CFR 2023 Title21 Vol3

Title 21
Food and Drugs

Parts 170 to 199
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 08:34 May 09, 2023 Jkt 259073 PO 00000 Frm 00001 Fmt 8091 Sfmt 8091 Q:\21\21V3.TXT PC31
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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 ....................................................... 613
Alphabetical List of Agencies Appearing in the CFR ......................... 633
List of CFR Sections Affected ............................................................. 643

iii
Cite this Code: CFR
To cite the regulations in

this volume use title,
part and section num-
ber. Thus, 21 CFR 170.3
refers to title 21, part
170, section 3.
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
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Each volume of the Code contains amendments published in the Federal Reg-
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PAST PROVISIONS OF THE CODE
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date stated on the cover of each volume are not carried. Code users may find
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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.
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(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
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vi
The Federal Register Index is issued monthly in cumulative form. This index
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revision dates of the 50 CFR titles.
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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 170 to 199)
Part
CHAPTER I—Food and Drug Administration, Department of

Health and Human Services (Continued) ........................... 170
CHAPTER I—FOOD AND DRUG
ADMINISTRATION, DEPARTMENT OF HEALTH
AND HUMAN SERVICES (CONTINUED)
(Parts 170 to 199)
EDITORIAL NOTE: Nomenclature changes to chapter I appear at 59 FR 14366, Mar. 28, 1994,
and 69 FR 18803, Apr. 9, 2004.
SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION (CONTINUED)
Part Page
170 Food additives ......................................................... 5
171 Food additive petitions ........................................... 28
172 Food additives permitted for direct addition to
food for human consumption ................................ 33
173 Secondary direct food additives permitted in food
for human consumption ....................................... 130
174 Indirect food additives: General .............................. 163
175 Indirect food additives: Adhesives and components
of coatings ............................................................ 164
176 Indirect food additives: Paper and paperboard com-
ponents ................................................................. 207
177 Indirect food additives: Polymers ........................... 245
178 Indirect food additives: Adjuvants, production
aids, and sanitizers ............................................... 367
179 Irradiation in the production, processing and han-
dling of food ......................................................... 461
180 Food additives permitted in food or in contact
with food on an interim basis pending additional
study .................................................................... 467
181 Prior-sanctioned food ingredients ........................... 473
182 Substances generally recognized as safe ................. 477
184 Direct food substances affirmed as generally recog-
nized as safe ......................................................... 490
186 Indirect food substances affirmed as generally rec-
ognized as safe ...................................................... 595
189 Substances prohibited from use in human food ...... 600

190 Dietary supplements ............................................... 608
3
21 CFR Ch. I (4–1–23 Edition)
Part Page
191–199 [Reserved]
SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION
(CONTINUED)
PART 170—FOOD ADDITIVES 170.106 Notification for a food contact sub-

stance formulation (NFCSF).
Subpart A—General Provisions Subpart E—Generally Recognized as Safe
Sec. (GRAS) Notice
170.3 Definitions.
170.203 Definitions.
170.6 Opinion letters on food additive sta-
170.205 Opportunity to submit a GRAS no-
tus.
tice.
170.10 Food additives in standardized foods.
170.210 How to send your GRAS notice to
170.15 Adoption of regulation on initiative
FDA.
of Commissioner.
170.215 Incorporation into a GRAS notice.
170.17 Exemption for investigational use
170.220 General requirements applicable to a
and procedure for obtaining authoriza-
GRAS notice.
tion to market edible products from ex-
170.225 Part 1 of a GRAS notice: Signed
perimental animals.
statements and certification.
170.18 Tolerances for related food additives.
170.230 Part 2 of a GRAS notice: Identity,
170.19 Pesticide chemicals in processed
method of manufacture, specifications,
foods.
and physical or technical effect.
170.235 Part 3 of a GRAS notice: Dietary ex-
Subpart B—Food Additive Safety
posure.
170.20 General principles for evaluating the 170.240 Part 4 of a GRAS notice: Self-lim-
safety of food additives. iting levels of use.
170.22 Safety factors to be considered. 170.245 Part 5 of a GRAS notice: Experience
170.30 Eligibility for classification as gen- based on common use in food before 1958.
erally recognized as safe (GRAS). 170.250 Part 6 of a GRAS notice: Narrative.
170.35 Affirmation of generally recognized 170.255 Part 7 of a GRAS notice: List of sup-
as safe (GRAS) status. porting data and information in your
170.38 Determination of food additive sta- GRAS notice.
tus. 170.260 Steps you may take before FDA re-
170.39 Threshold of regulation for sub- sponds to your GRAS notice.
stances used in food-contact articles. 170.265 What FDA will do with a GRAS no-
tice.
Subpart C—Specific Administrative Rulings 170.270 Procedures that apply when the in-
and Decisions tended conditions of use of a notified
substance include use in a product or
170.45 Fluorine-containing compounds. products subject to regulation by the
170.50 Glycine (aminoacetic acid) in food for Food Safety and Inspection Service
human consumption. (FSIS) of the United States Department
170.60 Nitrites and/or nitrates in curing pre- of Agriculture.
mixes. 170.275 Public disclosure of a GRAS notice.
170.280 Submission of a supplement.
Subpart D—Premarket Notifications 170.285 Disposition of pending GRAS affir-
mation petitions.
170.100 Submission of a premarket notifica-
tion for a food contact substance (FCN) AUTHORITY: 21 U.S.C. 321, 341, 342, 346a, 348,
to the Food and Drug Administration 371.
(FDA). SOURCE: 42 FR 14483, Mar. 15, 1977, unless
170.101 Information in a premarket notifica- otherwise noted.
tion for a food contact substance (FCN).
170.102 Confidentiality of information in a EDITORIAL NOTE: Nomenclature changes to
premarket notification for a food contact part 170 appear at 66 FR 56035, Nov. 6, 2001,
substance (FCN). and 69 FR 13717, Mar. 24, 2004.
170.103 Withdrawal without prejudice of a
premarket notification for a food contact Subpart A—General Provisions
substance (FCN).
170.104 Action on a premarket notification § 170.3 Definitions.
for a food contact substance (FCN).
170.105 The Food and Drug Administration’s For the purposes of this subchapter,
(FDA’s) determination that a premarket the following definitions apply:

notification for a food contact substance (a) Secretary means the Secretary of
(FCN) is no longer effective. Health and Human Services.
§ 170.3 21 CFR Ch. I (4–1–23 Edition)
(b) Department means the Department substance for food use by a significant
of Health and Human Services. number of consumers.
(c) Commissioner means the Commis- (g) The word substance in the defini-
sioner of Food and Drugs. tion of the term ‘‘food additive’’ in-
(d) As used in this part, the term act cludes a food or food component con-
means the Federal Food, Drug, and sisting of one or more ingredients.
Cosmetic Act approved June 25, 1936, 52 (h) Scientific procedures include the
Stat. 1040 et seq., as amended (21 U.S.C. application of scientific data (includ-
301–392). ing, as appropriate, data from human,
(e)(1) Food additives includes all sub- animal, analytical, or other scientific
stances not exempted by section 201(s) studies), information, and methods,
of the act, the intended use of which
whether published or unpublished, as
results or may reasonably be expected
well as the application of scientific
to result, directly or indirectly, either
principles, appropriate to establish the
in their becoming a component of food
or otherwise affecting the characteris- safety of a substance under the condi-
tics of food. A material used in the pro- tions of its intended use.
duction of containers and packages is (i) Safe or safety means that there is
subject to the definition if it may rea- a reasonable certainty in the minds of
sonably be expected to become a com- competent scientists that the sub-
ponent, or to affect the characteristics, stance is not harmful under the condi-
directly or indirectly, of food packed in tions of its intended use. It is impos-
the container. ‘‘Affecting the charac- sible in the present state of scientific
teristics of food’’ does not include such knowledge to establish with complete
physical effects, as protecting contents certainty the absolute harmlessness of
of packages, preserving shape, and pre- the use of any substance. Safety may
venting moisture loss. If there is no be determined by scientific procedures
migration of a packaging component or by general recognition of safety. In
from the package to the food, it does determining safety, the following fac-
not become a component of the food tors shall be considered:
and thus is not a food additive. A sub- (1) The probable consumption of the
stance that does not become a compo- substance and of any substance formed
nent of food, but that is used, for exam- in or on food because of its use.
ple, in preparing an ingredient of the (2) The cumulative effect of the sub-
food to give a different flavor, texture, stance in the diet, taking into account
or other characteristic in the food, any chemically or pharmacologically
may be a food additive. related substance or substances in such
(2) Uses of food additives not requiring diet.
a listing regulation. Use of a substance (3) Safety factors which, in the opin-
in a food contact article (e.g., food- ion of experts qualified by scientific
packaging or food-processing equip- training and experience to evaluate the
ment) whereby the substance migrates, safety of food and food ingredients, are
or may reasonably be expected to mi-
generally recognized as appropriate.
grate, into food at such levels that the
(j) The term nonperishable processed
use has been exempted from regulation
as a food additive under § 170.39, and food means any processed food not sub-
food contact substances used in accord- ject to rapid decay or deterioration
ance with a notification submitted that would render it unfit for consump-
under section 409(h) of the act that is tion. Examples are flour, sugar, cere-
effective. als, packaged cookies, and crackers.
(3) A food contact substance is any sub- Not included are hermetically sealed
stance that is intended for use as a foods or manufactured dairy products
component of materials used in manu- and other processed foods requiring re-
facturing, packing, packaging, trans- frigeration.
porting, or holding food if such use is (k) General recognition of safety shall
not intended to have any technical ef- be in accordance with § 170.30.
fect in such food. (l) Prior sanction means an explicit

(f) Common use in food means a sub- approval granted with respect to use of
stantial history of consumption of a a substance in food prior to September
Food and Drug Administration, HHS § 170.3
6, 1958, by the Food and Drug Adminis- (8) Condiments and relishes, includ-
tration or the United States Depart- ing plain seasoning sauces and spreads,
ment of Agriculture pursuant to the olives, pickles, and relishes, but not
Federal Food, Drug, and Cosmetic Act, spices or herbs.
the Poultry Products Inspection Act, (9) Confections and frostings, includ-
or the Meat Inspection Act. ing candy and flavored frostings,
(m) Food includes human food, sub- marshmallows, baking chocolate, and
stances migrating to food from food- brown, lump, rock, maple, powdered,
contact articles, pet food, and animal and raw sugars.
feed. (10) Dairy product analogs, including
(n) The following general food cat- nondairy milk, frozen or liquid cream-
egories are established to group spe- ers, coffee whiteners, toppings, and
cific related foods together for the pur- other nondairy products.
pose of establishing tolerances or limi- (11) Egg products, including liquid,
tations for the use of direct human frozen, or dried eggs, and egg dishes
food ingredients. Individual food prod- made therefrom, i.e., egg roll, egg foo
ucts will be included within these cat- young, egg salad, and frozen multi-
egories according to the detailed clas- course egg meals, but not fresh eggs.
sifications lists contained in Exhibit (12) Fats and oils, including mar-
33B of the report of the National Acad- garine, dressings for salads, butter,
emy of Sciences/National Research salad oils, shortenings and cooking
Council report, ‘‘A Comprehensive Sur- oils.
vey of Industry on the Use of Food (13) Fish products, including all pre-
Chemicals Generally Recognized as pared main dishes, salads, appetizers,
Safe’’ (September 1972), which is incor- frozen multicourse meals, and spreads
porated by reference. Copies are avail- containing fish, shellfish, and other
able from the National Technical Infor- aquatic animals, but not fresh fish.
mation Service (NTIS), 5285 Port Royal (14) Fresh eggs, including cooked
Rd., Springfield, VA 22161, or at the Na- eggs and egg dishes made only from
tional Archives and Records Adminis- fresh shell eggs.
tration (NARA). For information on (15) Fresh fish, including only fresh
the availability of this material at and frozen fish, shellfish, and other
NARA, call 202–741–6030, or go to: http:// aquatic animals.
www.archives.gov/federal_register/ (16) Fresh fruits and fruit juices, in-
code_of_federal_regulations/ cluding only raw fruits, citrus, melons,
ibr_locations.html. and berries, and home-prepared ‘‘ades’’
and punches made therefrom.
(1) Baked goods and baking mixes, in-
(17) Fresh meats, including only fresh
cluding all ready-to-eat and ready-to-
or home-frozen beef or veal, pork, lamb
bake products, flours, and mixes re-
or mutton and home-prepared fresh
quiring preparation before serving.
meat-containing dishes, salads, appe-
(2) Beverages, alcoholic, including tizers, or sandwich spreads made there-
malt beverages, wines, distilled liq- from.
uors, and cocktail mix. (18) Fresh poultry, including only
(3) Beverages and beverage bases, fresh or home-frozen poultry and game
nonalcoholic, including only special or birds and home-prepared fresh poultry-
spiced teas, soft drinks, coffee sub- containing dishes, salads, appetizers, or
stitutes, and fruit and vegetable fla- sandwich spreads made therefrom.
vored gelatin drinks. (19) Fresh vegetables, tomatoes, and
(4) Breakfast cereals, including potatoes, including only fresh and
ready-to-eat and instant and regular home-prepared vegetables.
hot cereals. (20) Frozen dairy desserts and mixes,
(5) Cheeses, including curd and whey including ice cream, ice milks, sher-
cheeses, cream, natural, grating, proc- bets, and other frozen dairy desserts
essed, spread, dip, and miscellaneous and specialties.
cheeses. (21) Fruit and water ices, including
(6) Chewing gum, including all forms. all frozen fruit and water ices.
(7) Coffee and tea, including regular, (22) Gelatins, puddings, and fillings,
decaffeinated, and instant types. including flavored gelatin desserts,
§ 170.3 21 CFR Ch. I (4–1–23 Edition)
puddings, custards, parfaits, pie fill- centrates, dilutions, ‘‘ades’’, and drink
ings, and gelatin base salads. substitutes made therefrom.
(23) Grain products and pastas, in- (36) Processed vegetables and vege-
cluding macaroni and noodle products, table juices, including all commer-
rice dishes, and frozen multicourse cially processed vegetables, vegetable
meals, without meat or vegetables. dishes, frozen multicourse vegetable
(24) Gravies and sauces, including all meals, and vegetable juices and blends.
meat sauces and gravies, and tomato, (37) Snack foods, including chips,
milk, buttery, and specialty sauces. pretzels, and other novelty snacks.
(25) Hard candy and cough drops, in- (38) Soft candy, including candy bars,
cluding all hard type candies. chocolates, fudge, mints, and other
(26) Herbs, seeds, spices, seasonings, chewy or nougat candies.
blends, extracts, and flavorings, includ- (39) Soups, home-prepared, including
ing all natural and artificial spices, meat, fish, poultry, vegetable, and
blends, and flavors. combination home-prepared soups.
(27) Jams and jellies, home-prepared,
(40) Soups and soup mixes, including
including only home-prepared jams,
commercially prepared meat, fish,
jellies, fruit butters, preserves, and
poultry, vegetable, and combination
sweet spreads.
soups and soup mixes.
(28) Jams and jellies, commercial, in-
(41) Sugar, white, granulated, includ-
cluding only commercially processed
ing only white granulated sugar.
jams, jellies, fruit butters, preserves,
and sweet spreads. (42) Sugar substitutes, including
(29) Meat products, including all granulated, liquid, and tablet sugar
meats and meat containing dishes, sal- substitutes.
ads, appetizers, frozen multicourse (43) Sweet sauces, toppings, and syr-
meat meals, and sandwich ingredients ups, including chocolate, berry, fruit,
prepared by commercial processing or corn syrup, and maple sweet sauces and
using commercially processed meats toppings.
with home preparation. (o) The following terms describe the
(30) Milk, whole and skim, including physical or technical functional effects
only whole, lowfat, and skim fluid for which direct human food ingredi-
milks. ents may be added to foods. They are
(31) Milk products, including flavored adopted from the National Academy of
milks and milk drinks, dry milks, top- Sciences/National Research Council na-
pings, snack dips, spreads, weight con- tional survey of food industries, re-
trol milk beverages, and other milk or- ported to the Food and Drug Adminis-
igin products. tration under the contract title ‘‘A
(32) Nuts and nut products, including Comprehensive Survey of Industry on
whole or shelled tree nuts, peanuts, co- the Use of Food Chemicals Generally
conut, and nut and peanut spreads. Recognized as Safe’’ (September 1972),
(33) Plant protein products, including which is incorporated by reference.
the National Academy of Sciences/Na- Copies are available from the National
tional Research Council ‘‘reconstituted Technical Information Service (NTIS),
vegetable protein’’ category, and meat, 5285 Port Royal Rd., Springfield, VA
poultry, and fish substitutes, analogs, 22161, or at the National Archives and
and extender products made from plant Records Administration (NARA). For
proteins. information on the availability of this
(34) Poultry products, including all material at NARA, call 202–741–6030, or
poultry and poultry-containing dishes, go to: http://www.archives.gov/fed-
salads, appetizers, frozen multicourse eral_register/code_of_federal_regulations/
poultry meals, and sandwich ingredi- ibr_locations.html.
ents prepared by commercial proc- (1) Anticaking agents and free-flow
essing or using commercially processed agents: Substances added to finely pow-
poultry with home preparation. dered or crystalline food products to
(35) Processed fruits and fruit juices, prevent caking, lumping, or agglomer-
including all commercially processed ation.

fruits, citrus, berries, and mixtures; (2) Antimicrobial agents: Substances
salads, juices and juice punches, con- used to preserve food by preventing
growth of microorganisms and subse- carriers, binders, fillers, plasticizers,

quent spoilage, including fungistats, film-formers, and tableting aids, etc.
mold and rope inhibitors, and the ef- (15) Fumigants: Volatile substances
fects listed by the National Academy of used for controlling insects or pests.
Sciences/National Research Council (16) Humectants: Hygroscopic sub-
under ‘‘preservatives.’’ stances incorporated in food to pro-
(3) Antioxidants: Substances used to mote retention of moisture, including
preserve food by retarding deteriora- moisture-retention agents and anti-
tion, rancidity, or discoloration due to dusting agents.
oxidation. (17) Leavening agents: Substances
(4) Colors and coloring adjuncts: Sub- used to produce or stimulate produc-
stances used to impart, preserve, or en- tion of carbon dioxide in baked goods
hance the color or shading of a food, in- to impart a light texture, including
cluding color stabilizers, color fixa- yeast, yeast foods, and calcium salts
tives, color-retention agents, etc. listed by the National Academy of
(5) Curing and pickling agents: Sub- Sciences/National Research Council
stances imparting a unique flavor and/ under ‘‘dough conditioners.’’
or color to a food, usually producing an (18) Lubricants and release agents: Sub-
increase in shelf life stability. stances added to food contact surfaces
(6) Dough strengtheners: Substances to prevent ingredients and finished
used to modify starch and gluten, products from sticking to them.
thereby producing a more stable dough, (19) Non-nutritive sweeteners: Sub-
including the applicable effects listed stances having less than 2 percent of
by the National Academy of Sciences/ the caloric value of sucrose per equiva-
National Research Council under lent unit of sweetening capacity.
‘‘dough conditioner.’’ (20) Nutrient supplements: Substances
(7) Drying agents: Substances with which are necessary for the body’s nu-
moisture-absorbing ability, used to tritional and metabolic processes.
maintain an environment of low mois- (21) Nutritive sweeteners: Substances
ture. having greater than 2 percent of the ca-
(8) Emulsifiers and emulsifier salts: loric value of sucrose per equivalent
Substances which modify surface ten- unit of sweetening capacity.
sion in the component phase of an (22) Oxidizing and reducing agents:
emulsion to establish a uniform disper- Substances which chemically oxidize
sion or emulsion. or reduce another food ingredient,
(9) Enzymes: Enzymes used to im- thereby producing a more stable prod-
prove food processing and the quality uct, including the applicable effect list-
of the finished food. ed by the National Academy of
(10) Firming agents: Substances added Sciences/National Research Council
to precipitate residual pectin, thus under ‘‘dough conditioners.’’
strengthening the supporting tissue (23) pH control agents: Substances
and preventing its collapse during added to change or maintain active
processing. acidity or basicity, including buffers,
(11) Flavor enhancers: Substances acids, alkalies, and neutralizing
added to supplement, enhance, or mod- agents.
ify the original taste and/or aroma of a (24) Processing aids: Substances used
food, without imparting a char- as manufacturing aids to enhance the
acteristic taste or aroma of its own. appeal or utility of a food or food com-
(12) Flavoring agents and adjuvants: ponent, including clarifying agents,
Substances added to impart or help im- clouding agents, catalysts, flocculents,
part a taste or aroma in food. filter aids, and crystallization inhibi-
(13) Flour treating agents: Substances tors, etc.
added to milled flour, at the mill, to (25) Propellants, aerating agents, and
improve its color and/or baking quali- gases: Gases used to supply force to
ties, including bleaching and maturing expel a product or used to reduce the
agents. amount of oxygen in contact with the
(14) Formulation aids: Substances used food in packaging.

to promote or produce a desired phys- (26) Sequestrants: Substances which
ical state or texture in food, including combine with polyvalent metal ions to
§ 170.6 21 CFR Ch. I (4–1–23 Edition)
form a soluble metal complex, to im- (b) Since enactment of the Food Ad-
prove the quality and stability of prod- ditives Amendment, the Food and Drug
ucts. Administration has advised such in-
(27) Solvents and vehicles: Substances quirers that an article:
used to extract or dissolve another sub- (1) Is a food additive within the
stance. meaning of section 201(s) of the act; or
(28) Stabilizers and thickeners: Sub- (2) Is generally recognized as safe
stances used to produce viscous solu- (GRAS); or
tions or dispersions, to impart body, (3) Has prior sanction or approval
improve consistency, or stabilize emul- under that amendment; or
sions, including suspending and body- (4) Is not a food additive under the
ing agents, setting agents, jellying conditions of intended use.
agents, and bulking agents, etc. (c) In the interest of the public
(29) Surface-active agents: Substances health, such articles which have been
used to modify surface properties of considered in the past by the Food and
liquid food components for a variety of Drug Administration to be safe under
effects, other than emulsifiers, but in- the provisions of section 402(a)(1), or to
cluding solubilizing agents, be generally recognized as safe for
dispersants, detergents, wetting their intended use, or to have prior
agents, rehydration enhancers, whip- sanction or approval, or not to be food
ping agents, foaming agents, and de- additives under the conditions of in-
foaming agents, etc. tended use, must be reexamined in the
(30) Surface-finishing agents: Sub- light of current scientific information
stances used to increase palatability, and current principles for evaluating
preserve gloss, and inhibit discolora- the safety of food additives if their use
tion of foods, including glazes, polishes, is to be continued.
waxes, and protective coatings. (d) Because of the time span in-
(31) Synergists: Substances used to act volved, copies of many of the letters in
or react with another food ingredient which the Food and Drug Administra-
to produce a total effect different or tion has expressed an informal opinion
greater than the sum of the effects pro- concerning the status of such articles
duced by the individual ingredients. may no longer be in the file of the Food
(32) Texturizers: Substances which af- and Drug Administration. In the ab-
fect the appearance or feel of the food. sence of information concerning the
names and uses made of all the articles
[42 FR 14483, Mar. 15, 1977, as amended at 47
FR 11835, Mar. 19, 1982; 53 FR 16546, May 10, referred to in such letters, their safety
1988; 54 FR 24896, June 12, 1989; 60 FR 36595, of use cannot be reexamined. For this
July 17, 1995; 67 FR 35729, May 21, 2002; 81 FR reason all food additive status opinions
55047, Aug. 17, 2016] of the kind described in paragraph (c)
of this section given by the Food and
§ 170.6 Opinion letters on food addi- Drug Administration are hereby re-
tive status. voked.
(a) Over the years the Food and Drug (e) The prior opinions of the kind de-
Administration has given informal scribed in paragraph (c) of this section
written opinions to inquiries as to the will be replaced by qualified and cur-
safety of articles intended for use as rent opinions if the recipient of each
components of, or in contact with, such letter forwards a copy of each to
food. Prior to the enactment of the the Department of Health and Human
Food Additives Amendment of 1958 Services, Food and Drug Administra-
(Pub. L. 85–929; Sept. 6, 1958), these tion, Center for Food Safety and Ap-
opinions were given pursuant to sec- plied Nutrition, 5001 Campus Dr., Col-
tion 402(a)(1) of the Federal Food, lege Park, MD 20740, along with a copy
Drug, and Cosmetic Act, which reads in of his letter of inquiry, on or before
part: ‘‘A food shall be deemed to be July 23, 1970.
adulterated if it bears or contains any (f) This section does not apply to food
poisonous or deleterious substance additive status opinion letters per-

which may render it injurious to taining to articles that were considered
health’’. by the Food and Drug Administration
10
to be food additives nor to articles in- additive regulation will be conditioned

cluded in regulations in parts 170 on such compliance and will expire
through 189 of this chapter if the arti- with the expiration of the temporary
cles are used in accordance with the re- permit.
quirements of such regulations.
§ 170.15 Adoption of regulation on ini-
FR 24896, June 12, 1989; 81 FR 49896, July 29,
tiative of Commissioner.
2016] (a) The Commissioner upon his own
initiative may propose the issuance of
§ 170.10 Food additives in standard- a regulation prescribing, with respect
ized foods.
to any particular use of a food additive,
(a) The inclusion of food ingredients the conditions under which such addi-
in parts 170 through 189 of this chapter tive may be safely used. Notice of such
does not imply that these ingredients proposal shall be published in the FED-
may be used in standardized foods un- ERAL REGISTER and shall state the rea-
less they are recognized as optional in- sons for the proposal.
gredients in applicable food standards. (b) Action upon a proposal made by
Where a petition is received for the the Commissioner shall proceed as pro-
issuance or amendment of a regulation vided in part 10 of this chapter.
establishing a definition and standard
of identity for a food under section 401 [42 FR 14486, Mar. 15, 1977, as amended at 42
of the Act, which proposes the inclu- FR 15673, Mar. 22, 1977]
sion of a food additive in such defini-
tion and standard of identity, the pro- § 170.17 Exemption for investigational
visions of the regulations in this part use and procedure for obtaining au-
thorization to market edible prod-
shall apply with respect to the infor- ucts from experimental animals.
mation that must be submitted with
respect to the food additive. Since sec- A food additive or food containing a
tion 409(b)(5) of the Act requires that food additive intended for investiga-
the Secretary publish notice of a peti- tional use by qualified experts shall be
tion for the establishment of a food-ad- exempt from the requirements of sec-
ditive regulation within 30 days after tion 409 of the Act under the following
filing, notice of a petition relating to a conditions:
definition and standard of identity (a) If intended for investigational use
shall also be published within that in vitro or in laboratory research ani-
time limitation if it includes a request, mals, it bears a label which states
so designated, for the establishment of prominently, in addition to the other
a regulation pertaining to a food addi- information required by the act, the
tive. warning:
(b) If a petition for a definition and
Caution. Contains a new food additive for
standard of identity contains a pro-
investigational use only in laboratory re-
posal for a food-additive regulation, search animals or for tests in vitro. Not for
and the petitioner fails to designate it use in humans.
as such, the Commissioner, upon deter-
mining that the petition includes a (b) If intended for use in animals
proposal for a food-additive regulation, other than laboratory research animals
shall so notify the petitioner and shall and if the edible products of the ani-
thereafter proceed in accordance with mals are to be marketed as food, per-
the regulations in this part. mission for the marketing of the edible
(c) A regulation will not be issued al- products as food has been requested by
lowing the use of a food additive in a the sponsor, and authorization has
food for which a definition and stand- been granted by the Food and Drug Ad-
ard of identity is established, unless its ministration in accordance with § 511.1
issuance is in conformity with section of this chapter or by the Department of
401 of the Act or with the terms of a Agriculture in accordance with 9 CFR
temporary permit issued under § 130.17 309.17, and it bears a label which states
of this chapter. When the contemplated prominently, in addition to the other

use of such additive complies with the information required by the Act, the
terms of a temporary permit, the food warning:
11
§ 170.18 21 CFR Ch. I (4–1–23 Edition)
Caution. Contains a new food additive for (2) Divide the quantity of each res-
use only in investigational animals. Not for idue by the tolerance that would apply
use in humans.
if it occurred alone, and multiply by
Edible products of investigational animals
are not to be used for food unless authoriza- 100 to determine the percentage of the
tion has been granted by the U.S. Food and permitted amount of residue present.
Drug Administration or by the U.S. Depart- (3) Add the percentages so obtained
ment of Agriculture. for all residues present.
(c) If intended for nonclinical labora- (4) The sum of the percentage shall
tory studies in food-producing animals, not exceed 100 percent.
the study is conducted in compliance
with the regulations set forth in part 58 § 170.19 Pesticide chemicals in proc-
of this chapter. essed foods.
[42 FR 14483, Mar. 15, 1977, as amended at 43 When pesticide chemical residues
FR 60021, Dec. 22, 1978] occur in processed foods due to the use
of raw agricultural commodities that
§ 170.18 Tolerances for related food ad- bore or contained a pesticide chemical
ditives.
in conformity with an exemption
(a) Food additives that cause similar granted or a tolerance prescribed under
or related pharmacological effects will section 408 of the Act, the processed
be regarded as a class, and in the ab- food will not be regarded as adulter-
sence of evidence to the contrary, as ated so long as good manufacturing
having additive toxic effects and will
practice has been followed in removing
be considered as related food additives.
any residue from the raw agricultural
(b) Tolerances established for such
related food additives may limit the commodity in the processing (such as
amount of a common component that by peeling or washing) and so long as
may be present, or may limit the the concentration of the residue in the
amount of biological activity (such as processed food when ready to eat is not
cholinesterase inhibition) that may be greater than the tolerance prescribed
present or may limit the total amount for the raw agricultural commodity.
of related food additives that may be But when the concentration of residue
present. in the processed food when ready to eat
(c) Where food additives from two or is higher than the tolerance prescribed
more chemicals in the same class are for the raw agricultural commodity,
present in or on a food, the tolerance the processed food is adulterated unless
for the total of such additives shall be the higher concentration is permitted
the same as that for the additive hav- by a tolerance obtained under section
ing the lowest numerical tolerance in 409 of the Act. For example, if fruit
this class, unless there are available bearing a residue of 7 parts per million
methods that permit quantitative de- of DDT permitted on the raw agricul-
termination of the amount of each food
tural commodity is dried and a residue
additive present or unless it is shown
in excess of 7 parts per million of DDT
that a higher tolerance is reasonably
required for the combined additives to results on the dried fruit, the dehy-
accomplish the physical or technical drated fruit is adulterated unless the
effect for which such combined addi- higher tolerance for DDT is authorized
tives are intended and that the higher by the regulations in this part. Food
tolerance will be safe. that is itself ready to eat, and which
(d) Where residues from two or more contains a higher residue than allowed
additives in the same class are present for the raw agricultural commodity,
in or on a food and there are available may not be legalized by blending or
methods that permit quantitative de- mixing with other foods to reduce the
termination of each residue, the quan- residue in the mixed food below the tol-
tity of combined residues that are erance prescribed for the raw agricul-
within the tolerance may be deter- tural commodity.
mined as follows:
(1) Determine the quantity of each
residue present.
12
Subpart B—Food Additive Safety tation data to man of 100 to 1, will be

used; that is, a food additive for use by
§ 170.20 General principles for evalu- man will not be granted a tolerance
ating the safety of food additives. that will exceed 1⁄100th of the maximum
(a) In reaching a decision on any pe- amount demonstrated to be without
tition filed under section 409 of the harm to experimental animals.
Act, the Commissioner will give full
consideration to the specific biological § 170.30 Eligibility for classification as
properties of the compound and the generally recognized as safe
adequacy of the methods employed to (GRAS).
demonstrate safety for the proposed (a) General recognition of safety may
use, and the Commissioner will be be based only on the views of experts
guided by the principles and procedures qualified by scientific training and ex-
for establishing the safety of food addi- perience to evaluate the safety of sub-
tives stated in current publications of stances directly or indirectly added to
the National Academy of Sciences-Na- food. The basis of such views may be ei-
tional Research Council. A petition ther (1) scientific procedures or (2) in
will not be denied, however, by reason the case of a substance used in food
of the petitioner’s having followed pro- prior to January 1, 1958, through expe-
cedures other than those outlined in rience based on common use in food.
the publications of the National Acad- General recognition of safety requires
emy of Sciences-National Research common knowledge throughout the sci-
Council if, from available evidence, the entific community knowledgeable
Commissioner finds that the proce- about the safety of substances directly
dures used give results as reliable as, or indirectly added to food that there
or more reliable than, those reasonably is reasonable certainty that the sub-
to be expected from the use of the out- stance is not harmful under the condi-
lined procedures. In reaching a deci- tions of its intended use (see § 170.3(i)).
sion, the Commissioner will give due
(b) General recognition of safety
weight to the anticipated levels and
based upon scientific procedures shall
patterns of consumption of the additive
require the same quantity and quality
specified or reasonably inferrable. For
the purposes of this section, the prin- of scientific evidence as is required to
ciples for evaluating safety of additives obtain approval of a food additive. Gen-
set forth in the abovementioned publi- eral recognition of safety through sci-
cations will apply to any substance entific procedures shall be based upon
that may properly be classified as a the application of generally available
food additive as defined in section and accepted scientific data, informa-
201(s) of the Act. tion, or methods, which ordinarily are
(b) Upon written request describing published, as well as the application of
the proposed use of an additive and the scientific principles, and may be cor-
proposed experiments to determine its roborated by the application of unpub-
safety, the Commissioner will advise a lished scientific data, information, or
person who wishes to establish the methods.
safety of a food additive whether he be- (c)(1) General recognition of safety
lieves the experiments planned will through experience based on common
yield data adequate for an evaluation use in food prior to January 1, 1958,
of the safety of the additive. may be achieved without the quantity
or quality of scientific procedures re-
§ 170.22 Safety factors to be consid- quired for approval of a food additive.
ered. General recognition of safety through
In accordance with section experience based on common use in
409(c)(5)(C) of the Act, the following food prior to January 1, 1958, shall be
safety factors will be applied in deter- based solely on food use of the sub-
mining whether the proposed use of a stance prior to January 1, 1958, and
food additive will be safe: Except where shall ordinarily be based upon gen-
evidence is submitted which justifies erally available data and information.

use of a different safety factor, a safety An ingredient not in common use in
factor in applying animal experimen- food prior to January 1, 1958, may
13
§ 170.30 21 CFR Ch. I (4–1–23 Edition)
achieve general recognition of safety GRAS without specific inclusion in

only through scientific procedures. part 182, part 184 or part 186 of this
(2) A substance used in food prior to chapter.
January 1, 1958, may be generally rec- (e) Food ingredients were listed as
ognized as safe through experience GRAS in part 182 of this chapter during
based on its common use in food when 1958–1962 without a detailed scientific
that use occurred exclusively or pri- review of all available data and infor-
marily outside of the United States if mation relating to their safety. Begin-
the information about the experience ning in 1969, the Food and Drug Admin-
establishes that the substance is safe istration has undertaken a systematic
under the conditions of its intended use review of the status of all ingredients
within the meaning of section 201(u) of used in food based on the view that
the Federal Food, Drug, and Cosmetic they are GRAS under the conditions of
Act (see also § 170.3(i)). Common use in their intended use or subject to a prior
food prior to January 1, 1958, that oc- sanction. All affirmations of GRAS sta-
curred outside of the United States tus or determinations of food additive
shall be documented by published or status or prior sanction status pursu-
other information and shall be corrobo- ant to this review shall be handled pur-
rated by information from a second, suant to §§ 170.35, 170.38, and 180.1 of
independent source that confirms the this chapter. Affirmation of GRAS sta-
history and circumstances of use of the tus shall be announced in part 184 or
substance. The information used to part 186 of this chapter.
document and to corroborate the his- (f) [Reserved]
tory and circumstances of use of the (g) A food ingredient that is not
substance must be generally available; GRAS or subject to a prior sanction re-
that is, it must be widely available in quires a food additive regulation pro-
the country in which the history of use mulgated under section 409 of the act
has occurred and readily available to before it may be directly or indirectly
interested qualified experts in the added to food.
United States. A person who concludes (h) A food ingredient that is listed as
that a use of a substance is GRAS GRAS in part 182 of this chapter or af-
through experience based on its com- firmed as GRAS in part 184 or part 186
mon use in food outside of the United of this chapter shall be regarded as
States should notify FDA of that view GRAS only if, in addition to all the re-
in accordance with subpart E of this quirements in the applicable regula-
part. tion, it also meets all of the following
(d) The food ingredients listed as requirements:
GRAS in part 182 of this chapter or af- (1) It complies with any applicable
firmed as GRAS in part 184 or part 186 food grade specifications of the Food
of this chapter do not include all sub- Chemicals Codex, 2d Ed. (1972), or, if
stances that are generally recognized specifically indicated in the GRAS af-
as safe for their intended use in food. firmation regulation, the Food Chemi-
Because of the large number of sub- cals Codex, 3d Ed. (1981), which are in-
stances the intended use of which re- corporated by reference, except that
sults or may reasonably be expected to any substance used as a component of
result, directly or indirectly, in their articles that contact food and affirmed
becoming a component or otherwise af- as GRAS in part 186 of this chapter
fecting the characteristics of food, it is shall comply with the specifications
impracticable to list all such sub- therein, or in the absence of such speci-
stances that are GRAS. A food ingre- fications, shall be of a purity suitable
dient of natural biological origin that for its intended use. Copies may be ob-
has been widely consumed for its nutri- tained from the National Academy
ent properties in the United States Press, 2101 Constitution Ave. NW.,
prior to January 1, 1958, without known Washington, DC 20418, or at the Na-
detrimental effects, which is subject tional Archives and Records Adminis-
only to conventional processing as tration (NARA). For information on
practiced prior to January 1, 1958, and the availability of this material at

for which no known safety hazard ex- NARA, call 202–741–6030, or go to: http://
ists, will ordinarily be regarded as www.archives.gov/federal_register/
14
code_of_federal_regulations/ chapter shall be accomplished pursuant

ibr_locations.html. to § 170.38.
(2) It performs an appropriate func-
tion in the food or food-contact article FR 5610, Feb. 14, 1984; 53 FR 16546, May 10,
in which it is used. 1988; 81 FR 55047, Aug. 17, 2016]
(3) It is used at a level no higher than
necessary to achieve its intended pur- § 170.35 Affirmation of generally recog-
pose in that food or, if used as a compo- nized as safe (GRAS) status.
nent of a food-contact article, at a (a) The Commissioner, on his own
level no higher than necessary to initiative, may affirm that a substance
achieve its intended purpose in that ar- that directly or indirectly becomes a
ticle. component of food is GRAS under the
(i) If a substance is affirmed as GRAS conditions of its intended use.
in part 184 or part 186 of this chapter (b)(1) If the Commissioner proposes
with no limitation other than good
on his own initiative that a substance
manufacturing practice, it shall be re-
is entitled to affirmation as GRAS
garded as GRAS if its conditions of use
under the conditions of its intended
are not significantly different from
use, he will place all of the data and in-
those reported in the regulation as the
formation on which he relies on public
basis on which the GRAS status of the
file in the office of the Dockets Man-
substance was affirmed. If the condi-
tions of use are significantly different, agement Staff and will publish in the
such use of the substance may not be FEDERAL REGISTER a notice giving the
GRAS. In such a case a manufacturer name of the substance, its proposed
may not rely on the regulation as au- uses, and any limitations proposed for
thorizing the use but must independ- purposes other than safety.
ently establish that the use is GRAS or (2) The FEDERAL REGISTER notice will
must use the substance in accordance allow a period of 60 days during which
with a food additive regulation. any interested person may review the
(j) If an ingredient is affirmed as data and information and/or file com-
GRAS in part 184 or part 186 of this ments with the Dockets Management
chapter with specific limitation(s), it Staff. Copies of all comments received
may be used in food only within such shall be made available for examina-
limitation(s) (including the category of tion in the Dockets Management
food(s), the functional use(s) of the in- Staff’s office.
gredient, and the level(s) of use). Any (3) The Commissioner will evaluate
use of such an ingredient not in full all comments received. If he concludes
compliance with each such established that there is convincing evidence that
limitation shall require a food additive the substance is GRAS under the con-
regulation. ditions of its intended use as described
(k) Pursuant to § 170.35, a food ingre- in § 170.30, he will publish a notice in
dient may be affirmed as GRAS in part the FEDERAL REGISTER listing the
184 or part 186 of this chapter for a spe- GRAS conditions of use of the sub-
cific use(s) without a general evalua- stance in part 184 or part 186 of this
tion of use of the ingredient. In addi- chapter, as appropriate.
tion to the use(s) specified in the regu- (4) If, after evaluation of the com-
lation, other uses of such an ingredient ments, the Commissioner concludes
may also be GRAS. Any affirmation of that there is a lack of convincing evi-
GRAS status for a specific use(s), with- dence that a substance is GRAS under
out a general evaluation of use of the
the conditions of its intended use and
ingredient, is subject to reconsider-
that it should be considered a food ad-
ation upon such evaluation.
ditive subject to section 409 of the Fed-
(l) New information may at any time
eral Food, Drug, and Cosmetic Act, he
require reconsideration of the GRAS
shall publish a notice thereof in the
status of a food ingredient. Any change

to the GRAS status of a food ingre-
dient in parts 182, 184, or 186 of this
15
§ 170.38 21 CFR Ch. I (4–1–23 Edition)
FEDERAL REGISTER in accordance with GRAS in part 182, part 184, or part 186
§ 170.38. of this chapter, as appropriate.
(Information collection requirements were
(c) A FEDERAL REGISTER notice deter-
approved by the Office of Management and mining that a substance is a food addi-
Budget under control number 0910–0132) tive shall provide for the use of the ad-
ditive in food or food contact surfaces
FR 7492, Feb. 22, 1985; 50 FR 16668, Apr. 26,
as follows:
1985; 53 FR 16547, May 10, 1988; 62 FR 40599, (1) It may promulgate a food additive
July 29, 1997; 65 FR 51762, Aug. 25, 2000; 81 FR regulation governing use of the addi-
55048, Aug. 17, 2016; 88 FR 17718, Mar. 24, 2023] tive.
(2) It may promulgate an interim
§ 170.38 Determination of food addi- food additive regulation governing use
tive status. of the additive.
(a) The Commissioner may, in ac- (3) It may require discontinuation of
cordance with § 170.35(b)(4), publish a the use of the additive.
notice in the FEDERAL REGISTER deter- (4) It may adopt any combination of
mining that a substance is not GRAS the above three approaches for dif-
under the conditions of its intended use ferent uses or levels of use of the addi-
and is a food additive subject to section tive.
409 of the Federal Food, Drug, and Cos- (d) If the Commissioner of Food and
metic Act. Drugs is aware of any prior sanction
(b)(1) The Commissioner, on his own for use of the substance, he will con-
initiative or on the petition of any in- currently propose a separate regulation
terested person, pursuant to part 10 of covering such use of the ingredient
this chapter, may issue a notice in the under part 181 of this chapter. If the
FEDERAL REGISTER proposing to deter- Commissioner is unaware of any such
mine that a substance is not GRAS and applicable prior sanction, the proposed
is a food additive subject to section 409 regulation will so state and will re-
of the Act. Any petition shall include quire any person who intends to assert
all relevant data and information of or rely on such sanction to submit
the type described in § 171.130(b). The proof of its existence. Any regulation
Commissioner will place all of the data promulgated pursuant to this section
and information on which he relies on constitutes a determination that ex-
public file in the office of the Dockets cluded uses would result in adultera-
Management Staff and will include in tion of the food in violation of section
the FEDERAL REGISTER notice the name 402 of the Act, and the failure of any
of the substance, its known uses, and a person to come forward with proof of
summary of the basis for the deter- such an applicable prior sanction in re-
mination. sponse to the proposal will constitute a
(2) The FEDERAL REGISTER notice will waiver of the right to assert or rely on
allow a period of 60 days during which such sanction at any later time. The
any interested person may review the notice will also constitute a proposal
data and information and/or file com- to establish a regulation under part 181
ments with the Dockets Management of this chapter, incorporating the same
Staff. Copies of all comments shall be provisions, in the event that such a
made available for examination in the regulation is determined to be appro-
Dockets Management Staff’s office. priate as a result of submission of proof
(3) The Commissioner will evaluate of such an applicable prior sanction in
all comments received. If he concludes response to the proposal.
that there is a lack of convincing evi-
dence that the substance is GRAS or is FR 15673, Mar. 22, 1977; 54 FR 24896, June 12,
otherwise exempt from the definition 1989; 81 FR 55048, Aug. 17, 2016; 88 FR 17718,
of a food additive in section 201(s) of Mar. 24, 2023]
the Act, he will publish a notice there-
of in the FEDERAL REGISTER. If he con- § 170.39 Threshold of regulation for
cludes that there is convincing evi- substances used in food-contact ar-
ticles.
dence that the substance is GRAS, he

will publish an order in the FEDERAL (a) A substance used in a food-con-
REGISTER listing the substance as tact article (e.g., food-packaging or
16
food-processing equipment) that mi- to grant an exemption in those cases in

grates, or that may be expected to mi- which available information estab-
grate, into food will be exempted from lishes that the proposed use may pose a
regulation as a food additive because it public health risk. The reasons for the
becomes a component of food at levels agency’s decision to decline to grant an
that are below the threshold of regula- exemption will be explained in the
tion if: Food and Drug Administration’s re-
(1) The substance has not been shown sponse to the requestor.
to be a carcinogen in humans or ani- (c) A request for the Food and Drug
mals, and there is no reason, based on Administration to exempt a use of a
the chemical structure of the sub- substance from regulation as a food ad-
stance, to suspect that the substance is ditive shall include three copies of the
a carcinogen. The substance must also
following information (If part of the
not contain a carcinogenic impurity or,
submitted material is in a foreign lan-
if it does, must not contain a carcino-
guage, it must be accompanied by an
genic impurity with a TD50 value based
on chronic feeding studies reported in English translation verified to be com-
the scientific literature or otherwise plete and accurate in accordance with
available to the Food and Drug Admin- § 10.20(c)(2) of this chapter):
istration of less than 6.25 milligrams (1) The chemical composition of the
per kilogram bodyweight per day (The substance for which the request is
TD50, for the purposes of this section, is made, including, whenever possible,
the feeding dose that causes cancer in the name of the chemical in accord-
50 percent of the test animals when ance with current Chemical Abstract
corrected for tumors found in control Service (CAS) nomenclature guidelines
animals. If more than one TD50 value and a CAS registry number, if avail-
has been reported in the scientific lit- able;
erature for a substance, the Food and (2) Detailed information on the con-
Drug Administration will use the low- ditions of use of the substance (e.g.,
est appropriate TD50 value in its re- temperature, type of food with which
view.); the substance will come into contact,
(2) The substance presents no other the duration of the contact, and wheth-
health or safety concerns because: er the food-contact article will be for
(i) The use in question has been repeated or single use applications);
shown to result in or may be expected (3) A clear statement as to whether
to result in dietary concentrations at the request for exemption from regula-
or below 0.5 parts per billion, cor- tion as a food additive is based on the
responding to dietary exposure levels fact that the use of the substance in
at or below 1.5 micrograms/person/day the food-contact article results in a di-
(based on a diet of 1,500 grams of solid etary concentration at or below 0.5
food and 1,500 grams of liquid food per parts per billion, or on the fact that it
person per day); or
involves the use of a regulated direct
(ii) The substance is currently regu-
food additive for which the dietary ex-
lated for direct addition into food, and
posure is at or below 1 percent of the
the dietary exposure to the substance
acceptable dietary intake (ADI);
resulting from the proposed use is at or
below 1 percent of the acceptable daily (4) Data that will enable the Food
intake as determined by safety data in and Drug Administration to estimate
the Food and Drug Administration’s the daily dietary concentration result-
files or from other appropriate sources; ing from the proposed use of the sub-
(3) The substance has no technical ef- stance. These data should be in the
fect in or on the food to which it mi- form of:
grates; and (i) Validated migration data obtained
(4) The substance use has no signifi- under worst-case (time/temperature)
cant adverse impact on the environ- intended use conditions utilizing ap-
ment. propriate food simulating solvents;
(b) Notwithstanding paragraph (a) of (ii) Information on the amount of the

this section, the Food and Drug Admin- substance used in the manufacture of
istration reserves the right to decline the food-contact article; or
17
§ 170.39 21 CFR Ch. I (4–1–23 Edition)
(iii) Information on the residual level (e) The Food and Drug Administra-
of the substance in the food-contact ar- tion will inform the requestor by letter
ticle. For repeat-use articles, an esti- whether the specific food-contact ap-
mate of the amount of food that con- plication is exempt from regulation as
tacts a specific unit of surface area a food additive or not. Although a sub-
over the lifetime of the article should stance that migrates to food at a level
also be provided. (In cases where data that results in a dietary concentration
are provided only in the form of manu- at or below the threshold of regulation
facturing use levels or residual levels will not be the subject of a regulation
of the substance present in the food- published in the FEDERAL REGISTER
contact article, the Food and Drug Ad- and will not appear in the Code of Fed-
ministration will calculate a worst- eral Regulations, the Food and Drug
case dietary concentration level as- Administration will maintain a list of
suming 100 percent migration.) A de- substances exempted from regulation
tailed description of the analytical as food additives under this section on
method used to quantify the substance display at the Dockets Management
should also be submitted along with Staff. This list will include the name of
data used to validate the detection the company that made the request,
limit. the chemical name of the substance,
(iv) In cases where there is no detect- the specific use for which it has re-
able migration into food or food ceived an exemption from regulation as
simulants, or when no residual level of
a food additive, and any appropriate
a substance is detected in the food-con-
limitations on its use. The list will not
tact article by a suitable analytical
include any trade names. This list will
method, the Food and Drug Adminis-
enable interested persons to see the
tration will, for the purposes of esti-
types of uses of food-contact materials
mating the dietary concentration, con-
sider the validated detection limit of being exempted under the regulation.
the method used to analyze for the sub- Interested persons may also obtain a
stance. copy of the list of exempted substances
(5) The results of an analysis of exist- by contacting the Food and Drug Ad-
ing toxicological information on the ministration’s Office of Food Additive
substance and its impurities. This in- Safety (HFS–200), 5001 Campus Dr., Col-
formation on the substance is needed lege Park, MD 20740. For actions re-
to show whether an animal carcinogen quiring an environmental assessment,
bioassay has been carried out, or the agency’s finding of no significant
whether there is some other basis for impact and the evidence supporting
suspecting that the substance is a car- that finding, contained in the peti-
cinogen or potent toxin. This type of tioner’s environmental assessment,
information on the impurities is need- also will be available for public inspec-
ed to show whether any of them are tion at the Dockets Management Staff
carcinogenic, and, if carcinogenic, in accordance with § 25.51(b)(2) of this
whether their TD50 values are greater chapter. Requests for copies of releas-
than 6.25 milligrams per kilogram able information contained in submis-
bodyweight per day in accordance with sions requesting exemptions from the
paragraph (a)(1) of this section. food additive regulations will be han-
(6) Information on the environmental dled in accordance with the Food and
impact that would result from the pro- Drug Administration’s Freedom of In-
posed use of the substance. The request formation Act procedures, as described
should contain either a claim for cat- in part 20 of this chapter. In particular,
egorical exclusion as specified in § 25.32 data and information that fall within
of this chapter or an environmental as- the definitions of a trade secret or con-
sessment as specified in § 25.40 of this fidential commercial or financial infor-
chapter. mation are not available for public dis-
(d) Data to be reviewed under this closure in accordance with § 20.61(c) of
section shall be submitted to the Food this chapter.
and Drug Administration’s Office of (f) If the request for an exemption

Food Additive Safety (HFS–200), 5001 from regulation as a food additive is
Campus Dr., College Park, MD 20740. not granted, the requestor may submit
18
a petition to the Food and Drug Ad- MD 20740. Interested persons are en-
ministration for reconsideration of the couraged to obtain specific guidance
decision in accordance with the provi- from the Food and Drug Administra-
sions of § 10.33 of this chapter. tion on the appropriate protocols to be
(g) If the Food and Drug Administra- used for obtaining migration data, on
tion receives significant new informa- the validation of the analytical meth-
tion that raises questions about the di- ods used to quantify migration levels,
etary concentration or the safety of a on the procedures used to relate migra-
substance that the agency has exempt- tion data to dietary exposures, and on
ed from regulation, the Food and Drug any other issue not specifically covered
Administration may reevaluate the in the Food and Drug Administration’s
substance. If the Food and Drug Ad- guidance documents.
ministration tentatively concludes [60 FR 36595, July 17, 1995, as amended at 62
that the information that is available FR 40599, July 29, 1997; 65 FR 56479, Sept. 19,
about the substance no longer supports 2000; 81 FR 49896, July 29, 2016; 88 FR 17718,
an exemption for the use of the food- Mar. 24, 2023]
contact material from the food addi-
tive regulations, the agency will notify Subpart C—Specific Administra-
any persons that requested an exemp- tive Rulings and Decisions
tion for the substance of its tentative
decision. The requestors will be given § 170.45 Fluorine-containing com-
an opportunity to show why the use of pounds.
the substance should not be regulated The Commissioner of Food and Drugs
under the food additive provisions of has concluded that it is in the interest
the act. If the requestors fail to ade- of the public health to limit the addi-
quately respond to the new evidence, tion of fluorine compounds to foods (a)
the agency will notify them that fur- to that resulting from the fluoridation
ther use of the substance in question of public water supplies, (b) to that re-
for the particular use will require a sulting from the fluoridation of bottled
food additive regulation. This notifica- water within the limitation established
tion will be placed on public display at in § 165.110(d) of this chapter, and (c) to
the Dockets Management Staff as part that authorized by regulations (40 CFR
of the file of uses of substances exempt- part 180) under section 408 of the Act.
ed from regulation as food additives.
The Food and Drug Administration [42 FR 14483, Mar. 15, 1977, as amended at 72
recognizes that manufacturers other FR 10357 Mar. 8, 2007]
than those that actually made a re- § 170.50 Glycine (aminoacetic acid) in
quest for exemption may also be using food for human consumption.
exempted substances in food-contact
articles under conditions of use (e.g., (a) Heretofore, the Food and Drug
use levels, temperature, type of food Administration has expressed the opin-
contacted, etc.) that are similar to ion in trade correspondence that gly-
those for which the exemption was cine is generally recognized as safe for
issued. Because only requestors will be certain technical effects in human food
notified as part of the revocation proc- when used in accordance with good
ess described in this section, the Food manufacturing practice; however:
and Drug Administration plans to no- (1) Reports in scientific literature in-
tify other manufacturers by means of a dicate that adverse effects were found
notice published in the FEDERAL REG- in cases where high levels of glycine
ISTER of its decision to revoke an ex-
were administered in diets of experi-
emption issued for a specific use of a mental animals.
substance in a food contact article. (2) Current usage information indi-
(h) Guidance documents to assist re- cates that the daily dietary intake of
questors in the preparation of submis- glycine by humans may be substan-
sions seeking exemptions from the food tially increasing due to changing use
additive regulations are available from patterns in food technology.
the Food and Drug Administration’s Therefore, the Food and Drug Adminis-
Office of Food Additive Safety (HFS– tration no longer regards glycine and
200), 5001 Campus Dr., College Park, its salts as generally recognized as safe
19
§ 170.60 21 CFR Ch. I (4–1–23 Edition)
for use in human food and all out- poultry and wild game. To assure safe
standing letters expressing sanction for use of such ingredients the labeling of
such use are rescinded. the premixes shall bear instructions to
(b) The Commissioner of Food and the user that such separately packaged
Drugs concludes that by May 8, 1971, ingredients are not to be combined
manufacturers: until just prior to use. Encapsulating
(1) Shall reformulate food products or coating some or all of the ingredi-
for human use to eliminate added gly- ents does not constitute separate pack-
cine and its salts; or aging.
(2) Shall bring such products into
compliance with an authorizing food Subpart D—Premarket
additive regulation. A food additive pe- Notifications
tition supported by toxicity data is re-
quired to show that any proposed level
SOURCE: 67 FR 35729, May 21, 2002, unless
of glycine or its salts added to foods for otherwise noted.
human consumption will be safe.
(c) The status of glycine as generally § 170.100 Submission of a premarket
recognized as safe for use in animal notification for a food contact sub-
feed, as prescribed in § 582.5049 of this stance (FCN) to the Food and Drug
chapter, remains unchanged because Administration (FDA).
the additive is considered an essential (a) An FCN is effective for the food
nutrient in certain animal feeds and is contact substance manufactured or
safe for such use under conditions of prepared by the manufacturer or sup-
good feeding practice. plier identified in the FCN submission.
If another manufacturer or supplier
§ 170.60 Nitrites and/or nitrates in cur- wishes to market the same food con-
ing premixes.
tact substance for the same use, that
(a) Nitrites and/or nitrates are food manufacturer or supplier must also
additives when combined in curing pre- submit an FCN to FDA.
mixes with spices and/or other fla- (1) An FCN must contain all of the
voring or seasoning ingredients that information described in § 170.101.
contain or constitute a source of sec- (2) An FCN may incorporate by ref-
ondary or tertiary amines, including erence any information in FDA’s files
but not limited to essential oils, diso- provided that the manufacturer or sup-
dium inosinate, disodium guanylate, plier is authorized to reference the in-
hydrolysates of animal or plant origin formation. The FCN must include in-
(such as hydrolyzed vegetable protein), formation establishing that the manu-
oleoresins of spices, soy products, and facturer or supplier is authorized to
spice extractives. Such food additives reference information in FDA’s files.
may be used only after the establish- (3) Any material submitted in or ref-
ment of an authorizing food additive erenced by an FCN that is in a foreign
regulation. A food additive petition language must be accompanied by an
submitted pursuant to §§ 171.1 and English translation verified to be com-
171.100 of this chapter, supported by plete and accurate.
data demonstrating that nitrosamines (b) FDA may choose not to accept an
are not formed in curing premixes con- FCN for either of the following:
taining such food additives, is required (1) A use of a food contact substance
to establish safety. that is the subject of a regulation in
(b) Nitrites and/or nitrates, when parts 173 through 189 of this chapter; or
packaged separately from flavoring (2) A use of a food contact substance
and seasoning in curing premixes, may that is the subject of an exemption
continue to be used under prior sanc- under the threshold of regulation proc-
tions in the commercial curing of meat ess described in § 170.39.
and meat products and poultry prod- (c) A petition must be submitted
ucts and in accordance with the provi- under § 171.1 of this chapter to author-
sions of §§ 172.170 and 172.175 of this ize the safe use of a food contact sub-
chapter that apply to meat curing stance in either of the following cir-
preparations for the home curing of cumstances, unless FDA agrees to ac-
meat and meat products, including cept an FCN for the proposed use.
20
(1) The use of the food contact sub- good laboratory practice regulations
stance increases the cumulative die- under part 58 of this chapter; or
tary concentration to a certain level. (2) A brief signed statement listing
For a substance that is a biocide (e.g., the reason(s) that the study was not
it is intended to exert microbial tox- conducted in compliance with part 58
icity), this level is equal to or greater of this chapter.
than 200 parts per billion in the daily (3) Data from any study conducted
diet (0.6 milligram (mg)/person/day). after 1978 but not conducted in compli-
For a substance that is not a biocide, ance with part 58 of this chapter must
this level is equal to or greater than 1 be validated by an independent third
part per million in the daily diet (3 mg/ party prior to submission to the Food
person/day); or and Drug Administration (FDA), and
(2) There exists a bioassay on the the report and signed certification of
food contact substance, FDA has not the validating party must be submitted
reviewed the bioassay, and the bio- as part of the notification.
assay is not clearly negative for car-
(d) Information to address FDA’s re-
cinogenic effects.
sponsibility under the National Envi-
(d) A manufacturer or supplier for
ronmental Policy Act, in the form of
which a notification is effective must
either:
keep a current address on file with
FDA. (1) A claim of categorical exclusion
under § 25.30 or § 25.32 of this chapter; or
(1) The current address may be either
the manufacturer’s (or supplier’s) ad- (2) An environmental assessment
dress or the address of the manufactur- complying with § 25.40 of this chapter.
er’s (or supplier’s) agent. (e) A completed and signed FDA
(2) FDA will deliver correspondence Form No. 3480.
to the manufacturer’s or supplier’s cur-
§ 170.102 Confidentiality of informa-
rent address. tion in a premarket notification for
a food contact substance (FCN).
§ 170.101 Information in a premarket
notification for a food contact sub- (a) During the 120-day period of the
stance (FCN). Food and Drug Administration (FDA)
An FCN must contain the following: review of an FCN, FDA will not dis-
(a) A comprehensive discussion of the close publicly any information in that
basis for the manufacturer’s or sup- FCN.
plier’s determination that the use of (b) FDA will not disclose publicly the
the food contact substance is safe. This information in an FCN that is with-
discussion must: drawn prior to the completion of FDA’s
(1) Discuss all information and data review.
submitted in the notification; and (c) Once FDA completes its review of
(2) Address any information and data an FCN, the agency will make its con-
that may appear to be inconsistent clusion about the FCN publicly avail-
with the determination that the pro- able. For example, if FDA objects to a
posed use of the food contact substance notification 90 days after the date of
is safe. receipt, the agency would make avail-
(b) All data and other information able its objection at that time.
that form the basis of the determina- (d) By submitting an FCN to FDA,
tion that the food contact substance is the manufacturer or supplier waives
safe under the intended conditions of any claim to confidentiality of the in-
use. Data must include primary bio- formation required to adequately de-
logical data and chemical data. scribe the food contact substance and
(c) A good laboratory practice state- the intended conditions of use that are
ment for each nonclinical laboratory the subject of that FCN.
study, as defined under § 58.3(d) of this (e) The following data and informa-
chapter, that is submitted as part of tion in an FCN are available for public
the FCN, in the form of either: disclosure, unless extraordinary cir-

(1) A signed statement that the study cumstances are shown, on the 121st day
was conducted in compliance with the after receipt of the notification by
21
§ 170.103 21 CFR Ch. I (4–1–23 Edition)
FDA, except that no data or informa- (b) If an FCN is complete when re-
tion are available for public disclosure ceived, the 120-day review period begins
if the FCN is withdrawn under § 170.103. on the date FDA receives the FCN.
(1) All safety and functionality data (1) If any element required under
and information submitted with or in- § 170.101 is missing from an FCN, then
corporated by reference into the notifi- FDA will not accept that FCN and FDA
cation. Safety and functionality data will send an FCN nonacceptance letter
include all studies and tests of a food to the manufacturer or supplier. If the
contact substance on animals and hu- manufacturer or supplier submits the
missing information before FDA sends
mans and all studies and tests on a
an FCN nonacceptance letter, the 120-
food contact substance for establishing
day review period begins on the date of
identity, stability, purity, potency, receipt of the missing information.
performance, and usefulness. (2) If FDA accepts an FCN, then FDA
(2) A protocol for a test or study, un- will acknowledge in writing its receipt
less it is exempt from disclosure under of that FCN.
§ 20.61 of this chapter. (c) Objection to an FCN:
(3) A list of all ingredients contained (1) If FDA objects to an FCN, then
in a food contact substance, excluding FDA will send an FCN objection letter.
information that is exempt from dis- The date of the letter will be the date
closure under § 20.61 of this chapter. of FDA’s objection for purposes of sec-
Where applicable, an ingredient list tion 409(h)(2)(A) of the act.
will be identified as incomplete. (2) If FDA objects to an FCN within
(4) An assay method or other analyt- the 120-day period for FDA review, the
ical method, unless it serves no regu- FCN will not become effective.
latory or compliance purpose and is ex- (3) FDA may object to an FCN if any
empt from disclosure under § 20.61 of part of FDA’s 120-day review occurs
during a period when this program is
this chapter.
not funded as required in section
(5) All correspondence and written 409(h)(5) of the act.
summaries of oral discussions relating (d) If FDA and a manufacturer or
to the notification, except information supplier agree that the notifier may
that is exempt for disclosure under submit a food additive petition pro-
§ 20.61 of this chapter. posing the approval of the food contact
(6) All other information not subject substance for the use in the manufac-
to an exemption from disclosure under turer’s or supplier’s FCN, FDA will
subpart D of part 20 of this chapter. consider that FCN to be withdrawn by
the manufacturer or supplier on the
§ 170.103 Withdrawal without preju- date the petition is received by FDA.
dice of a premarket notification for
a food contact substance (FCN). § 170.105 The Food and Drug Adminis-
tration’s (FDA’s) determination that
A manufacturer or supplier may a premarket notification for a food
withdraw an FCN without prejudice to contact substance (FCN) is no
a future submission to the Food and longer effective.
Drug Administration (FDA) if FDA has (a) If data or other information avail-
not completed review of the FCN. For able to FDA, including data not sub-
the purpose of this section, FDA’s re- mitted by the manufacturer or sup-
view is completed when FDA has al- plier, demonstrate that the intended
lowed 120 days to pass without object- use of the food contact substance is no
ing to the FCN or FDA has issued an longer safe, FDA may determine that
objection letter. the authorizing FCN is no longer effec-
tive.
§ 170.104 Action on a premarket notifi- (b) If FDA determines that an FCN is
cation for a food contact substance no longer effective, FDA will inform
(FCN).
the manufacturer or supplier in writing
(a) If the Food and Drug Administra- of the basis for that determination.
tion (FDA) does not object to an FCN FDA will give the manufacturer or sup-
within the 120-day period for FDA re- plier an opportunity to show why the
view, the FCN becomes effective. FCN should continue to be effective
22
and will specify the time that the man- Amendment means any data and infor-
ufacturer or supplier will have to re- mation that you submit regarding a
spond. filed GRAS notice before we respond to
(c) If the manufacturer or supplier your notice by letter in accordance
fails to respond adequately to the safe- with § 170.265(b)(1) or cease to evaluate
ty concerns regarding the notified use, your notice in accordance with
FDA will publish a notice of its deter- § 170.265(b)(3).
mination that the FCN is no longer ef- GRAS means generally recognized as
fective. FDA will publish this notice in safe.
the FEDERAL REGISTER, stating that a GRAS notice means a submission that
detailed summary of the basis for
informs us of your view that a sub-
FDA’s determination that the FCN is
stance is not subject to the premarket
no longer effective has been placed on
public display and that copies are approval requirements of the Federal
available upon request. The date that Food, Drug, and Cosmetic Act based on
the notice publishes in the FEDERAL your conclusion that the substance is
REGISTER is the date on which the noti- GRAS under the conditions of its in-
fication is no longer effective. tended use in accordance with § 170.30.
(d) FDA’s determination that an FCN Notified substance means the sub-
is no longer effective is final agency stance that is the subject of your
action subject to judicial review. GRAS notice.
Notifier means the person (e.g., an in-
§ 170.106 Notification for a food con- dividual, partnership, corporation, as-
tact substance formulation sociation, or other legal entity) who is
(NFCSF).
responsible for the GRAS notice, even
(a) In order for the Food and Drug if another person (such as an attorney,
Administration (FDA) to accept an agent, or qualified expert) prepares or
NFCSF, any food additive that is a submits the notice or provides an opin-
component of the formulation must be ion about the basis for a conclusion of
authorized for its intended use in that GRAS status.
NFCSF. Qualified expert means an individual
(b) FDA may publish a notice in the who is qualified by scientific training
FEDERAL REGISTER stating that the
and experience to evaluate the safety
agency has insufficient resources to re-
of substances under the conditions of
view NFCSFs. From the date that this
their intended use in food.
notice publishes in the FEDERAL REG-
ISTER, FDA will no longer accept Supplement means any data and infor-
NFCSFs. mation that you submit regarding a
(c) An NFCSF must contain the fol- filed GRAS notice after we respond to
lowing: your notice by letter in accordance
(1) A completed and signed FDA with § 170.265(b)(1) or cease to evaluate
Form No. 3479; and your notice in accordance with
(2) Any additional documentation re- § 170.265(b)(3).
quired to establish that each compo- We, our, and us refer to the United
nent of the formulation already may be States Food and Drug Administration
marketed legally for its intended use. (FDA).
You and your refer to a notifier.
Subpart E—Generally Recognized
§ 170.205 Opportunity to submit a
as Safe (GRAS) Notice GRAS notice.
SOURCE: 81 FR 55048, Aug. 17, 2016, unless Any person may notify FDA of a view
otherwise noted. that a substance is not subject to the
premarket approval requirements of
§ 170.203 Definitions. section 409 of the Federal Food, Drug,
The definitions and interpretations and Cosmetic Act based on that per-
son’s conclusion that the substance is
of terms in § 170.3 apply to such terms

when used in this subpart. The fol- GRAS under the conditions of its in-
lowing definitions also apply: tended use.
23
§ 170.210 21 CFR Ch. I (4–1–23 Edition)
§ 170.210 How to send your GRAS no- (1) Inform us that you are submitting
tice to FDA. a GRAS notice in accordance with this
(a) Send your GRAS notice to the Of- subpart;
fice of Food Additive Safety (HFS–200), (2) Provide the name and address of
Center for Food Safety and Applied Nu- your organization;
trition, Food and Drug Administration, (3) Provide the name of the notified
5001 Campus Dr., College Park, MD substance, using an appropriately de-
20740. scriptive term;
(b) When you submit your GRAS no- (4) Describe the intended conditions
tice, you may do so either in an elec- of use of the notified substance, includ-
tronic format that is accessible for our ing the foods in which the substance
evaluation or on paper. If you send will be used, the levels of use in such
your GRAS notice on paper, a single foods, and the purposes for which the
paper copy is sufficient. substance will be used, including, when
appropriate, a description of a sub-
§ 170.215 Incorporation into a GRAS population expected to consume the
notice. notified substance;
You may incorporate into your (5) Inform us of the statutory basis
GRAS notice either specifically identi- for your conclusion of GRAS status
fied data and information that you pre- (i.e., through scientific procedures in
viously submitted to the Center for accordance with § 170.30(a) and (b) or
Food Safety and Applied Nutrition through experience based on common
(CFSAN), or specifically identified pub- use in food in accordance with
licly available data and information § 170.30(a) and (c));
submitted by another party, when such (6) State your view that the notified
data and information remain in substance is not subject to the pre-
CFSAN’s records, such as data and in- market approval requirements of the
formation contained in a previous Federal Food, Drug, and Cosmetic Act
GRAS notice or a food additive peti- based on your conclusion that the noti-
tion. fied substance is GRAS under the con-
ditions of its intended use;
§ 170.220 General requirements appli- (7) State that, if we ask to see the
cable to a GRAS notice. data and information that are the basis
(a) A GRAS notice has seven parts as for your conclusion of GRAS status, ei-
required by §§ 170.225 through 170.255. ther during or after our evaluation of
You must submit the data and infor- your notice, you will:
mation specified in each of these parts (i) Agree to make the data and infor-
on separate pages or sets of pages. mation available to us; and
(b) You must include each of the (ii) Agree to both of the following
seven parts in your GRAS notice. If procedures for making the data and in-
you do not include a part, you must information available to us:
clude with your GRAS notice an expla- (A) Upon our request, you will allow
nation of why that part does not apply us to review and copy the data and in-
to your GRAS notice. formation during customary business
hours at the address you specify for
§ 170.225 Part 1 of a GRAS notice: where these data and information will
Signed statements and certification. be available to us; and
(a) Part 1 of your GRAS notice must (B) Upon our request, you will pro-
be dated and signed by a responsible of- vide us with a complete copy of the
ficial of your organization, or by your data and information either in an elec-
attorney or agent. tronic format that is accessible for our
(b) Except as required by paragraph evaluation or on paper;
(c)(8) of this section, you must not in- (8) State your view as to whether any
clude any information that is trade se- of the data and information in Parts 2
cret or confidential commercial infor- through 7 of your GRAS notice are ex-
mation in Part 1 of your GRAS notice. empt from disclosure under the Free-
(c) In Part 1 of your GRAS notice, dom of Information Act, 5 U.S.C. 552
you must: (e.g., as trade secret or as commercial
24
or financial information that is privi- (d) When necessary to demonstrate

leged or confidential). safety, relevant data and information
(9) Certify that, to the best of your bearing on the physical or other tech-
knowledge, your GRAS notice is a com- nical effect the notified substance is
plete, representative, and balanced intended to produce, including the
submission that includes unfavorable quantity of the notified substance re-
information, as well as favorable infor- quired to produce such effect.
mation, known to you and pertinent to
the evaluation of the safety and GRAS § 170.235 Part 3 of a GRAS notice: Die-
status of the use of the substance; tary exposure.
(10) State both the name and position In part 3 of your GRAS notice, you
or title of the person who signs the must provide data and information
GRAS notice; and about dietary exposure (i.e., the
(11) When applicable, state as re-
amount of relevant substances that
quired by § 170.270 whether you:
consumers are likely to eat or drink as
(i) Authorize us to send any trade se-
part of a total diet), regardless of
crets to the Food Safety and Inspection
whether your conclusion of GRAS sta-
Service (FSIS) of the U.S. Department
of Agriculture; or tus is through scientific procedures or
(ii) Ask us to exclude any trade se- through experience based on common
crets from the copy of the GRAS notice use in food, as follows:
that we will send to FSIS. (a) You must provide an estimate of
dietary exposure to the notified sub-
§ 170.230 Part 2 of a GRAS notice: stance that includes exposure from its
Identity, method of manufacture, intended use and all sources in the
specifications, and physical or tech- diet; and
nical effect. (b) When applicable, you must pro-
In Part 2 of your GRAS notice, you vide an estimate of dietary exposure to
must include: any other substance that is expected to
(a) Scientific data and information be formed in or on food because of the
that identifies the notified substance. use of the notified substance (e.g.,
(1) Examples of appropriate data and hydrolytic products or reaction prod-
information include the chemical ucts);
name, applicable registry numbers (c) When applicable, you must pro-
(such as a Chemical Abstracts Service vide an estimate of dietary exposure to
(CAS) registry number or an Enzyme any other substance that is present
Commission (EC) number), empirical with the notified substance either nat-
formula, structural formula, quan- urally or due to its manufacture (e.g.,
titative composition, and char- contaminants or by-products);
acteristic properties.
(d) You must describe the source of
(2) When the source of a notified sub-
any food consumption data that you
stance is a biological material, you
use to estimate dietary exposure in ac-
must include data and information suf-
cordance with paragraphs (a) through
ficient to identify:
(c) of this section; and
(i) The taxonomic source (e.g., genus,
species) including, as applicable, data (e) You must explain any assump-
and information at the sub-species tions you made to estimate dietary ex-
level (e.g., variety, strain); posure in accordance with paragraphs
(ii) The part of any plant or animal (a) through (c) of this section.
used as the source; and
§ 170.240 Part 4 of a GRAS notice: Self-
(iii) Any known toxicants that could
limiting levels of use.
be in the source;
(b) A description of the method of In circumstances where the amount
manufacture of the notified substance of the notified substance that can be
in sufficient detail to evaluate the added to food is limited because food
safety of the notified substance as containing levels of the notified sub-
manufactured; stance above a particular level would

(c) Specifications for food-grade ma- become unpalatable or technologically
terial; and impractical, in Part 4 of your GRAS
25
§ 170.245 21 CFR Ch. I (4–1–23 Edition)
notice you must include data and infor- gardless of whether those data and in-
mation on such self-limiting levels of formation are generally available; or
use. (2) State that you have reviewed the
available data and information and are
§ 170.245 Part 5 of a GRAS notice: Ex- not aware of any data and information
perience based on common use in
food before 1958. that are, or may appear to be, incon-
sistent with your conclusion of GRAS
If the statutory basis for your con- status;
clusion of GRAS status is through ex- (d) If you view any of the data and in-
perience based on common use in food, formation in your notice as exempt
in Part 5 of your GRAS notice you from disclosure under the Freedom of
must include evidence of a substantial Information Act, you must identify the
history of consumption of the notified specific data and information; and
substance for food use by a significant
(e) For non-public, safety-related
number of consumers prior to January
data and information considered in
1, 1958.
reaching a conclusion of GRAS status,
§ 170.250 Part 6 of a GRAS notice: Nar- you must explain how there could be a
rative. basis for a conclusion of GRAS status
if qualified experts do not have access
In Part 6 of your GRAS notice, you
to such data and information.
must include a narrative that provides
the basis for your conclusion of GRAS § 170.255 Part 7 of a GRAS notice: List
status, in which: of supporting data and information
(a)(1) You must explain why the data in your GRAS notice.
and information in your notice provide
a basis for your view that the notified (a) In part 7 of your GRAS notice,
substance is safe under the conditions you must include a list of all of the
of its intended use. In your expla- data and information that you discuss
nation, you must address the safety of in Part 6 of your GRAS notice to pro-
the notified substance, considering all vide a basis for your view that the no-
dietary sources and taking into ac- tified substance is safe under the condi-
count any chemically or pharmacologi- tions of its intended use as described in
cally related substances in such diet; accordance with § 170.250(a)(1).
(2) In your explanation, you must (b) You must specify which data and
identify what specific data and infor- information that you list in accordance
mation that you discuss in accordance with paragraph (a) of this section are
with paragraph (a)(1) of this section are generally available, and which data
generally available, and what specific and information are not generally
data and information that you discuss available.
in accordance with paragraph (a)(1) of
this section are not generally avail- § 170.260 Steps you may take before
FDA responds to your GRAS notice.
able, by providing citations to the list
of data and information that you in- (a) You may submit a timely amend-
clude in Part 7 of your GRAS notice in ment to your filed GRAS notice, to up-
accordance with § 170.255; date your GRAS notice or in response
(b) You must explain how the gen- to a question from us, before we re-
erally available data and information spond to your notice by letter in ac-
that you rely on to establish safety in cordance with § 170.265(b)(1) or cease to
accordance with paragraph (a) of this evaluate your notice in accordance
section provide a basis for your conclu- with § 170.265(b)(3).
sion that the notified substance is gen- (b) At any time before we respond to
erally recognized, among qualified ex- your GRAS notice in accordance with
perts, to be safe under the conditions of § 170.265(b)(1), you may request in writ-
its intended use; ing that we cease to evaluate your
(c) You must either: GRAS notice. Your request does not
(1) Identify, discuss, and place in con- preclude you from submitting a future
text, data and information that are, or GRAS notice in accordance with this
may appear to be, inconsistent with subpart with respect to the notified
your conclusion of GRAS status, re- substance.
26
§ 170.265 What FDA will do with a product or products subject to regula-

GRAS notice. tion by FSIS under statutes that it ad-
(a)(1) We will conduct an initial eval- ministers:
uation of your submission to determine (a) When applicable, you must in-
whether to file it as a GRAS notice for clude in your GRAS notice a statement
evaluation of your view that the noti- as to whether you:
fied substance is GRAS under the con- (1) Authorize us to send any trade se-
ditions of its intended use. crets to FSIS; or
(2) If we file your submission as a (2) Ask us to exclude any trade se-
GRAS notice, we will send you a letter crets from the copy of the GRAS notice
that informs you of the date of filing. that we will send to FSIS.
(3) If we do not file your submission (b)(1) We will forward a copy of a
as a GRAS notice, we will send you a GRAS notice or relevant portions
letter that informs you of that fact and thereof to FSIS;
provides our reasons for not filing the (2) We will exclude any trade secrets
submission as a GRAS notice. unless you have authorized us to do so
(4) We will consider any timely in accordance with paragraph (a)(1) of
amendment that you submit to a filed this section; and
GRAS notice, to update your GRAS no- (c) We will ask FSIS to advise wheth-
tice or in response to a question from er the intended conditions of use com-
us, before we respond to you by letter ply with applicable statutes and regu-
in accordance with paragraph (b)(1) of lations, or, if not, whether the use of
this section, if we deem that doing so is the substance would be permitted in
feasible within the timeframes estab- products under FSIS’ jurisdiction
lished in paragraph (b) of this section. under specified conditions or restric-
If we deem that considering your tions.
amendment is not feasible within the
(d) As appropriate, we will inform
timeframes established in paragraph
you of the advice we receive from FSIS
(b) of this section or if we have granted
in the letter we send you in accordance
your request to cease to evaluate your
with § 170.265(b)(1).
notice, we will inform you that we are
not considering your amendment. § 170.275 Public disclosure of a GRAS
(b)(1) Within 180 days of filing, we notice.
will respond to you by letter based on
our evaluation of your notice. We may (a) The data and information in a
extend the 180 day timeframe by 90 GRAS notice (including data and infor-
days on an as needed basis. mation submitted in any amendment
(2) If we extend the timeframe, we or supplement to your GRAS notice or
will inform you in writing of the exten- incorporated into your GRAS notice)
sion as soon as practicable but no later are:
than within 180 days of filing. (1) Considered a mandatory, rather
(3) If you ask us to cease to evaluate than voluntary, submission for pur-
your GRAS notice in accordance with poses of their status under the Free-
§ 170.260(b), we will send you a letter in- dom of Information Act and our public
forming you of our decision regarding information requirements in part 20 of
your request. this chapter; and
(c) If circumstances warrant, we will (2) Available for public disclosure in
send you a subsequent letter about the accordance with part 20 of this chapter
notice. as of the date that we receive your
GRAS notice.
§ 170.270 Procedures that apply when (b) We will make the following read-
the intended conditions of use of a ily accessible to the public:
notified substance include use in a
product or products subject to reg- (1) A list of filed GRAS notices, in-
ulation by the Food Safety and In- cluding the information described in
spection Service (FSIS) of the § 170.225(c)(2) through (c)(5);
United States Department of Agri- (2) The text of any letter that we
culture.
issue under § 170.265(b)(1) or (c); and

