § 133.104 Asiago old cheese.
(c)(1) For the purposes of this sec-
Asiago old cheese conforms to the
tion, the word ‘‘milk’’ means cow’s
definition and standard of identity and
milk, which may be adjusted by sepa- is subject to the requirements for label
rating part of the fat therefrom or by statement of ingredients prescribed by
adding thereto one or more of the fol- § 133.102 for asiago fresh cheese, except
lowing: Cream, skim milk, con- that it contains not more than 32 per-
centrated skim milk, nonfat dry milk, cent moisture, its solids contain not
water in a quantity sufficient to recon- less than 42 percent of milk fat, and it
stitute any concentrated skim milk or is cured for not less than 1 year.
nonfat dry milk used.
[58 FR 2892, Jan. 6, 1993]
(2) Such milk may be bleached by the
use of benzoyl peroxide or a mixture of § 133.106 Blue cheese.
benzoyl peroxide with potassium alum,
calcium sulfate, and magnesium car- (a) Description. (1) Blue cheese is the
bonate; but the weight of the benzoyl food prepared by the procedure set
peroxide is not more than 0.002 percent forth in paragraph (a)(2), of this sec-
of the weight of the milk bleached, and tion, or by any other procedure which
the weight of the potassium alum, cal- produces a finished cheese having the
cium sulfate, and magnesium car- same physical and chemical properties.
It is characterized by the presence of
bonate, singly or combined, is not more
bluish-green mold, Penicillium
than six times the weight of the ben-
roquefortii, throughout the cheese. The
zoyl peroxide used. If milk is bleached
minimum milkfat content is 50 percent
in this manner, sufficient vitamin A is by weight of the solids and the max-
added to the curd to compensate for imum moisture content is 46 percent
the vitamin A or its precursors de- by weight, as determined by the meth-
stroyed in the bleaching process, and ods described in § 133.5. The dairy ingre-
artificial coloring is not used. dients used may be pasteurized. Blue
(d) Safe and suitable antimycotic cheese is at least 60 days old.
agent(s), the cumulative levels of (2) One or more of the dairy ingredi-
which shall not exceed current good ents specified in paragraph (b)(1) of
manufacturing practice, may be added this section may be homogenized,
to the surface of the cheese. bleached, warmed, and is subjected to
(e) Label declaration. Each of the in- the action of a lactic acid-producing
gredients used in the food shall be de- bacterial culture. One or more of the
clared on the label as required by the clotting enzymes specified in para-