If the intended conditions of use of (3) The text of any letter that we
the notified substance include use in a issue under § 170.265(b)(3) if we grant
27
§ 170.280 21 CFR Ch. I (4–1–23 Edition)
your request that we cease to evaluate Subpart A—General Provisions

your notice.
(c) We will disclose all remaining § 171.1 Petitions.
data and information that are not ex- (a) Petitions to be filed with the
empt from public disclosure in accord- Commissioner under the provisions of
ance with part 20 of this chapter. section 409(b) of the Federal Food,
§ 170.280 Submission of a supplement. Drug, and Cosmetic Act (the act) shall
be submitted in triplicate (quadru-
If circumstances warrant, you may plicate, if intended uses include use in
submit a supplement to a filed GRAS meat, meat food product, or poultry
notice after we respond to your notice product). If any part of the material
by letter in accordance with submitted is in a foreign language, it
§ 170.265(b)(1) or cease to evaluate your shall be accompanied by an accurate
notice in accordance with § 170.265(b)(3). and complete English translation. The
petition shall state petitioner’s post of-
§ 170.285 Disposition of pending GRAS fice address to which published notices
affirmation petitions.
or orders issued or objections filed pur-
Because the procedure to submit a suant to section 409 of the Act may be
GRAS notice is replacing the former sent.
process to submit a GRAS affirmation (b) Pertinent information may be in-
petition, the following will happen to a corporated in, and will be considered as
filed GRAS affirmation petition that is part of, a petition on the basis of spe-
pending on October 17, 2016. cific reference to such information sub-
(a) On October 17, 2016, we will close mitted to and retained in the files of
the docket for any GRAS affirmation the Food and Drug Administration.
petition that is still pending as of Oc- However, any reference to unpublished
tober 17, 2016. information furnished by a person
(b) Any person who submitted a other than the applicant will not be
GRAS affirmation petition described in considered unless use of such informa-
this section may submit a GRAS notice tion is authorized in a written state-
as described in this subpart and request ment signed by the person who sub-
that we incorporate the GRAS affirma- mitted it. Any reference to published
tion petition as described in § 170.215. information offered in support of a food
additive petition should be accom-
PART 171—FOOD ADDITIVE panied by reprints or photostatic cop-
PETITIONS ies of such references.
(c) Petitions shall include the fol-
Subpart A—General Provisions lowing data and be submitted in the
following form:
Sec.
171.1 Petitions. (Date)
171.6 Amendment of petition. Name of petitioner lllllllllllll
171.7 Withdrawal of petition without preju- Post-office address lllllllllllll
dice. Date lllllllllllllllllllll
171.8 Threshold of regulation for substances Name of food additive and proposed use ll
used in food-contact articles. llllllllllllllllllllllll
Office of Food Additive Safety (HFS–200),
Subpart B—Administrative Actions on Center for Food Safety and Applied Nutri-
Applications tion, Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740.
171.100 Regulation based on petition.
171.102 Effective date of regulation. DEAR SIRS:
171.110 Procedure for objections and hear- The undersigned, __________ submits this
ings. petition pursuant to section 409(b)(1) of the
171.130 Procedure for amending and repeal- Federal Food, Drug, and Cosmetic Act with
ing tolerances or exemptions from toler- respect to __________
ances.
(Name of the food additive and proposed use)
AUTHORITY: 21 U.S.C. 321, 342, 348, 371.
Attached hereto, in triplicate (quadru-

SOURCE: 42 FR 14489, Mar. 15, 1977, unless plicate, if intended uses include use in meat,
otherwise noted. meat food product, or poultry product), and
28
constituting a part of this petition are the and what residues may reasonably be antici-
following: pated.
A. The name and all pertinent information (Typewritten or other draft-labeling copy
concerning the food additive, including will be accepted for consideration of the pe-
chemical identity and composition of the tition, provided a statement is made that
food additive, its physical, chemical, and bi- final printed labeling identical in content to
ological properties, and specifications pre- the draft copy will be submitted as soon as
scribing the minimum content of the desired available and prior to the marketing of the
component(s) and identifying and limiting food additive.)
the reaction byproducts and other impuri- (If the food additive is one for which a tol-
ties. Where such information is not avail- erance limitation is required to assure its
able, a statement as to the reasons why it is safety, the level of use proposed should be no
not should be submitted. higher than the amount reasonably required
When the chemical identity and composi- to accomplish the intended physical or other
tion of the food additive is not known, the technical effect, even though the safety data
petition shall contain information in suffi- may support a higher tolerance.)
cient detail to permit evaluation regarding C. Data establishing that the food additive
the method of manufacture and the analyt- will have the intended physical or other
ical controls used during the various stages technical effect or that it may reasonably be
of manufacturing, processing, or packing of expected to become a component, or to affect
the food additive which are relied upon to es- the characteristics, directly or indirectly, of
tablish that it is a substance of reproducible food and the amount necessary to accom-
composition. Alternative methods and con- plish this. These data should include infor-
trols and variations in methods and controls mation in sufficient detail to permit evalua-
within reasonable limits that do not affect tion with control data.
the characteristics of the substance or the D. A description of practicable methods to
reliability of the controls may be specified. determine the amount of the food additive in
If the food additive is a mixture of chemi- the raw, processed, and/or finished food and
cals, the petition shall supply a list of all of any substance formed in or on such food
substances used in the synthesis, extraction, because of its use. The test proposed shall be
or other method of preparation, regardless of one that can be used for food-control pur-
whether they undergo chemical change in poses and that can be applied with consistent
the process. Each substance should be identi- results by any properly equipped and trained
fied by its common English name and com- laboratory personnel.
plete chemical name, using structural for- E. Full reports of investigations made with
mulas when necessary for specific identifica- respect to the safety of the food additive.
tion. If any proprietary preparation is used (A petition may be regarded as incomplete
as a component, the proprietary name should unless it includes full reports of adequate
be followed by a complete quantitative tests reasonably applicable to show whether
statement of composition. Reasonable alter- or not the food additive will be safe for its
natives for any listed substance may be spec- intended use. The reports ordinarily should
ified. include detailed data derived from appro-
If the petitioner does not himself perform priate animal and other biological experi-
all the manufacturing, processing, and pack- ments in which the methods used and the re-
ing operations for a food additive, the peti- sults obtained are clearly set forth. The peti-
tion shall identify each person who will per- tion shall not omit without explanation any
form a part of such operations and designate reports of investigations that would bias an
the part. evaluation of the safety of the food additive.)
The petition shall include stability data, F. Proposed tolerances for the food addi-
and, if the data indicate that it is needed to tive, if tolerances are required in order to in-
insure the identity, strength, quality, or pu- sure its safety. A petitioner may include a
rity of the additive, the expiration date that proposed regulation.
will be employed. G. If submitting petition to modify an ex-
B. The amount of the food additive pro- isting regulation issued pursuant to section
posed for use and the purposes for which it is 409(c)(1)(A) of the Act, full information on
proposed, together with all directions, rec- each proposed change that is to be made in
ommendations, and suggestions regarding the original regulation must be submitted.
the proposed use, as well as specimens of the The petition may omit statements made in
labeling proposed for the food additive and the original petition concerning which no
any labeling that will be required by applica- change is proposed. A supplemental petition
ble provisions of the Federal Food, Drug, and must be submitted for any change beyond
Cosmetic Act on the finished food by reason the variations provided for in the original
of the use of the food additive. If the additive petition and the regulation issued on the
results or may reasonably be expected to re- basis of the original petition.

sult from the use of packaging material, the H. The petitioner is required to submit ei-
petitioner shall show how this may occur ther a claim for categorical exclusion under
29
§ 171.1 21 CFR Ch. I (4–1–23 Edition)
§ 25.30 or 25.32 of this chapter or an environ- and confidential commercial informa-
mental assessment under § 25.40 of this chap- tion in § 20.61 of this chapter.
ter.
(iii) Adverse reaction reports, prod-
Yours very truly, uct experience reports, consumer com-
Petitioner llllllllllllllllll plaints, and other similar data and in-
By llllllllllllllllllllll formation, after deletion of:
(Indicate authority)
(a) Names and any information that
(d) The petitioner will be notified of would identify the person using the
the date on which his petition is filed; product.
and an incomplete petition, or one that (b) Names and any information that
has not been submitted in triplicate, would identify any third party involved
will usually be retained but not filed as with the report, such as a physician or
a petition under section 409 of the Act. hospital or other institution.
The petitioner will be notified in what (iv) A list of all ingredients contained
respects his petition is incomplete. in a food additive, whether or not it is
(e) The petition must be signed by in descending order of predominance. A
the petitioner or by his attorney or particular ingredient or group of ingre-
agent, or (if a corporation) by an au- dients shall be deleted from any such
thorized official. list prior to public disclosure if it is
(f) The data specified under the sev- shown to fall within the exemption es-
eral lettered headings should be sub- tablished in § 20.61 of this chapter, and
mitted on separate sheets or sets of a notation shall be made that any such
sheets, suitably identified. If such data ingredient list is incomplete.
have already been submitted with an
(v) An assay method or other analyt-
earlier application, the present peti-
ical method, unless it serves no regu-
tion may incorporate it by specific ref-
latory or compliance purpose and is
erence to the earlier. If part of the data
shown to fall within the exemption es-
have been submitted by the manufac-
tablished in § 20.61 of this chapter.
turer of the food additive as a master
file, the petitioner may refer to the (2) The following data and informa-
master file if and to the extent he ob- tion in a food additive petition are not
tains the manufacturer’s written per- available for public disclosure unless
mission to do so. The manufacturer they have been previously disclosed to
may authorize specific reference to the the public as defined in § 20.81 of this
data without disclosure to the peti- chapter or they relate to a product or
tioner. Nothing herein shall prevent ingredient that has been abandoned
reference to published data. and they no longer represent a trade
(g) A petition shall be retained but secret or confidential commercial or fi-
shall not be filed if any of the data pre- nancial information as defined in § 20.61
scribed by section 409(b) of the Act are of this chapter:
lacking or are not set forth so as to be (i) Manufacturing methods or proc-
readily understood. esses, including quality control proce-
(h)(1) The following data and infor- dures.
mation in a food additive petition are (ii) Production, sales, distribution,
available for public disclosure, unless and similar data and information, ex-
extraordinary circumstances are cept that any compilation of such data
shown, after the notice of filing of the and information aggregated and pre-
petition is published in the FEDERAL pared in a way that does not reveal
REGISTER or, if the petition is not data or information which is not avail-
promptly filed because of deficiencies able for public disclosure under this
in it, after the petitioner is informed provision is available for public disclo-
that it will not be filed because of the sure.
deficiencies involved: (iii) Quantitative or semiquantita-
(i) All safety and functionality data tive formulas.
and information submitted with or in- (3) All correspondence and written
corporated by reference in the petition. summaries of oral discussions relating
(ii) A protocol for a test or study, un- to a food additive petition are avail-
less it is shown to fall within the ex- able for public disclosure in accordance
emption established for trade secrets with the provisions of part 20 of this
30
chapter when the food additive regula- that of one of the original components,
tion is published in the FEDERAL REG- the name of the parent component, the
ISTER. maximum quantity of the migratory
(4) For purposes of this regulation, substance that is proposed for use in
safety and functionality data include food, and the physical or other tech-
all studies and tests of a food additive nical effect which the migratory sub-
on animals and humans and all studies stance or its parent component is in-
and tests on a food additive for iden- tended to have in the packaging mate-
tity, stability, purity, potency, per- rial. A copy of the notice will be
formance, and usefulness. mailed to the petitioner when the
(i)(1)(i) Within 15 days after receipt, original is forwarded to the FEDERAL
the Food and Drug Administration will REGISTER for publication.
notify the petitioner of the acceptance (j) The Commissioner may request a
or nonacceptance of a petition, and if full description of the methods used in,
not accepted, the reasons therefor. If and the facilities and controls used for,
accepted, the petitioner will be sent a the production of the food additive, or
letter stating this and the date of the a sample of the food additive, articles
letter shall become the date of filing used as components thereof, or of the
for the purposes of section 409(b)(5) of food in which the additive is proposed
the act. In cases in which the Food and to be used, at any time while a petition
Drug Administration agrees that a pre- is under consideration. The Commis-
market notification for a food contact sioner shall specify in the request for a
substance (Food Contact Notification sample of the food additive, or articles
(FCN)) submitted under section 409(h) used as components thereof, or of the
of the act may be converted to a peti- food in or on which the additive is pro-
tion, the withdrawal date for the FCN posed to be used, a quantity deemed
will be deemed the date of receipt for adequate to permit tests of analytical
the petition. methods to determine quantities of the
(ii) If the petitioner desires, he may food additive present in foods for which
supplement a deficient petition after it is intended to be used or adequate
being notified regarding deficiencies. If for any study or investigation reason-
the supplementary material or expla- ably required with respect to the safety
nation of the petition is deemed ac- of the food additive or the physical or
ceptable, the petitioner shall be noti- technical effect it produces. The date
fied. The date of such notification be- used for computing the 90-day limit for
comes the date of filing. If the peti- the purposes of section 409(c)(2) of the
tioner does not wish to supplement or Act shall be moved forward 1 day for
explain the petition and requests in each day after the mailing date of the
writing that it be filed as submitted, request taken by the petitioner to sub-
the petition shall be filed and the peti- mit the sample. If the information or
tioner so notified. sample is requested a reasonable time
(iii) Notwithstanding paragraph in advance of the 180 days, but is not
(i)(1)(ii) of this section, the petition submitted within such 180 days after
shall not be filed if the Food and Drug filing of the petition, the petition will
Administration determines that the be considered withdrawn without prej-
use identified in the petition should be udice.
the subject of an FCN under section (k) If nonclinical laboratory studies
409(h) of the act rather than a petition. are involved, petitions filed with the
(2) The Commissioner will publish in Commissioner under section 409(b) of
the FEDERAL REGISTER within 30 days the act shall include, with respect to
from the date of filing of such petition, each nonclinical study contained in the
a notice of the filing, the name of the petition, either a statement that the
petitioner, and a brief description of study has been, or will be, conducted in
the proposal in general terms. In the compliance with the good laboratory
case of a food additive which becomes a practice regulations as set forth in part
component of food by migration from 58 of this chapter, or, if any such study
packaging material, the notice shall was not conducted in compliance with
include the name of the migratory sub- such regulations, a brief statement of
stance, and where it is different from the reason for the noncompliance.
31
§ 171.6 21 CFR Ch. I (4–1–23 Edition)
(l) [Reserved] each nonclinical study, either a state-

(m) If clinical investigations involv- ment that the study was conducted in
ing human subjects are involved, peti- compliance with the requirements set
tions filed with the Commissioner forth in part 58 of this chapter, or, if
under section 409(b) of the Act shall in- the study was not conducted in compli-
clude statements regarding each such ance with such regulations, a brief
clinical investigation relied upon in statement of the reason for the non-
the petition that it either was con- compliance.
ducted in compliance with the require- [50 FR 7492, Feb. 22, 1985, as amended at 50
ments for institutional review set forth FR 16668, Apr. 26, 1985]
in part 56 of this chapter, or was not
subject to such requirements in accord- § 171.7 Withdrawal of petition without
ance with § 56.104 or § 56.105, and that it prejudice.
was conducted in compliance with the (a) In some cases the Commissioner
requirements for informed consent set will notify the petitioner that the peti-
forth in part 50 of this chapter. tion, while technically complete, is in-
(n)(1) If intended uses of the food ad- adequate to justify the establishment
ditive include uses in meat, meat food of a regulation or the regulation re-
product, or poultry product subject to quested by petitioner. This may be due
regulation by the U.S. Department of to the fact that the data are not suffi-
Agriculture (USDA) under the Poultry ciently clear or complete. In such
Products Inspection Act (PPIA) (21 cases, the petitioner may withdraw the
U.S.C. 451 et seq.) or the Federal Meat petition pending its clarification or the
Inspection Act (FMIA) (21 U.S.C. 601 et obtaining of additional data. This with-
seq.), FDA shall, upon filing of the peti- drawal will be without prejudice to a
tion, forward a copy of the petition or future filing. Upon refiling, the time
relevant portions thereof to the Food limitation will begin to run anew from
Safety and Inspection Service, USDA, the date of refiling.
for simultaneous review under the (b) At any time before the order pro-
PPIA and FMIA. vided for in § 171.100(a) has been for-
(2) FDA will ask USDA to advise warded to the FEDERAL REGISTER for
whether the proposed meat and poultry publication, the petitioner may with-
uses comply with the FMIA and PPIA, draw the petition without prejudice to
or if not, whether use of the substance a future filing. Upon refiling the time
would be permitted in products under limitation will begin to run anew.
USDA jurisdiction under specified con- (c) Any petitioner who has a food ad-
ditions or restrictions. ditive petition pending before the agen-
cy and who subsequently submits a
[42 FR 14489, Mar. 15, 1977, as amended at 42 premarket notification for a food con-
FR 15674, Mar. 22, 1977; 46 FR 8952, Jan. 27,
tact substance (FCN) for a use or uses
1981; 50 FR 7492, Feb. 22, 1985; 50 FR 16668,
Apr. 26, 1985; 62 FR 40599, July 29, 1997; 65 FR described in such petition shall be
51763, Aug. 25, 2000; 67 FR 35731, May 21, 2002; deemed to have withdrawn the petition
72 FR 10357, Mar. 8, 2007; 81 FR 49896, July 29, for such use or uses without prejudice
2016] to a future filing on the date the FCN
is received by the Food and Drug Ad-
§ 171.6 Amendment of petition. ministration.
After a petition has been filed, the [42 FR 14489, Mar. 15, 1977, as amended at 67
petitioner may submit additional in- FR 35731, May 21, 2002]
formation or data in support thereof.
In such cases, if the Commissioner de- § 171.8 Threshold of regulation for
termines that the additional informa- substances used in food-contact ar-
tion or data amount to a substantive ticles.
amendment, the petition as amended Substances used in food-contact arti-
will be given a new filing date, and the cles (e.g., food-packaging or food-proc-
time limitation will begin to run anew. essing equipment) that migrate or that
If nonclinical laboratory studies are in- may be expected to migrate into food
volved, additional information and at negligible levels may be reviewed

data submitted in support of filed peti- under § 170.39 of this chapter. The Food
tions shall include, with respect to and Drug Administration will exempt
32
Food and Drug Administration, HHS Pt. 172
substances whose uses it determines § 171.102 Effective date of regulation.

meet the criteria in § 170.39 of this A regulation published in accordance
chapter from regulation as food addi- with § 171.100(a) shall become effective
tives and, therefore, a food additive pe- upon publication in the FEDERAL REG-
tition will not be required for the ex- ISTER.
empted use.
§ 171.110 Procedure for objections and
[60 FR 36596, July 17, 1995] hearings.
Objections and hearings relating to
Subpart B—Administrative Actions food additive regulations under section
on Applications 409 (c), (d), or (h) of the Act shall be
governed by part 12 of this chapter.
§ 171.100 Regulation based on petition.
(a) The Commissioner will forward FR 15674, Mar. 22, 1977]
for publication in the FEDERAL REG-
ISTER, within 90 days after filing of the § 171.130 Procedure for amending and
petition (or within 180 days if the time repealing tolerances or exemptions
from tolerances.
is extended as provided for in section
409(c)(2) of the Act), a regulation pre- (a) The Commissioner, on his own
scribing the conditions under which initiative or on the petition of any in-
the food additive may be safely used terested person, pursuant to part 10 of
(including, but not limited to, speci- this chapter, may propose the issuance
fications as to the particular food or of a regulation amending or repealing a
classes of food in or on which such ad- regulation pertaining to a food additive
ditive may be used, the maximum or granting or repealing an exception
quantity that may be used or per- for such additive.
(b) Any such petition shall include an
mitted to remain in or on such food,
assertion of facts, supported by data,
the manner in which such additive may
showing that new information exists
be added to or used in or on such food, with respect to the food additive or
and any directions or other labeling or that new uses have been developed or
packaging requirements for such addi- old uses abandoned, that new data are
tive deemed necessary by him to assure available as to toxicity of the chem-
the safety of such use), and prior to the ical, or that experience with the exist-
forwarding of the order to the FEDERAL ing regulation or exemption may jus-
REGISTER for publication shall notify tify its amendment or repeal. New data
the petitioner of such order and the shall be furnished in the form specified
reasons for such action; or by order in §§ 171.1 and 171.100 for submitting pe-
deny the petition, and shall notify the titions.
petitioner of such order and of the rea-
sons for such action. FR 15674, Mar. 22, 1977]
(b) The regulation shall describe the
conditions under which the substance
may be safely used in any meat prod-
PART 172—FOOD ADDITIVES PER-
uct, meat food product, or poultry
MITTED FOR DIRECT ADDITION TO
product subject to the Federal Meat In- FOOD FOR HUMAN CONSUMP-
spection Act (FMIA) (21 U.S.C. 601 et TION
seq.) or the Poultry Products Inspec-
tion Act (PPIA) (21 U.S.C. 451 et seq.). Subpart A—General Provisions
(c) If the Commissioner determines Sec.
that additional time is needed to study 172.5 General provisions for direct food ad-
and investigate the petition, he shall ditives.
by written notice to the petitioner ex-
Subpart B—Food Preservatives
tend the 90-day period for not more
than 180 days after the filing of the pe- 172.105 Anoxomer.
tition. 172.110 BHA.
172.115 BHT.
[42 FR 14489, Mar. 15, 1977, as amended at 65 172.120 Calcium disodium EDTA.
FR 51763, Aug. 25, 2000] 172.130 Dehydroacetic acid.
33
Pt. 172 21 CFR Ch. I (4–1–23 Edition)
172.133 Dimethyl dicarbonate. 172.430 Iron ammonium citrate.
172.135 Disodium EDTA. 172.480 Silicon dioxide.
172.140 Ethoxyquin. 172.490 Yellow prussiate of soda.
172.145 Heptylparaben.
172.150 4-Hydroxymethyl-2,6-di-tert-butyl- Subpart F—Flavoring Agents and Related
phenol. Substances
172.155 Natamycin (pimaricin).
172.160 Potassium nitrate. 172.510 Natural flavoring substances and
172.165 Quaternary ammonium chloride natural substances used in conjunction
combination. with flavors.
172.167 Silver nitrate and hydrogen peroxide 172.515 Synthetic flavoring substances and
solution. adjuvants.
172.170 Sodium nitrate. 172.520 Cocoa with dioctyl sodium sulfo-
172.175 Sodium nitrite. succinate for manufacturing.
172.177 Sodium nitrite used in processing 172.530 Disodium guanylate.
smoked chub. 172.535 Disodium inosinate.
172.180 Stannous chloride. 172.540 DL-Alanine.
172.185 TBHQ. 172.560 Modified hop extract.
172.190 THBP. 172.575 Quinine.
172.580 Safrole-free extract of sassafras.
Subpart C—Coatings, Films and Related 172.585 Sugar beet extract flavor base.
Substances 172.590 Yeast-malt sprout extract.
172.210 Coatings on fresh citrus fruit. Subpart G—Gums, Chewing Gum Bases
172.215 Coumarone-indene resin. and Related Substances
172.225 Methyl and ethyl esters of fatty
acids produced from edible fats and oils. 172.610 Arabinogalactan.
172.230 Microcapsules for flavoring sub- 172.615 Chewing gum base.
stances. 172.620 Carrageenan.
172.235 Morpholine. 172.623 Carrageenan with polysorbate 80.
172.250 Petroleum naphtha. 172.626 Salts of carrageenan.
172.255 Polyacrylamide. 172.655 Furcelleran.
172.260 Oxidized polyethylene. 172.660 Salts of furcelleran.
172.270 Sulfated butyl oleate. 172.665 Gellan gum.
172.275 Synthetic paraffin and succinic de- 172.695 Xanthan gum.
rivatives.
172.280 Terpene resin. Subpart H—Other Specific Usage Additives
Subpart D—Special Dietary and Nutritional 172.710 Adjuvants for pesticide use dilu-
Additives tions.
172.712 1,3-Butylene glycol.
172.310 Aluminum nicotinate. 172.715 Calcium lignosulfonate.
172.315 Nicotinamide-ascorbic acid complex. 172.720 Calcium lactobionate.
172.320 Amino acids. 172.723 Epoxidized soybean oil.
172.325 Bakers yeast protein. 172.725 Gibberellic acid and its potassium
172.330 Calcium pantothenate, calcium chlo- salt.
ride double salt. 172.730 Potassium bromate.
172.335 D-Pantothenamide. 172.735 Glycerol ester of rosin.
172.340 Fish protein isolate. 172.736 Glycerides and polyglycides of hy-
172.345 Folic acid (folacin). drogenated vegetable oils.
172.350 Fumaric acid and salts of fumaric 172.755 Stearyl monoglyceridyl citrate.
acid. 172.765 Succistearin (stearoyl propylene gly-
172.365 Kelp. col hydrogen succinate).
172.370 Iron-choline citrate complex. 172.770 Ethylene oxide polymer.
172.372 N-Acetyl-L-methionine. 172.775 Methacrylic acid-divinylbenzene co-
172.375 Potassium iodide. polymer.
172.379 Vitamin D2. 172.780 Acacia (gum arabic).
172.380 Vitamin D3. 172.785 Listeria-specific bacteriophage prepa-
172.381 Vitamin D2 bakers yeast. ration.
172.382 Vitamin D2 mushroom powder.
172.385 Whole fish protein concentrate. Subpart I—Multipurpose Additives
172.395 Xylitol.
172.399 Zinc methionine sulfate. 172.800 Acesulfame potassium.
172.802 Acetone peroxides.
Subpart E—Anticaking Agents 172.803 Advantame.

172.804 Aspartame.
172.410 Calcium silicate. 172.806 Azodicarbonamide.
34
172.808 Copolymer condensates of ethylene 172.898 Bakers yeast glycan.
oxide and propylene oxide.
AUTHORITY: 21 U.S.C. 321, 341, 342, 348, 371,
172.809 Curdlan.
379e.
172.810 Dioctyl sodium sulfosuccinate.
172.811 Glyceryl tristearate. SOURCE: 42 FR 14491, Mar. 15, 1977, unless
172.812 Glycine. otherwise noted.
172.814 Hydroxylated lecithin.
EDITORIAL NOTE: Nomenclature changes to
172.816 Methyl glucoside-coconut oil ester.
part 172 appear at 61 FR 14482, Apr. 2, 1996; 66
172.818 Oxystearin.
FR 56035, Nov. 6, 2001; 66 FR 66742, Dec. 27,
172.820 Polyethylene glycol (mean molec-
2001; 68 FR 15355, Mar. 31, 2003; 70 FR 40880,
ular weight 200-9,500).
July 15, 2005; 70 FR 67651, Nov. 8, 2005; 70 FR
172.822 Sodium lauryl sulfate.
72074, Dec. 1, 2005; and 81 FR 49896, July 29,
172.824 Sodium mono- and dimethyl naph-
2016.
thalene sulfonates.
172.826 Sodium stearyl fumarate.
172.828 Acetylated monoglycerides. Subpart A—General Provisions
172.829 Neotame.
172.830 Succinylated monoglycerides. § 172.5 General provisions for direct
172.831 Sucralose. food additives.
172.832 Monoglyceride citrate. (a) Regulations prescribing condi-
172.833 Sucrose acetate isobutyrate (SAIB).
172.834 Ethoxylated mono- and diglycerides. tions under which food additive sub-
172.836 Polysorbate 60. stances may be safely used predicate
172.838 Polysorbate 65. usage under conditions of good manu-
172.840 Polysorbate 80. facturing practice. For the purposes of
172.841 Polydextrose. this part, good manufacturing practice
172.842 Sorbitan monostearate. shall be defined to include the fol-
172.844 Calcium stearoyl-2-lactylate. lowing restrictions.
172.846 Sodium stearoyl lactylate. (1) The quantity of the substance
172.848 Lactylic esters of fatty acids.
172.850 Lactylated fatty acid esters of glyc- added to food does not exceed the
erol and propylene glycol. amount reasonably required to accom-
172.852 Glyceryl-lacto esters of fatty acids. plish its intended physical, nutritive,
172.854 Polyglycerol esters of fatty acids. or other technical effect in food.
172.856 Propylene glycol mono- and diesters (2) Any substance intended for use in
of fats and fatty acids. or on food is of appropriate food grade
172.858 Propylene glycol alginate. and is prepared and handled as a food
172.859 Sucrose fatty acid esters. ingredient.
172.860 Fatty acids.
172.861 Cocoa butter substitute from coco-
(b) The existence of a regulation pre-
nut oil, palm kernel oil, or both oils. scribing safe conditions of use for a
172.862 Oleic acid derived from tall oil fatty food additive shall not be construed to
acids. relieve the use of the substance from
172.863 Salts of fatty acids. compliance with any other provision of
172.864 Synthetic fatty alcohols. the Act.
172.866 Synthetic glycerin produced by the (c) The existence of any regulation
hydrogenolysis of carbohydrates.
prescribing safe conditions of use for a
172.867 Olestra.
172.868 Ethyl cellulose. nutrient substance does not constitute
172.869 Sucrose oligoesters. a finding that the substance is useful
172.870 Hydroxypropyl cellulose. or required as a supplement to the diet
172.872 Methyl ethyl cellulose. of humans.
172.874 Hydroxypropyl methylcellulose.
172.876 Castor oil.
172.878 White mineral oil.
Subpart B—Food Preservatives
172.880 Petrolatum.
172.882 Synthetic isoparaffinic petroleum
§ 172.105 Anoxomer.
hydrocarbons. Anoxomer as identified in this sec-
172.884 Odorless light petroleum hydro- tion may be safely used in accordance
carbons. with the following conditions:
172.886 Petroleum wax. (a) Anoxomer is 1,4-benzenediol, 2-
172.888 Synthetic petroleum wax.
(1,1-dimethylethyl)-polymer with
172.890 Rice bran wax.
172.892 Food starch-modified. diethenylbenzene, 4-(1,1-dimethyl-
172.894 Modified cottonseed products in- ethyl)phenol, 4- methoxyphenol, 4,4′-(1-

tended for human consumption. methylethylidene)bis(phenol) and 4-
172.896 Dried yeasts. methylphenol (CAS Reg. No. 60837–57–2)
35
§ 172.110 21 CFR Ch. I (4–1–23 Edition)
prepared by condensation polymeriza- code_of_federal_regulations/

tion of divinylbenzene (m- and p-) with ibr_locations.html.
tert-butylhydroquinone, tert-butyl- (4) Heavy metals as lead (as Pb), not
phenol, hydroxyanisole, p-cresol and more than 10 parts per million. Arsenic
4,4′-isopropylidenediphenol. (as As), not more than 3 parts per mil-
(b) The polymeric antioxidant meets lion. Mercury (as Hg), not more than 1
the following specifications: part per million.
(1) Polymer, not less than 98.0 per- (c) Anoxomer may be safely used as
cent as determined by an ultraviolet an antioxidant in food at a level of not
method entitled ‘‘Ultraviolet Assay, more than 5,000 parts per million based
‘‘1982, which is incorporated by ref- on fat and oil content of the food.
erence. Copies are available from the [48 FR 18798, Apr. 26, 1983, as amended at 54
Office of Food Additive Safety (HFS– FR 24896, June 12, 1989; 88 FR 17719, Mar. 24,
200), Center for Food Safety and Ap- 2023]
plied Nutrition, Food and Drug Admin-
istration, 5001 Campus Dr., College § 172.110 BHA.
Park, MD 20740, 240–402–1200, or at the The food additive BHA (butylated hy-
National Archives and Records Admin- droxyanisole) alone or in combination
istration (NARA). For information on with other antioxidants permitted in
the availability of this material at food for human consumption in this
NARA, call 202–741–6030, or go to: http:// subpart B may be safely used in or on
www.archives.gov/federal_register/ specified foods, as follows:
code_of_federal_regulations/ (a) The BHA meets the following
ibr_locations.html. specification:
(2) Molecular weight: Total mono-
mers, dimers and trimers below 500 not Assay (total BHA), 98.5 percent minimum.
Melting point 48 °C minimum.
more than 1 percent as determined by a
method entitled ‘‘Low Molecular (b) The BHA is used alone or in com-
Weight Anoxomer Analysis,’’ 1982, bination with BHT, as an antioxidant
which is incorporated by reference. in foods, as follows:
Copies are available from the Office of
Limitations
Food Additive Safety (HFS–200), Center (total BHA
for Food Safety and Applied Nutrition, Food and BHT)
parts per
Food and Drug Administration, 5001 million
Campus Dr., College Park, MD 20740,
Dehydrated potato shreds ................................... 50
240–402–1200, or at the National Ar- Active dry yeast ................................................... 1 1,000
chives and Records Administration Beverages and desserts prepared from dry
(NARA). For information on the avail- mixes ................................................................ 12
ability of this material at NARA, call Dry breakfast cereals .......................................... 50

Dry diced glazed fruit .......................................... 1 32
202–741–6030, or go to: http:// Dry mixes for beverages and desserts ............... 1 90
www.archives.gov/federal_register/ Emulsion stabilizers for shortenings .................... 200

code_of_federal_regulations/ Potato flakes ........................................................ 50
Potato granules ................................................... 10
ibr_locations.html. Sweet potato flakes ............................................. 50
(3) Phenol content: Not less than 3.2 1 BHA only.
milliequivalent/gram and not more
than 3.8 milliequivalent/gram as deter- (c) To assure safe use of the additive:
mined by a method entitled ‘‘Total (1) The label of any market package
Phenols,’’ 1982, which is incorporated of the additive shall bear, in addition
by reference. Copies are available from to the other information required by
the Office of Food Additive Safety the Act, the name of the additive.
(HFS–200), Center for Food Safety and (2) When the additive is marketed in
Applied Nutrition, Food and Drug Ad- a suitable carrier, in addition to meet-
ministration, 5001 Campus Dr., College ing the requirement of paragraph (c)(1)
Park, MD 20740, 240–402–1200, or at the of this section, the label shall declare
National Archives and Records Admin- the percentage of the additive in the
istration (NARA). For information on mixture.
the availability of this material at (3) The label or labeling of dry mixes
NARA, call 202–741–6030, or go to: http:// for beverages and desserts shall bear
www.archives.gov/federal_register/ adequate directions for use to provide
36
that beverages and desserts prepared Limita-

tion
from the dry mixes contain no more Food (parts Use
than 2 parts per million BHA. per mil-
lion)
§ 172.115 BHT. Cabbage, pickled .......... 220 Promote color, flavor,
and texture retention.
The food additive BHT (butylated hy-
Canned carbonated soft 33 Promote flavor reten-
droxytoluene), alone or in combination drinks. tion.
with other antioxidants permitted in Canned white potatoes 110 Promote color retention.
this subpart B may be safely used in or Clams (cooked canned) 340 Promote color retention.
on specified foods, as follows: Crabmeat (cooked 275 Retard struvite forma-
canned). tion; promote color
(a) The BHT meets the following retention.
specification: Assay (total BHT) 99 per- Cucumbers pickled ....... 220 Promote color, flavor,
cent minimum. and texture retention.
Distilled alcoholic bev- 25 Promote stability of
(b) The BHT is used alone or in com- erages. color, flavor, and/or
bination with BHA, as an antioxidant product clarity.
in foods, as follows: Dressings, nonstandard- 75 Preservative.
ized.
Limitations Dried lima beans 310 Promote color retention.
(total BHA (cooked canned).
Food and BHT) Egg product that is 1 200 Preservative.
parts per hard-cooked and con-
million
sists, in a cylindrical
shape, of egg white
Dehydrated potato shreds ................................... 50
with an inner core of
Dry breakfast cereals .......................................... 50 egg yolk.
Emulsion stabilizers for shortenings .................... 200 Fermented malt bev- 25 Antigushing agent.
Potato flakes ........................................................ 50 erages.
Potato granules ................................................... 10 French dressing ............ 75 Preservative.
Sweetpotato flakes .............................................. 50 Legumes (all cooked 365 Promote color retention.
canned, other than
(c) To assure safe use of the additive: dried lima beans, pink
beans, and red
(1) The label of any market package beans).
of the additive shall bear, in addition Mayonnaise .................. 75 Do.
to the other information required by Mushrooms (cooked 200 Promote color retention.
canned).
the Act, the name of the additive. Oleomargarine .............. 75 Preservative.
(2) When the additive is marketed in Pecan pie filling ............ 100 Promote color retention.
a suitable carrier, in addition to meet- Pink beans (cooked 165 Promote color retention.
ing the requirement of paragraph (c)(1) canned).
Potato salad .................. 100 Preservative.
of this section, the label shall declare
Processed dry pinto 800 Promote color retention.
the percentage of the additive in the beans.
mixture. Red beans (cooked 165 Promote color retention.
canned).
§ 172.120 Calcium disodium EDTA. Salad dressing .............. 75 Preservative.
Sandwich spread .......... 100 Do.
The food additive calcium disodium Sauces .......................... 75 Do.
EDTA (calcium disodium ethylene- Shrimp (cooked 250 Retard struvite forma-
canned). tion; promote color
diaminetetraacetate) may be safely retention.
used in designated foods for the pur- Spice extractives in 60 Promote color and fla-
poses and in accordance with the condi- soluble carriers. vor retention.
tions prescribed, as follows: Spreads, artificially col- 100 Promote color retention.
ored and lemon-fla-
(a) The additive contains a minimum vored or orange-fla-
of 99 percent by weight of either the di- vored.
hydrate C10H12O8N2CaNa2·2H2O or the 1 By weight of egg yolk portion.
trihydrate C10H12O8N2CaNa2·3H2O, or
any mixture of the two. (2) With disodium EDTA (disodium
(b) It is used or intended for use as ethylenediaminetetraacetate) in the
follows: following foods at not to exceed, in
(1) Alone, in the following foods at combination, the levels prescribed, cal-
not to exceed the levels prescribed, calculated as anhydrous C10H12O8N2CaNa2:

culated as the anhydrous compound:
37
§ 172.130 21 CFR Ch. I (4–1–23 Edition)
Limita- accordance with the following pre-

tion scribed conditions:
Food (parts Use
per mil- (a) The additive meets the following
lion) specifications:
Dressings, nonstandardized .... 75 Preservative. (1) The additive has a purity of not
French dressing ...................... 75 Do. less than 99.8 percent as determined by
Mayonnaise ............................. 75 Do. the following titration method:
Salad dressing ........................ 75 Do.
Sandwich spread ..................... 100 Do. PRINCIPLES OF METHOD
Sauces .................................... 75 Do.
Dimethyl dicarbonate (DMDC) is mixed
with excess diisobutylamine with which it
(c) To assure safe use of the additive: reacts quantitatively. The excess amine is
(1) The label and labeling of the addi- backtitrated with acid.
tive container shall bear, in addition to
APPARATUS
the other information required by the
Act, the name of the additive. 250-milliliter (mL) Beaker
(2) The label or labeling of the addi- 100-mL Graduate cylinder
25-mL Pipette
tive container shall bear adequate use
10-mL Burette (automatic, e.g., Metrohm bu-
directions to provide a final food prod- rette)
uct that complies with the limitations Stirrer
provided in paragraph (b) of this sec- Device for potentiometric titration
tion. Reference electrode
(d) In the standardized foods listed in Glass electrode
paragraph (b) of this section, the addi- REAGENTS
tives are used only in compliance with
Acetone, analytical-grade
the applicable standards of identity for
Solution of 1 N diisobutylamine in chloro-
such foods. benzene, distilled
[42 FR 14491, Mar. 15, 1977, as amended at 48 1 N Acetic Acid
FR 10815, Mar. 15, 1983; 58 FR 52222, Oct. 7, PROCEDURE
1993; 60 FR 33710, June 29, 1995; 65 FR 48379,
Aug. 8, 2000] Accurately weigh in about 2 grams of the
sample (W) and dissolve in 100 mL acetone.
§ 172.130 Dehydroacetic acid. Add accurately 25 mL of the 1 N diisobutyl-
amine solution by pipette and allow to stand
The food additive dehydroacetic acid for 5 minutes. Subsequently, titrate the re-
and/or its sodium salt may be safely action mixture potentiometrically with 1 N
used in accordance with the following hydrochloric acid (consumption=a mL) while
prescribed conditions: stirring. For determining the blank con-
(a) The food additive meets the fol- sumption, carry out the analysis without a
lowing specifications: sample (consumption=b mL).
CALCULATION
Dehydroacetic acid: Melting point, 109 °C–111
°C; assay, minimum 98 percent (dry basis).
Sodium salt of dehydroacetic acid: Assay, ( b − a ) × 13.4
minimum 98 percent (dry basis). = % DMDC
(b) It is used or intended for use as a W
preservative for cut or peeled squash, NOTE: For adding the diisobutylamine so-
lution, always use the same pipette and wait
and is so used that no more than 65 for a further three drops to fall when the
parts per million expressed as dehydro- flow has stopped.
acetic acid remains in or on the pre- (2) The additive contains not more
pared squash. than 2,000 ppm (0.2 percent) dimethyl
(c) The label or labeling of any pack- carbonate as determined by a method
age of the additive intended for use in entitled ‘‘Gas Chromatography Method
food shall bear adequate directions for for Dimethyl Carbonate Impurity in
use to insure compliance with this sec- Dimethyl Dicarbonate,’’ which is incor-
tion. porated by reference in accordance
with 5 U.S.C. 552(a). Copies are avail-
§ 172.133 Dimethyl dicarbonate.
able from the Office of Food Additive

Dimethyl dicarbonate (CAS Reg. No. Safety (HFS–200), Center for Food Safe-
4525–33–1) may be safely used in food in ty and Applied Nutrition, Food and
38
ER10MR99.023</GPH>
Drug Administration, 5001 Campus Dr., § 172.135 Disodium EDTA.

College Park, MD 20740, 240–402–1200, or
The food additive disodium EDTA
at the National Archives and Records
(disodium ethylenediaminetetraace-
Administration (NARA). For informa-
tate) may be safely used in designated
tion on the availability of this mate-
foods for the purposes and in accord-
rial at NARA, call 202–741–6030, or go
ance with the following prescribed con-
to: http://www.archives.gov/fed-
ditions:
eral_register/code_of_federal_regulations/
ibr_locations.html. (a) The additive contains a minimum
of 99 percent disodium ethylenedia-
(b) The additive is used or intended
minetetraacetate dihydrate
for use as a microbial control agent in
the following beverages under normal (C10H14O8N2Na2·2H2O).
circumstances of bottling, canning, or (b) It is used or intended for use as
other forms of final packaging, where follows:
the viable microbial load has been re- (1) Alone, in the following foods at
duced to 500 microorganisms per milli- not to exceed the levels prescribed, cal-
liter or less by current good manufac- culated as anhydrous calcium disodium
turing practices such as heat treat- EDTA:
ment, filtration, or other technologies Limita-
prior to the use of dimethyl dicar- tion
bonate: Food (parts Use
per mil-
(1) In wine, dealcoholized wine, and lion)
low alcohol wine in an amount not to
Aqueous multivitamin prep- 150 With iron salts as a
exceed 200 parts per million. arations. stabilizer for vita-
(2) In ready-to-drink teas in an min B 12 in liquid
amount not to exceed 250 parts per mil- multivitamin prep-
arations.
lion. Canned black-eyed peas .... 145 Promote color re-
(3) In carbonated or noncarbonated, tention.
nonjuice-containing (less than or equal Canned kidney beans ......... 165 Preservative.
to 1 percent juice), flavored or Canned strawberry pie filling 500 Promote color re-
tention.
unflavored beverages containing added Cooked sausage ................. 36 As a cure accel-
electrolytes (5–20 milliequivalents/liter erator with so-
sodium ion (Na + ) and 3–7 milli- dium ascorbate
or ascorbic acid.
equivalents/liter potassium ion (K + ))
Dressings, nonstandardized 75 Preservative.
in an amount not to exceed 250 parts French dressing .................. 75 Do.
per million. Frozen white potatoes in- 100 Promote color re-
(4) In carbonated, dilute beverages cluding cut potatoes. tention.
Gefilte fish balls or patties in 1 50 Inhibit discoloration.
containing juice, fruit flavor, or both,
packing medium.
with juice content not to exceed 50 per- Legumes (all cooked 165 Promote color re-
cent, in an amount not to exceed 250 canned, other than black- tention.
parts per million. eyed peas).
Mayonnaise ......................... 75 Preservative.
(c) To ensure the safe use of the food 2 315
Ready-to-eat cereal prod- Promote color re-
additive, the label of the package con- ucts containing dried ba- tention.
taining the additive shall bear, in addi- nanas.
tion to other information required by Salad dressing .................... 75 Preservative.
the Federal Food, Drug, and Cosmetic Sandwich spread ................. 100 Do.
Sauces ................................ 75 Do.
Act:
1 Based on total weight of finished product including packing
(1) The name of the additive ‘‘di- medium.
methyl dicarbonate.’’ 2 In dried banana component of cereal product.
(2) The intended use of the additive.

(2) With calcium disodium EDTA
(3) Adequate directions for use to en-
(calcium disodium ethylenediamine-
sure compliance with this section.
tetraacetate; calcium disodium
[53 FR 41329, Oct. 21, 1988, as amended at 58 (ethylenedinitrilo) tetraacetate), in the
FR 6091, Jan. 26, 1993; 59 FR 5319, Feb. 4, 1994; following foods at not to exceed, in
61 FR 14245, Apr. 1, 1996; 61 FR 26788, May 29, combination, the levels prescribed, cal-
1996; 66 FR 13653, Mar. 7, 2001; 88 FR 17719,
Mar. 24, 2023]
culated as anhydrous C10H12O8N2CaNa2:
39
§ 172.140 21 CFR Ch. I (4–1–23 Edition)
Limita- Zero in milk.

tion
Food (parts Use
per mil- § 172.145 Heptylparaben.
lion)
(a) The food additive heptylparaben
Dressings, nonstandardized 75 Preservative. is the chemical n-heptyl p-hydroxy-
French dressing .................. 75 Do. benzoate.
Mayonnaise ......................... 75 Do.
Salad dressing .................... 75 Do. (b) It may be safely used to inhibit
Sandwich spread ................. 100 Do. microbiological spoilage in accordance
Sauces ................................ 75 Do. with the following prescribed condi-
tions:
(3) Alone, as a sequestrant in the (1) In fermented malt beverages in
nonnutritive sweeteners that are listed amounts not to exceed 12 parts per mil-
in § 180.37 of this chapter and that, in lion.
addition, are designed for aqueous solu- (2) In noncarbonated soft drinks and
tion: Provided, That the amount of the fruit-based beverages in amounts not
additive, calculated as anhydrous cal- to exceed 20 parts per million, when
cium disodium EDTA, does not exceed standards of identity established under
0.1 percent by weight of the dry non- section 401 of the Act (21 U.S.C. 341) do
nutritive sweetener. not preclude such use.
(c) To assure the safe use of the addi-
tive: § 172.150 4-Hydroxymethyl-2,6-di-tert-
(1) The label and labeling of the addi- butylphenol.
tive container shall bear, in addition to The food additive 4-hydroxymethyl-
the other information required by the 2,6-di-tert-butylphenol may be safely
act, the name of the additive. used in food in accordance with the fol-
(2) The label or labeling of the addi- lowing prescribed conditions:
tive container shall bear adequate use (a) The additive has a solidification
directions to provide a final food prod- point of 140 °C–141 °C.
uct that complies with the limitations (b) The additive is used as an anti-
provided in paragraph (b) of this sec- oxidant alone or in combination with
tion. other permitted antioxidants.
(d) In the standardized foods listed in
(c) The total amount of all anti-
paragraphs (b)(1) and (2) of this section
oxidants added to such food shall not
the additives are used only in compli-
exceed 0.02 percent of the oil or fat con-
ance with the applicable standards of
tent of the food, including the essential
identity for such foods.
(volatile) oil content of the food.
FR 48379, Aug. 8, 2000] § 172.155 Natamycin (pimaricin).
(a) Natamycin (CAS Reg. No. 7681–93–
§ 172.140 Ethoxyquin.
8), also known as pimaricin, is a pol-
(a) Ethoxyquin (1,2-dihydro-6-ethoxy- yene macrolide antimycotic substance
2,2,4-trimethylquinoline) may be safely possessing an empirical formula of
used as an antioxidant for preservation C33H47NO13 and a molecular weight of
of color in the production of chili pow- 665.7.
der, paprika, and ground chili at levels (b) The additive shall conform to the
not in excess of 100 parts per million. following specifications:
(b) In order to provide for the safe
use of the additive in feed prepared in Purity: 97 percent ±2 percent on an anhy-
drous basis.
accordance with §§ 573.380 and 573.400 of
Arsenic: Not more than 1 part per million.
this chapter, tolerances are established Heavy metals (as Pb): Not more than 20 parts
for residues of ethoxyquin in or on edi- per million.
ble products of animals as follows:
(c) The additive may be applied on
5 parts per million in or on the uncooked fat cheese, as an antimycotic, in amounts
of meat from animals except poultry.
3 parts per million in or on the uncooked
not to exceed 20 milligrams per kilo-
liver and fat of poultry. gram (20 parts per million) in the fin-
0.5 part per million in or on the uncooked ished product as determined by Inter-
muscle meat of animals. national Dairy Federation (IDF) Stand-
0.5 part per million in poultry eggs. ard 140A:1992, ‘‘Cheese and Cheese
40
Rind-Determination of Natamycin Con- (b) The additive meets the following

tent-Method by Molecular Absorption specifications: pH (5 percent active so-
Spectrometry and by High-Perform- lution) 7.0–8.0; total amines, maximum
ance Liquid Chromatography,’’ which 1 percent as combined free amines and
is incorporated by reference. The Di- amine hydrochlorides.
rector of the Office of the Federal Reg- (c) The additive is used as an anti-
ister approves this incorporation by microbial agent, as defined in
reference in accordance with 5 U.S.C. § 170.3(o)(2) of this chapter, in raw sugar
552(a) and 1 CFR part 51. Copies are cane juice. It is added prior to clari-
available from the Office of Food Addi- fication when further processing of the
tive Safety (HFS–200), Center for Food sugar cane juice must be delayed.
Safety and Applied Nutrition, Food and (d) The additive is applied to the
Drug Administration, 5001 Campus Dr., sugar juice in the following quantities,
College Park, MD 20740, 240–402–1200, or based on the weight of the raw cane:
may be examined at the Dockets Man-
agement Staff (HFA–305), Food and Parts per
Component million
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852, n-Dodecyl dimethyl benzyl ammonium chloride 0.25–1.0
240–402–7500, between 9 a.m. and 4 p.m., n-Dodecyl dimethyl ethylbenzyl ammonium
chloride ........................................................... 3.4–13.5
Monday through Friday, or at the Na- n-Hexadecyl dimethyl benzyl ammonium chlo-
tional Archives and Records Adminis- ride ................................................................. 1.5–6.0
tration (NARA). For information on n-Octadecyl dimethyl benzyl ammonium chlo-
ride ................................................................. 0.25–1.0
the availability of this material at n-Tetradecyl dimethyl benzyl ammonium chlo-
NARA, call 202–741–6030, or go to: http:// ride ................................................................. 3.0–12.0
www.archives.gov/federal_register/ n-Tetradecyl dimethyl ethylbenzyl ammonium
code_of_federal_regulations/ chloride ........................................................... 1.6–6.5
ibr_locations.html.
[50 FR 3890, Jan. 29, 1985]
[47 FR 26823, June 22, 1982, as amended at 50
FR 49536, Dec. 3, 1985; 63 FR 66015, Dec. 1,
1998; 66 FR 13847, Mar. 8, 2001; 81 FR 5591, Feb.
§ 172.167 Silver nitrate and hydrogen
3, 2016; 88 FR 17719, Mar. 24, 2023]
peroxide solution.
An aqueous solution containing a
§ 172.160 Potassium nitrate. mixture of silver nitrate and hydrogen
The food additive potassium nitrate peroxide may be safely used in accord-
may be safely used as a curing agent in ance with the following prescribed con-
the processing of cod roe, in an amount ditions:
not to exceed 200 parts per million of (a) The additive is used as an anti-
the finished roe. microbial agent in bottled water.
(b) Hydrogen peroxide meets the
§ 172.165 Quaternary ammonium chlo- specifications of the Food Chemicals
ride combination. Codex, 7th ed. (2010), pp. 496–497, which
The food additive, quaternary ammo- is incorporated by reference. The Di-
nium chloride combination, may be rector of the Office of the Federal Reg-
safely used in food in accordance with ister approves this incorporation by
the following conditions: reference in accordance with 5 U.S.C.
(a) The additive contains the fol- 552(a) and 1 CFR part 51. You may ob-
lowing compounds: n-dodecyl dimethyl tain copies from the United States
benzyl ammonium chloride (CAS Reg. Pharmacopeial Convention, 12601
No. 139–07–1); n-dodecyl dimethyl ethyl- Twinbrook Pkwy., Rockville, MD 20852
benzyl ammonium chloride (CAS Reg. (Internet address http://www.usp.org).
No. 27479–28–3); n-hexadecyl dimethyl Copies may be examined at the Dock-
benzyl ammonium chloride (CAS Reg. ets Management Staff (HFA–305), Food
No. 122–18–9); n-octadecyl dimethyl and Drug Administration, 5630 Fishers
benzyl ammonium chloride (CAS Reg. Lane, Rm. 1061, Rockville, MD 20852,
No. 122–19–0); n-tetradecyl dimethyl 240–402–7500, between 9 a.m. and 4 p.m.,
benzyl ammonium chloride (CAS Reg. Monday through Friday, or at the Na-
No. 139–08–2); n-tetradecyl dimethyl tional Archives and Records Adminis-

ethylbenzyl ammonium chloride (CAS tration (NARA). For information on
Reg. No. 27479–29–4). the availability of this material at
41
§ 172.170 21 CFR Ch. I (4–1–23 Edition)
NARA, call 202–741–6030 or go to: http:// for total silver and nitrate, unless the
www.archives.gov/federal-register/cfr/ibr- water bears a label statement of sub-
locations.html. standard quality, as provided for under
(c) The amount of silver added will § 165.110(c) of this chapter.
not exceed 17 micrograms per kilogram
in the treated bottled water, and the FR 71461, Nov. 29, 2013; 81 FR 5591, Feb. 3,
amount of hydrogen peroxide will not 2016; 88 FR 17719, Mar. 24, 2023]
exceed 23 milligrams per kilogram in
the treated bottled water. Analyses for § 172.170 Sodium nitrate.
silver and hydrogen peroxide shall be
The food additive sodium nitrate
conducted on samples of treated bot-
may be safely used in or on specified
tled water at the site of bottling, using
foods in accordance with the following
samples of the water intended for
prescribed conditions:
treatment for the blank determination.
(a) It is used or intended for use as
(d)(1) The amount of silver in the
follows:
treated bottled water is determined
using the method for silver designated (1) As a preservative and color fixa-
in 21 CFR 165.110(b)(4)(iii)(G)(2)(i). tive, with or without sodium nitrite, in
(2) The amount of hydrogen peroxide smoked, cured sablefish, smoked, cured
in the treated bottled water is deter- salmon, and smoked, cured shad, so
mined using a Hydrogen Peroxide Test that the level of sodium nitrate does
Kit from the HACH Co., or equivalent. not exceed 500 parts per million and the
The manual from the Hydrogen Per- level of sodium nitrite does not exceed
oxide Test Kit, Model HYP–1, Catalog 200 parts per million in the finished
Number 22917–00, 1991, is incorporated product.
by reference. The Director of the Fed- (2) As a preservative and color fixa-
eral Register approves this incorpora- tive, with or without sodium nitrite, in
tion by reference in accordance with 5 meat-curing preparations for the home
U.S.C. 552(a) and 1 CFR part 51. You curing of meat and meat products (in-
may obtain copies of the test kit man- cluding poultry and wild game), with
ual from the HACH Co., P.O. Box 389, directions for use which limit the
Loveland CO, 80359 (1–800–227–4224), amount of sodium nitrate to not more
Model HYP–1, Catalog Number 22917–00. than 500 parts per million in the fin-
Copies may be examined at the Dock- ished meat product and the amount of
ets Management Staff (HFA–305), Food sodium nitrite to not more than 200
and Drug Administration, 5630 Fishers parts per million in the finished meat
Lane, Rm. 1061, Rockville, MD 20852, product.
240–402–7500, between 9 a.m. and 4 p.m., (b) To assure safe use of the additive,
Monday through Friday, or at the Na- in addition to the other information re-
tional Archives and Records Adminis- quired by the Act:
tration (NARA). For information on (1) The label of the additive or of a
the availability of this material at mixture containing the additive shall
NARA, call 202–741–6030 or go to: http:// bear:
www.archives.gov/federal_register/ (i) The name of the additive.
code_of_federal_regulations/ (ii) A statement of the concentration
ibr_locations.html. of the additive in any mixture.
(e) Substances generally recognized (2) If in a retail package intended for
as safe in or on food may be used to household use, the label and labeling of
stabilize the additive to ensure that the additive, or of a mixture con-
the additive will perform its intended taining the additive, shall bear ade-
technical effect. quate directions for use to provide a
(f) The additive may not be added to final food product that complies with
bottled water that has been filtered or the limitations prescribed in paragraph
is intended to be filtered through a sil- (a) of this section.
ver-containing water filter. (3) If in a retail package intended for
(g) Bottled water must meet the household use, the label of the additive
quality standards for bottled water in or of a mixture containing the addi-

§ 165.110(b)(2) through (b)(5) of this tive, shall bear the statement ‘‘Keep
chapter, including the limits specified out of the reach of children’’.
42
§ 172.175 Sodium nitrite. (NaCl) to aid in inhibiting the out-

The food additive sodium nitrite may growth and toxin formation from Clos-
be safely used in or on specified foods tridium botulinum type E in the com-
in accordance with the following pre- mercial processing of smoked chub in
scribed conditions: accordance with the following pre-
(a) It is used or intended for use as scribed conditions:
follows: (a) All fish in smoking establish-
(1) As a color fixative in smoked ments shall be clean and wholesome
cured tunafish products so that the and shall be expeditiously processed,
level of sodium nitrite does not exceed packed, and stored under adequate san-
10 parts per million (0.001 percent) in itary conditions in accordance with
the finished product. good manufacturing practice.
(2) As a preservative and color fixa- (b) The brining procedure is con-
tive, with or without sodium nitrate, trolled in such a manner that the
in smoked, cured sablefish, smoked, water phase portion of the edible por-
cured salmon, and smoked, cured shad tion of the finished smoked product has
so that the level of sodium nitrite does a salt (NaCl) content of not less than
not exceed 200 parts per million and the 3.5 percent, as measured in the loin
level of sodium nitrate does not exceed muscle, and the sodium nitrite content
500 parts per million in the finished of the edible portion of the finished
product. smoked product is not less than 100
(3) As a preservative and color fixa- parts per million and not greater than
tive, with sodium nitrate, in meat-cur- 200 parts per million, as measured in
ing preparations for the home curing of the loin muscle.
meat and meat products (including (c) Smoked chub shall be heated by a
poultry and wild game), with directions controlled heat process which provides
for use which limit the amount of so- a monitoring system positioned in as
dium nitrite to not more than 200 parts many strategic locations in the smoke-
per million in the finished meat prod- house as necessary to assure a contin-
uct, and the amount of sodium nitrate uous temperature throughout each fish
to not more than 500 parts per million of at least 160 °F for a minimum of 30
in the finished meat product. minutes.
(b) To assure safe use of the additive, (d) The finished product shall be
in addition to the other information re- cooled to a temperature of 50 °F or
quired by the Act: below within 3 hours after smoking and
(1) The label of the additive or of a further cooled to a temperature of 38 °F
mixture containing the additive shall or below within 12 hours after smoking.
bear: A temperature of 38 °F or below shall
(i) The name of the additive. be maintained during all subsequent
(ii) A statement of the concentration storage and distribution. All shipping
of the additive in any mixture. containers, retail packages, and ship-
(2) If in a retail package intended for ping records shall indicate with appro-
household use, the label and labeling of priate notice the perishable nature of
the additive, or of a mixture con- the product and specify that the prod-
taining the additive, shall bear ade- uct shall be held under refrigeration (38
quate directions for use to provide a °F or below) until consumed.
final food product which complies with (e) To assure safe use of the additive:
the limitations prescribed in paragraph (1) The label and labeling of the addi-
(a) of this section. tive container shall bear, in addition to
(3) If in a retail package intended for the other information required by the
household use, the label of the addi- Act, the name of the additive.
tive, or of a mixture containing the ad- (2) The label or labeling of the addi-
ditive, shall bear the statement ‘‘Keep tive container shall bear adequate di-
out of the reach of children’’. rections to assure use in compliance
with the provisions of this section.
§ 172.177 Sodium nitrite used in proc-
essing smoked chub. § 172.180 Stannous chloride.
The food additive sodium nitrite may The food additive stannous chloride
be safely used in combination with salt may be safely used for color retention
43
§ 172.185 21 CFR Ch. I (4–1–23 Edition)
in asparagus packed in glass, with lids (d) The total antioxidant content of a
lined with an inert material, in an food containing the additive will not
amount not to exceed 20 parts per mil- exceed 0.02 percent of the oil or fat con-
lion calculated as tin (Sn). tent of the food, including the essential
(volatile) oil content of the food.
§ 172.185 TBHQ.
The food additive TBHQ, which is the FR 34276, June 16, 2015; 88 FR 17719, Mar. 24,
chemical 2-(1,1-dimethylethyl)-1,4-benz- 2023]
enediol (Chemical Abstracts Service
Registry Number 1948–33–0), also known § 172.190 THBP.
as tertiary butylhydroquinone, may be The food additive THBP (2,4,5-tri-
safely used in food in accordance with hydroxybutyrophenone) may be safely
the following prescribed conditions: used in food in accordance with the fol-
(a) The food additive has a melting lowing prescribed conditions:
point of not less than 126.5 °C. (a) The food additive has a melting
(b) The percentage of TBHQ in the point of 149 °C–153 °C.
food additive is not less than 99.0 per- (b) It is used as an antioxidant alone
cent when tested by the assay de- or in combination with other permitted
scribed in the Food Chemicals Codex, antioxidants.
9th ed. (2014), pp. 1192–1194, which is in- (c) The total antioxidant content of a
corporated by reference, or an equiva- food containing the additive will not
lent method. The Director of the Office exceed 0.02 percent of the oil or fat con-
of the Federal Register approves this tent of the food, including the essential
incorporation by reference in accord- (volatile) oil content of the food.
ance with 5 U.S.C. 552(a) and 1 CFR
part 51. You may obtain copies from Subpart C—Coatings, Films and
the United States Pharmacopeial Con- Related Substances
vention, 12601 Twinbrook Pkwy., Rock-
ville, MD 20852 (Internet address: http:// § 172.210 Coatings on fresh citrus fruit.
www.usp.org). Copies may be examined Coatings may be applied to fresh cit-
at the Dockets Management Staff rus fruit for protection of the fruit in
(HFA–305), Food and Drug Administra- accordance with the following condi-
tion, 5630 Fishers Lane, Rm. 1061, Rock- tions:
ville, MD 20852, 240–402–7500, between 9 (a) The coating is applied in the min-
a.m. and 4 p.m., Monday through Fri- imum amount required to accomplish
day, or at the National Archives and the intended effect.
Records Administration (NARA). For (b) The coating may be formulated
information on the availability of this from the following components, each
material at NARA, call 202–741–6030 or used in the minimum quantity required
go to: http://www.archives.gov/federal- to accomplish the intended effect:
register/cfr/ibr-locations.html. (1) Substances generally recognized
(c) It is used as an antioxidant alone as safe for the purpose or previously
or in combination with BHA and/or sanctioned for the purpose.
BHT. (2) One or more of the following:
Component Limitations
Fatty acids ............................................................ Complying with § 172.860.

Oleic acid derived from tall oil fatty acids ............ Complying with § 172.862.
Partially hydrogenated rosin ................................ Catalytically hydrogenated to a maximum refractive index of 1.5012 at 100
°C. Color of WG or paler.
Pentaerythritol ester of maleic anhydride-modi- Acid number of 134–145; drop-softening point of 127 °C–173 °C; saponifica-
fied wood rosin. tion number of less than 280; and a color of M or paler.
Do .................................................................. Acid number of 176–186; drop-softening point of 110 °C–118 °C; saponifica-
tion number of less than 280; and a color of M or paler.
Polyethylene glycol .............................................. Complying with § 172.820. As a defoamer and dispersing adjuvant.
44
Polyhydric alcohol diesters of oxidatively refined Complying with § 178.3770 of this chapter and having a dropping point of 77
(Gersthofen process) montan wax acids. to 83 °C (170.6 to 181.4 °F), as determined by ASTM Method D566–76
(Reapproved 1982), ‘‘Standard Test Method for Dropping Point of Lubri-
cating Grease,’’ which is incorporated by reference (Copies are available
from the American Society for Testing and Materials, 100 Barr Harbor Dr.,
West Conshohocken, Philadelphia, PA 19428-2959, or at the National Ar-
chives and Records Administration (NARA). For information on the avail-
ability of this material at NARA, call 202–741–6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.) using as a solvent xylene-ethyl alcohol in a 2:1 ratio in-
stead of toluene-ethyl alcohol in a 2:1 ratio.
Sodium lauryl sulfate ............................................ Complying with § 172.822. As a film former.
Wood rosin ........................................................... Color of K or paler.
(3) In lieu of the components listed in the following copolymer and one or
paragraph (b)(2) and (4) of this section, more of the listed adjuvants.
Vinyl chloride-vinylidene chloride copolymer ....... As an aqueous dispersion containing a minimum of 75 percent water when
applied.
Polyethylene glycol .............................................. Complying with § 172.820. As a defoamer and dispersing adjuvant.
Polyvinylpyrrolidone .............................................. As an adjuvant.
Potassium persulfate ............................................ Do.
Propylene glycol alginate ..................................... Do.
Sodium decylbenzenesulfonate ........................... Do.
(4) In lieu of the components listed in the following rosin derivative and ei-
paragraph (b)(2) and (3) of this section, ther or both of the listed adjuvants:
Calcium salt of partially dimerized rosin .............. Having a maximum drop-softening point of 197 °C and a color of H or paler.
It is prepared by reaction with not more than 7 parts hydrated lime per 100
parts of partially dimerized rosin. The partially dimerized rosin is rosin that
has been dimerized by sulfuric acid catalyst to a drop-softening point of 95
°C to 105 °C and a color of WG or paler.
Petroleum naphtha ............................................... As adjuvant. Complying with § 172.250.
Sperm oil .............................................................. As adjuvant.
[42 FR 14491, Mar. 15, 1977; 49 FR 5747, Feb. 15, 1984, as amended at 51 FR 2693, Jan. 21, 1986;
52 FR 18911, May 20, 1987; 61 FR 14245, Apr. 1, 1996]
§ 172.215 Coumarone-indene resin. (b) The food additive meets the fol-
lowing specifications:
The food additive coumarone-indene
resin may be safely used on grapefruit, (1) Softening point, ring and ball: 126
lemons, limes, oranges, tangelos, and °C minimum as determined by ASTM
tangerines in accordance with the fol- method E28–67 (Reapproved 1982),
lowing prescribed conditions: ‘‘Standard Test Method for Softening
(a) The food additive is manufactured Point by Ring-and-Ball Apparatus,’’
by the polymerization of a crude, which is incorporated by reference.
heavy coal-tar solvent naphtha meet- Copies may be obtained from the Amer-
ing the following specifications: ican Society for Testing Materials, 100
(1) It is a mixture of indene, indan Barr Harbor Dr., West Conshohocken,
(hydrindene), substituted benzenes, and Philadelphia, PA 19428-2959, or may be
related compounds. examined at the National Archives and
(2) It contains no more than 0.25 per- Records Administration (NARA). For
information on the availability of this
cent tar bases.

(3) 95 percent distills in the range 167 material at NARA, call 202–741–6030, or
°C–184 °C.
45
§ 172.225 21 CFR Ch. I (4–1–23 Edition)
go to: http://www.archives.gov/fed- recognized as safe for their intended

eral_register/code_of_federal_regulations/ use or are regulated under this part, in
ibr_locations.html. accordance with the following condi-
(2) Refractive index (n25/D) 1.63–1.64. tions:
(c) It is used or intended for use as a (a) The microcapsules may be formu-
protective coating for grapefruit, lem- lated from the following components,
ons, limes, oranges, tangelos, and tan- each used in the minimum quantity re-
gerines whereby the maximum amount quired to accomplish the intended ef-
of the resin remaining on the fruit does fect:
not exceed 200 parts per million on a (1) Substances generally recognized
fresh-weight basis. as safe for the purpose.
(d) To assure safe use of the additive: (2) One or more of the following com-
(1) The label of the market package ponents:
or any intermediate premix of the ad-
COMPONENT AND LIMITATIONS
ditive shall bear, in addition to the
other information required by the act: Succinylated gelatin—Not to exceed 15 per-
(i) The name of the additive, cou- cent by combined weight of the microcap-
marone-indene resin. sule and flavoring oil. Succinic acid con-
(ii) A statement of the concentration tent of the gelatin is 4.5 to 5.5 percent.
Arabinogalactan—Complying with § 172.610;
of the additive therein. as adjuvant.
(2) The label or accompanying label- Silicon dioxide—Complying with § 172.480; as
ing shall bear adequate directions that, adjuvant.
if followed, will result in a finished
food not in conflict with the require- (3) In lieu of the components listed in
ments of this section. paragraph (a)(2) of this section, the fol-
lowing components:
FR 10103, Mar. 19, 1984] COMPONENT AND LIMITATIONS
§ 172.225 Methyl and ethyl esters of Glutaraldehyde—As cross-linking agent for

fatty acids produced from edible insolubilizing a coacervate of gum arabic
fats and oils. and gelatin.
n-Octyl alcohol—As a defoamer.
Methyl esters and ethyl esters of
fatty acids produced from edible fats (4) In lieu of the components listed in
and oils may be safely used in food, paragraphs (a)(2) and (3) of this section,
subject to the following prescribed con- the following component:
ditions:
(a) The additive consists of a mixture COMPONENT AND LIMITATIONS
of either methyl or ethyl esters of Petroleum wax—Complying with § 172.886.
fatty acids produced from edible fats Not to exceed 50 percent by combined
and oils and meets the following speci- weight of the microcapsule and spice-fla-
fications: voring substance.
(1) Not less than 90 percent methyl or (b) The microcapsules produced from
ethyl esters of fatty acids. the components listed in paragraphs
(2) Not more than 1.5 percent unsa- (a)(1), (2), and (3) of this section may be
ponifiable matter. used for encapsulating authorized fla-
(b) The additive is used or intended voring oils for use, in accordance with
for use at the level not to exceed 3 per- good manufacturing practice, in foods
cent by weight in an aqueous emulsion for which standards of identity estab-
in dehydrating grapes to produce rai- lished under section 401 of the Act do
sins, whereby the residue of the addi- not preclude such use, except that
tive on the raisins does not exceed 200 microcapsules formulated from compo-
parts per million. nents listed in paragraph (a)(2) of this
[57 FR 12711, Apr. 13, 1992] section may be used only for encap-
sulating lemon oil, distilled lime oil,
§ 172.230 Microcapsules for flavoring orange oil, peppermint oil, and spear-
substances. mint oil for use in dry mixes for pud-
Microcapsules may be safely used for dings and gelatin desserts.

encapsulating discrete particles of fla- (c) The microcapsules produced from
voring substances that are generally the components listed in paragraphs
46
(a)(1) and (4) of this section may be oil, grease, detergent residues, etc. Examine
used only for encapsulating authorized all glassware, including stoppers and stop-
spice-flavoring substances for use, in cocks, under ultraviolet light to detect any
residual fluorescent contamination. As a pre-
accordance with good manufacturing cautionary measure, it is recommended prac-
practice, in frozen pizzas which are to tice to rinse all glassware with purified iso-
be further processed by heat. Such piz- octane immediately before use. No grease is
zas shall bear labels or labeling includ- to be used on stopcocks or joints. Great care
ing adequate directions for use to en- to avoid contamination of petroleum naph-
sure heating to temperatures which tha samples in handling and to assure ab-
will melt the wax to release the spice- sence of any extraneous material arising
from inadequate packaging is essential. Be-
flavoring substances. cause some of the polynuclear hydrocarbons
[45 FR 48123, July 18, 1980] sought in this test are very susceptible to
photo-oxidation, the entire procedure is to
§ 172.235 Morpholine. be carried out under subdued light.
Morpholine may be safely used as a APPARATUS
component of food, subject to the fol- Separatory funnels. 250-milliliter, and 2,000-
lowing restrictions. milliliter capacity, equipped with tetra-
(a) It is used as the salt(s) of one or fluoroethylene polymer stopcocks.
more of the fatty acids meeting the re- Erlenmeyer flask. 125-milliliter with 24/40
quirements of § 172.860, as a component standard taper neck.
of protective coatings applied to fresh Evaporation flask. 250-milliliter capacity
fruits and vegetables. all-glass flask equipped with 24/40 standard
taper stopper having inlet and outlet tubes
(b) It is used at a level not in excess to permit passage of nitrogen across the sur-
of that reasonably required to produce face of the container liquid to be evaporated.
its intended effect. Condenser. 24/40 joints, fitted with drying
tube, length optional.
§ 172.250 Petroleum naphtha. Spectrophotometric cells. Fused quartz cells,
Petroleum naphtha may be safely optical path length in the range of 5,000 cen-
timeters ±0.005 centimeter; also for checking
used in food in accordance with the fol- spectrophotometer performance only, optical
lowing conditions: path length in the range 1,000 centimeter
(a) The additive is a mixture of liquid ±0.005 centimeter. With distilled water in the
hydrocarbons, essentially paraffinic cells, determine any absorbance difference.
and naphthenic in nature obtained Spectrophotometer. Spectral range 250–400
from petroleum, mμ with spectral slit width of 2 mμ or less;
(b) The additive is refined to meet under instrument operating conditions for
these absorbance measurements, the spectro-
the following specifications when sub-
photometer shall also meet the following
jected to the procedures described in performance requirements:
this paragraph.
(1) Boiling-point range: 175 °F–300 °F. Absorbance repeatability, ±0.01 at 0.4 absorb-
ance.
(2) Nonvolatile residue: 0.002 gram Absorbance accuracy, 1 ±0.05 at 0.4 absorb-
per 100 milliliters maximum. ance.
(3) Ultraviolet absorbance limits, as
follows: 1 As determined by procedure using potas-
Maximum sium chromate for reference standard and

absorb- described in National Bureau of Standards
ance per Circular 484, Spectrophotometry, U.S. De-
Wavelength (milli-microns) centimeter
optical partment of Commerce, (1949). The accuracy
pathlength is to be determined by comparison with the
standard values at 290, 345, and 400 milli-
280–289 ............................................................... 0.15 microns. The procedure is incorporated by
290–299 ............................................................... .13 reference. Copies of the material incor-
300–359 ............................................................... .08
360–400 ............................................................... .02
porated by reference are available from the
Office of Food Additive Safety (HFS–200),
Center for Food Safety and Applied Nutri-
ANALYTICAL SPECIFICATION FOR PETROLEUM tion, Food and Drug Administration, 5001
NAPHTHA Campus Dr., College Park, MD 20740, 240–402–
1200, or available for inspection at the Na-
GENERAL INSTRUCTIONS
tional Archives and Records Administration
All glassware should be scrupulously (NARA). For information on the availability
cleaned to remove all organic matter such as Continued
47
§ 172.250 21 CFR Ch. I (4–1–23 Edition)
Wavelength repeatability, ±0.2 millimicron. ameter tube, drawn out into a 2±1-centimeter
Wavelength accuracy, ±1.0 millimicron. long and 1±0.5-millimeter inner-diameter
capillary tip. This is positioned so that the
Ultraviolet lamp. Long wavelength (3400–
3800A°). capillary tip extends 4 centimeters into the
flask. The nitrogen flow rate is such that the
REAGENTS surface of the liquid is barely disturbed.
After the volume is reduced to that of the 1
Isooctane (2,2,4-trimethylpentane). Use 180 milliliter of hexadecane, the flask is left on
milliliters in a 250-milliliter Erlenmeyer
the steam bath for 10 more minutes before
flask, add 1 milliliter of purified n-hexa-
removing. Add 10 milliliters of purified iso-
decane, insert the head assembly, allow ni-
octane to the flask and reevaporate the solu-
trogen gas to flow into the inlet tube and
tion to a 1-milliliter volume in the same
connect the outlet tube to a solvent trap and
manner as described above, except do not
vacuum line in such a way as to prevent any
back flow of condensate into the flask. The heat for an added 10 minutes. Repeat this op-
contents of the flask are evaporated on a eration twice more. Let the flask cool.
steam bath until 1 milliliter of residue re- Add 10 milliliters of methyl alcohol and
mains. Dissolve the 1 milliliter of hexa- about 0.3 gram of sodium borohydride. (Mini-
decane residue in isooctane and make up to mize exposure of the borohydride to the at-
25 milliliters. Determine the absorbance in a mosphere; a measuring dipper may be used.)
5-centimeter path length cell compared to Immediately fit a water-cooled condenser
isooctane as reference. The absorbance equipped with a 24/40 joint and with a drying
should not exceed 0.01 per centimeter path tube into the flask, mix until the sodium
length between 280–400 mμ. If necessary, iso- borohydride is dissolved, and allow to stand
octane may be purified by passage through a for 30 minutes at room temperature, with
column of activated silica gel (Grade 12, Da- intermittent swirling. At the end of this
vidson Chemical Co., Baltimore, Md., or time, disconnect the flask and evaporate the
equivalent) or by distillation. methyl alcohol on the steam bath under ni-
Methyl alcohol, A.C.S. reagent grade. Use 10 trogen until sodium borohydride begins to
milliliters and proceed as with isooctane. drop out of solution. Remove the flask and
The absorbance per centimeter of path let it cool.
length should be 0.00 between 280–400 mμ. Add 6 milliliters of isooctane to the flask
Methyl alcohol may be purified by simple and swirl to wash the crystalline slurry.
distillation or by refluxing in the presence of Carefully transfer the isooctane extract to a
potassium hydroxide (10 grams/2 liters) and 250-milliliter separatory funnel. Dissolve the
zinc dust (25 grams/2 liters) for 3 hours fol- crystals in the flask with about 25 milliliters
lowed by distillation. of distilled water and pour this also into the
n-Hexadecane, 99 percent olefin-free. Dilute separatory funnel. Adjust the water volume
1.0 milliliter of n-hexadecane to 25 milliliters in the separatory funnel to about 100 milli-
with isooctane and determine the absorbance liters and shake for 1 minute. After separa-
in a 5-centimeter cell compared to isooctane tion of the layers, draw off the aqueous layer
as reference between 280–400 mμ. The absorb- into a second 250-milliliter separatory fun-
ance per centimeter path length shall not ex- nel. Transfer the hydrocarbon layer in the
ceed 0.00 in this range. Purify, if necessary, first funnel to a 25-milliliter volumetric
by percolation through activated silica gel flask.
or by distillation. Carefully wash the Erlenmeyer flask with
Sodium borohydride. 98 percent. an additional 6 milliliters of isooctane, swirl,
Water. All distilled water must be ex- and transfer to the second separatory funnel.
tracted with isooctane before use. A series of Shake the funnel for 1 minute. After separa-
three successive extracts of 1.5 liters of dis- tion of the layers, draw off the aqueous layer
tilled water with 100-milliliter portions of into the first separatory funnel. Transfer the
isooctane is satisfactory. isooctane in the second funnel to the volu-
PROCEDURE
metric flask. Again wash the Erlenmeyer
flask with an additional 6 milliliters of iso-
Determination of ultraviolet absorbance. Add octane, swirl, and transfer to the first sepa-
a 25-milliliter aliquot of the hydrocarbon ratory funnel. Shake the funnel for 1 minute.
solvent together with 1 milliliter of hexa- After separation of the layers, draw off the
decane to the 125-milliliter Erlenmeyer aqueous layer and discard. Transfer the iso-
flask. While flushing with nitrogen, evapo- octane layer to the volumetric flask and ad-
rate to 1 milliliter on a steam bath. Nitrogen just the volume to 25 milliliters of isooctane.
is admitted through a 8±1-milliliter outer-di- Mix the contents well, then transfer to the
first separatory funnel and wash twice with
of this material at NARA, call 202–741–6030, 50-milliliter portions of distilled water. Dis-
or go to: http://www.archives.gov/fed- card the aqueous layers after each wash.

eral_register/code_of_federal_regulations/ Determine the ultraviolet absorbance of
ibr_locations.html. the isooctane extract in 5-centimeter path
48
length cells compared to isooctane as ref- § 172.255 Polyacrylamide.
erence between 280–400 mμ. Determine a rea-
gent blank concurrently with the sample, Polyacrylamide containing not more
using 25 milliliters of purified isooctane in- than 0.2 percent of acrylamide mon-
stead of a solvent sample and measuring the omer may be safely used as a film
ultraviolet absorbance of the blank between former in the imprinting of soft-shell
280–400mμ. gelatin capsules when the amount used
The reagent blank absorbance should not is not in excess of the minimum re-
exceed 0.04 per centimeter path length be- quired to produce the intended effect.
tween 280–289 mμ; 0.020 between 290–359 mμ;
and 0.010 between 360–400 mμ. § 172.260 Oxidized polyethylene.
Determination of boiling-point range. Use Oxidized polyethylene may be safely
ASTM method D86–82, ‘‘Standard Method for
used as a component of food, subject to
Distillation of Petroleum Products,’’ which
is incorporated by reference. Copies may be the following restrictions:
obtained from the American Society for (a) Oxidized polyethylene is the basic
Testing Materials, 100 Barr Harbor Dr., West resin produced by the mild air oxida-
Conshohocken, Philadelphia, PA 19428-2959, tion of polyethylene. The polyethylene
or may be examined at the National Ar- used in the oxidation process conforms
chives and Records Administration (NARA). to the density, maximum n-hexane ex-
For information on the availability of this tractable fraction, and maximum xy-
material at NARA, call 202–741–6030, or go to: lene soluble fraction specifications pre-
http://www.archives.gov/federal_register/ scribed in item 2.3 of the table in
code_of_federal_regulations/ibr_locations.html. § 177.1520(c) of this chapter. The
Determination of nonvolatile residue. For hy- oxidized polyethylene has a minimum
drocarbons boiling below 121 °C, determine
the nonvolatile residue by ASTM method
number average molecular weight of
D1353–78, ‘‘Standard Test Method for Non- 1,200, as determined by high tempera-
volatile Matter in Volatile Solvents for Use ture vapor pressure osmometry; con-
in Paint, Varnish, Lacquer, and Related tains a maximum of 5 percent by
Products;’’ for those boiling above 121 °C, use weight of total oxygen; and has an acid
ASTM method D381–80, ‘‘Standard Test value of 9 to 19.
Method for Existent Gum in Fuels by Jet (b) The additive is used or intended
Evaporation,’’ which methods are incor- for use as a protective coating or com-
porated by reference. Copies may be obtained ponent of protective coatings for fresh
from the American Society for Testing Ma- avocados, bananas, beets, coconuts,
terials, 100 Barr Harbor Dr., West
eggplant, garlic, grapefruit, lemons,
Conshohocken, Philadelphia, PA 19428-2959,
or may be examined at the National Ar- limes, mango, muskmelons, onions, or-
chives and Records Administration (NARA). anges, papaya, peas (in pods), pine-
For information on the availability of this apple, plantain, pumpkin, rutabaga,
material at NARA, call 202–741–6030, or go to: squash (acorn), sweetpotatoes, tan-
http://www.archives.gov/federal_register/ gerines, turnips, watermelon, Brazil
code_of_federal_regulations/ibr_locations.html. nuts, chestnuts, filberts, hazelnuts, pe-
cans, and walnuts (all nuts in shells).
(c) Petroleum naphtha containing
(c) The additive is used in accordance
antioxidants shall meet the specified
with good manufacturing practice and
ultraviolet absorbance limits after cor-
in an amount not to exceed that re-
rection for any absorbance due to the quired to produce the intended effect.
antioxidants. Petroleum naphtha may
contain antioxidants authorized for use § 172.270 Sulfated butyl oleate.
in food in an amount not to exceed
Sulfate butyl oleate may be safely
that reasonably required to accomplish used in food, subject to the following
the intended effect or to exceed any prescribed conditions:
prescribed limitations. (a) The additive is prepared by sul-
(d) Petroleum naphtha is used or in- fation, using concentrated sulfuric
tended for use as a solvent in protec- acid, of a mixture of butyl esters pro-
tive coatings on fresh citrus fruit in duced by transesterification of an edi-
compliance with § 172.210. ble vegetable oil using 1-butanol. Fol-
[42 FR 14491, Mar. 15, 1977, as amended at 47 lowing sulfation, the reaction mixture
FR 11835, Mar. 19, 1982; 49 FR 10104, Mar. 19, is washed with water and neutralized
1984; 54 FR 24896, June 12, 1989; 88 FR 17719, with aqueous sodium or potassium hy-
Mar. 24, 2023] droxide. Prior to sulfation, the butyl
49
§ 172.275 21 CFR Ch. I (4–1–23 Edition)
oleate reaction mixture meets the fol- § 172.280 Terpene resin.

The food additive terpene resin may
(1) Not less than 90 percent butyl ole- be safely used in accordance with the
ate. following prescribed conditions:
(2) Not more than 1.5 percent unsa- (a) The food additive is the beta-
ponifiable matter. pinene polymer obtained by polym-
(b) The additive is used or intended erizing terpene hydrocarbons derived
for use at a level not to exceed 2 per- from wood. It has a softening point of
cent by weight in an aqueous emulsion 112 °C–118 °C, as determined by ASTM
in dehydrating grapes to produce rai- method E28–67 (Reapproved 1982),
sins, whereby the residue of the addi- ‘‘Standard Test Method for Softening
tive on the raisins does not exceed 100 Point By Ring-and-Ball Apparatus,’’
parts per million. which is incorporated by reference.
Copies may be obtained from the Amer-
[57 FR 12711, Apr. 13, 1992] ican Society for Testing Materials, 100
Barr Harbor Dr., West Conshohocken,
§ 172.275 Synthetic paraffin and suc-
cinic derivatives. Philadelphia, PA 19428-2959, or may be
examined at the National Archives and
Synthetic paraffin and succinic de- Records Administration (NARA). For
rivatives identified in this section may information on the availability of this
be safely used as a component of food, material at NARA, call 202–741–6030, or
subject to the following restrictions: go to: http://www.archives.gov/fed-
(a) The additive is prepared with 50 eral_register/code_of_federal_regulations/
percent Fischer-Tropsch process syn- ibr_locations.html.
thetic paraffin, meeting the definition (b) It is used or intended for use as
and specifications of § 172.615, and 50 follows:
percent of such synthetic paraffin to (1) As a moisture barrier on soft gela-
which is bonded succinic anhydride and tin capsules in an amount not to ex-
succinic acid derivatives of isopropyl ceed 0.07 percent of the weight of the
alcohol, polyethylene glycol, and poly- capsule.
propylene glycol. It consists of a mix- (2) As a moisture barrier on powders
ture of the Fischer-Tropsch process of ascorbic acid or its salts in an
paraffin (alkane), alkyl succinic anhy- amount not to exceed 7 percent of the
dride, alkyl succinic anhydride iso- weight of the powder.
propyl half ester, dialkyl succinic an- [42 FR 14491, Mar. 15, 1977, as amended at 49
hydride polyethylene glycol half ester, FR 10104, Mar. 19, 1984]
and dialkyl succinic anhydride poly-
propylene glycol half ester, where the Subpart D—Special Dietary and
alkane (alkyl) has a chain length of 30– Nutritional Additives
70 carbon atoms and the polyethylene
and polypropylene glycols have molec- § 172.310 Aluminum nicotinate.
ular weights of 600 and 260, respec- Aluminum nicotinate may be safely
tively. used as a source of niacin in foods for
(b) The additive meets the following special dietary use. A statement of the
specifications: Molecular weight, 880– concentration of the additive, ex-
930; melting point, 215°–217 °F; acid pressed as niacin, shall appear on the
number, 43–47; and saponification num- label of the food additive container or
ber, 75–78. on that of any intermediate premix
(c) It is used or intended for use as a prepared therefrom.
protective coating or component of
protective coatings for fresh grape- § 172.315 Nicotinamide-ascorbic acid
complex.
fruit, lemons, limes, muskmelons, or-
anges, sweetpotatoes, and tangerines. Nicotinamide-ascorbic acid complex
(d) It is used in an amount not to ex- may be safely used in accordance with
ceed that required to produce the in- the following prescribed conditions:
tended effect. (a) The additive is the product of the
controlled reaction between ascorbic
50
acid and nicotinamide, melting in the (xiv) L-Threonine, pages 1031 and 1032.
range 141 °C to 145 °C. (xv) L-Glutamic Acid Hydrochloride,
(b) It is used as a source of ascorbic page 440.
acid and nicotinamide in multivitamin (xvi) L-Isoleucine, pages 544 and 545.
preparations. (xvii) L-Lysine Monohydrochloride,
pages 598 and 599.
§ 172.320 Amino acids. (xviii) Monopotassium L-glutamate,
The food additive amino acids may pages 697 and 698.
be safely used as nutrients added to (xix) L-Tyrosine, page 1061.
foods in accordance with the following (xx) L-Valine, pages 1072.
conditions: (2) As found in ‘‘Specifications and
(a) The food additive consists of one Criteria for Biochemical Compounds,’’
or more of the following individual NAS/NRC Publication, for the fol-
amino acids in the free, hydrated, or lowing:
anhydrous form, or as the hydro- (i) L-Asparagine
chloride, sodium, or potassium salts: (ii) L-Aspartic acid
(1) L-Alanine (iii) L-Glutamine
(2) L-Arginine (iv) L-Histidine
(3) L-Asparagine (c) The additive(s) is used or intended
(4) L-Aspartic acid for use to significantly improve the bi-
(5) L-Cysteine ological quality of the total protein in
(6) L-Cystine a food containing naturally occurring
(7) L-Glutamic acid primarily intact protein that is consid-
(8) L-Glutamine ered a significant dietary protein
(9) Aminoacetic acid (glycine) source, provided that:
(10) L-Histidine (1) A reasonable daily adult intake of
(11) L-Isoleucine the finished food furnishes at least 6.5
(12) L-Leucine grams of naturally occurring primarily
(13) L-Lysine intact protein (based upon 10 percent of
(14) DL-Methionine (not for infant the daily allowance for the ‘‘reference’’
foods) adult male recommended by the Na-
(15) L-Methionine tional Academy of Sciences in ‘‘Rec-
(16) L-Phenylalanine ommended Dietary Allowances,’’ NAS
(17) L-Proline Publication No. 1694.
(18) L-Serine (2) The additive(s) results in a pro-
(19) L-Threonine tein efficiency ratio (PER) of protein
(20) L-Tryptophan in the finished ready-to-eat food equiv-
(21) L-Tyrosine alent to casein as determined by the
(22) L-Valine method specified in paragraph (d) of
(b) The food additive meets the fol- this section.
lowing specifications: (3) Each amino acid (or combination
(1) As found in Food Chemicals of the minimum number necessary to
Codex: achieve a statistically significant in-
(i) L-Alanine, pages 28 and 29. crease) added results in a statistically
(ii) L-Arginine, pages 69 and 70. significant increase in the PER as de-
(iii) L-Arginine Monohydrochloride, termined by the method described in
pages 70 and 71. paragraph (d) of this section. The min-
(iv) L-Cysteine Monohydrochloride, imum amount of the amino acid(s) to
pages 269 and 270. achieve the desired effect must be used
(v) L-Cystine, pages 270 and 271. and the increase in PER over the pri-
(vi) Aminoacetic acid (glycine), pages marily intact naturally occurring pro-
457 and 458. tein in the food must be substantiated
(vii) L-Leucine, pages 577 and 578. as a statistically significant difference
(viii) DL-Methionine, pages 641 and 642. with at least a probability (P) value of
(ix) L-Methionine, pages 642 and 643. less than 0.05.
(x) L-Tryptophan, pages 1060 and 1061. (4) The amount of the additive added
(xi) L-Phenylalanine, pages 794 and 795. for nutritive purposes plus the amount
(xii) L-Proline, pages 864 and 865. naturally present in free and combined
(xiii) L-Serine, pages 915 and 916. (as protein) form does not exceed the
51
§ 172.320 21 CFR Ch. I (4–1–23 Edition)
following levels of amino acids ex- (3) Adequate directions for use to
pressed as percent by weight of the provide a finished food meeting the
total protein of the finished food: limitations prescribed by paragraph (c)
of this section.
Percent by
weight of total (f) The food additive amino acids
protein (ex- added as nutrients to special dietary
pressed as free
amino acid) foods that are intended for use solely
under medical supervision to meet nu-
L-Alanine ...................................................... 6.1
L-Arginine ..................................................... 6.6 tritional requirements in specific med-
L-Aspartic acid (including L-asparagine) ...... 7.0 ical conditions and comply with the re-
L-Cystine (including L-cysteine) ................... 2.3 quirements of part 105 of this chapter
L-Glutamic acid (including L-glutamine) ....... 12.4
Aminoacetic acid (glycine) ........................... 3.5 are exempt from the limitations in
L-Histidine ..................................................... 2.4 paragraphs (c) and (d) of this section
L-Isoleucine .................................................. 6.6 and may be used in such foods at levels
L-Leucine ...................................................... 8.8
L-Lysine ........................................................ 6.4 not to exceed good manufacturing
L- and DL-Methionine ................................... 3.1 practices.
L-Phenylalanine ............................................ 5.8
L-Proline ....................................................... 4.2
(g) The standards required in this
L-Serine ........................................................ 8.4 section are incorporated by reference
L-Threonine .................................................. 5.0 into this section with the approval of
L-Tryptophan ................................................ 1.6
L-Tyrosine ..................................................... 4.3
the Director of the Federal Register
L-Valine ........................................................ 7.4 under 5 U.S.C. 552(a) and 1 CFR part 51.
Copies may be examined at the Dock-
(d) Compliance with the limitations ets Management Staff (HFA–305), Food
concerning PER under paragraph (c) of and Drug Administration, 5630 Fishers
this section shall be determined by the Lane, Rm. 1061, Rockville, MD 20852,
method described in sections 43.212– 240–402–7500, between 9 a.m. and 4 p.m.,
43.216, ‘‘Official Methods of Analysis of Monday through Friday, or at the Na-
the Association of Official Analytical tional Archives and Records Adminis-
Chemists.’’ Each manufacturer or per- tration (NARA). For information on
son employing the additive(s) under the availability of this material at
the provisions of this section shall NARA, call 202–741–6030 or go to: http://
keep and maintain throughout the pe- www.archives.gov/federal-register/cfr/ibr-
riod of his use of the additive(s) and for locations.html.
a minimum of 3 years thereafter, (1) AOAC INTERNATIONAL, 481
records of the tests required by this North Frederick Ave., suite 500, Gai-
paragraph and other records required thersburg, MD 20877:
to assure effectiveness and compliance (i) Sections 43.212–43.216, ‘‘Official
with this regulation and shall make Methods of Analysis of the Association
such records available upon request at of Official Analytical Chemists,’’ 13th
all reasonable hours by any officer or Ed. (1980).
employee of the Food and Drug Admin-
(ii) [Reserved]
istration, or any other officer or em-
ployee acting on behalf of the Sec- (2) National Academy of Sciences,
retary of Health and Human Services available from the Dockets Manage-
and shall permit such officer or em- ment Staff (HFA–305), Food and Drug
ployee to conduct such inventories of Administration, 5630 Fishers Lane, Rm.
raw and finished materials on hand as 1061, Rockville, MD 20852, 240–402–7500,
he deems necessary and otherwise to between 9 a.m. and 4 p.m., Monday
check the correctness of such records. through Friday:
(e) To assure safe use of the additive, (i) ‘‘Recommended Dietary Allow-
the label and labeling of the additive ances,’’ NAS Publication No. 1694, 7th
and any premix thereof shall bear, in Ed. (1968).
addition to the other information re- (ii) ‘‘Specifications and Criteria for
quired by the Act, the following: Biochemical Compounds,’’ NAS/NRC
(1) The name of the amino acid(s) Publication, 3rd Ed. (1972).
contained therein including the spe- (3) United States Pharmacopeial Con-
cific optical and chemical form. vention, 12601 Twinbrook Pkwy., Rock-
(2) The amounts of each amino acid ville, MD 20852 (Internet address http://
contained in any mixture. www.usp.org):
52
(i) Food Chemicals Codex, 7th ed. shall bear, in addition to the other in-
(2010), pages 28, 29, 69, 70, 71, 269, 270, formation required by the Act, the fol-
271, 440, 457, 458, 544, 545, 577, 578, 598, lowing:
599, 641, 642, 643, 697, 698, 794, 795, 864, (1) The name of the additive ‘‘cal-
865, 915, 916, 1031, 1032, 1060, 1061, and cium chloride double salt of d-calcium
1072. pantothenate’’ or ‘‘calcium chloride
(ii) [Reserved] double salt of dl-calcium panto-
[78 FR 71461, Nov. 29, 2013, as amended at 88 thenate’’, whichever is appropriate.
FR 17719, Mar. 24, 2023] (2) A statement of the appropriate
concentration of the additive, ex-
§ 172.325 Bakers yeast protein. pressed as pantothenic acid.
Bakers yeast protein may be safely § 172.335 D-Pantothenamide.
used in food in accordance with the fol-
lowing conditions: The food additive D-pantothenamide
(a) Bakers yeast protein is the insol- as a source of pantothenic acid activ-
uble proteinaceous material remaining ity, may be safely used in foods for spe-
after the mechanical rupture of yeast cial dietary use in an amount not in
cells of Saccharomyces cerevisiae and re- excess of that reasonably required to
moval of whole cell walls by cen- produce its intended effect.
trifugation and separation of soluble
§ 172.340 Fish protein isolate.
cellular materials.
(b) The additive meets the following (a) The food additive fish protein iso-
specifications on a dry weight basis: late may be safely used as a food sup-
(1) Zinc salts less than 500 parts per plement in accordance with the fol-
million (ppm) as zinc. lowing prescribed conditions:
(2) Nucleic acid less than 2 percent. (1) The additive shall consist prin-
(3) Less than 0.3 ppm arsenic, 0.1 ppm cipally of dried fish protein prepared
cadmium, 0.4 ppm lead, 0.05 ppm mer- from the edible portions of fish after
cury, and 0.3 ppm selenium. removal of the heads, fins, tails, bones,
(c) The viable microbial content of scales, viscera, and intestinal contents.
the finished ingredient is: (2) The additive shall be derived only
(1) Less than 10,000 organisms/gram from species of bony fish that are gen-
by aerobic plate count. erally recognized by qualified sci-
(2) Less than 10 yeasts and molds/ entists as safe for human consumption
gram. and that can be processed as prescribed
(3) Negative for Salmonella, E. coli, to meet the required specifications.
coagulase positive Staphylococci, Clos- (3) Only wholesome fresh fish other-
tridium perfringens, Clostridium botu- wise suitable for human consumption
linum, or any other recognized micro- may be used. The fish shall be handled
bial pathogen or any harmful microbial expeditiously under sanitary condi-
toxin. tions. These conditions shall be in ac-
(d) The ingredient is used in food as cordance with recognized good manu-
a nutrient supplement as defined in facturing practice for fish to be used as
§ 170.3(o)(20) of this chapter. human food.
(4) The additive shall be prepared by
§ 172.330 Calcium pantothenate, cal- extraction with hexane and food-grade
cium chloride double salt. ethanol to remove fat and moisture.
The food additive calcium chloride Solvent residues shall be reduced by
double salt of calcium pantothenate drying.
may be safely used in foods for special (b) The food additive meets the fol-
dietary uses in accordance with good lowing specifications: (Where methods
manufacturing practice and under the of determination are specified, they are
following prescribed conditions: Association of Official Analytical
(a) The food additive is of the d (dex- Chemists Methods, 13th ed., 1980, which
trorotatory) or the dl (racemic) form. are incorporated by reference). 1
(b) To assure safe use of the additive,
the label and labeling of the food addi- 1 Copies are available from: AOAC INTER-
tive container, or that of any inter- NATIONAL, 481 North Frederick Ave., suite
mediate premixes prepared therefrom, Continued
53
§ 172.345 21 CFR Ch. I (4–1–23 Edition)
(1) Protein content, as N × 6.25, shall (HFA–305), Food and Drug Administra-
not be less than 90 percent by weight of tion, 5630 Fishers Lane, Rm. 1061, Rock-
the final product, as determined by the ville, MD 20852, 240–402–7500, between 9
method described in section 2.057, Im- a.m. and 4 p.m., Monday through Fri-
proved Kjeldahl Method for Nitrate- day, or at the National Archives and
Free Samples (20)—Official Final Ac- Records Administration (NARA). For
tion. information on the availability of this
(2) Moisture content shall not be material at NARA, call 202–741–6030 or
more than 10 percent by weight of the go to: http://www.archives.gov/federal-
final product, as determined by the register/cfr/ibr-locations.html.
method described in section 24.003, Air
(c) Folic acid may be added to foods
Drying (1)—Official First Action.
subject to a standard of identity estab-
(3) Fat content shall not be more
than 0.5 percent by weight of the final lished under section 401 of the Federal
product, as determined by the method Food, Drug, and Cosmetic Act (the act)
described in section 24.005, Crude Fat when the standard of identity specifi-
or Ether Extract—Official Final Ac- cally provides for the addition of folic
tion. acid.
(4) Solvent residues in the final prod- (d) Folic acid may be added, at levels
uct shall not be more than 5 parts per not to exceed 400 micrograms (μg) per
million of hexane and 3.5 percent eth- serving, to breakfast cereals, as defined
anol by weight. under § 170.3(n)(4) of this chapter, and
[46 FR 38072, July 24, 1981, as amended at 47
to corn grits at a level such that each
FR 53344, Nov. 26, 1982; 54 FR 24897, June 12, pound of corn grits contains not more
1989] than 1.0 milligram of folic acid.
(e) Folic acid may be added to infant
§ 172.345 Folic acid (folacin). formula in accordance with section
Folic acid (CAS Reg. No. 59–30–3), 412(i)(1) of the act or with regulations
also known as folacin or folate, may be issued under section 412(i)(2) of the act
safely used in food as a nutrient in ac- which are codified in § 107.100 of this
cordance with the following prescribed chapter.
conditions: (f) Folic acid may be added to a med-
(a) Folic acid is the chemical N-[4- ical food, as defined in section 5(b)(3) of
[[(2-amino-1,4-dihydro-4-oxo-6-pteri- the Orphan Drug Act (21 U.S.C.
dinyl)methyl]amino]benzoyl]-L-glu- 360ee(b)(3)), at levels not to exceed the
tamic acid. amount necessary to meet the distinc-
(b) Folic acid meets the specifica- tive nutritional requirements of the
tions of the Food Chemicals Codex, 9th disease or condition for which the food
ed., updated through Third Supple-
is formulated.
ment, effective December 1, 2015, pp.
495–496, which is incorporated by ref- (g) Folic acid may be added to food
erence. The Director of the Office of for special dietary use at levels not to
the Federal Register approves this in- exceed the amount necessary to meet
corporation by reference in accordance the special dietary needs for which the
with 5 U.S.C. 552(a) and 1 CFR part 51. food is formulated.
You may obtain copies from the United (h) Folic acid may be added to foods
States Pharmacopeial Convention, represented as meal-replacement prod-
12601 Twinbrook Pkwy., Rockville, MD ucts, in amounts not to exceed:
20852 (Internet address http:// (1) Four hundred μg per serving if the
www.usp.org). Copies may be examined food is a meal-replacement that is rep-
at the Dockets Management Staff resented for use once per day; or
(2) Two hundred μg per serving if the
500, Gaithersburg, MD 20877, or examined at food is a meal-replacement that is rep-
the National Archives and Records Adminis- resented for use more than once per
tration (NARA). For information on the day.
availability of this material at NARA, call
(i) Folic acid may be added to corn
202–741–6030, or go to: http://www.archives.gov/

federal_register/code_of_federal_regulations/ masa flour at a level not to exceed 0.7
ibr_locations.html.
54
milligrams of folic acid per pound of dehydrated, ground product prepared

corn masa flour. from Macrocystis pyrifera, Laminaria
[61 FR 8807, Mar. 5, 1996, as amended at 61 FR
digitata, Laminaria saccharina, and Lam-
27779, June 3, 1996; 64 FR 1758, Jan. 12, 1999; 78 inaria cloustoni.
FR 71463, Nov. 29, 2013; 81 FR 22183, Apr. 15,
2016; 88 FR 17719, Mar. 24, 2023] § 172.370 Iron-choline citrate complex.
Iron-choline citrate complex made by
§ 172.350 Fumaric acid and salts of fu- reacting approximately equimolecular
maric acid.
quantities of ferric hydroxide, choline,
Fumaric acid and its calcium, fer- and citric acid may be safely used as a
rous, magnesium, potassium, and so- source of iron in foods for special die-
dium salts may be safely used in food tary use.
in accordance with the following pre-
scribed conditions: § 172.372 N-Acetyl-L-methionine.
(a) The additives meet the following
The food additive N-acetyl-L-methio-
specifications:
nine may be safely added to food (ex-
(1) Fumaric acid contains a minimum
cept infant foods and foods containing
of 99.5 percent by weight of fumaric
added nitrites/nitrates) as a source of
acid, calculated on the anhydrous
L-methionine for use as a nutrient in
basis.
accordance with the following condi-
(2) The calcium, magnesium, potas-
tions:
sium, and sodium salts contain a min-
imum of 99 percent by weight of the re- (a) N-Acetyl-L-methionine (Chemical
spective salt, calculated on the anhy- Abstracts Service Registry No. 65–82–7)
drous basis. Ferrous fumarate contains is the derivative of the amino acid me-
a minimum of 31.3 percent total iron thionine formed by addition of an ace-
and not more than 2 percent ferric tyl group to the alpha-amino group of
iron. methionine. It may be in the free, hy-
(b) With the exception of ferrous fu- drated or anhydrous form, or as the so-
marate, fumaric acid and the named dium or potassium salts.
salts are used singly or in combination (b) The additive meets the following
in food at a level not in excess of the specifications:
amount reasonably required to accom- (1) Purity assay, on a dry basis: Min-
plish the intended effect. imum 99 percent.
(c) Ferrous fumarate is used as a (2) Residue on ignition: Maximum 0.1
source of iron in foods for special die- percent.
tary use, when the use is consistent (3) Specific optical rotation
with good nutrition practice. [alpha]20D: Between ¥19° and ¥23°.
(4) The additive may contain residues
§ 172.365 Kelp. of not more than 500 ppm ethyl ace-
Kelp may be safely added to a food as tate; 50 ppm ethyl alcohol; 10 ppm
a source of the essential mineral io- methyl alcohol; and 10 ppm acetone,
dine, provided the maximum intake of when used as processing solvents.
the food as may be consumed during a (c) The additive is used or intended
period of one day, or as directed for use for use as a source of L-methionine to
in the case of a dietary supplement, improve significantly the biological
will not result in daily ingestion of the quality of the total protein in a food
additive so as to provide a total containing naturally occurring pri-
amount of iodine in excess of 225 marily intact vegetable protein that is
micrograms for foods labeled without considered a significant dietary protein
reference to age or physiological state; source, provided that:
and when age or the conditions of preg- (1) A reasonable daily adult intake of
nancy or lactation are specified, in ex- the finished food furnishes at least 6.5
cess of 45 micrograms for infants, 105 grams of naturally occurring primarily
micrograms for children under 4 years intact vegetable protein.
of age, 225 micrograms for adults and (2) The additive results in a protein
children 4 or more years of age, and 300 efficiency ratio (PER) of protein in the
micrograms for pregnant or lactating finished ready-to-eat food equivalent
women. The food additive kelp is the to casein as determined by the method
55
§ 172.375 21 CFR Ch. I (4–1–23 Edition)
specified in paragraph (d) of this sec- Those officers or employees shall be

tion. permitted to conduct inventories of
(3) The use of the additive results in raw and finished materials on hand as
a statistically significant increase in are deemed necessary to verify the
the PER as determined by the method records.
described in paragraph (d) of this sec- (e) To assure safe use of the additive,
tion. The minimum amount of the ad- the label and labeling of the additive
ditive to achieve the desired effect and any premix thereof shall bear, in
must be used, and the increase in PER addition to the other information re-
over the primarily intact naturally oc- quired by the Act, the following:
curring vegetable protein in the food (1) The name of the additive con-
must be substantiated as a statis- tained therein.
tically significant difference with at (2) The amounts of additive and each
least a probability (P) value of less amino acid contained in any mixture.
than 0.05. (3) Adequate directions for use to
(4) The amount of the additive added provide a finished food meeting the
for nutritive purpose shall not exceed limitations prescribed by paragraph (c)
the level that will provide a total of 3.1 of this section.
percent L- and DL-methionine (ex- (f) When the food additive is added as
pressed as the free amino acid) by a nutrient to special dietary foods that
weight of the total protein of the fin- are intended for use solely under med-
ished food, including the amount natu- ical supervision to meet nutritional re-
rally present in free and combined (as quirements in specific medical condi-
protein) form. tions and these foods comply with the
(5) The additive shall not be added to requirements of part 105 of this chap-
infant foods or to foods containing ter, the food additive is exempt from
added nitrites/nitrates. the limitations in paragraphs (c)(1)
(d) Compliance with the limitations through (4) and (d) of this section and
concerning PER under paragraph (c) of may be used in those foods at levels
the section shall be determined by the not to exceed good manufacturing
method described in sections 43.212– practices.
43.216, ‘‘Official Methods of Analysis of
the Association of Official Analytical [43 FR 27784, June 27, 1978, as amended at 46
Chemists,’’ 13th Ed. (1980), which is in- FR 59968, Dec. 8, 1981; 49 FR 10104, Mar. 19,
corporated by reference. Copies may be 1984; 54 FR 24897, June 12, 1989]
obtained from the AOAC INTER-
§ 172.375 Potassium iodide.
NATIONAL, 481 North Frederick Ave.,
suite 500, Gaithersburg, MD 20877, or The food additive potassium iodide
may be examined at the National Ar- may be safely used in accordance with
chives and Records Administration the following prescribed conditions:
(NARA). For information on the avail- (a) Potassium iodide may be safely
ability of this material at NARA, call added to a food as a source of the es-
202–741–6030, or go to: http:// sential mineral iodine, provided the
www.archives.gov/federal_register/ maximum intake of the food as may be
code_of_federal_regulations/ consumed during a period of one day,
ibr_locations.html. Each manufacturer or as directed for use in the case of a
or person employing the additive under dietary supplement, will not result in
the provisions of this section shall daily ingestion of the additive so as to
keep and maintain throughout the pe- provide a total amount of iodine in ex-
riod of use of the additive and for a cess of 225 micrograms for foods labeled
minimum of 3 years thereafter, records without reference to age or physio-
of the tests required by this paragraph logical state; and when age or the con-
and other records required to assure ef- ditions of pregnancy or lactation are
fectiveness and compliance with this specified, in excess of 45 micrograms
regulation. Those records shall be for infants, 105 micrograms for children
made available upon request at all rea- under 4 years of age, 225 micrograms
sonable hours by any officer or em- for adults and children 4 or more years
ployee acting on behalf of the Sec- of age, and 300 micrograms for preg-
retary of Health and Human Services. nant or lactating women.
56
(b) To assure safe use of the additive, ment), effective December 1, 2015, pp.
in addition to the other information re- 1260–1261, which is incorporated by ref-
quired by the Act, the label of the addi- erence. The Director of the Office of
tive shall bear: the Federal Register approves this in-
(1) The name of the additive. corporation by reference in accordance
(2) A statement of the concentration with 5 U.S.C. 552(a) and 1 CFR part 51.
of the additive in any mixture. You may obtain copies from the United
States Pharmacopeial Convention,
§ 172.379 Vitamin D2. 12601 Twinbrook Pkwy., Rockville, MD
Vitamin D2 may be used safely in 20852 (Internet address http://
foods as a nutrient supplement defined www.usp.org). Copies may be examined
under § 170.3(o)(20) of this chapter in ac- at the Dockets Management Staff
cordance with the following prescribed (HFA–305), Food and Drug Administra-
conditions: tion, 5630 Fishers Lane, Rm. 1061, Rock-
(a) Vitamin D2, also known as ville, MD 20852, 240–402–7500, between 9
ergocalciferol, is the chemical 9,10- a.m. and 4 p.m., Monday through Fri-
seco(5Z,7E,22E)-5,7,10(19),22- day, or at the National Archives and
ergostatetraen-3-ol. Vitamin D2 is pro- Records Administration (NARA). For
duced by ultraviolet irradiation of er- information on the availability of this
gosterol isolated from yeast and is pu- material at NARA, call 202–741–6030 or
rified by crystallization. go to: http://www.archives.gov/federal-
(b) Vitamin D2 meets the specifica- register/cfr/ibr-locations.html.
tions of the 2015 Food Chemical Codex, (c) The additive may be used as fol-
9th edition (through Third Supple- lows:
Category of Food Maximum Levels in Food (as Served)
Edible plant-based beverages intended as milk alternatives 84 IU/100 g.
Edible plant-based yogurt alternatives 89 IU/100 g.
Soy beverage products 89 IU/100 g
Soy-based butter substitute spreads 330 IU/100 g
Soy-based cheese substitutes and soy-based cheese substitute 270 IU/100 g

products
[74 FR 11022, Mar. 16, 2009, as amended at 78 the Federal Register approves this in-
FR 71463, Nov. 29, 2013; 81 FR 46581, July 18, corporation by reference in accordance
2016; 88 FR 17719, Mar. 24, 2023]
with 5 U.S.C. 552(a) and 1 CFR part 51.
§ 172.380 Vitamin D3. You may obtain copies from the U.S.
Pharmacopeial Convention, 12601
Vitamin D3 may be used safely in
Twinbrook Pkwy., Rockville, MD 20852;
foods as a nutrient supplement defined
under § 170.3(o)(20) of this chapter in ac- website: https://www.usp.org. Copies
cordance with the following prescribed may be examined at the FDA or the
conditions: National Archives and Records Admin-
(a) Vitamin D3, also known as chole- istration (NARA). Contact FDA at: the
calciferol, is the chemical 9,10- Dockets Management Staff (HFA–305),
seco(5Z,7E)-5,7,10(19)-cholestatrien-3-ol. Food and Drug Administration, 5630
Vitamin D3 occurs in and is isolated Fishers Lane, Rm. 1061, Rockville, MD
from fish liver oils. It also is manufac- 20852, 240–402–7500, between 9 a.m. and 4
tured by ultraviolet irradiation of 7-de- p.m., Monday through Friday. For in-
hydrocholesterol produced from choles- formation on inspecting this material
terol and is purified by crystallization. at NARA, visit www.archives.gov/fed-
(b) Vitamin D3 meets the specifica- eral-register/cfr/ibr-locations.html or
tions of ‘‘Vitamin D3,’’ Food Chemicals email fr.inspection@nara.gov.
Codex, 13th edition, effective June 1, (c) The additive may be used as fol-
2022, which is incorporated by ref- lows:
erence. The Director of the Office of
57
§ 172.381 21 CFR Ch. I (4–1–23 Edition)
(1) At levels not to exceed 100 Inter- ized term in accordance with § 130.10 of
national Units (IU) per 240 milliliters this chapter.
(mL) in 100 percent fruit juices (as de- (9) At levels not to exceed 560 IU per
fined under § 170.3(n)(35) of this chapter) 100 g in breakfast cereals (as defined
that are fortified with greater than or under § 170.3(n)(4) of this chapter).
equal to 330 milligrams (mg) of calcium (10) At levels not to exceed 400 IU per
per 240 mL, excluding fruit juices that 100 g in grain-based bars (e.g., break-
are specially formulated or processed fast bars, granola bars, rice cereal
for infants. bars).
(2) At levels not to exceed 100 IU per
[68 FR 9003, Feb. 27, 2003, as amended at 70
240 mL in fruit juice drinks (as defined FR 36025, June 22, 2005; 70 FR 37257, June 29,
under § 170.3(n)(35) of this chapter) that 2005; 70 FR 69438, Nov. 16, 2005; 78 FR 71463,
are fortified with greater than or equal Nov. 29, 2013; 79 FR 46996, Aug. 12, 2014; 81 FR
to 100 mg of calcium per 240 mL, ex- 46582, July 18, 2016; 83 FR 47559, Sept. 20, 2018;
cluding fruit juice drinks that are spe- 88 FR 749, Jan. 5, 2023; 88 FR 17719, Mar. 24,
cially formulated or processed for in- 2023]
fants.
§ 172.381 Vitamin D2 bakers yeast.
240 mL (prepared beverage) in soy-pro- Vitamin D2 bakers yeast may be used
tein based meal replacement beverages safely in foods as a source of vitamin
(powder or liquid) that are represented D2 and as a leavening agent in accord-
for special dietary use in reducing or ance with the following prescribed con-
maintaining body weight in accordance ditions:
with § 105.66 of this chapter. (a) Vitamin D2 bakers yeast is the
(4) At levels not to exceed 100 IU per substance produced by exposing bakers
40 grams in meal replacement bars or yeast (Saccharomyces cerevisiae) to ul-
other-type bars that are represented traviolet light, resulting in the photo-
for special dietary use in reducing or chemical conversion of endogenous er-
maintaining body weight in accordance gosterol in bakers yeast to vitamin D2
with § 105.66 of this chapter. (also known as ergocalciferol or (9,10-
(5) At levels not to exceed 81 IU per 30 seco(5Z,7E,22E)-5,7,10(19),22-
grams in cheese and cheese products as ergostatetraen-3-ol)).
defined under § 170.3(n)(5) of this chap- (b) Vitamin D2 bakers yeast may be
ter, excluding cottage cheese, ricotta used alone as an active dry yeast con-
cheese, and hard grating cheeses such centrate or in combination with con-
as Parmesan and Romano as defined in ventional bakers yeast.
§§ 133.165 and 133.183 of this chapter, and (c) The additive may be used in
those defined by standard of identity in yeast-leavened baked goods and baking
§ 133.148 of this chapter. mixes and yeast-leavened baked snack
(6) At levels not to exceed 500 IU per foods at levels not to exceed 400 Inter-
240 mL (prepared beverage) in meal re- national Units of vitamin D2 per 100
placement beverages that are not in- grams in the finished food.
tended for special dietary use in reduc- (d) To assure safe use of the additive,
ing or maintaining body weight and the label or labeling of the food addi-
that are represented for use such that tive container shall bear, in addition to
the total amount of Vitamin D3 pro- the other information required by the
vided by the product does not exceed Federal Food, Drug, and Cosmetic Act,
1,000 IU per day. adequate directions for use to provide a
final product that complies with the
(7) At levels not to exceed 1.0 IU per
limitations prescribed in paragraph (c)
kilocalorie in foods represented for use
of this section.
as a sole source of nutrition for enteral
feeding. (e) Labels of manufactured food prod-
ucts containing the additive shall bear,
in the ingredient statement, the name
100 g (800 IU/quart) in milk that con-
of the additive, ‘‘vitamin D2 bakers
tains more than 42 IU vitamin D per 100
yeast,’’ in the proper order of decreas-
g (400 IU/quart) and that meets the re-

ing predominance in the finished food.
quirements for foods named by use of a
nutrient content claim and a standard- [77 FR 52231, Aug. 29, 2012]
58
§ 172.382 Vitamin D2 mushroom pow- (3) Standard plate count, not more
der. than 5,000 colony forming units per
Vitamin D2 mushroom powder may gram (CFU/g).
be used safely in foods as a source of vi- (4) Yeasts and molds, not more than
tamin D2 in accordance with the fol- 100 CFU/g.
lowing prescribed conditions: (5) Lead, not more than 0.5 milli-
(a) Vitamin D2 mushroom powder is grams per kilogram (mg/kg).
the substance produced by exposing an (6) Arsenic, not more than 0.3 mg/kg.
aqueous homogenate of edible cultivars (d) To assure safe use of the additive,
of Agaricus bisporus mushrooms to ul- the label or labeling of the food addi-
traviolet (UV) light, resulting in the tive container shall bear, in addition to
photochemical conversion of endoge-
the other information required by the
nous ergosterol in the mushrooms to
Federal Food, Drug, and Cosmetic Act,
vitamin D2 (also known as
ergocalciferol or [9,10-Seco(5Z,7E,22E)- adequate directions for use to provide a
5,7,10(19),22- ergostatetraen-3-ol]). final product that complies with the
(b) The total dose of UV light applied limitations prescribed in paragraph (f)
to the mushroom homogenate shall not of this section.
exceed 12 Joules/square centimeter (J/ (e) Labels of manufactured food prod-
cm2). ucts containing the additive shall bear,
(c) Vitamin D2 mushroom powder in the ingredient statement, the name
meets the following specifications: of the additive ‘‘vitamin D2 mushroom
(1) Moisture, not more than 10 per- powder,’’ in the proper order of de-
cent. creasing predominance in the finished
(2) Negative for Salmonella, Staphy- food.
lococcus aureus, and Listeria (f) Vitamin D2 mushroom powder
monocytogenes, and any other recog- may be used as a source of vitamin D2
nized microbial pathogen or any harm- in food as follows:
ful microbial toxin.
TABLE 1 TO PARAGRAPH (f)
Category of food Maximum level of vitamin D2
Breakfast cereals ............................................................................................................ 350 IU/100 g.

Edible plant-based beverages marketed as milk alternatives ....................................... 84 IU/100 g.
Edible plant-based products marketed as yogurt alternatives ....................................... 89 IU/100 g.
Extruded vegetable snacks ............................................................................................ 80 IU/28 g.
Fruit smoothies ............................................................................................................... 100 IU/240 mL.
100% fruit juices that are fortified with greater than or equal to 330 mg of calcium 100 IU/240 mL.
per 240 mL, excluding fruit juices that are specially formulated or processed for in-
fants.
Fruit juice drinks that are fortified with greater than or equal to 100 mg of calcium 100 IU/240 mL.
per 240 mL, excluding fruit juice drinks that are specially formulated or processed
for infants.
Grain products and pastas ............................................................................................. 90 IU/100 g.
Meal replacement bars or other-type bars that are represented for special dietary 100 IU/40 g.
use in reducing or maintaining body weight.
Meal replacement beverages that are not intended for special dietary use in reduc- 500 IU/240 mL.
ing or maintaining body weight and that are represented for use such that the total
amount of Vitamin D provided by the product does not exceed 1,000 IU per day.
Plant protein products .................................................................................................... 80 IU/85 g.
Soups and soup mixes, except for soup and soup mixes containing meat or poultry 100 IU/245 mL.
that are subject to regulation by the U.S. Department of Agriculture under the Fed-
eral Meat Inspection Act or the Poultry Products Inspection Act.
Soy-based spreads marketed as butter alternatives ..................................................... 330 IU/100 g.
Soy-based products marketed as cheese and cheese-product alternatives ................. 270 IU/100 g.
Soy beverage products .................................................................................................. 89 IU/100 g.
Soy-protein based meal replacement beverages (powder or liquid) that are rep- 140 IU/240 mL.
resented for special dietary use in reducing or maintaining body weight.
Vegetable juices ............................................................................................................. 100 IU/240 mL.
Yeast-leavened baked goods and baking mixes and yeast-leavened baked snack 400 IU/100 g.
foods.
59
§ 172.385 21 CFR Ch. I (4–1–23 Edition)
[85 FR 41920, July 13, 2020] uct, as determined by the method de-
scribed in section 24.003 of the AOAC.
§ 172.385 Whole fish protein con- See paragraph (c)(1) of this section for
centrate. availability of the material incor-
The food additive whole fish protein porated by reference.
concentrate may be safely used as a (3) Fat content shall not exceed 0.5
food supplement in accordance with percent by weight of the final product,
the following prescribed conditions: as determined by the method described
(a) The additive is derived from in section 24.005 of the AOAC. See para-
whole, wholesome hake and hakelike graph (c)(1) of the this section for
fish, herring of the genera Clupea, men- availability of the material incor-
haden, and anchovy of the species En- porated by reference.
graulis mordax, handled expeditiously (4) The additive may contain residues
and under sanitary conditions in ac- of isopropyl alcohol and ethylene di-
cordance with good manufacturing chloride not in excess of 250 parts per
practices recognized as proper for fish million and 5 parts per million, respec-
that are used in other forms for human tively, when used as solvents in the ex-
food. traction process.
(b) The additive consists essentially (5) Microwave radiation meeting the
of a dried fish protein processed from requirements of § 179.30 of this chapter
the whole fish without removal of may be used to reduce residues of the
heads, fins, tails, viscera, or intestinal solvents used in the extraction process.
contents. It is prepared by solvent ex- (6) The additive shall contain not in
traction of fat and moisture with iso- excess of 100 parts per million fluorides
propyl alcohol or with ethylene dichlo- (expressed as F).
ride followed by isopropyl alcohol, ex- (7) The additive shall be free of Esch-
cept that the additive derived from erichia coli and pathogenic organisms,
herring, menhaden and anchovy is pre- including Salmonella, and shall have a
pared by solvent extraction with iso- total bacterial plate count of not more
propyl alcohol alone. Solvent residues than 10,000 per gram.
are reduced by conventional heat dry- (8) The additive shall have no more
ing and/or microwave radiation and than a faint characteristic fish odor
there is a partial removal of bone. and taste.
(c) The food additive meets the fol- (d) When the additive is used or in-
lowing specifications: tended for use in the household as a
(1) Protein content (N × 6.25) shall protein supplement in food for regular
not be less than 75 percent by weight of consumption by children up to 8 years
the final product, as determined by the of age, the amount of the additive from
method described in section 2.057 in this source shall not exceed 20 grams
‘‘Official Methods of Analysis of the per day (about one heaping table-
Association of Official Analytical spoon).
Chemists’’ (AOAC), 13th Ed. (1980). Pro- (e) When the additive is used as a
tein quality shall not be less than 100, protein supplement in manufactured
as determined by the method described food, the total fluoride content (ex-
in sections 43.212–43.216 of the AOAC. pressed as F) of the finished food shall
The 13th Ed. is incorporated by ref- not exceed 8 ppm based on the dry
erence, and copies may be obtained weight of the food product.
from the AOAC INTERNATIONAL, 481 (f) To assure safe use of the additive,
North Frederick Ave., suite 500, Gai- in addition to the other information re-
thersburg, MD 20877, or may be exam- quired by the Act:
ined at the National Archives and (1) The label of consumer-sized or
Records Administration (NARA). For bulk containers of the additive shall
information on the availability of this bear the name ‘‘whole fish protein con-
material at NARA, call 202–741–6030, or centrate’’.
go to: http://www.archives.gov/fed- (2) The label or labeling of containers
eral_register/code_of_federal_regulations/ of the additive shall bear adequate di-
ibr_locations.html. rections for use to comply with the

(2) Moisture content shall not exceed limitations prescribed by paragraphs
10 percent by weight of the final prod- (d) and (e) of this section.
60
(3) Labels of manufactured foods con- (a) The additive is the chemical
taining the additive shall bear, in the green ferric ammonium citrate.
ingredient statement, the name of the (b) The additive is used, or intended
additive, ‘‘whole fish protein con- for use as an anticaking agent in salt
centrate’’ in the proper order of de- for human consumption so that the
creasing predominance in the finished level of iron ammonium citrate does
food. not exceed 25 parts per million (0.0025
percent) in the finished salt.
FR 10104, Mar. 19, 1984; 54 FR 24897, June 12,
(c) To assure safe use of the additive
1989] the label or labeling of the additive
shall bear, in addition to the other in-
§ 172.395 Xylitol. formation required by the Act:
(1) The name of the additive.
Xylitol may be safely used in foods
(2) Adequate directions to provide a
for special dietary uses, provided the
final product that complies with the
amount used is not greater than that
limitations prescribed in paragraph (b)
required to produce its intended effect.
of this section.
§ 172.399 Zinc methionine sulfate.
§ 172.480 Silicon dioxide.
Zinc methionine sulfate, CAS Reg.
The food additive silicon dioxide may
No. 56329–42–1, may be safely used in
be safely used in food in accordance
accordance with the following pre-
with the following conditions:
scribed conditions:
(a) The food additive is manufactured
(a) The additive is the product of the
by vapor phase hydrolysis or by other
reaction between equimolar amounts of
means whereby the particle size is such
zinc sulfate and DL-methionine in puri-
as to accomplish the intended effect.
fied water.
(b) It is used as an anticaking agent,
(b) The additive meets the following
subject to the following conditions:
specifications:
(1) It is used in only those foods in
Zinc content—19 to 22 percent. which the additive has been dem-
C5H11NO2S ‘‘DL-methionine’’—46 to 50 per- onstrated to have an anticaking effect.
cent. (2) It is used in an amount not in ex-
Cadmium—not more than 0.05 part per mil- cess of that reasonably required to
lion.
produce its intended effect.
(c) The additive is used in tablet form (3) [Reserved]
as a source of dietary zinc. (4) It is used in an amount not to ex-
ceed 2 percent by weight of the food.
[46 FR 58297, Dec. 1, 1981]
(c) It is used or intended for use as a
stabilizer in the production of beer, and
Subpart E—Anticaking Agents is removed from the beer by filtration
prior to final processing.
§ 172.410 Calcium silicate. (d) It is used or intended for use as an
Calcium silicate, including synthetic adsorbent for dl-a-tocopheryl acetate
calcium silicate, may be safely used in and pantothenyl alcohol in tableted
food in accordance with the following foods for special dietary use, in an
prescribed conditions: amount not greater than that required
(a) It is used as an anticaking agent to accomplish the intended physical or
in food in an amount not in excess of technical effect.
that reasonably required to produce its
intended effect. § 172.490 Yellow prussiate of soda.
(b) It will not exceed 2 percent by (a) The food additive yellow prussiate
weight of the food, except that it may of soda (sodium ferrocyanide decahy-
be present up to 5 percent by weight of drate; Na4Fe(CN)6·10H2O contains a
baking powder. minimum of 99 percent by weight of so-
dium ferrocyanide decahydrate.
§ 172.430 Iron ammonium citrate. (b) The additive is used or intended
Iron ammonium citrate may be safe- for use as an anticaking agent in salt
ly used in food in accordance with the and as an adjuvant in the production of
following prescribed conditions: dendritic crystals of salt in an amount
61
§ 172.510 21 CFR Ch. I (4–1–23 Edition)
needed to produce its intended effect (a) They are used in the minimum
but not in excess of 13 parts per million quantity required to produce their in-
calculated as anhydrous sodium ferro- tended physical or technical effect and
cyanide. in accordance with all the principles of
[42 FR 14491, Mar. 15, 1977, as amended at 58 good manufacturing practice.
FR 17098, Apr. 1, 1993] (b) In the appropriate forms (plant
parts, fluid and solid extracts, con-
Subpart F—Flavoring Agents and centrates, absolutes, oils, gums, bal-
Related Substances sams, resins, oleoresins, waxes, and dis-
tillates) they consist of one or more of
§ 172.510 Natural flavoring substances the following, used alone or in com-
and natural substances used in con- bination with flavoring substances and
junction with flavors.
adjuvants generally recognized as safe
Natural flavoring substances and in food, previously sanctioned for such
natural adjuvants may be safely used use, or regulated in any section of this
in food in accordance with the fol- part.
lowing conditions.
Common name Scientific name Limitations
Aloe ................................................................ Aloe perryi Baker, A. barbadensis Mill., A. ferox Mill.,

and hybrids of this sp. with A. africana Mill. and A.
spicata Baker.
Althea root and flowers .................................. Althea officinalis L.
Amyris (West Indian sandalwood) ................. Amyris balsamifera L.
Angola weed .................................................. Roccella fuciformis Ach .............................................. In alcoholic beverages
only
Arnica flowers ................................................. Arnica montana L., A. fulgens Pursh, A. sororia Do.
Greene, or A. cordifolia Hooker.
Artemisia (wormwood) .................................... Artemisia spp .............................................................. Finished food thujone
free 1
Artichoke leaves ............................................. Cynara scolymus L ..................................................... In alcoholic beverages
only
Benzoin resin ................................................. Styrax benzoin Dryander, S. paralleloneurus Per-
kins, S. tonkinensis (Pierre) Craib ex Hartwich, or
other spp. of the Section Anthostyrax of the genus
Styrax.
Blackberry bark .............................................. Rubus, Section Eubatus.
Boldus (boldo) leaves .................................... Peumus boldus Mol .................................................... Do.
Boronia flowers .............................................. Boronia megastigma Nees.
Bryonia root .................................................... Bryonia alba L., or B. diocia Jacq .............................. Do.
Buchu leaves .................................................. Barosma betulina Bartl. et Wendl., B. crenulata (L.)
Hook. or B. serratifolia Willd.
Buckbean leaves ............................................ Menyanthes trifoliata L ............................................... Do.
Cajeput ........................................................... Melaleuca leucadendron L. and other Melaleuca spp.
Calumba root .................................................. Jateorhiza palmata (Lam.) Miers ................................ Do.
Camphor tree ................................................. Cinnamomum camphora (L.) Nees et Eberm ............ Safrole free
Cascara sagrada ............................................ Rhamnus purshiana DC.
Cassie flowers ................................................ Acacia farnesiana (L.) Willd.
Castor oil ........................................................ Ricinus communis L.
Catechu, black ............................................... Acacia catechu Willd.
Cedar, white (aborvitae), leaves and twigs ... Thuja occidentalis L .................................................... Finished food thujone
free 1
Centuary ......................................................... Centaurium umbellatum Gilib ..................................... In alcoholic beverages
only
Cherry pits ...................................................... Prunus avium L. or P. cerasus L ............................... Not to exceed 25 p.p.m.
prussic acid
Cherry-laurel leaves ....................................... Prunus laurocerasus L ............................................... Do.
Chestnut leaves ............................................. Castanea dentata (Marsh.) Borkh.
Chirata ............................................................ Swertia chirata Buch.-Ham ......................................... In alcoholic beverages
only
Cinchona, red, bark ........................................ Cinchona succirubra Pav. or its hybrids .................... In beverages only; not
more than 83 p.p.m.
total cinchona alkaloids
in finished beverage
Cinchona, yellow, bark ................................... Cinchona ledgeriana Moens, C. calisaya Wedd., or Do.
hybrids of these with other spp. of Cinchona..
Copaiba .......................................................... South American spp. of Copaifera L.
Cork, oak ........................................................ Quercus suber L., or Q. occidentalis F. Gay ............. In alcoholic beverages
only
Costmary ........................................................ Chrysanthemum balsamita L ...................................... Do.
62
Costus root ..................................................... Saussurea lappa Clarke.

Cubeb ............................................................. Piper cubeba L. f.
Currant, black, buds and leaves .................... Ribes nigrum L.
Damiana leaves .............................................. Turnera diffusa Willd.
Davana ........................................................... Artemisia pallens Wall.
Dill, Indian ...................................................... Anethum sowa Roxb. (Peucedanum graveolens
Benth et Hook., Anethum graveolens L.).
Dittany (fraxinella) roots ................................. Dictamnus albus L ...................................................... Do.
Dittany of Crete .............................................. Origanum dictamnus L.
Dragon’s blood (dracorubin) ........................... Daemonorops spp.
Elder tree leaves ............................................ Sambucus nigra L ...................................................... In alcoholic beverages
only; not to exceed 25
p.p.m. prussic acid in
the flavor
Elecampane rhizome and roots ..................... Inula helenium L ......................................................... In alcoholic beverages
only
Elemi .............................................................. Canarium commune L. or C. luzonicum Miq.
Erigeron .......................................................... Erigeron canadensis L.
Eucalyptus globulus leaves ............................ Eucalyptus globulus Labill.
Fir (‘‘pine’’) needles and twigs ....................... Abies sibirica Ledeb., A. alba Mill., A. sachalinesis
Masters or A. mayriana Miyabe et Kudo.
Fir, balsam, needles and twigs ...................... Abies balsamea (L.) Mill.
Galanga, greater ............................................ Alpinia galanga Willd .................................................. Do.
Galbanum ....................................................... Ferula galbaniflua Boiss. et Buhse and other Ferula
spp.
Gambir (catechu, pale) .................................. Uncaria gambir Roxb.
Genet flowers ................................................. Spartium junceum L.
Gentian rhizome and roots ............................ Gentiana lutea L.
Gentian, stemless ........................................... Gentiana acaulis L ...................................................... Do.
Germander, chamaedrys ................................ Teucrium chamaedrys L ............................................. Do.
Germander, golden ........................................ Teucrium polium L ...................................................... Do.
Guaiac ............................................................ Guaiacum officinale L., G. santum L., Bulnesia
sarmienti Lor.
Guarana ......................................................... Paullinia cupana HBK.
Haw, black, bark ............................................ Viburnum prunifolium L.
Hemlock needles and twigs ........................... Tsuga canadensis (L.) Carr. or T. heterophylla (Raf.)
Sarg.
Hyacinth flowers ............................................. Hyacinthus orientalis L.
Iceland moss .................................................. Cetraria islandica Ach ................................................ Do.
Imperatoria ..................................................... Peucedanum ostruthium (L.). Koch (Imperatoria
ostruthium L.).
Iva ................................................................... Achillea moschata Jacq .............................................. Do.
Labdanum ...................................................... Cistus spp.
Lemon-verbena .............................................. Lippia citriodora HBK .................................................. Do.
Linaloe wood .................................................. Bursera delpechiana Poiss. and other Bursera spp.
Linden leaves ................................................. Tillia spp ..................................................................... Do.
Lovage ............................................................ Levisticum officinale Koch.
Lungmoss (lungwort) ...................................... Sticta pulmonacea Ach.
Maidenhair fern .............................................. Adiantum capillus-veneris L ....................................... Do.
Maple, mountain ............................................. Acer spicatum Lam.
Mimosa (black wattle) flowers ........................ Acacia decurrens Willd. var. dealbata.
Mullein flowers ................................................ Verbascum phlomoides L. or V. thapsiforme Schrad Do.
Myrrh .............................................................. Commiphora molmol Engl., C. abyssinica (Berg)
Engl., or other Commiphora spp.
Myrtle leaves .................................................. Myrtus communis L .................................................... Do.
Oak, English, wood ........................................ Quercus robur L ......................................................... Do.
Oak, white, chips ............................................ Quercus alba L.
Oak moss ....................................................... Evernia prunastri (L.) Ach., E. furfuracea (L.) Mann, Finished food thujone
and other lichens. free 1
Olibanum ........................................................ Boswellia carteri Birdw. and other Boswellia spp.
Opopanax (bisabolmyrrh) ............................... Opopanax chironium Koch (true opopanax) of
Commiphora erythraea Engl. var. Llabrescens.
Orris root ........................................................ Iris germanica L. (including its variety florentina
Dykes) and I. pallida Lam.
Pansy ............................................................. Viola tricolor L ............................................................. In alcoholic beverages
only
Passion flower ................................................ Passiflora incarnata L.
Patchouly ........................................................ Pogostemon cablin Benth. and P. heyneanus Benth.
Peach leaves .................................................. Prunus persica (L.) Batsch ......................................... In alcoholic beverages
only; not to exceed 25
p.p.m. prussic acid in
the flavor
Pennyroyal, American .................................... Hedeoma pulegioides (L.) Pers.
Pennyroyal, European .................................... Mentha pulegium L.
63
§ 172.510 21 CFR Ch. I (4–1–23 Edition)
Pine, dwarf, needles and twigs ...................... Pinus mugo Turra var. pumilio (Haenke) Zenari.
Pine, Scotch, needles and twigs .................... Pinus sylvestris L.
Pine, white, bark ............................................ Pinus strobus L ........................................................... In alcoholic beverages
only
Pine, white oil ................................................. Pinus palustris Mill., and other Pinus spp.
Poplar buds .................................................... Populus balsamifera L. (P. tacamahacca Mill.), P. Do.
candicans Ait., or P. nigra L.
Quassia .......................................................... Picrasma excelsa (Sw.) Planch, or Quassia amara L.
Quebracho bark ............................................. Aspidosperma quebracho-blanco Schlecht, or Schinopsis lorentzii
(Quebrachia lorentzii (Griseb)). (Griseb.) Engl.
Quillaia (soapbark) ......................................... Quillaja saponaria Mol.
Red saunders (red sandalwood) .................... Pterocarpus san alinus L ............................................ In alcoholic beverages
only
Rhatany root ................................................... Krameria triandra Ruiz et Pav. or K. argentea Mart.
Rhubarb, garden root ..................................... Rheum rhaponticum L ................................................ Do.
Rhubarb root .................................................. Rheum officinale Baill., R. palmatum L., or other
spp. (excepting R. rhaponticum L.) or hybrids of
Rheum grown in China.
Roselle ........................................................... Hibiscus sabdariffa L .................................................. Do.
Rosin (colophony) .......................................... Pinus palustris Mill., and other Pinus spp .................. Do.
St. Johnswort leaves, flowers, and caulis ...... Hypericum perforatum L ............................................. Hypericin-free alcohol dis-
tillate form only; in alco-
holic beverages only
Sandalwood, white (yellow, or East Indian) ... Santalum album L.
Sandarac ........................................................ Tetraclinis articulata (Vahl.), Mast .............................. In alcoholic beverages
only
Sarsaparilla ..................................................... Smilax aristolochiaefolia Mill., (Mexican sarsaparilla),
S. regelii Killip et Morton (Honduras sarsaparilla),
S. febrifuga Kunth (Ecuadorean sarsaparilla), or
undetermined Smilax spp. (Ecuadorean or Central
American sarsaparilla).
Sassafras leaves ............................................ Sassafras albidum (Nutt.) Nees ................................. Safrole free
Senna, Alexandria .......................................... Cassia acutifolia Delile.
Serpentaria (Virginia snakeroot) .................... Aristolochia serpentaria L ........................................... In alcoholic beverages
only
Simaruba bark ................................................ Simaruba amara Aubl ................................................. Do.
Snakeroot, Canadian (wild ginger) ................ Asarum canadense L.
Spruce needles and twigs .............................. Picea glauca (Moench) Voss or P. mariana (Mill.)
BSP.
Storax (styrax) ................................................ Liquidambar orientalis Mill. or L. styraciflua L.
Tagetes (marigold) ......................................... Tagetes patula L., T. erecta L., or T. minuta L. (T. As oil only
glandulifera Schrank).
Tansy .............................................................. Tanacetum vulgare L .................................................. In alcoholic beverages
only; finished alcoholic
beverage thujone free 1
Thistle, blessed (holy thistle) .......................... Onicus benedictus L ................................................... In alcoholic beverages
only
Thymus capitatus (Spanish ‘‘origanum’’) ....... Thymus capitatus Hoffmg. et Link.
Tolu ................................................................ Myroxylon balsamum (L.) Harms.
Turpentine ...................................................... Pinus palustris Mill. and other Pinus spp. which yield
terpene oils exclusively.
Valerian rhizome and roots ............................ Valeriana officinalis L.
Veronica ......................................................... Veronica officinalis L .................................................. Do.
Vervain, European ......................................... Verbena officinalis L ................................................... Do.
Vetiver ............................................................ Vetiveria zizanioides Stapf ......................................... Do.
Violet, Swiss ................................................... Viola calcarata L.
Walnut husks (hulls), leaves, and green nuts Juglans nigra L. or J. regia L.
Woodruff, sweet ............................................. Asperula odorata L ..................................................... In alcoholic beverages
only
Yarrow ............................................................ Achillea millefolium L .................................................. In beverages only; fin-
ished beverage thujone
free 1
Yerba santa .................................................... Eriodictyon californicum (Hook, et Arn.) Torr.
Yucca, Joshua-tree ........................................ Yucca brevifolia Engelm.
Yucca, Mohave .............................................. Yucca schidigera Roezl ex Ortgies (Y. mohavensis
Sarg.).
1 As determined by using the method (or, in other than alcoholic beverages, a suitable adaptation thereof) in section 9.129 of
the ‘‘Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), which is incorporated by ref-
erence. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD
20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of
this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
64
[42 FR 14491, Mar. 15, 1977, as amended at 43 FR 14644, Apr. 7, 1978; 49 FR 10104, Mar. 19, 1984;
54 FR 24897, June 12, 1989; 69 FR 24511, May 4, 2004; 72 FR 10357, Mar. 8, 2007]
§ 172.515 Synthetic flavoring sub- Amyl heptanoate.

stances and adjuvants. Amyl hexanoate.
Amyl octanoate.
Synthetic flavoring substances and Anisole; methoxybenzene.
adjuvants may be safely used in food in Anisyl acetate.
accordance with the following condi- Anisyl alcohol; p-methoxybenzyl alcohol.
tions. Anisyl butyrate
(a) They are used in the minimum Anisyl formate.
Anisyl phenylacetate.
quantity required to produce their in- Anisyl propionate.
tended effect, and otherwise in accord- Beechwood creosote.
ance with all the principles of good Benzaldehyde dimethyl acetal.
manufacturing practice. Benzaldehyde glyceryl acetal; 2-phenyl-m-di-
(b) They consist of one or more of the oxan-5-ol.
following, used alone or in combination Benzaldehyde propylene glycol acetal; 4-
with flavoring substances and adju- methyl-2-phenyl-m-dioxolane.
Benzenethiol; thiophenol.
vants generally recognized as safe in Benzoin; 2-hydroxy-2-phenylacetophenone.
food, prior-sanctioned for such use, or Benzyl acetate.
regulated by an appropriate section in Benzyl acetoacetate.
this part. Benzyl alcohol.
Benzyl benzoate.
Acetal; acetaldehyde diethyl acetal. Benzyl butyl ether.
Acetaldehyde phenethyl propyl acetal. Benzyl butyrate.
Acetanisole; 4′-methoxyacetophenone. Benzyl cinnamate.
Acetophenone; methyl phenyl ketone. Benzyl 2,3–dimethylcrotonate; benzyl methyl
Allyl anthranilate. tiglate.
Allyl butyrate. Benzyl disulfide; dibenzyl disulfide.
Allyl cinnamate. Benzyl ethyl ether.
Allyl cyclohexaneacetate. Benzyl formate.
Allyl cyclohexanebutyrate. 3-Benzyl-4-heptanone; benzyl dipropyl ke-
Allyl cyclohexanehexanoate. tone.
Allyl cyclohexaneproprionate. Benzyl isobutyrate.
Allyl cyclohexanevalerate. Benzyl isovalerate.
Allyl disulfide. Benzyl mercaptan; a-toluenethiol.
Allyl 2-ethylbutyrate. Benzyl methoxyethyl acetal; acetaldehyde
Allyl hexanoate; allyl caproate. benzyl b-methoxyethyl acetal.
Allyl a-ionone; 1-(2,6,6-trimethyl-2-cyclo-hex- Benzyl phenylacetate.
ene-1-yl)-1,6-heptadiene-3-one. Benzyl propionate.
Allyl isothiocyanate; mustard oil. Benzyl salicylate.
Allyl isovalerate. Birch tar oil.
Allyl mercaptan; 2-propene-1-thiol. Borneol; d-camphanol.
Allyl nonanoate. Bornyl acetate.
Allyl octanoate. Bornyl formate.
Allyl phenoxyacetate. Bornyl isovalerate.
Allyl phenylacetate. Bornyl valerate.
Allyl propionate. b-Bourbonene; 1,2,3,3a,3bb,4,5,6,6ab,6ba-deca-
Allyl sorbate; allyl 2,4-hexadienoate. hydro-la-isopropyl-3aa-methyl-6-meth-
Allyl sulfide. ylene-cyclobuta [1,2:3,4] dicyclopentene.
Allyl tiglate; allyl trans-2-methyl-2- 2-Butanol.
butenoate. 2-Butanone; methyl ethyl ketone.
Allyl 10-undecenoate. Butter acids.
Ammonium isovalerate. Butter esters.
Ammonium sulfide. Butyl acetate.
Amyl alcohol; pentyl alcohol. Butyl acetoacetate.
Amyl butyrate. Butyl alcohol; 1-butanol.
a-Amylcinnamaldehyde. Butyl anthranilate.
a-Amylcinnamaldehyde dimethyl acetal. Butyl butyrate.
a-Amylcinnamyl acetate. Butyl butyryllactate; lactic acid, butyl
a-Amylcinnamyl alcohol. ester, butyrate.
a-Amylcinnamyl formate. a-Butylcinnamaldehyde.

a-Amylcinnamyl isovalerate. Butyl cinnamate.
Amyl formate. Butyl 2-decenoate.
65
§ 172.515 21 CFR Ch. I (4–1–23 Edition)
Butyl ethyl malonate. p-Cresol.
Butyl formate. Cuminaldehyde; cuminal; p-isopropyl benz-
Butyl heptanoate. aldehyde.
Butyl hexanoate. Cyclohexaneacetic acid.
Butyl p-hydroxybenzoate. Cyclohexaneethyl acetate.
Butyl isobutyrate. Cyclohexyl acetate.
Butyl isovalerate. Cyclohexyl anthranilate.
Butyl lactate. Cyclohexyl butyrate.
Butyl laurate. Cyclohexyl cinnamate.
Butyl levulinate. Cyclohexyl formate.
Butyl phenylacetate. Cyclohexyl isovalerate.
Butyl propionate. Cyclohexyl propionate.
Butyl stearate. p-Cymene.
Butyl sulfide. g-Decalactone; 4-hydroxy-decanoic acid, g-
Butyl 10-undecenoate. lactone.
Butyl valerate. g-Decalactone; 5-hydroxy-decanoic acid, d-
Butyraldehyde. lactone.
Cadinene. Decanal dimethyl acetal.
Camphene; 2,2-dimethyl-3-methylene- 1-Decanol; decylic alcohol.
norbornane. 2-Decenal.
d-Camphor.
3-Decen-2-one; heptylidene acetone.
Carvacrol; 2-p-cymenol.
Decyl actate.
Carvacryl ethyl ether; 2-ethoxy-p-cymene.
Decyl butyrate.
Carveol; p-mentha-6,8-dien-2-ol.
Decyl propionate.
4-Carvomenthenol; 1-p-menthen-4-ol; 4-
Dibenzyl ether.
terpinenol.
cis Carvone oxide; 1,6-epoxy-p-menth-8-en-2- 4,4-Dibutyl-g-butyrolactone; 4,4-dibutyl-4-hy-
one. droxy-butyric acid, g-lactone.
Carvyl acetate. Dibutyl sebacate.
Carvyl propionate. Diethyl malate.
b-Caryophyllene. Diethyl malonate; ethyl malonate.
Caryophyllene alcohol. Diethyl sebacate.
Caryophyllene alcohol acetate. Diethyl succinate.
b-Caryophyllene oxide; 4-12,12-trimethyl-9- Diethyl tartrate.
methylene-5-oxatricylo [8.2.0.0 4 6] dode- 2,5-Diethyltetrahydrofuran.
cane. Dihydrocarveol; 8-p-menthen-2-ol; 6-methyl-
Cedarwood oil alcohols. 3-isopropenylcyclohexanol.
Cedarwood oil terpenes. Dihydrocarvone.
1,4-Cineole. Dihydrocarvyl acetate.
Cinnamaldehyde ethylene glycol acetal. m-Dimethoxybenzene.
Cinnamic acid. p-Dimethoxybenzene; dimethyl hydro-
Cinnamyl acetate. quinone.
Cinnamyl alcohol; 3-phenyl-2-propen-1-ol. 2,4-Dimethylacetophenone.
Cinnamyl benzoate. a,a-Dimethylbenzyl isobutyrate; phenyldi-
Cinnamyl butyrate. methylcarbinyl isobutyrate.
Cinnamyl cinnamate. 2,6-Dimethyl-5-heptenal.
Cinnamyl formate. 2,6-Dimethyl octanal; isodecylaldehyde.
Cinnamyl isobutyrate. 3,7-Dimethyl-1-octanol; tetrahydrogeraniol.
Cinnamyl isovalerate. a,a-Dimethylphenethyl acetate; benzyl-
Cinnamyl phenylacetate. propyl acetate; benzyldimethylcarbinyl ac-
Cinnamyl propionate. etate.
Citral diethyl acetal; 3,7-dimethyl-2,6-octa- a,a-Dimethylphenethyl alcohol; dimethyl-
dienal diethyl acetal. benzyl carbinol.
Citral dimethyl acetal; 3,7-dimethyl-2,6-octa- a,a-Dimethylphenethyl butyrate; benzyl-
dienal dimethyl acetal. dimethylcarbinyl butyrate.
Citral propylene glycol acetal. a,a-Dimethylphenethyl formate; benzyldi-
Citronellal; 3,7-dimethyl-6-octenal; rhodinal. methylcarbinyl formate.
Citronellol; 3,7-dimethyl-6-octen-1-ol; d-cit- Dimethyl succinate.
ronellol. 1,3-Diphenyl-2-propanone; dibenzyl ketone.
Citronelloxyacetaldehyde. delta-Dodecalactone; 5-hydroxydodecanoic
Citronellyl acetate. acid, deltalactone.
Citronellyl butyrate. g-Dodecalactone; 4-hydroxydodecanoic acid g-
Citronellyl formate. lactone.
Citronellyl isobutyrate. 2-Dodecenal.
Citronellyl phenylacetate. Estragole.

Citronellyl propionate. r-Ethoxybenzaldehyde.
Citronellyl valerate. Ethyl acetoacetate.
66
Ethyl 2-acetyl-3-phenylpropionate; ethyl- Fusel oil, refined (mixed amyl alcohols).
benzyl acetoacetate. Geranyl acetoacetate; trans-3,7-dimethyl-2, 6-
Ethyl aconitate, mixed esters. octadien-1-yl acetoacetate.
Ethyl r-anisate. Geranyl acetone; 6,10-dimethyl-5,9-
Ethyl anthranilate. undecadien-2-one.
Ethyl benzoate. Geranyl benzoate.
Ethyl benzoylacetate. Geranyl butyrate.
a-Ethylbenzyl butyrate; a-phenylpropyl bu- Geranyl formate.
tyrate. Geranyl hexanoate
Ethyl brassylate; tridecanedioic acid cyclic Geranyl isobutyrate.
ethylene glycol diester; cyclo 1,13-ethyl- Geranyl isovalerate.
enedioxytridecan-1,13-dione. Geranyl phenylacetate.
2-Ethylbutyl acetate. Geranyl propionate.
2-Ethylbutyraldehyde. Glucose pentaacetate.
2-Ethylbutyric acid. Guaiacol; μ-methoxyphenol.
Ethyl cinnamate. Guaiacyl acetate; μ-methoxyphenyl acetate.
Ethyl crotonate; trans-2-butenoic acid ethyl- Guaiacyl phenylacetate.
ester. Guaiene; 1,4-dimethyl-7-isopropenyl-D9,10-
Ethyl cyclohexanepropionate. octahydroazulene.
Ethyl decanoate. Guaiol acetate; 1,4-dimethyl-7-(a-hydroxy-
2-Ethylfuran. isopropyl)-d9,10-octahydroazulene acetate.
Ethyl 2-furanpropionate. g-Heptalactone; 4-hydroxyheptanoic acid, g-
4-Ethylguaiacol; 4-ethyl-2-methoxyphenol. lactone.
Ethyl heptanoate. Heptanal; enanthaldehyde.
2-Ethyl-2-heptenal; 2-ethyl-3-butylacrolein. Heptanal dimethyl acetal.
Ethyl hexanoate. Heptanal 1,2-glyceryl acetal.
Ethyl isobutyrate. 2,3-Heptanedione; acetyl valeryl.
Ethyl isovalerate. 3-Heptanol.
Ethyl lactate. 2-Heptanone; methyl amyl ketone.
Ethyl laurate. 3-Heptanone; ethyl butyl ketone.
Ethyl levulinate. 4-Heptanone; dipropyl ketone.
Ethyl maltol; 2-ethyl-3-hydroxy-4H-pyran-4- cis-4-Heptenal; cis-4-hepten-1-al.
one. Heptyl acetate.
Ethyl 2-methylbutyrate. Heptyl alcohol; enanthic alcohol.
Ethyl myristate. Heptyl butyrate.
Ethyl nitrite. Heptyl cinnamate.
Ethyl nonanoate. Heptyl formate.
Ethyl 2-nonynoate; ethyl octyne carbonate. Heptyl isobutyrate.
Ethyl octanoate. Heptyl octanoate.
Ethyl oleate. 1-Hexadecanol; cetyl alcohol.
Ethyl phenylacetate. w-6-Hexadecenlactone; 16-hydroxy-6-
Ethyl 4-phenylbutyrate. hexadecenoic acid, w-lactone;
Ethyl 3-phenylglycidate. ambrettolide.
Ethyl 3-phenylpropionate; ethyl hydro- g-Hexalactone; 4-hydroxyhexanoic acid, g-lac-
cinnamate. tone; tonkalide.
Ethyl propionate. Hexanal; caproic aldehyde.
Ethyl pyruvate. 2,3-Hexanedione; acetyl butyryl.
Ethyl salicylate. Hexanoic acid; caproic acid.
Ethyl sorbate; ethyl 2,4-hexadienoate. 2-Hexenal.
Ethyl tiglate; ethyl trans-2-methyl-2- 2-Hexen-1-ol.
butenoate. 3-Hexen-1-ol; leaf alcohol.
Ethyl undecanoate. 2-Hexen-1-yl acetate.
Ethyl 10-undecenoate. 3-Hexenyl isovalerate.
Ethyl valerate. 3-Hexenyl 2-methylbutyrate.
Eucalyptol; 1,8-epoxy-p-menthane; cineole. 3-Hexenyl phenylacetate; cis-3-hexenyl phen-
Eugenyl acetate. ylacetate.
Eugenyl benzoate. Hexyl acetate.
Eugenyl formate. 2-Hexyl-4-acetoxytetrahydrofuran.
Farnesol; 3,7,11-trimethyl-2,6,10-dodecatrien- Hexyl alcohol.
1-ol. Hexyl butyrate.
d-Fenchone; d-1,3,3-trimethyl-2-nor- a-Hexylcinnamaldehyde.
bornanone. Hexyl formate.
Fenchyl alcohol; 1,3,3-trimethyl-2-nor- Hexyl hexanoate.
bornanol. 2-Hexylidene cyclopentanone.
Formic acid Hexyl isovalerate.

(2-Furyl)-2-propanone; furyl acetone. Hexyl 2-methylbutyrate.
1-Furyl-2-propanone; furyl acetone. Hexyl octanoate.
67
§ 172.515 21 CFR Ch. I (4–1–23 Edition)
Hexyl phenylacetate; n-hexyl phenylacetate. Isobutyl salicylate.
Hexyl propionate. 2-Isobutylthiazole.
Hydroxycitronellal; 3,7-dimethyl-7-hydroxy- Isobutyraldehyde.
octanal. Isobutyric acid.
Hydroxycitronellal diethyl acetal. Isoeugenol; 2-methoxy-4-propenylphenol.
Hydroxycitronellal dimethyl acetal. Isoeugenyl acetate.
Hydroxycitronellol; 3,7-dimethyl-1,7- Isoeugenyl benzyl ether; benzyl isoeugenol.
octanediol. Isoeugenyl ethyl ether; 2-ethoxy-5-propenyl-
N-(4-Hydroxy-3-methoxybenzyl)-nonanamide; anisole; ethyl isoeugenol.
pelargonyl vanillylamide. Isoeugenyl formate.
5-Hydroxy-4-octanone; butyroin. Isoeugenyl methyl ether; 4-propenyl-
4-(p-Hydroxyphenyl)-2-butanone; p-hydroxy- veratrole; methyl isoeugenol.
benzyl acetone. Isoeugenyl phenylacetate.
Indole. Isojasmone; mixture of 2-hexylidenecyclo-
a-Ionone; 4-(2,6,6-trimethyl-2-cyclohexen-1- pentanone and 2-hexyl-2-cyclopenten-1-one.
yl)-3-buten-2-one. a-Isomethylionone; 4-(2,6,6-trimethyl-2-
b-Ionone; 4-(2,6,6-trimethyl-1-cyclohexen-1- cyclohexen-1-yl)-3-methyl-3-buten-2-one;
yl)-3-buten-2-one. methyl g-ionone.
a-Irone; 4-(2,5,6,6-tetramethyl-2-cyclohexene- Isopropyl acetate.
1-yl)-3-buten-2-one; 6-methylionone. r-Isopropylacetophenone.
Isoamyl acetate. Isopropyl alcohol; isopropanol.
Isoamyl acetoacetate. Isopropyl benzoate.
Isoamyl alcohol; isopentyl alcohol; 3-methyl- r-Isopropylbenzyl alcohol; cuminic alcohol;
1-butanol. r-cymen-7-ol.
Isoamyl benzoate. Isopropyl butyrate.
Isoamyl butyrate.
Isopropyl cinnamate.
Isoamyl cinnamate.
Isopropyl formate.
Isoamyl formate.
Isopropyl hexanoate.
Isoamyl 2-furanbutyrate; a-isoamyl furfuryl-
Isopropyl isobutyrate.
propionate.
Isopropyl isovalerate.
Isoamyl 2-furanpropionate; a-isoamyl fur-
furylacetate. r-Isopropylphenylacetaldehyde; r-cymen-7-
Isoamyl hexanoate. carboxaldehyde.
Isoamyl isobutyrate. Isopropyl phenylacetate.
Isoamyl isovalerate. 3-(r-Isopropylphenyl)-propionaldehyde; r-iso-
Isoamyl laurate. propylhydrocinnamaldehyde; cuminyl ac-
Isoamyl-2-methylbutyrate; isopentyl-2- etaldehyde.
methylbutyrate. Isopropyl propionate.
Isoamyl nonanoate. Isopulegol; p-menth-8-en-3-ol.
Isoamyl octanoate. Isopulegone; p-menth-8-en-3-one.
Isoamyl phenylacetate. Isopulegyl acetate.
Isoamyl propionate. Isoquinoline.
Isoamyl pyruvate. Isovaleric acid.
Isoamyl salicylate. cis-Jasmone; 3-methyl-2-(2-pentenyl)-2-cyclo-
Isoborneol. penten-1-one.
Isobornyl acetate. Lauric aldehyde; dodecanal.
Isobornyl formate. Lauryl acetate.
Isobornyl isovalerate. Lauryl alcohol; 1-dodecanol.
Isobornyl propionate. Lepidine; 4-methylquinoline.
Isobutyl acetate. Levulinic acid.
Isobutyl acetoacetate. Linalool oxide; cis- and trans-2-vinyl-2-meth-
Isobutyl alcohol. yl-5-(1′-hydroxy-1′-methylethyl) tetra-
Isobutyl angelate; isobutyl cis-2-methyl-2- hydrofuran.
butenoate. Linalyl anthranilate; 3,7-dimethyl-1,6-
Isobutyl anthranilate. octadien-3-yl anthranilate.
Isobutyl benzoate. Linalyl benzoate.
Isobutyl butyrate. Linalyl butyrate.
Isobutyl cinnamate. Linalyl cinnamate.
Isobutyl formate. Linalyl formate.
Isobutyl 2-furanpropionate. Linalyl hexanoate.
Isobutyl heptanoate. Linalyl isobutyrate.
Isobutyl hexanoate. Linalyl isovalerate.
Isobutyl isobutyrate. Linalyl octanoate.
a-Isobutylphenethyl alcohol; isobutyl benzyl Linalyl propionate.
carbinol; 4-methyl-1-phenyl-2-pentanol. Maltol; 3-hydroxy-2-methyl-4H-pyran-4-one.

Isobutyl phenylacetate. Menthadienol; p-mentha-1,8(10)-dien-9-ol.
Isobutyl propionate. p-Mentha-1,8-dien-7-ol; perillyl alcohol.
68
Menthadienyl acetate; p-mentha-1,8(10)-dien- Methyl 2-hexanoate.
9-yl acetate. Methyl p-hydroxybenzoate; methylparaben.
p-Menth-3-en-1-ol. Methyl a-ionone; 5-(2,6,6-trimethyl-2-cyclo-
1-p-Menthen-–9-yl acetate; p-menth-1-en-9-yl hexen-1-yl)-4-penten-3-one.
acetate. Methyl b-ionone; 5-(2,6,6-trimethyl-1-cyclo-
Menthol; 2-isopropyl-5-methylcyclohexanol. hexen-1-yl)-4-penten-3-one.
Menthone; p-menthan-3-one. Methyl D-ionone; 5-(2,6,6-trimethyl-3-cyclo-
Menthyl acetate; p-menth-3-yl acetate. hexen-1-yl-)-4-penten-3-one.
Menthyl isovalerate; p-menth-3-yl iso- Methyl isobutyrate.
valerate. 2-Methyl-3-(p-isopropylphenyl)-propionalde-
o-Methoxybenzaldehyde. hyde; a-methyl-p-isopropylhydro-
p-Methoxybenzaldehyde; p-anisaldehyde. cinnamaldehyde; cyclamen aldehyde.
o-Methoxycinnamaldehyde. Methyl isovalerate.
2-Methoxy-4-methylphenol; 4-methyl- Methyl laurate.
guaiacol; 2-methoxy-p-cresol. Methyl mercaptan; methanethiol.
4-(p-Methoxyphenyl)-2-butanone; anisyl ace- Methyl o-methoxybenzoate.
tone. Methyl N-methylanthranilate; dimethyl an-
1-(4-Methoxyphenyl)-4-methyl-1-penten-3- thranilate.
one; methoxystyryl isopropyl ketone. Methyl 2-methylbutyrate.
1-(p-Methoxyphenyl)-1-penten-3-one; a- Methyl-3-methylthiopropionate.
methylanisylidene acetone; ethone. Methyl 4-methylvalerate.
1-(p-Methoxyphenyl)-2-propanone; Methyl myristate.
anisylmethyl ketone; anisic ketone. Methyl b-naphthyl ketone; 2′-acetonaph-
2-Methoxy-4-vinylphenol; p-vinylguaiacol. thone.
Methyl acetate. Methyl nonanoate.
4′-Methylacetophenone; p-methylaceto- Methyl 2-nonenoate.
phenone; methyl p-tolyl ketone. Methyl 2-nonynoate; methyloctyne car-
2-Methylallyl butyrate; 2-methyl-2-propenl- bonate.
yl butyrate. 2-Methyloctanal; methyl hexyl acetaldehyde.
Methyl anisate. Methyl octanoate.
o-Methylanisole; o-cresyl methyl ether. Methyl 2-octynoate; methyl heptine car-
p-Methylanisole; p-cresyl methyl ether; p- bonate.
methoxytoluene. 4-Methyl-2,3-pentanedione; acetyl iso-
Methyl benzoate. butyryl.
Methylbenzyl acetate, mixed o-,m-,p-. 4-Methyl-2-pentanone; methyl isobutyl ke-
a-Methylbenzyl acetate; styralyl acetate. tone.
a-Methylbenzyl alcohol; styralyl alcohol. b-Methylphenethyl alcohol; hydratropyl al-
a-Methylbenzyl butyrate; styralyl butyrate. cohol.
a-Methylbenzyl isobutyrate; styralyl iso- Methyl phenylacetate.
butyrate. 3-Methyl-4-phenyl-3-butene-2-one.
a-Methylbenzyl formate; styralyl formate. 2-Methyl-4-phenyl-2-butyl acetate; dimethyl-
a-Methylbenzyl propionate; styralyl propio- phenylethyl carbinyl acetate.
nate. 2-Methyl-4-phenyl-2-butyl isobutyrate;
2-Methyl-3-buten-2-ol. dimethylphenyl ethylcarbinyl isobutyrate.
2-Methylbutyl isovalerate. 3-Methyl-2-phenylbutyraldehyde; a-isopropyl
Methyl p-tert-butylphenylacetate. phenylacetaldehyde.
2-Methylbutyraldehyde; methyl ethyl acetal- Methyl 4-phenylbutyrate.
dehyde. 4-Methyl-1-phenyl-2-pentanone; benzyl iso-
3-Methylbutyraldehyde; isovaleraldehyde. butyl ketone.
Methyl butyrate. Methyl 3-phenylpropionate; methyl hydro-
2-Methylbutyric acid. cinnamate.
a-Methylcinnamaldehyde. Methyl propionate.
p-Methylcinnamaldehyde. 3-Methyl-5-propyl-2-cyclohexen-1-one.
Methyl cinnamate. Methyl sulfide.
2-Methyl-1,3-cyclohexadiene. 3-Methylthiopropionaldehyde; methional.
Methylcyclopentenolone; 3-methylcyclopen- 2-Methyl-3-tolylpropionaldehyde, mixed o-,
tane-1,2-dione. m-, p-.
Methyl disulfide; dimethyl disulfide. 2-Methylundecanal; methyl nonyl acetal-
Methyl ester of rosin, partially hydrogenated dehyde.
(as defined in § 172.615); methyl Methyl 9-undecenoate.
dihydroabietate. Methyl 2-undecynoate; methyl decyne car-
Methyl heptanoate. bonate.
2-Methylheptanoic acid. Methyl valerate.
6-Methyl-3,5-heptadien-2-one. 2-Methylvaleric acid.
Methyl-5-hepten-2-ol. Myristaldehyde; tetradecanal.