applicable sections of parts 101 and 130 graph (b)(2) of this section is added to
of this chapter, except that enzymes of set the dairy ingredients to a semisolid
493
§ 133.108 21 CFR Ch. I (4–1–23 Edition)
mass. The mass is cut into smaller por- bonate, singly or combined, is not more
tions and allowed to stand for a time. than six times the weight of the ben-
The mixed curd and whey is placed in zoyl peroxide used. If milk is bleached
forms permitting further drainage. in this manner, vitamin A is added to
While the curd is being placed in forms, the curd in such quantity as to com-
spores of the mold Penicillium pensate for the vitamin A or its precur-
roquefortii are added. The forms are sors destroyed in the bleaching process,
turned several times during drainage. and artificial coloring is not used.
When sufficiently drained, the shaped (vi) Vegetable fats or oils, which may
curd is removed from the forms and be hydrogenated, used as a coating for
salted with dry salt or brine. Perfora- the rind.
tions are then made in the shaped curd, (c) Nomenclature. The name of the
and it is held at a temperature of ap- food is ‘‘blue cheese.’’
proximately 50 °F. at 90 to 95 percent (d) Label declaration. Each of the in-
relative humidity, until the char- gredients used in the food shall be de-
acteristic mold growth has developed. clared on the label as required by the
During storage the surface of the applicable sections of parts 101 and 130
cheese may be scraped to remove sur- of this chapter, except that:
face growth of undesirable microorga- (1) Enzymes of animal, plant, or mi-
nisms. Antimycotics may be applied to crobial origin may be declared as ‘‘en-
the surface of the whole cheese. One or zymes’’; and
more of the other optional ingredients (2) The dairy ingredients may be de-
specified in paragraph (b)(3) of this sec- clared, in descending order of predomi-
tion may be added during the proce- nance, by the use of the terms ‘‘milkfat
dure. and nonfat milk’’ or ‘‘nonfat milk and
(b) Optional ingredients. The following milkfat’’, as appropriate.
safe and suitable ingredients may be [48 FR 2742, Jan. 21, 1983, as amended at 54
used: FR 32052, Aug. 4, 1989; 58 FR 2892, Jan. 6, 1993]
(1) Dairy ingredients. Milk, nonfat
milk, or cream, as defined in § 133.3, § 133.108 Brick cheese.
used alone or in combination. (a) Description. (1) Brick cheese is the
(2) Clotting enzymes. Rennet and/or food prepared from dairy ingredients
other clotting enzymes of animal, and other ingredients specified in this
plant, or microbial origin. section by the procedure set forth in
(3) Other optional ingredients. (i) Blue paragraph (a)(3) of this section, or by
or green color in an amount to neu- any other procedure which produces a
tralize the natural yellow color of the finished cheese having the same phys-
curd. ical and chemical properties. The min-
(ii) Calcium chloride in an amount imum milkfat content is 50 percent by
not more than 0.02 percent (calculated weight of the solids and the maximum
as anhydrous calcium chloride) of the moisture content is 44 percent by
weight of the dairy ingredients, used as weight, as determined by the methods
a coagulation aid. described in § 133.5. If the dairy ingredi-
(iii) Enzymes of animal, plant, or mi- ents used are not pasteurized, the
crobial origin, used in curing or flavor cheese is cured at a temperature of not
development. less than 35 °F for at least 60 days.
(iv) Antimycotic agents, applied to (2) If pasteurized dairy ingredients
the surface of slices or cuts in con- are used, the phenol equivalent value
sumer-sized packages or to the surface of 0.25 gram of brick cheese is not more
of the bulk cheese during curing. than 5 micrograms as determined by
(v) Benzoyl peroxide or a mixture of the method described in § 133.5.
benzoyl peroxide with potassium alum, (3) One or more of the dairy ingredi-
calcium sulfate, and magnesium car- ents specified in paragraph (b)(1) of
bonate used to bleach the dairy ingre- this section is brought to a tempera-
dients. The weight of the benzoyl per- ture of about 88 °F and subjected to the
oxide is not more than 0.002 percent of action of a lactic acid-producing bac-
the weight of the milk being bleached, terial culture. One or more of the clot-
and the weight of the potassium alum, ting enzymes specified in paragraph
calcium sulfate, and magnesium car- (b)(2) of this section is added to set the
494
dairy ingredients to a semisolid mass. and nonfat milk’’ or ‘‘nonfat milk and
The mass is cut into cubes with sides milkfat’’, as appropriate.
approximately 3⁄8 inch long, and stirred [54 FR 32052, Aug. 4, 1989; 54 FR 35756, Aug. 29,
and heated so that the temperature 1989, as amended at 58 FR 2892, Jan. 6, 1993;
rises slowly to about 96 °F. The stirring 58 FR 17105, Apr. 1, 1993]
is continued until the curd is suffi-
ciently firm. Part of the whey is then § 133.109 Brick cheese for manufac-
removed, and the mixture diluted with turing.
water or salt brine to control the acid- Brick cheese for manufacturing con-
ity. The curd is transferred to forms, forms to the definition and standard of
and drained. During drainage it is identity for brick cheese prescribed by
pressed and turned. After drainage the § 133.108, except that the dairy ingredi-
curd is salted, and the biological curing ents are not pasteurized and curing is
agents characteristic of brick cheese not required.
are applied to the surface. The cheese
[54 FR 32053, Aug. 4, 1989]
is then cured to develop the character-
istics of brick cheese. One or more of § 133.111 Caciocavallo siciliano cheese.
the other optional ingredients specified
(a) Caciocavallo siciliano cheese is
in paragraph (b)(3) of this section may
the food prepared from cow’s milk or
be added during the procedure.
sheep’s milk or goat’s milk or mixtures
(b) Optional ingredients. The following of two or all of these and other ingredi-
safe and suitable ingredients may be ents specified in this section, by the
used: procedure set forth in paragraph (b) of
(1) Dairy ingredients. Milk, nonfat this section, or by another procedure
milk, or cream, as defined in § 133.3, which produces a finished cheese hav-
used alone or in combination. ing the same physical and chemical
(2) Clotting enzymes. Rennet and/or properties as the cheese produced when
other clotting enzymes of animal, the procedure set forth in paragraph (b)
plant, or microbial origin. of this section is used. It has a stringy
(3) Other optional ingredients. (i) texture, and is made in oblong shapes.
Coloring. It contains not more than 40 percent of
(ii) Calcium chloride in an amount moisture, and its solids contain not
not more than 0.02 percent (calculated less than 42 percent milkfat as deter-
as anhydrous calcium chloride) of the mined by the methods prescribed in
weight of the dairy ingredients, used as § 133.5 (a), (b), and (d). It is cured for
a coagulation aid. not less than 90 days at a temperature
(iii) Enzymes of animal, plant, or mi- of not less than 35 °F.
crobial origin, used in curing or flavor (b) Milk, which may be pasteurized or
development. clarified or both, and which may be
(iv) Antimycotic agents, the cumu- warmed, is subjected to the action of
lative level of which shall not exceed harmless lactic-acid-producing bac-
current good manufacturing practice, teria, present in such milk or added
may be added to the surface of the thereto. Harmless artificial blue or
cheese. green coloring in a quantity which neu-
tralizes any natural yellow coloring in
(c) Nomenclature. The name of the
the curd may be added. Sufficient
food is ‘‘brick cheese’’.
rennet, rennet paste, extract of rennet
(d) Label declaration. Each of the in- paste, or other safe and suitable milk-
gredients used in the food shall be de- clotting enzyme that produces equiva-
clared on the label as required by the lent curd formation, singly or in any
applicable sections of parts 101 and 130 combination (with or without purified
of this chapter, except that: calcium chloride in a quantity not
(1) Enzymes of animal, plant, or mi- more than 0.02 percent, calculated as
crobial origin may be declared as ‘‘en- anhydrous calcium chloride, of the
zymes’’; and weight of the milk) is added to set the
(2) The dairy ingredients may be de- milk to a semisolid mass. The mass is
clared, in descending order of predomi- cut, stirred, and heated so as to pro-
nance, by the use of the terms ‘‘milkfat mote and regulate the separation of
495
§ 133.113 21 CFR Ch. I (4–1–23 Edition)
whey from curd. The whey is drained stretching process and/or applied to the
off, and the curd is removed to another surface of the cheese.
vat containing hot whey, in which it is (e) When caciocavallo siciliano
soaked for several hours. This whey is cheese is made solely from cow’s milk,
withdrawn, the curd is allowed to mat, the name of such cheese is
and is cut into blocks. These are ‘‘Caciocavallo siciliano cheese’’. When
washed in hot whey until the desired made from sheep’s milk or goat’s milk
elasticity is obtained. The curd is re- or mixtures of these, or one or both of
moved from the vat, drained, pressed these with cow’s milk, the name is fol-
into oblong forms, dried, and salted in lowed by the words ‘‘made from
brine, and cured. It may be paraffined. ______’’, the blank being filled in with
A harmless preparation of enzymes of the name or names of the milks used,
animal or plant origin capable of aid- in order of predominance by weight.
ing in the curing or development of fla- (f) Label declaration. Each of the in-
vor of caciocavallo siciliano cheese gredients used in the food shall be de-
may be added during the procedure, in clared on the label as required by the
such quantity that the weight of the applicable sections of parts 101 and 130
solids of such preparation is not more of this chapter, except that enzymes of
than 0.1 percent of the weight of the animal, plant, or microbial origin may
be declared as ‘‘enzymes’’.
milk used.
(c)(1) For the purposes of this sec- [42 FR 14366, Mar. 15, 1977, as amended at 42
tion, the word ‘‘milk’’ means cow’s FR 39102, Aug. 2, 1977; 48 FR 49013, Oct. 24,
milk or goat’s milk or sheep’s milk or 1983; 49 FR 10093, Mar. 19, 1984; 58 FR 2892,
Jan. 6, 1993]
mixtures of two or all of these. Such
milk may be adjusted by separating § 133.113 Cheddar cheese.
part of the fat therefrom or (in the case
(a) Description. (1) Cheddar cheese is
of cow’s milk) by adding one or more of
the food prepared by the procedure set
the following: Cream, skim milk, con-
forth in paragraph (a)(3) of this section,
centrated skim milk, nonfat dry milk;
or by any other procedure which pro-
(in the case of goat’s milk) the cor-
duces a finished cheese having the
responding products from goat’s milk;
same physical and chemical properties.
(in the case of sheep’s milk) the cor-
The minimum milkfat content is 50
responding products from sheep’s milk;
percent by weight of the solids, and the
water in a quantity sufficient to recon-
maximum moisture content is 39 per-
stitute any such concentrated or dried
cent by weight, as determined by the
products used. methods described in § 133.5. If the
(2) Such milk may be bleached by the dairy ingredients used are not pasteur-
use of benzoyl peroxide or a mixture of ized, the cheese is cured at a tempera-
benzoyl peroxide with potassium alum, ture of not less than 35 °F for at least
calcium sulfate, and magnesium car- 60 days.
bonate; but the weight of the benzoyl (2) If pasteurized dairy ingredients
peroxide is not more than 0.002 percent are used, the phenol equivalent value
of the weight of the milk bleached, and of 0.25 gram of cheddar cheese is not
the weight of the potassium alum, cal- more than 3 micrograms as determined
cium sulfate, and magnesium car- by the method described in § 133.5.
bonate, singly or combined, is not more (3) One or more of the dairy ingredi-
than six times the weight of the ben- ents specified in paragraph (b)(1) of
zoyl peroxide used. If milk is bleached this section may be warmed, treated
in this manner, sufficient vitamin A is with hydrogen peroxide/catalase, and is
added to the curd to compensate for subjected to the action of a lactic acid-
the vitamin A or its precursors de- producing bacterial culture. One or
stroyed in the bleaching process, and more of the clotting enzymes specified
artificial coloring is not used. in paragraph (b)(2) of this section is
(d) Safe and suitable antimycotic added to set the dairy ingredients to a
agent(s), the cumulative levels of semisolid mass. The mass is so cut,
which shall not exceed current good stirred, and heated with continued stir-
manufacturing practice, may be added ring, as to promote and regulate the
to the cheese during the kneading and separation of whey and curd. The whey
496
is drained off, and the curd is matted (2) The dairy ingredients may be de-
into a cohesive mass. The mass is cut clared, in descending order or predomi-
into slabs, which are so piled and han- nance, by the use of the terms ‘‘milkfat
dled as to promote the drainage of and nonfat milk’’ or ‘‘nonfat milk and
whey and the development of acidity. milkfat’’, as appropriate.
The slabs are then cut into pieces, [48 FR 2743, Jan. 21, 1983; 48 FR 11426, Mar. 18,
which may be rinsed by sprinkling or 1983, as amended at 58 FR 2892, Jan. 6, 1993]
pouring water over them, with free and
continuous drainage; but the duration § 133.114 Cheddar cheese for manufac-
of such rinsing is so limited that only turing.
the whey on the surface of such pieces Cheddar cheese for manufacturing
is removed. The curd is salted, stirred, conforms to the definition and stand-
further drained, and pressed into ard of identity prescribed for cheddar
forms. One or more of the other op- cheese by § 133.113, except that the milk
tional ingredients specified in para- is not pasteurized, curing is not re-
graph (b)(3) of this section may be quired, and the provisions of paragraph
added during the procedure. (b)(3)(iv) of that section do not apply.
(b) Optional ingredients. The following
[48 FR 2743, Jan. 21, 1983]
safe and suitable ingredients may be
used: § 133.116 Low sodium cheddar cheese.
(1) Dairy ingredients. Milk, nonfat
Low sodium cheddar cheese is the
milk, or cream, as defined in § 133.3,
food prepared from the same ingredi-
used alone or in combination.
ents and in the same manner pre-
(2) Clotting enzymes. Rennet and/or scribed in § 133.113 for cheddar cheese
other clotting enzymes of animal, and complies with all the provisions of
plant, or microbial origin. § 133.113, including the requirements for
(3) Other optional ingredients. (i) label statement of ingredients, except
Coloring. that:
(ii) Calcium chloride in an amount (a) It contains not more than 96 mil-
not more than 0.02 percent (calculated ligrams of sodium per pound of finished
as anhydrous calcium chloride) of the food.
weight of the dairy ingredients, used as (b) The name of the food is ‘‘low so-
a coagulation aid. dium cheddar cheese’’. The letters in
(iii) Enzymes of animal, plant, or mi- the words ‘‘low sodium’’ shall be of the
crobial origin, used in curing or flavor same size and style of type as the let-
development. ters in the words ‘‘cheddar cheese’’,
(iv) Antimycotic agents, applied to wherever such words appear on the
the surface of slices or cuts in con- label.
sumer-sized packages. (c) If a salt substitute is used, the
(v) Hydrogen peroxide, followed by a label shall bear the statement ‘‘______
sufficient quantity of catalase prepara- added as a salt substitute’’, the blank
tion to eliminate the hydrogen per- being filled in with the common name
oxide. The weight of the hydrogen per- or names of the ingredient or ingredi-
oxide shall not exceed 0.05 percent of ents used as a salt substitute.
the weight of the milk and the weight [48 FR 2743, Jan. 21, 1983, as amended at 85
of the catalase shall not exceed 20 parts FR 72907, Nov. 16, 2020]
per million of the weight of the milk
treated. § 133.118 Colby cheese.
(c) Nomenclature. The name of the (a) Colby cheese is the food prepared
food is ‘‘cheddar cheese’’. from milk and other ingredients speci-
(d) Label declaration. Each of the in- fied in this section, by the procedure
gredients used in the food shall be de- set forth in paragraph (b) of this sec-
clared on the label as required by the tion, or by another procedure which
applicable sections of parts 101 and 130 produces a finished cheese having the
of this chapter, except that: same physical and chemical properties
(1) Enzymes of animal, plant, or mi- as the cheese produced when the proce-
crobial origin may be declared as ‘‘en- dure set forth in paragraph (b) of this
zymes’’; and section is used. It contains not more
497
§ 133.118 21 CFR Ch. I (4–1–23 Edition)
than 40 percent of moisture, and its alent of more than 3 micrograms when
solids contain not less than 50 percent tested by the method prescribed in
of milkfat, as determined by the meth- § 133.5(c).
ods prescribed in § 133.5 (a), (b), and (d). (3) During the cheesemaking process
If the milk used is not pasteurized, the the milk may be treated with hydrogen
cheese so made is cured at a tempera- peroxide/catalase as provided in
ture of not less than 35 °F for not less § 133.113(a)(3).
than 60 days. (d)(1) Colby cheese in the form of
(b) Milk, which may be pasteurized or slices or cuts may have added to it a
clarified or both, and which may be clear aqueous solution prepared by con-
warmed, is subjected to the action of densing or precipitating wood smoke in
harmless lactic-acid-producing bac- water.
teria, present in such milk or added (2) Colby cheese in the form of slices
thereto. Harmless artificial coloring or cuts in consumer-sized packages
may be added. Sufficient rennet, or may contain an optional mold-inhib-
other safe and suitable milk-clotting iting ingredient consisting of sorbic
enzyme that produces equivalent curd acid, potassium sorbate, sodium sor-
formation, or both, with or without pu- bate, or any combination of two or
rified calcium chloride in a quantity more of these, in an amount not to ex-
not more than 0.02 percent (calculated ceed 0.3 percent by weight calculated
as anhydrous calcium chloride) of the as sorbic acid.
weight of the milk, is added to set the (e)(1) If colby cheese has added to it
milk to a semisolid mass. The mass is a clear aqueous solution prepared by
so cut, stirred, and heated with contin- condensing or precipitating wood
ued stirring, as to promote and regu- smoke in water as provided in para-
late the separation of whey and curd. A graph (d)(1) of this section, the name of
part of the whey is drained off, and the the food is immediately followed by
curd is cooled by adding water, the the words ‘‘with added smoke fla-
stirring being continued so as to pre- voring’’ with all words in this phrase of
vent the pieces of curd from matting. the same type size, style, and color
The curd is drained, salted, stirred, fur- without intervening written, printed,
ther drained, and pressed into forms. A or graphic matter.
harmless preparation of enzymes of (2) If colby cheese in sliced or cut
animal or plant origin capable of aid- form contains an optional mold-inhib-
ing in the curing or development of fla- iting ingredient as specified in para-
vor of colby cheese may be added dur- graph (d)(2) of this section, the label
ing the procedure, in such quantity shall bear the statement ‘‘______ added
that the weight of the solids of such to retard mold growth’’ or ‘‘______
preparation is not more than 0.1 per- added as a preservative’’, the blank
cent of the weight of the milk used. being filled in with the common name
(c) For the purposes of this section: or names of the mold-inhibiting ingre-
(1) The word ‘‘milk’’ means cow’s dient or ingredients used.
milk, which may be adjusted by sepa- (3) Wherever the name of the food ap-
rating part of the fat therefrom or by pears on the label so conspicuously as
adding thereto one or more of the fol- to be easily seen under customary con-
lowing: Cream, skim milk, conditions of purchase, the statement
centrated skim milk, nonfat dry milk, specified in paragraph (e)(2) of this sec-
water, in a quantity sufficient to re- tion, showing the optional ingredient
constitute any concentrated skim milk used, shall immediately and conspicu-
or nonfat dry milk used. ously precede or follow such name,
(2) Milk shall be deemed to have been without intervening written, printed,
pasteurized if it has been held at a tem- or graphic matter except for the state-
perature of not less than 143 °F for a ment ‘‘with added smoke flavoring,’’ as
period of not less than 30 minutes, or set forth in paragraph (e)(1) of this sec-
for a time and at a temperature equiva- tion.
lent thereto in phosphatase destruc- (f) Each of the ingredients used in the
tion. Colby cheese shall be deemed not food shall be declared on the label as
to have been made from pasteurized required by the applicable sections of
milk if 0.25 gram shows a phenol equiv- parts 101 and 130 of this chapter, except
498
that enzymes of animal, plant, or mi- curd, hard grating cheese, semisoft
crobial origin may be declared as ‘‘en- part-skim cheese, part-skim spiced
zymes’’. cheese and skim milk cheese for manu-
facturing, into a homogeneous plastic
FR 10093, Mar. 19, 1984; 58 FR 2892, Jan. 6, mass. One or more of the optional in-
1993] gredients designated in paragraph (c) of
this section may be used.
§ 133.119 Colby cheese for manufac- (2) All cheeses used in a cold-pack
turing. cheese are made from pasteurized milk
Colby cheese for manufacturing con- or are held for not less than 60 days at
forms to the definition and standard of a temperature of not less than 35 °F be-
identity prescribed for colby cheese by fore being comminuted.
§ 133.118, except that the milk is not (3)(i) The moisture content of a cold-
pasteurized, curing is not required, and pack cheese made from a single variety
the provisions of paragraph (d) of that of cheese is not more than the max-
section do not apply. imum moisture content prescribed by
the definition and standard of identity,
§ 133.121 Low sodium colby cheese. if any there be, for the variety of
Low sodium colby cheese is the food cheese used. If there is no applicable
prepared from the same ingredients definition and standard of identity, or
and in the same manner prescribed in if such standard contains no provision
§ 133.118 for colby cheese and complies as to maximum moisture content, no
with all the provisions of § 133.118, in- water is used in the preparation of the
cluding the requirements for label cold-pack cheese.
statement of ingredients, except that: (ii) The fat content of the solids of a
(a) Salt is not used. Any safe and cold-pack cheese made from a single
suitable ingredient or combination of variety of cheese is not less than the
ingredients that contains no sodium minimum prescribed by the definition
and that is recognized as a salt sub- and standard of identity, if any there
stitute may be used. be, for the variety of cheese used, but
(b) Sodium sorbate is not used. in no case is less than 47 percent, ex-
(c) It contains not more than 96 mil- cept that the fat content of the solids
ligrams of sodium per pound of finished of cold-pack swiss cheese is not less
food. than 43 percent, and the fat content of
(d) The name of the food is ‘‘low so- the solids of cold-pack gruyere cheese
dium colby cheese’’. The letters in the is not less than 45 percent.
words ‘‘low sodium’’ shall be of the (4)(i) The moisture content of a cold-
same size and style of type as the let- pack cheese made from two or more va-
ters in the words ‘‘colby cheese’’, wher- rieties of cheese is not more than the
ever such words appear on the label. arithmetical average of the maximum
(e) If a salt substitute as provided for moisture contents prescribed by the
in paragraph (a) of this section is used, definitions and standards of identity, if
the label shall bear the statement any there be, for the varieties of cheese
‘‘______ added as a salt substitute’’, the used, but in no case is the moisture
blank being filled in with the common content more than 42 percent, except
name or names of the ingredient or in- that the moisture content of a cold-
gredients used as a salt substitute. pack cheese made from two or more of
[42 FR 14366, Mar. 15, 1977, as amended at 58 the varieties cheddar cheese, washed
FR 2892, Jan. 6, 1993; 85 FR 72907, Nov. 16, curd cheese, colby cheese, and granular
2020] cheese is not more than 39 percent.
(ii) The fat content of the solids of a
§ 133.123 Cold-pack and club cheese. cold-pack cheese made from two or
(a)(1) Cold-pack cheese, club cheese, more varieties of cheese is not less
is the food prepared by comminuting, than the arithmetical average of the
without the aid of heat, one or more minimum percent of fat prescribed by
cheeses of the same or two or more va- the definitions and standards of iden-
rieties, except cream cheese, neuf- tity, if any there be, for the varieties of
chatel cheese, cottage cheese, lowfat cheese used, but in no case is less than
cottage cheese, cottage cheese dry 47 percent, except that the fat content
499
§ 133.123 21 CFR Ch. I (4–1–23 Edition)
of the solids of a cold-pack cheese (6) Cold-pack cheese in consumer-