6-Methyl-5-hepten-2-one. d-Neomenthol; 2-isopropyl-5-methylcyclo-
Methyl hexanoate. hexanol.
69
§ 172.515 21 CFR Ch. I (4–1–23 Edition)
Nerol; cis-3,7-dimethyl-2,6-octadien-1-ol. Phenethyl isobutyrate.
Nerolidol; 3,7,11-trimethyl-1,6,10-dodecatrien- Phenethyl isovalerate.
3-ol. Phenethyl 2-methylbutyrate.
Neryl acetate. Phenethyl phenylacetate.
Neryl butyrate. Phenethyl propionate.
Neryl formate. Phenethyl salicylate.
Neryl isobutyrate. Phenethyl senecioate; phenethyl 3,3-di-
Neryl isovalerate. methylacrylate.
Neryl propionate. Phenethyl tiglate.
2,6-Nonadien-1-ol. Phenoxyacetic acid.
g-Nonalactone; 4-hydroxynonanoic acid, g- 2-Phenoxyethyl isobutyrate.
lactone; aldehyde C–18. Phenylacetaldehyde; a-toluic aldehyde.
Nonanal; pelargonic aldehyde. Phenylacetaldehyde 2,3-butylene glycol ace-
1,3-Nonanediol acetate, mixed esters. tal.
Nonanoic acid; pelargonic acid. Phenylacetaldehyde dimethyl acetal.
2-Nonanone; methylheptyl ketone. Phenylacetaldehyde glyceryl acetal.
3-Nonanon-1-yl acetate; 1-hydroxy-3- Phenylacetic acid; a-toluic acid.
nonanone acetate. 4-Phenyl-2-butanol; phenylethyl methyl car-
Nonyl acetate. binol.
Nonyl alcohol; 1-nonanol. 4-Phenyl-3-buten-2-ol; methyl styryl car-
Nonyl octanoate. binol.
Nonyl isovalerate. 4-Phenyl-3-buten-2-one.
Nootkatone; 5,6-dimethyl-8-isopropenyl- 4-Phenyl-2-butyl acetate; phenylethyl meth-
bicyclo[4,4,0]-dec-1-en-3-one. yl carbinyl acetate.
Ocimene; trans-b-ocimene; 3,7-dimethyl-1,3,6- 1-Phenyl-3-methyl-3-pentanol; phenylethyl
octatriene. methyl ethyl carbinol.
g-Octalactone; 4-hydroxyoctanoic acid, g-lac- 1-Phenyl-1-propanol; phenylethyl carbinol.
tone. 3-Phenyl-1-propanol; hydrocinnamyl alcohol.
Octanal; caprylaldehyde. 2-Phenylpropionaldehyde; hydratropalde-
Octanal dimethyl acetal. hyde.
1-Octanol; octyl alcohol. 3-Phenylpropionaldehyde; hydrocinnamal-
2-Octanol. dehyde.
3-Octanol. 2-Phenylpropionalde-hyde dimethyl acetal;
2-Octanone; methyl hexyl ketone. hydratropic aldehyde dimethyl acetal.
3-Octanone; ethyl amyl ketone. 3-Phenylpropionic acid; hydrocinnamic acid.
3-Octanon-1-ol. 3-Phenylpropyl acetate.
1-Octen-3-ol; amyl vinyl carbinol. 2-Phenylpropyl butyrate.
1-Octen-3-yl acetate. 3-Phenylpropyl cinnamate.
Octyl acetate. 3-Phenylpropyl formate.
3-Octyl acetate. 3-Phenylpropyl hexanoate.
Octyl butyrate. 2-Phenylpropyl isobutyrate.
Octyl formate. 3-Phenylpropyl isobutyrate.
Octyl heptanoate. 3-Phenylpropyl isovalerate.
Octyl isobutyrate. 3-Phenylpropyl propionate.
Octyl isovalerate. 2-(3-Phenylpropyl)-tetrahydrofuran.
Octyl octanoate. a-Pinene; 2-pinene.
Octyl phenylacetate. b-Pinene; 2(10)-pinene.
Octyl propionate. Pine tar oil.
w-Pentadecalactone; 15-hydroxypentadeca- Pinocarveol; 2(10)-pinen-3-ol.
noic acid, w-lactone; pentadecanolide; an- Piperidine.
gelica lactone. Piperine.
2,3-Pentanedione; acetyl propionyl. d-Piperitone; p-menth-1-en-3-one.
2-Pentanone; methyl propyl ketone. Piperitenone; p-mentha-1,4(8)-dien-3-one.
4-Pentenoic acid. Piperitenone oxide; 1,2-epoxy-p-menth-4-(8)-
1-Penten-3-ol. en-3-one.
Perillaldehyde; 4-isopropenyl-1-cyclohexene- Piperonyl acetate; heliotropyl acetate.
1-carboxaldehyde;p-mentha-1,8-dien-7-al. Piperonyl isobutyrate.
Perillyl acetate; p-mentha-1,8-dien-7-yl ace- Polylimonene.
tate. Polysorbate 20; polyoxyethylene (20) sorbitan
a-Phellandrene; r-mentha-1,5-diene. monolaurate.
Phenethyl acetate. Polysorbate 60; polyoxyethylene (20) sorbitan
Phenethyl alcohol; b-phenylethyl alcohol. monostereate.
Phenethyl anthranilate. Polysorbate 80; polyoxyethylene (20) sorbitan
Phenethyl benzoate. monooleate.
Phenethyl butyrate. Potassium acetate.

Phenethyl cinnamate. Propenylguaethol; 6-ethoxy-m-anol.
Phenethyl formate. Propionaldehyde.
70
Propyl acetate. p-Tolylacetaldehyde.
Propyl alcohol; 1-propanol. o-Tolyl acetate; o-cresyl acetate.
p-Propyl anisole; dihydroanethole. p-Tolyl acetate; p-cresyl acetate.
Propyl benzoate. 4-(p-Tolyl)-2-butanone; p-methylbenzylace-
Propyl butyrate. tone.
Propyl cinnamate. p-Tolyl isobutyrate.
Propyl disulfide. p-Tolyl laurate.
Propyl formate. p-Tolyl phenylacetate.
Propyl 2-furanacrylate. 2-(p-Tolyl)-propionaldehyde; p-methylhydra-
Propyl heptanoate. tropic aldehyde.
Propyl hexanoate. Tributyl acetylcitrate.
Propyl p-hydroxybenzoate; propylparaben. 2-Tridecenal.
3-Propylidenephthalide. 2,3-Undecadione; acetyl nonyryl.
Propyl isobutyrate. g-Undecalactone; 4-hydroxyundecanoic acid
Propyl isovalerate. g-lactone; peach aldehyde; aldehyde C–14.
Propyl mercaptan. Undecenal.
a-Propylphenethyl alcohol. 2-Undecanone; methyl nonyl ketone.
Propyl phenylacetate. 9-Undecenal; undecenoic aldehyde.
Propyl propionate. 10-Undecenal.
Pyroligneous acid extract. Undecen-1-ol; undecylenic alcohol.
Pyruvaldehyde. 10-Undecen-1-yl acetate.
Pyruvic acid. Undecyl alcohol.
Rhodinol; 3,7-dimethyl-7-octen-1-ol; l- Valeraldehyde; pentanal.
citronellol. Valeric acid; pentanoic acid.
Rhodinyl acetate. Vanillin acetate; acetyl vanillin.
Rhodinyl butyrate. Veratraldehyde.
Rhodinyl formate. Verbenol; 2-pinen-4-ol.
Rhodinyl isobutyrate. Zingerone; 4-(4-hydroxy-3-methoxyphenyl)-2-
Rhodinyl isovalerate. butanone.
Rhodinyl phenylacetate. (c) D-Decalactone and D-
Rhodinyl propionate. dodecalactone when used separately or
Rum ether; ethyl oxyhydrate.
Salicylaldehyde.
in combination in oleomargarine are
Santalol, a and b. used at levels not to exceed 10 parts per
Santalyl acetate. million and 20 parts per million, re-
Santalyl phenylacetate. spectively, in accordance with § 166.110
Skatole. of this chapter.
Sorbitan monostearate. (d) BHA (butylated hydroxyanisole)
Sucrose octaacetate. may be used as an antioxidant in fla-
a-Terpinene. voring substances whereby the additive
g-Terpinene.
a-Terpineol; p-menth-1-en-8-ol.
does not exceed 0.5 percent of the es-
b-Terpineol. sential (volatile) oil content of the fla-
Terpinolene; p-menth-1,4(8)-diene. voring substance.
Terpinyl acetate. [42 FR 14491, Mar. 15, 1977, as amended at 42
Terpinyl anthranilate. FR 23148, May 6, 1977; 43 FR 19843, May 9,
Terpinyl butyrate. 1978; 45 FR 22915, Apr. 4, 1980; 47 FR 27810,
Terpinyl cinnamate. June 25, 1982; 48 FR 10812, Mar. 15, 1983; 48 FR
Terpinyl formate. 51907, Nov. 15, 1983; 49 FR 5747, Feb. 15, 1984;
Terpinyl isobutyrate. 50 FR 42932, Oct. 23, 1985; 54 FR 7402, Feb. 21,
Terpinyl isovalerate. 1989; 61 FR 14245, Apr. 1, 1996; 69 FR 24511,
Terpinyl propionate. May 4, 2004; 83 FR 50490, 50503, Oct. 9, 2018]
Tetrahydrofurfuryl acetate.
Tetrahydrofurfuryl alcohol. § 172.520 Cocoa with dioctyl sodium
Tetrahydrofurfuryl butyrate. sulfosuccinate for manufacturing.
Tetrahydrofurfuryl propionate.
Tetrahydro-pseudo-ionone; 6,10-dimethyl-9- The food additive ‘‘cocoa with dioctyl
undecen-2-one. sodium sulfosuccinate for manufac-
Tetrahydrolinalool; 3,7-dimethyloctan-3-ol. turing,’’ conforming to § 163.117 of this
Tetramethyl ethylcyclohexenone; mixture of chapter and § 172.810, is used or in-
5-ethyl-2,3,4,5-tetramethyl-2-cyclohexen-1- tended for use as a flavoring substance
one and 5-ethyl-3,4,5,6-tetramethyl-2-cyclo-
in dry beverage mixes whereby the
hexen-1-one.
2-Thienyl mercaptan; 2-thienylthiol. amount of dioctyl sodium sulfo-
Thymol. succinate does not exceed 75 parts per

Tolualdehyde glyceryl acetal, mixed o, m, p. million of the finished beverage. The
Tolualdehydes, mixed o, m, p. labeling of the dry beverage mix shall
71
§ 172.530 21 CFR Ch. I (4–1–23 Edition)
bear adequate directions to assure use sorbance is obtained by approximately

in compliance with this section. 0.03 milligram solids permilliliter.) The
ultraviolet absorption spectrum of this
§ 172.530 Disodium guanylate. solution exhibits the following charac-
Disodium guanylate may be safely teristics: An absorption peak at 253
used as a flavor enhancer in foods, at a millimicrons; no absorption peak at 325
level not in excess of that reasonably to 330 millimicrons; the absorbance at
required to produce the intended effect. 268 millimicrons does not exceed the
absorbance at 272 millimicrons.
§ 172.535 Disodium inosinate. (ii) The boron content of the food ad-
The food additive disodium inosinate ditive does not exceed 310 parts per
may be safely used in food in accord- million (0.0310 percent), calculated as
ance with the following prescribed con- boron.
ditions: (2) The additive is manufactured
(a) The food additive is the disodium from hops by a sequence of extractions
salt of inosinic acid, manufactured and and fractionations, using benzene, light
purified so as to contain no more than petroleum spirits, and methyl alcohol
150 parts per million of soluble barium as solvents, followed by isomerization
in the compound disodium inosinate by potassium carbonate treatment.
with seven and one-half molecules of Residues of solvents in the modified
water of crystallization. hop extract shall not exceed 1.0 part
(b) The food additive is used as a fla- per million of benzene, 1.0 part per mil-
voring adjuvant in food. lion of light petroleum spirits, and 250
parts per million of methyl alcohol.
§ 172.540 DL-Alanine. The light petroleum spirits and ben-
DL-Alanine (a racemic mixture of D- zene solvents shall comply with the
and L-alanine; CAS Reg. No. 302–72–7) specifications in § 172.250 except that
may be safely used as a flavor enhancer the boiling point range for light petro-
for sweeteners in pickling mixtures at leum spirits is 150 °F–300 °F.
a level not to exceed 1 percent of the (3) The additive is manufactured
pickling spice that is added to the from hops by a sequence of extractions
pickling brine. and fractionations, using methylene
chloride, hexane, and methyl alcohol as
[56 FR 6968, Feb. 21, 1991] solvents, followed by isomerization by
sodium hydroxide treatment. Residues
§ 172.560 Modified hop extract. of the solvents in the modified hop ex-
The food additive modified hop extract shall not exceed 5 parts per mil-
tract may be safely used in beer in ac- lion of methylene chloride, 25 parts per
cordance with the following prescribed million of hexane, and 100 parts per
conditions: million of methyl alcohol.
(a) The food additive is used or in- (4) The additive is manufactured
tended for use as a flavoring agent in from hops by a sequence of extractions
the brewing of beer. and fractionations, using benzene, light
(b) The food additive is manufactured petroleum spirits, methyl alcohol, n-
by one of the following processes: butyl alcohol, and ethyl acetate as sol-
(1) The additive is manufactured vents, followed by isomerization by po-
from a hexane extract of hops by si- tassium carbonate treatment. Residues
multaneous isomerization and selec- of solvents in the modified hop extract
tive reduction in an alkaline aqueous shall not exceed 1.0 part per million of
medium with sodium borohydride, benzene, 1.0 part per million of light
whereby the additive meets the fol- petroleum spirits, 50 parts per million
lowing specifications: of methyl alcohol, 50 parts per million
(i) A solution of the food additive sol- of n-butyl alcohol, and 1 part per mil-
ids is made up in approximately 0.012 n lion of ethyl acetate. The light petro-
alkaline methyl alcohol (6 milliliters leum spirits and benzene solvents shall
of 1 n sodium hydroxide diluted to 500 comply with the specifications in
milliliters with methyl alcohol) to § 172.250 except that the boiling point
show an absorbance at 253 millimicrons range for light petroleum spirits is 150
of 0.6 to 0.9 per centimeter. (This ab- °F to 300 °F.
72
(5) The additive is manufactured volatile hop resin by an initial extrac-

from hops by an initial extraction and tion and fractionation using one or
fractionation using one or more of the more of the solvents listed in para-
following solvents: Ethylene dichlo- graph (b)(5) of this section followed by
ride, hexane, isopropyl alcohol, methyl a sequence of aqueous extractions and
alcohol, methylene chloride, trichloro- removal of nonaqueous solvents to less
ethylene, and water; followed by than 0.5 percent. The additive is added
isomerization by calcium chloride or to the wort before or during cooking in
magnesium chloride treatment in the manufacture of beer.
ethylene dichloride, methylene chlo-
ride, or trichloroethylene and a further § 172.575 Quinine.
sequence of extractions and fraction- Quinine, as the hydrochloride salt or
ations using one or more of the sol- sulfate salt, may be safely used in food
vents set forth in this paragraph. Resi- in accordance with the following condi-
dues of the solvents in the modified tions:
hop extract shall not exceed 125 parts
per million of hexane; 150 parts per mil- Uses Limitations
lion of ethylene dichloride, methylene In carbonated bev- Not to exceed 83 parts per million, as
chloride, or trichloroethylene; or 250 erages as a flavor. quinine. Label shall bear a promi-
parts per million of isopropyl alcohol nent declaration of the presence of
or methyl alcohol. quinine either by the use of the
word ‘‘quinine’’ in the name of the
(6) The additive is manufactured article or through a separate dec-
from hops by an initial extraction and laration.
fractionation using one or more of the
solvents listed in paragraph (b)(5) of § 172.580 Safrole-free extract of sas-
this section followed by: Hydro- safras.
genation using palladium as a catalyst
in methyl alcohol, ethyl alcohol, or The food additive safrole-free extract
isopropyl alcohol acidified with hydro- of sassafras may be safely used in ac-
chloric or sulfuric acid; oxidation with cordance with the following prescribed
peracetic acid; isomerization by cal- conditions:
cium chloride or magnesium chloride (a) The additive is the aqueous ex-
treatment in ethylene dichloride, tract obtained from the root bark of
methylene chloride, or trichloro- the plant Sassafras albidum (Nuttall)
ethylene (alternatively, the hydro- Nees (Fam. Lauraceae).
genation and isomerization steps may (b) It is obtained by extracting the
be performed in reverse order); and a bark with dilute alcohol, first concen-
further sequence of extractions and trating the alcoholic solution by vacu-
fractionations using one or more of the um distillation, then diluting the con-
solvents listed in paragraph (b)(5) of centrate with water and discarding the
this section. The additive shall meet oily fraction.
the residue limitations as prescribed in (c) The purified aqueous extract is
paragraph (b)(5) of this section. safrole-free.
(7) The additive is manufactured (d) It is used as a flavoring in food.
from hops as set forth in paragraph
(b)(6) of this section followed by reduc- § 172.585 Sugar beet extract flavor
base.
tion with sodium borohydride in aque-
ous alkaline methyl alcohol, and a se- Sugar beet extract flavor base may
quence of extractions and fraction- be safely used in food in accordance
ations using one or more of the sol- with the provisions of this section.
vents listed in paragraph (b)(5) of this (a) Sugar beet extract flavor base is
section. The additive shall meet the the concentrated residue of soluble
residue limitations as prescribed in sugar beet extractives from which
paragraph (b)(5) of this section, and a sugar and glutamic acid have been re-
boron content level not in excess of 300 covered, and which has been subjected
parts per million (0.0300 percent), cal- to ion exchange to minimize the con-
culated as boron. centration of naturally occurring trace

(8) The additive is manufactured minerals.
from hops as a nonisomerizable non- (b) It is used as a flavor in food.
73
§ 172.590 21 CFR Ch. I (4–1–23 Edition)
§ 172.590 Yeast-malt sprout extract. (a) Arabinogalactan is a poly-

Yeast-malt sprout extract, as de- saccharide extracted by water from
scribed in this section, may be safely Western larch wood, having galactose
used in food in accordance with the fol- units and arabinose units in the ap-
lowing prescribed conditions: proximate ratio of six to one.
(a) The additive is produced by par- (b) It is used in the following foods in
tial hydrolysis of yeast extract (de- the minimum quantity required to
rived from Saccharomyces cereviseae, produce its intended effect as an emul-
Saccharomyces fragilis, or Candida utilis) sifier, stabilizer, binder, or bodying
using the sprout portion of malt barley agent: Essential oils, nonnutritive
as the source of enzymes. The additive sweeteners, flavor bases, nonstandard-
contains a maximum of 6 percent 5′ nu- ized dressings, and pudding mixes.
cleotides by weight.
(b) The additive may be used as a fla- § 172.615 Chewing gum base.
vor enhancer in food at a level not in The food additive chewing gum base
excess of that reasonably required to may be safely used in the manufacture
produce the intended effect. of chewing gum in accordance with the
following prescribed conditions:
Subpart G—Gums, Chewing Gum (a) The food additive consists of one
Bases and Related Substances or more of the following substances
that meet the specifications and limi-
§ 172.610 Arabinogalactan. tations prescribed in this paragraph,
Arabinogalactan may be safely used used in amounts not to exceed those re-
in food in accordance with the fol- quired to produce the intended physical
lowing conditions: or other technical effect.
MASTICATORY SUBSTANCES
NATURAL (COAGULATED OR CONCENTRATED LATICES) OF VEGETABLE ORIGIN
Family Genus and species
Sapotaceae:
Chicle ............................................................ Manilkara zapotilla Gilly and Manilkara chicle Gilly.
Chiquibul ....................................................... Manilkara zapotilla Gilly.
Crown gum .................................................... Manilkara zapotilla Gilly and Manilkara chicle Gilly.
Gutta hang kang ........................................... Palaquium leiocarpum Boerl. and Palaquium oblongifolium Burck.
Massaranduba balata (and the solvent-free Manilkara huberi (Ducke) Chevalier.
resin extract of Massaranduba balata).
Massaranduba chocolate .............................. Manilkara solimoesensis Gilly.
Nispero .......................................................... Manilkara zapotilla Gilly and Manilkara chicle Gilly.
Rosidinha (rosadinha) ................................... Micropholis (also known as Sideroxylon) spp.
Venezuelan chicle ......................................... Manilkara williamsii Standley and related spp.
Apocynaceae:
Jelutong ......................................................... Dyera costulata Hook, F. and Dyera lowii Hook, F.
Leche caspi (sorva) ...................................... Couma macrocarpa Barb. Rodr.
Pendare ......................................................... Couma macrocarpa Barb. Rodr. and Couma utilis (Mart.) Muell. Arg.
Perillo ............................................................ Couma macrocarpa Barb. Rodr. and Couma utilis (Mart.) Muell. Arg.
Moraceae:
Leche de vaca .............................................. Brosimum utile (H.B.K.) Pittier and Poulsenia spp.; also Lacmellea standleyi
(Woodson), Monachino (Apocynaceae).
Niger gutta .................................................... Ficus platyphylla Del.
Tunu (tuno) ................................................... Castilla fallax Cook.
Euphorbiaceae:
Chilte ............................................................. Cnidoscolus (also known as Jatropha) elasticus Lundell and Cnidoscolus
tepiquensis (Cost. and Gall.) McVaugh.
Natural rubber (smoked sheet and latex sol- Hevea brasiliensis.
ids).
Synthetic Specifications
Butadiene-styrene rubber .............................. Basic polymer.

Isobutylene-isoprene copolymer (butyl rub- Do.

ber).
74
MASTICATORY SUBSTANCES—Continued
NATURAL (COAGULATED OR CONCENTRATED LATICES) OF VEGETABLE ORIGIN
Family Genus and species
Paraffin ................................................................. Synthesized by Fischer-Tropsch process from carbon monoxide and hydro-
gen which are catalytically converted to a mixture of paraffin hydrocarbon.
Lower molecular weight fractions are removed by distillation. The residue is
hydrogenated and further treated by percolation through activated charcoal.
The product has a congealing point of 93°–99 °C as determined by ASTM
method D938–71 (Reapproved 1981), ‘‘Standard Test Method for Con-
gealing Point of Petroleum Waxes, Including Petrolatum,’’ a maximum oil
content of 0.5 percent as determined by ASTM method D721–56T, ‘‘Ten-
tative Method of Test for Oil Content of Petroleum Waxes,’’ and an absorp-
tivity of less than 0.01 at 290 millimicrons in decahydronaphthalene at 88
°C as determined by ASTM method D2008–80, ‘‘Standard Test Method for
Ultraviolet Absorbance and Absorptivity of Petroleum Products,’’ which are
incorporated by reference. Copies may be obtained from the American So-
ciety for Testing Materials, 100 Barr Harbor Dr., West Conshohocken,
Philadelphia, PA 19428-2959, or may be examined at the National Ar-
chives and Records Administration (NARA). For information on the avail-
ability of this material at NARA, call 202–741–6030, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.
Petroleum wax .............................................. Complying with § 172.886.
Petroleum wax synthetic ............................... Complying with § 172.888.
Polyethylene .................................................. Molecular weight 2,000–21,000.
Polyisobutylene ............................................. Minimum molecular weight 37,000 (Flory).
Polyvinyl acetate ........................................... Molecular weight, minimum 2,000.
PLASTICIZING MATERIALS (SOFTENERS)
Glycerol ester of partially dimerized rosin ........... Having an acid number of 3–8, a minimum drop-softening point of 109 °C,
and a color of M or paler.
Glycerol ester of partially hydrogenated gum or Having an acid number of 3–10, a minimum drop-softening point of 79 °C,
wood rosin. and a color of N or paler.
Glycerol ester of polymerized rosin ..................... Having an acid number of 3–12, a minimum melting-point of 80 °C, and a
color of M or paler.
Glycerol ester of gum rosin .................................. Having an acid number of 5–9, a minimum drop-softening point of 88 °C, and
a color of N or paler. The ester is purified by steam stripping.
Glycerol ester of tall oil rosin ............................... Having an acid number of 2–12, a softening point (ring and ball) of 80°–88
°C, and a color of N or paler. The ester is purified by steam stripping.
Glycerol ester of wood rosin ................................ Having an acid number of 3–9, a drop-softening point of 88 °C–96 °C, and a
color of N or paler. The ester is purified by steam stripping.
Lanolin ..................................................................
Methyl ester of rosin, partially hydrogenated ....... Having an acid number of 4–8, a refractive index of 1.5170–1.5205 at 20 °C,
and a viscosity of 23–66 poises at 25 °C. The ester is purified by steam
stripping.
Pentaerythritol ester of partially hydrogenated Having an acid number of 7–18, a minimum drop-softening point of 102 °C,
gum or wood rosin. and a color of K or paler.
Pentaerythritol ester of gum or wood rosin ......... Having an acid number of 6–16, a minimum drop-softening point of 109 °C,
and a color of M or paler.
Rice bran wax ...................................................... Complying with § 172.890.
Stearic acid .......................................................... Complying with § 172.860.
Sodium and potassium stearates ........................ Complying with § 172.863.
TERPENE RESINS
Synthetic resin ...................................................... Consisting of polymers of apinene, bpinene, and/or dipentene; acid value
less than 5, saponification number less than 5, and color less than 4 on the
Gardner scale as measured in 50 percent mineral spirit solution.
Natural resin ......................................................... Consisting of polymers of a-pinene; softening point minimum 155 °C, deter-
mined by U.S.P. closed-capillary method, United States Pharmacopeia XX
(1980) (page 961).
ANTIOXIDANTS
Butylated hydroxyanisole ..................................... Not to exceed antioxidant content of 0.1% when used alone or in any com-
bination.
Butylated hydroxytoluene ..................................... Do.
Propyl gallate ....................................................... Do.
MISCELLANEOUS
Sodium sulfate .....................................................

Sodium sulfide ...................................................... Reaction-control agent in synthetic polymer production.
75
§ 172.620 21 CFR Ch. I (4–1–23 Edition)
(b) In addition to the substances list- § 172.623 Carrageenan with poly-

ed in paragraph (a) of this section, sorbate 80.
chewing gum base may also include Carrageenan otherwise meeting the
substances generally recognized as safe definition and specifications of § 172.620
in food. (a) and (b) and salts of carrageenan
(c) To assure safe use of the additive, otherwise meeting the definition of
in addition to the other information re- § 172.626(a) may be safely produced with
quired by the act, the label and label- the use of polysorbate 80 meeting the
ing of the food additive shall bear the specifications and requirements of
name of the additive, ‘‘chewing gum § 172.840 (a) and (b) in accordance with
base.’’ As used in this paragraph, the the following prescribed conditions:
term ‘‘chewing gum base’’ means the
(a) The polysorbate 80 is used only to
manufactured or partially manufac-
facilitate separation of sheeted carra-
tured nonnutritive masticatory sub-
geenan and salts of carrageenan from
stance comprised of one or more of the
drying rolls.
ingredients named and so defined in
(b) The carrageenan and salts of car-
paragraph (a) of this section.
rageenan contain not more than 5 per-
[42 FR 14491, Mar. 15, 1977, as amended at 45 cent by weight of polysorbate 80, and
FR 56051, Aug. 22, 1980; 49 FR 5747, Feb. 15, the final food containing the additives
1984; 49 FR 10105, Mar. 19, 1984; 66 FR 38153, contains polysorbate 80 in an amount
July 23, 2001; 66 FR 53711, Oct. 24, 2001]
not to exceed 500 parts per million.
§ 172.620 Carrageenan. (c) The carrageenan and salts of car-
rageenan so produced are used only in
The food additive carrageenan may producing foods in gel form and only
be safely used in food in accordance for the purposes defined in §§ 172.620(c)
with the following prescribed condi- and 172.626(b), respectively.
tions:
(d) The carrageenan and salts of car-
(a) The food additive is the refined
rageenan so produced are not used in
hydrocolloid prepared by aqueous ex-
foods for which standards of identity
traction from the following members of
exist unless the standards provide for
the families Gigartinaceae and Solier-
the use of carrageenan, or salts of car-
iaceae of the class Rodophyceae (red
rageenan, combined with polysorbate
seaweed):
80.
Chondrus crispus. (e) The carrageenan and salts of car-
Chondrus ocellatus. rageenan produced in accordance with
Eucheuma cottonii.
this section, and foods containing the
Eucheuma spinosum.
Gigartina acicularis. same, in addition to the other require-
Gigartina pistillata. ments of the Act, are labeled to show
Gigartina radula. the presence of polysorbate 80, and the
Gigartina stellata. label or labeling of the carrageenan
(b) The food additive conforms to the and salts of carrageenan so produced
following conditions: bear adequate directions for use.
(1) It is a sulfated polysaccharide the
§ 172.626 Salts of carrageenan.
dominant hexose units of which are ga-
lactose and anhydrogalactose. The food additive salts of carra-
(2) Range of sulfate content: 20 per- geenan may be safely used in food in
cent to 40 percent on a dry-weight accordance with the following pre-
basis. scribed conditions:
(c) The food additive is used or in- (a) The food additive consists of car-
tended for use in the amount necessary rageenan, meeting the provisions of
for an emulsifier, stabilizer, or thick- § 172.620, modified by increasing the
ener in foods, except for those stand- concentration of one of the naturally
ardized foods that do not provide for occurring salts (ammonium, calcium,
such use. potassium, or sodium) of carrageenan
(d) To assure safe use of the additive, to the level that it is the dominant salt
the label and labeling of the additive in the additive.

shall bear the name of the additive, (b) The food additive is used or in-
carrageenan. tended for use in the amount necessary
76
for an emulsifier, stabilizer, or thick- (c) To assure safe use of the additive,
ener in foods, except for those stand- the label and labeling of the additive
ardized foods that do not provide for shall bear the name of the salt of fur-
such use. celleran that dominates the mixture by
(c) To assure safe use of the additive, reason of the modification, e.g., ‘‘so-
the label and labeling of the additive dium furcelleran’’, ‘‘potassium furcel-
shall bear the name of the salt of car- leran’’, etc.
rageenan that dominates the mixture
by reason of the modification, e.g., § 172.665 Gellan gum.
‘‘sodium carrageenan’’, ‘‘potassium The food additive gellan gum may be
carrageenan’’, etc. safely used in food in accordance with
the following prescribed conditions:
§ 172.655 Furcelleran. (a) The additive is a high molecular
The food additive furcelleran may be weight polysaccharide gum produced
safely used in food in accordance with from Pseudomonas elodea by a pure cul-
the following prescribed conditions: ture fermentation process and purified
(a) The food additive is the refined by recovery with isopropyl alcohol. It
hydrocolloid prepared by aqueous ex- is composed of tetrasaccharide repeat
traction of furcellaria fastigiata of the units, each containing one molecule of
class Rodophyceae (red seaweed). rhamnose and glucuronic acid, and two
(b) The food additive conforms to the molecules of glucose. The glucuronic
following: acid is neutralized to a mixed potas-
(1) It is a sulfated polysaccharide the sium, sodium, calcium, and magnesium
dominant hexose units of which are ga- salt. The polysaccharide may contain
lactose and anhydrogalactose. acyl (glyceryl and acetyl) groups as the
O-glycosidically linked esters.
(2) Range of sulfate content: 8 per-
(b) The strain of P. elodea is non-
cent to 19 percent, on a dry-weight
pathogenic and nontoxic in man and
basis.
animals.
(c) The food additive is used or in- (c) The additive is produced by a
tended for use in the amount necessary process that renders it free of viable
for an emulsifier, stabilizer, or thick- cells of P. elodea.
ener in foods, except for those stand- (d) The additive meets the following
ardized foods that do not provide for specifications:
such use. (1) Positive for gellan gum when sub-
(d) To assure safe use of the additive, jected to the following identification
the label and labeling of the additive tests:
shall bear the name of the additive, (i) A 1-percent solution is made by
furcelleran. hydrating 1 gram of gellan gum in 99
milliliters of distilled water. The mix-
§ 172.660 Salts of furcelleran.
ture is stirred for about 2 hours, using
The food additive salts of furcelleran a motorized stirrer and a propeller-
may be safely used in food in accord- type stirring blade. A small amount of
ance with the following prescribed con- the above solution is drawn into a wide
ditions: bore pipet and transferred into a solu-
(a) The food additive consists of fur- tion of 10-percent calcium chloride. A
celleran, meeting the provisions of tough worm-like gel will form in-
§ 172.655, modified by increasing the stantly.
concentration of one of the naturally (ii) To the 1-percent distilled water
occurring salts (ammonium, calcium, solution prepared for identification
potassium, or sodium) of furcelleran to test (i), 0.50 gram of sodium chloride is
the level that it is the dominant salt in added. The solution is heated to 80 °C
the additive. with stirring, held at 80 °C for 1
(b) The food additive is used or in- minute, and allowed to cool to room
tended for use in the amount necessary temperature without stirring. A firm
for an emulsifier, stabilizer, or thick- gel will form.
ener in foods, except for those stand- (2) Residual isopropyl alcohol (IPA)
ardized foods that do not provide for not to exceed 0.075 percent as deter-
such use. mined by the procedure described in
77
§ 172.695 21 CFR Ch. I (4–1–23 Edition)
the ‘‘Gellan gum’’ monograph in the is manufactured as the sodium, potas-

Food Chemicals Codex, 7th ed. (2010), sium, or calcium salt.
pp. 425–426, which is incorporated by (b) The strain of Xanthomonas
reference. The Director of the Office of campestris is nonpathogenic and
the Federal Register approves this in- nontoxic in man or other animals.
corporation by reference in accordance (c) The additive is produced by a
with 5 U.S.C. 552(a) and 1 CFR part 51. process that renders it free of viable
You may obtain copies from the United cells of Xanthomonas campestris.
States Pharmacopeial Convention, (d) The additive meets the following
12601 Twinbrook Pkwy., Rockville, MD specifications:
20852 (Internet address http:// (1) Residual isopropyl alcohol not to
www.usp.org). Copies may be examined exceed 750 parts per million.
at the Dockets Management Staff (2) An aqueous solution containing 1
(HFA–305), Food and Drug Administra- percent of the additive and 1 percent of
tion, 5630 Fishers Lane, Rm. 1061, Rock- potassium chloride stirred for 2 hours
ville, MD 20852, 240–402–7500, between 9 has a minimum viscosity of 600 centi-
a.m. and 4 p.m., Monday through Fri- poises at 75 °F, as determined by
day, or at the National Archives and Brookfield Viscometer, Model LVF (or
Records Administration (NARA). For equivalent), using a No. 3 spindle at 60
information on the availability of this r.p.m., and the ratio of viscosities at 75
material at NARA, call 202–741–6030 or °F and 150 °F is in the range of 1.02 to
go to: http://www.archives.gov/federal- 1.45.
register/cfr/ibr-locations.html. (3) Positive for xanthan gum when
(e) The additive is used or intended subjected to the following procedure:
for use in accordance with current good
manufacturing practice as a stabilizer LOCUST BEAN GUM GEL TEST
and thickener as defined in § 170.3(o)(28) Blend on a weighing paper or in a weighing
of this chapter. The additive may be pan 1.0 gram of powdered locust bean gum
used in foods where standards of iden- with 1.0 gram of the powdered polysaccharide
tity established under section 401 of to be tested. Add the blend slowly (approxi-
the Federal Food, Drug, and Cosmetic mately 1⁄2 minute) at the point of maximum
Act do not preclude such use. agitation to a stirred solution of 200 milli-
liters of distilled water previously heated to
(f) To assure safe use of the additive:
80 °C in a 400-milliliter beaker. Continue me-
(1) The label of its container shall chanical stirring until the mixture is in solu-
bear, in addition to other information tion, but stir for a minimum time of 30 min-
required by the Federal Food, Drug, utes. Do not allow the water temperature to
and Cosmetic Act, the name of the ad- drop below 60 °C.
ditive and the designation ‘‘food Set the beaker and its contents aside to
grade’’. cool in the absence of agitation. Allow a
(2) The label or labeling of the food minimum time of 2 hours for cooling. Exam-
additive container shall bear adequate ine the cooled beaker contents for a firm
rubbery gel formation after the temperature
directions for use. drops below 40 °C.
[55 FR 39614, Sept. 28, 1990, as amended at 57 In the event that a gel is obtained, make
FR 55445, Nov. 25, 1992; 64 FR 1758, Jan. 12, up a 1 percent solution of the polysaccharide
1999; 78 FR 71463, Nov. 29, 2013; 88 FR 17719, to be tested in 200 milliliters of distilled
Mar. 24, 2023] water previously heated to 80 °C (omit the lo-
cust bean gum). Allow the solution to cool
§ 172.695 Xanthan gum. without agitation as before. Formation of a
gel on cooling indicates that the sample is a
The food additive xanthan gum may gelling polysaccharide and not xanthan gum.
be safely used in food in accordance Record the sample as ‘‘positive’’ for xan-
with the following prescribed condi- than gum if a firm, rubbery gel forms in the
tions: presence of locust bean gum but not in its
(a) The additive is a polysaccharide absence. Record the sample as ‘‘negative’’ for
gum derived from Xanthomonas xanthan gum if no gel forms or if a soft or
campestris by a pure-culture fermenta- brittle gel forms both with locust bean gum
tion process and purified by recovery and in a 1 percent solution of the sample
(containing no locust bean gum).
with isopropyl alcohol. It contains D-

glucose, D-mannose, and D-glucuronic (4) Positive for xanthan gum when
acid as the dominant hexose units and subjected to the following procedure:
78
PYRUVIC ACID TEST Subpart H—Other Specific Usage
Pipet 10 milliliters of an 0.6 percent solu- Additives
tion of the polysaccharide in distilled water
(60 milligrams of water-soluble gum) into a § 172.710 Adjuvants for pesticide use
50-milliliter flask equipped with a standard dilutions.
taper glass joint. Pipet in 20 milliliters of 1N The following surfactants and related
hydrochloric acid. Weigh the flask. Reflux adjuvants may be safely added to pes-
the mixture for 3 hours. Take precautions to ticide use dilutions by a grower or ap-
avoid loss of vapor during the refluxing. Cool plicant prior to application to the
the solution to room temperature. Add dis-
growing crop:
tilled water to make up any weight loss from
the flask contents. n-Alkyl (C8-C18) amine acetate, where the
Pipet 1 milliliter of a 2,4-dinitrophenyl- alkyl groups (C8-C18) are derived from coco-
hydrazine reagent (0.5 percent in 2N hydro- nut oil, as a surfactant in emulsifier blends
chloric acid) into a 30-milliliter separatory at levels not in excess of 5 percent by weight
funnel followed by a 2-milliliter aliquot (4 of the emulsifier blends that are added to
milligrams of water-soluble gum) of the herbicides for application to corn and sor-
polysaccharide hydrolyzate. Mix and allow ghum.
Di-n-alkyl (C8-C18) dimethyl ammonium
the reaction mixture to stand at room tem-
chloride, where the alkyl groups (C8-C18) are
perature for 5 minutes. Extract the mixture derived from coconut oil, as surfactants in
with 5 milliliters of ethyl acetate. Discard emulsifier blends at levels not in excess of 5
the aqueous layer. percent by weight of emulsifier blends that
Extract the hydrazone from the ethyl ace- are added to herbicides for application to
tate with three 5 milliliter portions of 10 per- corn or sorghum.
cent sodium carbonate solution. Dilute the Diethanolamide condensate based on a
combined sodium carbonate extracts to 100 mixture of saturated and unsaturated soy-
milliliters with additional 10 percent sodium bean oil fatty acids (C16-C18) as a surfactant
carbonate in a 10-milliliter volumetric flask. in emulsifier blends that are added to the
Measure the optical density of the sodium herbicide atrazine for application to corn.
carbonate solution at 375 millimicrons. Diethanolamide condensate based on
Compare the results with a curve of the op- stripped coconut fatty acids (C10 C18) as a
surfactant in emulsifier blends that are
tical density versus concentration of an au-
added to the herbicide atrazine for applica-
thentic sample of pyruvic acid that has been
tion to corn.
run through the procedure starting with the a-(p-Dodecylphenyl)-omega-hydroxypoly
preparation of the hydrazone. (oxyethylene) produced by the condensation
Record the percent by weight of pyruvic of 1 mole of dodecylphenol (dodecyl group is
acid in the test polysaccharide. Note ‘‘posi- a proplyene tetramer isomer) with an aver-
tive’’ for xanthan gum if the sample contains age of 4–14 or 30–70 moles of ethylene oxide;
more than 1.5 percent of pyruvic acid and if a blend of products is used, the average
‘‘negative’’ for xanthan gum if the sample number of moles of ethylene oxide reacted to
contains less than 1.5 percent of pyruvic acid produce any product that is a component of
by weight. the blend shall be in the range of 4–14 or 30–
70.
(e) The additive is used or intended Ethylene dichloride.
for use in accordance with good manu- Polyglyceryl phthalate ester of coconut oil
facturing practice as a stabilizer, emul- fatty acids.
a-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-
sifier, thickener, suspending agent, omega-hydroxypoly(oxyethylene) produced
bodying agent, or foam enhancer in by the condensation of 1 mole of p-(1,1,3,3-
foods for which standards of identity tetramethylbutyl) phenol with an average of
established under section 401 of the Act 4–14 or 30–70 moles of ethylene oxide; if a
do not preclude such use. blend of products is used, the average num-
ber of moles of ethylene oxide reacted to
(f) To assure safe use of the additive: produce any product that is a component of
(1) The label of its container shall the blend shall be in the range of 4–14 or 30–
bear, in addition to other information 70.
required by the Act, the name of the a-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-
additive and the designation ‘‘food omega-hydroxypoly(oxyethylene) produced
by the condensation of 1 mole of p-(1,1,3,3-
grade’’.
tetramethylbutyl) phenol with 1 mole of
(2) The label or labeling of the food ethylene oxide.
additive container shall bear adequate Sodium acrylate and acrylamide copoly-
directions for use. mer with a minimum average molecular
weight of 10,000,000 in which 30 percent of the
79
§ 172.712 21 CFR Ch. I (4–1–23 Edition)
polymer is comprised of acrylate units and 70 preharvest or postharvest application
percent acrylamide units, for use as a drift to bananas.
control agent in herbicide formulations ap-
plied to crops at a level not to exceed 0.5 § 172.720 Calcium lactobionate.
ounces of the additive per acre.
The food additive calcium
§ 172.712 1,3-Butylene glycol. lactobionate may be safely used in food
The food additive 1,3-butylene glycol in accordance with the following pre-
(CAS Reg. No. 107–88–0) may be safely scribed conditions:
used in food in accordance with the fol- (a) The food additive is the calcium
lowing prescribed conditions: salt of lactobionic acid (4-(b,D-
(a) It is prepared by the aldol con- galactosido)-D-gluconic acid) produced
densation of acetaldehyde followed by by the oxidation of lactose.
catalytic hydrogenation. (b) It is used or intended for use as a
(b) The food additive shall conform firming agent in dry pudding mixes at
to the identity and specifications of a level not greater than that required
the Food Chemicals Codex, 7th ed. to accomplish the intended effect.
(2010), p. 126, which is incorporated by
reference. The Director of the Office of § 172.723 Epoxidized soybean oil.
the Federal Register approves this in- Epoxidized soybean oil may be safely
corporation by reference in accordance used in accordance with the following
with 5 U.S.C. 552(a) and 1 CFR part 51. prescribed conditions:
You may obtain copies from the United (a) The additive is prepared by react-
States Pharmacopeial Convention, ing soybean oil in toluene with hydro-
12601 Twinbrook Pkwy., Rockville, MD gen peroxide and formic acid.
20852 (Internet address http:// (b) It meets the following specifica-
www.usp.org). Copies may be examined tions:
at the Dockets Management Staff (1) Epoxidized soybean oil contains
(HFA–305), Food and Drug Administra- oxirane oxygen, between 7.0 and 8.0 per-
tion, 5630 Fishers Lane, Rm. 1061, Rock- cent, as determined by the American
ville, MD 20852, 240–402–7500, between 9 Oil Chemists’ Society (A.O.C.S.) meth-
a.m. and 4 p.m., Monday through Fri- od Cd 9–57, ‘‘Oxirane Oxygen,’’ re-
day, or at the National Archives and approved 1989, which is incorporated by
Records Administration (NARA). For reference in accordance with 5 U.S.C
information on the availability of this 552(a) and 1 CFR part 51. Copies are
material at NARA, call 202–741–6030 or available from the American Oil Chem-
go to: http://www.archives.gov/federal- ists’ Society, P. O. Box 3489, Cham-
register/cfr/ibr-locations.html. paign, IL 61826–3489, or may be exam-
(c) It is used in the manufacture of ined at the Dockets Management Staff
sausage casings as a formulation aid as (HFA–305), Food and Drug Administra-
defined in § 170.3(o)(14) of this chapter tion, 5630 Fishers Lane, Rm. 1061, Rock-
and as a processing aid as defined in ville, MD 20852, 240–402–7500, between 9
§ 170.3(o)(24) of this chapter. a.m. and 4 p.m., Monday through Fri-
[62 FR 26228, May 13, 1997, as amended at 78 day, or at the National Archives and
FR 14664, Mar. 7, 2013; 78 FR 71463, Nov. 29, Records Administration (NARA). For
2013; 88 FR 17719, Mar. 24, 2023] information on the availability of this
material at NARA, call 202–741–6030, or
§ 172.715 Calcium lignosulfonate. go to: http://www.archives.gov/fed-
Calcium lignosulfonate may be safely eral_register/code_of_federal_regulations/
used in or on food, subject to the provi- ibr_locations.html.
sions of this section. (2) The maximum iodine value is 3.0,
(a) Calcium lignosulfonate consists of as determined by A.O.C.S. method Cd
sulfonated lignin, primarily as calcium 1–25, ‘‘Iodine Value of Fats and Oils
and sodium salts. Wijs Method,’’ revised 1993, which is in-
(b) It is used in an amount not to ex- corporated by reference in accordance
ceed that reasonably required to ac- with 5 U.S.C. 552(a) and 1 CFR part 51.
complish the intended physical or tech- The availability of this incorporation

nical effect when added as a dispersing by reference is given in paragraph
agent and stabilizer in pesticides for (b)(1) of this section.
80
(3) The heavy metals (as Pb) content (6) The gibberellic acid or potassium
cannot be more than 10 parts per mil- gibberellate may be diluted with sub-
lion, as determined by the ‘‘Heavy Met- stances generally recognized as safe in
als Test,’’ of the ‘‘Food Chemicals foods or with salts of fatty acids con-
Codex,’’ 4th ed. (1996), pp. 760–761, Meth- forming to § 172.863.
od II (with a 2-gram sample and 20 (b) They are used or intended for use
microgram of lead ion in the control), in the malting of barley under condi-
which is incorporated by reference in tions whereby the amount of either or
accordance with 5 U.S.C. 552(a) and 1 both additives present in the malt is
CFR part 51. Copies are available from not in excess of 2 parts per million ex-
the National Academy Press, Box 285, pressed as gibberellic acid, and the
2101 Constitution Ave. NW., Wash- treated malt is to be used in the pro-
ington, DC 20055 (Internet address duction of fermented malt beverages or
http://www.nap.edu), or may be exam- distilled spirits only, whereby the fin-
ined at the Dockets Management Staff ished distilled spirits contain none and
(HFA–305), Food and Drug Administra- the finished malt beverage contains
tion, 5630 Fishers Lane, Rm. 1061, Rock- not more than 0.5 part per million of
ville, MD 20852, 240–402–7500, between 9 gibberellic acid.
a.m. and 4 p.m., Monday through Fri- (c) To insure the safe use of the food
day, or at the National Archives and additives the label of the package shall
Records Administration (NARA). For bear, in addition to the other informa-
information on the availability of this tion required by the Act:
material at NARA, call 202–741–6030, or (1) The name of the additive,
go to: http://www.archives.gov/fed- ‘‘gibberellic acid’’ or ‘‘potassium
eral_register/code_of_federal_regulations/ gibberellate’’, whichever is appro-
ibr_locations.html. priate.
(c) The additive is used as a halogen (2) An accurate statement of the con-
stabilizer in brominated soybean oil at centration of the additive contained in
a level not to exceed 1 percent. the package.
(3) Adequate use directions to provide
[60 FR 32903, June 26, 1995, as amended at 64 not more than 2 parts per million of
FR 1759, Jan. 12, 1999; 78 FR 14665, Mar. 7,
gibberellic acid in the finished malt.
2013; 81 FR 5591, Feb. 3, 2016; 88 FR 17719, Mar.
24, 2023] (4) Adequate labeling directions to
provide that the final malt is properly
§ 172.725 Gibberellic acid and its po- labeled as described in paragraph (d) of
tassium salt. this section.
(d) To insure the safe use of the addi-
The food additives gibberellic acid
tive the label of the treated malt shall
and its potassium salt may be used in
bear, in addition to the other informa-
the malting of barley in accordance
tion required by the Act, the state-
with the following prescribed condi-
ments:
tions: (1) ‘‘Contains not more than 2 parts
(a) The additives meet the following per million ______’’, the blank being
specifications: filled in with the words ‘‘gibberellic
(1) The gibberellic acid is produced acid’’ or ‘‘potassium gibberellate’’,
by deep-culture fermentation of a suit- whichever is appropriate; and
able nutrient medium by a strain of (2) ‘‘Brewer’s malt—To be used in the
Fusarium moniliforme or a selection of production of fermented malt bev-
this culture. erages only’’ or ‘‘Distiller’s malt—To
(2) The gibberellic acid produced is of be used in the production of distilled
80 percent purity or better. spirits only’’, whichever is appropriate.
(3) The empirical formula of
gibberellic acid is represented by § 172.730 Potassium bromate.
C19H22O6. The food additive potassium bromate
(4) Potassium gibberellate is the po- may be safely used in the malting of
tassium salt of the specified gibberellic barley under the following prescribed
acid. conditions:
(5) The potassium gibberellate is of 80 (a)(1) It is used or intended for use in
percent purity or better. the malting of barley under conditions
81
§ 172.735 21 CFR Ch. I (4–1–23 Edition)
whereby the amount of the additive § 172.736 Glycerides and polyglycides

present in the malt from the treatment of hydrogenated vegetable oils.
does not exceed 75 parts per million of
The food additive glycerides and
bromate (calculated as Br), and the
polyglycides of hydrogenated vegetable
treated malt is used only in the pro-
oils may be safely used in food in ac-
duction of fermented malt beverages or
cordance with the following prescribed
distilled spirits.
(2) The total residue of inorganic bro- conditions:
mides in fermented malt beverages, re- (a) The additive is manufactured by
sulting from the use of the treated heating a mixture of hydrogenated oils
malt plus additional residues of inor- of vegetable origin and polyethylene
ganic bromides that may be present glycol in the presence of an alkaline
from uses in accordance with other reg- catalyst followed by neutralization
ulations in this chapter promulgated with any acid that is approved or is
under sections 408 and/or 409 of the act, generally recognized as safe for this
does not exceed 25 parts per million of use to yield the finished product.
bromide (calculated as Br). No toler- (b) The additive consists of a mixture
ance is established for bromide in dis- of mono-, di- and tri-glycerides and
tilled spirits because there is evidence polyethylene glycol mono- and di-
that inorganic bromides do not pass esters of fatty acids (polyglycides) of
over in the distillation process. hydrogenated vegetable oils and meets
(b) To assure safe use of the additive, the following specifications:
the label or labeling of the food addi- (1) Total ester content, greater than
tive shall bear, in addition to the other 90 percent as determined by a method
information required by the Act, the entitled ‘‘Determination of Esterified
following: Glycerides and Polyoxyethylene
(1) The name of the additive. Glycols,’’ approved November 16, 2001,
(2) Adequate directions for use. printed by Gattefosse S.A.S., and in-
(c) To assure safe use of the additive, corporated by reference. The Director
the label or labeling of the treated of the Office of the Federal Register
malt shall bear, in addition to other in- approves this incorporation by ref-
formation required by the Act, the erence in accordance with 5 U.S.C.
statement, ‘‘Brewer’s Malt—To be used 552(a) and 1 CFR part 51. You may ob-
in the production of fermented malt tain a copy from the Office of Food Ad-
beverages only’’, or ‘‘Distiller’s Malt— ditive Safety (HFS–200), Center for
To be used in the production of dis- Food Safety and Applied Nutrition,
tilled spirits only’’, whichever is the Food and Drug Administration, 5001
case. Campus Dr., College Park, MD 20740,
240–402–1200 or you may examine a copy
§ 172.735 Glycerol ester of rosin. at the Dockets Management Staff
Glycerol ester of wood rosin, gum (HFA–305), Food and Drug Administra-
rosin, or tall oil rosin may be safely tion, 5630 Fishers Lane, Rm. 1061, Rock-
used in food in accordance with the fol- ville, MD 20852, 240–402–7500, between 9
lowing prescribed conditions: a.m. and 4 p.m., Monday through Fri-
(a) It has an acid number of 3 to 9, a day, or at the National Archives and
drop-softening point of 88 to 96 °C; and Records Administration (NARA). For
a color of N or paler as determined in information on the availability of this
accordance with Official Naval Stores material at NARA, call 202–741–6030, or
Standards of the United States. It is go to http://www.archives.gov/fed-
purified by countercurrent steam dis- eral_register/code_of_federal_regulations/
tillation or steam stripping. ibr_locations.html.
(b) It is used to adjust the density of (2) Acid value, not greater than 2,
citrus oils used in the preparation of and hydroxyl value, not greater than
beverages whereby the amount of the 56, as determined by the methods enti-
additive does not exceed 100 parts per tled ‘‘Acid Value,’’ p. 1220 and
million of the finished beverage. ‘‘Hydroxyl Value,’’ p. 1223, respec-
[42 FR 14491, Mar. 15, 1977, as amended at 70 tively, in the Food Chemicals Codex,
FR 15758, Mar. 29, 2005; 72 FR 46896, Aug. 22, 7th ed. (2010), which is incorporated by
2007] reference. The Director of the Office of
82
the Federal Register approves this in- plement tablets, capsules, and liquid
corporation by reference in accordance formulations that are intended for in-
with 5 U.S.C. 552(a) and 1 CFR part 51. gestion in daily quantities measured in
You may obtain copies from the United drops or similar small units of meas-
States Pharmacopeial Convention, ure.
12601 Twinbrook Pkwy., Rockville, MD [71 FR 12620, Mar. 13, 2006, as amended at 78
20852 (Internet address http:// FR 71463, Nov. 29, 2013; 81 FR 5591, Feb. 3,
www.usp.org). Copies may be examined 2016; 88 FR 17720, Mar. 24, 2023]
at the Dockets Management Staff
(HFA–305), Food and Drug Administra- § 172.755 Stearyl monoglyceridyl cit-
tion, 5630 Fishers Lane, Rm. 1061, Rock- rate.
ville, MD 20852, 240–402–7500, between 9 The food additive stearyl
a.m. and 4 p.m., Monday through Fri- monoglyceridyl citrate may be safely
day, or at the National Archives and used in food in accordance with the fol-
Records Administration (NARA). For lowing provisions:
information on the availability of this (a) The additive is prepared by con-
material at NARA, call 202–741–6030 or trolled chemical reaction of the fol-
go to: http://www.archives.gov/federal- lowing:
register/cfr/ibr-locations.html.
(3) Lead, not greater than 0.1 mg/kg Reactant Limitations
as determined by the American Oil Citric acid ......................
Chemists’ Society (A.O.C.S.) method Monoglycerides of fatty Prepared by the glycerolysis of ed-
Ca 18c–91, ‘‘Determination of Lead by acids. ible fats and oils or derived from
fatty acids conforming with
Direct Graphite Furnace Atomic Ab- § 172.860.
sorption Spectrophotometry,’’ updated Stearyl alcohol .............. Derived from fatty acids con-
1995, and incorporated by reference in forming with § 172.860, or de-
rived synthetically in conformity
accordance with 5 U.S.C. 552(a) and 1 with § 172.864.
CFR part 51. Copies are available from
American Oil Chemists’ Society, P. O. (b) The additive stearyl
Box 3489, Champaign, IL 61826–3489, or monoglyceridyl citrate, produced as
may be examined at the Dockets Man- described under paragraph (a) of this
agement Staff (HFA–305), Food and section, meets the following specifica-
Drug Administration, 5630 Fishers tions:
Lane, Rm. 1061, Rockville, MD 20852,
240–402–7500, between 9 a.m. and 4 p.m., Acid number 40 to 52.
Total citric acid 15 to 18 percent.
Monday through Friday, or at the Na- Saponification number 215–255.
tional Archives and Records Adminis-
tration (NARA). For information on (c) The additive is used or intended
the availability of this material at for use as an emulsion stabilizer in or
NARA, call 202–741–6030, or go to http:// with shortenings containing emulsi-
www.archives.gov/federal_register/ fiers.
code_of_federal_regulations/
ibr_locations.html. § 172.765 Succistearin (stearoyl pro-
pylene glycol hydrogen succinate).
(4) 1,4-Dioxane, not greater than 10
milligrams per kilogram (mg/kg), and The food additive succistearin (ste-
ethylene oxide, not greater than 1 mg/ aroyl propylene glycol hydrogen succi-
kg, as determined by a gas nate) may be safely used in food in ac-
chromatographic method entitled cordance with the following prescribed
‘‘Determination of Ethylene Oxide and conditions:
1,4-Dioxane by Headspace Gas Chroma- (a) The additive is the reaction prod-
tography,’’ approved November 5, 1998, uct of succinic anhydride, fully hydro-
printed by Gattefosse S.A.S., and in- genated vegetable oil (predominantly
corporated by reference in accordance C16 or C18 fatty acid chain length), and
with 5 U.S.C. 552(a) and 1 CFR part 51; propylene glycol.
see paragraph (b)(1) of this section for (b) The additive meets the following
availability of the incorporation by specifications:
reference. Acid number 50–150.

(c) The additive is used or intended Hydroxyl number 15–50.
for use as an excipient in dietary sup- Succinated ester content 45–75 percent.
83
§ 172.770 21 CFR Ch. I (4–1–23 Edition)
(c) The additive is used or intended (c) The additive is used as a carrier of
for use as an emulsifier in or with vitamin B12 in foods for special dietary
shortenings and edible oils intended for use.
use in cakes, cake mixes, fillings,
icings, pastries, and toppings, in ac- § 172.780 Acacia (gum arabic).
cordance with good manufacturing The food additive may be safely used
practice. in food in accordance with the fol-
§ 172.770 Ethylene oxide polymer. lowing prescribed conditions:
(a) Acacia (gum arabic) is the dried
The polymer of ethylene oxide may gummy exudate from stems and
be safely used as a foam stabilizer in branches of trees of various species of
fermented malt beverages in accord-
the genus Acacia, family Leguminosae.
ance with the following conditions.
(a) It is the polymer of ethylene (b) The ingredient meets the speci-
oxide having a minimum viscosity of fications of the Food Chemicals Codex,
1,500 centipoises in a 1 percent aqueous 8th ed. (2012), p. 516, which is incor-
solution at 25 °C. porated by reference. The Director of
(b) It is used at a level not to exceed the Office of the Federal Register ap-
300 parts per million by weight of the proves this incorporation by reference
fermented malt beverage. in accordance with 5 U.S.C. 552(a) and 1
(c) The label of the additive bears di- CFR part 51. You may obtain copies
rections for use to insure compliance from the United States Pharmacopeial
with paragraph (b) of this section. Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address:
§ 172.775 Methacrylic acid- http://www.usp.org). Copies may be ex-
divinylbenzene copolymer. amined at the Dockets Management
Methacrylic acid-divinylbenzene co- Staff (HFA–305), Food and Drug Admin-
polymer may be safely used in food in istration, 5630 Fishers Lane, Rm. 1061,
accordance with the following pre- Rockville, MD 20852, 240–402–7500, be-
scribed conditions: tween 9 a.m. and 4 p.m., Monday
(a) The additive is produced by the through Friday. For information on
polymerization of methacrylic acid and the availability of this material at
divinylbenzene. The divinylbenzene NARA, call 202–741–6030, or go to: http://
functions as a cross-linking agent and www.archives.gov/federal-register/cfr/ibr-
constitutes a minimum of 4 percent of locations.html.
the polymer. (c) The ingredient is used in food in
(b) Aqueous extractives from the ad- accordance with good manufacturing
ditive do not exceed 2 percent (dry practices under the following condi-
basis) after 24 hours at 25 °C. tions:
MAXIMUM USAGE LEVELS PERMITTED
Food (as served) Percent Function
Beverages, alcoholic .............................................. 20.0 ............................... Thickener, emulsifier, or stabilizer.

Breakfast cereals, § 170.3(n)(4) of this chapter ..... 6.0 ................................. Dietary fiber; emulsifier and emulsifier salt; fla-
voring agent and adjuvant; formulation aid;
processing aid; stabilizer and thickener; sur-
face-finishing agent; texturizer.
Cakes, brownies, pastries, biscuits, muffins, and 3.0 ................................. Do.
cookies.
Grain-based bars (e.g., breakfast bars, granola 35.0 ............................... Do.
bars, rice cereal bars).
Soups and soup mixes, § 170.3(n)(40) of this 2.5 ................................. Do.
chapter, except for soups and soup mixes con-
taining meat or poultry that are subject to regu-
lation by the U.S. Department of Agriculture
under the Federal Meat Inspection Act or the
Poultry Products Inspection Act.
Food categories listed in § 184.1330 of this chap- Levels prescribed in Dietary fiber.
ter, except for meat, poultry, and foods for § 184.1330 of this
which standards of identity established under chapter.

section 401 of the Federal Food, Drug, and
Cosmetic Act preclude the use of acacia.
84
[70 FR 8034, Feb. 17, 2005, as amended at 78 code_of_federal_regulations/
FR 71464, Nov. 29, 2013; 78 FR 73437, Dec. 6, ibr_locations.html.
2013; 88 FR 17720, Mar. 24, 2023]
(2) The mean phage titer of each
§ 172.785 Listeria-specific monophage in the additive is 1 × 109
bacteriophage preparation. plaque forming units (PFU)/ml. The an-
alytical method for determining phage
The additive may be safely used as an
titer entitled ‘‘Method to Determine
antimicrobial agent specific for Listeria
monocytogenes (L. monocytogenes) in ac- Lytic Activity/Phage Titer,’’ dated No-
cordance with the following conditions: vember 6, 2001, and printed by
(a) Identity. (1) The additive consists Intralytix, Inc., is incorporated by ref-
of a mixture of equal proportions of six erence. Copies are available at loca-
different individually purified lytic- tions cited in paragraph (b)(1) of this
type (lacking lysogenic activity) section.
bacteriophages (phages) specific (3) The phages present in the prepara-
against L. monocytogenes. tion must not contain a functional por-
(2) Each phage is deposited at, and tion of any of the toxin-encoding se-
assigned an identifying code by, a sci- quences described in 40 CFR 725.421(d).
entifically-recognized culture collec- No sequences derived from genes en-
tion center, and is made available to coding bacterial 16S ribosomal RNA
FDA upon request. are present in the complete genomic
(3) The additive is produced from one sequence of the phages.
or more cell cultures of L. (4) L. monocytogenes toxin,
monocytogenes in a safe and suitable nu- listeriolysin O (LLO), is not greater
trient medium. than 5 hemolytic units (HU)/ml. The
(b) Specifications. (1) The additive analytical method for determining
achieves a positive lytic result (OD600 LLO entitled ‘‘Quantitation of
≤0.06) when tested against any of the Listeriolysin O Levels in LMP–102 TM,’’
following L. monocytogenes isolates dated September 27, 2004, and printed
available from American Type Culture by Intralytix, Inc., is incorporated by
Collection (ATCC): ATCC 35152 reference. Copies are available at loca-
(serogroup 1/2a), ATCC 19118 (serogroup
tions cited in paragraph (b)(1) of this
4b), and ATCC 15313 (serogroup 1/2b).
section.
The analytical method for determining
the potency of the additive entitled (5) The additive is negative for L.
‘‘Determination of Potency of LMP– monocytogenes. The modified version of
102 TM,’’ dated October 9, 2003, and the U.S. Department of Agriculture’s
printed by Intralytix, Inc., is incor- method for determining L.
porated by reference. The Director of monocytogenes entitled ‘‘LMP–102 TM
the Office of the Federal Register ap- Listeria monocytogenes Sterility Test-
proves this incorporation by reference ing,’’ dated May 24, 2004, and printed by
in accordance with 5 U.S.C. 552(a) and 1 Intralytix, Inc., is incorporated by ref-
CFR part 51. You may obtain a copy erence. Copies are available at loca-
from the Office of Food Additive Safety tions cited in paragraph (b)(1) of this
(HFS–200), Center for Food Safety and section.
Applied Nutrition, Food and Drug Ad- (6) The additive is negative for gram-
ministration, 5001 Campus Dr., College positive and gram-negative bacteria
Park, MD 20740, 240–402–1200, or you capable of growing in commonly used
may examine a copy at the Dockets microbiological media (e.g., Luria-
Management Staff (HFA–305), Food and Bertani (LB) medium), including Esch-
Drug Administration, 5630 Fishers erichia coli, Salmonella species and
Lane, Rm. 1061, Rockville, MD 20852, coagulase-positive Staphylococci, as de-
240–402–7500, between 9 a.m. and 4 p.m., termined by the ‘‘Method to Determine
Monday through Friday, or at the Na-
Microbial Contamination,’’ dated July
11, 2003, and printed by Intralytix, Inc.,
tration (NARA). For information on
is incorporated by reference. Copies are
the availability of this material at

NARA, call 202–741–6030, or go to: http:// available at locations cited in para-
www.archives.gov/federal_register/ graph (b)(1) of this section.
85
§ 172.800 21 CFR Ch. I (4–1–23 Edition)
(7) Total organic carbon (TOC) is less (NARA). For information on the avail-
than or equal to 36 mg/kg. The analyt- ability of this material at NARA, call
ical method for determining TOC enti- 202–741–6030, or go to: http://
tled ‘‘Determination of Total Organic www.archives.gov/federal_register/
Carbon by Automated Analyzer,’’ dated code_of_federal_regulations/
March 30, 2001, and printed by ibr_locations.html.
Intralytix, Inc., is incorporated by ref- (2) Fluoride content is not more than
erence. Copies are available at loca- 30 milligrams per kilogram, as deter-
tions cited in paragraph (b)(1) of this
mined by method III of the Fluoride
section.
(c) Conditions of use. The additive is Limit Test of the Food Chemicals
used in accordance with current good Codex, 7th ed. (2010), p. 1151, which is
manufacturing practice to control L. incorporated by reference. The Direc-
monocytogenes by direct application to tor of the Office of the Federal Register
meat and poultry products that comply approves this incorporation by ref-
with the ready-to-eat definition in 9 erence in accordance with 5 U.S.C.
CFR 430.1. Current good manufacturing 552(a) and 1 CFR part 51. You may ob-
practice is consistent with direct spray tain copies from the United States
application of the additive at a rate of Pharmacopeial Convention, 12601
approximately 1 mL of the additive per Twinbrook Pkwy., Rockville, MD 20852
500 cm2 product surface area. (Internet address http://www.usp.org).
[71 FR 47731, Aug. 18, 2006, as amended at 81 Copies may be examined at the Dock-
FR v5591, Feb. 3, 2016; 88 FR 17720, Mar. 24, ets Management Staff (HFA–305), Food
2023] and Drug Administration, 5630 Fishers
Subpart I—Multipurpose Additives 240–402–7500, between 9 a.m. and 4 p.m.,
§ 172.800 Acesulfame potassium. tional Archives and Records Adminis-
Acesulfame potassium (CAS Reg. No. tration (NARA). For information on
55589–62–3), also known as acesulfame the availability of this material at
K, may be safely used as a general-pur- NARA, call 202–741–6030 or go to: http://
pose sweetener and flavor enhancer in www.archives.gov/federal-register/cfr/ibr-
foods generally, except in meat and locations.html.
poultry, in accordance with current (c) If the food containing the additive
good manufacturing practice and in an is represented to be for special dietary
amount not to exceed that reasonably
uses, it shall be labeled in compliance
required to accomplish the intended
with part 105 of this chapter.
technical effect in foods for which
standards of identity established under [53 FR 28382, July 28, 1988, as amended at 57
section 401 of the Federal Food, Drug, FR 57961, Dec. 8, 1992; 59 FR 61540, 61543, 61545,
and Cosmetic Act do not preclude such Dec. 1, 1994; 60 FR 21702, May 3, 1995; 63 FR
use, under the following conditions: 36362, July 6, 1998; 68 FR 75413, Dec. 31, 2003;
(a) Acesulfame potassium is the po- 78 FR 71464, Nov. 29, 2013; 88 FR 17720, Mar.
tassium salt of 6-methyl-1,2,3- 24, 2023]
oxathiazine-4(3H)-one-2,2-dioxide.
(b) The additive meets the following § 172.802 Acetone peroxides.
specifications: The food additive acetone peroxides
(1) Purity is not less than 99 percent may be safely used in flour, and in
on a dry basis. The purity shall be de- bread and rolls where standards of
termined by a method titled identity do not preclude its use, in ac-
‘‘Acesulfame Potassium Assay,’’ which cordance with the following prescribed
is incorporated by reference. Copies are conditions:
available from the Office of Food Addi-
(a) The additive is a mixture of
tive Safety (HFS–200), Center for Food
monomeric and linear dimeric acetone
Safety and Applied Nutrition, Food and
peroxide, with minor proportions of
Drug Administration, 5001 Campus Dr.,
higher polymers, manufactured by re-

available for inspection at the National action of hydrogen peroxide and ace-
Archives and Records Administration tone.
86
(b) The additive may be mixed with 240–402–1200. Copies may be examined
an edible carrier to give a concentra- at the Dockets Management Staff
tion of: (1) 3 grams to 10 grams of hy- (HFA–305), Food and Drug Administra-
drogen peroxide equivalent per 100 tion, 5630 Fishers Lane, Rm. 1061, Rock-
grams of the additive, plus carrier, for ville, MD 20852, 240–402–7500, between 9
use in flour maturing and bleaching; or a.m. and 4 p.m., Monday through Fri-
(2) approximately 0.75 gram of hydro- day, or at the National Archives and
gen peroxide equivalent per 100 grams Records Administration (NARA). For
of the additive, plus carrier, for use in information on the availability of this
dough conditioning. material at NARA, call 202–741–6030 or
(c) It is used or intended for use: (1) go to: http://www.archives.gov/federal-
In maturing and bleaching of flour in a register/cfr/ibr-locations.html.
quantity not more than sufficient for (1) Assay for advantame, not less
such effect; and (2) as a dough-condi- than 97.0 percent and not more than
tioning agent in bread and roll produc- 102.0 percent on a dry basis.
tion at not to exceed the quantity of (2) Free N-[N-[3-(3-hydroxy-4-
hydrogen peroxide equivalent nec- methoxyphenyl)propyl]-a-aspartyl]-L-
essary for the artificial maturing ef- phenylalanine, not more than 1.0 per-
fect. cent.
(d) To insure safe use of the additive, (3) Total other related substances,
the label of the food additive container not more than 1.5 percent.
and any intermediate premix thereof (4) Lead, not more than 1.0 milligram
shall bear, in addition to the other in- per kilogram.
formation required by the act: (5) Water, not more than 5.0 percent.
(1) The name of the additive, ‘‘ace- (6) Residue on ignition, not more
tone peroxides’’. than 0.2 percent.
(2) The concentration of the additive (7) Specific rotation, determined at20
expressed in hydrogen peroxide equiva- °C [a]D: ¥45.0 to ¥38.0° calculated on a
lents per 100 grams. dry basis.
(3) Adequate use directions to provide (c) The food additive advantame may
a final product that complies with the be safely used as a sweetening agent
limitations prescribed in paragraph (c) and flavor enhancer in foods generally,
of this section. except in meat and poultry, in accord-
ance with current good manufacturing
§ 172.803 Advantame. practice, in an amount not to exceed
(a) Advantame is the chemical N-[N- that reasonably required to achieve the
[3-(3-hydroxy-4- intended technical effect, in foods for
methoxyphenyl)propyl]-a-aspartyl]-L- which standards of identity established
phenylalanine 1-methyl ester, under section 401 of the Federal Food,
monohydrate (CAS Reg. No. 714229–20– Drug, and Cosmetic Act do not pre-
6). clude such use.
(b) Advantame meets the following (d) If the food containing the additive
specifications when it is tested accord- purports to be or is represented to be
ing to the methods described or ref- for special dietary use, it must be la-
erenced in the document entitled beled in compliance with part 105 of
‘‘Specifications and Analytical Meth- this chapter.
ods for Advantame’’ dated April 1, 2009, [79 FR 29085, May 21, 2014, as amended at 88
by the Ajinomoto Co. Inc., Sweetener FR 17720, Mar. 24, 2023]
Department 15–1, Kyobashi 1-chome,
Chuo-ku, Tokyo 104–8315, Japan. The § 172.804 Aspartame.
Director of the Office of the Federal The food additive aspartame may be
Register approves this incorporation safely used in food in accordance with
by reference in accordance with 5 good manufacturing practice as a
U.S.C. 552(a) and 1 CFR part 51. Copies sweetening agent and a flavor enhancer
are available from the Office of Food in foods for which standards of identity
Additive Safety (HFS–200), Center for established under section 401 of the
Food Safety and Applied Nutrition, Federal Food, Drug, and Cosmetic Act
Food and Drug Administration, 5001 do not preclude such use under the fol-
Campus Dr., College Park, MD 20740, lowing conditions:
87
§ 172.804 21 CFR Ch. I (4–1–23 Edition)
(a) Aspartame is the chemical 1- Staff (HFA–305), Food and Drug Admin-
methyl N-L-a-aspartyl-L-phenylalanine istration, 5630 Fishers Lane, Rm. 1061,
(C14H18N2O5). Rockville, MD 20852, 240–402–7500, be-
(b) The additive meets the specifica- tween 9 a.m. and 4 p.m., Monday
tions of the Food Chemicals Codex, 7th through Friday, and at the National
ed. (2010), pp. 73–74, which is incor- Archives and Records Administration
porated by reference. The Director of (NARA). For information on the avail-
the Office of the Federal Register ap- ability of this material at NARA, call
proves this incorporation by reference 202–741–6030, or go to: http://
in accordance with 5 U.S.C. 552(a) and 1 www.archives.gov/federal_register/
CFR part 51. You may obtain copies code_of_federal_regulations/
from the United States Pharmacopeial
ibr_locations.html.
Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (Internet address (d) To assure safe use of the additive,
http://www.usp.org). Copies may be ex- in addition to the other information re-
amined at the Dockets Management quired by the Act:
Staff (HFA–305), Food and Drug Admin- (1) The principal display panel of any
istration, 5630 Fishers Lane, Rm. 1061, intermediate mix of the additive for
Rockville, MD 20852, 240–402–7500, be- manufacturing purposes shall bear a
tween 9 a.m. and 4 p.m., Monday statement of the concentration of the
through Friday, or at the National Ar- additive contained therein;
chives and Records Administration (2) The label of any food containing
(NARA). For information on the avail- the additive shall bear, either on the
ability of this material at NARA, call principal display panel or on the infor-
202–741–6030 or go to: http:// mation panel, the following statement:
www.archives.gov/federal-register/cfr/ibr-
locations.html. PHENYLKETONURICS: CONTAINS
(c)(1) When aspartame is used as a PHENYLALANINE
sugar substitute tablet for sweetening
hot beverages, including coffee and tea, The statement shall appear in the la-
L-leucine may be used as a lubricant in beling prominently and conspicuously
the manufacture of such tablets at a as compared to other words, state-
level not to exceed 3.5 percent of the ments, designs or devices and in bold
weight of the tablet. type and on clear contrasting back-
(2) When aspartame is used in baked ground in order to render it likely to
goods and baking mixes, the amount of be read and understood by the ordinary
the additive is not to exceed 0.5 percent individual under customary conditions
by weight of ready-to-bake products or of purchase and use.
of finished formulations prior to bak- (3) When the additive is used in a
ing. Generally recognized as safe sugar substitute for table use, its label
(GRAS) ingredients or food additives shall bear instructions not to use in
approved for use in baked goods shall cooking or baking.
be used in combination with aspartame (4) Packages of the dry, free-flowing
to ensure its functionality as a sweet- additive shall prominently display the
ener in the final baked product. The
sweetening equivalence in teaspoons of
level of aspartame used in these prod-
sugar.
ucts is determined by an analytical
method entitled ‘‘Analytical Method (e) If the food containing the additive
for the Determination of Aspartame purports to be or is represented for spe-
and Diketopiperazine in Baked Goods cial dietary uses, it shall be labeled in
and Baking Mixes,’’ October 8, 1992, compliance with part 105 of this chap-
which was developed by the Nutrasweet ter.
Co. Copies are available from the Office [39 FR 27319, July 26, 1974]
of Food Additive Safety (HFS–200),
Center for Food Safety and Applied Nu- EDITORIAL NOTE: For FEDERAL REGISTER ci-
trition, Food and Drug Administration, tations affecting § 172.804, see the List of CFR
Sections Affected, which appears in the
5001 Campus Dr., College Park, MD

Finding Aids section of the printed volume
20740, 240–402–1200, or are available for
and at www.govinfo.gov.
inspection at the Dockets Management
88
§ 172.806 Azodicarbonamide. minimum cloud point of 9 °C–12 °C in 10

percent aqueous solution.
The food additive azodicarbonamide
(4) a-Hydro-omega-hydroxy-poly(ox-
may be safely used in food in accord-
yethylene) poly (oxypropylene)-(51–57
moles) poly(oxyethylene) block copoly-
ditions:
mer, having an average molecular
(a) It is used or intended for use: weight of 14,000 and a cloud point above
(1) As an aging and bleaching ingre- 100 °C in 1 percent aqueous solution.
dient in cereal flour in an amount not (b) The additive is used or intended
to exceed 2.05 grams per 100 pounds of for use as follows:
flour (0.0045 percent; 45 parts per mil- (1) The additive identified in para-
lion). graph (a)(1) of this section is used in
(2) As a dough conditioner in bread practice as a solubilizing and stabi-
baking in a total amount not to exceed lizing agent in flavor concentrates
0.0045 percent (45 parts per million) by (containing authorized flavoring oils)
weight of the flour used, including any for use in foods for which standards of
quantity of azodicarbonamide added to identity established under section 401
flour in accordance with paragraph of the Act do not preclude such use,
(a)(1) of this section. provided that the weight of the addi-
(b) To assure safe use of the additive: tive does not exceed the weight of the
(1) The label and labeling of the addi- flavoring oils in the flavor concentrate.
tive and any intermediate premix pre- (2) The additive identified in para-
pared therefrom shall bear, in addition graph (a)(2) of this section is used as a
to the other information required by processing aid and wetting agent in
the Act, the following: combination with dioctyl sodium sulfo-
(i) The name of the additive. succinate for fumaric acid as pre-
(ii) A statement of the concentration scribed in § 172.810.
or the strength of the additive in any (3) The additive identified in para-
intermediate premixes. graph (a)(3) of this section is used:
(2) The label or labeling of the food (i) As a surfactant and defoaming
additive shall also bear adequate direc- agent, at levels not to exceed 0.05 per-
tions for use. cent by weight, in scald baths for poul-
try defeathering, followed by potable
§ 172.808 Copolymer condensates of water rinse. The temperatures of the
ethylene oxide and propylene oxide. scald baths shall be not less than 125
Copolymer condensates of ethylene °F.
oxide and propylene oxide may be safe- (ii) As a foam control and rinse adju-
ly used in food under the following pre- vant in hog dehairing machines at a
scribed conditions: use level of not more than 5 grams per
(a) The additive consists of one of the hog.
following: (4) The additive identified in para-
(1) a-Hydro-omega-hydroxy-poly (oxy- graph (a)(4) of this section is used as a
ethylene) poly(oxypropylene)-(55–61 dough conditioner in yeast-leavened
moles)poly(oxyethylene) block copoly- bakery products for which standards of
mer, having a molecular weight range identity established under section 401
of 9,760–13,200 and a cloud point above of the Act do not preclude such use,
100 °C in 1 percent aqueous solution. provided that the amount of the addi-
(2) a-Hydro-omega-hydroxy-poly (oxy- tive dose not exceed 0.5 percent by
ethylene)poly(oxypropylene)-(53–59 weight of the flour used.
moles)poly(oxyethylene)(14–16 moles) [42 FR 14491, Mar. 15, 1977, as amended at 46
block copolymer, having a molecular FR 57476, Nov. 24, 1981]
weight range of 3,500–4,125 and a cloud
point of 9 °C–12 °C in 10 percent aqueous § 172.809 Curdlan.
solution. Curdlan may be safely used in ac-
(3) a-Hydro-omega-hydroxy-poly(ox- cordance with the following conditions:
yethylene)/poly(oxypropylene) (min- (a) Curdlan is a high molecular
imum 15 moles)/poly(oxyethylene) weight polymer of glucose (b-1,3-

block copolymer, having a minimum glucan; CAS Reg. No. 54724–00–4) pro-
average molecular weight of 1900 and a duced by pure culture fermentation
89
§ 172.810 21 CFR Ch. I (4–1–23 Edition)
from the nonpathogenic and standards of identity established under

nontoxicogenic bacterium Alcaligenes section 401 of the act do not preclude
faecalis var. myxogenes. such use.
(b) Curdlan meets the following spec-
[61 FR 65941, Dec. 16, 1996, as amended at 78
ifications when it is tested according
FR 14665, Mar. 7, 2013; 81 FR 5591, Feb. 3, 2016;
to the methods described or referenced 88 FR 17720, Mar. 24, 2023]
in the document entitled ‘‘Analytical
Methods for Specification Tests for § 172.810 Dioctyl sodium sulfo-
Curdlan,’’ by Takeda Chemical Indus- succinate.
tries, Ltd., 12–10 Nihonbashi, 2–Chome,
Chuo-ku, Tokyo, 103, Japan, 1996, which The food additive, dioctyl sodium
is incorporated by reference in accord- sulfosuccinate, meets the specifica-
ance with 5 U.S.C. 552(a) and 1 CFR tions of the Food Chemicals Codex, 7th
part 51. Copies are available from the ed. (2010), pp. 313–314, which is incor-
Office of Food Additive Safety (HFS– porated by reference. The Director of
200), Center for Food Safety and Ap- the Office of the Federal Register ap-
plied Nutrition, Food and Drug Admin- proves this incorporation by reference
istration, 5001 Campus Dr., College in accordance with 5 U.S.C. 552(a) and 1
Park, MD 20740, 240–402–1200, or may be CFR part 51. You may obtain copies
examined at the Dockets Management from the United States Pharmacopeial
Staff (HFA–305), Food and Drug Admin- Convention, 12601 Twinbrook Pkwy.,
istration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 (Internet address
Rockville, MD 20852, 240–402–7500, be- http://www.usp.org). Copies may be ex-
tween 9 a.m. and 4 p.m., Monday amined at the Dockets Management
through Friday, or at the National Ar- Staff (HFA–305), Food and Drug Admin-
chives and Records Administration istration, 5630 Fishers Lane, Rm. 1061,
(NARA). For information on the avail- Rockville, MD 20852, 240–402–7500, be-
ability of this material at NARA, call tween 9 a.m. and 4 p.m., Monday
202–741–6030, or go to: http:// through Friday, or at the National Ar-
www.archives.gov/federal_register/ chives and Records Administration
code_of_federal_regulations/ (NARA). For information on the avail-
ibr_locations.html. ability of this material at NARA, call
(1) Positive for curdlan. 202–741–6030 or go to: http://
(2) Assay for curdlan (calculated as www.archives.gov/federal-register/cfr/ibr-
anhydrous glucose), not less than 80 locations.html). The food additive,
percent. dioctyl sodium sulfosuccinate, may be
(3) pH of 1 percent aqueous suspen- safely used in food in accordance with
sion, 6.0–7.5. the following prescribed conditions:
(4) Lead, not more than 0.5 mg/kg.
(a) As a wetting agent in the fol-
(5) Heavy metals (as Pb), not more
lowing fumaric acid-acidulated foods:
than 0.002 percent.
Dry gelatin dessert, dry beverage base,
(6) Total nitrogen, not more than 0.2
percent. and fruit juice drinks, when standards
(7) Loss on drying, not more than 10 of identity do not preclude such use.
percent. The labeling of the dry gelatin dessert
(8) Residue on ignition, not more and dry beverage base shall bear ade-
than 6 percent. quate directions for use, and the addi-
(9) Gel strength of 2 percent aqueous tive shall be used in such an amount
suspension, not less than 600 × 103 dyne that the finished gelatin dessert will
per square centimeter. contain not in excess of 15 parts per
(10) Aerobic plate count, not more million of the additive and the finished
than 103 per gram. beverage or fruit juice drink will con-
(11) Coliform bacteria, not more than tain not in excess of 10 parts per mil-
3 per gram. lion of the additive.
(c) Curdlan is used or intended for (b) As a processing aid in sugar fac-
use in accordance with good manufac- tories in the production of unrefined
turing practice as a formulation aid, cane sugar, in an amount not in excess

processing aid, stabilizer and thick- of 0.5 part per million of the additive
ener, and texturizer in foods for which per percentage point of sucrose in the
90
juice, syrup, or massecuite being proc- (b) The food additive meets the fol-
essed, and so used that the final molas- lowing specifications:
ses will contain no more than 25 parts
Acid number: Not to exceed 1.0.
per million of the additive. Iodine number: Not to exceed 1.0.
(c) As a solubilizing agent on gums Saponification number: 186–192.
and hydrophilic colloids to be used in Hydroxyl number: Not to exceed 5.0.
food as stabilizing and thickening Free glycerol content: Not to exceed 0.5 per-
agents, when standards of identity do cent.
not preclude such use. The additive is Unsaponifiable matter: Not to exceed 0.5 per-
used in an amount not to exceed 0.5 cent.
percent by weight of the gums or hy- Melting point (Class II): 69 °C–73 °C.
drophilic colloids. (c) The additive is used or intended
(d) As an emulsifying agent for cocoa for use as follows when standards of
fat in noncarbonated beverages con- identity established under section 401
taining cocoa, whereby the amount of of the Act do not preclude such use:
the additive does not exceed 25 parts
Uses Limitations
per million of the finished beverage.
(e) As a dispersing agent in ‘‘cocoa 1. As a crystallization accel- Not to exceed 1 percent of
with dioctyl sodium sulfosuccinate for erator in cocoa products, in the combined weight of
imitation chocolate, and in the formulation.
manufacturing’’ that conforms to the compound coatings.
provisions of § 163.117 of this chapter 2. As a formulation aid as de- Not to exceed 0.5 percent.
and the use limitations prescribed in fined in § 170.3(o)(14) of this
§ 172.520, in an amount not to exceed 0.4 chapter, lubricant and release
agent as defined in
percent by weight thereof. § 170.3(o)(18) of this chapter,
(f) As a processing aid and wetting and surface-finishing agent as
agent in combination with a-hydro- defined in § 170.3(o)(30) of
this chapter in food.
omega -hydroxy - poly(oxyethylene) - 3. As a formulation aid as de- Not to exceed 3.0 percent
poly-(oxypropylene) (53–59 moles) fined in § 170.3(o)(14) of this of the combined weight
poly(oxyethylene) (14–16 moles) block chapter in confections. of the formulation.
4. As a formulation aid as de- Not to exceed 1.0 percent
copolymer, having a molecular weight fined in § 170.3(o)(14) of this of the combined weight
range of 3,500–4,125 and a cloud point of chapter in fats and oils as de- of the formulation.
9 °C–12 °C in 10 percent aqueous solu- fined in § 170.3 (n)(12) of this
tion, for fumaric acid used in fumaric chapter.
5. As a winterization and frac- Not to exceed 0.5 percent
acid-acidulated dry beverage base and tionation aid in fat and oil by weight of the proc-
in fumaric acid-acidulated fruit juice processing. essed fat or oil.
drinks, when standards of identity do
not preclude such use. The labeling of (d) To assure safe use of the additive:
the dry beverage base shall bear ade- (1) In addition to the other informa-
quate directions for use, and the addition required by the act, the label or
tives shall be used in such an amount labeling of the additive shall bear the
that the finished beverage or fruit juice name of the additive.
drink will contain not in excess of a (2) The label of the additive shall
total of 10 parts per million of the bear adequate directions to provide a
dioctyl sodium sulfosuccinate-block final product that complies with the
copolymer combination. limitations prescribed in paragraph (c)
of this section.
FR 10105, Mar. 19, 1984; 78 FR 71464, Nov. 29, [53 FR 21632, June 9, 1988, as amended at 59
2013; 88 FR 17720, Mar. 24, 2023] FR 24924, May 13, 1994]
§ 172.811 Glyceryl tristearate. § 172.812 Glycine.

The food additive glyceryl tristearate The food additive glycine may be
may be safely used in food in accord- safely used for technological purposes
ance with the following prescribed con- in food in accordance with the fol-
ditions: lowing prescribed conditions:
(a) The food additive (CAS Reg. No. (a) The additive meets the specifica-
555–43–1) is prepared by reacting stearic tions of the Food Chemicals Codex, 7th
acid with glycerol in the presence of a ed. (2010), pp. 457–458, which is incor-
suitable catalyst. porated by reference. The Director of
91
§ 172.814 21 CFR Ch. I (4–1–23 Edition)
the Office of the Federal Register ap- fraction of the resultant product has
proves this incorporation by reference an acetyl value of 30 to 38:
in accordance with 5 U.S.C. 552(a) and 1 (1) With hydrogen peroxide, benzoyl
CFR part 51. You may obtain copies peroxide, lactic acid, and sodium hy-
from the United States Pharmacopeial droxide.
Convention, 12601 Twinbrook Pkwy., (2) With hydrogen peroxide, acetic
Rockville, MD 20852 (Internet address acid, and sodium hydroxide.
http://www.usp.org). Copies may be ex- (b) It is used or intended for use, in
amined at the Dockets Management accordance with good manufacturing
Staff (HFA–305), Food and Drug Admin- practice, as an emulsifier in foods, ex-
istration, 5630 Fishers Lane, Rm. 1061, cept for those standardized foods that
Rockville, MD 20852, 240–402–7500, be- do not provide for such use.
tween 9 a.m. and 4 p.m., Monday (c) To assure safe use of the additive,
through Friday, or at the National Ar- the label of the food additive container
chives and Records Administration shall bear, in addition to the other in-
(NARA). For information on the avail- formation required by the Act:
ability of this material at NARA, call (1) The name of the additive,
202–741–6030 or go to: http:// ‘‘hydroxylated lecithin’’.
www.archives.gov/federal-register/cfr/ibr- (2) Adequate directions for its use.
locations.html.
(b) The additive is used or intended § 172.816 Methyl glucoside-coconut oil
ester.
for use as follows:
Methyl glucoside-coconut oil ester
Uses Limitations may be safely used in food in accord-
As a masking agent for the Not to exceed 0.2 percent in ance with the following conditions:
bitter aftertaste of sac- the finished beverage. (a) It is the methyl glucoside-coconut
charin used in manufac- oil ester having the following specifica-
tured beverages and bev-
erage bases.
tions:
As a stabilizer in mono- and Not to exceed 0.02 percent of Acid number: 10–20
diglycerides prepared by the mono- and Hydroxyl number: 200–300
the glycerolysis of edible diglycerides.
fats or oils.
pH (5% aqueous): 4.8–5.0
Saponification number: 178–190
(c) To assure safe use of the additive, (b) It is used or intended for use as
in addition to the other information re- follows:
quired by the Act: (1) As an aid in crystallization of su-
(1) The labeling of the additive shall crose and dextrose at a level not to ex-
bear adequate directions for use of the ceed the minimum quantity required to
additive in compliance with the provi- produce its intended effect.
sions of this section. (2) As a surfactant in molasses at a
(2) The labeling of beverage bases level not to exceed 320 parts per million
containing the additive shall bear ade- in the molasses.
quate directions for use to provide that
beverages prepared therefrom shall § 172.818 Oxystearin.
contain no more than 0.2 percent gly- The food additive oxystearin may be
cine. safely used in foods, when such use is
not precluded by standards of identity
FR 10105, Mar. 19, 1984; 78 FR 71464, Nov. 29, in accordance with the following condi-
2013; 88 FR 17720, Mar. 24, 2023] tions:
(a) The additive is a mixture of the
§ 172.814 Hydroxylated lecithin. glycerides of partially oxidized stearic
The food additive hydroxylated and other fatty acids obtained by heat-
lecithin may be safely used as an emul- ing hydrogenated cottonseed or soy-
sifier in foods in accordance with the bean oil under controlled conditions, in
following conditions: the presence of air and a suitable cata-
(a) The additive is obtained by the lyst which is not a food additive as so
defined. The resultant product meets
treatment of lecithin in one of the fol-

lowing ways, under controlled condi- the following specifications:
tions whereby the separated fatty acid Acid number: Maximum 15.
92
Iodine number: Maximum 15. APPARATUS
Saponification number: 225–240. Gas chromatograph with hydrogen flame
Hydroxyl number: 30–45. ionization detector (Varian Aerograph 600 D
Unsaponifiable material: Maximum 0.8 per- or equivalent). The following conditions
cent. shall be employed with the Varian
Refractive index (butyro): 60±1 at 48 °C. Aerograph 600 D gas chromatograph:
Column temperature: 165 °C.
(b) It is used or intended for use as a
Inlet temperature: 260 °C.
crystallization inhibitor in vegetable Carrier gas (nitrogen) flow rate: 70 milli-
oils and as a release agent in vegetable liters per minute.
oils and vegetable shortenings, where- Hydrogen and air flow to burner: Optimize
by the additive does not exceed 0.125 to give maximum sensitivity.
percent of the combined weight of the Sample size: 2 microliters.
oil or shortening. Elution time: Ethylene glycol: 2.0 minutes.
Diethylene glycol: 6.5 minutes.
(c) To insure safe use of the additive, Recorder: ¥0.5 to + 1.05 millivolt, full span,
the label and labeling of the additive 1 second full response time.
container shall bear, in addition to the Syringe: 10-microliter (Hamilton 710 N or
other information required by the Act: equivalent).
(1) The name of the additive. Chromatograph column: 5 feet × 1⁄8 inch.
(2) Adequate directions to provide an I.D. stainless steel tube packed with sorbitol
(Mathieson-Coleman-Bell 2768 Sorbitol
oil or shortening that complies with SX850, or equivalent) 12 percent in H2O by
the limitations prescribed in paragraph weight on 60–80 mesh nonacid washed diato-
(b) of this section. maceous earth (Chromosorb W. Johns-Man-
ville, or equivalent).
§ 172.820 Polyethylene glycol (mean
molecular weight 200-9,500). REAGENTS AND MATERIALS
Polyethylene glycol identified in this Carrier gas, nitrogen: Commercial grade in

section may be safely used in food in cylinder equipped with reducing regulator to
provide 50 p.s.i.g. to the gas chromatograph.
accordance with the following pre- Ethylene glycol: Commercial grade. Purify
scribed conditions: if necessary, by distillation.
(a) Identity. (1) The additive is an ad- Diethylene glycol: Commercial grade. Pu-
dition polymer of ethylene oxide and rify, if necessary, by distillation.
water with a mean molecular weight of Glycol standards: Prepare
200 to 9,500. chromatographic standards by dissolving
known amounts of ethylene glycol and
(2) It contains no more than 0.2 per-
diethylene glycol in water. Suitable con-
cent total by weight of ethylene and centrations for standardization range from 1
diethylene glycols when tested by the to 6 milligrams of each component per milli-
analytical methods prescribed in para- liter (for example 10 milligrams diluted to
graph (b) of this section. volume in a 10-milliliter volumetric flask is
(b) Analytical method. (1) The analyt- equivalent to 1 milligram per milliliter).
ical method prescribed in the National STANDARDIZATION
Formulary XV (1980), page 1244, for pol-
yethylene glycol 400 shall be used to Inject a 2-microliter aliquot of the glycol
standard into the gas chromatograph em-
determine the total ethylene and
ploying the conditions described above.
diethylene glycol content of poly- Measure the net peak heights for the ethyl-
ethylene glycols having mean molec- ene glycol and for the diethylene glycol.
ular weights of 450 or higher. Record the values as follows:
(2) The following analytical method A = Peak height in millimeters of the
shall be used to determine the total ethylene glycol peak.
ethylene and diethylene glycol content B = milligrams of ethylene glycol per mil-
of polyethylene glycols having mean liliter of standard solution.
C = Peak height in millimeters of the
molecular weights below 450. diethylene glycol peak.
D = Milligrams of diethylene glycol per
ANALYTICAL METHOD milliliter of standard solution.
ETHYLENE GLYCOL AND DIETHYLENE GLYCOL PROCEDURE
CONTENT OF POLYETHYLENE GLYCOLS
Weigh approximately 4 grams of poly-
The analytical method for determining ethylene glycol sample accurately into a 10-
ethylene glycol and diethylene glycol is as milliliter volumetric flask. Dilute to volume
follows: with water. Mix the solution thoroughly and
93
§ 172.822 21 CFR Ch. I (4–1–23 Edition)
inject a 2-microliter aliquot into the gas not exceed 25 parts per million of the
chromatograph. Measure the heights, in mil- finished beverage and such beverage
limeters, of the ethylene glycol peak and of base is not for use in a food for which
the diethylene glycol peak and record as E
a standard of identity established
and F, respectively.
under section 401 of the Act precludes
Percent ethylene glycol = (E × B) / (A × sam- such use.
ple weight in grams) (ii) Fumaric acid-acidulated fruit
Percent diethylene glycol = (F × D) / (C × juice drinks whereby the additive does
sample weight in grams) not exceed 25 parts per million of the
(c) Uses. It may be used, except in finished fruit juice drink and it is not
milk or preparations intended for addi- used in a fruit juice drink for which a
tion to milk, as follows: standard of identity established under
(1) As a coating, binder, plasticizing section 401 of the Act precludes such
agent, and/or lubricant in tablets used use.
for food. (4) As a wetting agent at a level not
(2) As an adjuvant to improve flavor to exceed 10 parts per million in the
and as a bodying agent in nonnutritive partition of high and low melting frac-
sweeteners identified in § 180.37 of this tions of crude vegetable oils and ani-
chapter. mal fats, provided that the partition
(3) As an adjuvant in dispersing vita- step is followed by a conventional re-
min and/or mineral preparations. fining process that includes alkali neu-
(4) As a coating on sodium nitrite to tralization and deodorization of the
inhibit hygroscopic properties. fats and oils.
(d) Limitations. (1) It is used in an (c) To insure the safe use of the addi-
amount not greater than that required tive, the label of the food additive con-
to produce the intended physical or tainer shall bear, in addition to the
technical effect. other information required by the Act:
(2) A tolerance of zero is established (1) The name of the additive, sodium
for residues of polyethylene glycol in lauryl sulfate.
milk. (2) Adequate use directions to provide
a final product that complies with the
[42 FR 14491, Mar. 15, 1977, as amended at 49 limitations prescribed in paragraph (b)
FR 10105, Mar. 19, 1984] of this section.
§ 172.822 Sodium lauryl sulfate. [42 FR 14491, Mar. 15, 1977, as amended at 43
The food additive sodium lauryl sul- FR 18668, May 2, 1978]
fate may be safely used in food in ac- § 172.824 Sodium mono- and dimethyl
cordance with the following conditions: naphthalene sulfonates.
(a) The additive meets the following
specifications: The food additive sodium mono- and
(1) It is a mixture of sodium alkyl dimethyl naphthalene sulfonates may
sulfates consisting chiefly of sodium be safely used in accordance with the
lauryl sulfate [CH2(CH2)10CH2OSO2Na]. following prescribed conditions:
(2) It has a minimum content of 90 (a) The additive has a molecular
percent sodium alkyl sulfates. weight range of 245–260.
(b) It is used or intended for use: (b) The additive is used or intended
(1) As an emulsifier in or with egg for use:
whites whereby the additive does not (1) In the crystallization of sodium
exceed the following limits: carbonate in an amount not to exceed
250 parts per million of the sodium car-
Egg white solids, 1,000 parts per million. bonate. Such sodium carbonate is used
Frozen egg whites, 125 parts per million. or intended for use in potable water
Liquid egg whites, 125 parts per million.
systems to reduce hardness and aid in
(2) As a whipping agent at a level not sedimentation and coagulation by rais-
to exceed 0.5 percent by weight of gela- ing the pH for the efficient utilization
tine used in the preparation of marsh- of other coagulation materials.
mallows. (2) As an anticaking agent in sodium
(3) As a surfactant in: nitrite at a level not in excess of 0.1

(i) Fumaric acid-acidulated dry bev- percent by weight thereof for author-
erage base whereby the additive does ized uses in cured fish and meat.
94
(c) In addition to the general labeling additives or are authorized by regula-

requirements of the Act: tion, followed by a molecular distilla-
(1) Sodium carbonate produced in action or by steam stripping; or
cordance with paragraph (b)(1) of this (2) The direct acetylation of edible
section shall be labeled to show the monoglycerides with acetic anhydride
presence of the additive and its label or without the use of catalyst or molec-
labeling shall bear adequate directions ular distillation, and with the removal
for use. by vacuum distillation, if necessary, of
(2) Sodium nitrite produced in ac- the acetic acid, acetic anhydride, and
cordance with paragraph (b)(2) of this triacetin.
section shall bear the labeling required (b) The food additive has a Reichert-
by § 172.175 and a statement declaring Meissl value of 75–200 and an acid value
the presence of sodium mono- and di- of less than 6.
methyl naphthalene sulfonates. (c) The food additive is used at a
[42 FR 14491, Mar. 15, 1977, as amended at 63 level not in excess of the amount rea-
FR 7069, Feb. 12, 1998] sonably required to produce its in-
tended effect in food, or in food-proc-
§ 172.826 Sodium stearyl fumarate. essing, food-packing, or food-storage
Sodium stearyl fumarate may be equipment.
safely used in food in accordance with
the following conditions:
FR 3508, Jan. 25, 1985]
(a) It contains not less than 99 per-
cent sodium stearyl fumarate cal- § 172.829 Neotame.
culated on the anhydrous basis, and
not more than 0.25 percent sodium ste- (a) Neotame is the chemical N-[N-
aryl maleate. (3,3-dimethylbutyl)-L-a-aspartyl]-L-
(b) The additive is used or intended phenylalanine-1-methyl ester (CAS
for use: Reg. No. 165450–17–9).
(1) As a dough conditioner in yeast- (b) Neotame meets the following
leavened bakery products in an amount specifications when it is tested accord-
not to exceed 0.5 percent by weight of ing to the methods described or ref-
the flour used. erenced in the document entitled
(2) As a conditioning agent in dehy- ‘‘Specifications and Analytical Meth-
drated potatoes in an amount not to ods for Neotame’’ dated April 3, 2001,
exceed 1 percent by weight thereof. by the NutraSweet Co., 699 North
(3) As a stabilizing agent in Wheeling Rd., Mount Prospect, IL
nonyeast-leavened bakery products in 60056. The Director of the Office of the
an amount not to exceed 1 percent by Federal Register has approved the in-
weight of the flour used. corporation by reference of this mate-
(4) As a conditioning agent in proc- rial in accordance with 5 U.S.C. 552(a)
essed cereals for cooking in an amount and 1 CFR part 51. Copies are available
not to exceed 1 percent by weight of from the Office of Food Additive Safety
the dry cereal, except for foods for (HFS–200), Center for Food Safety and
which standards of identity preclude Applied Nutrition, Food and Drug Ad-
such use. ministration, 5001 Campus Dr., College
(5) As a conditioning agent in starch- Park, MD 20740, 240–402–1200. Copies
thickened or flour-thickened foods in may be examined at the Dockets Man-
an amount not to exceed 0.2 percent by agement Staff (HFA–305), Food and
weight of the food. Drug Administration, 5630 Fishers
§ 172.828 Acetylated monoglycerides. 240–402–7500, between 9 a.m. and 4 p.m.,
The food additive acetylated Monday through Friday, or at the Na-
monoglycerides may be safely used in tional Archives and Records Adminis-
or on food in accordance with the fol- tration (NARA). For information on
lowing prescribed conditions: the availability of this material at
(a) The additive is manufactured by: NARA, call 202–741–6030, or go to: http://
(1) The interesterification of edible www.archives.gov/federal_register/

fats with triacetin and in the presence code_of_federal_regulations/
of catalytic agents that are not food ibr_locations.html.
95
§ 172.830 21 CFR Ch. I (4–1–23 Edition)
(1) Assay for neotame, not less than Melting point: 50 °C–60 °C.
97.0 percent and not more than 102.0 Acid number: 70–120
percent on a dry basis. (c) The additive is used or intended
(2) Free dipeptide acid (N-[N-(3,3- for use in the following foods:
dimethylbutyl)-L-a-aspartyl]-L- (1) As an emulsifier in liquid and
phenylalanine), not more than 1.5 per- plastic shortenings at a level not to ex-
cent. ceed 3 percent by weight of the short-
(3) Other related substances, not ening.
more than 2.0 percent. (2) As a dough conditioner in bread
(4) Lead, not more than 2.0 milli- baking, when such use is permitted by
grams per kilogram. an appropriate food standard, at a level
(5) Water, not more than 5.0 percent. not to exceed 0.5 percent by weight of
(6) Residue on ignition, not more the flour used.
than 0.2 percent
(7) Specific rotation, determined at § 172.831 Sucralose.
20 °C [a]D: ¥40.0° to 43.4° calculated on (a) Sucralose is the chemical 1,6-
a dry basis. dichloro-1,6-dideoxy-b-D-
(c) The food additive neotame may be fructofuranosyl-4-chloro-4-deoxy-a-D-
safely used as a sweetening agent and galactopyranoside (CAS Reg. No. 56038–
flavor enhancer in foods generally, ex- 13–2).
cept in meat and poultry, in accord- (b) The additive meets the specifica-
ance with current good manufacturing tions of the Food Chemicals Codex, 7th
practice, in an amount not to exceed ed. (2010), pp. 993–995, which is incor-
that reasonably required to accomplish porated by reference. The Director of
the intended technical effect, in foods the Office of the Federal Register ap-
for which standards of identity estab- proves this incorporation by reference
lished under section 401 of the Federal in accordance with 5 U.S.C. 552(a) and 1
Food, Drug, and Cosmetic Act do not CFR part 51. You may obtain copies
preclude such use. from the United States Pharmacopeial
(d) When neotame is used as a sugar Convention, 12601 Twinbrook Pkwy.,
substitute tablet, L-leucine may be Rockville, MD 20852 (Internet address
used as a lubricant in the manufacture http://www.usp.org). Copies may be ex-
of tablets at a level not to exceed 3.5 amined at the Dockets Management
percent of the weight of the tablet. Staff (HFA–305), Food and Drug Admin-
(e) If the food containing the additive istration, 5630 Fishers Lane, Rm. 1061,
purports to be or is represented to be
Rockville, MD 20852, 240–402–7500, be-
for special dietary use, it shall be la-
tween 9 a.m. and 4 p.m., Monday
beled in compliance with part 105 of
through Friday, or at the National Ar-
this chapter.
chives and Records Administration
[67 FR 45310, July 9, 2002, as amended at 81 (NARA). For information on the avail-
FR 5591, Feb. 3, 2016; 88 FR 17721, Mar. 24, ability of this material at NARA, call
2023] 202–741–6030 or go to: http://
§ 172.830 Succinylated monoglycerides.
locations.html.
The food additive succinylated (c) The additive may be used as a
monoglycerides may be safely used in sweetener in foods generally, in accord-
food in accordance with the following ance with current good manufacturing
prescribed conditions: practice in an amount not to exceed
(a) The additive is a mixture of semi- that reasonably required to accomplish
and neutral succinic acid esters of the intended effect.
mono- and diglycerides produced by the (d) If the food containing the additive
succinylation of a product obtained by purports to be or is represented to be
the glycerolysis of edible fats and oils, for special dietary use, it shall be la-
or by the direct esterification of glyc- beled in compliance with part 105 of
erol with edible fat-forming fatty this chapter.
acids.
(b) The additive meets the following [63 FR 16433, Apr. 3, 1998, as amended at 64
specifications: FR 43909, Aug. 12, 1999; 78 FR 14665, Mar. 7,

2013; 78 FR 71464, Nov. 29, 2013; 88 FR 17721,
Succinic acid content: 14.8%–25.6% Mar. 24, 2023]
96
§ 172.832 Monoglyceride citrate. in the ‘‘Compendium of Food Additive

A food additive that is a mixture of Specifications, Addendum 4, Food and
glyceryl monooleate and its citric acid Agriculture Organization of the United
monoester manufactured by the reac- Nations (FAO), Food and Nutrition
tion of glyceryl monooleate with citric Paper 5, Revision 2’’ (1991), pp. 203 and
acid under controlled conditions may 204, which is incorporated by reference,
be safely used as a synergist and solu- in accordance with 5 U.S.C. 552(a) and 1
bilizer for antioxidants in oils and fats, CFR part 51. Copies are available from
when used in accordance with the con- the Office of Food Additive Safety
ditions prescribed in this section. (HFS–200), Center for Food Safety and
(a) The food additive meets the fol- Applied Nutrition, Food and Drug Ad-
lowing specifications: ministration, 5001 Campus Dr., College
Park, MD 20740, 240–402–1200, or may be
Acid number, 70–100. examined at the Dockets Management
Total citric acid (free and combined), 14 per-
Staff (HFA–305), Food and Drug Admin-
cent–17 percent.
istration, 5630 Fishers Lane, Rm. 1061,
(b) It is used, or intended for use, in Rockville, MD 20852, 240–402–7500, be-
antioxidant formulations for addition tween 9 a.m. and 4 p.m., Monday
to oils and fats whereby the additive through Friday, or at the National Ar-
does not exceed 200 parts per million of chives and Records Administration
the combined weight of the oil or fat (NARA). For information on the avail-
and the additive. ability of this material at NARA, call
(c) To assure safe use of the additive: 202–741–6030, or go to: http://
(1) The container label shall bear, in www.archives.gov/federal_register/
addition to the other information re- code_of_federal_regulations/
quired by the Act, the name of the ad- ibr_locations.html.
ditive. (3) Acid value: Not to exceed 0.20 de-
(2) The label or accompanying label- termined using 50 grams of sample by
ing shall bear adequate directions for the ‘‘Guide to Specifications for Gen-
the use of the additive which, if fol- eral Notices, General Analytical Tech-
lowed, will result in a food that com- niques, Identification Tests, Test Solu-
plies with the requirements of this sections, and Other Reference Materials,’’
tion. in the ‘‘Compendium of Food Additive
Specifications, Addendum 4, FAO Food
§ 172.833 Sucrose acetate isobutyrate
(SAIB). and Nutrition Paper 5, Revision 2,’’ p.
189 (1991), which is incorporated by ref-
Sucrose acetate isobutyrate may be erence; see paragraph (b)(2) of this sec-
safely used in foods in accordance with tion for availability of the incorpora-
the following prescribed conditions: tion by reference.
(a) Sucrose acetate isobutyrate (CAS (4) Lead: Not to exceed 1.0 milli-
Reg. No. 27216–37–1), or SAIB, is the grams/kilogram determined by the
chemical alpha-D-glucopyranoside, O- ‘‘Atomic Absorption
acetyl-tris-O-(2-methyl-1-oxopropyl)- Spectrophotometric Graphite Furnace
beta-D-fructofuranosyl, acetate tris(2- Method, Method I,’’ in the ‘‘Food
methyl propanoate). Chemicals Codex,’’ 4th ed. (1996), pp. 763
(b) SAIB, a pale, straw-colored liquid, and 764, with an attached modification
meets the following specifications: (1) to the sample digestion section in Ap-
Assay: Not less than 98.8 percent and pendix III.B (July 1996), which is incor-
not more than 101.9 percent, based on porated by reference. Copies are avail-
the following formula: able from the National Academy Press,
Assay = ((SV 0.10586) ÷ 56.1) × 100 2101 Constitution Ave. NW., Box 285,
Washington, DC 20055 (Internet http://
Where SV = Saponification value
www.nap.edu), or may be examined at
(2) Saponification value: 524–540 de- the Dockets Management Staff (HFA–
termined using 1 gram of sample by the 305), Food and Drug Administration,
‘‘Guide to Specifications for General 5630 Fishers Lane, Rm. 1061, Rockville,
Notices, General Analytical Tech- MD 20852, 240–402–7500, between 9 a.m.

niques, Identification Tests, Test Solu- and 4 p.m., Monday through Friday, or
tions, and Other Reference Materials,’’ at the National Archives and Records
97
§ 172.834 21 CFR Ch. I (4–1–23 Edition)
Administration (NARA). For informa- (c) The additive is used or intended

tion on the availability of this mate- for use in the following foods when
rial at NARA, call 202–741–6030, or go standards of identity established under
to: http://www.archives.gov/fed- section 401 of the Act do not preclude
eral_register/code_of_federal_regulations/ such use:
ibr_locations.html.
Use Limitations
(5) Triacetin: Not to exceed 0.10 per-
cent determined by gas chroma- 1. As an emulsifier in pan-re- Not to exceed levels required
tography as described in the ‘‘Guide to lease agents for and as a to produce the intended ef-
Specifications for General Notices, dough conditioner in yeast- fects, total not to exceed
leavened bakery products. 0.5 percent by weight of
General Analytical Techniques, Identi- the flour used.
fication Tests, Test Solutions, and 2. As an emulsifier in cakes Not to exceed 0.5 percent by
Other Reference Materials,’’ in the and cake mixes. weight of the dry ingredi-
‘‘Compendium of Food Additive Speci- ents.
3. As an emulsifier in Not to exceed 0.45 percent
fications, Addendum 4, FAO Food and whipped vegetable oil top- by weight of the finished
Nutrition Paper 5, Revision 2,’’ (1991), pings and topping mixes. whipped vegetable oil top-
pp. 13–26, which is incorporated by ref- pings.
erence; see paragraph (b)(2) of this sec- 4. As an emulsifier in icings Not to exceed 0.5 percent by
and icing mixes. weight of the finished
tion for availability of the incorpora- icings.
tion by reference. 5. As an emulsifier in frozen Not to exceed 0.2 percent by
(c) The food additive is used as a sta- desserts. weight of the finished fro-
zen desserts.
bilizer (as defined in § 170.3(o)(28) of this 6. As an emulsifier in edible Not to exceed 0.4 percent by
chapter) of emulsions of flavoring oils vegetable fat-water emul- weight of the finished vege-
in nonalcoholic beverages. sions intended for use as table fat-water emulsions.
(d) The total SAIB content of a bev- substitutes for milk or
cream in beverage coffee.
erage containing the additive does not
exceed 300 milligrams/kilogram of the
(d) When the name ‘‘polyglycerate
finished beverage.
60’’ is used in labeling it shall be fol-
[64 FR 29958, June 4, 1999; 64 FR 43072, Aug. 9, lowed by either ‘‘polyoxyethylene (20)
1999, as amended at 78 FR 14665, Mar. 7, 2013; mono-and diglycerides of fatty acids’’
81 FR 5591, Feb. 3, 2016; 88 FR 17721, Mar. 24, or ‘‘ethoxylated mono- and
2023]
diglycerides’’ in parentheses.
§ 172.834 Ethoxylated mono- and [42 FR 14491, Mar. 15, 1977, as amended at 42
diglycerides. FR 37973, July 26, 1977; 50 FR 49536, Dec. 3,
The food additive ethoxylated mono- 1985]
and diglycerides (polyoxyethylene (20)
mono- and diglycerides of fatty acids) § 172.836 Polysorbate 60.
(polyglycerate 60) may be safely used The food additive polysorbate 60
in food in accordance with the fol- (polyoxyethylene (20) sorbitan mono-
lowing prescribed conditions: stearate) which is a mixture of
(a) The food additive is manufactured polyoxyethylene ethers of mixed par-
by: tial stearic and palmitic acid esters of
(1) Glycerolysis of edible fats pri- sorbitol anhydrides and related com-
marily composed of stearic, palmitic, pounds, may be safely used in food in
and myristic acids; or accordance with the following pre-
(2) Direct esterification of glycerol scribed conditions:
with a mixture of primarily stearic, (a) The food additive is manufactured
palmitic, and myristic acids; by reacting stearic acid (usually con-
to yield a product with less than 0.3 taining associated fatty acids, chiefly
acid number and less than 0.2 percent palmitic) with sorbitol to yield a prod-
water, which is then reacted with uct with a maximum acid number of 10
ethylene oxide. and a maximum water content of 0.2
(b) The additive meets the following percent, which is then reacted with
specifications: ethylene oxide.
(b) The food additive meets the fol-
Saponification number, 65–75. lowing specifications:
Acid number, 0–2.

Hydroxyl number, 65–80. Saponification number 45–55.
Oxyethylene content, 60.5–65.0 percent. Acid number 0–2.
98
Hydroxyl number 81–96. of the finished nonstandardized confec-
Oxyethylene content 65 percent–69.5 percent. tionery coating or standardized cacao
(c) It is used or intended for use as product.
follows: (4) [Reserved]
(1) As an emulsifier in whipped edible (5) As an emulsifier in cake icings
oil topping with or without one or a and cake fillings, with or without one
combination of the following: or a combination of the following:
(i) Sorbitan monostearate; (i) Polysorbate 65.
(ii) Polysorbate 65; (ii) Sorbitan monostearate.
(iii) Polysorbate 80;
When used alone, the maximum
whereby the maximum amount of the amount of polysorbate 60 shall not ex-
additive or additives used does not exceed 0.46 percent of the weight of the
ceed 0.4 percent of the weight of the cake icings and cake fillings. When
finished whipped edible oil topping; ex- used with polysorbate 65 and/or sorbi-
cept that a combination of the additive tan monostearate, it shall not exceed
with sorbitan monostearate may be 0.46 percent, nor shall the polysorbate
used in excess of 0.4 percent, provided 65 exceed 0.32 percent or the sorbitan
that the amount of the additive does monostearate exceed 0.7 percent, and
not exceed 0.77 percent and the amount no combination of these emulsifiers
of sorbitan monostearate does not ex- shall exceed 1 percent of the weight of
ceed 0.27 percent of the weight of the the cake icing or cake filling.
finished whipped edible oil topping. (6) To impart greater opacity to
(2) As an emulsifier in cakes and cake sugar-type confection coatings where-
mixes, with or without one or a com- by the maximum amount of the addi-
bination of the following: tive does not exceed 0.2 percent of the
(i) Polysorbate 65. weight of the finished sugar coating.
(ii) Sorbitan monostearate. (7) As an emulsifier in nonstandard-
When used alone, the maximum ized dressings whereby the maximum
amount of polysorbate 60 shall not ex- amount of the additive does not exceed
ceed 0.46 percent of the cake or cake 0.3 percent of the weight of the finished
mix, on a dry-weight basis. When used dressings.
with polysorbate 65 and/or sorbitan (8) As an emulsifier, alone or in com-
monostearate, it shall not exceed 0.46 bination with polysorbate 80, in
percent, nor shall the polysorbate 65 shortenings and edible oils intended for
exceed 0.32 percent or the sorbitan use in foods as follows, when standards
monostearate exceed 0.61 percent, and of identity established under section
no combination of these emulsifiers 401 of the act do not preclude such use:
shall exceed 0.66 percent of the cake or (i) It is used alone in an amount not
cake mix, all calculated on a dry- to exceed 1 percent of the weight of the
weight basis. finished shortening or oil.
(3) As an emulsifier, alone or in com- (ii) It is used with polysorbate 80 in
bination with sorbitan monostearate, any combination providing no more
in nonstandardized confectionery coat- than 1 percent of polysorbate 60 and no
ings and standardized cacao products more than 1 percent of polysorbate 80,
specified in §§ 163.123, 163.130, 163.135, provided that the total combination
163.140, 163.145, and 163.150 of this chap- does not exceed 1 percent of the fin-
ter, as follows: ished shortening or oil.
(i) It is used alone in an amount not (iii) The 1–percent limitation speci-
to exceed 0.5 percent of the weight of fied in paragraph (c)(8)(i) and (ii) of
the finished nonstandardized confec- this section may be exceeded in premix
tionery coating or standardized cacao concentrates of shortening or edible oil
product. if the labeling complies with the re-
(ii) It is used with sorbitan mono- quirements of paragraph (d) of this sec-
stearate in any combination of up to tion.
0.5 percent of polysorbate 60 and up to (9) As an emulsifier in solid-state, ed-
1 percent of sorbitan monostearate: ible vegetable fat-water emulsions in-

Provided, That the total combination tended for use as substitutes for milk
does not exceed 1 percent of the weight or cream in beverage coffee, with or
99
§ 172.838 21 CFR Ch. I (4–1–23 Edition)
without one or a combination of the sorbate 65 and/or polysorbate 80, where-

following: by the maximum amount of the addi-
(i) Polysorbate 65. tives, alone or in combination, does not
(ii) Sorbitan monostearate. exceed 0.1 percent of the finished frozen
The maximum amount of the additive dessert.
or additives shall not exceed 0.4 per- (d) To assure safe use of the additive,
cent by weight of the finished edible in addition to the other information re-
vegetable fat-water emulsion. quired by the Act:
(10) As a foaming agent in non- (1) The label of the additive and any
alcoholic mixes, to be added to alco- intermediate premixes shall bear:
holic beverages in the preparation of (i) The name of the additive.
mixed alcoholic drinks, at a level not (ii) A statement of the concentration
to exceed 4.5 percent by weight of the or strength of the additive in any in-
nonalcoholic mix. termediate premixes.
(11) As a dough conditioner in yeast- (2) The label or labeling shall bear
leavened bakery products in an amount adequate directions to provide a final
not to exceed 0.5 percent by weight of product that complies with the limita-
the flour used. tions prescribed in paragraph (c) of this
(12) As an emulsifier, alone or in section.
combination with sorbitan monostea-
rate, in the minimum quantity re- [42 FR 14491, Mar. 15, 1977, as amended at 43
FR 2871, Jan. 25, 1978; 45 FR 58836, Sept. 5,
quired to accomplish the intended ef-
1980; 46 FR 8466, Jan. 27, 1981; 64 FR 57976,
fect, in formulations of white mineral Oct. 28, 1999]
oil conforming with § 172.878 and/or pe-
troleum wax conforming with § 172.886 § 172.838 Polysorbate 65.
for use as protective coatings on raw
fruits and vegetables. The food additive polysorbate 65
(13) As a dispersing agent in artifi- (polyoxyethylene (20) sorbitan
cially sweetened gelatin desserts and in tristearate), which is a mixture of
artificially sweetened gelatin dessert polyoxyethylene ethers of mixed ste-
mixes, whereby the amount of the addi- aric acid esters of sorbitol anhydrides
tive does not exceed 0.5 percent on a and related compounds, may be safely
dry-weight basis. used in food in accordance with the fol-
(14) As an emulsifier in chocolate fla- lowing prescribed conditions:
vored syrups, whereby the maximum (a) The food additive is manufactured
amount of the additive does not exceed by reacting stearic acid (usually con-
0.05 percent in the finished product. taining associated fatty acids, chiefly
(15) As a surfactant and wetting palmitic) with sorbitol to yield a prod-
agent for natural and artificial colors uct with a maximum acid number of 15
in food as follows: and a maximum water content of 0.2
(i) In powdered soft drink mixes in an percent, which is then reacted with
amount not to exceed 4.5 percent by ethylene oxide.
weight of the mix. (b) The food additive meets the fol-
(ii) In sugar-based gelatin dessert lowing specifications:
mixes in an amount not to exceed 0.5 Saponification number 88–98.
percent by weight of the mix. Acid number 0–2.
(iii) In artificially sweetened gelatin Hydroxyl number 44–60.
dessert mixes in an amount not to ex- Oxyethylene content 46 percent–50 percent.
ceed 3.6 percent by weight of the mix.
(iv) In sugar-based pudding mixes in (c) The additive is used, or intended
an amount not to exceed 0.5 percent by for use, as follows:
weight of the mix. (1) As an emulsifier in ice cream, fro-
(v) In artificially sweetened pudding zen custard, ice milk, fruit sherbet and
mixes in an amount not to exceed 0.5 nonstandardized frozen desserts when
percent by weight of the mix. used alone or in combination with
(16) As an emulsifier in ice cream, polysorbate 80, whereby the maximum
frozen custard, fruit sherbet, and non- amount of the additives, alone or in
standardized frozen desserts when used combination, does not exceed 0.1 per-
alone or in combination with poly- cent of the finished frozen dessert.
100
(2) As an emulsifier in cakes and cake (d) To assure safe use of the additive,
mixes, with or without one or a com- in addition to the other information re-
bination of the following: quired by the Act:
(i) Sorbitan monostearate. (1) The label of the additive and any
(ii) Polysorbate 60. intermediate premixes shall bear:
When used alone, the maximum (i) The name of the additive.
amount of polysorbate 65 shall not ex- (ii) A statement of the concentration
ceed 0.32 percent of the cake or cake or strength of the additive in any in-
mix, on a dry-weight basis. When used termediate premixes.
with sorbitan monostearate and/or (2) The label or labeling shall bear
polysorbate 60, it shall not exceed 0.32 adequate directions to provide a final
percent, nor shall the sorbitan mono- product that complies with the limita-
stearate exceed 0.61 percent or the tions prescribed in paragraph (c) of this
polysorbate 60 exceed 0.46 percent, and section.
no combination of these emulsifiers [42 FR 14491, Mar. 15, 1977, as amended at 43
shall exceed 0.66 percent of the cake or FR 2871, Jan. 20, 1978]
cake mix, all calculated on a dry-
weight basis. § 172.840 Polysorbate 80.
(3) As an emulsifier in whipped edible The food additive polysorbate 80
oil topping with or without one or a (polyoxyethylene (20) sorbitan
combination of the following: monooleate), which is a mixture of
(i) Sorbitan monostearate; polyoxyethylene ethers of mixed par-
(ii) Polysorbate 60; tial oleic acid esters of sorbitol anhy-
(iii) Polysorbate 80; drides and related compounds, may be
whereby the maximum amount of the safely used in food in accordance with
additive or additives used does not ex- the following prescribed conditions:
ceed 0.4 percent of the weight of the (a) The food additive is manufactured
finished whipped edible oil topping. by reacting oleic acid (usually con-
(4) As an emulsifier in solid-state, ed- taining associated fatty acids) with
ible vegetable fat-water emulsions in- sorbitol to yield a product with a max-
tended for use as substitutes for milk imum acid number of 7.5 and a max-
or cream in beverage coffee, with or imum water content of 0.5 percent,
without one or a combination of the which is then reacted with ethylene
following: oxide.
(i) Sorbitan monostearate. (b) The food additive meets the fol-
(ii) Polysorbate 60. lowing specifications:
The maximum amount of the additive Saponification number 45–55.
or additives shall not exceed 0.4 per- Acid number 0–2.
cent by weight of the finished edible Hydroxyl number 65–80.
vegetable fat-water emulsion. Oxyethylene content 65 percent–69.5 percent.
(5) As an emulsifier in cake icings (c) The additive is used or intended
and cake fillings, with or without one for use as follows:
or a combination of the following: (1) An emulsifier in ice cream, frozen
(i) Sorbitan monostearate. custard, ice milk, fruit sherbet, and
(ii) Polysorbate 60. nonstandardized frozen desserts, when
When used alone, the maximum used alone or in combination with
amount of polysorbate 65 shall not ex- polysorbate 65 whereby the maximum
ceed 0.32 percent of the weight of the amount of the additives, alone or in
cake icing or cake filling. When used combination, does not exceed 0.1 per-
with sorbitan monostearate and/or cent of the finished frozen dessert.
polysorbate 60, it shall not exceed 0.32 (2) In yeast-defoamer formulations
percent, nor shall the sorbitan mono- whereby the maximum amount of the
stearate exceed 0.7 percent or the poly- additive does not exceed 4 percent of
sorbate 60 exceed 0.46 percent, and no the finished yeast defoamer and the
combination of these emulsifiers shall maximum amount of the additive in

exceed 1 percent of the weight of the the yeast from such use does not ex-
cake icing or cake filling. ceed 4 parts per million.
101
§ 172.840 21 CFR Ch. I (4–1–23 Edition)
(3) As a solubilizing and dispersing (iii) The 1–percent limitation speci-

agent in pickles and pickle products, fied in paragraph (c)(8)(i) and (ii) of
whereby the maximum amount of the this section may be exceeded in premix
additive does not exceed 500 parts per concentrates of shortening or edible oil
million. if the labeling complies with the re-
(4) As a solubilizing and dispersing quirements of paragraph (d) of this sec-
agent in: tion.
(i) Vitamin-mineral preparations (9) As an emulsifier in whipped edible
containing calcium caseinate in the ab- oil topping with or without one or a
sence of fat-soluble vitamins, whereby combination of the following:
the maximum intake of polysorbate 80 (i) Sorbitan monostearate;
shall not exceed 175 milligrams from (ii) Polysorbate 60;
the recommended daily dose of the (iii) Polysorbate 65;
preparations. whereby the maximum amount of the
(ii) Fat-soluble vitamins in vitamin additive or additives used does not ex-
and vitamin-mineral preparations con- ceed 0.4 percent of the weight of the
taining no calcium caseinate, whereby finished whipped edible oil topping.
the maximum intake of polysorbate 80 (10) It is used as a wetting agent in
shall not exceed 300 milligrams from scald water for poultry defeathering,
the recommended daily dose of the followed by potable water rinse. The
preparations. concentration of the additive in the
(iii) In vitamin-mineral preparations scald water does not exceed 0.0175 per-
containing both calcium caseinate and cent.
fat-soluble vitamins, whereby the max- (11) As a dispersing agent in gelatin
imum intake of polysorbate 80 shall desserts and in gelatin dessert mixes,
not exceed 475 milligrams from the rec- whereby the amount of the additive
ommended daily dose of the prepara- does not exceed 0.082 percent on a dry-
tions. weight basis.
(5) As a surfactant in the production (12) As an adjuvant added to herbi-
of coarse crystal sodium chloride cide use and plant-growth regulator
whereby the maximum amount of the use dilutions by a grower or applicator
additive in the finished sodium chlo- prior to application of such dilutions to
ride does not exceed 10 parts per mil- the growing crop. Residues resulting
lion. from such use are exempt from the re-
(6) In special dietary foods, as an quirement of a tolerance. When so used
emulsifier for edible fats and oils, with or intended for use, the additive shall
directions for use which provide for the be exempt from the requirements of
ingestion of not more than 360 milli- paragraph (d)(1) of this section.
grams of polysorbate 80 per day. (13) As a defoaming agent in the prep-
(7) As a solubilizing and dispersing aration of the creaming mixture for
agent for dill oil in canned spiced green cottage cheese as identified in § 133.128
beans, not to exceed 30 parts per mil- of this chapter, whereby the amount of
lion. the additive does not exceed .008 per-
(8) As an emulsifier, alone or in com- cent by weight of the finished product.
bination with polysorbate 60, in (14) As a surfactant and wetting
shortenings and edible oils intended for agent for natural and artificial colors
use in foods as follows, when standards for use in barbecue sauce where the
of identity established under section level of the additive does not exceed
401 of the act do not preclude such use: 0.005 percent by weight of the barbecue
(i) It is used alone in an amount not sauce.
to exceed 1 percent of the weight of the (d) To assure safe use of the additive,
finished shortening or oil. in addition to the other information re-
(ii) It is used with polysorbate 60 in quired by the Act:
any combination providing no more (1) The label of the additive and any
than 1 percent of polysorbate 80 and no intermediate premixes shall bear:
more than 1 percent of polysorbate 60, (i) The name of the additive.
provided that the total combination (ii) A statement of the concentration

does not exceed 1 percent of the fin- or strength of the additive in any in-
ished shortening or oil. termediate premixes.
102
(2) The label or labeling shall bear bulking agent, formulation aid, humec-
adequate directions to provide a final tant, and texturizer in all foods, except
product that complies with the limita- meat and poultry, baby food, and in-
tions prescribed in paragraph (c) of this fant formula.
section. (d) If the food containing the additive
[42 FR 14491, Mar. 15, 1977, as amended at 43 purports to be or is represented for spe-
FR 2871, Jan. 20, 1978; 45 FR 58835, Sept. 5, cial dietary uses, it shall be labeled in
1980; 46 FR 8466, Jan. 27, 1981; 85 FR 72907, compliance with part 105 of this chap-
Nov. 16, 2020] ter.
(e) The label and labeling of food a
§ 172.841 Polydextrose. single serving of which would be ex-
Polydextrose as identified in this sec- pected to exceed 15 grams of the addi-
tion may be safely used in food in active shall bear the statement: ‘‘Sen-
cordance with the following prescribed sitive individuals may experience a
conditions: laxative effect from excessive con-
(a)(1) Polydextrose (CAS Reg. No. sumption of this product’’.
68424–04–4) is a partially metabolizable [46 FR 30081, June 5, 1981, as amended at 59
water-soluble polymer prepared by the FR 37421, July 22, 1994; 60 FR 54425, Oct. 24,
condensation of a melt which consists 1995; 61 FR 14480, Apr. 2, 1996; 62 FR 30985,
either of approximately 89 percent D- June 6, 1997; 63 FR 57597, Oct. 28, 1998; 65 FR
glucose, 10 percent sorbitol, and 1 per- 64605, Oct. 30, 2000; 65 FR 79719, Dec. 20, 2000;
cent citric acid or of approximately 90 72 FR 46564, Aug. 21, 2007; 78 FR 71464, Nov. 29,
percent D-glucose, 10 percent sorbitol, 2013; 88 FR 17721, Mar. 24, 2023]
and 0.1 percent phosphoric acid, on a
§ 172.842 Sorbitan monostearate.
weight basis.
(2) Polydextrose may be partially The food additive sorbitan monostea-
neutralized with potassium hydroxide, rate, which is a mixture of partial ste-
or partially reduced by transition aric and palmitic acid esters of sorbitol
metal catalytic hydrogenation in aque- anhydrides, may be safely used in or on
ous solution. food in accordance with the following
(b) The additive meets the specifica- prescribed conditions:
tions of the Food Chemicals Codex, 7th (a) The food additive is manufactured
ed. (2010), pp. 811–814, which is incor- by reacting stearic acid (usually con-
porated by reference. The Director of taining associated fatty acids, chiefly
the Office of the Federal Register ap- palmitic) with sorbitol to yield essen-
proves this incorporation by reference tially a mixture of esters.
in accordance with 5 U.S.C. 552(a) and 1 (b) The food additive meets the fol-
CFR part 51. You may obtain copies lowing specifications:
from the United States Pharmacopeial Saponification number, 147–157
Convention, 12601 Twinbrook Pkwy., Acid number, 5–10
Rockville, MD 20852 (Internet address Hydroxyl number, 235–260
http://www.usp.org). Copies may be ex-
(c) It is used or intended for use,
amined at the Dockets Management
alone or in combination with poly-
Staff (HFA–305), Food and Drug Admin-
sorbate 60 as follows:
istration, 5630 Fishers Lane, Rm. 1061,
(1) As an emulsifier in whipped edible
Rockville, MD 20852, 240–402–7500, be-
oil topping with or without one or a
tween 9 a.m. and 4 p.m., Monday
combination of the following:
(i) Polysorbate 60;
(ii) Polysorbate 65;
(NARA). For information on the avail-
(iii) Polysorbate 80;
ability of this material at NARA, call
202–741–6030 or go to: http:// whereby the maximum amount of the
www.archives.gov/federal-register/cfr/ibr- additive or additives used does not ex-
locations.html. ceed 0.4 percent of the weight of the
(c) When standards of identity estab- finished whipped edible oil topping; ex-
lished under section 401 of the act do cept that a combination of the additive
not preclude such use, polydextrose with polysorbate 60 may be used in ex-
may be used in accordance with cur- cess of 0.4 percent: Provided, That the
rent good manufacturing practices as a amount of the additive does not exceed
103
§ 172.844 21 CFR Ch. I (4–1–23 Edition)
0.27 percent and the amount of poly- (5) As an emulsifier in solid-state, ed-
sorbate 60 does not exceed 0.77 percent ible vegetable fat-water emulsions in-
of the weight of the finished whipped tended for use as substitutes for milk
edible oil topping. or cream in beverage coffee, with or
(2) As an emulsifier in cakes and cake without one or a combination of the
mixes, with or without one or a com- following:
bination of the following: (i) Polysorbate 60.
(i) Polysorbate 65. (ii) Polysorbate 65.
(ii) Polysorbate 60. The maximum amount of the additive
When used alone, the maximum or additives shall not exceed 0.4 per-
amount of sorbitan monostearate shall cent by weight of the finished edible
not exceed 0.61 percent of the cake or vegetable fat-water emulsion.
cake mix, on a dry-weight basis. When (6) It is used alone as a rehydration
used with polysorbate 65 and/or poly- aid in the production of active dry
sorbate 60, it shall not exceed 0.61 per- yeast in an amount not to exceed 1 per-
cent, nor shall the polysorbate 65 ex- cent by weight of the dry yeast.
ceed 0.32 percent or the polysorbate 60 (7) As an emulsifier, alone or in com-
exceed 0.46 percent, and no combina- bination with polysorbate 60, in the
tion of the emulsifiers shall exceed 0.66 minimum quantity required to accom-
percent of the weight of the cake or plish the intended effect, in formula-
cake mix, calculated on a dry-weight tions of white mineral oil conforming
basis. with § 172.878 and/or petroleum wax
(3) As an emulsifier, alone or in com- conforming with § 172.886 for use as pro-
bination with polysorbate 60 in non- tective coatings on raw fruits and vege-
standardized confectionery coatings tables.
and standardized cacao products speci- (d) To assure safe use of the additive,
fied in §§ 163.123, 163.130, 163.135, 163.140, in addition to the other information re-
163.145, and 163.150 of this chapter, as quired by the Act:
follows: (1) The label of the additive and any
(i) It is used alone in an amount not intermediate premixes shall bear:
to exceed 1 percent of the weight of the (i) The name of the additive.
finished nonstandardized confectionery (ii) A statement of the concentration
coating or standardized cacao product. or strength of the additive in any in-
(ii) It is used with polysorbate 60 in termediate premixes.
any combination of up to 1 percent sor- (2) The label or labeling shall bear
bitan monostearate and up to 0.5 per- adequate directions to provide a final
cent polysorbate 60 provided that the product that complies with the limita-
total combination does not exceed 1 tions prescribed in paragraph (c) of this
percent of the weight of the finished section.
nonstandardized confectionery coating [42 FR 14491, Mar. 15, 1977, as amended at 43
or standardized cacao product. FR 2871, Jan. 20, 1978]
(4) As an emulsifier in cake icings
and cake fillings, with or without one § 172.844 Calcium stearoyl-2-lactylate.
or a combination of the following: The food additive calcium stearoyl-2-
(i) Polysorbate 65. lactylate may be safely used in or on
(ii) Polysorbate 60. food in accordance with the following
When used alone, the maximum prescribed conditions:
amount of sorbitan monostearate shall (a) The additive, which is a mixture
not exceed 0.7 percent of the weight of of calcium salts of stearoyl lactylic
the cake icing or cake filling. When acids and minor proportions of other
used with polysorbate 65 and/or poly- calcium salts of related acids, is manu-
sorbate 60, it shall not exceed 0.7 per- factured by the reaction of stearic acid
cent, nor shall the polysorbate 65 ex- and lactic acid and conversion to the
ceed 0.32 percent or the polysorbate 60 calcium salts.
exceed 0.46 percent, and no combina- (b) The additive meets the following
specifications:
tion of these emulsifiers shall exceed 1

percent of the weight of the cake icing Acid number, 50–86.
or cake filling. Calcium content, 4.2–5.2 percent.
104
Lactic acid content, 32–38 percent. Records Administration (NARA). For
Ester number, 125–164. information on the availability of this
(c) It is used or intended for use as material at NARA, call 202–741–6030, or
follows: go to: http://www.archives.gov/fed-
(1) As a dough conditioner in yeast- eral_register/code_of_federal_regulations/
leavened bakery products and prepared ibr_locations.html.
mixes for yeast-leavened bakery prod- (c) It is used or intended for use as
ucts in an amount not to exceed 0.5 follows when standards of identity es-
part for each 100 parts by weight of tablished under section 401 of the Act
flour used. do not preclude such use:
(2) As a whipping agent in: (1) As a dough strengthener, emulsi-
(i) Liquid and frozen egg white at a
fier, or processing aid in baked prod-
level not to exceed 0.05 percent.
ucts, pancakes, and waffles, in an
(ii) Dried egg white at a level not to
exceed 0.5 percent. amount not to exceed 0.5 part for each
(iii) Whipped vegetable oil topping at 100 parts by weight of flour used.
a level not to exceed 0.3 percent of the (2) As a surface-active agent, emulsi-
weight of the finished whipped vege- fier, or stabilizer in icings, fillings,
table oil topping. puddings, and toppings, at a level not
(3) As a conditioning agent in dehy- to exceed 0.2 percent by weight of the
drated potatoes in an amount not to finished food.
exceed 0.5 percent by weight thereof. (3) As an emulsifier or stabilizer in
(d) To assure safe use of the additive: liquid and solid edible fat-water emul-
(1) The label and labeling of the food sions intended for use as substitutes
additive and any intermediate premix for milk or cream in beverage coffee, at
prepared therefrom shall bear, in addi- a level not to exceed 0.3 percent by
tion to the other information required weight of the finished edible fat-water
by the act, the following: emulsion.
(i) The name of the additive. (4) As a formulation aid, processing
(ii) A statement of the concentration
aid, or surface-active agent in dehy-
or strength of the additive in any in-
termediate premixes. drated potatoes, in an amount not to
(2) The label or labeling of the food exceed 0.5 percent of the dry weight of
additive shall also bear adequate direc- the food.
tions of use to provide a finished food (5) As an emulsifier, stabilizer, or
that complies with the limitations pre- texturizer in snack dips, at a level not
scribed in paragraph (c) of this section. to exceed 0.2 percent by weight of the
finished product.
§ 172.846 Sodium stearoyl lactylate. (6) As an emulsifier, stabilizer, or
The food additive sodium stearoyl texturizer in cheese substitutes and
lactylate (CAS Reg. No. 25–383–997) may imitations and cheese product sub-
be safely used in food in accordance stitutes and imitations, at a level not
with the following prescribed condi- to exceed 0.2 percent by weight of the
tions: finished food.
(a) The additive, which is a mixture (7) As an emulsifier, stabilizer, or
of sodium salts of stearoyl lactylic texturizer in sauces or gravies, and the
acids and minor proportions of sodium products containing the same, in an
salts of related acids, is manufactured amount not to exceed 0.25 percent by
by the reaction of stearic acid and lac- weight of the finished food.
tic acid and conversion to the sodium
(8) In prepared mixes for each of the
salts.
foods listed in paragraphs (c)(1)
(b) The additive meets the specifica-
tions of the ‘‘Food Chemicals Codex,’’ through (7) of this section, provided the
3d Ed. (1981), pp. 300–301, which is incor- additive is used only as specified in
porated by reference. Copies may be each of those paragraphs.
obtained from the National Academy (9) As an emulsifier, stabilizer, or
texturizer in cream liqueur drinks, at a
Press, 2101 Constitution Ave. NW.,

Washington, DC 20418, or may be exam-
ined at the National Archives and
105
§ 172.848 21 CFR Ch. I (4–1–23 Edition)
level not to exceed 0.5 percent by the intended physical effect as an

weight of the finished product. emulsifier, plasticizer, or surface-ac-
[45 FR 51767, Aug. 5, 1980, as amended at 49
tive agent in food.
FR 10105, Mar. 19, 1984; 50 FR 49536, Dec. 3,
1985; 51 FR 1495, Jan. 14, 1986; 51 FR 3333, Jan. § 172.852 Glyceryl-lacto esters of fatty
27, 1986; 65 FR 60859, Oct. 13, 2000] acids.
Glyceryl-lacto esters of fatty acids
§ 172.848 Lactylic esters of fatty acids. (the lactic acid esters of mono- and
Lactylic esters of fatty acids may be diglycerides) may be safely used in
safely used in food in accordance with food in accordance with the following
the following prescribed conditions: prescribed conditions:
(a) They are prepared from lactic (a) They are manufactured from glyc-
acid and fatty acids meeting the re- erin, lactic acid, and fatty acids con-
quirements of § 172.860(b) and/or oleic forming with § 172.860 and/or oleic acid
acid derived from tall oil fatty acids derived from tall oil fatty acids con-
meeting the requirements of § 172.862. forming with § 172.862 and/or edible fats
(b) They are used as emulsifiers, plas- and oils.
ticizers, or surface-active agents in the (b) They are used in amounts not in
following foods, when standards of excess of those reasonably required to
identity do not preclude their use: accomplish their intended physical or
Foods Limitations technical effect as emulsifiers and plas-
ticizers in food.
Bakery mixes ................................
Baked products .............................
Cake icings, fillings, and toppings § 172.854 Polyglycerol esters of fatty
Dehydrated fruits and vegetables acids.
Dehydrated fruit and vegetable
juices. Polyglycerol esters of fatty acids, up
Edible vegetable fat-water emul- As substitutes for milk or to and including the decaglycerol
sions. cream in beverage cof- esters, may be safely used in food in ac-
fee.
Frozen desserts ............................ cordance with the following prescribed
Liquid shortening .......................... For household use. conditions:
Pancake mixes ............................. (a) They are prepared from corn oil,
Precooked instant rice ..................
Pudding mixes .............................. cottonseed oil, lard, palm oil from
fruit, peanut oil, safflower oil, sesame
(c) They are used in an amount not oil, soybean oil, and tallow and the
greater than required to produce the fatty acids derived from these sub-
intended physical or technical effect, stances (hydrogenated and nonhydro-
and they may be used with shortening genated) meeting the requirements of
and edible fats and oils when such are § 172.860(b) and/or oleic acid derived
required in the foods identified in para- from tall oil fatty acids meeting the
graph (b) of this section. requirements of § 172.862.
(b) They are used as emulsifiers in
§ 172.850 Lactylated fatty acid esters food, in amounts not greater than that
of glycerol and propylene glycol. required to produce the intended phys-
The food additive lactylated fatty ical or technical effect.
acid esters of glycerol and propylene (c) Polyglycerol esters of a mixture
glycol may be safely used in food in ac- of stearic, oleic, and coconut fatty
cordance with the following prescribed acids are used as a cloud inhibitor in
conditions: vegetable and salad oils when use is
(a) The additive is a mixture of esters not precluded by standards of identity.
produced by the lactylation of a prod- The fatty acids used in the production
uct obtained by reacting edible fats or of the polyglycerol esters meet the re-
oils with propylene glycol. quirements of § 172.860(b), and the
(b) The additive meets the following polyglycerol esters are used at a level
specifications: Water insoluble com- not in excess of the amount required to
bined lactic acid, 14–18 percent; and perform its cloud-inhibiting effect.
acid number, 12 maximum. Oleic acid derived from tall oil fatty
(c) It is used in amounts not in excess acids conforming with § 172.862 may be
of that reasonably required to produce used as a substitute for or together
106
with the oleic acid permitted by this tion 401 of the act do not preclude such
paragraph. use:
(d) Polyglycerol esters of butter oil (1) As a stabilizer in frozen dairy des-
fatty acids are used as emulsifiers in serts, in fruit and water ices, and in
combination with other approved emul- confections and frostings at a level not
sifiers in dry, whipped topping base. to exceed 0.5 percent by weight of the
The fatty acids used in the production finished product.
of the polyglycerol esters meet the re- (2) As an emulsifier, flavoring adju-
quirements of § 172.860(b), and the vant, stabilizer, or thickener in baked
polyglycerol esters are used at a level goods at a level not to exceed 0.5 per-
not in excess of the amount required to cent by weight of the finished product.
perform their emulsifying effect. (3) As an emulsifier, stabilizer, or
thickener in cheeses at a level not to
§ 172.856 Propylene glycol mono- and exceed 0.9 percent by weight of the fin-
diesters of fats and fatty acids. ished product.
(4) As an emulsifier, stabilizer, or
Propylene glycol mono- and diesters thickener in fats and oils at a level not
of fats and fatty acids may be safely to exceed 1.1 percent by weight of the
used in food, subject to the following finished product.
prescribed conditions: (5) As an emulsifier, stabilizer, or
(a) They are produced from edible thickener in gelatins and puddings at a
fats and/or fatty acids in compliance level not to exceed 0.6 percent by
with § 172.860 and/or oleic acid derived weight of the finished product.
from tall oil fatty acids in compliance (6) As a stabilizer or thickener in gra-
with § 172.862. vies and in sweet sauces at a level not
(b) They are used in food in amounts to exceed 0.5 percent by weight of the
not in excess of that reasonably re- finished product.
quired to produce their intended effect. (7) As a stabilizer in jams and jellies
at a level not to exceed 0.4 percent by
§ 172.858 Propylene glycol alginate. weight of the finished product.
The food additive propylene glycol (8) As an emulsifier, stabilizer, or
alginate (CAS Reg. No. 9005–37–2) may thickener in condiments and relishes
be used as an emulsifier, flavoring ad- at a level not to exceed 0.6 percent by
juvant, formulation aid, stabilizer, sur- weight of the finished product.
factant, or thickener in foods in ac- (9) As a flavoring adjunct or adjuvant
cordance with the following prescribed in seasonings and flavors at a level not
conditions: to exceed 1.7 percent by weight of the
(a) The additive meets the specifica- finished product.
tions of the Food Chemicals Codex, 3d (10) As an emulsifier, flavoring adju-
Ed. (1981), p. 256, which is incorporated vant, formulation aid, stabilizer or
by reference (Copies are available from thickener, or surface active agent in
the National Academy Press, 2101 Con- other foods, where applicable, at a
stitution Ave. NW., Washington, DC level not to exceed 0.3 percent by
20418, or available for inspection at the weight of the finished product.
National Archives and Records Admin- (c) To ensure safe use of the additive,
istration (NARA). For information on the label of the food additive container
the availability of this material at shall bear, in addition to the other in-
NARA, call 202–741–6030, or go to: http:// formation required by the act:
www.archives.gov/federal_register/ (1) The name of the additive, ‘‘pro-
code_of_federal_regulations/ pylene glycol alginate’’ or ‘‘propylene
ibr_locations.html.), and the additional glycol ester of alginic acid’’.
specification that it shall have up to 85 (2) Adequate directions for use.
percent of the carboxylic acid groups [47 FR 29950, July 9, 1982]
esterified with the remaining groups
either free or neutralized. § 172.859 Sucrose fatty acid esters.
(b) The additive is used or intended Sucrose fatty acid esters identified in
for use in the following foods as defined this section may be safely used in ac-
in § 170.3(n) of this chapter, when stand- cordance with the following prescribed
ards of identity established under sec- conditions:
107
§ 172.859 21 CFR Ch. I (4–1–23 Edition)
(a) Sucrose fatty acid esters are the (NARA). For information on the avail-
mono-, di-, and tri-esters of sucrose ability of this material at NARA, call
with fatty acids and are derived from 202–741–6030, or go to: http://
sucrose and edible tallow or hydro- www.archives.gov/federal_register/
genated edible tallow or edible vege- code_of_federal_regulations/
table oils. The only solvents which ibr_locations.html.
may be used in the preparation of su- (6) Arsenic is not more than 3 parts
crose fatty acid esters are those gen- per million.
erally recognized as safe in food or reg- (7) Total heavy metal content (as Pb)
ulated for such use by an appropriate is not more than 50 parts per million.
section in this part. Ethyl acetate or (8) Lead is not more than 10 parts per
methyl ethyl ketone or dimethyl sulf- million.
oxide and isobutyl alcohol (2-methyl-1- (9) The total content of methyl ethyl
propanol) may be used in the prepara-
ketone or of methanol shall not be
tion of sucrose fatty acid esters.
more than 10 parts per million as deter-
(b) Sucrose fatty acid esters meet the
mined by a method titled ‘‘Methyl
following specifications:
Ethyl Ketone Test; Methyl Alcohol
(1) The total content of mono-, di-,
Test,’’ which is incorporated by ref-
and tri-esters is not less than 80 per-
erence. Copies are available from the
cent as determined by a method title
Office of Food Additive Safety (HFS–
‘‘Sucrose Fatty Acid Esters, Method of
200), Center for Food Safety and Ap-
Assay,’’ which is incorporated by ref-
plied Nutrition, Food and Drug Admin-
istration, 5001 Campus Dr., College
Office of Food Additive Safety (HFS–
200), Center for Food Safety and Ap- Park, MD 20740, 240–402–1200, or avail-
plied Nutrition, Food and Drug Admin- able for inspection at the National Ar-
istration, 5001 Campus Dr., College chives and Records Administration
Park, MD 20740, 240–402–1200, or avail- (NARA). For information on the avail-
able for inspection at the National Ar- ability of this material at NARA, call
chives and Records Administration 202–741–6030, or go to: http://
(NARA). For information on the avail- www.archives.gov/federal_register/
ability of this material at NARA, call code_of_federal_regulations/
202–741–6030, or go to: http:// ibr_locations.html.
www.archives.gov/federal_register/ (10) The total dimethyl sulfoxide con-
code_of_federal_regulations/ tent is not more than 2 parts per mil-
ibr_locations.html. lion as determined by a method enti-
(2) The free sucrose content is not tled ‘‘Determination of Dimethyl Sulf-
more than 5 percent as determined by oxide,’’ which is incorporated by ref-
Test S.2 in the method titled ‘‘Sucrose erence. Copies are available from the
Fatty Acid Esters, Method of Assay,’’ Office of Food Additive Safety (HFS–
which is incorporated by reference. The 200), Center for Food Safety and Ap-
availability of this incorporation by plied Nutrition, Food and Drug Admin-
reference is given in paragraph (b)(1) of istration, 5001 Campus Dr., College
this section. Park, MD 20740, 240–402–1200, or avail-
(3) The acid value is not more than 6. able for inspection at the National Ar-
(4) The residue on ignition (sulfated chives and Records Administration
ash) is not more than 2 percent. (NARA). For information on the avail-
(5) The total ethyl acetate content is ability of this material at NARA, call
not more than 350 parts per million as 202–741–6030, or go to: http://
determined by a method titled ‘‘Deter- www.archives.gov/federal_register/
mination of Ethyl Acetate,’’ which is code_of_federal_regulations/
incorporated by reference. Copies are ibr_locations.html.
available from the Office of Food Addi- (11) The total isobuytl alcohol (2-
tive Safety (HFS–200), Center for Food methyl-1-propanol) content is not more
Safety and Applied Nutrition, Food and than 10 parts per million as determined
Drug Administration, 5001 Campus Dr., by a method entitled ‘‘Determination
College Park, MD 20740, 240–402–1200, or of Isobutyl Alcohol,’’ which is incor-

available for inspection at the National porated by reference. Copies are avail-
Archives and Records Administration able from the Office of Food Additive
108
Safety (HFS–200), Center for Food Safe- § 172.860 Fatty acids.

ty and Applied Nutrition, Food and
The food additive fatty acids may be
Drug Administration, 5001 Campus Dr.,
safely used in food and in the manufac-
ture of food components in accordance
available for inspection at the National
Archives and Records Administration
tions:
ability of this material at NARA, call (a) The food additive consists of one
202–741–6030, or go to: http:// or any mixture of the following
www.archives.gov/federal_register/ straight-chain monobasic carboxylic
code_of_federal_regulations/ acids and their associated fatty acids
ibr_locations.html. manufactured from fats and oils de-
(c) Sucrose fatty acid esters may be rived from edible sources: Capric acid,
used as follows when standards of iden- caprylic acid, lauric acid, myristic
tity established under section 401 of acid, oleic acid, palmitic acid, and ste-
the Federal Food, Drug, and Cosmetic aric acid.
Act do not preclude such use: (b) The food additive meets the fol-
(1) As emulsifiers as defined in lowing specifications:
§ 170.3(o)(8) of this chapter, or as stabi- (1) Unsaponifiable matter does not
lizers as defined in § 170.3(o)(28) of this exceed 2 percent.
chapter, in baked goods and baking (2) It is free of chick-edema factor:
mixes as defined in § 170.3(n)(1) of this (i) As evidenced during the bioassay
chapter, in chewing gum as defined in method for determining the chick-
§ 170.3(n)(6) of this chapter, in coffee edema factor as prescribed in para-
and tea beverages with added dairy in- graph (c)(2) of this section; or
gredients and/or dairy product ana- (ii) As evidenced by the absence of
logues, in confections and frostings as chromatographic peaks with a reten-
defined in § 170.3(n)(9) of this chapter, tion time relative to aldrin (RA) be-
in dairy product analogues as defined tween 10 and 25, using the gas
in § 170.3(n)(10) of this chapter, in frozen chromatographic-electron capture
dairy desserts and mixes as defined in method prescribed in paragraph (c)(3)
§ 170.3(n)(20) of this chapter, and in of this section. If chromatographic
whipped milk products. peaks are found with RA values be-
(2) As texturizers as defined in tween 10 and 25, the food additive shall
§ 170.3(o)(32) of this chapter in biscuit meet the requirements of the bioassay
mixes, in chewing gum as defined in method prescribed in paragraph (c)(2)
§ 170.3(n)(6) of this chapter, in confec- of this section for determining chick-
tions and frostings as defined in edema factor.
§ 170.3(n)(9) of this chapter, and in (c) For the purposes of this section:
surimi-based fabricated seafood prod- (1) Unsaponifiable matter shall be de-
ucts. termined by the method described in
(3) As components of protective coat- the 13th Ed. (1980) of the ‘‘Official
ings applied to fresh apples, avocados, Methods of Analysis of the Association
bananas, banana plantains, limes, mel- of Official Analytical Chemists,’’ which
ons (honeydew and cantaloupe), pa- is incorporated by reference. Copies are
paya, peaches, pears, pineapples, and available from the AOAC INTER-
plums to retard ripening and spoiling. NATIONAL, 481 North Frederick Ave.,
(d) Sucrose fatty acid esters are used suite 500, Gaithersburg, MD 20877, or
in accordance with current good manu- available for inspection at the National
facturing practice and in an amount Archives and Records Administration
not to exceed that reasonably required (NARA). For information on the avail-
to accomplish the intended effect. ability of this material at NARA, call
[47 FR 55475, Dec. 10, 1982, as amended at 48 202–741–6030, or go to: http://
FR 38226, Aug. 23, 1983; 52 FR 10883, Apr. 6, www.archives.gov/federal_register/
1987; 53 FR 22294, 22297, June 15, 1988; 54 FR code_of_federal_regulations/

24897, June 12, 1989; 60 FR 44756, Aug. 29, 1995; ibr_locations.html.
88 FR 17721, Mar. 24, 2023]
109
§ 172.861 21 CFR Ch. I (4–1–23 Edition)
(2) Chick-edema factor shall be deter- oil, or both oils, may be safely used in
mined by the bioassay method de- food in accordance with the following
scribed in ‘‘Official Methods of Anal- conditions:
ysis of the Association of Official Ana- (a) Cocoa butter substitute from co-
lytical Chemists,’’ 13th Ed. (1980), sec- conut oil, palm kernel oil (CAS Reg.
tions 28.127–28.130, which is incor- No. 85665–33–4), or both oils is a mixture
porated by reference. Copies may be of triglycerides. It is manufactured by
obtained from the AOAC INTER- esterification of glycerol with food-
NATIONAL, 481 North Frederick Ave., grade fatty acids (complying with
suite 500, Gaithersburg, MD 20877, or § 172.860) derived from edible coconut
may be examined at the National Ar- oil, edible palm kernel oil, or both oils.
chives and Records Administration (b) The ingredient meets the fol-
(NARA). For information on the avail- lowing specifications:
202–741–6030, or go to: http:// Acid number: Not to exceed 0.5.
www.archives.gov/federal_register/ Saponification number: 220 to 260.
Iodine number: Not to exceed 3.
Melting range: 30 to 44 °C.
ibr_locations.html.
(3) The gas chromatographic-electron (c) The ingredient is used or intended
capture method for testing fatty acids for use as follows:
for chick-edema shall be the method (1) As coating material for sugar,
described in the ‘‘Journal of the Asso- table salt, vitamins, citric acid, suc-
ciation of Official Analytical Chem- cinic acid, and spices; and
ists,’’ Volume 50 (No. 1), pages 216–218 (2) In compound coatings, cocoa
(1967), or the modified method using a creams, cocoa-based sweets, toffees,
sulfuric acid clean-up procedure, as de- caramel masses, and chewing sweets as
scribed in the ‘‘Journal of the Associa- defined in § 170.3 (n)(9) and (n)(38) of
tion of the Official Analytical Chem- this chapter, except that the ingredient
ists,’’ Volume 51 (No. 2), pages 489–490 may not be used in a standardized food
(1968), which are incorporated by ref- unless permitted by the standard of
erence. See paragraph (c)(2) of this sec- identity.
tion for availability of these ref- (d) The ingredient is used in accord-
erences. ance with current good manufacturing
(d) It is used or intended for use as practice and in an amount not to ex-
follows: ceed that reasonably required to ac-
(1) In foods as a lubricant, binder, complish the intended effect.
and as a defoaming agent in accordance
with good manufacturing practice. [56 FR 66970, Dec. 27, 1991; 57 FR 2814, Jan. 23,
(2) As a component in the manufac- 1992]
ture of other food-grade additives.
(e) To assure safe use of the additive, § 172.862 Oleic acid derived from tall
oil fatty acids.
the label and labeling of the additive
and any premix thereof shall bear, in The food additive oleic acid derived
addition to the other information re- from tall oil fatty acids may be safely
quired by the act, the following: used in food and as a component in the
(1) The common or usual name of the manufacture of food-grade additives in
acid or acids contained therein. accordance with the following pre-
(2) The words ‘‘food grade,’’ in jux- scribed conditions:
taposition with and equally as promi- (a) The additive consists of purified
nent as the name of the acid. oleic acid separated from refined tall
oil fatty acids.
FR 11837, Mar. 19, 1982; 49 FR 10105, Mar. 19, (b) The additive meets the following
1984; 54 FR 24897, June 12, 1989] specifications:
(1) Specifications for oleic acid pre-
§ 172.861 Cocoa butter substitute from scribed in the Food Chemicals Codex,
coconut oil, palm kernel oil, or both 7th ed. (2010), pp. 743–744, which is in-
oils.
corporated by reference, except that