made from swiss cheese and gruyere sized packages may contain an op-
cheese is not less than 45 percent. tional mold-inhibiting ingredient con-
(5) Moisture and fat are determined sisting of sorbic acid, potassium sor-
by the methods prescribed in § 133.5(a), bate, sodium sorbate, or any combina-
(b), and (d). tion of two or more of these, in an
(6) The weight of each variety of amount not to exceed 0.3 percent by
cheese in a cold-pack cheese made from weight, calculated as sorbic acid or
two varieties of cheese is not less than consisting of not more than 0.3 percent
25 percent of the total weight of both, by weight of sodium propionate, cal-
except that the weight of blue cheese, cium propionate, or a combination of
nuworld cheese, roquefort cheese, or sodium propionate and calcium propio-
gorgonzola cheese is not less than 10 nate.
percent of the total weight of both, and (d)(1) The name of a cold-pack cheese
the weight of limburger cheese is not for which a definition and standard of
less than 5 percent of the total weight identity is prescribed by this section is
of both. The weight of each variety of ‘‘Cold-pack ______ cheese’’, ‘‘______ cold-
cheese in a cold-pack cheese made from pack cheese’’ or ‘‘______ club cheese’’,
three or more varieties of cheese is not the blanks being filled in with the
less than 15 percent of the total weight name or names of the varieties of
of all, except that the weight of blue cheese used, in order of predominance
cheese, nuworld cheese, roquefort by weight.
cheese, or gorgonzola cheese is not less (2) If the cold-pack cheese is made of
than 5 percent of the total weight of cheddar cheese, washed curd cheese,
all, and the weight of limburger cheese colby cheese, or granular cheese or any
is not less than 3 percent of the total mixture of two or more of these, it may
weight of all. These limits do not apply be designated ‘‘Cold-pack American
to the quantity of cheddar cheese, cheese’’; or when cheddar cheese,
washed curd cheese, colby cheese, and washed curd cheese, colby cheese,
granular cheese in mixtures which are granular cheese, or any mixture of two
designated as ‘‘American cheese’’ as or more of these is combined with
prescribed in paragraph (d)(2) of this other varieties of cheese in the cheese
section. Such mixtures are considered ingredient any of such cheeses or such
as one variety of cheese for the purpose mixture may be designated as ‘‘Amer-
of this paragraph (a)(6). ican cheese’’.
(b) Cold-pack cheese may be smoked, (3) The full name of the food shall ap-
or the cheese or cheeses from which it pear on the principal display panel of
is made may be smoked, before the label in type of uniform size, style,
comminuting and mixing, or it may and color. Wherever any word or state-
contain substances prepared by con- ment emphasizing the name of any in-
densing or precipitating wood smoke. gredient appears on the label (other
(c) The optional ingredients referred than in an ingredient statement as
to in paragraph (a) of this section are: specified in paragraph (f) of this sec-
(1) An acidifying agent consisting of tion) so conspicuously as to be easily
one or any mixture of two or more of seen under customary conditions of
the following: A vinegar, lactic acid, purchase, the full name of the food
citric acid, acetic acid, and phosphoric shall immediately and conspicuously
acid, in such quantity that the pH of precede or follow such word or state-
the finished cold-pack cheese is not ment in type of at least the same size
below 4.5. For the purposes of this sec- as the type used in such word or state-
tion vinegar is considered to be acetic ment.
acid. (e) The name of the food shall include
(2) Water. a declaration of any flavoring, includ-
(3) Salt. ing smoke and substances prepared by
(4) Harmless artificial coloring. condensing or precipitating wood
(5) Spices or flavorings, other than smoke, that characterizes the product
any which singly or in combination as specified in § 101.22 of this chapter