The food additive, cocoa butter sub- titer (solidification point) shall not ex-
stitute from coconut oil, palm kernel ceed 13.5 °C and unsaponifiable matter
110
shall not exceed 0.5 percent. The Direc- (2) The words ‘‘food grade’’ in jux-
tor of the Office of the Federal Register taposition with and equally as promi-
approves this incorporation by ref- nent as the name of the acid.
erence in accordance with 5 U.S.C. [42 FR 14491, Mar. 15, 1977, as amended at 49
552(a) and 1 CFR part 51. You may ob- FR 10105, Mar. 19, 1984; 78 FR 71465, Nov. 29,
tain copies from the United States 2013; 88 FR 17721, Mar. 24, 2023]
Pharmacopeial Convention, 12601
Twinbrook Pkwy., Rockville, MD 20852 § 172.863 Salts of fatty acids.
(Internet address http://www.usp.org). The food additive salts of fatty acids
Copies may be examined at the Dock- may be safely used in food and in the
ets Management Staff (HFA–305), Food manufacture of food components in ac-
and Drug Administration, 5630 Fishers cordance with the following prescribed
Lane, Rm. 1061, Rockville, MD 20852, conditions:
240–402–7500, between 9 a.m. and 4 p.m., (a) The additive consists of one or
any mixture of two or more of the alu-
minum, calcium, magnesium, potas-
sium, and sodium salts of the fatty
tration (NARA). For information on acids conforming with § 172.860 and/or
the availability of this material at oleic acid derived from tall oil fatty
NARA, call 202–741–6030 or go to: http:// acids conforming with § 172.862.
www.archives.gov/federal-register/cfr/ibr- (b) The food additive is used or in-
locations.html. tended for use as a binder, emulsifier,
(2) The resin acid content does not and anticaking agent in food in accord-
exceed 0.01 as determined by ASTM ance with good manufacturing prac-
method D1240–82, ‘‘Standard Test Meth- tice.
od for Rosin Acids in Fatty Acids,’’ (c) To assure safe use of the additive,
which is incorporated by reference. the label and labeling of the additive
Copies may be obtained from the Amer- and any premix thereof shall bear, in
ican Society for Testing Materials, 100 addition to the other information re-
Barr Harbor Dr., West Conshohocken, quired by the Act, the following:
Philadelphia, PA 19428-2959, or may be (1) The common or usual name of the
examined at the National Archives and fatty acid salt or salts contained there-
Records Administration (NARA). For in.
(2) The words ‘‘food grade,’’ in jux-
taposition with and equally as promi-
nent as the name of the salt.
go to: http://www.archives.gov/fed-
eral_register/code_of_federal_regulations/ § 172.864 Synthetic fatty alcohols.
ibr_locations.html. Synthetic fatty alcohols may be safe-
(3) The requirements for absence of ly used in food and in the synthesis of
chick-edema factor as prescribed in food components in accordance with
§ 172.860. the following prescribed conditions:
(c) It is used or intended for use as (a) The food additive consists of any
follows: one of the following fatty alcohols:
(1) In foods as a lubricant, binder, (1) Hexyl, octyl, decyl, lauryl,
and defoaming agent in accordance myristyl, cetyl, and stearyl; manufac-
with good manufacturing practice. tured by fractional distillation of alco-
(2) As a component in the manufac- hols obtained by a sequence of oxida-
ture of other food-grade additives. tion and hydrolysis of organo-alu-
(d) To assure safe use of the additive, minums generated by the controlled re-
the label and labeling of the additive action of low molecular weight
and any premix thereof shall bear, in trialkylaluminum with purified ethyl-
ene (minimum 99 percent by volume
addition to the other information re-
C2H4), and utilizing the hydrocarbon
quired by the Act, the following:
solvent as defined in paragraph (b) of
(1) The common or usual name of the this section, such that:
acid.
(i) Hexyl, octyl, decyl, lauryl, and

myristyl alcohols contain not less than
99 percent of total alcohols and not less
111
§ 172.864 21 CFR Ch. I (4–1–23 Edition)
than 96 percent of straight chain alco- eral_register/code_of_federal_regulations/

hols. Any nonalcoholic impurities are ibr_locations.html.
primarily paraffins. (b) The hydrocarbon solvent used in
(ii) Cetyl and stearyl alcohols con- the process described in paragraph
tain not less than 98 percent of total (a)(1) of this section is a mixture of liq-
alcohols and not less than 94 percent of uid hydrocarbons essentially paraffinic
straight chain alcohols. Any non- in nature, derived from petroleum and
alcoholic impurities are primarily refined to meet the specifications de-
paraffins. scribed in paragraph (b)(1) of this sec-
(iii) The synthetic fatty alcohols con- tion when subjected to the procedures
tain no more than 0.1 weight percent of described in paragraph (b)(2) and (3) of
total diols as determined by a method this section.
available upon request from the Com- (1) The hydrocarbon solvent meets
missioner of Food and Drugs. the following specifications:
(2) Hexyl, octyl, and decyl; manufac- (i) Boiling-point range: 175 °C–275 °C.
tured by fractional distillation of alco- (ii) Ultraviolet absorbance limits as
hols obtained by a sequence of oxida- follows:
tion, hydrolysis, and catalytic hydro-
Maximum
genation (catalyst consists of copper, absorb-
chromium, and nickel) of organo-alu- ance per
Wavelength (millicrons) centimeter
minums generated by the controlled re- optical
action of low molecular weight path length
trialkylaluminum with purified ethyl- 280–289 ............................................................... 0.15
ene (minimum 99 percent by volume 290–299 ............................................................... .12
C2H4), and utilizing an external coolant 300–359 ............................................................... .05
such that these alcohols meet the spec- 360–400 ............................................................... .02
ifications prescribed in paragraph
(a)(1)(i) and (iii) of this section. (2) Use ASTM method D86–82,
(3) n-Octyl; manufactured by the ‘‘Standard Method for Distillation of
hydrodimerization of 1,3-butadiene, fol- Petroleum Products,’’ which is incor-
lowed by catalytic hydrogenation of porated by reference, to determine
the resulting dienol, and distillation to boiling point range. Copies of the ma-
produce n-octyl alcohol with a min- terial incorporated by reference may
imum purity of 99 percent. The analyt- be obtained from the American Society
ical method for n-octyl alcohol entitled for Testing Materials, 100 Barr Harbor
‘‘Test Method [Normal-octanol]’’ dated Dr., West Conshohocken, Philadelphia,
October 2003, and printed by Kuraray PA 19428-2959, or may be examined at
Co., Ltd., is incorporated by reference. the National Archives and Records Ad-
The Director of the Office of the Fed- ministration (NARA). For information
eral Register approves this incorpora- on the availability of this material at
tion by reference in accordance with 5 NARA, call 202–741–6030, or go to: http://
U.S.C. 552(a) and 1 CFR part 51. You www.archives.gov/federal_register/
may obtain a copy from the Office of code_of_federal_regulations/
Food Additive Safety (HFS–200), Center ibr_locations.html.
for Food Safety and Applied Nutrition, (3) The analytical method for deter-
Food and Drug Administration, 5001 mining ultraviolet absorbance limits is
Campus Dr., College Park, MD 20740, as follows:
240–402–1200, or you may examine a
copy at the Dockets Management Staff GENERAL INSTRUCTIONS
(HFA–305), Food and Drug Administra- All glassware should be scrupulously
tion, 5630 Fishers Lane, Rm. 1061, Rock- cleaned to remove all organic matter such as
ville, MD 20852, 240–402–7500, between 9 oil, grease, detergent residues, etc. Examine
a.m. and 4 p.m., Monday through Fri- all glassware, including stoppers and stop-
cocks, under ultraviolet light to detect any
day, or at the National Archives and
residual fluorescent contamination. As a pre-
Records Administration (NARA). For cautionary measure, it is recommended prac-
information on the availability of this tice to rinse all glassware with purified iso-
material at NARA, call 202–741–6030, or octane immediately before use. No grease is
go to http://www.archives.gov/fed- to be used on stopcocks or joints. Great care
112
to avoid contamination of hydrocarbon sol- Wavelength repeatability, ±0.2 milli-
vent samples in handling and to assure ab- micron.
sence of any extraneous material arising Wavelength accuracy, ±1.0 millimicron.
from inadequate packaging is essential. Be- Nitrogen cylinder. Water-pumped or equiva-
cause some of the polynuclear hydrocarbons lent purity nitrogen in cylinder equipped
sought in this test are very susceptible to with regulator and valve to control flow at 5
photo-oxidation, the entire procedure is to p.s.i.g.
be carried out under subdued light.
REAGENTS AND MATERIALS
APPARATUS Organic solvents. All solvents used through-
Chromatographic tube. 450 millimeters in out the procedure shall meet the specifica-
length (packing section), inside diameter 19 tions and tests described in this specifica-
millimeters ±1 millimeter, equipped with a tion. The isooctane, benzene, hexane, and 1,2-
wad of clean Pyrex brand filtering wool (Cor- dichloroethane designated in the list fol-
ning Glass Works Catalog No. 3950 or equiva- lowing this paragraph shall pass the fol-
lent). The tube shall contain a 250-milliliter lowing test:
reservoir and a 2-millimeter tetrafluoro- To the specified quantity of solvent in a
ethylene polymer stopcock at the opposite 250-milliliter beaker, add 1 milliliter of puri-
end. Overall length of the tube is 670 milli- fied n-hexadecane and evaporate in the vacu-
meters. um oven under a stream of nitrogen. Dis-
Stainless steel rod. 2 feet in length, 2 to 4 continue evaporation when not over 1 milli-
millimeters in diameter. liter of residue remains. (To the residue from
Vacuum oven. Similar to Labline No. 3610 benzene add a 5-milliliter portion of purified
but modified as follows: A copper tube one- isooctane, reevaporate, and repeat once to
fourth inch in diameter and 13 inches in insure complete removal of benzene.)
length is bent to a right angle at the 4-inch Dissolve the 1 milliliter of hexadecane res-
point and plugged at the opposite end; eight idue in isooctane and make to 5 milliliters
copper tubes one-eighth inch in diameter and volume. Determine the absorbance in the 1-
5 inches in length are silver soldered in centimeter path length cells compared to
drilled holes (one-eighth inch in diameter) to isooctane as reference. The absorbance of the
the one-fourth-inch tube, one on each side at solution of the solvent residue shall not ex-
the 5-, 7.5-, 10- and 12.5-inch points; the one- ceed 0.02 per centimeter path length between
eighth-inch copper tubes are bent to conform 280 and 300 mμ and shall not exceed 0.01 per
with the inner periphery of the oven. centimeter path length between 300 and 400
Beakers. 250-milliliter and 500-milliliter ca- mμ.
pacity. Isooctane (2,2,4-trimethylpentane). Use 10
Graduated cylinders. 25-milliliter, 50-milli- milliliters for the test described in the pre-
liter, and 150-milliliter capacity. ceding paragraph. If necessary, isooctane
Tuberculin syringe. 1-milliliter capacity, may be purified by passage through a column
with 3-inch, 22-gauge needle. of activated silica gel (Grade 12, Davison
Volumetric flask. 5-milliliter capacity. Chemical Co., Baltimore, Md., or equiva-
Spectrophotometric cells. Fused quartz lent).
ground glass stoppered cells, optical path Benzene, spectro grade (Burdick and Jackson
length in the range of 1.000 centimeter ±0.005 Laboratories, Inc., Muskegon, Mich., or equiva-
centimeter. With distilled water in the cells, lent). Use 80 milliliters for the test. If nec-
determine any absorbance difference. essary, benzene may be purified by distilla-
Spectrophotometer. Spectral range 250 milli- tion or otherwise.
microns—400 millimicrons with spectral slit Hexane, spectro grade (Burdick and Jackson
width of 2 millimicrons or less: under instru- Laboratories, Inc., Muskegon, Mich., or equiva-
ment operating conditions for these absorb- lent). Use 650 milliliters for the test. If nec-
ance measurements, the spectrophotometer essary, hexane may be purified by distilla-
shall also meet the following performance tion or otherwise.
requirements: 1,2-Dichloroethane, spectro grade (Matheson,
Absorbance repeatability, ±0.01 at 0.4 ab- Coleman, and Bell, East Rutherford, N.J., or
sorbance.
Absorbance accuracy, 1 ±0.05 at 0.4 absorb- are available from the Office of Food Addi-
ance. tive Safety (HFS–200), Center for Food Safe-
ty and Applied Nutrition, Food and Drug Ad-
1 As determined by using potassium chro- ministration, 5001 Campus Dr., College Park,
mate for reference standard and described in MD 20740, 240–402–1200, or available for in-
National Bureau of Standards Circular 484, spection at the National Archives and
Spectrophotometry, U.S. Department of Records Administration (NARA). For infor-
Commerce, (1949). The accuracy is to be de- mation on the availability of this material
termined by comparison with the standard at NARA, call 202–741–6030, or go to: http://
values at 290, 345, and 400 millimicrons. Cir- www.archives.gov/federal_register/
cular 484 is incorporated by reference. Copies code_of_federal_regulations/ibr_locations.html.
113
§ 172.864 21 CFR Ch. I (4–1–23 Edition)
equivalent). Use 20 milliliters for test. If nec- Weigh out 40 grams ±0.1 gram of the hydro-
essary, 1,2-dichloroethane may be purified by carbon solvent sample into a 250-milliliter
distillation. beaker, add 50 milliliters of hexane, and pour
Eluting mixtures: the solution into the column. Rinse the
1. 10 percent 1,2-dichloroethane in hexane. beaker with 50 milliliters of hexane and add
Pipet 100 milliliters of 1,2-dichloroethane this to the column. Allow the hexane sample
into a 1-liter glass-stoppered volumetric solution to elute into a 500-milliliter beaker
flask and adjust to volume with hexane, with until the solution is about one-half inch
mixing. above the gel. Rinse the column three times
2. 40 percent benzene in hexane. Pipet 400 with 50-milliliter portions of hexane. Allow
milliliters of benzene into a 1-liter glass- each hexane rinse to separately elute to
stoppered volumetric flask and adjust to vol- about one-half inch above the gel. Replace
ume with hexane, with mixing. the eluate beaker (discard the hexane eluate)
n-Hexadecane, 99 percent olefin-free. Dilute with a 250-milliliter beaker. Add two sepa-
1.0 milliliter of n-hexadecane to 5 milliliters rate 25-milliliter portions of 10 percent 1,2-
with isooctane and determine the absorbance dichloroethane and allow each to separately
in a 1-centimeter cell compared to isooctane elute as before. Finally, add 150 milliliters of
as reference between 280 mμ-400mμ. The ab- 10 percent 1,2-dichloroethane for a total of
sorbance per centimeter path length shall 200 milliliters. When the final 10 percent 1,2-
not exceed 0.00 in this range. If necessary, n- dichloroethane fraction is about one-half
hexadecane may be purified by percolation inch above the top of the gel bed, replace the
through activated silica gel or by distilla-
receiving beaker (discard the 1,2-
tion.
dichloroethane eluate) with a 250-milliliter
Silica gel, 28–200 mesh (Grade 12, Davison
beaker containing 1 milliliter of hexadecane.
Chemical Co., Baltimore, Md., or equivalent).
Adjust the elution rate to 2 to 3 milliliters
Activate as follows: Weigh about 900 grams
per minute, add two 25-milliliter portions of
into a 1-gallon bottle, add 100 milliliters of
40 percent benzene and allow each to sepa-
de-ionized water, seal the bottle and shake
and roll at intervals for 1 hour. Allow to rately elute as before to within about one-
equilibrate overnight in the sealed bottle. half inch of the gel bed. Finally, add 150 mil-
Activate the gel at 150 °C for 16 hours, in a liliters of 40 percent benzene for a total of 200
2-inch × 7-inch × 12-inch porcelain pan loose- milliliters. Evaporate the benzene in the
ly covered with aluminum foil, cool in a oven with vacuum and sufficient nitrogen
dessicator, transfer to a bottle and seal. flow to just ripple the top of the benzene so-
lution. When the benzene is removed (as de-
PROCEDURE termined by a constant volume of hexa-
decane) add 5 milliliters of isooctane and
Determination of ultraviolet absorbance. Be-
evaporate. Repeat once to insure complete
fore proceeding with the analysis of a sample
removal of benzene. Remove the beaker and
determine the absorbance in a 1-centimeter
path cell for the reagent blank by carrying cover with aluminum foil (previously rinsed
out the procedure without a sample. Record with hexane) until cool.
the absorbance in the wavelength range of Quantitatively transfer the hexadecane
280 to 400 millimicrons. Typical reagent residue to a 5-milliliter volumetric flask and
blank absorbance in this range should not dilute to volume with isooctane. Determine
exceed 0.04 in the 280 to 299 millimicron the absorbance of the solution in 1-centi-
range, 0.02 in the 300 to 359 millimicron meter path length cells between 280 and 400
range, and 0.01 in the 360 to 400 millimicron millimicrons using isooctane as a reference.
range. If the characteristic benzene peaks in Correct the absorbance values for any ab-
the 250 to 260 millimicron region are present, sorbance derived from reagents as deter-
remove the benzene by the procedure de- mined by carrying out the procedure without
scribed above under ‘‘Reagents and Mate- a sample. If the corrected absorbance does
rials,’’ ‘‘Organic Solvents,’’ and record ab- not exceed the limits prescribed in para-
sorbance again. graph (b)(1)(ii) of this section, the sample
Transfer 50 grams of silica gel to the meets the ultraviolet absorbance specifica-
chromatographic tube for sample analysis. tions for hydrocarbon solvent.
Raise and drop the column on a semisoft,
clean surface for about 1 minute to settle the (c) Synthetic fatty alcohols may be
gel. Pour 100 milliliters of hexane into the used as follows:
column with the stopcock open and allow to (1) As substitutes for the cor-
drain to about one-half inch above the gel. responding naturally derived fatty al-
Turn off the stopcock and allow the column cohols permitted in food by existing
to cool for 30 minutes. After cooling, vibrate
the column to eliminate air and stir the top regulations in this part or part 173 of
1 to 2 inches with a small diameter stainless this chapter provided that the use is in
steel rod. Take care not to get the gel above compliance with any prescribed limita-
the liquid and onto the sides of the column. tions.
114
(2) As substitutes for the cor- go to: http://www.archives.gov/federal-

responding naturally derived fatty al- register/cfr/ibr-locations.html.
cohols used as intermediates in the (c) Olestra may be used in place of
synthesis of food additives and other fats and oils in prepackaged ready-to-
substances permitted in food. eat savory (i.e., salty or piquant but
not sweet) snacks and prepackaged,
unpopped popcorn kernels that are
FR 11837, Mar. 19, 1982; 49 FR 10105, Mar. 19,
1984; 54 FR 24897, June 12, 1989; 70 FR 72908,
ready-to-heat. In such foods, the addi-
Dec. 8, 2005; 81 FR 5591, Feb. 3, 2016; 88 FR tive may be used in place of fats and
17721, Mar. 24, 2023] oils for frying or baking, in dough con-
ditioners, in sprays, in filling ingredi-
§ 172.866 Synthetic glycerin produced ents, or in flavors.
by the hydrogenolysis of carbo- (d) To compensate for any inter-
hydrates. ference with absorption of fat soluble
Synthetic glycerin produced by the vitamins, the following vitamins shall
hydrogenolysis of carbohydrates may be added to foods containing olestra:
be safely used in food, subject to the 1.9 milligrams alpha-tocopherol equiva-
provisions of this section: lents per gram olestra; 51 retinol
(a) It shall contain not in excess of equivalents per gram olestra (as
0.2 percent by weight of a mixture of retinyl acetate or retinyl palmitate); 12
IU vitamin D per gram olestra; and 8 μg
butanetriols.
vitamin K1 per gram olestra.
(b) It is used or intended for use in an (e)(1) Vitamins A, D, E, and K present
amount not to exceed that reasonably in foods as a result of the requirement
required to produce its intended effect. in paragraph (d) of this section shall be
declared in the listing of ingredients.
§ 172.867 Olestra.
Such vitamins shall not be considered
Olestra, as identified in this section, in determining nutrient content for the
may be safely used in accordance with nutritional label or for any nutrient
the following conditions: claims, express or implied.
(a) Olestra is a mixture of octa-, (i) An asterisk shall follow vitamins
hepta-, and hexa-esters of sucrose with A, D, E, and K in the listing of ingredi-
fatty acids derived from edible fats and ents;
oils or fatty acid sources that are gen- (ii) The asterisk shall appear as a su-
erally recognized as safe or approved perscript following each vitamin;
for use as food ingredients. The chain (iii) Immediately following the ingre-
lengths of the fatty acids are no less dient list an asterisk and statement,
than 12 carbon atoms. ‘‘Dietarily insignificant’’ shall appear
(b) Olestra meets the specifications prominently and conspicuously as spec-
of the Food Chemicals Codex, 7th ed. ified in § 101.2(c) of this chapter;
(2010), pp. 744–746, which is incorporated (2) Olestra shall not be considered as
by reference. The Director of the Office a source of fat or calories for purposes
of the Federal Register approves this of §§ 101.9 and 101.13 of this chapter.
incorporation by reference in accord- [61 FR 3171, Jan. 30, 1996; 61 FR 11546, Mar. 21,
ance with 5 U.S.C. 552(a) and 1 CFR 1996, as amended at 68 FR 46402, Aug. 5, 2003;
part 51. You may obtain copies from 69 FR 29432, May 24, 2004; 78 FR 71465, Nov. 29,
the United States Pharmacopeial Con- 2013; 88 FR 17721, Mar. 24, 2023]
vention, 12601 Twinbrook Pkwy., Rock-
ville, MD 20852 (Internet address http:// § 172.868 Ethyl cellulose.
www.usp.org). Copies may be examined The food additive ethyl cellulose may
at the Dockets Management Staff be safely used in food in accordance
(HFA–305), Food and Drug Administra- with the following prescribed condi-
tion, 5630 Fishers Lane, Rm. 1061, Rock- tions:
ville, MD 20852, 240–402–7500, between 9 (a) The food additive is a cellulose
a.m. and 4 p.m., Monday through Fri- ether containing ethoxy (OC2H5) groups
day, or at the National Archives and attached by an ether linkage and con-
Records Administration (NARA). For taining on an anhydrous basis not more

information on the availability of this than 2.6 ethoxy groups per
material at NARA, call 202–741–6030 or anhydroglucose unit.
115
§ 172.869 21 CFR Ch. I (4–1–23 Edition)
(b) It is used or intended for use as those solvents generally recognized as

follows: safe in food.
(1) As a binder and filler in dry vita- (b) Sucrose oligoesters meet the spec-
min preparations. ifications in the methods listed in the
(2) As a component of protective table in this paragraph. The methods
coatings for vitamin and mineral tab- for determining compliance with each
lets. specification are incorporated by ref-
(3) As a fixative in flavoring com- erence. The Director of the Office of
pounds. the Federal Register approves this in-
§ 172.869 Sucrose oligoesters. corporation by reference in accordance
Sucrose oligoesters, as identified in
this section, may be safely used in ac-
ets Management Staff (HFA–305), Food
cordance with the following conditions:
(a) Sucrose oligoesters consist of and Drug Administration, 5630 Fishers
mixtures of sucrose fatty acid esters Lane, Rm. 1061, Rockville, MD 20852,
with an average degree of 240–402–7500, between 9 a.m. and 4 p.m.,
esterification ranging from four to Monday through Friday, or at the Na-
seven. It is produced by tional Archives and Records Adminis-
interesterification of sucrose with tration (NARA). For information on
methyl esters of fatty acids derived the availability of this material at
from edible fats and oils (including hy- NARA, call 202–741–6030 or go to: http://
drogenated fats and oils). The only sol- www.archives.gov/federal-register/cfr/ibr-
vents which may be used in the prepa- locations.html. Copies of the methods
ration of sucrose oligoesters are di- are available from the sources listed in
methyl sulfoxide, isobutyl alcohol, and the table in this paragraph:
Specification Limit Method Cited Source for Obtaining Method
(1) Sucrose esters .................. Not less than 90% .................. ‘‘Method for Analyzing the Pu- Office of Food Additive Safety
rity of Sucrose Fatty Acid (HFS–200), Center for Food
Esters,’’ Chemical Corp., Safety and Applied Nutri-
June 17, 1998 tion, Food and Drug Admin-
istration, 5001 Campus Dr.,
College Park, MD 20740,
240–402–1200.
(2) Mono-, di-, and tri-esters ... Not more than 45% ................ ‘‘Method for Measuring the Do.
Ester Distribution of Su-
crose Oligoesters,’’ issued
by Mitsubishi Chemical
Corp., June 17, 1998.
(3) Tetra-, penta-, hexa-, and Not less than 50% .................. Do. Do.
hepta-esters.
(4) Octa-esters ........................ Not more than 40% ................ Do. Do.
(5) Free Sucrose ..................... Not more than 0.5% ............... ‘‘Free Sucrose Method,’’ Do.
issued by Mitsubishi Chem-
ical Corp., June 17, 1998.
(6) Acid Value ......................... Not more than 4.0 .................. ‘‘Acid Value,’’ Appendix VII, United States Pharmacopeial
Method I (Commercial Fatty Convention, 12601
Acids), in the Food Chemi- Twinbrook Pkwy., Rockville,
cals Codex, 7th ed. (2010), MD 20852 (Internet address
p. 1220. http://www.usp.org)
(7) Residue on Ignition ........... Not more than 0.7% ............... ‘‘Residue on Ignition,’’ Appen- Do.
dix IIC, Method I, in the
Food Chemicals Codex, 7th
ed. (2010), pp. 1141–1142
(using a 1-gram sample).
116
Specification Limit Method Cited Source for Obtaining Method
(8) Residual Methanol ............. Not more than 10 milligrams/ Method listed in the mono- Do
kilogram. graph for ‘‘Sucrose Fatty
Acid Esters’’ in the Food
Chemicals Codex, 7th ed.
(2010), pp. 998–1000.
(9) Residual Dimethyl Sulf- Not more than 2.0 milligrams/ ......do Do.
oxide. kilogram.
(10) Residual Isobutyl Alcohol Not more than 10 milligrams/ ......do Do.
kilogram.
(11) Lead ................................. Not more than 1.0 milligram/ ‘‘Atomic Absorption Do.
kilogram. Spectrophometric Graphite
Furnace Method,’’ Method I
in the Food Chemicals
Codex, 7th ed. (2010), p.
1154–1155
(c) The additive is used as an emulsi- (b) The additive is used or intended
fier (as defined in § 170.3(o)(8) of this for use as follows:
chapter) or stabilizer (as defined in (1) The additive identified in para-
§ 170.3(o)(28) of this chapter) in choco- graph (a)(1) of this section is used or
late and in butter-substitute spreads, intended for use as an emulsifier, film
at a level not to exceed 2.0 percent; ex- former, protective colloid, stabilizer,
cept that the additive may not be used suspending agent, or thickener in food,
in a standardized food unless permitted in accordance with good manufacturing
by the standard of identity. practice. The additive also may be used
[68 FR 50072, Aug. 20, 2003, as amended at 78
as a binder in dietary supplements, in
FR 71465, Nov. 29, 2013; 88 FR 17721, Mar. 24, accordance with good manufacturing
2023] practice.
(2) The additive identified in para-
§ 172.870 Hydroxypropyl cellulose. graph (a)(2) of this section is used or
The food additive hydroxypropyl cel- intended for use as a binder and dis-
lulose may be safely used in food, ex- integrator in tablets or wafers con-
cept standardized foods that do not taining dietary supplements of vita-
provide for such use, in accordance mins and/or minerals. The additive is
with the following prescribed condi- used in accordance with good manufac-
tions: turing practice.
(a) The additive consists of one of the [46 FR 50065, Oct. 9, 1981, as amended at 76 FR
following: 41689, July 15, 2011]
(1) A cellulose ether containing pro-
pylene glycol groups attached by an § 172.872 Methyl ethyl cellulose.
ether linkage that contains, on an an- The food additive methyl ethyl cel-
hydrous basis, not more than 4.6 lulose may be safely used in food in ac-
hydroxypropyl groups per cordance with the following prescribed
anhydroglucose unit. The additive has conditions.
a minimum viscosity of 10 centipoises (a) The additive is a cellulose ether
for a 10 percent by weight aqueous so- having the general formula
lution at 25 degrees C. [C6H(10-x-y)O5(CH3)x(C2H5)y]n, where x is
(2) A cellulose ether containing pro- the number of methyl groups and y is
pylene glycol groups attached by an the number of ethyl groups. The aver-
ether linkage having a hydroxypropoxy age value of x is 0.3 and the average
(OC3H6OH) content of 5 to 16 percent value of y is 0.7.
weight in weight (w/w) on an anhydrous (b) The additive meets the following
basis, i.e., 0.1 to 0.4 hydroxypropyl specifications:
groups per anhydroglucose unit. The (1) The methoxy content shall be not
common name for this form of the ad- less than 3.5 percent and not more than
ditive is low substituted hydroxypropyl 6.5 percent, calculated as OCH3, and the
cellulose. ethoxy content shall be not less than
117
§ 172.874 21 CFR Ch. I (4–1–23 Edition)
14.5 percent and not more than 19 per- Use and Limitations
cent, calculated as OC2H5, both meas- Hard candy production—As a release agent
ured on the dry sample. and antisticking agent, not to exceed 500
(2) The viscosity of an aqueous solu- parts per million in hard candy.
tion, 2.5 grams of the material in 100 Vitamin and mineral tablets—As a compo-
nent of protective coatings.
milliliters of water, at 20 °C, is 20 to 60
centipoises. [42 FR 14491, Mar. 15, 1977, as amended at 49
(3) The ash content on a dry basis has FR 10105, Mar. 19, 1984]
a maximum of 0.6 percent. § 172.878 White mineral oil.
(c) The food additive is used as an
aerating, emulsifying, and foaming White mineral oil may be safely used
agent, in an amount not in excess of in food in accordance with the fol-
lowing conditions:
that reasonably required to produce its
(a) White mineral oil is a mixture of
intended effect.
liquid hydrocarbons, essentially par-
§ 172.874 Hydroxypropyl affinic and naphthenic in nature ob-
methylcellulose. tained from petroleum. It is refined to
meet the following specifications:
The food additive hydroxypropyl (1) It meets the test requirements of
methylcellulose (CAS Reg. No. 9004–65– the United States Pharmacopeia XX
3) may be safely used in food, except in (1980) for readily carbonizable sub-
standardized foods which do not pro- stances (page 532).
vide for such use if: (2) It meets the test requirements of
(a) The additive complies with the U.S.P. XVII for sulfur compounds (page
definition and specifications prescribed 400).
in the National Formulary, 12th edi- (3) It meets the specifications pre-
tion. scribed in the ‘‘Journal of the Associa-
(b) It is used or intended for use as an tion of Official Analytical Chemists,’’
emulsifier, film former, protective col- Volume 45, page 66 (1962), which is in-
loid, stabilizer, suspending agent, or corporated by reference, after correc-
thickener, in accordance with good tion of the ultraviolet absorbance for
manufacturing practice. any absorbance due to added anti-
oxidants. Copies of the material incor-
(c) To insure safe use of the additive,
porated by reference are available from
the container of the additive, in addi-
the Office of Food Additive Safety
tion to being labeled as required by the
(HFS–200), Center for Food Safety and
general provisions of the act, shall be Applied Nutrition, Food and Drug Ad-
accompanied by labeling which con- ministration, 5001 Campus Dr., College
tains adequate directions for use to Park, MD 20740, 240–402–1200, or avail-
provide a final product that complies able for inspection at the National Ar-
with the limitations prescribed in para- chives and Records Administration
graph (b) of this section. (NARA). For information on the avail-
[42 FR 14491, Mar. 15, 1977, as amended at 47 ability of this material at NARA, call
FR 38273, Aug. 31, 1982] 202–741–6030, or go to: http://
www.archives.gov/federal_register/
§ 172.876 Castor oil. code_of_federal_regulations/
ibr_locations.html.
The food additive castor oil may be
(b) White mineral oil may contain
safely used in accordance with the fol- any antioxidant permitted in food by
lowing conditions: regulations issued in accordance with
(a) The additive meets the specifica- section 409 of the Act, in an amount
tions of the United States Pharma- not greater than that required to
copeia XX (1980). produce its intended effect.
(b) The additive is used or intended (c) White mineral oil is used or in-
for use as follows: tended for use as follows:
118
Limitation (inclusive of all petroleum hydro-

Use carbons that may be used in combination
with white mineral oil)
1. As a release agent, binder, and lubricant in or on capsules and tablets con- Not to exceed 0.6% of the capsule or tab-
taining concentrates of flavoring, spices, condiments, and nutrients intended for let.
addition to food, excluding confectionery.
2. As a release agent, binder, and lubricant in or on capsules and tablets con- Not to exceed 0.6% of the capsule or tab-
taining food for special dietary use. let.
3. As a float on fermentation fluids in the manufacture of vinegar and wine to pre- In an amount not to exceed good manu-
vent or retard access of air, evaporation, and wild yeast contamination during facturing practice.
fermentation.
4. As a defoamer in food ............................................................................................. In accordance with § 173.340 of this chap-
ter.
5. In bakery products, as a release agent and lubricant ............................................. Not to exceed 0.15% of bakery products.
6. In dehydrated fruits and vegetables, as a release agent ........................................ Not to exceed 0.02% of dehydrated fruits
and vegetables.
7. In egg white solids, as a release agent .................................................................. Not to exceed 0.1% of egg white solids.
8. On raw fruits and vegetables, as a protective coating ............................................ In an amount not to exceed good manu-
facturing practice.
9. In frozen meat, as a component of hot-melt coating .............................................. Not to exceed 0.095% of meat.
10. As a protective float on brine used in the curing of pickles .................................. In an amount not to exceed good manu-
facturing practice.
11. In molding starch used in the manufacture of confectionery ................................ Not to exceed 0.3 percent in the molding
starch.
12. As a release agent, binder, and lubricant in the manufacture of yeast ................ Not to exceed 0.15 percent of yeast.
13. As an antidusting agent in sorbic acid for food use .............................................. Not to exceed 0.25 percent in the sorbic
acid.
14. As release agent and as sealing and polishing agent in the manufacture of Not to exceed 0.2 percent of confectionery.
confectionery.
15. As a dust control agent for wheat, corn, soybean, barley, rice, rye, oats, and Applied at a level of no more than 0.02
sorghum. percent by weight of grain.
16. As a dust control agent for rice ............................................................................. ISO 100 oil viscosity (100 centistokes (cSt)
at 100 °F) applied at a level of no more
than 0.08 percent by weight of the rice
grain.
[42 FR 14491, Mar. 15, 1977, as amended at 47 FR 8764, Mar. 2, 1982; 47 FR 11838, Mar. 19, 1982;
48 FR 55728, Dec. 15, 1983; 49 FR 10105, Mar. 19, 1984; 54 FR 24897, June 12, 1989; 63 FR 66014,
Dec. 1, 1998; 88 FR 17722, Mar. 24, 2023]
§ 172.880 Petrolatum. subjected to the analytical procedure

described in § 172.886(b):
Petrolatum may be safely used in
food, subject to the provisions of this Ultraviolet absorbance per centimeter
section. path length:
(a) Petrolatum complies with the Millimicrons Maximum
specifications set forth in the United
280–289 ............................................................... 0.25
States Pharmacopeia XX (1980) for 290–299 ............................................................... .20
white petrolatum or in the National 300–359 ............................................................... .14
Formulary XV (1980) for petrolatum. 360–400 ............................................................... .04
(b) Petrolatum meets the following
ultraviolet absorbance limits when (c) Petrolatum is used or intended for
use as follows:
Limitation (inclusive of all petroleum hydrocarbons
Use that may be used in combination with petrolatum)
In bakery products; as release agent and lubricant ................................... With white mineral oil, not to exceed 0.15 percent of
bakery product.
In confectionery; as release agent and as sealing and polishing agent ... Not to exceed 0.2 percent of confectionery.
In dehydrated fruits and vegetables; as release agent .............................. Not to exceed 0.02 percent of dehydrated fruits and
vegetables.
In egg white solids; as release agent ........................................................ Not to exceed 0.1 percent of egg white solids.
On raw fruits and vegetables; as protective coating .................................. In an amount not to exceed good manufacturing prac-
tice.
In beet sugar and yeast; as defoaming agent ........................................... As prescribed in § 173.340 of this chapter.
119
§ 172.882 21 CFR Ch. I (4–1–23 Edition)
(d) Petrolatum may contain any ASTM method D1353–78, ‘‘Standard Test
antioxidant permitted in food by regu- Method for Nonvolatile Matter in Volatile
lations issued in accordance with sec- Solvents for Use in Paint, Varnish, Lacquer,
and Related Products;’’ for those boiling
tion 409 of the Act, in an amount not
above 121 °C, ASTM method D381–80, ‘‘Stand-
greater than that required to produce ard Test Method for Existent Gum in Fuels
its intended effect. by Jet Evaporation’’ shall be used. These
[42 FR 14491, Mar. 15, 1977, as amended at 49 methods are incorporated by reference. Cop-
FR 10105, Mar. 19, 1984] ies may be obtained from the American Soci-
ety for Testing Materials, 100 Barr Harbor
§ 172.882 Synthetic isoparaffinic petro- Dr., West Conshohocken, Philadelphia, PA
leum hydrocarbons. 19428-2959, or may be examined at the Na-
tional Archives and Records Administration
Synthetic isoparaffinic petroleum (NARA). For information on the availability
hydrocarbons may be safely used in of this material at NARA, call 202–741–6030,
food, in accordance with the following or go to: http://www.archives.gov/fed-
conditions: eral_register/code_of_federal_regulations/
(a) They are produced by synthesis ibr_locations.html.
from petroleum gases and consist of a (b) Isoparaffinic petroleum hydro-
mixture of liquid hydrocarbons meet- carbons may contain antioxidants au-
ing the following specifications: thorized for use in food in an amount
Boiling point 93–260 °C as determined by not to exceed that reasonably required
ASTM method D86–82, ‘‘Standard Method for to accomplish the intended technical
Distillation of Petroleum Products,’’ which effect nor to exceed any prescribed lim-
is incorporated by reference. Copies may be itations.
obtained from the American Society for (c) Synthetic isoparaffinic petroleum
Testing Materials, 100 Barr Harbor Dr., West hydrocarbons are used or intended for
Conshohocken, Philadelphia, PA 19428-2959, use as follows:
or may be examined at the National Ar-
chives and Records Administration (NARA). Uses Limitations
For information on the availability of this
material at NARA, call 202–741–6030, or go to: 1. In the froth-flotation cleaning of In an amount not to ex-
http://www.archives.gov/federal_register/ vegetables. ceed good manufac-
turing practice.
code_of_federal_regulations/ibr_locations.html.
2. As a component of insecticide Do.
Ultraviolet absorbance: formulations for use on proc-
260–319 millimicrons—1.5 maximum. essed foods.
320–329 millimicrons—0.08 maximum. 3. As a component of coatings on Do.
330–350 millimicrons—0.05 maximum. fruits and vegetables.
Nonvolatile residual: 0.002 gram per 100 4. As a coating on shell eggs ....... Do.
milliliters maximum. 5. As a float on fermentation Do.
Synthetic isoparaffinic petroleum hydro- fluids in the manufacture of vin-
egar and wine and on brine
carbons containing antioxidants shall meet used in curing pickles, to pre-
the specified ultraviolet absorbance limits vent or retard access of air,
after correction for any absorbance due to evaporation, and contamination
the antioxidants. The ultraviolet absorbance with wild organisms during fer-
shall be determined by the procedure de- mentation.
scribed for application of mineral oil, dis-
regarding the last sentence of the procedure,
under ‘‘Specifications’’ on page 66 of the
FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19,
‘‘Journal of the Association of Official Ana-
1984; 54 FR 24897, June 12, 1989; 88 FR 17722,
lytical Chemists,’’ Volume 45 (February
Mar. 24, 2023]
1962), which is incorporated by reference.
Copies are available from the Office of Food
§ 172.884 Odorless light petroleum hy-
Additive Safety (HFS–200), Center for Food
drocarbons.
Safety and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr., College Odorless light petroleum hydro-
Park, MD 20740, 240–402–1200, or available for carbons may be safely used in food, in
inspection at the National Archives and accordance with the following pre-
Records Administration (NARA). For infor- scribed conditions:
mation on the availability of this material
(a) The additive is a mixture of liquid
at NARA, call 202–741–6030, or go to: http://
www.archives.gov/federal_register/ hydrocarbons derived from petroleum
code_of_federal_regulations/ibr_locations.html. or synthesized from petroleum gases.

For hydrocarbons boiling below 250 °F, the The additive is chiefly paraffinic,
nonvolatile residue shall be determined by isoparaffinic, or naphthenic in nature.
120
(b) The additive meets the following Maximum

specifications: ultraviolet
absorb-
(1) Odor is faint and not kerosenic. ance per
(2) Initial boiling point is 300 °F min- centimeter
path length
imum.
(3) Final boiling point is 650 °F max- 290–299 millimicrons ........................................... 0.12
300–359 millimicrons ........................................... 0.08
imum. 360–400 millimicrons ........................................... 0.02
(4) Ultraviolet absorbance limits de-
termined by method specified in ANALYTICAL SPECIFICATION FOR PETROLEUM
§ 178.3620(b)(1)(ii) of this chapter, as fol- WAX
lows:
Maximum
absorb- Because of the sensitivity of the test, the
Wavelength mμ ance per possibility of errors arising from contamina-
centimeter tion is great. It is of the greatest importance
optical
pathlength that all glassware be scrupulously cleaned to
remove all organic matter such as oil,
280–289 ............................................................... 4.0 grease, detergent residues, etc. Examine all
290–299 ............................................................... 3.3 glassware, including stoppers and stopcocks,
300–329 ............................................................... 2.3 under ultraviolet light to detect any residual
330–360 ............................................................... .8
fluorescent contamination. As a pre-
cautionary measure it is recommended prac-
(c) The additive is used as follows: tice to rinse all glassware with purified iso-
octane immediately before use. No grease is
Use Limitations
to be used on stopcocks or joints. Great care
As a coating on shell eggs ........... In an amount not to ex- to avoid contamination of wax samples in
ceed good manufac- handling and to assure absence of any extra-
turing practice. neous material arising from inadequate
As a defoamer in processing beet Complying with packaging is essential. Because some of the
sugar and yeast. § 173.340 of this chap- polynuclear hydrocarbons sought in this test
ter. are very susceptible to photo-oxidation, the
As a float on fermentation fluids in In an amount not to ex-
entire procedure is to be carried out under
the manufacture of vinegar and ceed good manufac-
wine to prevent or retard ac- turing practice. subdued light.
cess of air, evaporation, and
APPARATUS
wild yeast contamination during
fermentation. Separatory funnels. 250–milliliter, 500–milli-
In the froth-flotation cleaning of Do. liter, 1,000–milliliter, and preferably 2,000–
vegetables.
As a component of insecticide for- Do.
milliliter capacity, equipped with tetra-
mulations used in compliance fluoroethylene polymer stopcocks.
with regulations issued in parts Reservoir. 500–milliliter capacity, equipped
170 through 189 of this chapter. with a 24/40 standard taper male fitting at
the bottom and a suitable ball-joint at the
top for connecting to the nitrogen supply.
§ 172.886 Petroleum wax. The male fitting should be equipped with
Petroleum wax may be safely used in glass hooks.
or on food, in accordance with the fol- Chromatographic tube. 180 millimeters in
length, inside diameter to be 15.7 millimeters
lowing conditions:
±0.1 millimeter, equipped with a coarse, frit-
(a) Petroleum wax is a mixture of ted-glass disc, a tetrafluoroethylene polymer
solid hydrocarbons, paraffinic in na- stopcock, and a female 24/40 standard tapered
ture, derived from petroleum, and re- fitting at the opposite end. (Overall length of
fined to meet the specifications pre- the column with the female joint is 235 milli-
scribed by this section. meters.) The female fitting should be
(b) Petroleum wax meets the fol- equipped with glass hooks.
lowing ultraviolet absorbance limits Disc. Tetrafluoroethylene polymer 2–inch
diameter disc approximately 3⁄16–inch thick
when subjected to the analytical proce- with a hole bored in the center to closely fit
dure described in this paragraph. the stem of the chromatographic tube.
Heating jacket. Conical, for 500–milliliter
Maximum
ultraviolet separatory funnel. (Used with variable trans-
absorb- former heat control.)
ance per Suction flask. 250–milliliter or 500–milliliter
centimeter
path length filter flask.
Condenser. 24/40 joints, fitted with a drying
280–289 millimicrons ........................................... 0.15 tube, length optional.
121
§ 172.886 21 CFR Ch. I (4–1–23 Edition)
Evaporation flask (optional). 250–milliliter tion. The isooctane, benzene, acetone, and
or 500–milliliter capacity all-glass flask methyl alcohol designated in the list fol-
equipped with standard taper stopper having lowing this paragraph shall pass the fol-
inlet and outlet tubes to permit passage of lowing test:
nitrogen across the surface of contained liq- To the specified quantity of solvent in a
uid to be evaporated. 250–milliliter Erlenmeyer flask, add 1 milli-
Vacuum distillation assembly. All glass (for liter of purified n-hexadecane and evaporate
purification of dimethyl sulfoxide); 2–liter on the steam bath under a stream of nitro-
distillation flask with heating mantle; gen (a) loose aluminum foil jacket around
Vigreaux vacuum-jacketed condenser (or the flask will speed evaporation). Dis-
equivalent) about 45 centimeters in length continue evaporation when not over 1 milli-
and distilling head with separable cold finger liter of residue remains. (To the residue from
condenser. Use of tetrafluoroethylene poly- benzene add a 10–milliliter portion of puri-
mer sleeves on the glass joints will prevent fied isooctane, reevaporate, and repeat once
freezing. Do not use grease on stopcocks or to insure complete removal of benzene.)
joints. Alternatively, the evaporation time can be
Spectrophotometric cells. Fused quartz cells, reduced by using the optional evaporation
optical path length in the range of 5.000 cen- flask. In this case the solvent and n-hexa-
timeters ±0.005 centimeter; also for checking decane are placed in the flask on the steam
spectrophotometer performance only, optical bath, the tube assembly is inserted, and a
path length in the range 1.000 centimeter stream of nitrogen is fed through the inlet
±0.005 centimeter. With distilled water in the tube while the outlet tube is connected to a
cells, determine any absorbance differences. solvent trap and vacuum line in such a way
Spectrophotometer. Spectral range 250 milli- as to prevent any flow-back of condensate
microns–400 millimicrons with spectral slit into the flask.
width of 2 millimicrons or less, under instru- Dissolve the 1 milliliter of hexadecane res-
ment operating conditions for these absorb- idue in isooctane and make to 25 milliliters
ance measurements, the spectrophotometer volume. Determine the absorbance in the 5–
shall also meet the following performance centimeter path length cells compared to
requirements: isooctane as reference. The absorbance of the
Absorbance repeatability, ±0.01 at 0.4 ab- solution of the solvent residue (except for
sorbance. methyl alcohol) shall not exceed 0.01 per cen-
Absorbance accuracy, 1 ±0.05 at 0.4 absorb- timeter path length between 280 and 400 mμ.
ance. For methyl alcohol this absorbance value
Wavelength repeatability, ±0.2 milli- shall be 0.00.
micron. Isooctane (2,2,4–trimethylpentane). Use 180
Wavelength accuracy, ±1.0 millimicron. milliliters for the test described in the pre-
Nitrogen cylinder. Water-pumped or equiva- ceding paragraph. Purify, if necessary, by
lent purity nitrogen in cylinder equipped passage through a column of activated silica
with regulator and valve to control flow at 5 gel (Grade 12, Davison Chemical Company,
p.s.i.g. Baltimore, Maryland, or equivalent) about 90
centimeters in length and 5 centimeters to 8
REAGENTS AND MATERIALS centimeters in diameter.
Organic solvents. All solvents used through- Benzene, A.C.S. reagent grade. Use 150 milli-
out the procedure shall meet the specifica- liters for the test. Purify, if necessary, by
tions and tests described in this specifica- distillation or otherwise.
Acetone, A.C.S. reagent grade. Use 200 milli-
liters for the test. Purify, if necessary, by
1 As determined by using potassium chro-
distillation.
mate for reference standard and described in Eluting mixtures:
National Bureau of Standards Circular 484, 1. 10 percent benzene in isooctane. Pipet 50
Spectrophotometry, U.S. Department of milliliters of benzene into a 500–milliliter
Commerce, (1949). The accuracy is to be de- glass-stoppered volumetric flask and adjust
termined by comparison with the standard to volume with isooctane, with mixing.
values at 290, 345, and 400 millimicrons. Cir- 2. 20 percent benzene in isooctane. Pipet 50
cular 484 is incorporated by reference. Copies milliliters of benzene into a 250–milliliter
are available from the Office of Food Addi- glass-stoppered volumetric flask, and adjust
tive Safety (HFS–200), Center for Food Safe- to volume with isooctane, with mixing.
ty and Applied Nutrition, Food and Drug Ad- 3. Acetone-benzene-water mixture. Add 20
ministration, 5001 Campus Dr., College Park, milliliters of water to 380 milliliters of ace-
MD 20740, 240–402–1200, or available for in- tone and 200 milliliters of benzene, and mix.
spection at the National Archives and n-Hexadecane, 99 percent olefin-free. Dilute
Records Administration (NARA). For infor- 1.0 milliliter of n-hexadecane to 25 milliliters
mation on the availability of this material with isooctane and determine the absorbance
at NARA, call 202–741–6030, or go to: http:// in a 5–centimeter cell compared to isooctane

www.archives.gov/federal_register/ as reference point between 280 mμ–400 mμ.
code_of_federal_regulations/ibr_locations.html. The absorbance per centimeter path length
122
shall not exceed 0.00 in this range. Purify, if sulfoxide through four thicknesses of fluted
necessary, by percolation through activated paper (18.5 centimeters, Schleicher &
silica gel or by distillation. Schuell, No. 597, or equivalent). If the initial
Methyl alcohol, A.C.S. reagent grade. Use filtrate contains carbon fines, refilter
10.0 milliliters of methyl alcohol. Purify, if through the same filter until a clear filtrate
necessary, by distillation. is obtained. Protect the sulfoxide from air
Dimethyl sulfoxide. Pure grade, clear, and moisture during this operation by cov-
water-white, m.p. 18° minimum. Dilute 120 ering the solvent in the funnel and collection
milliliters of dimethyl sulfoxide with 240 flask with a layer of isooctane. Transfer the
milliliters of distilled water in a 500–milli- filtrate to a 2–liter separatory funnel and
liter separatory funnel, mix and allow to draw off the dimethyl sulfoxide into the 2–
cool for 5–10 minutes. Add 40 milliliters of liter distillation flask of the vacuum dis-
isooctane to the solution and extract by tillation assembly and distill at approxi-
shaking the funnel vigorously for 2 minutes. mately 3–millimeter Hg pressure or less. Dis-
Draw off the lower aqueous layer into a sec- card the first 200–milliliter fraction of the
ond 500–milliliter separatory funnel and re- distillate and replace the distillate collec-
peat the extraction with 40 milliliters of iso- tion flask with a clean one. Continue the dis-
octane. Draw off and discard the aqueous tillation until approximately 1 liter of the
layer. Wash each of the 40–milliliter extrac- sulfoxide has been collected.
tives three times with 50–milliliter portions At completion of the distillation, the rea-
of distilled water. Shaking time for each gent should be stored in glass-stoppered bot-
wash is 1 minute. Discard the aqueous lay- tles since it is very hygroscopic and will
ers. Filter the first extractive through anhy- react with some metal containers in the
drous sodium sulfate prewashed with iso- presence of air.
octane (see Sodium sulfate under ‘‘Reagents
Phosphoric acid. 85 percent A.C.S. reagent
and Materials’’ for preparation of filter), into
grade.
a 250–milliliter Erlenmeyer flask, or option-
Sodium borohydride. 98 percent.
ally into the evaporating flask. Wash the
first separatory funnel with the second 40– Magnesium oxide (Sea Sorb 43, Food Machin-
milliliter isooctane extractive, and pass ery Company, Westvaco Division, distributed by
through the sodium sulfate into the flask. chemical supply firms, or equivalent). Place 100
Then wash the second and first separatory grams of the magnesium oxide in a large
funnels successively with a 10–milliliter por- beaker, add 700 milliliters of distilled water
tion of isooctane, and pass the solvent to make a thin slurry, and heat on a steam
through the sodium sulfate into the flask. bath for 30 minutes with intermittent stir-
Add 1 milliliter of n-hexadecane and evapo- ring. Stir well initially to insure that all the
rate the isooctane on the steam bath under absorbent is completely wetted. Using a
nitrogen. Discontinue evaporation when not Buchner funnel and a filter paper (Schleicher
over 1 milliliter of residue remains. To the & Schuell No. 597, or equivalent) of suitable
residue, add a 10–milliliter portion of iso- diameter, filter with suction. Continue suc-
octane and reevaporate to 1 milliliter of tion until water no longer drips from the
hexadecane. Again, add 10 milliliters of iso- funnel. Transfer the absorbent to a glass
octane to the residue and evaporate to 1 mil- trough lined with aluminum foil (free from
liliter of hexadecane to insure complete re- rolling oil). Break up the magnesia with a
moval of all volatile materials. Dissolve the clean spatula and spread out the absorbent
1 milliliter of hexadecane in isooctane and on the aluminum foil in a layer about 1 cen-
make to 25–milliliter volume. Determine the timeter to 2 centimeters thick. Dry for 24
reference. The absorbance of the solution hours at 160 °C ±1 °C. Pulverize the magnesia
should not exceed 0.02 per centimeter path with mortar and pestle. Sieve the pulverized
length in the 280 mμ–400 mμ range. (NOTE. absorbent between 60–180 mesh. Use the mag-
Difficulty in meeting this absorbance speci- nesia retained on the 180–mesh sieve.
fication may be due to organic impurities in Celite 545. Johns-Manville Company, diato-
the distilled water. Repetition of the test maceous earth, or equivalent.
omitting the dimethyl sulfoxide will disclose Magnesium oxide-Celite 545 mixture (2 + 1) by
their presence. If necessary to meet the spec- weight. Place the magnesium oxide (60–180
ification, purify the water by redistillation, mesh) and the Celite 545 in 2 to 1 propor-
passage through an ion-exchange resin, or tions, respectively, by weight in a glass-
otherwise.) stoppered flask large enough for adequate
Purify, if necessary, by the following pro- mixing. Shake vigorously for 10 minutes.
cedure: To 1,500 milliliters of dimethyl sulf- Transfer the mixture to a glass trough lined
oxide in a 2–liter glass-stoppered flask, add with aluminum foil (free from rolling oil)
6.0 milliliters of phosphoric acid and 50 and spread it out on a layer about 1 centi-
grams of Norit A (decolorizing carbon, alka- meter to 2 centimeters thick. Reheat the
line) or equivalent. Stopper the flask, and mixture at 160 °C ±1 °C for 2 hours, and store
with the use of a magnetic stirrer (tetra- in a tightly closed flask.

fluoroethylene polymer coated bar) stir the Sodium sulfate, anhydrous, A.C.S. reagent
solvent for 15 minutes. Filter the dimethyl grade, preferably in granular form. For each
123
§ 172.886 21 CFR Ch. I (4–1–23 Edition)
bottle of sodium sulfate reagent used, estab- Promptly complete the transfer of the
lish as follows the necessary sodium sulfate sample to the funnel in the jacket with por-
prewash to provide such filters required in tions of the preequilibrated isooctane, warm-
the method: Place approximately 35 grams of ing the beaker, if necessary, and using a
anhydrous sodium sulfate in a 30–milliliter total volume of just 50 milliliters of the sol-
coarse, fritted-glass funnel or in a 65–milli- vent. If the wax comes out of solution during
meter filter funnel with glass wool plug; these operations, let the stoppered funnel re-
wash with successive 15–milliliter portions of main in the jacket until the wax redissolves.
the indicated solvent until a 15–milliliter (Remove stopper from the funnel at intervals
portion of the wash shows 0.00 absorbance to release pressure.) When the wax is in solu-
per centimeter path length between 280 mμ tion, remove the funnel from the jacket and
and 400 mμ when tested as prescribed under shake it vigorously for 2 minutes. Set up
‘‘Organic solvents.’’ Usually three portions
three 250–milliliter separatory funnels with
of wash solvent are sufficient.
each containing 30 milliliters of
Before proceeding with analysis of a sam-
preequilibrated isooctane. After separation
ple, determine the absorbance in a 5–centi-
meter path cell between 250 mμ and 400 mμ of the liquid phases, allow to cool until the
for the reagent blank by carrying out the main portion of the wax-isooctane solution
procedure, without a wax sample, at room begins to show a precipitate. Gently swirl
temperature, recording the spectra after the the funnel when precipitation first occurs on
extraction stage and after the complete pro- the inside surface of the funnel to accelerate
cedure as prescribed. The absorbance per this process. Carefully draw off the lower
centimeter path length following the extrac- layer, filter it slowly through a thin layer of
tion stage should not exceed 0.040 in the glass wool fitted loosely in a filter funnel
wavelength range from 280 mμ to 400 mμ; the into the first 250–milliliter separatory fun-
absorbance per centimeter path length fol- nel, and wash in tandem with the 30–milli-
lowing the complete procedure should not liter portions of isooctane contained in the
exceed 0.070 in the wavelength range from 280 250–milliliter separatory funnels. Shaking
mμ to 299 mμ, inclusive, nor 0.045 in the time for each wash is 1 minute. Repeat the
wavelength range from 300 mμ to 400 mμ. If in extraction operation with two additional
either spectrum the characteristic benzene portions of the sulfoxide-acid mixture, re-
peaks in the 250 mμ–260 mμ region are placing the funnel in the jacket after each
present, remove the benzene by the proce- extraction to keep the wax in solution and
dure under ‘‘Organic solvents’’ and record washing each extractive in tandem through
absorbance again. the same three portions of isooctane.
Place 300 milliliters of dimethyl sulfoxide Collect the successive extractives (300 mil-
in a 1–liter separatory funnel and add 75 milliliters total) in a separatory funnel (pref-
liliters of phosphoric acid. Mix the contents
erably 2–liter), containing 480 milliliters of
of the funnel and allow to stand for 10 min-
distilled water, mix, and allow to cool for a
utes. (The reaction between the sulfoxide
few minutes after the last extractive has
and the acid is exothermic. Release pressure
after mixing, then keep funnel stoppered.) been added. Add 80 milliliters of isooctane to
Add 150 milliliters of isooctane and shake to the solution and extract by shaking the fun-
preequilibrate the solvents. Draw off the in- nel vigorously for 2 minutes. Draw off the
dividual layers and store in glass-stoppered lower aqueous layer into a second separatory
flasks. funnel (preferably 2–liter) and repeat the ex-
Place a representative 1–kilogram sample traction with 80 milliliters of isooctane.
of wax, or if this amount is not available, the Draw off and discard the aqueous layer.
entire sample, in a beaker of a capacity Wash each of the 80–milliliter extractives
about three times the volume of the sample three times with 100–milliliter portions of
and heat with occasional stirring on a steam distilled water. Shaking time for each wash
bath until the wax is completely melted and is 1 minute. Discard the aqueous layers. Fil-
homogeneous. Weigh four 25–gram ±0.2 gram ter the first extractive through anhydrous
portions of the melted wax in separate 100– sodium sulfate prewashed with isooctane (see
milliliter beakers. Reserve three of the por- Sodium Sulfate under ‘‘Reagents and Mate-
tions for later replicate analyses as nec- rials’’ for preparation of filter) into a 250–
essary. Pour one weighed portion imme- milliliter Erlenmeyer flask (or optionally
diately after remelting (on the steam bath) into the evaporation flask). Wash the first
into a 500–milliliter separatory funnel con- separatory funnel with the second 80–milli-
taining 100 milliliters of the preequilibrated liter isooctane extractive and pass through
sulfoxide-phosphoric acid mixture that has the sodium sulfate. Then wash the second
been heated in the heating jacket at a tem- and first separatory funnels successively
perature just high enough to keep the wax with a 20–milliliter portion of isooctane and
melted. (NOTE: In preheating the sulfoxide- pass the solvent through the sodium sulfate
acid mixture, remove the stopper of the sepa- into the flask. Add 1 milliliter of n-hexa-
ratory funnel at intervals to release the decane and evaporate the isooctane on the
pressure.) steam bath under nitrogen. Discontinue
124
evaporation when not over 1 milliliter of res- or metal plunger to make the depth of the
idue remains. To the residue, add a 10–milli- adsorbent bed approximately 12.5 centi-
liter portion of isooctane, reevaporate to 1 meters in depth. Turn off the vacuum and re-
milliliter of hexadecane, and repeat this op- move the suction flask. Fit the 500–milliliter
eration once. reservoir onto the top of the
Quantitatively transfer the residue with chromatographic column and prewet the col-
isooctane to a 25–milliliter volumetric flask, umn by passing 100 milliliters of isooctane
make to volume, and mix. Determine the ab- through the column. Adjust the nitrogen
sorbance of the solution in the 5–centimeter pressure so that the rate of descent of the
path length cells compared to isooctane as isooctane coming off of the column is be-
reference between 280 mμ–400 mμ (take care tween 2–3 milliliters per minute. Discontinue
to lose none of the solution in filling the pressure just before the last of the isooctane
sample cell). Correct the absorbance values reaches the level of the adsorbent. (CAUTION:
for any absorbance derived from reagents as Do not allow the liquid level to recede below
determined by carrying out the procedure the adsorbent level at any time.) Remove the
without a wax sample. If the corrected ab- reservoir and decant the 5–milliliter iso-
sorbance does not exceed the limits pre- octane concentrate solution onto the column
scribed in this paragraph (b), the wax meets and with slight pressure again allow the liq-
the ultraviolet absorbance specifications. If uid level to recede to barely above the ad-
the corrected absorbance per centimeter sorbent level. Rapidly complete the transfer
path length exceeds the limits prescribed in similarly with two 5–milliliter portions of
this paragraph (b), proceed as follows: isooctane, swirling the flask repeatedly each
Quantitatively transfer the isooctane solu- time to assure adequate washing of the res-
tion to a 125–milliliter flask equipped with idue. Just before the final 5–milliliter wash
24/40 joint and evaporate the isooctane on reaches the top of the adsorbent, add 100 mil-
the steam bath under a stream of nitrogen to liliters of isooctane to the reservoir and con-
a volume of 1 milliliter of hexadecane. Add tinue the percolation at the 2–3 milliliter per
10 milliliters of methyl alcohol and approxi- minute rate. Just before the last of the iso-
mately 0.3 gram of sodium borohydride. octane reaches the adsorbent level, add 100
(Minimize exposure of the borohydride to the milliliters of 10 percent benzene in isooctane
atmosphere. A measuring dipper may be to the reservoir and continue the percolation
used.) Immediately fit a water-cooled con- at the aforementioned rate. Just before the
denser equipped with a 24/40 joint and with a solvent mixture reaches adsorbent level, add
drying tube into the flask, mix until the 25 milliliters of 20 percent benzene in iso-
borohydride is dissolved, and allow to stand octane to the reservoir and continue the per-
for 30 minutes at room temperature, with colation at 2–3 milliliters per minute until
intermittent swirling. At the end of this pe- all this solvent mixture has been removed
riod, disconnect the flask and evaporate the from the column. Discard all the elution sol-
methyl alcohol on the steam bath under ni- vents collected up to this point. Add 300 mil-
trogen until the sodium borohydride begins liliters of the acetone-benzene-water mixture
to come out of the solution. Then add 10 mil- to the reservoir and percolate through the
liliters of isooctane and evaporate to a vol- column to elute the polynuclear compounds.
ume of about 2–3 milliliters. Again, add 10 Collect the eluate in a clean 1–liter sepa-
milliliters of isooctane and concentrate to a ratory funnel. Allow the column to drain
volume of approximately 5 milliliters. Swirl until most of the solvent mixture is re-
the flask repeatedly to assure adequate moved. Wash the eluate three times with
washing of the sodium borohydride residues. 300–milliliter portions of distilled water,
Fit the tetrafluoroethylene polymer disc shaking well for each wash. (The addition of
on the upper part of the stem of the small amounts of sodium chloride facilitates
chromatographic tube, then place the tube separation.) Discard the aqueous layer after
with the disc on the suction flask and apply each wash. After the final separation, filter
the vacuum (approximately 135 millimeters the residual benzene through anhydrous so-
Hg pressure). Weight out 14 grams of the 2:1 dium sulfate prewashed with benzene (see So-
magnesium oxide-Celite 545 mixture and dium sulfate under ‘‘Reagents and Materials’’
pour the adsorbent mixture into the for preparation of filter) into a 250–milliliter
chromatographic tube in approximately 3– Erlenmeyer flask (or optionally into the
centimeter layers. After the addition of each evaporation flask). Wash the separatory fun-
layer, level off the top of the adsorbent with nel with two additional 20–milliliter portions
a flat glass rod or metal plunger by pressing of benzene which are also filtered through
down firmly until the adsorbent is well the sodium sulfate. Add 1 milliliter of n-
packed. Loosen the topmost few millimeters hexadecane and completely remove the ben-
of each adsorbent layer with the end of a zene by evaporation under nitrogen, using
metal rod before the addition of the next the special procedure to eliminate benzene
layer. Continue packing in this manner until as previously described under ‘‘Organic Sol-
all the 14 grams of the adsorbent is added to vents.’’ Quantitatively transfer the residue
the tube. Level off the top of the adsorbent with isooctane to a 25–milliliter volumetric
by pressing down firmly with a flat glass rod flask and adjust to volume. Determine the
125
§ 172.888 21 CFR Ch. I (4–1–23 Edition)
absorbance of the solution in the 5–centi- the availability of this material at
meter path length cells compared to iso- NARA, call 202–741–6030, or go to: http://
octane as reference between 250 mμ–400 mμ. www.archives.gov/federal_register/
Correct for any absorbance derived from the
reagents as determined by carrying out the
procedure without a wax sample. If either ibr_locations.html. Petroleum wax shall
spectrum shows the characteristic benzene contain not more than 1,050 parts per
peaks in the 250 mμ–260 mμ region, evaporate million of poly(alkylacrylate) or
the solution to remove benzene by the proce- poly(alkylmethacrylate) residues as
dure under ‘‘Organic Solvents.’’ Dissolve the determined by a method entitled
residue, transfer quantitatively, and adjust ‘‘Method for Determining Residual
to volume in isooctane in a 25–milliliter vol-
Level of Poly(alkylacrylate) in Petro-
umetric flask. Record the absorbance again.
If the corrected absorbance does not exceed leum Wax,’’ which is incorporated by
the limits prescribed in this paragraph (b), reference. Copies are available from
the wax meets the ultraviolet absorbance the addresses cited in this paragraph.
specifications. (d) Petroleum wax is used or intended
(c) Petroleum wax may contain one for use as follows:
or more of the following adjuvants in Use Limitations
amounts not greater than that re-
In chewing gum base, as a mas- In an amount not to ex-
quired to produce their intended effect: ticatory substance. ceed good manufac-
(1) Antioxidants permitted in food by turing practice.
regulations issued in accordance with On cheese and raw fruits and Do.
section 409 of the act. vegetables as a protective coat-
ing.
(2) Poly(alkylacrylate) (CAS Reg. No. As a defoamer in food .................. In accordance with
27029–57–8), made from long chain (C16- § 173.340 of this chap-
C22) alcohols and acrylic acid, or ter.
As a component of microcapsules In accordance with
poly(alkylmethacrylate) (CAS Reg. No. for spice-flavoring substances. § 172.230 of this chap-
179529–36–3), made from long chain (C18- ter.
C22) methacrylate esters, having:
(i) A number average molecular
weight between 40,000 and 100,000; FR 48123, July 18, 1980; 47 FR 11838, Mar. 19,
(ii) A weight average molecular 1982; 50 FR 32561, Aug. 13, 1985; 51 FR 19544,
weight (MWw) to number average mo- May 30, 1986; 54 FR 24897, June 12, 1989; 64 FR
lecular weight (MWn) ratio (MWw/MWn) 44122, Aug. 13, 1999; 78 FR 14665, Mar. 7, 2013;
of not less than 3; and 81 FR 5592, Feb. 3, 2016; 88 FR 17722, Mar. 24,
(iii) Unreacted alkylacrylate or 2023]
alkylmethacrylate monomer content
not in excess of 14 percent, as deter- § 172.888 Synthetic petroleum wax.
mined by a method entitled ‘‘Method Synthetic petroleum wax may be
for Determining Weight-Average and safely used in or on foods in accordance
Number-Average Molecular Weight and with the following conditions:
for Determining Alkylacrylate Mon- (a) Synthetic petroleum wax is a
omer Content of Poly(alkylacrylate) mixture of solid hydrocarbons, par-
used as Processing Aid in Manufacture affinic in nature, prepared by either
of Petroleum Wax,’’ which is incor- catalytic polymerization of ethylene or
porated by reference in accordance copolymerization of ethylene with lin-
with 5 U.S.C. 552(a) and 1 CFR part 51. ear (C3 to C12) alpha-olefins, and refined
Copies are available from the Office of to meet the specifications prescribed in
Food Additive Safety (HFS–200), Center this section.
for Food Safety and Applied Nutrition, (b) Synthetic petroleum wax meets
Food and Drug Administration, 5001 the ultraviolet absorbance limits of
Campus Dr., College Park, MD 20740, § 172.886(b) when subjected to the ana-
240–402–1200, or may be examined at the lytical procedure described therein.
Dockets Management Staff (HFA–305), (c) Synthetic petroleum wax has a
Food and Drug Administration, 5630 number average molecular weight of
Fishers Lane, Rm. 1061, Rockville, MD not less than 500 nor greater than 1,200
20852, 240–402–7500, between 9 a.m. and 4 as determined by vapor pressure os-
p.m., Monday through Friday or at the mometry.

National Archives and Records Admin- (d) Synthetic petroleum wax may
istration (NARA). For information on contain any antioxidant permitted in
126
food by regulations issued in accord- (a) Food starch may be acid-modified

ance with section 409 of the act, in an by treatment with hydrochloric acid or
amount not greater than that required sulfuric acid or both.
to produce its intended effect. (b) Food starch may be bleached by
(e) Synthetic petroleum wax is used treatment with one or more of the fol-
or intended for use as follows: lowing:
Use Limitations Limitations
In chewing gum base, as a In accordance with § 172.615 Active oxygen obtained from hy-
masticatory substance. in an amount not to exceed drogen peroxide and/or per-
good manufacturing prac- acetic acid, not to exceed 0.45
tice. percent of active oxygen.
On cheese and raw fruits and In an amount not to exceed Ammonium persulfate, not to ex-
vegetables as a protective good manufacturing prac- ceed 0.075 percent and sulfur
coating. tice. dioxide, not to exceed 0.05 per-
As a defoamer in food ........... In accordance with § 173.340 cent.
of this chapter. Chlorine, as calcium hypochlorite, The finished food starch-
not to exceed 0.036 percent of modified is limited to
dry starch. use only as a compo-
[42 FR 14491, Mar. 15, 1977, as amended at 59 nent of batter for com-
FR 10986, Mar. 9, 1994] mercially processed
foods.
§ 172.890 Rice bran wax. Chlorine, as sodium hypochlorite,
not to exceed 0.0082 pound of
Rice bran wax may be safely used in chlorine per pound of dry starch.
food in accordance with the following Potassium permanganate, not to Residual manganese
exceed 0.2 percent. (calculated as Mn), not
conditions: to exceed 50 parts per
(a) It is the refined wax obtained million in food starch-
from rice bran and meets the following modified.
Sodium chlorite, not to exceed 0.5
specifications: percent.
Melting point 75 °C to 80 °C.
Free fatty acids, maximum 10 percent. (c) Food starch may be oxidized by
Iodine number, maximum 20. treatment with chlorine, as sodium hy-
Saponification number 75 to 120. pochlorite, not to exceed 0.055 pound of
chlorine per pound of dry starch.
(b) It is used or intended for use as
(d) Food starch may be esterified by
follows:
treatment with one of the following:
Food Limitation in food Use
Limitations
Candy ............................. 50 p.p.m ............ Coating.
Fresh fruits and fresh ......do ................ Do. Acetic anhydride ........................... Acetyl groups in food
vegetables. starch-modified not to
exceed 2.5 percent.
Chewing gum ................. 21⁄2 pct ............... Plasticizing
material. Adipic anhydride, not to exceed Do.
0.12 percent, and acetic anhy-
dride.
§ 172.892 Food starch-modified. Monosodium orthophosphate ....... Residual phosphate in
food starch-modified
Food starch-modified as described in not to exceed 0.4 per-
this section may be safely used in food. cent calculated as
phosphorus.
The quantity of any substance em- 1–Octenyl succinic anhydride, not
ployed to effect such modification shall to exceed 3 percent.
not exceed the amount reasonably re- 1–Octenyl succinic anhydride, not
quired to accomplish the intended to exceed 2 percent, and alu-
minum sulfate, not to exceed 2
physical or technical effect, nor exceed percent.
any limitation prescribed. To insure 1-Octenyl succinic anhydride, not Limited to use as a sta-
safe use of the food starch-modified, to exceed 3 percent, followed bilizer or emulsifier in
the label of the food additive container by treatment with a beta-amy- beverages and bev-
lase enzyme that is either an erage bases as de-
shall bear the name of the additive approved food additive of is fined in § 170.3(n)(3) of
‘‘food starch-modified’’ in addition to generally recognized as safe. this chapter.
Phosphorus oxychloride, not to
other information required by the Act.

exceed 0.1 percent.
Food starch may be modified by treat-
ment prescribed as follows:
127
§ 172.894 21 CFR Ch. I (4–1–23 Edition)
Limitations Limitations
Phosphorus oxychloride, not to Acetyl groups in food Chlorine, as sodium hypochlorite, Residual propylene
exceed 0.1 percent, followed by starch-modified not to not to exceed 0.055 pound of chlorohydrin not more
either acetic anhydride, not to exceed 2.5 percent. chlorine per pound of dry than 5 parts per million
exceed 8 percent, or vinyl ace- starch; 0.45 percent of active in food starch-modi-
tate, not to exceed 7.5 percent. oxygen obtained from hydrogen fied.
Sodium trimetaphosphate ............. Residual phosphate in peroxide; and propylene oxide,
food starch-modified not to exceed 25 percent.
not to exceed 0.04 Sodium hydroxide, not to exceed
percent, calculated as 1 percent.
phosphorus.
Sodium tripolyphosphate and so- Residual phosphate in
dium trimetaphosphate. food starch-modified
(h) Food starch may be modified by a
not to exceed 0.4 per- combination of the treatments pre-
cent calculated as scribed by paragraphs (a), (b), and/or (i)
phosphorus. of this section and any one of the
Succinic anhydride, not to exceed
4 percent.
treatments prescribed by paragraph (c),
Vinyl acetate ................................. Acetyl groups in food (d), (e), (f), or (g) of this section, sub-
starch-modified not to ject to any limitations prescribed by
exceed 2.5 percent. the paragraphs named.
(i) Food starch may be modified by
(e) Food starch may be etherified by treatment with the following enzymes:
treatment with one of the following:
Enzyme Limitations
Limitations
Alpha-amylase (E.C. 3.2.1.1) ....... The enzyme must be
Acrolein, not to exceed 0.6 per- generally recognized
cent. as safe or approved as
Epichlorohydrin, not to exceed a food additive for this
0.3 percent. purpose. The resulting
Epichlorohydrin, not to exceed Residual propylene nonsweet nutritive sac-
0.1 percent, and propylene chlorohydrin not more charide polymer has a
oxide, not to exceed 10 per- than 5 parts per million dextrose equivalent of
cent, added in combination or in food starch-modified. less than 20.
in any sequence. Beta-amylase (E.C. 3.2.1.2).
Epichlorohydrin, not to exceed Do. Glucoamylase (E.C. 3.2.1.3).
0.1 percent, followed by pro- Isoamylase (E.C. 3.2.1.68).
pylene oxide, not to exceed 25 Pullulanase (E.C. 3.2.1.41).
percent.
Propylene oxide, not to exceed Do.
25 percent. [42 FR 14491, Mar. 15, 1977, as amended at 43
FR 11697, Mar. 21, 1978; 46 FR 32015, June 19,
1981; 57 FR 54700, Nov. 20, 1992; 58 FR 21100,
(f) Food starch may be esterified and
Apr. 19, 1993; 66 FR 17509, Apr. 2, 2001]
etherified by treatment with one of the
following: § 172.894 Modified cottonseed products
intended for human consumption.
Limitations
The food additive modified cotton-
Acrolein, not to exceed 0.6 per- Acetyl groups in food seed products may be used for human
cent and vinyl acetate, not to starch-modified not to
exceed 7.5 percent. exceed 2.5 percent. consumption in accordance with the
Epichlorohydrin, not to exceed 0.3 Acetyl groups in food following prescribed conditions:
percent, and acetic anhydride. starch-modified not to (a) The additive is derived from:
exceed 2.5 percent.
(1) Decorticated, partially defatted,
Epichlorohydrin, not to exceed 0.3
percent, and succinic anhy- cooked, ground cottonseed kernels; or
dride, not to exceed 4 percent. (2) Decorticated, ground cottonseed
Phosphorus oxychloride, not to Residual propylene kernels, in a process that utilizes n-
exceed 0.1 percent, and pro- chlorohydrin not more
pylene oxide, not to exceed 10 than 5 parts per million
hexane as an extracting solvent in such
percent. in food starch-modi- a way that no more than 60 parts per
fied. million of n-hexane residues and less
than 1 percent fat by weight remain in
(g) Food starch may be modified by the finished product; or
treatment with one of the following: (3) Glandless cottonseed kernels
roasted to attain a temperature of not

less than 250 °F in the kernel for not
less than 5 minutes for use as a snack
128
food, or in baked goods, or in soft dried cell walls of the yeast, Saccharo-
candy; or myces cerevisiae. It is composed prin-
(4) Raw glandless cottonseed kernels cipally of long chain carbohydrates,
may be used in hard candy where the not less than 85 percent on a dry solids
kernel temperature during cooking basis. The carbohydrate is composed of
will exceed 250 °F for not less than 5 glycan and mannan units in approxi-
minutes. mately a 2:1 ratio.
(b) The additive is prepared to meet (b) The additive meets the following
the following specifications: specifications on a dry weight basis:
(1) Free gossypol content not to ex- Less than 0.4 part per million (ppm) ar-
ceed 450 parts per million. senic, 0.13 ppm cadmium, 0.2 ppm lead,
(2) It contains no added arsenic com- 0.05 ppm mercury, 0.09 ppm selenium,
pound and therefore may not exceed a and 10 ppm zinc.
maximum natural background level of (c) The viable microbial content of
0.2 part per million total arsenic, cal- the finished ingredient is:
culated as As. (1) Less than 10,000 organisms/gram
(c) To assure safe use of the additive, by aerobic plate count.
the label of the food additive container
(2) Less than 10 yeasts and molds/
shall bear, in addition to other infor-
gram.
mation required by the act, the name
of the additive as follows: (3) Negative for Salmonella, E. coli,
(1) The additive identified in para- coagulase positive Staphylococci, Clos-
graph (a)(1) of this section as ‘‘par- tridium perfringens, Clostridium botu-
tially defatted, cooked cottonseed linum, or any other recognized micro-
flour’’. bial pathogen or any harmful microbial
(2) The additive identified in para- toxin.
graph (a)(2) of this section as ‘‘defatted (d) The additive is used or intended
cottonseed flour’’. for use in the following foods when
(3) The additive identified in para- standards of identity established under
graph (a)(3) of this section as ‘‘roasted section 401 of the Act do not preclude
glandless cottonseed kernels’’. such use:
(4) The additive identified in para- Use Limitations
graph (a)(4) of this section as ‘‘raw
glandless cottonseed kernels for use in (1) In salad dressings as an emul- Not to exceed a con-
cooked hard candy’’. sifier and emulsifier salt as de- centration of 5 percent
fined in § 170.3(o)(8) of this of the finished salad
(d) The Food and Drug Administra- chapter, stabilizer and thickener dressing.
tion and the Environmental Protection as defined in § 170.3(o)(28) of
Agency have determined that glandless this chapter, or texturizer as de-
fined in § 170.3(o)(32) of this
cottonseed kernels permitted for use chapter.
by this section are a distinct com- (2) In frozen dessert analogs as a In an amount not to ex-
modity from glanded cottonseed. stabilizer and thickener as de- ceed good manufac-
fined in § 170.3(o)(28) of this turing practice.
§ 172.896 Dried yeasts. chapter, or texturizer as defined
in § 170.3(o)(32) of this chapter.
Dried yeast (Saccharomyces cerevisiae (3) In sour cream analogs as a Do.
and Saccharomyces fragilis) and dried stabilizer and thickener as de-
torula yeast (Candida utilis) may be fined in § 170.3(o)(28) of this
chapter, or texturizer as defined
safely used in food provided the total in § 170.3(o)(32) of this chapter.
folic acid content of the yeast does not (4) In cheese spread analogs as Do.
exceed 0.04 milligram per gram of yeast a stabilizer and thickener as de-
(approximately 0.008 milligram of fined in § 170.3(o)(28) of this
chapter, or texturizer as defined
pteroyglutamic acid per gram of in § 170.3(o)(32) of this chapter.
yeast). (5) In cheese-flavored and sour Do.
cream-flavored snack dips as a
§ 172.898 Bakers yeast glycan. stabilizer and thickener as de-
fined in § 170.3(o)(28) of this
Bakers yeast glycan may be safely chapter, or texturizer as defined
used in food in accordance with the fol- in § 170.3(o)(32) of this chapter.
lowing conditions:
(a) Bakers yeast glycan is the (e) The label and labeling of the in-
comminuted, washed, pasteurized, and gredient shall bear adequate directions
129
Pt. 173 21 CFR Ch. I (4–1–23 Edition)
to assure that use of the ingredient 173.255 Methylene chloride.

complies with this regulation. 173.270 Hexane.
173.275 Hydrogenated sperm oil.
[42 FR 14491, Mar. 15, 1977, as amended at 45 173.280 Solvent extraction process for citric
FR 58836, Sept. 5, 1980] acid.
173.290 Trichloroethylene.
PART 173—SECONDARY DIRECT Subpart D—Specific Usage Additives
FOOD ADDITIVES PERMITTED IN
FOOD FOR HUMAN CONSUMP- 173.300 Chlorine dioxide.
173.310 Boiler water additives.
TION 173.315 Chemicals used in washing or to as-
sist in the peeling of fruits and vegeta-
Subpart A—Polymer Substances and bles.
Polymer Adjuvants for Food Treatment 173.320 Chemicals for controlling micro-
organisms in cane-sugar and beet-sugar
Sec. mills.
173.5 Acrylate-acrylamide resins. 173.322 Chemicals used in delinting cotton-
173.10 Modified polyacrylamide resin. seed.
173.20 Ion-exchange membranes. 173.325 Acidified sodium chlorite solutions.
173.21 Perfluorinated ion exchange mem- 173.340 Defoaming agents.
branes. 173.342 Chlorofluorocarbon 113 and
173.25 Ion-exchange resins. perfluorohexane.
173.40 Molecular sieve resins. 173.345 Chloropentafluoroethane.
173.45 Polymaleic acid and its sodium salt. 173.350 Combustion product gas.
173.50 Polyvinylpolypyrrolidone. 173.355 Dichlorodifluoromethane.
173.55 Polyvinylpyrrolidone. 173.356 Hydrogen peroxide.
173.60 Dimethylamine-epichlorohydrin co- 173.357 Materials used as fixing agents in
polymer. the immobilization of enzyme prepara-
173.65 Divinylbenzene copolymer. tions.
173.70 Chloromethylated aminated styrene- 173.360 Octafluorocyclobutane.
divinylbenzene resin. 173.368 Ozone.
173.73 Sodium polyacrylate. 173.370 Peroxyacids.
173.75 Sorbitan monooleate. 173.375 Cetylpyridinium chloride.
173.385 Sodium methyl sulfate.
Subpart B—Enzyme Preparations and 173.395 Trifluoromethane sulfonic acid.
Microorganisms 173.400 Dimethyldialkylammonium chlo-
ride.
173.110 Amyloglucosidase derived from
173.405 Sodium dodecylbenzenesulfonate.
Rhizopus niveus.
173.115 Alpha-acetolactate decarboxylase (a- AUTHORITY: 21 U.S.C. 321, 342, 348.
ALDC) enzyme preparation derived from
SOURCE: 42 FR 14526, Mar. 15, 1977, unless
a recombinant Bacillus subtilis.
otherwise noted.
173.120 Carbohydrase and cellulase derived
from Aspergillus niger. EDITORIAL NOTE: Nomenclature changes to
173.130 Carbohydrase derived from Rhizopus part 173 appear at 61 FR 14482, Apr. 2, 1996; 66
oryzae. FR 56035, Nov. 6, 2001; 66 FR 66742, Dec. 27,
173.135 Catalase derived from Microccocus 2001; and 81 FR 49896, July 29, 2016.
lysodeikticus.
173.140 Esterase-lipase derived from Mucor
miehei.
Subpart A—Polymer Substances
173.145 Alpha-Galactosidase derived from and Polymer Adjuvants for
Mortierella vinaceae var. raffinoseutilizer. Food Treatment
173.150 Milk-clotting enzymes, microbial.
173.160 Candida guilliermondii. § 173.5 Acrylate-acrylamide resins.
173.165 Candida lipolytica.
173.170 Aminoglycoside 3′-
Acrylate-acrylamide resins may be
phosphotransferase II. safely used in food under the following
Subpart C—Solvents, Lubricants, Release (a) The additive consists of one of the
Agents and Related Substances following:
(1) Acrylamide-acrylic acid resin
173.210 Acetone.
(hydrolyzed polyacrylamide) is pro-
173.220 1,3-Butylene glycol.
173.228 Ethyl acetate. duced by the polymerization of acryl-
173.230 Ethylene dichloride. amide with partial hydrolysis, or by

173.240 Isopropyl alcohol. copolymerization of acrylamide and
173.250 Methyl alcohol residues. acrylic acid, with the greater part of
130
the polymer being composed of acryl- pliance with paragraph (c) of this sec-
amide units. tion.
(2) Sodium polyacrylate-acrylamide
resin is produced by the polymerization § 173.20 Ion-exchange membranes.
and subsequent hydrolysis of acrylo- Ion-exchange membranes may be
nitrile in a sodium silicate-sodium hy- safely used in the processing of food
droxide aqueous solution, with the under the following prescribed condi-
greater part of the polymer being com- tions:
posed of acrylate units.
(a) The ion-exchange membrane is
(b) The additive contains not more prepared by subjecting a polyethylene
than 0.05 percent of residual monomer
base conforming to § 177.1520 of this
calculated as acrylamide.
chapter to polymerization with styrene
(c) The additive is used or intended
until the polystyrene phase of the base
for use as follows:
is not less than 16 percent nor more
(1) The additive identified in para-
than 30 percent by weight. The base is
graph (a)(1) of this section is used as a
then modified by reaction with
flocculent in the clarification of beet
sugar juice and liquor or cane sugar chloromethyl methyl ether, and by
juice and liquor or corn starch subsequent amination with trimethyl-
hydrolyzate in an amount not to examine, dimethylamine, diethylene-
ceed 5 parts per million by weight of triamine, or dimethylethanolamine.
the juice or 10 parts per million by (b) The ion-exchange membrane is
weight of the liquor or the corn starch manufactured so as to comply with the
hydrolyzate. following extraction limitations when
(2) The additive identified in para- subjected to the described procedure:
graph (a)(2) of this section is used to Separate square-foot samples of mem-
control organic and mineral scale in brane weighing approximately 14 grams
beet sugar juice and liquor or cane each are cut into small pieces and
sugar juice and liquor in an amount refluxed for 4 hours in 150 cubic centi-
not to exceed 2.5 parts per million by meters of the following solvents: Dis-
weight of the juice or liquor. tilled water, 5 percent acetic acid, and
50 percent alcohol. Extraction from
each sample will not exceed 0.4 percent
FR 30494, June 9, 1981]
by weight of sample.
§ 173.10 Modified polyacrylamide (c) The ion-exchange membrane will
resin. be used in the production of grapefruit
Modified polyacrylamide resin may juice to adjust the ratio of citric acid
be safely used in food in accordance to total solids of the grapefruit juice
with the following prescribed condi- produced.
tions:
§ 173.21 Perfluorinated ion exchange
(a) The modified polyacrylamide membranes.
resin is produced by the copolymeriza-
tion of acrylamide with not more than Substances identified in paragraph
5–mole percent b-methacrylyloxyethy- (a) of this section may be safely used as
ltrimethylammonium methyl sulfate. ion exchange membranes intended for
(b) The modified polyacrylamide use in the treatment of bulk quantities
resin contains not more than 0.05 per- of liquid food under the following pre-
cent residual acrylamide. scribed conditions:
(c) The modified polyacrylamide (a) Identity. The membrane is a co-
resin is used as a flocculent in the clar- polymer of ethanesulfonyl fluoride, 2-
ification of beet or cane sugar juice in [1-[difluoro-[(trifluoro-
an amount not exceeding 5 parts per ethenyl)oxy]methyl]-1,2,2,2-tetrafluoro-
million by weight of the juice. ethoxy]-1,1,2,2,-tetrafluoro-, with tetra-
(d) To assure safe use of the additive, fluoroethylene that has been subse-
the label and labeling of the additive quently treated to hydrolyze the
shall bear, in addition to the other in- sulfonyl fluoride group to the sulfonic
formation required by the act, ade- acid. The Chemical Abstracts Service
quate directions to assure use in com- name of this polymer is ethanesulfonic
131
§ 173.25 21 CFR Ch. I (4–1–23 Edition)
acid, 2-[1-[difluoro-[(trifluoro- code_of_federal_regulations/

ethenyl)oxy]methyl]-1,2,2,2-tetrafluoro- ibr_locations.html.
ethoxy]-1,1,2,2,-tetrafluoro-, polymer (3) Sulfite-modified cross-linked phe-
with tetrafluoroethane (CAS Reg. No. nol-formaldehyde, with modification
31175–20–9). resulting in sulfonic acid groups on
(b) Optional adjuvant substances. The side chains.
basic polymer identified in paragraph (4) Methacrylic acid-divinylbenzene
(a) of this section may contain optional copolymer.
adjuvant substances required in the (5) Cross-linked polystyrene, first
production of such basic polymer. chloromethylated then aminated with
These optional adjuvant substances trimethylamine, dimethylamine, di-
may include substances used in accord- ethylenetriamine, or dimethylethanol-
ance with § 174.5 of this chapter. amine.
(c) Conditions of use. (1) (6) Diethylenetriamine, triethylene-
Perfluorinated ion exchange mem- tetramine, or tetraethylenepentamine
branes described in paragraph (a) of cross-linked with epichlorohydrin.
this section may be used in contact (7) Cross-linked phenol-formaldehyde
with all types of liquid foods at tem- activated with one or both of the fol-
peratures not exceeding 70° (158 °F). lowing: Triethylene tetramine and
(2) Maximum thickness of the copoly- tetraethylenepentamine.
mer membrane is 0.007 inch (0.017 centi- (8) Reaction resin of formaldehyde,
meter). acetone, and tetraethylenepentamine.
(3) Perfluorinated ion exchange mem- (9) Completely hydrolyzed copoly-
branes shall be maintained in a sani- mers of methyl acrylate and
tary manner in accordance with cur- divinylbenzene.
rent good manufacturing practice so as (10) Completely hydrolyzed
to prevent microbial adulteration of terpolymers of methyl acrylate,
food. divinylbenzene, and acrylonitrile.
(4) To assure their safe use, (11) Sulfonated terpolymers of sty-
perfluorinated ionomer membranes rene, divinylbenzene, and acrylonitrile
shall be thoroughly cleaned prior to or methyl acrylate.
their first use in accordance with cur- (12) Methyl acrylate-divinylbenzene
rent good manufacturing practice. copolymer containing not less than 2
percent by weight of divinylbenzene,
[59 FR 15623, Apr. 4, 1994] aminolyzed with dimethylaminopro-
pylamine.
§ 173.25 Ion-exchange resins.
(13) Methyl acrylate-divinylbenzene
Ion-exchange resins may be safely copolymer containing not less than 3.5
used in the treatment of food under the percent by weight of divinylbenzene,
following prescribed conditions: aminolyzed with dimethylaminopro-
(a) The ion-exchange resins are pre- pylamine.
pared in appropriate physical form, and (14) Epichlorohydrin cross-linked
consist of one or more of the following: with ammonia.
(1) Sulfonated copolymer of styrene (15) Sulfonated tetrapolymer of sty-
and divinylbenzene. rene, divinylbenzene, acrylonitrile, and
(2) Sulfonated anthracite coal meet- methyl acrylate derived from a mix-
ing the requirements of ASTM method ture of monomers containing not more
D388–38, Class I, Group 2, ‘‘Standard than a total of 2 percent by weight of
Specifications for Classification of Coal acrylonitrile and methyl acrylate.
by Rank,’’ which is incorporated by (16) Methyl acrylate-divinylbenzene-
reference. Copies are available from diethylene glycol divinyl ether
University Microfilms International, terpolymer containing not less than 3.5
300 N. Zeeb Rd., Ann Arbor, MI 48106, or percent by weight of divinylbenzene
available for inspection at the National and not more than 0.6 percent by
Archives and Records Administration weight of diethylene glycol divinyl
(NARA). For information on the avail- ether, aminolyzed with dimethyl-
ability of this material at NARA, call aminopropylamine.