with other ingredients simulate the and a declaration of any spice that
flavor of a cheese of any age or variety. characterizes the product.
500
(f) Each of the ingredients used in the weight of both, except that the weight
food shall be declared on the label as of blue cheese, nuworld cheese, roque-
required by the applicable sections of fort cheese, gorgonzola cheese, or lim-
parts 101 and 130 of this chapter, except burger cheese is not less than 10 per-
that cheddar cheese, washed curd cent of the total weight of both. The
cheese, colby cheese, granular cheese, weight of each variety of cheese in the
or any mixture of two or more of these, cold-pack cheese food made with three
may be designated as ‘‘American or more varieties of cheese is not less
cheese’’. than 15 percent of the total weight of
(1) Artificial coloring need not be de- all, except that the weight of blue
clared. cheese, nuworld cheese, roquefort
(2) If the cheese ingredient contains cheese, gorgonzola cheese, or limburger
cheddar cheese, washed curd cheese, cheese is not less than 5 percent of the
colby cheese, granular cheese, or any total weight of all. These limits do not
mixture of two or more of these, such apply to the quantity of cheddar
cheese or such mixture may be des- cheese, washed curd cheese, colby
ignated as ‘‘American cheese’’. cheese, and granular cheese in mix-
[42 FR 14366, Mar. 15, 1977, as amended at 49 tures which are designated as ‘‘Amer-
FR 10093, Mar. 19, 1984; 58 FR 2892, Jan. 6, ican cheese’’ as prescribed in paragraph
1993] (h)(5) of this section. Such mixtures are
considered as one variety of cheese for
§ 133.124 Cold-pack cheese food. the purposes of this paragraph (a)(6).
(a)(1) Cold-pack cheese food is the (b) Cold-pack cheese food may be
food prepared by comminuting and smoked, or the cheese or cheeses from
mixing, without the aid of heat, one or which it is made may be smoked, be-
more of the optional cheese ingredients fore comminuting and mixing, or it
prescribed in paragraph (c) of this sec- may contain substances prepared by
tion with one or more of the optional condensing or precipitating wood
dairy ingredients prescribed in para- smoke.
graph (d) of this section, into a homo- (c) The optional cheese ingredients
geneous plastic mass. One or more of referred to in paragraph (a) of this sec-
the optional ingredients specified in tion are: One or more cheeses of the
paragraph (e) of this section may be same or two or more varieties, except
used. that cream cheese, neufchatel cheese,
(2) All cheeses used in a cold-pack cottage cheese, creamed cottage
cheese food are made from pasteurized cheese, cook cheese, and skim-milk
milk, or are held for not less than 60 cheese for manufacturing are not used,
days at a temperature of not less than and except that semisoft part-skim
35 °F before being comminuted. cheese, part-skim spiced cheese, and
(3) The moisture content of a cold- hard grating cheese may not be used,
pack cheese food is not more than 44 alone or in combination with each
percent, and the fat content is not less other, as the cheese ingredient.
than 23 percent. (d) The optional dairy ingredients re-
(4) Moisture and fat are determined ferred to in paragraph (a) of this sec-
by the methods prescribed in § 133.5 (a), tion are: Cream, milk, skim milk, but-
(b), and (d), except that in determining termilk, cheese whey, any of the fore-
moisture the loss in weight which oc- going from which part of the water has
curs in drying for 5 hours, under the been removed, anhydrous milkfat, de-
conditions prescribed in such method, hydrated cream, skim milk cheese for
is taken as the weight of moisture. manufacturing, and albumin from
(5) The weight of the cheese ingre- cheese whey. All optional dairy ingre-
dient prescribed by paragraph (a)(1) of dients used in cold-pack cheese food
this section constitutes not less than 51 are pasteurized or made from products
percent of the weight of the finished that have been pasteurized.
cold-pack cheese food. (e) The other optional ingredients re-
(6) The weight of each variety of ferred to in paragraph (a) of this sec-
cheese in the cold-pack cheese food tion are:

made with two varieties of cheese is (1) An acidifying agent consisting of
not less than 25 percent of the total one or any mixture of two or more of
501
§ 133.125 21 CFR Ch. I (4–1–23 Edition)
the following: A vinegar, lactic acid, ously precede or follow such word or
citric acid, acetic acid, and phosphoric statement in type of at least the same
acid, in such quantity that the pH of size as the type used in such word or
the finished cold-pack cheese food is statement.
not below 4.5. (g) The name of the food shall include
(2) Water. a declaration of any flavoring, includ-
(3) Salt. ing smoke and substances prepared by
(4) Harmless artificial coloring. condensing or precipitating wood
(5) Spices or flavorings, other than smoke, that characterizes the product
any which singly or in combination as specified in § 101.22 of this chapter
with other ingredients simulate the
and a declaration of any spice that
flavor of cheese of any age or variety.
characterizes the product.
(6) A sweetening agent consisting of
one or any mixture of two or more of (h) Each of the ingredients used in
the following: Sugar, dextrose, corn the food shall be declared on the label
sugar, corn sirup, corn sirup solids, as required by the applicable sections
glucose sirup, glucose sirup solids, of parts 101 and 130 of this chapter, ex-
maltose, malt sirup, and hydrolyzed cept that cheddar cheese, washed curd
lactose, in a quantity necessary for cheese, colby cheese, granular cheese,
seasoning. or any mixture of two or more of these,
(7) Cold-pack cheese food in con- may be designated as ‘‘American
sumer-sized packages may contain an cheese’’.
optional mold-inhibiting ingredient
consisting of sorbic acid, potassium FR 10093, Mar. 19, 1984; 58 FR 2892, Jan. 6,
sorbate, sodium sorbate, or any com- 1993]
bination of two or more of these, in an
amount not to exceed 0.3 percent by § 133.125 Cold-pack cheese food with
weight, calculated as sorbic acid or fruits, vegetables, or meats.
consisting of not more than 0.3 percent
by weight of sodium propionate, cal- (a) Cold-pack cheese food with fruits,
cium propionate, or a combination of vegetables, or meats or mixtures of
sodium propionate and calcium propio- these is the food which conforms to the
nate. definition and standard of identity, and
(8) In the preparation of cold-pack is subject to the requirements for label
cheese food, guar gum or xanthan gum, declaration of ingredients, prescribed
or both, may be used, but the total for cold pack cheese food by § 133.124,
quantity of such ingredient or com- except that:
bination is not to exceed 0.3 percent of (1) Its milk fat content is not less
the weight of the finished food. When than 22 percent.
one or both such optional ingredients (2) It contains one or any mixture of
is used, dioctyl sodium sulfosuccinate two or more of the following: Any prop-
complying with the requirements of erly prepared fresh, cooked, canned, or
§ 172.810 of this chapter may be used in dried vegetable; any properly prepared
a quantity not in excess of 0.5 percent cooked or canned meat.
by weight of such ingredient or ingredi- (3) When the added fruits, vegetables,
ents. or meats contain fat, the method pre-
(f) The name of the food is ‘‘cold- scribed for the determination of fat by
pack cheese food’’. The full name of the § 133.5(b) and (d) is not applicable.
food shall appear on the principal dis- (b) The name of a cold-pack cheese
play panel of the label in type of uni-
food with fruits, vegetables or meats is
form size, style, and color. Wherever
‘‘Cold-pack cheese food with ______’’,
any word or statement emphasizing the
the blank being filled in with the com-
name of (other than in an ingredient
statement any ingredient appears on mon or usual name or names of the
the label as specified in paragraph (h) fruits, vegetables, or meats used, in
of this section) so conspicuously as to order of predominance by weight.
be easily seen under customary condi- [42 FR 14366, Mar. 15, 1977, as amended at 49
tions of purchase, the full name of the FR 10093, Mar. 19, 1984; 58 FR 2892, Jan. 6,
food shall immediately and conspicu- 1993]
502
§ 133.127 Cook cheese, koch kaese. (d) Label declaration. Each of the in-
(a) Description. (1) Cook cheese, koch gredients used in the food shall be de-
kaese, is the food prepared by the pro- clared on the label as required by the
cedure set forth in paragraph (a)(3) of applicable sections of parts 101 and 130,
this section or by any other procedure except that enzymes of animal, plant,
which produces a finished cheese hav- or microbial origin may be declared as
ing the same physical and chemical ‘‘enzymes’’.
properties. The maximum moisture [54 FR 32053, Aug. 4, 1989, as amended at 55
content is 80 percent by weight, as de- FR 51409, Dec. 14, 1990; 58 FR 2892, Jan. 6,
termined by the method described in 1993]
§ 133.5. The dairy ingredients used may
§ 133.128 Cottage cheese.
be pasteurized.
(2) The phenol equivalent value of (a) Cottage cheese is the soft uncured
0.25 gram of cook cheese is not more cheese prepared by mixing cottage
than 3 micrograms as determined by cheese dry curd with a creaming mix-
the method described in § 133.5. ture as provided in paragraph (b) of
(3) One or more of the dairy ingredi- this section. The milkfat content is not
ents specified in paragraph (b)(1) of less than 4 percent by weight of the fin-
this section may be warmed and is sub- ished food, within limits of good manu-
jected to the action of a lactic acid- facturing practice. The finished food
producing bacterial culture. One or contains not more than 80 percent of
more of the clotting enzymes specified moisture, as determined by the method
in paragraph (b)(2) of this section is prescribed in § 133.129(a).
added to set the dairy ingredients to a (b) The creaming mixture is prepared
semisolid mass. The mass is cut, from safe and suitable ingredients in-
stirred, and heated with continued stir- cluding, but not limited to, milk or
ring, so as to separate the curd and substances derived from milk. Any in-
whey. The whey is drained from the gredients used that are not derived
curd and the curd is cured for 2 or 3 from milk shall serve a useful function
days. It is then heated to a tempera- other than building the total solids
ture of not less than 180 °F until the content of the finished food, and shall
hot curd will drop from a ladle with a be used in a quantity not greater than
consistency like that of honey. The hot is reasonably required to accomplish
cheese is filled into packages and their intended effect. The creaming
cooled. One or more of the other op- mixture shall be pasteurized; however,
tional ingredients specified in para- heat labile ingredients, such as bac-
graph (b)(3) of this section may be terial starters, may be added following
added during the procedure. pasteurization.
(b) Optional ingredients. The following (c) The name of the food consists of
safe and suitable ingredients may be the following two phrases which shall
used: appear together:
(1) Dairy ingredients. Nonfat milk as (1) The words ‘‘cottage cheese’’ which
defined in § 133.3. shall appear in type of the same size
(2) Clotting enzymes. Rennet and/or and style.
other clotting enzymes of animal, (2) The statement ‘‘not less than __
plant, or microbial origin. percent milkfat’’ or ‘‘__ percent
(3) Other optional ingredients. (i) Cal- milkfat minimum’’, the blank being
cium chloride in an amount not more filled in with the whole number that is
than 0.02 percent (calculated as anhy- closest to, but does not exceed, the ac-
drous calcium chloride) of the weight tual fat content of the product. This
of the dairy ingredients, used as a co- statement of fat content shall appear
agulation aid. in letters not less than one-half of the
(ii) Culture of white mold. height of the letters in the phrase spec-
(iii) Pasteurized cream. ified in paragraph (c)(1) of this section,
(iv) Caraway seed. but in no case less than one-eighth of
(v) Salt. an inch in height.
(c) Nomenclature. The name of the (d) When the optional process de-
food is ‘‘cook cheese’’ or, alternatively, scribed in § 133.129(b)(1) (ii) or (iii) is
‘‘koch kaese’’. used to make the cottage cheese dry
503
§ 133.129 21 CFR Ch. I (4–1–23 Edition)
curd used in cottage cheese, the label without agitation during a continuous
shall bear the statement ‘‘Directly set’’ process. The coagulated mass may be
or ‘‘Curd set by direct acidification’’. cut; it may be warmed; it may be
Wherever the name of the food appears stirred; it is then drained. The curd is
on the label so conspicuously as to be washed with water, stirred, and further
seen under customary conditions of drained. It may be pressed, chilled,
purchase, the statement specified in worked, seasoned with salt.
this paragraph, showing the optional (iii) Food grade acids as provided in
process used, shall immediately and paragraph (b)(1)(ii) of this section, D-
conspicuously precede or follow such Glucono-delta-lactone with or without
name without intervening written, rennet, and/or other safe and suitable
printed, or graphic matter. milk clotting enzyme that produces
(e) Each of the ingredients used in equivalent curd formation, are added in
the food shall be declared on the label such amounts as to reach a final pH
as required by the applicable sections value in the range of 4.5–4.8, and it is
of parts 101 and 130 of this chapter, ex- held until it becomes coagulated. The
cept that milk-clotting enzymes may coagulated mass may be cut; it may be
be declared by the word ‘‘enzymes’’. warmed; it may be stirred; it is then
[42 FR 14366, Mar. 15, 1977, as amended at 58 drained. The curd is then washed with
FR 2892, Jan. 6, 1993] water, and further drained. It may be
pressed, chilled, worked, and seasoned
§ 133.129 Dry curd cottage cheese. with salt.
(a) Cottage cheese dry curd is the (2) The dairy ingredients referred to
soft uncured cheese prepared by the in paragraph (b)(1) of this section are
procedure set forth in paragraph (b) of sweet skim milk, concentrated skim
this section. The finished food contains milk, and nonfat dry milk. If con-
less than 0.5 percent milkfat. It concentrated skim milk or nonfat dry
tains not more than 80 percent of mois- milk is used, water may be added in a
ture, as determined by the method pre- quantity not in excess of that removed
scribed in § 133.5(a). when the skim milk was concentrated
(b)(1) One or more of the dairy ingre- or dried.
dients specified in paragraph (b)(2) of (3) For the purposes of this section
this section is pasteurized; calcium the term ‘‘skim milk’’ means the milk
chloride may be added in a quantity of of cows from which the milk fat has
not more than 0.02 percent (calculated been separated, and ‘‘concentrated
as anhydrous calcium chloride) of the skim milk’’ means skim milk from
weight of the mix; thereafter one of the which a portion of the water has been
following methods is employed: removed by evaporation.
(i) Harmless lactic-acid-producing (c) The name of the food consists of
bacteria, with or without rennet and/or the following two phrases which shall
other safe and suitable milk-clotting appear together:
enzyme that produces equivalent curd (1) The words ‘‘cottage cheese dry
formation, are added and it is held curd’’ or alternatively ‘‘dry curd cot-
until it becomes coagulated. The co- tage cheese’’ which shall all appear in
agulated mass may be cut; it may be type of the same size and style.
warmed; it may be stirred; it is then (2) The words ‘‘less than 1⁄2%
drained. The curd may be washed with milkfat’’ which shall all appear in let-
water and further drained; it may be ters not less than one-half of the
pressed, chilled, worked, seasoned with height of the letters in the phrase spec-
salt; or ified in paragraph (c)(1) of this section,
(ii) Food grade phosphoric acid, lac- but in no case less than one-eighth of
tic acid, citric acid, or hydrochloric an inch in height.
acid, with or without rennet and/or (d) When either of the optional proc-
other safe and suitable milk-clotting esses described in paragraph (b)(1) (ii)
enzyme that produces equivalent curd or (iii) of this section is used to make
formation, is added in such amount as cottage cheese dry curd, the label shall
to reach a pH of between 4.5 and 4.7; co- bear the statement ‘‘Directly set’’ or
agulation to a firm curd is achieved ‘‘Curd set by direct acidification’’.
while heating to a maximum of 120 °F Wherever the name of the food appears
504
on the label so conspicuously as to be (1) Dairy ingredients. Milk, nonfat