202–741–6030, or go to: http:// (17) Styrene-divinylbenzene cross-
www.archives.gov/federal_register/ linked copolymer, first
132
chloromethylated then aminated with this section, and the ion-exchange

dimethylamine and oxidized with hy- resin identified in paragraph (a)(20) of
drogen peroxide whereby the resin con- this section is used only in accordance
tains not more than 15 percent by with paragraphs (b)(5) and (d) of this
weight of vinyl N,N-dimethylbenzyl- section.
amine-N-oxide and not more than 6.5 (1) The ion-exchange resins identified
percent by weight of nitrogen. in paragraphs (a)(12) and (16) of this
(18) Methyl acrylate-divinylbenzene- section are used to treat water for use
diethylene glycol divinyl ether in the manufacture of distilled alco-
terpolymer containing not less than 7 holic beverages, subject to the fol-
percent by weight of divinylbenzene lowing conditions:
and not more than 2.3 percent by (i) The water is subjected to treat-
weight of diethylene glycol divinyl ment through a mixed bed consisting of
ether, aminolyzed with dimethyl- one of the resins identified in para-
aminopropylamine and quaternized graph (a)(12) or (16) of this section and
with methyl chloride. one of the strongly acidic cation-ex-
(19) Epichlorohydrin cross-linked change resins in the hydrogen form
with ammonia and then quaternized identified in paragraphs (a)(1), (2), and
with methyl chloride to contain not (11) of this section; or
more than 18 percent strong base ca- (ii) The water is first subjected to
pacity by weight of total exchange ca- one of the resins identified in para-
pacity [Chemical Abstracts Service graph (a)(12) or (16) of this section and
name: Oxirane (chloromethyl)-, poly- is subsequently subjected to treatment
mer with ammonia, reaction product through a bed of activated carbon or
with chloromethane; CAS Reg. No. one of the strongly acidic cation-ex-
68036–99–7]. change resins in the hydrogen form
(20) Regenerated cellulose, cross- identified in paragraphs (a)(1), (2), and
linked and alkylated with epichloro- (11) of this section.
hydrin and propylene oxide, then sulfo- (iii) The temperature of the water
nated whereby the amount of epi- passing through the resin beds identi-
chlorohydrin plus propylene oxide em- fied in paragraphs (b)(1)(i) and (ii) of
ployed does not exceed 250 percent by this section is maintained at 30 °C or
weight of the starting quantity of cel- less, and the flow rate of the water
lulose. passing through the beds is not less
(b) Ion-exchange resins are used in than 2 gallons per cubic foot per
the purification of foods, including po- minute.
table water, to remove undesirable ions (iv) The ion-exchange resins identi-
or to replace less desirable ions with fied in paragraph (a)(12) or (16) of this
one or more of the following: bicarbon- section are exempted from the require-
ate, calcium, carbonate, chloride, hy- ments of paragraph (c)(4) of this sec-
drogen, hydroxyl, magnesium, potas- tion, but the strongly acidic cation-ex-
sium, sodium, and sulfate except that: change resins referred to in paragraphs
The ion-exchange resin identified in (b)(1)(i) and (ii) of this section used in
paragraph (a)(12) of this section is used the process meet the requirements of
only in accordance with paragraph paragraph (c)(4) of this section, except
(b)(1) of this section, the ion-exchange for the exemption described in para-
resin identified in paragraph (a)(13) of graph (d) of this section.
this section is used only in accordance (2) The ion-exchange resins identified
with paragraph (b)(2) of this section, in paragraphs (a)(13) and (16) of this
the resin identified in paragraph (a)(16) section are used to treat water and
of this section is used only in accord- aqueous food only of the types identi-
ance with paragraph (b)(1) or (b)(2) of fied under Categories I, II, and VI-B in
this section, the ion-exchange resin table 1 of § 176.170(c) of this chapter:
identified in paragraph (a)(17) of this Provided, That the temperature of the
section is used only in accordance with water or food passing through the resin
paragraph (b)(3) of this section, the beds is maintained at 50 °C or less and
ion-exchange resin identified in para- the flow rate of the water or food pass-
graph (a)(18) of this section is used only ing through the beds is not less than 0.5
in accordance with paragraph (b)(4) of gallon per cubic foot per minute.
133
§ 173.25 21 CFR Ch. I (4–1–23 Edition)
(i) The ion-exchange resin identified (3) The ion-exchange resin identified
in paragraph (a)(13) of this section is in paragraph (a)(17) of this section is
used to treat water and aqueous food used only for industrial application to
only of the types identified under cat- treat bulk quantities of aqueous food,
egories I, II, and VI-B in Table 1 of including potable water, or for treat-
§ 176.170(c) of this chapter: Provided, ment of municipal water supplies, sub-
That the temperature of the water or ject to the condition that the tempera-
food passing through the resin bed is ture of the food or water passing
maintained at 50 °C or less and the flow through the resin bed is maintained at
rate of the water or food passing 25 °C or less and the flow rate of the
through the bed is not less than 0.5 gal- food or water passing through the bed
lon per cubic foot per minute. is not less than 2 gallons per cubic foot
(ii) The ion-exchange resin identified per minute.
in paragraph (a)(16) of this section is (4) The ion-exchange resin identified
used to treat water and aqueous food in paragraph (a)(18) of this section is
only of the types identified under cat- used to treat aqueous sugar solutions
egories I, II, and VI-B in Table 1 of subject to the condition that the tem-
§ 176.170(c) of this chapter, Provided, perature of the sugar solution passing
that either: through the resin bed is maintained at
(A) The temperature of the water or 82 °C (179.6 °F) or less and the flow rate
food passing through the resin bed is of the sugar solution passing through
maintained at 50 °C or less and the flow the bed is not less than 46.8 liters per
rate of the water or food passing cubic meter (0.35 gallon per cubic foot)
through the bed is not less than 0.5 gal- of resin bed volume per minute.
lon per cubic foot per minute; or (5) The ion-exchange resin identified
(B) Extracts of the resin will be found in paragraph (a)(20) of this section is
to contain no more than 1 milligram/ limited to use in aqueous process
kilogram dimethylaminopropylamine
streams for the isolation and purifi-
in each of the food simulants, distilled
cation of protein concentrates and iso-
water and 10 percent ethanol, when,
lates under the following conditions:
following washing and pretreatment of
the resin in accordance with (i) For resins that comply with the
§ 173.25(c)(1), the resin is subjected to requirements in paragraph (d)(2)(i) of
the following test under conditions this section, the pH range for the resin
simulating the actual temperature and shall be no less than 3.5 and no more
flow rate of use: ‘‘The Determination of than 9, and the temperatures of water
3-Dimethylaminopropylamine in Food and food passing through the resin bed
Simulating Extracts of Ion Exchange shall not exceed 25 °C.
Resins,’’ February 4, 1998, which is in- (ii) For resins that comply with the
corporated by reference in accordance requirements in paragraph (d)(2)(ii) of
with 5 U.S.C. 552(a) and 1 CFR part 51. this section, the pH range for the resin
Copies are available from the Office of shall be no less than 2 and no more
Food Additive Safety (HFS–200), Center than 10, and the temperatures of water
for Food Safety and Applied Nutrition, and food passing through the resin
Food and Drug Administration, 5001 shall not exceed 50 °C.
Campus Dr., College Park, MD 20740, (c) To insure safe use of ion-exchange
240–402–1200, or may be examined at the resins, each ion-exchange resin will be:
Dockets Management Staff (HFA–305), (1) Subjected to pre-use treatment by
Food and Drug Administration, 5630 the manufacturer and/or the user in ac-
Fishers Lane, Rm. 1061, Rockville, MD cordance with the manufacturer’s di-
20852, 240–402–7500, between 9 a.m. and 4 rections prescribed on the label or la-
p.m., Monday through Friday, or at the beling accompanying the resins, to
National Archives and Records Admin- guarantee a food-grade purity of ion-
istration (NARA). For information on exchange resins, in accordance with
the availability of this material at good manufacturing practice.
NARA, call 202–741–6030, or go to: http:// (2) Accompanied by label or labeling
www.archives.gov/federal_register/ to include directions for use consistent

code_of_federal_regulations/ with the intended functional purpose of
ibr_locations.html. the resin.
134
(3) Used in compliance with the label cohol, and 5 percent acetic acid, will be
or labeling required by paragraph (c)(2) found to result in not more than 7
of this section. parts per million of nitrogen extrac-
(4) Found to result in no more than 1 tives (calculated as nitrogen) when the
part per million of organic extractives resin in the free-base form is subjected
obtained with each of the named sol- to the following test immediately be-
vents, distilled water, 15 percent alco- fore each use: Using a separate 1–inch
hol, and 5 percent acetic acid when, diameter glass ion-exchange column
having been washed and otherwise for each solvent, prepare each column
treated in accordance with the manu- using 100 milliliters of ready to use ion-
facturer’s directions for preparing exchange resin that is to be tested.
them for use with food, the ion-ex-
With the bottom outlet closed, fill each
change resin is subjected to the fol-
ion-exchange column with one of the
lowing test: Using a separate ion-ex-
three solvents at a temperature of 25 °C
change column for each solvent, pre-
pare columns using 50 milliliters of the until the solvent level is even with the
ready to use ion-exchange resin that is top of the resin bed. Seal each column
to be tested. While maintaining the at the top and bottom and store in a
highest temperature that will be en- vertical position at a temperature of 25
countered in use pass through these °C. After 96 hours, open the top of each
beds at the rate of 350–450 milliliters column, drain the solvent into a collec-
per hour the three test solvents dis- tion vessel, and analyze each drained
tilled water, 15 percent (by volume) solvent and a solvent blank for nitro-
ethyl alcohol, and 5 percent (by weight) gen by a standard micro-Kjeldahl
acetic acid. The first liter of effluent method.
from each solvent is discarded, then (d)(1) The ion-exchange resins identi-
the next 2 liters are used to determine fied in paragraphs (a)(1), (a)(2), (a)(11),
organic extractives. The 2-liter sample and (a)(15) of this section are exempted
is carefully evaporated to constant from the acetic acid extraction re-
weight at 105 °C; this is total extrac- quirement of paragraph (c)(4) of this
tives. This residue is fired in a muffle section.
furnace at 850 °C to constant weight; (2) The ion-exchange resin identified
this is ash. Total extractives, minus in paragraph (a)(20) of this section
ash equals the organic extractives. If
shall comply either with:
the organic extractives are greater
than 1 part per million of the solvent (i) The extraction requirement in
used, a blank should be run on the sol- paragraph (c)(4) of this section by using
vent and a correction should be made dilute sulfuric acid, pH 3.5 as a sub-
by subtracting the total extractives ob- stitute for acetic acid; or
tained with the blank from the total (ii) The extraction requirement in
extractives obtained in the resin test. paragraph (c)(4) of this section by using
The solvents used are to be made as reagent grade hydrochloric acid, di-
follows: luted to pH 2, as a substitute for acetic
acid. The resin shall be found to result
Distilled water (de-ionized water is distilled).
15 percent ethyl alcohol made by mixing 15 in no more than 25 parts per million of
volumes of absolute ethyl alcohol A.C.S. organic extractives obtained with each
reagent grade, with 85 volumes of distilled of the following solvents: Distilled
de-ionized water. water; 15 percent alcohol; and hydro-
5 percent acetic acid made by mixing 5 parts chloric acid, pH 2. Blanks should be run
by weight of A.C.S. reagent grade glacial
for each of the solvents, and correc-
acetic acid with 95 parts by weight of dis-
tilled de-ionized water. tions should be made by subtracting
the total extractives obtained with the
In addition to the organic extractives blank from the total extractives ob-
limitation prescribed in this para- tained in the resin test.
graph, the ion-exchange resin identi- (e) Acrylonitrile copolymers identi-
fied in paragraph (a)(17) of this section, fied in this section shall comply with
when extracted with each of the named
solvents, distilled water, 50 percent al-
135
§ 173.40 21 CFR Ch. I (4–1–23 Edition)
the provisions of § 180.22 of this chap- the Office of Food Additive Safety
ter. (HFS–200), Center for Food Safety and
Applied Nutrition, Food and Drug Ad-
FR 40181, Aug. 7, 1981; 46 FR 57033, Nov. 20,
ministration, 5001 Campus Dr., College
1981; 49 FR 28830, July 17, 1984; 56 FR 16268, Park, MD 20740, 240–402–1200, or are
Apr. 22, 1991; 62 FR 7679, Feb. 20, 1997; 64 FR available for inspection at the Dockets
14609, Mar. 26, 1999; 64 FR 56173, Oct. 18, 1999; Management Staff (HFA–305), Food and
78 FR 14665, Mar. 7, 2013; 81 FR 5592, Feb. 3, Drug Administration, 5630 Fishers
2016; 88 FR 17722, Mar. 24, 2023] Lane, Rm. 1061, Rockville, MD 20852,
240–402–7500, between 9 a.m. and 4 p.m.,
§ 173.40 Molecular sieve resins. Monday through Friday, or at the Na-
Molecular sieve resins may be safely tional Archives and Records Adminis-
used in the processing of food under the tration (NARA). For information on
following prescribed conditions: the availability of this material at
(a) The molecular sieve resins consist NARA, call 202–741–6030, or go to: http://
of purified dextran having an average www.archives.gov/federal_register/
molecular weight of 40,000, cross-linked code_of_federal_regulations/
with epichlorohydrin in a ratio of 1 ibr_locations.html.
part of dextran to 10 parts of (b) The additives may be used, indi-
epichlorohydrin, to give a stable three vidually or together, in the processing
dimensional structure. The resins have of beet sugar juice and liquor or of cane
a pore size of 2.0 to 3.0 milliliters per sugar juice and liquor to control min-
gram of dry resin (expressed in terms eral scale.
of water regain), and a particle size of (c) The additives are to be used so
10 to 300 microns. that the amount of either or both addi-
(b) The molecular sieve resins are tives does not exceed 4 parts per mil-
thoroughly washed with potable water lion (calculated as the acid) by weight
prior to their first use in contact with of the beet or cane sugar juice or liquor
food. process stream.
(c) Molecular sieve resins are used as [51 FR 5315, Feb. 13, 1986, as amended at 61
the gel filtration media in the final pu- FR 386, Jan. 5, 1996; 78 FR 14665, Mar. 7, 2013;
rification of partially delactosed whey. 81 FR 5592, Feb. 3, 2016; 88 FR 17722, Mar. 24,
The gel bed shall be maintained in a 2023]
sanitary manner in accordance with
good manufacturing practice so as to § 173.50 Polyvinylpolypyrrolidone.
prevent microbial build-up on the bed The food additive polyvinylpoly-
and adulteration of the product. pyrrolidone may be safely used in ac-
§ 173.45 Polymaleic acid and its so- conditions:
dium salt. (a) The additive is a homopolymer of
Polymaleic acid (CAS Reg. No. 26099– purified vinylpyrrolidone catalytically
09–2) and its sodium salt (CAS Reg. No. produced under conditions producing
70247–90–4) may be safely used in food polymerization and cross-linking such
in accordance with the following pre- that an insoluble polymer is produced.
scribed conditions: (b) The food additive is so processed
(a) The additives have a weight-aver- that when the finished polymer is
age molecular weight in the range of refluxed for 3 hours with water, 5 per-
540 to 850 and a number-average molec- cent acetic acid, and 50 percent alco-
ular weight in the range of 520 to 650, hol, no more than 50 parts per million
calculated as the acid. Molecular of extractables is obtained with each
weights shall be determined by a meth- solvent.
od entitled ‘‘Determination of Molec- (c) It is used or intended for use as a
ular Weight Distribution of clarifying agent in beverages and vin-
Poly(Maleic) Acid,’’ March 17, 1992, pro- egar, followed by removal with filtra-
duced by Ciba-Geigy, Inc., Seven Sky- tion.
line Dr., Hawthorne, NY 10532–2188,
§ 173.55 Polyvinylpyrrolidone.
which is incorporated by reference in

accordance with 5 U.S.C. 552(a) and 1 The food additive polyvinylpyrroli-
CFR part 51. Copies are available from done may be safely used in accordance
136
with the following prescribed condi- polyvinylpyrrolidone used in beer is

tions: that having an average molecular
(a) The additive is a polymer of puri- weight of 360,000 and a maximum
fied vinylpyrrolidone catalytically pro- unsaturation of 1 percent, calculated as
duced, having an average molecular the monomer.
weight of 40,000 and a maximum (b) The additive is used or intended
unsaturation of 1 percent, calculated as for use in foods as follows:
the monomer, except that the
Food Limitations
Beer ......................................................................... As a clarifying agent, at a residual level not to exceed 10 parts per million.
Flavor concentrates in tablet form .......................... As a tableting adjuvent in an amount not to exceed good manufacturing
practice.
Nonnutritive sweeteners in concentrated liquid As a stabilizer, bodying agent, and dispersant, in an amount not to exceed
form. good manufacturing practice.
Nonnutritive sweeteners in tablet form ................... As a tableting adjuvant in an amount not to exceed good manufacturing
practice.
Vitamin and mineral concentrates in liquid form .... As a stabilizer, bodying agent, and dispersant, in an amount not to exceed
good manufacturing practice.
Vitamin and mineral concentrates in tablet form .... As a tableting adjuvant in an amount not to exceed good manufacturing
practice.
Vinegar .................................................................... As a clarifying agent, at a residual level not to exceed 40 parts per million.
Wine ........................................................................ As a clarifying agent, at a residual level not to exceed 60 parts per million.
§ 173.60 Dimethylamine- amine-Epichlorohydrin Copolymer,’’

epichlorohydrin copolymer. which is incorporated by reference.
Dimethylamine-epichlorohydrin co- Copies are available from the Office of
polymer (CAS Reg. No. 25988–97–0) may Food Additive Safety (HFS–200), Center
be safely used in food in accordance for Food Safety and Applied Nutrition,
with the following prescribed condi- Food and Drug Administration, 5001
tions: Campus Dr., College Park, MD 20740,
(a) The food additive is produced by 240–402–1200, or available for inspection
copolymerization of dimethylamine at the National Archives and Records
and epichlorohydrin in which not more Administration (NARA). For informa-
than 5 mole-percent of dimethylamine tion on the availability of this mate-
may be replaced by an equimolar rial at NARA, call 202–741–6030, or go
amount of ethylenediamine, and in to: http://www.archives.gov/fed-
which the mole ratio of total amine to eral_register/code_of_federal_regulations/
epichlorohydrin is approximately 1:1. ibr_locations.html.
(b) The additive meets the following (4) Heavy metals (as Pb), 2 parts per
specifications: million maximum.
(1) The nitrogen content of the co- (5) Arsenic (as As), 2 parts per million
polymer is 9.4 to 10.8 weight percent on maximum.
a dry basis. (c) The food additive is used as a de-
(2) A 50-percent-by-weight aqueous colorizing agent and/or flocculant in
solution of the copolymer has a min- the clarification of refinery sugar liq-
imum viscosity of 175 centipoises at 25 uors and juices. It is added only at the
°C as determined by LVT-series Brook- defecation/clarification stage of sugar
field viscometer using a No. 2 spindle liquor refining at a concentration not
at 60 RPM (or by another equivalent to exceed 150 parts per million of co-
method). polymer by weight of sugar solids.
(3) The additive contains not more (d) To assure safe use of the additive,
than 1,000 parts per million of 1,3- the label and labeling of the additive
dichloro-2-propanol and not more than shall bear, in addition to other infor-
10 parts per million epichlorohydrin. mation required by the Act, adequate
The epichlorohydrin and 1,3-dichloro-2- directions to assure use in compliance
propanol content is determined by an with paragraph (c) of this section.
analytical method entitled ‘‘The Deter- [48 FR 37614, Aug. 19, 1983, as amended at 54
mination of Epichlorohydrin and 1,3- FR 24897, June 12, 1989; 88 FR 17722, Mar. 24,
Dichloro-2-Propanol in Dimethyl- 2023]
137
§ 173.65 21 CFR Ch. I (4–1–23 Edition)
§ 173.65 Divinylbenzene copolymer. No. 60177–39–1) may be safely used in

food in accordance with the following
Divinylbenzene copolymer may be
used for the removal of organic sub-
(a) The additive is an aqueous disper-
stances from aqueous foods under the
sion of styrene-divinylbenzene copoly-
mers, first chloromethylated then
(a) The copolymer is prepared in ap- aminated with trimethylamine, having
propriate physical form and is derived an average particle size of not more
by the polymerization of a grade of than 2.0 microns.
divinylbenzene which comprises at (b) The additive shall contain no
least 79 weight-percent divinylbenzene, more than 3.0 percent nonvolatile,
15 to 20 weight-percent ethylvinyl- soluble extractives when tested as fol-
benzene, and no more than 4 weight- lows: One hundred grams of the addi-
percent nonpolymerizable impurities. tive is centrifuged at 17,000 r/min for 2
(b) In accordance with the manufac- hours. The resulting clear supernatant
turer’s directions, the copolymer de- is removed from the compacted solids
scribed in paragraph (a) of this section and concentrated to approximately 10
is subjected to pre-use extraction with grams on a steam bath. The 10-gram
a water soluble alcohol until the level sample is again centrifuged at 17,000 r/
of divinylbenzene in the extract is less min for 2 hours to remove any residual
than 50 parts per billion as determined insoluble material. The supernatant
by a method titled, ‘‘The Determina- from the second centrifugation is then
tion of Divinylbenzene in Alcohol Ex- removed from any compacted solids
tracts of Amberlite XAD–4,’’ which is and dried to constant residual weight
incorporated by reference. Copies of using a steam bath. The percent non-
this method are available from the Of- volatile solubles is obtained by divid-
fice of Food Additive Safety (HFS–200), ing the weight of the dried residue by
Center for Food Safety and Applied Nu- the weight of the solids in the original
trition, Food and Drug Administration, resin dispersion.
5001 Campus Dr., College Park, MD (c) The additive is used as a decol-
20740, 240–402–1200, or available for in- orizing and clarification agent for
spection at the National Archives and treatment of refinery sugar liquors and
Records Administration (NARA). For juices at levels not to exceed 500 parts
information on the availability of this of additive solids per million parts of
material at NARA, call 202–741–6030, or sugar solids.
[50 FR 29209, July 18, 1985]
ibr_locations.html. The copolymer is § 173.73 Sodium polyacrylate.
then treated with water according to
Sodium polyacrylate (CAS Reg. No.
the manufacturer’s recommendation to
9003–04–7) may be safely used in food in
remove the extraction solvent to guar-
antee a food-grade purity of the resin
scribed conditions:
at the time of use, in accordance with
(a) The additive is produced by the
current good manufacturing practice.
polymerization of acrylic acid and sub-
(c) The temperature of the aqueous
sequent hydrolysis of the polyacrylic
food stream contacting the polymer is
acid with an aqueous sodium hydroxide
maintained at 79.4 °C (175 °F) or less.
solution. As determined by a method
(d) The copolymer may be used in entitled ‘‘Determination of Weight Av-
contact with food only of Types I, II, erage and Number Average Molecular
and VI-B (excluding carbonated bev- Weight of Sodium Polyacrylate,’’
erages) described in table 1 of para- which is incorporated by reference in
graph (c) of § 176.170 of this chapter. accordance with 5 U.S.C. 552(a), the ad-
[50 FR 61, Jan. 2, 1985, as amended at 88 FR ditive has—
17722, Mar. 24, 2023] (1) A weight average molecular
weight of 2,000 to 2,300; and
§ 173.70 Chloromethylated aminated (2) A weight average molecular
styrene-divinylbenzene resin.
weight to number average molecular

Chloromethylated aminated styrene- weight ratio of not more than 1.3. Cop-
divinylbenzene copolymer (CAS Reg. ies of the method are available from
138
the Office of Food Additive Safety (a) Rhizopus niveus is classified as fol-
(HFS–200), Center for Food Safety and lows: Class, Phycomycetes; order,
Applied Nutrition, Food and Drug Ad- Mucorales; family, Mucoraceae; genus,
ministration, 5001 Campus Dr., College Rhizopus; species, niveus.
Park, MD 20740, 240–402–1200, or avail- (b) The strain of Rhizopus niveus is
able for inspection at the National Ar- nonpathogenic and nontoxic in man or
chives and Records Administration other animals.
(NARA). For information on the avail- (c) The enzyme is produced by a proc-
ability of this material at NARA, call ess which completely removes the or-
202–741–6030, or go to: http:// ganism Rhizopus niveus from the
www.archives.gov/federal_register/ amyloglucosidase.
code_of_federal_regulations/ (d) The additive is used or intended
ibr_locations.html. for use for degrading gelatinized starch
(b) The additive is used to control into constituent sugars, in the produc-
mineral scale during the evaporation of tion of distilled spirits and vinegar.
beet sugar juice or cane sugar juice in (e) The additive is used at a level not
the production of sugar in an amount to exceed 0.1 percent by weight of the
not to exceed 3.6 parts per million by gelatinized starch.
weight of the raw juice.
§ 173.115 Alpha-acetolactate
[53 FR 39456, Oct. 7, 1988; 53 FR 49823, Dec. 9, decarboxylase (α-ALDC) enzyme
1988, as amended at 88 FR 17722, Mar. 24, 2023] preparation derived from a recom-
binant Bacillus subtilis.
§ 173.75 Sorbitan monooleate.
The food additive alpha-acetolactate
Sorbitan monooleate may be safely
decarboxylase (a-ALDC) enzyme prepa-
used in accordance with the following
ration, may be safely used in accord-
(a) The additive is produced by the ance with the following conditions:
esterification of sorbitol with commer- (a) The food additive is the enzyme
cial oleic acid. preparation derived from a modified
(b) It meets the following specifica- Bacillus subtilis strain that contains the
tions: gene coding for a-ALDC from Bacillus
(1) Saponification number, 145–160. brevis.
(2) Hydroxyl number, 193–210. (b)(1) The manufacturer produces the
(c) The additive is used or intended additive from a pure culture fermenta-
for use as follows: tion of a strain of Bacillus subtilis that
(1) As an emulsifier in polymer dis- is nonpathogenic and nontoxigenic in
persions that are used in the clarifica- man or other animals.
tion of cane or beet sugar juice or liq- (2) The manufacturer may stabilize
uor in an amount not to exceed 7.5 per- the enzyme preparation with
cent by weight in the final polymer dis- glutaraldehyde or with other suitable
persion. approved food additives or generally
(2) The additive is used in an amount recognized as safe substances.
not to exceed 0.70 part per million in (3) The enzyme preparation must
sugar juice and 1.4 parts per million in meet the general and additional re-
sugar liquor. quirements for enzyme preparations in
the Food Chemicals Codex, 4th ed., 1996,
[51 FR 11720, Apr. 7, 1986] pp. 133–134, which is incorporated by
reference. The Director of the Office of
Subpart B—Enzyme Preparations the Federal Register approves this in-
and Microorganisms corporation by reference in accordance
§ 173.110 Amyloglucosidase derived Copies may be obtained from the Na-
from Rhizopus niveus. tional Academy Press, 2101 Constitu-
Amyloglucosidase enzyme product, tion Ave. NW., Washington, DC 20055,
consisting of enzyme derived from or may be examined at the Dockets
Rhizopus niveus, and diatomaceous sili- Management Staff (HFA–305), Food and
ca as a carrier, may be safely used in Drug Administration, 5630 Fishers

food in accordance with the following Lane, Rm. 1061, Rockville, MD 20852,
conditions: 240–402–7500, between 9 a.m. and 4 p.m.,
139
§ 173.120 21 CFR Ch. I (4–1–23 Edition)
Monday through Friday, or at the Na- (b) The strain of Rhizopus oryzae is
tional Archives and Records Adminis- nonpathogenic and nontoxic.
tration (NARA). For information on (c) The carbohydrase is produced
the availability of this material at under controlled conditions to main-
NARA, call 202–741–6030, or go to: http:// tain nonpathogenicity and nontoxicity,
www.archives.gov/federal_register/ including the absence of aflatoxin.
code_of_federal_regulations/ (d) The carbohydrase is produced by a
ibr_locations.html. process which completely removes the
(c) The additive is used in an amount organism Rhizopus oryzae from the
not in excess of the minimum required carbohydrase product.
to produce its intended effect as a proc-
(e) The carbohydrase is maintained
essing aid in the production of alco-
holic malt beverages and distilled liq- under refrigeration from production to
uors. use and is labeled to include the neces-
sity of refrigerated storage.
[66 FR 27022, May 16, 2001, as amended at 88
FR 17722, Mar. 24, 2023] § 173.135 Catalase derived from Micro-
coccus lysodeikticus.
§ 173.120 Carbohydrase and cellulase
derived from Aspergillus niger. Bacterial catalase derived from
Micrococcus lysodeikticus by a pure cul-
Carbohydrase and cellulase enzyme
ture fermentation process may be safe-
preparation derived from Aspergillus
ly used in destroying and removing hy-
niger may be safely used in food in ac-
cordance with the following prescribed drogen peroxide used in the manufac-
conditions: ture of cheese, in accordance with the
(a) Aspergillus niger is classified as following conditions.
follows: Class, Deuteromycetes; order, (a) The organism Micrococcus
Moniliales; family, Moniliaceae; genus, lysodeikticus from which the bacterial
Aspergillus; species, niger. catalase is to be derived is dem-
(b) The strain of Aspergillus niger is onstrated to be nontoxic and nonpatho-
nonpathogenic and nontoxic in man or genic.
other animals. (b) The organism Micrococcus
(c) The additive is produced by a lysodeikticus is removed from the bac-
process that completely removes the terial catalase prior to use of the bac-
organism Aspergillus niger from the terial catalase.
carbohydrase and cellulase enzyme (c) The bacterial catalase is used in
product. an amount not in excess of the min-
(d) The additive is used or intended imum required to produce its intended
for use as follows: effect.
(1) For removal of visceral mass (bel-
lies) in clam processing. § 173.140 Esterase-lipase derived from
(2) As an aid in the removal of the Mucor miehei.
shell from the edible tissue in shrimp Esterase-lipase enzyme, consisting of
processing. enzyme derived from Mucor miehei var.
(e) The additive is used in an amount Cooney et Emerson by a pure culture fer-
not in excess of the minimum required mentation process, with maltodextrin
to produce its intended effect.
or sweet whey as a carrier, may be
§ 173.130 Carbohydrase derived from safely used in food in accordance with
Rhizopus oryzae. the following conditions:
(a) Mucor miehei var. Cooney et Emer-
Carbohydrase from Rhizopus oryzae
may be safely used in the production of son is classified as follows: Class,
dextrose from starch in accordance Phycomycetes; subclass, Zygomycetes;
with the following prescribed condi- order, Mucorales; family, Mucoraceae;
tions: genus, Mucor; species, miehei; variety
(a) Rhizopus oryzae is classified as fol- Cooney et Emerson.
(b) The strain of Mucor miehei var.
lows: Class, Phycomycetes; order,

Mucorales; family, Mucoraceae; genus, Cooney et Emerson is nonpathogenic and
Rhizopus; species, Rhizopus oryzae. nontoxic in man or other animals.
140
(c) The enzyme is produced by a proc- (d) The enzyme removal is such that
ess which completely removes the or- there are no enzyme or mycelial resi-
ganism Mucor miehei var. Cooney et dues remaining in the finished sucrose.
Emerson from the esterase-lipase. [42 FR 14526, Mar. 15, 1977, as amended at 54
(d) The enzyme is used as a flavor FR 24897, June 12, 1989]
enhancer as defined in § 170.3(o)(12).
(e) The enzyme is used at levels not § 173.150 Milk-clotting enzymes, micro-
to exceed current good manufacturing bial.
practice in the following food cat- Milk-clotting enzyme produced by
egories: cheeses as defined in pure-culture fermentation process may
§ 170.3(n)(5) of this chapter; fat and oils be safely used in the production of
as defined in § 170.(3)(n)(12) of this chap- cheese in accordance with the fol-
ter; and milk products as defined in lowing prescribed conditions:
§ 170.(3)(n)(31) of this chapter. Use of (a) Milk-clotting enzyme is derived
this food ingredient is limited to from one of the following organisms by
nonstandarized foods and those foods a pure-culture fermentation process:
for which the relevant standards of (1) Endothia parasitica classified as
identity permit such use. follows: Class, Ascomycetes; order,
(f) The enzyme is used in the min- Sphaeriales; family, Diaporthacesae;
imum amount required to produce its genus, Endothia; species, parasitica.
limited technical effect. (2) Bacillus cereus classified as fol-
[47 FR 28090, June 29, 1982; 48 FR 2748, Jan. 21,
lows: Class, Schizomycetes; order,
1983] Eubacteriales; family, Bacillaceae;
genus, Bacillus; species, cereus
§ 173.145 Alpha-Galactosidase derived (Frankland and Frankland).
from Mortierella vinaceae var. (3) Mucor pusillus Lindt classified as
raffinoseutilizer. follows: Class, Phycomycetes; subclass,
The food additive alpha-galactosidase Zygomycetes; order, Mucorales; fam-
and parent mycelial microorganism ily, Mucoraceae; genus, Mucor; species,
Mortierella vinaceae var. raffinoseutilizer pusillus; variety, Lindt.
may be safely used in food in accord- (4) Mucor miehei Cooney et Emerson
ance with the following conditions: classified as follows: Class,
(a) The food additive is the enzyme Phycomycetes; subclass, Zygomycetes;
alpha-galactosidase and the mycelia of order, Mucorales; family, Mucoraceae;
the microorganism Mortierella vinaceae genus, Mucor; species, miehei; variety,
var. raffinoseutilizer which produces the Cooney et Emerson.
enzyme. (5) Aspergillus oryzae modified by re-
(b) The nonpathogenic microorga- combinant deoxyribonucleic (DNA)
nism matches American Type Culture techniques to contain the gene coding
Collection (ATCC) No. 20034, 1 and is for aspartic proteinase from
classified as follows: Rhizomucor miehei var. Cooney et Emer-
son as defined in paragraph (a)(4) of
Class: Phycomycetes. this section, and classified as follows:
Order: Mucorales. Class, Blastodeuteromycetes
Family: Mortierellaceae. (Hyphomycetes); order, Phialidales
Genus: Mortierella.
Species: vinaceae.
(Moniliales); genus, Aspergillus; species
Variety: raffinoseutilizer. oryzae.
(b) The strains of organism identified
(c) The additive is used or intended in paragraph (a) of this section are
for use in the production of sugar (su- nonpathogenic and nontoxic in man or
crose) from sugar beets by addition as other animals.
mycelial pellets to the molasses to in- (c) The additive is produced by a
crease the yield of sucrose, followed by process that completely removes the
removal of the spent mycelial pellets generating organism from the milk-
by filtration. clotting enzyme product.
(d) The additive is used in an amount
1 Available from: American Type Culture not in excess of the minimum required
Collection, 12301 Parklawn Drive, Rockville, to produce its intended effect in the
MD 20852. production of those cheeses for which
141
§ 173.160 21 CFR Ch. I (4–1–23 Edition)
it is permitted by standards of identity of citric acid using an acceptable aque-

established pursuant to section 401 of ous carbohydrate substrate.
the Act. (2) The organism Candida
quilliermondii is made nonviable and is
[42 FR 14526, Mar. 15, 1977; 42 FR 56728, Oct.
28, 1977, as amended at 62 FR 59284, Nov. 3,
completely removed from the citric
1997] acid during the recovery and purifi-
cation process.
§ 173.160 Candida guilliermondii. (d) The additive is so used that the
citric acid produced conforms to the
The food additive Candida
specifications of the Food Chemicals
guilliermondii may be safely used as the
Codex, 7th ed. (2010), pp. 226–227, which
organism for fermentation production
is incorporated by reference. The Di-
of citric acid in accordance with the rector of the Office of the Federal Reg-
following conditions: ister approves this incorporation by
(a) The food additive is the enzyme reference in accordance with 5 U.S.C.
system of the viable organism Candida 552(a) and 1 CFR part 51. You may ob-
guilliermondii and its concomitant me- tain copies from the United States
tabolites produced during the fer- Pharmacopeial Convention, 12601
mentation process. Twinbrook Pkwy., Rockville, MD 20852
(b)(1) The nonpathogenic and (Internet address http://www.usp.org).
nontoxicogenic organism descending Copies may be examined at the Dock-
from strain, American Type Culture ets Management Staff (HFA–305), Food
Collection (ATCC) No. 20474, 1 is classi- and Drug Administration, 5630 Fishers
fied as follows: Lane, Rm. 1061, Rockville, MD 20852,
Class: Deuteromycetes. 240–402–7500, between 9 a.m. and 4 p.m.,
Order: Moniliales. Monday through Friday, or at the Na-
Family: Cryptococcaceae. tional Archives and Records Adminis-
Genus: Candida. tration (NARA). For information on
Species: guilliermondii. the availability of this material at
Variety: guilliermondii. NARA, call 202–741–6030 or go to: http://
(2) The toxonomic characteristics of www.archives.gov/federal-register/cfr/ibr-
the reference culture strain ATCC No. locations.html.
20474 agree in the essentials with the [42 FR 14526, Mar. 15, 1977, as amended at 47
standard description for Candida FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19,
guilliermondii variety guilliermondii list- 1984; 54 FR 24897, June 12, 1989; 78 FR 71466,
ed in ‘‘The Yeasts—A Toxonomic Nov. 29, 2013; 88 FR 17722, Mar. 24, 2023]
Study;’’ 2d Ed. (1970), by Jacomina
Lodder, which is incorporated by ref- § 173.165 Candida lipolytica.
erence. Copies are available from the The food additive Candida lipolytica
Office of Food Additive Safety (HFS– may be safely used as the organism for
200), Center for Food Safety and Ap- fermentation production of citric acid
plied Nutrition, Food and Drug Admin- in accordance with the following condi-
istration, 5001 Campus Dr., College tions:
Park, MD 20740, 240–402–1200, or avail- (a) The food additive is the enzyme
able for inspection at the National Ar- system of the organism Candida
chives and Records Administration lipolytica and its concimitant metabo-
(NARA). For information on the avail- lites produced during the fermentation
ability of this material at NARA, call process.
202–741–6030, or go to: http:// (b)(1) The nonpathogenic organism is
www.archives.gov/federal_register/ classified as follows:
code_of_federal_regulations/ Class: Deuteromycetes.
ibr_locations.html. Order: Moniliales.
(c)(1) The additive is used or intended Family: Cryptococcaceae.
for use as a pure culture in the fer- Genus: Candida.
mentation process for the production Species: lipolytica.
(2) The taxonomic characteristics of
1 Availablefrom: American Type Culture the culture agree in essential with the
Collection, 12301 Parklawn Drive, Rockville, standard description for Candida
MD 20852. lipolytica variety lipolytica listed in
142
‘‘The Yeasts—A Toxonomic Study,’’ 2d ANALYTICAL PROCEDURE FOR CITRIC ACID

Ed. (1970), by Jacomina Lodder, which
is incorporated by reference. Copies are
available from the Office of Food Addi- Because of the sensitivity of the test, the
tive Safety (HFS–200), Center for Food possibility of errors arising from contamina-
tion is great. It is of the greatest importance
Safety and Applied Nutrition, Food and that all glassware be scrupulously cleaned to
Drug Administration, 5001 Campus Dr., remove all organic matter such as oil,
College Park, MD 20740, 240–402–1200, or grease, detergent residues, etc. Examine all
available for inspection at the National glassware including stoppers and stopcocks,
Archives and Records Administration under ultraviolet light to detect any residual
(NARA). For information on the avail- fluorescent contamination. As a pre-
cautionary measure it is recommended prac-
tice to rinse all glassware with purified iso-
202–741–6030, or go to: http:// octane immediately before use. No grease is
www.archives.gov/federal_register/ to be used on stopcocks or joints. Great care
code_of_federal_regulations/ to avoid contamination of citric acid sam-
ibr_locations.html. ples in handling is essential to assure ab-
(c) The additive is used or intended sence of any extraneous material arising
from inadequate packaging. Because some of
for use as a pure culture in the fer- the polynuclear hydrocarbons sought in this
mentation process for the production test are very susceptible to photo-oxidation,
of citric acid from purified normal the entire procedure is to be carried out
alkanes. under subdued light.
(d) The additive is so used that the
APPARATUS
citric acid produced conforms to the
specifications of the Food Chemicals 1. Aluminum foil, oil free.
Codex, 7th ed. (2010), pp. 226–227, which 2. Separatory funnels, 500-milliliter capac-
ity, equipped with tetrafluoroethylene poly-
is incorporated by reference. The Di-
mer stopcocks.
rector of the Office of the Federal Reg- 3. Chromatographic tubes: (a) 80-milli-
ister approves this incorporation by meter ID × 900-millimeter length equipped
reference in accordance with 5 U.S.C. with tetrafluoroethylene polymer stopcock
552(a) and 1 CFR part 51. You may ob- and course fritted disk; (b) 18-millimeter ID
tain copies from the United States × 300-millimeter length equipped with tetra-
Pharmacopeial Convention, 12601 fluoroethylene polymer stopcock.
4. Rotary vacuum evaporator, Buchi or
Twinbrook Pkwy., Rockville, MD 20852
equivalent.
(Internet address http://www.usp.org). 5. Spectrophotometer—Spectral range 250–
Copies may be examined at the Dock- 400 nanometers with spectral slit width of 2
ets Management Staff (HFA–305), Food nanometers or less; under instrument oper-
and Drug Administration, 5630 Fishers ating conditions for these absorbance meas-
Lane, Rm. 1061, Rockville, MD 20852, urements, the spectrophotometer shall also
meet the following performance require-
240–402–7500, between 9 a.m. and 4 p.m.,
ments:
Monday through Friday, or at the Na- Absorbance repeatability, ±0.01 at 0.4 ab-
tional Archives and Records Adminis- sorbance.
tration (NARA). For information on Wavelength repeatability, ±0.2 nanometer.
the availability of this material at Wavelength accuracy, ±1.0 nanometer.
NARA, call 202–741–6030 or go to: http:// The spectrophotometer is equipped with
www.archives.gov/federal-register/cfr/ibr- matched 1 centimeter path length quartz
locations.html. The additive meets the microcuvettes with 0.5-milliliter volume ca-
pacity.
following ultraviolet absorbance limits
6. Vacuum oven, minimum inside dimen-
when subjected to the analytical proce- sions: 200 mm × 200 mm × 300 mm deep.
dure described in this paragraph:
REAGENTS AND MATERIALS
Ultraviolet absorbance per centimeter path Maximum
length Organic solvents. All solvents used through-
out the procedure shall meet the specifica-
280 to 289 millimicrons ....................................... 0.25
tions and tests described in this specifica-
290 to 299 millimicrons ....................................... 0.20
tion. The methyl alcohol, isooctane, benzene,
300 to 359 millimicrons ....................................... 0.13

hexane and 1,2-dichloroethane designated in
360 to 400 millimicrons ....................................... 0.03
the list following this paragraph shall pass
the following test:
143
§ 173.165 21 CFR Ch. I (4–1–23 Edition)
The specified quantity of solvent is added wash with an additional 6 liters of purified
to a 250-milliliter round bottom flask con- water and wash with 3,600 milliliters of puri-
taining 0.5 milliliter of purified n-hexa- fied methyl alcohol at a relatively slow rate.
decane and evaporated on the rotary evapo- Drain all of the solvents and transfer the
rator at 45 °C to constant volume. Six milli- silica gel to an aluminum foil-lined drying
liters of purified isooctane are added to this dish. Place foil over the top of the dish. Acti-
residue and evaporated under the same con- vate in a vacuum oven at low vacuum (ap-
ditions as above for 5 minutes. Determine proximately 750 millimeters Mercury or 27
the absorbance of the residue compared to inches of Mercury below atmospheric pres-
purified n-hexadecane as reference. The ab- sure) at 173° to 177 °C for at least 20 hours.
sorbance of the solution of the solvent res- Cool under vacuum and store in an amber
idue shall not exceed 0.03 per centimeter bottle.
path length between 280 and 299 nanometers Sodium sulfate, anhydrous, A.C.S. reagent
and 0.01 per centimeter path length between grade. This reagent should be washed with
300 and 400 nanometers. purified isooctane. Check the purity of this
Methyl alcohol, A.C.S. reagent grade. Use 100 reagent as described in § 172.886 of this chap-
milliliters for the test described in the pre- ter.
ceding paragraph. If necessary, methyl alco- Water, purified. All water used must meet
hol may be purified by distillation through a the specifications of the following test:
Virgreaux column discarding the first and Extract 600 milliliters of water with 50 mil-
last ten percent of the distillate or other- liliters of purified isooctane. Add 1 milliliter
wise. of purified n-hexadecane to the isooctane ex-
Benzene, spectrograde (Burdick and Jackson tract and evaporate the resulting solution to
Laboratories, Inc., Muskegon, Mich., or equiva- 1 milliliter. The absorbance of this residue
lent). Use 80 milliliters for the test. If nec- shall not exceed 0.02 per centimeter path
essary, benzene may be purified by distilla- length between 300–400 nanometers and 0.03
tion or otherwise. per centimeter path length between 280–299
Isooctane (2,2,4-trimethylpentane). Use 100 nanometers. If necessary, water may be puri-
milliliters for the test. If necessary, iso- fied by distillation, extraction with purified
octane may be purified by passage through a organic solvents, treatment with an absorb-
column of activated silica gel, distillation or ent (e.g., activated carbon) followed by fil-
otherwise. tration of the absorbent or otherwise.
Hexane, spectrograde (Burdick and Jackson
Laboratories, Inc., Muskegon, Mich., or equiva- PROCEDURE
lent). Use 100 milliliters for the test. If nec- Separate portions of 200 milliliters of puri-
essary, hexane may be purified by distilla- fied water are taken through the procedure
tion or otherwise. for use as control blanks. Each citric acid
1,2-Dichloroethane, spectrograde (Matheson, sample is processed as follows: Weigh 200
Coleman and Bell, East Rutherford, N.J., or grams of anhydrous citric acid into a 500 mil-
equivalent). Use 100 milliliters for the test. If liliter flask and dissolve in 200 milliliters of
necessary, 1,2-dichloroethane may be puri- pure water. Heat the solution to 60 °C and
fied by distillation or otherwise. transfer to a 500 milliliter separatory funnel.
Rinse the flask with 50 milliliters of iso-
ELUTING MIXTURES
octane and add the isooctane to the sepa-
1. 10 percent 1,2-dichloroethane in hexane. ratory funnel. Gently shake the mixture 90
Prepare by mixing the purified solvents in times (caution: vigorous shaking will cause
the volume ratio of 1 part of 1,2- emulsions) with periodic release of the pres-
dichloroethane to 9 parts of hexane. sure caused by shaking.
2. 40 percent benzene in hexane. Prepare by Allow the phases to separate for at least 5
mixing the purified solvents in the volume minutes. Draw off the lower aqueous layer
ratio of 4 parts of benzene to 6 parts of into a second 500-milliliter separatory funnel
hexane. and repeat the extraction with a second ali-
n-Hexadecane, 99 percent olefin-free. Deter- quot of 50 milliliters of isooctane. After sep-
mine the absorbance compared to isooctane aration of the layers, draw off and discard
as reference. The absorbance per centimeter the water layer. Combine both isooctane ex-
path length shall not exceed 0.00 in the range tracts in the funnel containing the first ex-
of 280–400 nanometers. If necessary, n-hexa- tract. Rinse the funnel which contained the
decane may be purified by percolation second extract with 10 milliliters of iso-
through activated silica gel, distillation or octane and add this portion to the combined
otherwise. isooctane extract.
Silica gel, 28–200 mesh (Grade 12, Davison A chromatographic column containing 5.5
Chemical Co., Baltimore, MD, or equivalent). grams of silica gel and 3 grams of anhydrous
Activate as follows: Slurry 900 grams of sili- sodium sulfate is prepared for each citric
ca gel reagent with 2 liters of purified water acid sample as follows: Fit 18 × 300 column
in a 3-liter beaker. Cool the mixture and with a small glass wool plug. Rinse the in-
pour into a 80 × 900 chromatographic column side of the column with 10 milliliters of puri-
with coarse fritted disc. Drain the water, fied isooctane. Drain the isooctane from the
144
column. Pour 5.5 grams of activated silica § 173.170 Aminoglycoside 3′-phospho-
gel into the column. Tap the column ap- transferase II.
proximately 20 times on a semisoft, clean
surface to settle the silica gel. Carefully The food additive aminoglycoside 3′-
pour 3 grams of anhydrous sodium sulfate phosphotransferase II may be safely
onto the top of the silica gel in the column. used in the development of genetically
Carefully drain the isooctane extract of modified cotton, oilseed rape, and to-
the citric acid solution into the column in a matoes in accordance with the fol-
series of additions while the isooctane is
draining from the column at an elution rate lowing prescribed conditions:
of approximately 3 milliliters per minute. (a) The food additive is the enzyme
Rinse the separatory funnel with 10 milli- aminoglycoside 3′-phosphotransferase
liters of isooctane after the last portion of II (CAS Reg. No. 58943–39–8) which cata-
the extract has been applied to the column lyzes the phosphorylation of certain
and add this rinse to the column. After all of
aminoglycoside antibiotics, including
the extract has been applied to the column
and the solvent layer reaches the top of the kanamycin, neomycin, and gentamicin.
sulfate bed, rinse the column with 25 milli- (b) Aminoglycoside 3′-phosphotrans-
liters of isooctane followed by 10 milliliters ferase II is encoded by the kanr gene
of a 10-percent dichloroethane in hexane so- originally isolated from transposon Tn5
lution. For each rinse solution, drain the col- of the bacterium Escherichia coli.
umn until the solvent layer reaches the top
(c) The level of the additive does not
of the sodium sulfate bed. Discard the rinse
solvents. Place a 250-milliliter round bottom exceed the amount reasonably required
flask containing 0.5 milliliter of purified n- for selection of plant cells carrying the
hexadecane under the column. Elute the kanr gene along with the genetic mate-
polynuclear aromatic hydrocarbons from the rial of interest.
column with 30 milliliters of 40-percent ben-
zene in hexane solution. Drain the eluate [59 FR 26711, May 23, 1994]
until the 40-percent benzene in the hexane
solvent reaches the top of the sodium sulfate Subpart C—Solvents, Lubricants,
bed.
Evaporate the 40-percent benzene in Release Agents and Related
hexane eluate on the rotary vacuum evapo- Substances
rator at 45 °C until only the n-hexadecane
residue of 0.5 milliliter remains. Treat the n- § 173.210 Acetone.
hexadecane residue twice with the following
wash step: Add 6 milliliters of purified iso-
A tolerance of 30 parts per million is
octane and remove the solvents by vacuum established for acetone in spice
evaporation at 45 °C to constant volume, i.e., oleoresins when present therein as a
0.5 milliliter. Cool the n-hexadecane residue residue from the extraction of spice.
and transfer the solution to an 0.5-milliliter
microcuvette. Determine the absorbance of § 173.220 1,3-Butylene glycol.
this solution compared to purified n-hexa-
decane as reference. Correct the absorbance 1,3-Butylene glycol (1,3-butanediol)
values for any absorbance derived from the may be safely used in food in accord-
control reagent blank. If the corrected ab- ance with the following prescribed con-
sorbance does not exceed the limits pre- ditions:
scribed, the samples meet the ultraviolet ab-
(a) The substance meets the fol-
sorbance specifications.
The reagent blank is prepared by using 200
milliliters of purified water in place of the (1) 1,3-Butylene glycol content: Not
citric acid solution and carrying the water less than 99 percent.
sample through the procedure. The typical (2) Specific gravity at 20/20 °C: 1.004
control reagent blank should not exceed 0.03 to 1.006.
absorbance per centimeter path length be-
tween 280 and 299 nanometers, 0.02 absorb- (3) Distillation range: 200°–215 °C.
ance per centimeter path length between 300 (b) It is used in the minimum amount
and 359 nanometers, and 0.01 absorbance per required to perform its intended effect.
centimeter path length between 360 and 400 (c) It is used as a solvent for natural
nanometers. and synthetic flavoring substances ex-
[42 FR 14491, Mar. 15, 1977, as amended at 47 cept where standards of identity issued
FR 11838, Mar. 19, 1982; 49 FR 10106, Mar. 19, under section 401 of the act preclude
1984; 54 FR 24897, June 12, 1989; 78 FR 71466, such use.
Nov. 29, 2013; 88 FR 17722, Mar. 24, 2023]
145
§ 173.228 21 CFR Ch. I (4–1–23 Edition)
§ 173.228 Ethyl acetate. (c) In hops extract as a residue from

the extraction of hops at a level not to
Ethyl acetate (CAS Reg. No. 141–78–6)
exceed 2.0 percent by weight: Provided,
That,
ance with the following conditions: (1) The hops extract is added to the
(a) The additive meets the specifica- wort before or during cooking in the
tions of the Food Chemicals Codex, 7th manufacture of beer.
ed. (2010), pp. 343–344, which is incor- (2) The label of the hops extract
porated by reference. The Director of specifies the presence of the isopropyl
the Office of the Federal Register ap- alcohol and provides for the use of the
proves this incorporation by reference hops extract only as prescribed by
in accordance with 5 U.S.C. 552(a) and 1 paragraph (c)(1) of this section.
CFR part 51. You may obtain copies
from the United States Pharmacopeial § 173.250 Methyl alcohol residues.
Convention, 12601 Twinbrook Pkwy., Methyl alcohol may be present in the
Rockville, MD 20852 (Internet address following foods under the conditions
http://www.usp.org). Copies may be ex- specified:
amined at the Dockets Management (a) In spice oleoresins as a residue
Staff (HFA–305), Food and Drug Admin- from the extraction of spice, at a level
istration, 5630 Fishers Lane, Rm. 1061, not to exceed 50 parts per million.
Rockville, MD 20852, 240–402–7500, be- (b) In hops extract as a residue from
tween 9 a.m. and 4 p.m., Monday the extraction of hops, at a level not to
through Friday, or at the National Ar- exceed 2.2 percent by weight; Provided,
chives and Records Administration That:
(NARA). For information on the avail- (1) The hops extract is added to the
ability of this material at NARA, call wort before or during cooking in the
202–741–6030 or go to: http:// manufacture of beer.
www.archives.gov/federal-register/cfr/ibr- (2) The label of the hops extract
locations.html. specifies the presence of methyl alco-
(b) The additive is used in accordance hol and provides for the use of the hops
with current good manufacturing prac- extract only as prescribed by para-
tice as a solvent in the decaffeination graph (b)(1) of this section.
of coffee and tea.
§ 173.255 Methylene chloride.
[47 FR 146, Jan. 5, 1982, as amended at 49 FR
28548, July 13, 1984; 78 FR 71466, Nov. 29, 2013; Methylene chloride may be present in
88 FR 17722, Mar. 24, 2023] food under the following conditions:
(a) In spice oleoresins as a residue
§ 173.230 Ethylene dichloride. from the extraction of spice, at a level
not to exceed 30 parts per million; Pro-
A tolerance of 30 parts per million is
vided, That, if residues of other
established for ethylene dichloride in
chlorinated solvents are also present,
spice oleoresins when present therein
the total of all residues of such sol-
as a residue from the extraction of
vents shall not exceed 30 parts per mil-
spice; Provided, however, That if resi-
lion.
dues of other chlorinated solvents are
(b) In hops extract as a residue from
also present the total of all residues of
the extraction of hops, at a level not to
such solvents shall not exceed 30 parts
exceed 2.2 percent, Provided, That:
per million.
(1) The hops extract is added to the
§ 173.240 Isopropyl alcohol. wort before or during cooking in the
manufacture of beer.
Isopropyl alcohol may be present in (2) The label of the hops extract iden-
the following foods under the condi- tifies the presence of the methylene
tions specified: chloride and provides for the use of the
(a) In spice oleoresins as a residue hops extract only as prescribed by
from the extraction of spice, at a level paragraph (b)(1) of this section.
not to exceed 50 parts per million. (c) In coffee as a residue from its use
(b) In lemon oil as a residue in pro- as a solvent in the extraction of caf-

duction of the oil, at a level not to ex- feine from green coffee beans, at a level
ceed 6 parts per million. not to exceed 10 parts per million (0.001
146
percent) in decaffeinated roasted coffee (b) The component substances are

and in decaffeinated soluble coffee ex- used solely as a solvent mixture and in
tract (instant coffee). a manner that does not result in for-
mation of products not present in con-
§ 173.270 Hexane. ventionally produced citric acid.
Hexane may be present in the fol- (c) The citric acid so produced meets
lowing foods under the conditions spec- the polynuclear aromatic hydrocarbon
ified: specifications of § 173.165 and the speci-
(a) In spice oleoresins as a residue fications of the Food Chemicals Codex,
from the extraction of spice, at a level 7th ed. (2010), pp. 226–227, which is in-
not to exceed 25 parts per million. corporated by reference. The Director
(b) In hops extract as a residue from of the Office of the Federal Register
the extraction of hops, at a level not to approves this incorporation by ref-
exceed 2.2 percent by weight; Provided, erence in accordance with 5 U.S.C.
That: 552(a) and 1 CFR part 51. You may ob-
(1) The hops extract is added to the tain copies from the United States
wort before or during cooking in the Pharmacopeial Convention, 12601
manufacture of beer. Twinbrook Pkwy., Rockville, MD 20852
(2) The label of the hops extract (Internet address http://www.usp.org).
specifies the presence of the hexane
and provides for the use of the hops ex-
ets Management Staff (HFA–305), Food
tract only as prescribed by paragraph
and Drug Administration, 5630 Fishers
(b)(1) of this section.
§ 173.275 Hydrogenated sperm oil. 240–402–7500, between 9 a.m. and 4 p.m.,
The food additive hydrogenated
sperm oil may be safely used in accord-
ditions: the availability of this material at
(a) The sperm oil is derived from ren- NARA, call 202–741–6030 or go to: http://
dering the fatty tissue of the sperm www.archives.gov/federal-register/cfr/ibr-
whale or is prepared by synthesis of locations.html.
fatty acids and fatty alcohols derived (d) Residues of n-octyl alcohol and
from the sperm whale. The sperm oil synthetic isoparaffinic petroleum hy-
obtained by rendering is refined. The drocarbons are removed in accordance
oil is hydrogenated. with good manufacturing practice. Cur-
(b) It is used alone or as a component rent good manufacturing practice re-
of a release agent or lubricant in bak- sults in residues not exceeding 16 parts
ery pans. per million (ppm) n-octyl alcohol and
(c) The amount used does not exceed 0.47 ppm synthetic isoparaffinic petro-
that reasonably required to accomplish leum hydrocarbons in citric acid.
the intended lubricating effect. (e) Tridodecyl amine may be present
as a residue in citric acid at a level not
§ 173.280 Solvent extraction process to exceed 100 parts per billion.
for citric acid.
A solvent extraction process for re-
FR 10106, Mar. 19, 1984; 78 FR 71466, Nov. 29,
covery of citric acid from conventional
2013; 88 FR 17722, Mar. 24, 2023]
Aspergillus niger fermentation liquor
may be safely used to produce food- § 173.290 Trichloroethylene.
grade citric acid in accordance with
the following conditions: Tolerances are established for resi-
(a) The solvent used in the process dues of trichloroethylene resulting
consists of a mixture of n-octyl alcohol from its use as a solvent in the manu-
meeting the requirements of § 172.864 of facture of foods as follows:
this chapter, synthetic isoparaffinic
Decaffeinated ground coffee 25 parts per million.
petroleum hydrocarbons meeting the

Decaffeinated soluble (in- 10 parts per million.
requirements of § 172.882 of this chap- stant) coffee extract.
ter, and tridodecyl amine.
147
§ 173.300 21 CFR Ch. I (4–1–23 Edition)
Spice oleoresins .................... 30 parts per million (provided chives and Records Administration
that if residues of other
chlorinated solvents are
also present, the total of all ability of this material at NARA, call
residues of such solvents 202–741–6030, or go to: http://
in spice oleoresins shall www.archives.gov/federal_register/
not exceed 30 parts per
million). code_of_federal_regulations/
ibr_locations.html.
(b)(1) The additive may be used as an
Subpart D—Specific Usage antimicrobial agent in water used in
Additives poultry processing in an amount not to
exceed 3 parts per million (ppm) resid-
§ 173.300 Chlorine dioxide. ual chlorine dioxide as determined by
Chlorine dioxide (CAS Reg. No. 10049– Method 4500–ClO2 E, referenced in para-
04–4) may be safely used in food in ac- graph (a)(2) of this section, or an equiv-
cordance with the following prescribed alent method.
conditions: (2) The additive may be used as an
(a)(1) The additive is generated by antimicrobial agent in water used to
one of the following methods: wash fruits and vegetables that are not
(i) Treating an aqueous solution of raw agricultural commodities in an
sodium chlorite with either chlorine amount not to exceed 3 ppm residual
gas or a mixture of sodium hypo- chlorine dioxide as determined by
chlorite and hydrochloric acid. Method 4500–ClO2 E, referenced in para-
(ii) Treating an aqueous solution of graph (a)(2) of this section, or an equiv-
sodium chlorate with hydrogen per- alent method. Treatment of the fruits
oxide in the presence of sulfuric acid. and vegetables with chlorine dioxide
(iii) Treating an aqueous solution of shall be followed by a potable water
sodium chlorite by electrolysis. rinse or by blanching, cooking, or can-
(2) The generator effluent contains at ning.
least 90 percent (by weight) of chlorine
dioxide with respect to all chlorine spe- [60 FR 11900, Mar. 3, 1995. Redesignated at 61
cies as determined by Method 4500–ClO2 FR 14245, Apr. 1, 1996, as amended at 61 FR
E in the ‘‘Standard Methods for the Ex- 14480, Apr. 2, 1996; 63 FR 38747, July 20, 1998;
65 FR 34587, May 31, 2000; 70 FR 7396, Feb. 14,
amination of Water and Wastewater,’’
2005; 81 FR 5592, Feb. 3, 2016; 88 FR 17723, Mar.
20th ed., 1998, or an equivalent method. 24, 2023]
Method 4500–ClO2 E (‘‘Amperometric
Method II’’) is incorporated by ref- § 173.310 Boiler water additives.
erence in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. You may ob- Boiler water additives may be safely
tain a copy from the Office of Food Ad- used in the preparation of steam that
ditive Safety (HFS–200), Center for will contact food, under the following
Food Safety and Applied Nutrition, conditions:
Food and Drug Administration, 5001 (a) The amount of additive is not in
Campus Dr., College Park, MD 20740, excess of that required for its func-
240–402–1200, or the American Public tional purpose, and the amount of
Health Association, 800 I St. NW., steam in contact with food does not ex-
Washington, DC 20001–3750. You may in- ceed that required to produce the in-
spect a copy at the Dockets Manage- tended effect in or on the food.
ment Staff (HFA–305), Food and Drug (b) The compounds are prepared from
Administration, 5630 Fishers Lane, Rm. substances identified in paragraphs (c)
1061, Rockville, MD 20852, 240–402–7500, and (d) of this section, and are subject
between 9 a.m. and 4 p.m., Monday to the limitations, if any, prescribed:
through Friday, or at the National Ar- (c) List of substances:
Substances Limitations
Acrylamide-sodium acrylate resin ................................................. Contains not more than 0.05 percent by weight of acrylamide
monomer.
148
Acrylic acid/2-acrylamido-2-methyl propane sulfonic acid copoly- Total not to exceed 20 parts per million (active) in boiler
mer having a minimum weight average molecular weight of feedwater.
9,900 and a minimum number average molecular weight of
5,700 as determined by a method entitled ‘‘Determination of
Weight Average and Number Average Molecular Weight of
60/40 AA/AMPS’’.
Ammonium alginate.
Cobalt sulfate (as catalyst).
1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg. No.
2809–21–4) and its sodium and potassium salts.
Lignosulfonic acid.
Monobutyl ethers of polyethylene-polypropylene glycol produced Minimum mol. wt. 1,500.
by random condensation of a 1:1 mixture by weight of ethyl-
ene oxide and propylene oxide with butanol.
Poly(acrylic acid-co-hypophosphite), sodium salt (CAS Reg. No. Total not to exceed 1.5 parts per million in boiler feed water.
71050–62–9), produced from a 4:1 to a 16:1 mixture by Copolymer contains not more than 0.5 percent by weight of
weight of acrylic acid and sodium hypophosphite. acrylic acid monomer (dry weight basis).
Polyethylene glycol ....................................................................... As defined in § 172.820 of this chapter.
Polymaleic acid [CAS Reg. No. 26099–09–2], and/or its sodium Total not to exceed 1 part per million in boiler feed water (cal-
salt. [CAS Reg. No. 30915–61–8 or CAS Reg. No. 70247– culated as the acid).
90–4].
Polyoxypropylene glycol ............................................................... Minimum mol. wt. 1,000.
Potassium carbonate.
Potassium tripolyphosphate.
Sodium acetate.
Sodium alginate.
Sodium aluminate.
Sodium carbonate.
Sodium carboxymethylcellulose ................................................... Contains not less than 95 percent sodium
carboxymethylcellulose on a dry-weight basis, with max-
imum substitution of 0.9 carboxymethylcellulose groups per
anhydroglucose unit, and with a minimum viscosity of 15
centipoises for 2 percent by weight aqueous solution at 25
°C; by the ‘‘Viscosity of Cellulose Gum’’ method prescribed
in the Food Chemicals Codex, pp. 1128–1129.
Sodium glucoheptonate ................................................................ Less than 1 part per million cyanide in the sodium
glucoheptonate.
Sodium hexametaphosphate.
Sodium humate.
Sodium hydroxide.
Sodium lignosulfonate.
Sodium metabisulfite.
Sodium metasilicate.
Sodium nitrate.
Sodium phosphate (mono-, di-, tri-).
Sodium polyacrylate.
Sodium polymethacrylate.
Sodium silicate.
Sodium sulfate.
Sodium sulfite (neutral or alkaline).
Sodium tripolyphosphate.
Sorbitol anhydride esters: A mixture consisting of sorbitan The mixture is used as an anticorrosive agent in steam boiler
monostearate as defined in § 172.842 of this chapter; poly- distribution systems, with each component not to exceed 15
sorbate 60 ((polyoxyethylene (20) sorbitan monostearate)) as milligrams per kilogram in the steam.
defined in § 172.836 of this chapter; and polysorbate 20
((polyoxyethylene (20) sorbitan monolaurate)), meeting the
specifications of the Food Chemicals Codex, pp. 825–827..
Tannin (including quebracho extract).
Tetrasodium EDTA.
Tetrasodium pyrophosphate.
(d) Substances used alone or in com-

bination with substances in paragraph
(c) of this section:
Cyclohexylamine ............................................ Not to exceed 10 parts per million in steam, and excluding use of such steam in
contact with milk and milk products.
149
§ 173.315 21 CFR Ch. I (4–1–23 Edition)
Diethylaminoethanol ....................................... Not to exceed 15 parts per million in steam, and excluding use of such steam in
Hydrazine ....................................................... Zero in steam.
Morpholine ...................................................... Not to exceed 10 parts per million in steam, and excluding use of such steam in
Octadecylamine .............................................. Not to exceed 3 parts per million in steam, and excluding use of such steam in
Trisodium nitrilotriacetate ............................... Not to exceed 5 parts per million in boiler feedwater; not to be used where steam
will be in contact with milk and milk products.
(e) To assure safe use of the additive, (ii) [Reserved]

in addition to the other information re- (2) United States Pharmacopeial Con-
quired by the Act, the label or labeling vention, 12601 Twinbrook Pkwy., Rock-
shall bear: ville, MD 20852 (Internet address http://
(1) The common or chemical name or www.usp.org):
names of the additive or additives. (i) Food Chemicals Codex, 7th ed.
(2) Adequate directions for use to as- (2010), pp. 1128–1129.
sure compliance with all the provisions (ii) Food Chemicals Codex, 7th ed.
of this section. (2010), pp. 825–827.
(f) The standards required in this sec-
tion are incorporated by reference into [42 FR 14526, Mar. 15, 1977, as amended at 45
this section with the approval of the FR 73922, Nov. 7, 1980; 45 FR 85726, Dec. 30,
1980; 48 FR 7439, Feb. 22, 1983; 49 FR 5748, Feb.
Director of the Federal Register under 15, 1984; 49 FR 10106, Mar. 19, 1984; 50 FR 49536,
5 U.S.C. 552(a) and 1 CFR part 51. Cop- Dec. 3, 1985; 53 FR 15199, Apr. 28, 1988; 54 FR
ies may be examined at the Dockets 31012, July 26, 1989; 55 FR 12172, Apr. 2, 1990;
Management Staff (HFA–305), Food and 61 FR 14245, Apr. 1, 1996; 64 FR 1759, Jan. 12,
Drug Administration, 5630 Fishers 1999; 64 FR 29227, June 1, 1999; 78 FR 71466,
Lane, Rm. 1061, Rockville, MD 20852, Nov. 29, 2013; 88 FR 17723, Mar. 24, 2023]
240–402–7500, between 9 a.m. and 4 p.m.,
Monday through Friday, or at the Na- § 173.315 Chemicals used in washing
tional Archives and Records Adminis- or to assist in the peeling of fruits
and vegetables.
the availability of this material at Chemicals may be safely used to
NARA, call 202–741–6030 or go to: http:// wash or to assist in the peeling of
www.archives.gov/federal-register/cfr/ibr- fruits and vegetables in accordance
locations.html. with the following conditions:
(1) Dockets Management Staff (HFA– (a) The chemicals consist of one or
305), Food and Drug Administration, more of the following:
5630 Fishers Lane, Rm. 1061, Rockville, (1) Substances generally recognized
MD 20852, 240–402–7500, between 9 a.m. as safe in food or covered by prior sanc-
and 4 p.m., Monday through Friday: tions for use in washing fruits and
(i) ‘‘Determination of Weight Aver- vegetables.
age and Number Average Molecular (2) Substances identified in this sub-
Weight of 60/40 AA/AMPS’’ (October 23, paragraph and subject to such limita-
1987). tions as are provided:
A mixture of alkylene oxide adducts of alkyl alcohols and phosphate May be used at a level not to exceed 0.2 percent in
esters of alkylene oxide adducts of alkyl alcohols consisting of: a-alkyl lye-peeling solution to assist in the lye peeling of
(C12-C18)-omega-hydroxy-poly (oxyethylene) (7.5–8.5 moles)/poly fruit and vegetables.
(oxypropylene) block copolymer having an average molecular weight
of 810; a-alkyl (C12-C18)-omega-hydroxy-poly (oxyethylene) (3.3–3.7
moles) polymer having an average molecular weight of 380, and sub-
sequently esterified with 1.25 moles phosphoric anhydride; and a-alkyl
(C10-C12)-omega-hydroxypoly (oxyethylene) (11.9–12.9 moles)/poly
(oxypropylene) copolymer, having an average molecular weight of
810, and subsequently esterified with 1.25 moles phosphoric anhy-
dride.
Aliphatic acid mixture consisting of valeric, caproic, enanthic, caprylic, May be used at a level not to exceed 1 percent in lye
and pelargonic acids. peeling solution to assist in the lye peeling of fruits
and vegetables.
150
Polyacrylamide ............................................................................................ Not to exceed 10 parts per million in wash water.