seen under customary conditions of milk, or cream, as defined in § 133.3,
purchase, the statement specified in used alone or in combination.
this paragraph, showing the optional (2) Clotting enzymes. Rennet and/or
process used, shall immediately and other clotting enzymes of animal,
conspicuously precede or follow such plant, or microbial origin.
name without intervening written, (3) Other optional ingredients. (i) Salt.
printed, or graphic matter. (ii) Cheese whey, concentrated cheese
(e) Each of the ingredients used in whey, dried cheese whey, or reconsti-
the food shall be declared on the label tuted cheese whey prepared by addition
as required by the applicable sections of water to concentrated cheese whey
of parts 101 and 130 of this chapter, ex- or dried cheese whey.
cept that milk-clotting enzymes may (iii) Stabilizers, in a total amount
be declared by the word ‘‘enzymes’’. not to exceed 0.5 percent of the weight
of the finished food, with or without
[42 FR 14366, Mar. 15, 1977, as amended at 47 the addition of dioctyl sodium sulfo-
FR 11826, Mar. 19, 1982; 49 FR 10093, Mar. 19, succinate in a maximum amount of 0.5
1984; 58 FR 2892, Jan. 6, 1993] percent of the weight of the sta-
bilizer(s) used.
§ 133.133 Cream cheese. (c) Nomenclature. The name of the
(a) Description. (1) Cream cheese is food is ‘‘cream cheese’’.
the soft, uncured cheese prepared by (d) Label declaration. Each of the in-
the procedure set forth in paragraph gredients used in the food shall be de-
(a)(2) of this section, or by any other clared on the label as required by the
procedure which produces a finished applicable sections of parts 101 and 130
cheese having the same physical and of this chapter, except that:
chemical properties. The minimum (1) Enzymes of animal, plant, or mi-
milkfat content is 33 percent by weight crobial original may be declared as
of the finished food, and the maximum ‘‘enzymes’’; and
moisture content is 55 percent by (2) The dairy ingredients may be de-
weight, as determined by the methods clared, in descending order of predomi-
described in § 133.5. The dairy ingredi- nance, by the use of the terms ‘‘milkfat
ents used are pasteurized. and nonfat milk’’ or ‘‘nonfat milk and
(2) One or more of the dairy ingredi- milkfat’’, as appropriate.
ents specified in paragraph (b)(1) of [54 FR 32053, Aug. 4, 1989, as amended at 58
this section may be homogenized and is FR 2892, Jan. 6, 1993]
subjected to the action of lactic acid-
producing bacterial culture. One or § 133.134 Cream cheese with other
more of the clotting enzymes specified foods.
in paragraph (b)(2) of this section is (a) Description. Cream cheese with
added to coagulate the dairy ingredi- other foods is the class of foods pre-
ents. The coagulated mass may be pared by mixing, with or without the
warmed and stirred and it is drained. aid of heat, cream cheese with one or a
The moisture content may be adjusted mixture of two or more types of foods
with one or more of the optional ingre- (except other cheeses) listed in para-
dients specified in paragraph (b)(3)(ii) graph (b)(1) of this section, in an
of this section. The curd may be amount sufficient to differentiate the
pressed, chilled, and worked and it may mixture from cream cheese. One or
be heated until it becomes fluid. It may more of the other optional ingredients
then be homogenized or otherwise in paragraph (b)(2) of this section may
mixed. One or more of the optional be used. The maximum moisture con-
dairy ingredients specified in para- tent of the mixture is 60 percent by
graph (b)(1) and the other optional in- weight. The minimum milkfat is 33
gredients specified in paragraph (b)(3) percent by weight of the cream cheese
of this section may be added during the and in no case less than 27 percent of
procedure. the finished food. The moisture and fat
(b) Optional ingredients. The following contents will be determined by the

safe and suitable ingredients may be methods described in § 133.5, except
used: that the method for determination of
505
§ 133.136 21 CFR Ch. I (4–1–23 Edition)
fat content is not applicable when the not more than 3 micrograms as deter-
added food contains fat. mined by the method described in
(b) Optional ingredients. The following § 133.5.
safe and suitable optional ingredients (3) One or more of the dairy ingredi-
may be used: ents specified in paragraph (b)(1) of
(1) Foods. Properly prepared fresh, this section may be warmed, treated
cooked, canned, or dried fruits or vege- with hydrogen peroxide/catalase, and is
tables; cooked or canned meats, rel- subjected to the action of a lactic acid-
ishes, pickles, or other suitable foods. producing bacterial culture. One or
(2) Other optional ingredients. (i) Sta- more of the clotting enzymes specified
bilizers, in a total amount not to ex- in paragraph (b)(2) of this section is
ceed 0.8 percent, with or without the added to set the dairy ingredients to a
addition of dioctyl sodium sulfo- semisolid mass. The mass is so cut,
succinate in a maximum amount of 0.5 stirred, and heated with continued stir-
percent of the weight of the sta- ring, as to promote and regulate the
bilizer(s) used. separation of whey and curd. The whey
(ii) Coloring. is drained off, and the curd is matted
(c) Nomenclature. The name of the into a cohesive mass. The mass is cut
food is ‘‘cream cheese with ______’’ or, into slabs, which are so piled and han-
alternatively, ‘‘cream cheese and dled as to promote the drainage of
______’’, the blank being filled in with whey and the development of acidity.
the name of the foods used in order of The slabs are then cut into pieces,
predominance by weight. cooled in water, and soaked therein
(d) Label declaration. Each of the in- until the whey is partly extracted and
gredients used in the food shall be de- water is absorbed. The curd is drained,
clared on the label as required by the salted, stirred, and pressed into forms.
applicable sections of parts 101 and 130 One or more of the other optional in-
of this chapter, except that: gredients specified in paragraph (b)(3)
(1) Enzymes of animal, plant, or mi- of this section may be added during the
crobial origin may be declared as ‘‘en- procedure.
zymes’’; and (b) Optional ingredients. The following
(2) The dairy ingredients may be de- safe and suitable ingredients may be
clared, in descending order of predomi- used:
nance, by the use of the terms ‘‘milkfat (1) Dairy ingredients. Milk, nonfat
and nonfat milk’’ or ‘‘nonfat milk and milk, or cream, as defined in § 133.3,
milkfat’’, as appropriate. used alone or in combination.
[54 FR 32053, Aug. 4, 1989, as amended at 58 (2) Clotting enzymes. Rennet and/or
FR 2893, Jan. 6, 1993] other clotting enzymes of animal,
plant, or microbial origin.
§ 133.136 Washed curd and soaked (3) Other optional ingredients. (i)
curd cheese. Coloring.
(a) Description. (1) Washed curd, (ii) Calcium chloride in an amount
soaked curd cheese is the food prepared not more than 0.02 percent (calculated
by the procedure set forth in paragraph as anhydrous calcium chloride) of the
(a)(3) of this section or by any other weight of the dairy ingredients, used as
procedure which produces a finished a coagulation aid.
cheese having the same physical and (iii) Enzymes of animal, plant, or mi-
chemical properties. The minimum crobial origin, used in curing or flavor
milkfat content is 50 percent by weight development.
of the solids and the maximum mois- (iv) Antimycotic agents, the cumu-
ture content is 42 percent by weight, as lative levels of which shall not exceed
determined by the methods described current good manufacturing practice,
in § 133.5. If the dairy ingredients used may be added to the surface of the
are not pasteurized, the cheese is cured cheese.
at a temperature of not less than 35 °F (v) Hydrogen peroxide, followed by a
for at least 60 days. sufficient quantity of catalase prepara-
(2) If pasteurized dairy ingredients tion to eliminate the hydrogen per-

are used, the phenol equivalent value oxide. The weight of the hydrogen per-
of 0.25 gram of washed curd cheese is oxide shall not exceed 0.05 percent of
506
the weight of the dairy ingredients and producing bacterial culture. One or
the weight of the catalase shall not ex- more of the clotting enzymes specified
ceed 20 parts per million of the weight in paragraph (b)(2) of this section is
of dairy ingredients treated. added to set the dairy ingredients to a
(c) Nomenclature. The name of the semisolid mass. After coagulation the
food is ‘‘washed curd cheese’’ or, alter- mass is cut into small cube-shaped
natively, ‘‘soaked curd cheese’’. pieces with sides approximately three-
(d) Label declaration. Each of the in- eighths-inch long. The mass is stirred
gredients used in the food shall be de- and heated to about 90 °F. and so han-
clared on the label as required by the dled by further stirring, heating, dilu-
applicable sections of parts 101 and 130 tion with water or salt brine, and salt-
of this chapter, except that: ing as to promote and regulate the sep-
(1) Enzymes of animal, plant or mi- aration of curd and whey. When the de-
crobial origin may be declared as ‘‘en- sired curd is obtained, it is transferred
zymes’’; and to forms permitting drainage of whey.
(2) The dairy ingredients may be de- During drainage the curd is pressed and
clared, in descending order of predomi- turned. After drainage the curd is re-
nance, by the use of the terms ‘‘milkfat moved from the forms and is salted and
and nonfat milk’’ or ‘‘nonfat milk and cured. One or more of the other op-
milkfat’’, as appropriate. tional ingredients specified in para-
graph (b)(3) of this section may be
FR 2893, Jan. 6, 1993]
added during the procedures.
§ 133.137 Washed curd cheese for man- safe and suitable ingredients may be
ufacturing. used:
Washed curd cheese for manufac- (1) Dairy ingredients. Milk, nonfat
turing conforms to the definition and milk, or cream, as defined in § 133.3,
standard of identity prescribed for used alone or in combination.
washed curd cheese by § 133.136, except (2) Clotting enzymes. Rennet and/or
that the dairy ingredients are not pas- other clotting enzymes of animal,
teurized and curing is not required. plant, or microbial origin.
(3) Other optional ingredients. (i)
[54 FR 32054, Aug. 4, 1989] Coloring.
(ii) Calcium chloride in an amount
§ 133.138 Edam cheese. not more than 0.02 percent (calculated
(a) Description. (1) Edam cheese is the as anhydrous calcium chloride) of the
food prepared by the procedure set weight of the dairy ingredients, used as
forth in paragraph (a)(3) of this section a coagulation aid.
or by any other procedure which pro- (iii) Enzymes of animal, plant, or mi-
duces a finished cheese having the crobial origin, used in curing or flavor
same physical and chemical properties. development.
The minimum milkfat content is 40 (iv) Antimycotic agents, the cumu-
percent by weight of the solids and the lative levels of which shall not exceed
maximum moisture content is 45 per- current good manufacturing practice,
cent by weight, as determined by the may be added to the surface of the
methods described in § 133.5. If the cheese.
dairy ingredients used are not pasteur- (c) Nomenclature. The name of the
ized, the cheese is cured at a tempera- food is ‘‘edam cheese.’’
ture of not less than 35 °F for at least (d) Label declaration. Each of the in-
60 days. gredients used in the food shall be de-
(2) If pasteurized dairy ingredients clared on the label as required by the
are used, the phenol equivalent value applicable sections of parts 101 and 130
of 0.25 gram of edam cheese is not more of this chapter, except that:
than 3 micrograms, as determined by (1) Enzymes of animal, plant, or mi-
the method described in § 133.5. crobial origin may be declared as ‘‘en-
(3) One or more of the dairy ingredi- zymes’’; and
ents specified in paragraph (b)(1) of (2) The dairy ingredients may be de-
this section may be warmed and is sub- clared, in descending order of predomi-
jected to the action of a lactic acid- nance, by the use of the terms ‘‘milkfat
507
§ 133.140 21 CFR Ch. I (4–1–23 Edition)
and nonfat milk’’ or ‘‘nonfat milk and dients used may be pasteurized. Gor-
milkfat,’’ as appropriate. gonzola cheese is at least 90 days old.
(2) One or more of the dairy ingredi-
[48 FR 2743, Jan. 21, 1983; 48 FR 11426, Mar. 18,
1983, as amended at 55 FR 6795, Feb. 27, 1990; ents specified in paragraph (b)(1) of
58 FR 2893, Jan. 6, 1993] this section may be warmed and is sub-
jected to the action of a lactic acid-
§ 133.140 Gammelost cheese. producing bacterial culture. One or
more of the clotting enzymes specified
(a) Description. (1) Gammelost cheese
in paragraph (b)(2) of this section is
is the food prepared from nonfat milk,
added to set the dairy ingredients to a
as defined in § 133.3, by the procedure
semisolid mass. The mass is cut into
set forth in paragraph (a)(2) of this sec-
smaller portions and allowed to stand
tion, or by any other procedure which
for a time. The mixed curd and whey is
produces a finished cheese having the
placed into forms permitting further
same physical and chemical properties.
drainage. While being placed in forms,
The maximum moisture content is 52
spores of the mold Penicillium
percent by weight, as determined by
roquefortii are added. The forms are
the methods described in § 133.5.
turned several times during drainage.
(2) The dairy ingredients are sub-
When sufficiently drained, the shaped
jected to the action of a lactic acid-
curd is removed from the forms and
producing bacterial culture. The devel-
salted with dry salt or brine. Perfora-
opment of acidity is continued until
tions are then made in the shaped curd
the dairy ingredients coagulate to a
and it is held at a temperature of ap-
semisolid mass. The mass is stirred and
proximately 50 °F at 90 to 95 percent
heated until a temperature of about 145
relative humidity, until the char-
°F is reached, and is held at that tem-
acteristic mold growth has developed.
perature for at least 30 minutes. The
During storage, the surface of the
whey is drained off and the curd re-
cheese may be scraped to remove sur-
moved and placed in forms and pressed. face growth of undesirable microorga-
The shaped curd is placed in whey and nisms. One or more of the other op-
heated for 3 or 4 hours, and may again tional ingredients specified in para-
be pressed. It is then stored under con- graph (b)(3) of this section may be
ditions suitable for curing. added during the procedure.
(b) Nomenclature. The name of the (b) Optional ingredients. The following
food is ‘‘gammelost cheese’’. safe and suitable ingredients may be
(c) Label declaration. Each of the in- used:
gredients used in the food shall be de- (1) Dairy ingredients. Milk, nonfat
clared on the label as required by the milk, or cream, as defined in § 133.3, or
applicable sections of parts 101 and 130 corresponding products of goat origin,
of this chapter. used alone or in combination.
[54 FR 32054, Aug. 4, 1989, as amended at 58 (2) Clotting enzymes. Rennet and/or
FR 2893, Jan. 6, 1993] other clotting enzymes of animal,
plant, or microbial origin.
§ 133.141 Gorgonzola cheese. (3) Other optional ingredients. (i) Blue
(a) Description. (1) Gorgonzola cheese or green color in an amount to neu-
is the food prepared by the procedure tralize the natural yellow color of the
set forth in paragraph (a)(2) of this sec- curd.
tion or by any other procedure which (ii) Calcium chloride in an amount
produces a finished cheese having the not more than 0.02 percent (calculated
same physical and chemical properties. as anhydrous calcium chloride) of the
It is characterized by the presence of weight of the dairy ingredients, used as
bluish-green mold, Penicillium a coagulation aid.
roquefortii, throughout the cheese. The (iii) Enzymes of animal, plant, or mi-
minimum milkfat content is 50 percent crobial origin, used in curing or flavor
by weight of the solids and the max- development.
imum moisture content is 42 percent (iv) Antimycotic agents, the cumu-

by weight, as determined by the meth- lative levels of which shall not exceed
ods described in § 133.5. The dairy ingre- current good manufacturing practice,
508
may be added to the surface of the § 133.144 Granular and stirred curd
cheese. cheese.
(v) Benzoyl peroxide, or a mixture of (a) Description. (1) Granular cheese,
benzoyl peroxide with potassium alum, stirred curd cheese is the food prepared
calcium sulfate, and magnesium car- by the procedure set forth in paragraph
bonate used to bleach the dairy ingre- (a)(3) of this section or by any other
dients. The weight of the benzoyl per- procedure which produces a finished
oxide is not more than 0.002 percent of cheese having the same physical and
the weight of the dairy ingredients chemical properties. The minimum
being bleached, and the weight of the milkfat content is 50 percent by weight
potassium alum, calcium sulfate, and of the solids and the maximum mois-
magnesium carbonate, singly or com- ture content is 39 percent by weight as
bined, is not more than six times the determined by the methods described
weight of the benzoyl peroxide used. If in § 133.5. If the dairy ingredients used
the dairy ingredients are bleached in are not pasteurized, the cheese is cured
this manner, vitamin A is added to the at a temperature of not less than 35 °F
curd in such quantity as to compensate for at least 60 days.
for the vitamin A or its precursors de- (2) If pasteurized dairy ingredients
stroyed in the bleaching process, and are used, the phenol equivalent value
artificial coloring is not used. of 0.25 gram of granular cheese is not
more than 3 micrograms as determined
(vi) Vegetable fats or oil which may
by the method described in § 133.5.
be hydrogenated, used as a coating for
(3) One or more of the dairy ingredi-
the rind.
ents specified in paragraph (b)(1) of
(c) Nomenclature. The name of the this section may be warmed, treated
food is ‘‘gorgonzola cheese’’. with hydrogen peroxide/catalase, and is
(d) Label declaration. Each of the in- subjected to the action of a lactic acid-
gredients used in the food shall be de- producing bacterial culture. One or
clared on the label as required by the more of the clotting enzymes specified
applicable sections of parts 101 and 130 in paragraph (b)(2) of this section is
of this chapter, except that: added to set the dairy ingredients to a
(1) Enzymes of animal, plant, or mi- semisolid mass. The mass is so cut,
crobial origin may be declared as ‘‘en- stirred, and heated with continued stir-
zymes’’; and ring, as to promote and regulate the
(2) The dairy ingredients may be de- separation of whey and curd. A part of
clared, in descending order of predomi- the whey is drained off. The curd is
nance, by the use of the terms ‘‘milkfat then alternately stirred and drained to
and nonfat milk’’ or ‘‘nonfat milk and prevent matting and to remove whey
milkfat’’, as appropriate; ‘‘milkfat from curd. The curd is then salted,
from goat’s milk and nonfat goat’s stirred, drained, and pressed into
milk’’, etc. forms. One or more of the other op-
tional ingredients specified in para-
[54 FR 32054, Aug. 4, 1989, as amended at 58 graph (b)(3) of this section may be
FR 2893, Jan. 6, 1993] added during the procedure.
§ 133.142 Gouda cheese. safe and suitable ingredients may be
Gouda cheese conforms to the defini- used:
tion and standard of identity and com- (1) Dairy ingredients. Milk, nonfat
plies with the requirements for label milk, or cream, as defined in § 133.3,
declaration of ingredients prescribed used alone or in combination.
for edam cheese by § 133.138, except that (2) Clotting enzymes. Rennet and/or
the minimum milkfat content is 46 per- other clotting enzymes of animal,
cent by weight of the solids, as deter- plant, or microbial origin.
mined by the methods described in (3) Other optional ingredients. (i)
§ 133.5 and the maximum moisture con- Coloring.
tent is 45 percent by weight. (ii) Calcium chloride in an amount

not more than 0.02 percent (calculated
[48 FR 2744, Jan. 21, 1983] as anhydrous calcium chloride) by
509
§ 133.145 21 CFR Ch. I (4–1–23 Edition)
weight of the dairy ingredients, used as tage cheese, creamed cottage cheese,
a coagulation aid. cook cheese, and skim milk cheese for
(iii) Enzymes of animal, plant, or mi- manufacturing may not be used. All
crobial origin, used in curing or flavor cheese ingredients used are either
development. made from pasteurized milk or held at
(iv) Antimycotic agents, the cumu- a temperature of not less than 35 °F for
lative levels of which shall not exceed at least 60 days. Moisture may be re-
current good manufacturing practice, moved from the cheese ingredients in
may be added to the surface of the the manufacture of the finished food,
cheese. but no moisture is added. One or more
(v) Hydrogen peroxide, followed by a of the optional ingredients specified in
sufficient quantity of catalase prepara- paragraph (c) of this section may be
tion to eliminate the hydrogen per- used.
oxide. The weight of the hydrogen per- (b) Composition. (1) Each cheese ingre-
oxide shall not exceed 0.05 percent of dient used is present at a minimum
the weight of the dairy ingredients and level of 2 percent of the weight of the
the weight of the catalase shall not ex- finished food.
ceed 20 parts per million of the weight (2) When one variety of cheese is
of the dairy ingredients treated. used, the minimum milkfat content of
(c) Nomenclature. The name of the the food is not more than 1 percent
food is ‘‘granular cheese’’ or, alter- lower than the minimum prescribed by
natively, ‘‘stirred curd cheese’’. the standard of identity for that
(d) Label declaration. Each of the in- cheese.
gredients used in the food shall be de- (3) When two or more varieties of
clared on the label as required by the cheese are used, the minimum milkfat
applicable sections of parts 101 and 130 content is not more than 1 percent
of this chapter, except that: below the arithmetical average of the
(1) Enzymes of animal, plant, or mi- minimum fat content percentages pre-
crobial origin may be declared as ‘‘en- scribed by the standards of identity for
zymes’’; and the varieties of cheese used, and in no
(2) The dairy ingredients may be de- case is the milkfat content less than 31
clared, in descending order of predomi- percent.
nance, by the use of the terms ‘‘milkfat (4) Milkfat and moisture contents are
and nonfat milk’’ or ‘‘nonfat milk and determined by the methods described
milkfat’’, as appropriate. in § 133.5.
[54 FR 32055, Aug. 4, 1989, as amended at 58 (c) Optional ingredients. The following
FR 2893, Jan. 6, 1993] safe and suitable ingredients may be
used:
§ 133.145 Granular cheese for manu- (1) Antimycotics.
facturing.
(2) Anticaking agents.
Granular cheese for manufacturing (3) Spices.
conforms to the definition and stand- (4) Flavorings other than those
ard of identity prescribed for granular which, singly or in combination with
cheese by § 133.144, except that the other ingredients, simulate the flavor
dairy ingredients are not pasteurized of cheese of any age or variety.
and curing is not required.
(d) Nomenclature. (1) The name of the
[54 FR 32056, Aug. 4, 1989] food is ‘‘grated cheese’’ or ‘‘grated
cheeses’’, as appropriate. The name of
§ 133.146 Grated cheeses. the food shall be accompanied by a dec-
(a) Description. Grated cheeses is the laration of the specific variety of
class of foods prepared by grinding, cheese(s) used in the food and by a dec-
grating, shredding, or otherwise laration indicating the presence of any
comminuting cheese of one variety or a added spice or flavoring.
mixture of two or more varieties. The (2) Any cheese varietal names used in
cheese varieties that may be used are the name of the food are those speci-
those for which there are definitions fied by applicable standards of iden-
and standards of identity, except that tity, except that the designation
cream cheese, neufchatel cheese, cot- ‘‘American cheese’’ may be used for
510
cheddar, washed curd, colby, or granu- (ii) ‘‘Chipped’’ or ‘‘chopped’’, if the

lar cheese or for any mixture of these particles of cheese are in the form of
cheeses. chips.
(3) The following terms may be used (e) Label declaration. Each of the in-
in place of the name of the food to de- gredients used in the food shall be de-
scribe specific types of grated cheese: clared on the label as required by the
(i) If only one variety of cheese is applicable sections of parts 101 and 130
used, the name of the food is ‘‘grated of this chapter, except that:
(1) Enzymes of animal, plant, or mi-
______ cheese’’, the name of the cheese
crobial origin may be declared as ‘‘en-
filling the blank.
zymes’’; and
(ii) If only parmesan and romano (2) The dairy ingredients may be de-
cheeses are used and each is present at clared, in descending order of predomi-
a level of not less than 25 percent by nance, by the use of the terms ‘‘milkfat
weight of the finished food, the name of and nonfat milk’’ or ‘‘nonfat milk and
the food is ‘‘grated ______ and ______ milkfat’’, ‘‘milkfat from goat’s milk
cheese’’, the blanks being filled with and nonfat goat’s milk’’, ‘‘milkfat from
the names ‘‘parmesan’’ and ‘‘romano’’ sheep’s milk and nonfat sheep’s milk’’,
in order of predominance by weight. etc., as appropriate.
The name ‘‘reggiano’’ may be used for
[54

CFR 2023 Title21 Vol2

Uploaded by

Copyright:

Available Formats

You might also like

CFR 2023 Title21 Vol2

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

CFR 2023 Title21 Vol2

Uploaded by

Copyright:

Available Formats

Title 21

Food and Drugs

Revised as of April 1, 2023

Containing a codification of documents

Published by the Office of the Federal Register

Legal Status and Use of Seals and Logos

Use of ISBN Prefix

U.S. GOVERNMENT PUBLISHING OFFICE

U.S. Superintendent of Documents • Washington, DC 20402–0001

Phone: toll-free (866) 512-1800; DC area (202) 512-1800

Chapter I—Food and Drug Administration, Department of Health

Table of CFR Titles and Chapters ....................................................... 735

Alphabetical List of Agencies Appearing in the CFR ......................... 755

List of CFR Sections Affected ............................................................. 765

To cite the regulations in

lishing in the CFR are also included in this volume.

CHAPTER I—Food and Drug Administration, Department of

SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION

115 Shell eggs ................................................................ 382

PART 100—GENERAL ticular need for information that is not

(4) The State requirement is subject A. Action Requested

Subpart F—Misbranding for Subpart G—Specific Administra-

or to further reduce the size of the (d) Individual serving-sized packages

with this section. diced, etc.), the particular form shall

declared in letters of a type size bear- tion establishing a nutritional quality

indicating the type of dietary ingredi- culture, or conforms to a definition and

or oils is partially hydrogenated, the used in the product. Such ingredients

the ingredient statement, in order of present, such as ‘‘or’’, ‘‘and/or’’, or

common or usual name in the manner rather than ‘‘flos’’);

are followed. The propellant is included specified in paragraphs (h)(1) through

bossed, or molded on a glass or plastic mainder in terms of ounces or common

quantity of contents as provided for in the identical commodity and in the

packages, or prepared by the machine, The visible nutrition information must

of food as sold at the point of purchase. regardless of whether the packaged

isters to be subject to the requirements tion to the requirements of this section

(4) If any vitamin or mineral is added of evaluating whether weight-control

most closely approximates the ref- generated by further division by 2 or 3.

tray). In expressing serving size in ponent or as a composite. The serving

with separate ingredient packages, cept for single-serving containers.

total package by the number of reference amount must provide an ad-

unit amount. When a nutrient content spectively, as described in USDA Hand-

the statement ‘‘Not a significant part 51 (the availability of this incorpo-

to the nearest gram, except that if a resented or purported to be for adults

this paragraph (c)(8). paragraph (c)(8)(ii), calculated as a per-

added as a nutrient supplement, or (or other symbol) that refers to an-

Vitamin D ............. Micrograms (mcg) 2 ............................ 20 10 15 15

Phosphorus .......... Milligrams (mg) ................................... 1,250 275 460 1,250

(v) The following synonyms may be folate, and/or synthetic folate as a

food or a dietary supplement, the nu-

Fat ........................................ Grams (g) ............................ 1 78 30 2 39 1 78

Saturated fat ........................ Grams (g) ............................ 1 20 N/A 2 10 1 20

Cholesterol ........................... Milligrams (mg) ................... 300 N/A 300 300

Sodium ................................. Milligrams (mg) ................... 2,300 N/A 1,500 2,300

Protein ................................. Grams (g) ............................ 1 50 N/A 2 13 N/A

(d)(1) Nutrient information specified (iii) Information required in para-

section as shown in paragraph (d)(12), (c) of this section (i.e., ‘‘Calories,’’

and the percentage amounts required small packages as shown in paragraph

(14) In accordance with § 101.15(c)(2), provided, equal prominence shall be

Cereals, dry instant ................. 15 g ........................................ cup ( g)

Grain-based bars with or 40 g ........................................ piece(s) ( g)

Pastas, dry, ready-to-eat, 25 g ........................................ cup(s) ( g)

Starches, e.g., cornstarch, 10 g ........................................ tbsp ( g)

Cake frostings or icings .... 2 tbsp ...................................... tbsp(s) ( g)

meat 9; fish or shellfish cup(s) ( g); 2 oz (56 g/

Dietary supplements ......... The maximum amount rec- tablet(s), capsules(s),

Marshmallows ................... 30 g ........................................ cup(s) ( g) for small

Sugar ................................ 8 g .......................................... tsp ( g); piece(s) ( g)