Contains not more than 0.2 percent acrylamide
monomer. May be used in the washing of fruits
and vegetables.
Potassium bromide ..................................................................................... May be used in the washing or to assist in the lye
peeling of fruits and vegetables.
Sodium n-alkylbenzene-sulfonate (alkyl group predominantly C12 and C13 Not to exceed 0.2 percent in wash water. May be
and not less than 95 percent C10 to C16). used in washing or to assist in the lye peeling of
fruits and vegetables.
Sodium dodecylbenzene-sulfonate (alkyl group predominantly C12 and Do.
not less than 95% C10 to C16).
Sodium 2 ethyl-hexyl sulfate ....................................................................... Do.
Sodium hypochlorite .................................................................................... May be used in the washing or to assist in the lye
peeling of fruits and vegetables.
Sodium mono- and dimethyl naphthalene sulfonates (mol. wt. 245–260) Not to exceed 0.2 percent in wash water. May be
used in the washing or to assist in the lye peeling
of fruits and vegetables.
(3) Sodium mono- and dimethyl naph- Substances Limitations

thalene sulfonates (mol. wt. 245–260)
Hydrogen peroxide ......... Used in combination with acetic
may be used in the steam/scald vacuum acid to form peroxyacetic acid.
peeling of tomatoes at a level not to Not to exceed 59 ppm in wash
exceed 0.2 percent in the condensate or water.
1-Hydroxyethylidene-1,1- May be used only with peroxy-
scald water. diphosphonic acid. acetic acid. Not to exceed 4.8
(4) Substances identified in this para- ppm in wash water.
graph (a)(4) for use in flume water for Peroxyacetic acid ............ Prepared by reacting acetic acid
with hydrogen peroxide. Not to
washing sugar beets prior to the slicing exceed 80 ppm in wash water.
operation and subject to the limita-
tions as are provided for the level of (b) The chemicals are used in
the substances in the flume water: amounts not in excess of the minimum
Substance Limitations
required to accomplish their intended
effect.
a-Alkyl-omega-hydroxypoly-(oxy- Not to exceed 3 ppm. (c) The use of the chemicals listed
ethylene) produced by con-
densation of 1 mole of C11-
under paragraphs (a)(1), (a)(2), and
C486315 straight chain ran- (a)(4) is followed by rinsing with pota-
domly substituted secondary al- ble water to remove, to the extent pos-
cohols with an average of 9
moles of ethylene oxide.
sible, residues of the chemicals.
Linear undecylbenzenesulfonic Do. (d) To assure safe use of the additive:
acid. (1) The label and labeling of the addi-
Dialkanolamide produced by con- Not to exceed 2 ppm. tive container shall bear, in addition to
densing 1 mole of methyl lau-
rate with 1.05 moles of the other information required by the
diethanolamine. act, the name of the additive or a
Triethanolamine ............................ Do. statement of its composition.
Ethylene glycol monobutyl ether .. Not to exceed 1 ppm.
(2) The label or labeling of the addi-
Oleic acid conforming with Do.
§ 172.860 of this chapter. tive container shall bear adequate use
Tetrapotassium pyrophosphate .... Not to exceed 0.3 ppm. directions to assure use in compliance
Monoethanolamine ....................... Do. with all provisions of this section.
Ethylene dichloride ....................... Not to exceed 0.2 ppm.
Tetrasodium ethylenediamine- Not to exceed 0.1 ppm. [42 FR 14526, Mar. 15, 1977, as amended at 42
tetraacetate. FR 29856, June 10, 1977; 42 FR 32229, June 24,
1977; 43 FR 54926, Nov. 24, 1978; 61 FR 46376,
(5) Substances identified in this para- 46377, Sept. 3, 1996; 63 FR 7069, Feb. 12, 1998;
64 FR 38564, July 19, 1999]
graph (a)(5) for use on fruits and vege-
tables that are not raw agricultural § 173.320 Chemicals for controlling
commodities and subject to the limita- microorganisms in cane-sugar and
tions provided: beet-sugar mills.
Agents for controlling microorga-

nisms in cane-sugar and beet-sugar
151
§ 173.322 21 CFR Ch. I (4–1–23 Edition)
mills may be safely used in accordance Parts per mil-

lion
with the following conditions:
(a) They are used in the control of n-Dodecyl dimethyl ethylbenzyl ammonium
microorganisms in cane-sugar and/or chloride ....................................................... 0.68±0.068
beet-sugar mills as specified in para- n-Hexadecyl dimethyl benzyl ammonium
chloride ....................................................... 0.30±0.030
graph (b) of this section. n-Octadecyl dimethyl benzyl ammonium
(b) They are applied to the sugar mill chloride ....................................................... 0.05±0.005
grinding, crusher, and/or diffuser sys- n-Tetradecyl dimethyl benzyl ammonium
tems in one of the combinations listed chloride ....................................................... 0.60±0.060
n-Tetradecyl dimethyl ethylbenzyl ammo-
in paragraph (b)(1), (2), (3), or (5) of this nium chloride .............................................. 0.32±0.032
section or as a single agent listed in
paragraph (b)(4) or (6) of this section.
Quantities of the individual additives Limitations. Byproduct molasses, ba-
in parts per million are expressed in gasse, and pulp containing residues of
terms of the weight of the raw cane or these quaternary ammonium salts are
raw beets. not authorized for use in animal feed.
(1) Combination for cane-sugar mills: (6) Single additive for beet-sugar
mills:
Parts
per mil- Parts per million
lion
Glutaraldehyde (CAS Reg. No. Not more than 250.
Disodium cyanodithioimidocarbonate ........................ 2.5
111–30–8).
Ethylenediamine ........................................................ 1.0
Potassium N-methyldithiocarbamate ......................... 3.5
(c) To assure safe use of the addi-
(2) Combination for cane-sugar mills: tives, their label and labeling shall
conform to that registered with the
Parts Environmental Protection Agency.
per mil-
lion
Disodium ethylenebisdithiocarbamate ....................... 3.0 FR 35756, Aug. 17, 1982; 50 FR 3891, Jan. 29,
Sodium dimethyldithiocarbamate .............................. 3.0 1985; 57 FR 8065, Mar. 6, 1992]
(3) Combinations for cane-sugar mills § 173.322 Chemicals used in delinting

and beet-sugar mills: cottonseed.
Parts Chemicals may be safely used to as-
per mil- sist in the delinting of cottonseed in
lion
accordance with the following condi-
(i) Disodium ethylenebisdithiocarbamate .................. 3.0 tions:
Ethylenediamine ........................................................ 2.0 (a) The chemicals consist of one or
Sodium dimethyldithiocarbamate .............................. 3.0
(ii) Disodium cyanodithioimidocarbonate ................... 2.9
more of the following:
Potassium N-methyldithiocarbamate ......................... 4.1 (1) Substances generally recognized
as safe for direct addition to food.
(4) Single additive for cane-sugar (2) Substances identified in this para-
mills and beet-sugar mills. graph and subject to such limitations
Parts per million
as are provided:
2,2-Dibromo-3-nitrilopropionamide (CAS Not more than Substances Limitations

Reg. No. 10222–01–2). Limitations: By- 10.0 and not
product molasses, bagasse, and pulp less than 2.0. alpha-Alkyl-omega- May be used at an applica-
containing residues of 2,2-dibromo-3- hydroxypoly-(oxyethylene) tion rate not to exceed 0.3
nitrilopropionamide are not authorized produced by condensation percent by weight of cot-
for use in animal feed. of a linear primary alcohol tonseeds to enhance
containing an average delinting of cottonseeds in-
chain length of 10 carbons tended for the production
(5) Combination for cane-sugar mills: with poly(oxyethylene) hav- of cottonseed oil. Byprod-
ing an average of 5 ethyl- ucts including lint, hulls,
Parts per mil- ene oxide units. and meal may be used in
lion animal feed.
n-Dodecyl dimethyl benzyl ammonium chlo-

ride ............................................................. 0.05±0.005
152
Substances Limitations (c) The additive is used as an anti-

microbial agent in accordance with
An alkanomide produced by May be used at an applica-
condensation of coconut oil tion rate not to exceed 0.2 current industry practice in the proc-
fatty acids and dietha- percent by weight of cot- essing of red meat, red meat parts, and
nolamine, CAS Reg. No. tonseeds to enhance organs as a component of a spray or in
068603–42–9. delinting of cottonseeds in-
tended for the production
the processing of red meat parts and
of cottonseed oil. Byprod- organs as a component of a dip. Applied
ucts including lint, hulls, as a dip or spray, the additive is used
and meal may be used in at levels that result in sodium chlorite
animal feed.
concentrations between 500 and 1,200
ppm in combination with any GRAS
[47 FR 8346, Feb. 26, 1982] acid at levels sufficient to achieve a so-
lution pH of 2.5 to 2.9.
§ 173.325 Acidified sodium chlorite so- (d)(1) The additive is used as an anti-
lutions. microbial agent in water and ice that
Acidified sodium chlorite solutions are used to rinse, wash, thaw, trans-
may be safely used in accordance with port, or store seafood in accordance
the following prescribed conditions: with current industry standards of
(a) The additive is produced by mix- good manufacturing practice. The addi-
ing an aqueous solution of sodium chlo- tive is produced by mixing an aqueous
rite (CAS Reg. No. 7758–19–2) with any solution of sodium chlorite with any
generally recognized as safe (GRAS) GRAS acid to achieve a pH in the range
acid. of 2.5 to 2.9 and diluting this solution
(b)(1) The additive is used as an anti- with water to achieve an actual use
microbial agent in poultry processing concentration of 40 to 50 parts per mil-
water in accordance with current in- lion (ppm) sodium chlorite. Any sea-
dustry practice under the following food that is intended to be consumed
conditions: raw shall be subjected to a potable
(i) As a component of a carcass spray water rinse prior to consumption.
or dip solution prior to immersion of (2) The additive is used as a single ap-
the intact carcass in a prechiller or plication in processing facilities as an
chiller tank; antimicrobial agent to reduce patho-
genic bacteria due to cross-contamina-
(ii) In a prechiller or chiller solution
tion during the harvesting, handling,
for application to the intact carcass;
heading, evisceration, butchering, stor-
(iii) As a component of a spray or dip ing, holding, packing, or packaging of
solution for application to poultry car- finfish and crustaceans; or following
cass parts; the filleting of finfish; in accordance
(iv) In a prechiller or chiller solution with current industry standards of
for application to poultry carcass good manufacturing practice. Applied
parts; or as a dip or spray, the additive is used
(v) As a component of a post-chill at levels that result in a sodium chlo-
carcass spray or dip solution when ap- rite concentration of 1,200 ppm, in com-
plied to poultry meat, organs, or re- bination with any GRAS acid at levels
lated parts or trim. sufficient to achieve a pH of 2.3 to 2.9.
(2) When used in a spray or dip solu- Treated seafood shall be cooked prior
tion, the additive is used at levels that to consumption.
result in sodium chlorite concentra- (e) The additive is used as an anti-
tions between 500 and 1,200 parts per microbial agent on raw agricultural
million (ppm), in combination with any commodities in the preparing, packing,
GRAS acid at a level sufficient to or holding of the food for commercial
achieve a solution pH of 2.3 to 2.9. purposes, consistent with section
(3) When used in a prechiller or chill- 201(q)(1)(B)(i) of the act, and not ap-
er solution, the additive is used at lev- plied for use under section
els that result in sodium chlorite con- 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or
centrations between 50 and 150 ppm, in (q)(1)(B)(i)(III) of the act, in accordance
combination with any GRAS acid at with current industry standards of

levels sufficient to achieve a solution good manufacturing practice. Applied
pH of 2.8 to 3.2. as a dip or a spray, the additive is used
153
§ 173.340 21 CFR Ch. I (4–1–23 Edition)
at levels that result in chlorite con- a level sufficient to achieve a solution

centrations of 500 to 1200 parts per mil- pH of 2.3 to 2.9.
lion (ppm), in combination with any (h) The concentration of sodium chlo-
GRAS acid at levels sufficient to rite is determined by a method entitled
achieve a pH of 2.3 to 2.9. Treatment of ‘‘Determination of Sodium Chlorite: 50
the raw agricultural commodities with ppm to 1500 ppm Concentration,’’ Sep-
acidified sodium chlorite solutions tember 13, 1995, developed by Alcide
shall be followed by a potable water Corp., Redmond, WA, which is incor-
rinse, or by blanching, cooking, or can- porated by reference in accordance
ning. with 5 U.S.C. 552(a) and 1 CFR part 51.
(f) The additive is used as an anti- Copies are available from the Office of
microbial agent on processed, Food Additive Safety (HFS–200), Center
comminuted or formed meat food prod- for Food Safety and Applied Nutrition,
ucts (unless precluded by standards of Food and Drug Administration, 5001
identity in 9 CFR part 319) prior to Campus Dr., College Park, MD 20740,
packaging of the food for commercial 240–402–1200, or may be examined at the
purposes, in accordance with current Dockets Management Staff (HFA–305),
industry standards of good manufac- Food and Drug Administration, 5630
turing practice. Applied as a dip or Fishers Lane, Rm. 1061, Rockville, MD
spray, the additive is used at levels 20852, 240–402–7500, between 9 a.m. and 4
that result in sodium chlorite con- p.m., Monday through Friday, or at the
centrations of 500 to 1200 ppm, in com- National Archives and Records Admin-
bination with any GRAS acid at levels istration (NARA). For information on
sufficient to achieve a pH of 2.5 to 2.9. the availability of this material at
(g) The additive is used as an anti- NARA, call 202–741–6030, or go to: http://
microbial agent in the water applied to www.archives.gov/federal_register/
processed fruits and processed root, code_of_federal_regulations/
tuber, bulb, legume, fruiting (i.e., egg- ibr_locations.html.
plant, groundcherry, pepino, pepper,
tomatillo, and tomato), and cucurbit [61 FR 17829, Apr. 23, 1996, as amended at 63
vegetables in accordance with current FR 11119, Mar. 6, 1998; 64 FR 44123, Aug. 13,
industry standards of good manufac- 1999; 64 FR 49982, Sept. 15, 1999; 65 FR 1776,
turing practices, as a component of a Jan. 12, 2000; 65 FR 16312, Mar. 28, 2000; 66 FR
22922, May 7, 2001; 66 FR 31841, June 13, 2001;
spray or dip solution, provided that
67 FR 15720, Apr. 3, 2002; 69 FR 78304, Dec. 30,
such application be followed by a pota- 2004; 78 FR 14665, Mar. 7, 2013; 81 FR 5592, Feb.
ble water rinse and a 24-hour holding 3, 2016; 88 FR 17723, Mar. 24, 2023]
period prior to consumption. However,
for processed leafy vegetables (i.e., § 173.340 Defoaming agents.
vegetables other than root, tuber, bulb,
legume, fruiting, and cucurbit vegeta- Defoaming agents may be safely used
bles) and vegetables in the Brassica in processing foods, in accordance with
[Cole] family, application must be by the following conditions:
dip treatment only, and must be pre- (a) They consist of one or more of the
ceded by a potable water rinse and fol- following:
lowed by a potable water rinse and a (1) Substances generally recognized
24-hour holding period prior to con- by qualified experts as safe in food or
sumption. When used in a spray or dip covered by prior sanctions for the use
solution, the additive is used at levels prescribed by this section.
that result in sodium chlorite con- (2) Substances listed in this para-
centrations between 500 and 1,200 ppm, graph (a)(2) of this section, subject to
in combination with any GRAS acid at any limitations imposed:
154
Dimethylpolysiloxane (substantially free from hydrolyzable chlo- 10 parts per million in food, or at such level in a concentrated
ride and alkoxy groups; no more than 18 percent loss in food that when prepared as directed on the labels, the food
weight after heating 4 hours at 200 °C; viscosity 300 to 1,050 in its ready-for-consumption state will have not more than
centistokes at 25 °C; refractive index 1.400–1.404 at 25 °C). 10 parts per million except as follows: Zero in milk; 110
parts per million in dry gelatin dessert mixes labeled for use
whereby no more than 16 parts per million is present in the
ready-to-serve dessert; 250 parts per million in salt labeled
for cooking purposes, whereby no more than 10 parts per
million is present in the cooked food.
Formaldehyde ............................................................................... As a preservative in defoaming agents containing
dimethylpolysiloxane, in an amount not exceeding 1.0 per-
cent of the dimethylpolysiloxane content.
a-Hydro-omega-hydroxy-poly (oxyethylene)/poly(oxypropylene) For use as prescribed in § 172.808(b)(3) of this chapter.
(minimum 15 moles)/poly(oxyethylene) block copolymer (CAS
Reg. No. 9003–11–6) as defined in § 172.808(a)(3) of this
chapter.
Polyacrylic acid, sodium salt ........................................................ As a stabilizer and thickener in defoaming agents containing
dimethylpolysiloxane in an amount reasonably required to
accomplish the intended effect.
Polyethylene glycol ....................................................................... As defined in § 172.820 of this chapter.
Polyoxyethylene 40 monostearate ............................................... As defined in U.S.P. XVI.
Polysorbate 60 .............................................................................. As defined in § 172.836 of this chapter.
Polysorbate 65 .............................................................................. As defined in § 172.838 of this chapter.
Propylene glycol alginate .............................................................. As defined in § 172.858 of this chapter.
Silicon dioxide ............................................................................... As defined in § 172.480 of this chapter.
Sorbitan monostearate ................................................................. As defined in § 172.842 of this chapter.
White mineral oil: Conforming with § 172.878 of this chapter ...... As a component of defoaming agents for use in wash water
for sliced potatoes at a level not to exceed 0.008 percent of
the wash water.
(3) Substances listed in this para- use in processing beet sugar and yeast,
graph (a)(3), provided they are compo- and subject to any limitations im-
nents of defoaming agents limited to posed:
Aluminum stearate ...................................................................................... As defined in § 172.863 of this chapter.

Butyl stearate.
BHA ............................................................................................................. As an antioxidant, not to exceed 0.1 percent by
weight of defoamer.
BHT ............................................................................................................. Do.
Calcium stearate ......................................................................................... As defined in § 172.863 of this chapter.
Fatty acids ................................................................................................... As defined in § 172.860 of this chapter.
Formaldehyde ............................................................................................. As a preservative.
Hydroxylated lecithin ................................................................................... As defined in § 172.814 of this chapter.
Isopropyl alcohol.
Magnesium stearate .................................................................................... As defined in § 172.863 of this chapter.
Mineral oil: Conforming with § 172.878 of this chapter .............................. Not more than 150 p.p.m. in yeast, measured as hy-
drocarbons.
Odorless light petroleum hydrocarbons: Conforming with § 172.884 of
this chapter.
Petrolatum: Conforming with § 172.880 of this chapter ..............................
Petroleum wax: Conforming with § 172.886 of this chapter.
Petroleum wax, synthetic.
Polyethylene glycol (400)dioleate: Conforming with § 172.820(a)(2) of As an emulsifier not to exceed 10 percent by weight
this chapter and providing the oleic acid used in the production of this of defoamer formulation.
substance complies with § 172.860 or § 172.862 of this chapter.
Synthetic isoparaffinic petroleum hydrocarbons: Conforming with
§ 172.882 of this chapter.
Oleic acid derived from tall oil fatty acids ................................................... Complying with § 172.862 of this chapter.
Oxystearin ................................................................................................... As defined in § 172.818 of this chapter.
Polyoxyethylene (600) dioleate.
Polyoxyethylene (600) monoricinoleate.
Polypropylene glycol ................................................................................... Molecular weight range, 1,200–3,000.
Polysorbate 80 ............................................................................................ As defined in § 172.840 of this chapter.
Potassium stearate ..................................................................................... As defined in § 172.863 of this chapter.
Propylene glycol mono- and diesters of fats and fatty acids ..................... As defined in § 172.856 of this chapter.
Soybean oil fatty acids, hydroxylated.

Tallow, hydrogenated, oxidized or sulfated.
Tallow alcohol, hydrogenated.
155
§ 173.342 21 CFR Ch. I (4–1–23 Edition)
(4) The substances listed in this para- § 173.342 Chlorofluorocarbon 113 and
graph (a)(4), provided they are compo- perfluorohexane.
nents of defoaming agents limited to A mixture of 99 percent
use in processing beet sugar only, and chlorofluorocarbon 113 (1,1,2-trichloro-
subject to the limitations imposed: 1,2,2-trifluoroethane) (CAS Reg. No. 76–
Substances Limitations 13–1, also known as fluorocarbon 113,
CFC 113 and FC 113) and 1 percent
n-Butoxypoly(oxyethylene)- Viscosity range, 4,850–5,350
poly(oxypropylene)glycol. Saybolt Universal Seconds
perfluorohexane (CAS Reg. No. 355–42–
(SUS) at 37.8 °C (100 °F). 0) may be safely used in accordance
The viscosity range is de- with the following prescribed condi-
teRmined by the method tions:
‘‘Viscosity DeteRmination
of n- (a) The additive chlorofluorocarbon
butoxypoly(oxyethylene)- 113 has a purity of not less than 99.99
poly(oxypropylene) glycol’’ percent.
dated April 26, 1995, de-
veloped by Union Carbide
(b) The additive mixture is intended
Corp., P.O. Box 670, for use to quickly cool or crust-freeze
Bound Brook, NJ 08805, chickens sealed in intact bags com-
which is incorporated by posed of substances regulated in parts
reference in accordance
with 5 U.S.C. 552(a) and 1 174, 175, 177, 178, and § 179.45 of this
CFR part 51. Copies of the chapter and conforming to any limita-
material incorporated by tions or specifications in such regula-
reference are available
from the Office of Food Ad-
tions.
ditive Safety (HFS–200), [55 FR 8913, Mar. 9, 1990]
Center for Food Safety and
Applied Nutrition, Food and
Drug Administration, 5001 § 173.345 Chloropentafluoroethane.
Campus Dr., College Park, The food additive
MD 20740, 240–402–1200,
and may be examined at chloropentafluoroethane may be safely
the Dockets Management used in food in accordance with the fol-
Staff (HFA–305), Food and lowing prescribed conditions:
Drug Administration, 5630
Fishers Lane, Rm. 1061,
(a) The food additive has a purity of
Rockville, MD 20852, 240– not less than 99.97 percent, and con-
402–7500, between 9 a.m. tains not more than 200 parts per mil-
and 4 p.m., Monday lion saturated fluoro compounds and 10
through Friday, or at the
National Archives and parts per million unsaturated fluoro
Records Administration compounds as impurities.
(NARA). For infoRmation (b) The additive is used or intended
on the availability of this
material at NARA, call
for use alone or with one or more of the
202–741–6030, or go to: following substances: Carbon dioxide,
https://www.archives.gov/ nitrous oxide, propane, and
federallregister/ octafluorocyclobutane complying with
codeloflfederal
lregulations/ § 173.360, as an aerating agent for
ibrllocations.html. foamed or sprayed food products, with
Monoester of alpha-hydro- any propellant effect being incidental
omega-hydroxy-
poly(oxyethylene)
and no more than is minimally nec-
poly(oxypropylene) essary to achieve the aerating func-
poly(oxyethylene) (15 mole tion, except that use is not permitted
minimum) blocked copoly- for those standardized foods that do
mer derived from low eru-
cic acid rapeseed oil. not provide for such use.
(c) To assure safe use of the additive
(b) They are added in an amount not (1) The label of the food additive con-
in excess of that reasonably required to tainer shall bear, in addition to the
inhibit foaming. other information required by the act,
the following:
FR 2872, Jan. 20, 1978; 46 FR 30493, June 9,
(i) The name of the additive,
1981; 46 FR 57476, Nov. 24, 1981; 60 FR 54036, chloropentafluoroethane.
Oct. 19, 1995; 61 FR 632, Jan. 9, 1996; 63 FR (ii) The percentage of the additive
29134, May 28, 1998; 81 FR 5592, Feb. 3, 2016; 88 present in the case of a mixture.
FR 17723, Mar. 24, 2023] (iii) The designation ‘‘food grade’’.
156
(2) The label or labeling of the food microns to 310 millimicrons, under the same
additive container shall bear adequate instrumental conditions. The standard ref-
directions for use. erence absorbance is the absorbance at 275
millimicrons of a standard reference solution
[42 FR 14526, Mar. 15, 1977, as amended at 43 of naphthalene (National Bureau of Stand-
FR 11317, Mar. 17, 1978; 43 FR 14644, Apr. 7, ards Material No. 577 or equivalent in purity)
1978] containing a concentration of 1.4 milligrams
per liter in purified isooctane, measured
§ 173.350 Combustion product gas. against isooctane of the same spectral purity
in 5-centimeter cells. (This absorbance will
The food additive combustion prod-
be approximately 0.30.)
uct gas may be safely used in the proc- Solvent. The solvent used is pure grade iso-
essing and packaging of the foods des- octane having an ultraviolet absorbance not
ignated in paragraph (c) of this section to exceed 0.05 measured against distilled
for the purpose of removing and dis- water as a reference. Upon passage of puri-
placing oxygen in accordance with the fied inert gas through some isooctane under
following prescribed conditions: the identical conditions of the test, a low-
(a) The food additive is manufactured ering of the absorbance value has been ob-
served. The absorbance of isooctane to be
by the controlled combustion in air of used in this procedure shall not be more than
butane, propane, or natural gas. The 0.02 lower in the range 255 millimicrons to
combustion equipment shall be pro- 310 millimicrons, inclusive, than that of the
vided with an absorption-type filter ca- untreated solvent as measured in a 5-centi-
pable of removing possible toxic impu- meter cell. If necessary to obtain the pre-
rities, through which all gas used in scribed purities, the isooctane may be passed
the treatment of food shall pass; and through activated silica gel.
with suitable controls to insure that Apparatus. To assure reproducible results,
the additive is passed into the isooctane so-
any combustion products failing to lution through a gas-absorption train con-
meet the specifications provided in this sisting of the following components and nec-
section will be prevented from reaching essary connections:
the food being treated. 1. A gas flow meter with a range up to 30
(b) The food additive meets the fol- liters per hour provided with a constant dif-
lowing specifications: ferential relay or other device to maintain a
(1) Carbon monoxide content not to constant flow rate independent of the input
pressure.
exceed 4.5 percent by volume.
2. An absorption apparatus consisting of an
(2) The ultraviolet absorbance in iso- inlet gas dispersion tube inserted to the bot-
octane solution in the range 255 milli- tom of a covered cylindrical vessel with a
microns to 310 millimicrons not to ex- suitable outlet on the vessel for effluent gas.
ceed one-third of the standard ref- The dimensions and arrangement of tube and
erence absorbance when tested as de- vessel are such that the inlet tube introduces
scribed in paragraph (e) of this section. the gas at a point not above 51⁄4 inches below
(c) It is used or intended for use to the surface of the solvent through a sintered
glass outlet. The dimensions of the vessel are
displace or remove oxygen in the proc-
such, and both inlet and vessel are so de-
essing, storage, or packaging of bev- signed, that the gas can be bubbled through
erage products and other food, except 60 milliliters of isooctane solvent at a rate
fresh meats. up to 30 liters per hour without mechanical
(d) To assure safe use of the additive loss of solvent. The level corresponding to 60
in addition to the other information re- milliliters should be marked on the vessel.
quired by the act, the label or labeling 3. A cooling bath containing crushed ice
of the combustion device shall bear and water to permit immersion of the ab-
sorption vessel at least to the solvent level
adequate directions for use to provide a
mark.
combustion product gas that complies Caution. The various parts of the absorp-
with the limitations prescribed in para- tion train must be connected by gas-tight
graph (b) of this section, including in- tubing and joints composed of materials
structions to assure proper filtration. which will neither remove components from
(e) The food additive is tested for nor add components to the gas stream. The
compliance with paragraph (b)(2) by gas source is connected in series to the flow-
the following empirical method: rate device, the flow meter, and the absorp-
tion apparatus in that order. Ventilation
Spectrophotometric measurements. All meas- should be provided for the effluent gases
urements are made in an ultraviolet spectro- which may contain carbon monoxide.
photometer in optical cells of 5 centimeters Sampling procedure. Immerse the gas-ab-
in length, and in the range of 255 milli- sorption apparatus containing 60 milliliters
157
§ 173.355 21 CFR Ch. I (4–1–23 Edition)
of isooctane in the coolant bath so that the corporated by reference. The Director
solvent is completely immersed. Cool for at of the Federal Register approves this
least 15 minutes and then pass 120 liters of incorporation by reference in accord-
the test gas through the absorption train at
ance with 5 U.S.C. 552(a) and 1 CFR
a rate of 30 liters per hour or less. Maintain
the coolant bath at 0 °C throughout. Remove part 51. You may obtain copies from
the absorption vessel from the bath, dis- the United States Pharmacopeial Con-
connect, and warm to room temperature. vention, 12601 Twinbrook Pkwy., Rock-
Add isooctane to bring the contents of the ville, MD 20852 (Internet address http://
absorption vessel to 60 milliliters, and mix. www.usp.org). Copies may be examined
Determine the absorbance of the solution in at the Dockets Management Staff
the 5-centimeter cell in the range 255 milli- (HFA–305), Food and Drug Administra-
microns to 310 millimicrons, inclusive, com-
tion, 5630 Fishers Lane, Rm. 1061, Rock-
pared to isooctane. The absorbance of the so-
lution of combustion product gas shall not ville, MD 20852, 240–402–7500, between 9
exceed that of the isooctane solvent at any a.m. and 4 p.m., Monday through Fri-
wavelength in the specified range by more day, or at the National Archives and
than one-third of the standard reference ab- Records Administration (NARA). For
sorbance. information on the availability of this
§ 173.355 Dichlorodifluoromethane. go to: http://www.archives.gov/fed-
The food additive dichlorodi- eral_register/code_of_federal_regulations/
fluoromethane may be safely used in ibr_locations.html.
food in accordance with the following (b) The additive is used as an anti-
prescribed conditions: microbial agent in the production of
(a) The additive has a purity of not modified whey (including, but not lim-
less than 99.97 percent. ited to, whey protein concentrates and
(b) It is used or intended for use, in whey protein isolates) by
accordance with good manufacturing ultrafiltration methods, at a level not
practice, as a direct-contact freezing to exceed 0.001 percent by weight of the
agent for foods. whey, providing that residual hydrogen
(c) To assure safe use of the additive: peroxide is removed by appropriate
(1) The label of its container shall chemical or physical means during the
bear, in addition to the other informa- processing of the modified whey.
tion required by the act, the following:
(i) The name of the additive, dichlo- FR 5592, Feb. 3, 2016; 88 FR 17723, Mar. 24,
rodifluoromethane, with or without the 2023]
parenthetical name ‘‘Food Freezant
12’’. § 173.357 Materials used as fixing
(ii) The designation ‘‘food grade’’. agents in the immobilization of en-
(2) The label or labeling of the food zyme preparations.
additive container shall bear adequate Fixing agents may be safely used in
directions for use. the immobilization of enzyme prepara-
tions in accordance with the following
§ 173.356 Hydrogen peroxide. conditions:
Hydrogen peroxide (CAS Reg. No. (a) The materials consist of one or
7722–84–1) may be safely used to treat more of the following:
food in accordance with the following (1) Substances generally recognized
conditions: as safe in food.
(a) The additive meets the specifica- (2) Substances identified in this sub-
tions of the Food Chemicals Codex, 7th paragraph and subject to such limita-
ed. (2010), pp. 496 and 497, which is in- tions as are provided:
Acrylamide-acrylic acid resin: Complying May be used as a fixing material in the immobilization of glucose isomerase en-
with § 173.5(a)(1) and (b) of this chapter. zyme preparations for use in the manufacture of high fructose corn syrup, in ac-
cordance with § 184.1372 of this chapter.
Cellulose triacetate ..................................... May be used as a fixing material in the immobilization of lactase for use in reducing
the lactose content of milk.
Diethylaminoethyl-cellulose ........................ May be used as a fixing material in the immobilization of glucose isomerase en-
zyme preparations for use in the manufacture of high fructose corn syrup, in ac-
cordance with § 184.1372 of this chapter.
158
Dimethylamine-epichlorohydrin resin: May be used as a fixing material in the immobilization of glucose isomerase en-
Complying with § 173.60(a) and (b) of zyme preparations for use in the manufacture of high fructose corn syrup, in ac-
this chapter. cordance with § 184.1372 of this chapter.
Glutaraldehyde ........................................... Do.
Periodic acid (CAS Reg. No. 10450–60–
9)..
Polyethylenimine reaction product with May be used as a fixing material in the immobilization of glucoamylase enzyme
1,2-dichloroethane (CAS Reg. No. preparations from Aspergillus niger for use in the manufacture of beer.
68130–97–2) is the reaction product of May be used as a fixing material in the immobilization of:
homopolymerization of ethylenimine in 1. Glucose isomerase enzyme preparations for use in the manufacture of high fruc-
aqueous hydrochloric acid at 100 °C tose corn syrup, in accordance with § 184.1372 of this chapter.
and of cross-linking with 1,2- 2. Glucoamylase enzyme preparations from Aspergillus niger for use in the manu-
dichloroethane. The finished polymer facture of beer. Residual ethylenimine in the finished polyethylenimine polymer
has an average molecular weight of will be less than 1 part per million as determined by gas chromatography-mass
50,000 to 70,000 as determined by gel spectrometry. The residual ethylenimine is determined by an analytical method
permeation chromatography. The analyt- entitled ‘‘Methodology for Ethylenimine Detection in Polyethylenimine,’’ which is
ical method is entitled ‘‘Methodology for incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
Molecular Weight Detection of Residual 1,2-dichloroethane in the finished polyethylenimine polymer will be less
Polyethylenimine,’’ which is incorporated than 1 part per million as determined by gas chromatography. The residual 1,2-
by reference in accordance with 5 dichloroethane is determined by an analytical method entitled, ‘‘Methodology for
U.S.C. 552(a) and 1 CFR part 51. Cop- Ethylenedichloride Detection in Polyethylenimine,’’ which is incorporated by ref-
ies may be obtained from the Office of erence in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be
Food Additive Safety (HFS–200), Center obtained from the Office of Food Additive Safety (HFS–200), Center for Food
for Food Safety and Applied Nutrition, Safety and Applied Nutrition, 5001 Campus Dr., College Park, MD 20740, 240–
5001 Campus Dr., College Park, MD 402–7500, or may be examined at the Dockets Management Staff (HFA–305),
20740, 240–402–1200, and may be ex- Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
amined at the Dockets Management 20852, 240–402–7500, between 9 a.m. and 4 p.m., Monday through Friday, or at
Staff (HFA–305), Food and Drug Admin- the National Archives and Records Administration (NARA). For information on the
istration, 5630 Fishers Lane, Rm. 1061, availability of this material at NARA, call 202–741–6030, or go to: http://
Rockville, MD 20852, 240–402–7500, www.archives.gov/federallregister/codeloflfederallregulations/
between 9 a.m. and 4 p.m., Monday ibrllocations.html.
202–741–6030, or go to: http://
www.archives.gov/federallregister/
codeloflfederallregulations/
ibrllocations.html.
(b) The fixed enzyme preparation is nitrous oxide, and propane, as a propel-
washed to remove residues of the fixing lant and aerating agent for foamed or
materials. sprayed food products, except for those
[48 FR 5716, Feb. 8, 1983, as amended at 52 FR
standardized foods that do not provide
39512, Oct. 22, 1987; 55 FR 12172, Apr. 2, 1990; for such use.
59 FR 36937, July 20, 1994; 61 FR 4873, Feb. 9, (c) To assure safe use of the additive:
1996; 61 FR 14245, Apr. 1, 1996; 67 FR 42716, (1) The label of the food additive con-
June 25, 2002; 81 FR 5592, Feb. 3, 2016; 88 FR tainer shall bear, in addition to the
17723, Mar. 24, 2023] other information required by the act,
the following:
§ 173.360 Octafluorocyclobutane.
(i) The name of the additive,
The food additive octafluorocyclo-bu- octafluorocyclobutane.
tane may be safely used as a propellant (ii) The percentage of the additive
and aerating agent in foamed or present in the case of a mixture.
sprayed food products in accordance (iii) The designation ‘‘food grade’’.
with the following conditions: (2) The label or labeling of the food
(a) The food additive meets the fol- additive container shall bear adequate
lowing specifications: directions for use.
99.99 percent octafluorocyclobutane.
Less than 0.1 part per million fluoroolefins, § 173.368 Ozone.
calculated as perfluoroisobutylene.
Ozone (CAS Reg. No. 10028–15–6) may
(b) The additive is used or intended be safely used in the treatment, stor-
for use alone or with one or more of the age, and processing of foods, including
following substances: Carbon dioxide, meat and poultry (unless such use is
159
§ 173.370 21 CFR Ch. I (4–1–23 Edition)
precluded by standards of identity in 9 § 173.370 Peroxyacids.

CFR part 319), in accordance with the Peroxyacids may be safely used in ac-
following prescribed conditions: cordance with the following prescribed
(a) The additive is an unstable, color- conditions:
less gas with a pungent, characteristic (a) The additive is a mixture of per-
odor, which occurs freely in nature. It oxyacetic acid, octanoic acid, acetic
is produced commercially by passing acid, hydrogen peroxide,
electrical discharges or ionizing radi- peroxyoctanoic acid, and 1-
ation through air or oxygen. hydroxyethylidene-1,1-diphosphonic
(b) The additive is used as an anti- acid.
microbial agent as defined in (b)(1) The additive is used as an anti-
§ 170.3(o)(2) of this chapter. microbial agent on meat carcasses,
(c) The additive meets the specifica- parts, trim, and organs in accordance
with current industry practice where
tions for ozone in the Food Chemicals
the maximum concentration of
Codex, 7th ed. (2010), pp. 754–755, which
peroxyacids is 220 parts per million
is incorporated by reference. The Di- (ppm) as peroxyacetic acid, and the
rector of the Office of the Federal Reg- maximum concentration of hydrogen
ister approves this incorporation by peroxide is 75 ppm.
reference in accordance with 5 U.S.C. (2) The additive is used as an anti-
552(a) and 1 CFR part 51. You may ob- microbial agent on poultry carcasses,
tain copies from the United States poultry parts, and organs in accord-
Pharmacopeial Convention, 12601 ance with current industry standards
Twinbrook Pkwy., Rockville, MD 20852 of good manufacturing practice (unless
(Internet address http://www.usp.org). precluded by the U.S. Department of
Copies may be examined at the Dock- Agriculture’s standards of identity in 9
ets Management Staff (HFA–305), Food CFR part 381, subpart P) where the
and Drug Administration, 5630 Fishers maximum concentration of
Lane, Rm. 1061, Rockville, MD 20852, peroxyacids is 220 parts per million
240–402–7500, between 9 a.m. and 4 p.m., (ppm) as peroxyacetic acid, the max-
Monday through Friday, or at the Na- imum concentration of hydrogen per-
tional Archives and Records Adminis- oxide is 110 ppm, and the maximum
concentration of 1-hydroxyethylidene-
1,1-diphosphonic acid (HEDP) is 13 ppm.
(c) The concentrations of peroxyacids
NARA, call 202–741–6030 or go to: http:// and hydrogen peroxide in the additive
www.archives.gov/federal-register/cfr/ibr- are determined by a method entitled
locations.html. ‘‘Hydrogen Peroxide and Peracid (as
(d) The additive is used in contact Peracetic Acid) Content,’’ July 26, 2000,
with food, including meat and poultry developed by Ecolab, Inc., St. Paul,
(unless such use is precluded by stand- MN, which is incorporated by ref-
ards of identity in 9 CFR part 319 or 9 erence. The concentration of 1-
CFR part 381, subpart P), in the gas- hydroxyethylidene-1,1-diphosphonic
eous or aqueous phase in accordance acid is determined by a method enti-
with current industry standards of tled ‘‘Determination of 1-
good manufacturing practice. hydroxyethylidene-1,1-diphosphonic
(e) When used on raw agricultural acid (HEDP) Peroxyacid/Peroxide-Con-
commodities, the use is consistent with taining Solutions,’’ August 21, 2001, de-
section 201(q)(1)(B)(i) of the Federal veloped by Ecolab, Inc., St. Paul, MN,
Food, Drug, and Cosmetic Act (the act) which is incorporated by reference. The
and not applied for use under section Director of the Office of the Federal
201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or Register approves these incorporations
(q)(1)(B)(i)(III) of the act. by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. You
[66 FR 33830, June 26, 2001; 67 FR 271, Jan. 3, may obtain copies of these methods
2002, as amended at 78 FR 14665, Mar. 7, 2013; from the Office of Food Additive Safety
78 FR 71467, Nov. 29, 2013; 88 FR 17724, Mar. (HFS–200), Center for Food Safety and
24, 2023] Applied Nutrition, Food and Drug Ad-
160
Park, MD 20740, 240–402–1200, or you (c) The additive is used as follows:

may examine a copy at the Dockets (1) As a fine mist spray of an ambient
Management Staff (HFA–305), Food and temperature aqueous solution applied
Drug Administration, 5630 Fishers to raw poultry carcasses prior to im-
Lane, Rm. 1061, Rockville, MD 20852, mersion in a chiller, at a level not to
240–402–7500, between 9 a.m. and 4 p.m., exceed 0.3 gram cetylpyridinium chlo-
Monday through Friday, or at the Na- ride per pound of raw poultry carcass,
tional Archives and Records Adminis- provided that the additive is used in
tration (NARA). For information on systems that collect and recycle solu-
the availability of this material at tion that is not carried out of the sys-
NARA, call 202–741–6030, or go to: http:// tem with the treated poultry carcasses;
www.archives.gov/federal_register/ or
code_of_federal_regulations/ (2) As a liquid aqueous solution ap-
ibr_locations.html. plied to raw poultry carcasses either
prior to or after chilling at an amount
[65 FR 70660, Nov. 27, 2000, as amended at 66
FR 48208, Sept. 19, 2001; 67 FR 61784, Oct. 2, not to exceed 5 gallons of solution per
2002; 81 FR 5593, Feb. 3, 2016; 88 FR 17724, Mar. carcass, provided that the additive is
24, 2023] used in systems that recapture at least
99 percent of the solution that is ap-
§ 173.375 Cetylpyridinium chloride. plied to the poultry carcasses. The con-
Cetylpyridinium chloride (CAS Reg. centration of cetylpyridinium chloride
No. 123–93–5) may be safely used in food in the solution applied to the carcasses
in accordance with the following condi- shall not exceed 0.8 percent by weight.
tions: When application of the additive is not
(a) The additive meets the specifica- followed by immersion in a chiller, the
tions of the United States Pharma- treatment will be followed by a potable
copeia (USP)/National Formulary (NF) water rinse of the carcass.
described in USP 30/NF 25, May 1, 2007, [72 FR 67576, Nov. 29, 2007, as amended at 76
pp. 1700–1701, which is incorporated by FR 59248, Sept. 26, 2011; 81 FR 5593, Feb. 3,
reference. The Director of the Office of 2016; 88 FR 17724, Mar. 24, 2023]
the Federal Register approves this in-
corporation by reference in accordance § 173.385 Sodium methyl sulfate.
with 5 U.S.C. 552(a) and 1 CFR part 51. Sodium methyl sulfate may be
You may obtain copies from the United present in pectin in accordance with
States Pharmacopeial Convention, the following conditions.
Inc., 12601 Twinbrook Pkwy., Rock- (a) It is present as the result of
ville, MD 20852, or you may examine a methylation of pectin by sulfuric acid
copy at the Dockets Management Staff and methyl alcohol and subsequent
(HFA–305), Food and Drug Administra- treatment with sodium bicarbonate.
tion, 5630 Fishers Lane, Rm. 1061, Rock- (b) It does not exceed 0.1 percent by
ville, MD 20852, 240–402–7500, between 9 weight of the pectin.
a.m. and 4 p.m., Monday through Fri-
day, or at the National Archives and § 173.395 Trifluoromethane sulfonic
Records Administration (NARA). For acid.
information on the availability of this Trifluoromethane sulfonic acid has
material at NARA, call 202–741–6030, or the empirical formula CF3SO3H (CAS
go to: http://www.archives.gov/federal- Reg. No. 1493–13–6). The catalyst
register/cfr/ibr-locations.html. (Trifluoromethane sulfonic acid) may
(b) The additive is used in food as an safely be used in the production of
antimicrobial agent as defined in cocoa butter substitute from palm oil
§ 170.3(o)(2) of this chapter to treat the (1-palmitoyl-2-oleoyl-3-stearin) (see
surface of raw poultry carcasses. The § 184.1259 of this chapter) in accordance
solution in which the additive is used with the following conditions:
to treat raw poultry carcasses shall (a) The catalyst meets the following
also contain propylene glycol (CAS specifications:
Reg. No. 57–55–6) complying with Appearance, Clear liquid.
§ 184.1666 of this chapter, at a con- Color, Colorless to amber.

centration of 1.5 times that of Neutralization equivalent, 147–151.
cetylpyridinium chloride. Water, 1 percent maximum.
161
§ 173.400 21 CFR Ch. I (4–1–23 Edition)
Fluoride ion, 0.03 percent maximum. (2) Ammonolysis of natural tallow
Heavy metals (as Pb), 30 parts per million fatty acids to form amines that are
maximum. then reacted with 2-ethylhexanal, re-
Arsenic (as As), 3 parts per million max-
imum.
duced, methylated, and subsequently
reacted with methyl chloride to form
(b) It is used at levels not to exceed the quaternary ammonium compound
0.2 percent of the reaction mixture to known as dimethyl(2-ethylhexyl) hy-
catalyze the directed esterification. drogenated tallow ammonium chloride
(c) The esterification reaction is and consisting primarily of dimethyl(2-
quenched with steam and water and ethylhexyl)octadecylammonium chlo-
the catalyst is removed with the aque- ride and dimethyl(2-ethyl-
ous phase. Final traces of catalyst are hexyl)hexadecylammonium chloride.
removed by washing batches of the (b) The food additive described in
product three times with an aqueous paragraph (a)(1) of this section con-
solution of 0.5 percent sodium bicar- tains not more than a total of 2 percent
bonate. by weight of free amine and amine hy-
(d) No residual catalyst may remain drochloride. The food additive de-
in the product at a detection limit of scribed in paragraph (a)(2) of this sec-
0.2 part per million fluoride as deter- tion contains not more than 3 percent
mined by the method described in ‘‘Of- by weight, each, of free amine and
ficial Methods of Analysis of the Asso- amine hydrochloride as determined by
ciation of Official Analytical Chem- A.O.C.S. method Te 3a–64, ‘‘Acid Value
ists,’’ sections 25.049–25.055, 13th Ed. and Free Amine Value of Fatty Quater-
(1980), which is incorporated by ref-
nary Ammonium Chlorides,’’ 2d print-
erence. Copies may be obtained from
ing including additions and revisions
the AOAC INTERNATIONAL, 481 North
1990, which is incorporated by reference
Frederick Ave., suite 500, Gaithersburg,
in accordance with 5 U.S.C. 552(a) and 1
MD 20877, or may be examined at the
CFR part 51. Copies are available from
National Archives and Records Admin-
the Office of Food Additive Safety
istration (NARA). For information on
(HFS–200), Center for Food Safety and
NARA, call 202–741–6030, or go to: http://
Park, MD 20740, 240–402–1200, and from
ibr_locations.html. the American Oil Chemists’ Society,
P.O. Box 5037, Station A, Champaign,
[43 FR 54237, Nov. 11, 1978, as amended at 49 IL 61820, or available for inspection at
FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, the National Archives and Records Ad-
1989; 70 FR 40880, July 15, 2005; 70 FR 67651, ministration (NARA). For information
Nov. 8, 2005]
on the availability of this material at
§ 173.400 Dimethyldialkylammonium NARA, call 202–741–6030, or go to: http://
chloride. www.archives.gov/federal_register/
Dimethyldialkylammonium chloride
ibr_locations.html.
ance with the following prescribed con- (c) The food additive is used as a de-
ditions: colorizing agent in the clarification of
(a) The food additive is produced by refinery sugar liquors under the fol-
one of the following methods: lowing limitations:
(1) Ammonolysis of natural tallow (1) The food additive described in
fatty acids to form amines that are paragraph (a)(1) of this section is added
subsequently reacted with methyl chlo- only at the defecation/clarification
ride to form the quaternary ammonium stage of sugar liquor refining in an
compounds consisting primarily of amount not to exceed 700 parts per mil-
dimethyldioctadecylammonium chlo- lion by weight of sugar solids.
ride and dimethyldihexadecyl- (2) The food additive described in
ammonium chloride. The additive may paragraph (a)(2) of this section is used
contain residues of isopropyl alcohol under the following conditions:

not in excess of 18 percent by weight (i) The additive is adsorbed onto a
when used as a processing solvent. support column composed of suitable
162
polymers that are regulated for con- (c) To assure safe use of the additive,
tact with aqueous food. Excess non- the label or labeling of the additive
adsorbed additive shall be rinsed away container shall bear, in addition to the
with potable water prior to passage of other information required by the Fed-
sugar liquor through the column. eral Food, Drug, and Cosmetic Act,
(ii) The residue of the additive in the adequate directions to assure use in
decolorized sugar liquor prior to crys- compliance with the provisions of this
tallization shall not exceed 1 part per section.
million of sugar as determined by a [77 FR 71697, Dec. 4, 2012]
method entitled ‘‘Colorimetric Deter-
mination of Residual Quaternary Am-
monium Compounds (Arquad HTL8) in PART 174—INDIRECT FOOD
Sugar and Sugar Solutions,’’ June 13, ADDITIVES: GENERAL
1990, which is incorporated by reference
in accordance with 5 U.S.C. 552(a) and 1 Sec.
CFR part 51. Copies are available from 174.5 General provisions applicable to indi-
rect food additives.
the Office of Food Additive Safety 174.6 Threshold of regulation for substances
(HFS–200), Center for Food Safety and used in food-contact articles.
ministration, 5001 Campus Dr., College AUTHORITY: 21 U.S.C. 321, 342, 348, 371.
Park, MD 20740, 240–402–1200, or avail- § 174.5 General provisions applicable
able for inspection at the National Ar- to indirect food additives.
(NARA). For information on the avail- (a) Regulations prescribing condi-
tions under which food additive sub-
stances may be safely used predicate
202–741–6030, or go to: http://
usage under conditions of good manu-
facturing practice. For the purpose of
this part and parts 175, 176, and 177 of
ibr_locations.html.
this chapter, good manufacturing prac-
(d) To assure safe use of the additive,
tice shall be defined to include the fol-
the label and labeling of the additive
lowing restrictions:
shall bear, in addition to other infor-
(1) The quantity of any food additive
mation required by the Federal Food,
substance that may be added to food as
Drug, and Cosmetic Act, adequate di-
a result of use in articles that contact
rections to assure use in compliance food shall not exceed, where no limits
with paragraph (c) of this section. are specified, that which results from
[56 FR 42686, Aug. 29, 1991, as amended at 88 use of the substance in an amount not
FR 17724, Mar. 24, 2023] more than reasonably required to ac-
complish the intended physical or tech-
§ 173.405 Sodium nical effect in the food-contact article;
dodecylbenzenesulfonate. shall not exceed any prescribed limita-
Sodium dodecylbenzenesulfonate tions; and shall not be intended to ac-
(CAS No. 25155–30–0) may be safely used complish any physical or technical ef-
in accordance with the following pre- fect in the food itself, except as such
scribed conditions: may be permitted by regulations in
(a) The additive is an antimicrobial parts 170 through 189 of this chapter.
agent used in wash water for fruits and (2) Any substance used as a compo-
vegetables. The additive may be used nent of articles that contact food shall
at a level not to exceed 111 milligrams be of a purity suitable for its intended
per kilogram in the wash water. Fruits use.
and vegetables treated by the additive (b) The existence in the subchapter B
do not require a potable water rinse. of a regulation prescribing safe condi-
(b) The additive is limited to use in tions for the use of a substance as an
commissaries, cafeterias, restaurants, article or component of articles that
retail food establishments, nonprofit contact food shall not be construed to
food establishments, and other food relieve such use of the substance or ar-
service operations in which food is pre- ticle from compliance with any other
pared for or served directly to the con- provision of the Federal Food, Drug,
sumer. and Cosmetic Act. For example, if a
163
§ 174.6 21 CFR Ch. I (4–1–23 Edition)
regulated food-packaging material PART 175—INDIRECT FOOD ADDI-

were found on appropriate test to im- TIVES: ADHESIVES AND COMPO-
part odor or taste to a specific food NENTS OF COATINGS
product such as to render it unfit with-
in the meaning of section 402(a)(3) of Subpart A [Reserved]
the Act, the regulation would not be
construed to relieve such use from Subpart B—Substances for Use Only as
compliance with section 402(a)(3). Components of Adhesives
(c) The existence in this subchapter B
Sec.
of a regulation prescribing safe condi- 175.105 Adhesives.
tions for the use of a substance as an 175.125 Pressure-sensitive adhesives.
article or component of articles that
contact food shall not be construed as Subpart C—Substances for Use as
implying that such substance may be Components of Coatings
safely used as a direct additive in food.
175.210 Acrylate ester copolymer coating.
(d) Substances that under conditions 175.230 Hot-melt strippable food coatings.
of good manufacturing practice may be 175.250 Paraffin (synthetic).
safely used as components of articles 175.260 Partial phosphoric acid esters of pol-
that contact food include the fol- yester resins.
lowing, subject to any prescribed limi- 175.270 Poly(vinyl fluoride) resins.
tations: 175.300 Resinous and polymeric coatings.
(1) Substances generally recognized 175.320 Resinous and polymeric coatings for
polyolefin films.
as safe in or on food.
175.350 Vinyl acetate/crotonic acid copoly-
(2) Substances generally recognized mer.
as safe for their intended use in food 175.360 Vinylidene chloride copolymer coat-
packaging. ings for nylon film.
(3) Substances used in accordance 175.365 Vinylidene chloride copolymer coat-
with a prior sanction or approval. ings for polycarbonate film.
175.380 Xylene-formaldehyde resins con-
(4) Substances permitted for use by densed with 4,4′-isopropylidenediphenol-
regulations in this part and parts 175, epichlorohydrin epoxy resins.
176, 177, 178 and § 179.45 of this chapter. 175.390 Zinc-silicon dioxide matrix coatings.
(5) Food contact substances used in AUTHORITY: 21 U.S.C. 321, 342, 348, 379e.
accordance with an effective pre-
market notification for a food contact SOURCE: 42 FR 14534, Mar. 15, 1977, unless
otherwise noted.
substance (FCN) submitted under sec-
tion 409(h) of the act. EDITORIAL NOTE: Nomenclature changes to
[42 FR 14534, Mar. 15, 1977, as amended at 67 FR 56035, Nov. 6, 2001; and 70 FR 72074, Dec.
FR 35731, May 21, 2002] 1, 2005.
§ 174.6 Threshold of regulation for

substances used in food-contact ar- Subpart A [Reserved]
ticles.
Substances used in food-contact arti-
Subpart B—Substances for Use
cles (e.g., food-packaging or food-proc- Only as Components of Adhesives
essing equipment) that migrate, or § 175.105 Adhesives.
that may be expected to migrate, into
food at negligible levels may be re- (a) Adhesives may be safely used as
viewed under § 170.39 of this chapter. components of articles intended for use
The Food and Drug Administration in packaging, transporting, or holding
will exempt substances whose uses it food in accordance with the following
determines meet the criteria in § 170.39 prescribed conditions:
of this chapter from regulation as food (1) The adhesive is prepared from one
or more of the optional substances
additives and, therefore, a food addi-
named in paragraph (c) of this section,
tive petition will not be required for
subject to any prescribed limitations.

the exempted use.
(2) The adhesive is either separated
[60 FR 36596, July 17, 1995] from the food by a functional barrier or
164
used subject to the following additional hesives, the optional substances used
limitations: in the formulation of adhesives may in-
(i) In dry foods. The quantity of adhe- clude the following:
sive that contacts packaged dry food (1) Substances generally recognized
shall not exceed the limits of good as safe for use in food or food pack-
manufacturing practice. aging.
(ii) In fatty and aqueous foods. (a) The (2) Substances permitted for use in
quantity of adhesive that contacts adhesives by prior sanction or approval
packaged fatty and aqueous foods shall and employed under the specific condi-
not exceed the trace amount at seams tions of use prescribed by such sanc-
and at the edge exposure between pack- tion or approval.
aging laminates that may occur within (3) Flavoring substances permitted
the limits of good manufacturing prac- for use in food by regulations in this
tice. part, provided that such flavoring sub-
(b) Under normal conditions of use stances are volatilized from the adhe-
the packaging seams or laminates will sives during the packaging fabrication
remain firmly bonded without visible process.
separation. (4) Color additives approved for use in
(b) To assure safe usage of adhesives, food.
the label of the finished adhesive con- (5) Substances permitted for use in
tainer shall bear the statement ‘‘food- adhesives by other regulations in this
packaging adhesive’’. subchapter and substances named in
(c) Subject to any limitation pre- this subparagraph: Provided, however,
scribed in this section and in any other That any substance named in this
regulation promulgated under section paragraph and covered by a specific
409 of the Act which prescribes safe regulation in this subchapter, must
conditions of use for substances that meet any specifications in such regula-
may be employed as constituents of ad- tion.
Abietic acid.
Acetone.
Acetone-formaldehyde condensate (CAS Reg. No. 25619–09–4).
Acetone-urea-formaldehyde resin.
N-Acetyl ethanolamine.
Acetyl tributyl citrate.
Acetyl triethyl citrate.
2-Acrylamido-2-methyl-propanesulfonic acid, homopolymer, sodium salt
(CAS Reg. No. 35641–59–9).
Albumin, blood.
(2-Alkenyl) succinic anhydrides in which the alkenyl groups are derived
from olefins which contain not less than 78 percent C30 and higher
groups (CAS Reg. No. 70983–55–0).
4-[2-[2-2-(Alkoxy (C12-C15) ethoxy) ethoxy]ethyl] disodium sulfosuccinate.
1-Alkyl (C6-C18) amino-3-amino-propane monoacetate.
Alkylated (C4 and/or C8) phenols.
Alkyl (C7-C12) benzene.
Alkyl (C10-C20) dimethylbenzyl ammonium chloride.
n-Alkyl(C12, C14, C16, or C18) dimethyl (ethylbenzyl) ammonium For use as preservative only.
cyclohexylsulfamate.
Alkyl ketene dimers as described in § 176.120 of this chapter.
Alkyl (C7-C12) naphthalene.
alpha Olefin sulfonate [alkyl group is in the range of C10-C18 with not
less than 50 percent C14-C16], ammonium, calcium, magnesium, po-
tassium, and sodium salts.
2-[(2-aminoethyl)amino]ethanol (CAS Reg. No. 111–41–1).
3-Aminopropanediol .................................................................................... For use only in the preparation of polyurethane res-
ins.
Aluminum.
Aluminum acetate.
Aluminum di(2-ethylhexoate).
Aluminum potassium silicate.
N-b-Aminoethyl-gamma-aminopropyl trimethoxysilane.
3-(Aminomethyl)-3,5,5-trimethylcyclohexylamine.
Aminomethylpropanol.
Ammonium benzoate .................................................................................. For use as preservative only.
165
§ 175.105 21 CFR Ch. I (4–1–23 Edition)
Ammonium bifluoride .................................................................................. For use only as bonding agent for aluminum foil, sta-
bilizer or preservative. Total fluoride from all
sources not to exceed 1 percent by weight of the
finished adhesive.
Ammonium borate.
Ammonium citrate.
Ammonium persulfate.
Ammonium polyacrylate.
Ammonium potassium hydrogen phosphate.
Ammonium silico-fluoride ............................................................................ For use only as bonding agent for aluminum foil, sta-
bilizer, or preservative. Total fluoride from all
finished adhesive.
Ammonium sulfamate.
Ammonium thiocyanate.
Ammonium thiosulfate.
Amyl acetate.
Anhydroenneaheptitol.
Animal glue as described in § 178.3120 of this chapter.
2-Anthraquinone sulfonic acid, sodium salt ................................................ For use only as polymerization-control agent.
Antimony oxide.
Asbestos.
Asphalt, paraffinic and naphthenic.
Azelaic acid.
Azo-bis-isobutyronitrile.
Balata rubber.
Barium acetate.
Barium peroxide.
Barium sulfate.
Bentonite.
Benzene (benzol).
1,4-Benzenedicarboxylic acid, bis[2-(1,1-dimethylethyl)-6-[[3-(1,1- For use as a stabilizer.
dimethylethyl)-2-hydroxy-5-methylphenyl]methyl]-4-methyl-phenyl]ester
(CAS Reg. No. 57569–40–1).
1,2–Benzisothiazolin–3–one (CAS Registry No. 2634–33–5) .................... For use as preservative only.
Benzothiazyldisulfide.
p-Benzoxyphenol ......................................................................................... For use as preservative only.
Benzoyl peroxide.
Benzyl alcohol.
Benzyl benzoate.
Benzyl bromoacetate .................................................................................. For use as preservative only.
p-Benzyloxyphenol ...................................................................................... Do.
BHA (butylated hydroxyanisole).
BHT (butylated hydroxytoluene).
Bicyclo[2.2.1]hept-2-ene-6-methyl acrylate.
2-Biphenyl diphenyl phosphate.
Bis(benzoate-O)(2-propanolato)aluminum (CAS Reg. No. 105442–85–1) For use only as a reactant in the preparation of poly-
ester resins.
1,2-Bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamoyl)hy-drazine (CAS Reg. For use at a level not to exceed 2 percent by weight
No. 32687–78–8). of the adhesive.
1,3-Bis(2-benzothiazolylmercaptomethyl) urea.
4,4′-Bis(a,a-dimethylbenzyl)diphenylamine.
2,6-Bis(1,1-dimethylethyl)-4-(1-methylpropyl)phenol (CAS Reg. No. For use as an antioxidant and/or stabilizer only.
17540–75–9).
2,6-Bis (1-methylheptadecyl)-p-cresol.
4-[[4, 6-Bis(octylthio)6-Bis(octylthio)6-Bis(octylthio)-s-triazin-2-yl]amino]-
2,6-di-tert-butylphenol (CAS Reg. No. 991–84–4).
Bis(tri-n-butyltin) oxide ................................................................................ For use as preservative only.
Bis(trichloromethyl)sulfone C.A. Registry No. 3064–70–8 ......................... Do.
Borax.
Boric acid.
2-Bromo-2-nitro-1, 3-propanediol (CAS Reg. No. 52–51–7) ...................... For use only as an antibacterial preservative.
Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium salt (also For use as a surface active agent in adhesives.
known as butanedioic acid, sulfo-1,4-diisodecyl ester, ammonium salt
[CAS Reg. No. 144093–88–9])..
1,3-Butanediol.
1,4-Butanediol.
1,4-Butanediol modified with adipic acid.
Butoxy polyethylene polyproplyene glycol (molecular weight 900–4,200).
Butyl acetate.
Butyl acetyl ricinoleate.
Butyl alcohol.
Butylated reaction product of p-cresol and dicyclopentadiene ................... As identified in § 178.2010(b) of this chapter.
Butylated, styrenated cresols identified in § 178.2010(b) of this chapter.
166
Butyl benzoate.
1,3-Butylene glycoldiglycolic acid copolymer.
tert-Butyl hydroperoxide.
4,4′-Butylidenebis(6-tert-butyl-m-cresol).
Butyl lactate.
p-tert-Butylphenyl salicylate.
p-tert-Butylpyrocatechol .............................................................................. For use only as polymerization-control agent.
Butyl ricinoleate.
Butyl rubber polymer.
Butyl stearate.
Butyl titanate, polymerized.
Butyraldehyde.
Calcium ethyl acetoacetate.
Calcium nitrate.
Calcium metasilicate.
Camphor.
Camphor fatty acid esters.
Candelilla wax.
epsilon-Caprolactam-(ethylene-ethyl acrylate) graft polymer.
Carbon black, channel process.
Carbon disulfide-1,1′-methylenedipiperidine reaction product.
Carbon tetrachloride.
Carboxymethylcellulose.
Castor oil, polyoxyethylated (4–84 moles ethylene oxide).
Cellulose acetate butyrate.
Cellulose acetate propionate.
Ceresin wax (ozocerite).
Cetyl alcohol.
Chloracetamide.
Chloral hydrate.
Chlorinated liquid n-paraffins with chain lengths of C10-C17, containing
40–70 percent chlorine by weight.
Chlorinated pyridine mixture with active ingredients consisting of 2,3,5,6- For use as preservative only.
tetrachloro-4-(methylsulfonyl) pyridine, 2,3,5,6-tetrachloro-4-
(methylsulfinyl) pyridine and pentachloropyridine.
Chlorinated rubber polymer (natural rubber polymer containing approxi-
mately 67 percent chlorine).
1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride ....................... For use as preservative only.
Chlorobenzene.
4-Chloro-3,5-dimethylphenol (p-chloro-m-xylenol) ...................................... For use as preservative only.
4-Chloro-3-methylphenol ............................................................................. Do.
5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172–55–4) and For use only as an antimicrobial agent in polymer
2-methyl-4-isothiazolin-3-one (CAS Reg. No. 2682–20–4) mixture at a latex emulsions.
ratio of 3 parts to 1 part, manufactured from methyl-3-
mercaptopropionate (CAS Reg. No. 2935–90–2). The mixture may
contain magnesium nitrate (CAS Reg. No. 10377–60–3) at a con-
centration equivalent to the isothiazolone active ingredients (weight/
weight).
Chloroform.
Chloroprene.
Chromium caseinate.
Chromium nitrate.
Chromium potassium sulfate.
Cobaltous acetate.
Coconut fatty acid amine salt of tetrachlorophenol .................................... For use as preservative only.
Copal.
Copper 8-quinolinolate ................................................................................ For use as preservative only.
Coumarone-indene resin.
Cresyl diphenyl phosphate.
Cumene hydroperoxide.
Cyanoguanidine.
Cyclized rubber as identified in § 176.170(b)(2) of this chapter.
Cyclohexane.
1,4-Cyclohexanedimethanoldibenzoate (CAS Reg. No. 35541–81–2).
Cyclohexanol.
Cyclohexanone resin.
Cyclohexanone-formaldehyde condensate.
N-Cyclohexyl p-toluene sulfonamide.
(h5-Cyclopentadienyl)-(h6-isopropylbenzene)iron(II) hexafluorophosphate For use only as a photoinitiator.
(CAS Reg. No. 32760–80–8).
Damar.
Defoaming agents as described in § 176.210 of this chapter.

Dehydroacetic acid ......................................................................................
Diacetone alcohol.
167
§ 175.105 21 CFR Ch. I (4–1–23 Edition)
Diacetyl peroxide.
N,N′-Dialkoyl-4,4′-diaminodiphenylmethane mixtures where; the alkoyl
groups are derived from marine fatty acids (C12-C24).
2,5-Di-tert-amylhydroquinone.
Diamines derived from dimerized vegetable oil acids.
Diaryl-p-phenylenediamine, where the aryl group may be phenyl, tolyl, or
xylyl.
1,2–Dibromo–2,4–dicyanobutane (CAS Registry No. 3569–65–7) ............ For use as a preservative only.
2,2-Dibromo-3-nitrilopropionamide (CAS Reg. No. 10222–01–2). ............. For use as a preservative only.
2,5-Di-tert-butylhydroquinone.
Dibutyl maleate.
2,6-Di-tert-butyl-4-methylphenol .................................................................. For use as preservative only.
Di(C7, C9-alkyl)adipate.
Dibutyl sebacate.
Dibutyltin dilaurate for use only as a catalyst for polyurethane resins.
1,2-Dichloroethylene (mixed isomers).
Dicumyl peroxide.
Dicyclohexyl phthalate.
Diethanolamine.
Diethanolamine condensed with animal or vegetable fatty acids.
Diethylamine.
Diethylene glycol.
Diethylene glycol adipic acid copolymer.
Diethylene glycol dibenzoate.
Diethylene glycol hydrogenated tallowate monoester.
Diethylene glycol laurate.
Diethylene glycol monobutyl ether.
Diethylene glycol monobutyl ether acetate.
Diethylene glycol monoethyl ether.
Diethylene glycol monoethyl ether acetate.
Diethylene glycol monomethyl ether.
Diethylene glycol monooleate.
Diethylene glycol monophenyl ether.
Diethylene glycol copolymer of adipic acid and phthalic anhydride.
Di(2-ethylhexyl) adipate.
Di(2-ethylhexyl)phthalate.
Diethyl oxalate.
Di(2-hydroxy-5-tert-butylphenyl) sulfide.
2,2′-Dihydroxy-5,5′-dichlorodiphenylmethane (dichlorophene).
4,5-Dihydroxy-2-imidazolidinone.
4-(Diiodomethylsulfonyl) toluene CA Registry No.: 20018–09–01 ............. For use as an antifungal preservative only.
Diisobutyl adipate.
Diisobutyl ketone.
Diisobutylphenoxyethoxyethyl dimethyl benzyl ammonium chloride.
Diisodecyl adipate.
Diisodecyl phthalate.
Diisopropylbenzene hydroperoxide.
N,N-Dimethylcyclohexylamine dibutyldithiocarbamate.
Dimethyl formamide.
Dimethyl hexynol.
2,2-Dimethyl-1,3-propanediol dibenzoate.
Dimethyl octynediol.
N-(1,1-dimethyl-3-oxobutyl) acrylamide.
3,5-Dimethyl-1,3,5,2H-tetrahydrothiadiazine-2-thione ................................. For use as preservative only.
Di-b-naphthyl-p-phenylenediamine.
4,6-Dinonyl-o-cresol.
Dinonylphenol.
Di-n-octyldecyl adipate.
Dioctyldiphenylamine.
Dioctylsebacate.
Dioxane.
Dipentaerythritol pentastearate.
Dipentamethylene-thiuram-tetrasulfide.
Dipentene ....................................................................................................
Dipentene resins.
Dipentene-beta-pinene-styrene resins.
Dipentene-styrene resin (CAS Registry No. 64536–06–7).
Diphenyl-2-ethylhexyl phosphate.
Diphenyl, hydrogen ated.
N,N′-Diphenyl-p-phenylenediamine.
1,3-Diphenyl-2-thiourea.
Dipropylene glycol.
Dipropylene glycol dibenzoate.
Dipropylene glycol monomethyl ether.
168
Dipropylene glycol copolymer of adipic acid and phthalic anhydride.

Disodium cyanodithioimidocarbonate.
Disodium 4-isodecyl sulfosuccinate (CAS Reg. No. 37294–49–8).
N,N′-Distearoylethylenediamine.
Distearyl thiodipropionate.
3,5-Di-tert-butyl-4-hydroxyhydrocinnamic acid triester with 1,3,5-tris(2-hy- For use as antioxidant only.
droxyethyl)-s-triazine-2,4,6(1H, 3H, 5H)-trione.
4,4′-Dithiodimorpholine.
n-Dodecylmercaptan.
tert-Dodecylmercaptan.
Dodecylphenoxybenzene-disulfonic acid and/or its calcium, magnesium,
and sodium salts.
Elemi gum.
Epichlorohydrin-4,4′-isopropylidenediphenol resin.
Epichlorohydrin-4,4′-sec-butylidenediphenol resin.
Epichlorohydrin-4,4′-isopropylidene-di-o-cresol resin.
Epichlorohydrin-phenolformaldehyde resin.
Erucamide (erucylamide).
Ethanolamine.
Ethoxylated primary linear alcohols of greater than 10 percent ethylene
oxide by weight having molecular weights of 390 to 7,000 (CAS Reg.
No. 97953–22–5).
Ethoxypropanol butyl ether.
Ethyl alcohol (ethanol).
5-Ethyl-1,3-diglycidyl-5-methylhydantoin (CAS Reg. No. 15336–82–0).
Ethylene-acrylic acid-carbon monoxide copolymer (CAS Reg. No.
97756–27–9).
Ethylene-acrylic acid copolymer, partial sodium salt containing no more
than 20 percent acrylic acid by weight, and no more than 16 percent
of the acrylic acid as the sodium salt (CAS Reg. No. 25750–82–7).
Ethylenediamine.
Ethylenediaminetetra-acetic acid, calcium, ferric, potassium, or sodium
salts, single or mixed.
Ethylene dichloride.
Ethylene glycol.
Ethylene glycol monobutyl ether.
Ethylene glycol monobutyl ether acetate.
Ethylene glycol monoethyl ether.
Ethylene glycol monoethyl ether acetate.
Ethylene glycol monoethyl ether ricinoleate.
Ethylene glycol monomethyl ether.
Ethylene glycol monophenyl ether.
Ethylene-carbon monoxide copolymer (CAS Reg. No. 25052–62–4) con-
taining not more than 30 weight percent of the units derived from car-
bon monoxide.
Ethylene-maleic anhydride copolymer, ammonium or potassium salt.
Ethylene-methacrylic acid copolymer partial salts: Ammonium, calcium,
magnesium, sodium, and/or zinc.
Ethylene-methacrylic acid-vinyl acetate copolymer partial salts: Ammo-
nium, calcium, magnesium, sodium, and/or zinc.
Ethylene-octene-1 copolymers containing not less than 70 weight per-
cent ethylene (CAS Reg. No. 26221–73–8).
Ethylene-propylene-dicyclopentadiene copolymer rubber.
Ethylene, propylene, 1,4-hexadiene and 2,5-norbornadiene tetrapolymer.
Ethylene-vinyl acetate carbon monoxide terpolymer (CAS Registry No.
26337–35–9) containing not more than 15 weight percent of units de-
rived from carbon monoxide.
2,2′-Ethylidenebis (4,6-di-tert-butylphenol) (CAS Reg. No. 35958–30–6).
Ethyl-p-hydroxybenzoate ............................................................................. For use as preservative only.
Ethyl hydroxyethylcellulose.
Ethyl lactate.
2,2′-Ethylidenebis(4,6-di-tert-butylphenyl)fluorophosphonite (CAS Reg. For use as an antioxidant and/or stabilizer only.
No. 118337–09–0).
Ethyl-p-toluene sulfonamide ........................................................................
Fats and oils derived from animal or vegetable sources, and the hydro-
genated, sulfated, or sulfonated forms of such fats and oils.
Fatty acids derived from animal or vegetable fats and oils; and salts of
such acids, single or mixed, as follows:
Aluminum.
Ammonium.
Calcium.
Magnesium.
Potassium.
Sodium.
169
§ 175.105 21 CFR Ch. I (4–1–23 Edition)
Zinc.
Ferric chloride.
Fluosilicic acid (hydrofluosilicic acid) .......................................................... For use only as bonding agent for aluminum foil, sta-
finished adhesive.
Formaldehyde.
Formaldehyde o- and p-toluene sulfonamide.
Formamide.
Fumaratochromium (III) nitrate.
Furfural.
Furfuryl alcohol.
Fumaric acid.
gamma-Aminopropyltrimethoxysilane (CAS Reg. No. 13822–56–5).
Glutaraldehyde.
Glycerides, di- and monoesters.
Glycerol polyoxypropylene triol, minimum average molecular weight 250 For use only in the preparation of polyester and poly-
(CAS Reg. No. 25791–96–2). urethane resins in adhesives.
Glyceryl borate (glycol boriborate resin).
Glyceryl ester of damar, copal, elemi, and sandarac.
Glyceryl monobutyl ricinoleate.
Glyceryl monohydroxy stearate.
Glyceryl monohydroxy tallowate.
Glyceryl polyoxypropylene triol (average molecular weight 1,000).
Glyceryl tribenzoate.
Glycol diacetate.
Glyoxal.
Heptane.
Hexamethylenetetramine.
Hexane.
Hexanetriols.
Hexylene glycol.
Hydroabietyl alcohol.
Hydrocarbon resins (produced by polymerization of mixtures of mono-
and di-unsaturated hydrocarbons of the aliphatic, alicyclic, and
monobenzenoid type derived both from cracked petroleum and ter-
pene stocks) (CAS Reg. No. 68239–99–6).
Hydrocarbon resins (produced by the polymerization of styrene and
alpha-methyl styrene), hydrogenated (CAS Reg. No. 68441–37–2).
Hydrofluoric acid ......................................................................................... For use only as bonding agent for aluminum foil, sta-
finished adhesive.
Hydrogen peroxide.
Hydrogenated dipentene resin (CAS Reg. No. 106168–39–2).
Hydrogenated dipentene-styrene copolymer resin (CAS Reg. No.
106168–36–9).
Hydrogenated-beta-pinene-alpha-pinene-dipentene copolymer resin
(CAS Reg. No. 106168–37–0).
a-Hydro-omega-hydroxypoly-(oxytetramethylene) ...................................... For use only in the preparation of polyurethane res-
ins.
Hydroquinone.
Hydroquinone monobenzyl ether.
Hydroquinone monoethyl ether.
2(2′-Hydroxy-3′,5′ di-tert-amylphenyl) benzotriazole.
Hydroxyacetic acid.
7-Hydroxycoumarin.
Hydroxyethylcellulose.
2–Hydroxy-1-[4-(2-hydroxyethoxy)phenyl]-2-methyl-1-propanone(CAS For use only as a photoinitiator at a level not to ex-
Reg. No. 106797–53–9). ceed 5 percent by weight of the adhesive.
1-(2-Hydroxyethyl)-1-(4-chlorobutyl)-2 alkyl (C6-C17) imidazolinium chlo-
ride.
Hydroxyethyldiethylenetriamine.
b-Hydroxyethyl pyridinium 2-mercaptobenzothiazol.
Hydroxyethyl starch.
Hydroxyethylurea ........................................................................................
Hydroxylamine sulfate.
5-Hydroxymethoxymethyl-1-aza-3,7-dioxabicyclo[3.3.0]octane, 5- For use only as an antibacterial preservative.
hydroxymethyl-1-aza-3,7-dioxabicyclo[3.3.0]octane, and 5-hydroxypoly-
[methyleneoxy]methyl-1-aza-3,7-dioxabicyclo[3.3.0] octane mixture.
Hydroxypropyl methylcellulose.
2-(Hydroxymethyl)-2-methyl-1,3-propanediol tribenzoate.
2-Imidazolidinone.
3–Iodo–2–propynyl-N-butyl carbamate (CAS Reg. No. 55406–53–6) ....... For use only as an antifungal preservative.
170
Iodoform ...................................................................................................... For use only as polymerization-control agent.

Isoascorbic acid.
Isobutyl alcohol (isobutanol).
Isobutylene-isoprene copolymer.
Isodecyl benzoate (CAS Reg. No. 131298–44–7).
Isophorone.
Isopropanolamine (mono-, di-, tri-).
Isopropyl acetate.
Isopropyl alcohol (isopropanol).
Isopropyl-m- and p-cresol (thymol derived).
4,4′-Isopropylidenediphenol.
4,4′-Isopropylidenediphenol, polybutylated mixture .................................... For use as preservative only.
Isopropyl peroxydicarbonate.
p-Isopropoxy diphenylamine.
4,4′-Isopropylidene-bis(p-phenyleneoxy)-di-2-propanol.
Itaconic acid.
Japan wax.
Kerosene.
Lauroyl peroxide.
Lauroyl sulfate salts:
Ammonium.
Magnesium.
Potassium.
Sodium.
Lauryl alcohol.
Lauryl pyridinium 5-chloro-2-mercaptobenzothiazole.
Lignin calcium sulfonate.
Lignin sodium sulfonate.
Linoleamide (linoleic acid amide).
Magnesium fluoride ..................................................................................... For use only as bonding agent for aluminum foil, sta-
finished adhesives.
Magnesium glycerophosphate.
Maleic acid.
Maleic anhydride-diisobutylene copolymer, ammonium or sodium salt.
Manganese acetate.
Marine oil fatty acid soaps, hydrogenated.
Melamine.
Melamine-formaldehyde copolymer.
2-Mercaptobenzothiazole.
2-Mercaptobenzothiazole and dimethyl dithiocarbamic acid mixture, so- For use as preservative only.
dium salt.
2-Mercaptobenzothiazole, sodium or zinc salt ........................................... For use as preservative only.
Methacrylate-chromic chloride complex, ethyl or methyl ester.
p-Menthane hydroperoxide.
Methyl acetate.
Methyl acetyl ricinoleate.
Methyl alcohol (methanol).
Methylcellulose.
Methylene chloride.
4,4′-Methylenebis(2,6-di-tert-butylphenol).
2,2-Methylenebis (4-ethyl-6-tert-butylphenol).
2,2-Methylenebis (4-methyl-6-nonylphenol).
2,2-Methylenebis (4-methyl-6-tert-butylphenol).
Methyl ethyl ketone.
Methyl ethyl ketone-formaldehyde condensate.
2-Methylhexane.
1-Methyl-2-hydroxy-4-isopropyl benzene.
Methyl isobutyl ketone.
Methyl oleate.
Methyl oleate-palmitate mixture.
Methyl ricinoleate.
Methyl salicylate.
a-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1 a
methylstyrene to 3 vinyltoluene).
Methyl tallowate.
Mineral oil.
Monochloracetic acid.
Monooctyldiphenylamine.
Montan wax.
Morpholine.
Myristic acid-chromic chloride complex.
Myristyl alcohol.
171
§ 175.105 21 CFR Ch. I (4–1–23 Edition)
Naphtha.
Naphthalene, monosulfonated.
Naphthalene sulfonic acid-formaldehyde condensate, sodium salt.
a-Naphthylamine.
a,a′,a″,a″′-Neopentane tetrayltetrakis [omega-hydroxypoly
(oxypropylene) (1–2 moles)], average molecular weight 400.
Nitric acid.
μ-Nitrobiphenyl.
Nitrocellulose.
2-Nitropropane.
a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of dihydro-
gen phosphate and monohydrogen phosphate esters; the nonyl group
is a propylene trimer isomer and the poly (oxyethylene) content aver-
ages 6–9 moles or 50 moles.
a(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) produced by the
condensation of 1 mole of p-nonylphenol (nonyl group is a propylene
trimer isomer) with an average of 1–40 moles of ethylene oxide.
a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) sulfate, ammonium
salt: the nonyl group is a propylene trimer isomer and the poly (oxy-
ethylene) content averages 9 or 30 moles.
endo-cis-5-Norbornene-2,3-dicarboxylic anhydride.
a-cis-9-Octadecenyl-omega-hydroxypoly (oxyethylene); the octadecenyl
group is derived from oleyl alcohol and the poly (oxyethylene) content
averages 20 moles.
Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate.
Octyl alcohol.
Octylphenol.
Octylphenoxyethanols.
Octylphenoxypolyethoxy-polypropoxyethanol (13 moles of ethylene oxide
and propylene oxide).
Odorless light petroleum hydrocarbons.
Oleamide (oleic acid amide).
Oleic acid, sulfated.
2,2′-Oxamidobis[ethyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
(CAS Reg. No. 70331–94–1).
Oxazoline.
a-(oxiranylmethyl)-w-(oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], For use as a reactant in the preparation of epoxy-
(alternative name: epichlorohydrin-polypropylene glycol) (CAS Reg. based resins.
No. 26142–30–3).
2,2′-[oxybis[(methyl-2,1-ethanediyl)-oxymethylene]]bisoxirane, (alternative For use as a reactant in the preparation of epoxy-
name: epichlorohydrin-dipropylene glycol) (CAS Reg. No. 41638–13– based resins.
5).
n-Oxydiethylene-benzothiazole.
Palmitamide (palmitic acid amide).
Paraffin (C12-C20) sulfonate.
Paraformaldehyde.
Pentachlorophenol.
Pentaerythritol ester of maleic anhydride.
Pentaerythritol monostearate ...................................................................... For use as preservative only.
Pentaerythritol tetrabenzoate [CAS Registry No. 4196–86–5].
Pentaerythritol tetrastearate.
2,4-Pentanedione.
Pentasodium diethylenetriaminepentaacetate (CAS Reg. No. 140–01–2).
Perchloroethylene.
Petrolatum.
Petroleum hydrocarbon resin (cyclopentadiene type), hydrogenated.
Petroleum hydrocarbon resin (produced by the catalytic polymerization
and subsequent hydrogenation of styrene, vinyltoluene, and indene
types from distillates of cracked petroleum stocks).
Petroleum hydrocarbon resins (produced by the homo-and copolymeriza-
tion of dienes and olefins of the aliphatic, alicyclic, and
monobenzenoid arylalkene types from distillates of cracked petroleum
stocks).
Phenol ......................................................................................................... For use as preservative only.
Phenol-coumarone-indene resin.
Phenolic resins as described in § 175.300(b)(3)(vi).
Phenothiazine .............................................................................................. For use only as polymerization-control agent.
Phenyl-b-naphthylamine (free of b-naphthylamine).
o-Phenylphenol ........................................................................................... For use as preservative only.
o-Phthalic acid.
Pimaric acid .................................................................................................
Pine oil.
Piperazine.
Piperidinium pentamethylenedithiocarbamate.
172
Poly(acrylamide-[2-acrylamide-2-methylpropylsulfonate]-dimethylidiallyl
ammonium chloride) sodium salt (CAS Reg. No. 72275-68-4).
Polyamides derived from reaction of one or more of the following acids
with one or more of the following amines:
Acids:
Azelaic acid.
Dimerized vegetable oil acids.
Amines:
Bis(hexamethylene) triamine and higher homologues.
Diethylenetriamine.
Diphenylamine.
Ethylenediamine.
Hexamethylenediamine.
Poly(oxypropylene)diamine (weight average molecular
weight 2010) (CAS Reg. No. 9046–10–0).
Poly(oxypropylene)diamine (weight average molecular
weight 440) (CAS Reg. No. 9046–10–0).
Tetraethylenepentamine.
Triethylenetetramine.
Polybutene, hydrogenated.
Polybutylene glycol (molecular weight 1,000).
Poly [2(diethylamino) ethyl methacrylate] phosphate.
Polyester of adipic acid, phthalic acid, and propylene glycol, terminated
with butyl alcohol.
Polyester of diglycolic acid and propylene glycol containing ethylene gly-
col monobutyl ether as a chain stopper.
Polyester resins (including alkyd type), as the basic polymer, formed as
esters when one or more of the following acids are made to react with
one or more of the following alcohols:
Acids:
Azelaic acid.
Dimethyl 1,4-cyclohexanedicarboxylate (CAS Reg. No.
94–60–0).
Dimethyl-5-sulfoisophthalic acid (CAS Reg. No.
50975–82–1) and/or its sodium salt (CAS Reg. No.
3965–55–7).
Polybasic and monobasic acids identified in
§ 175.300(b)(3)(vii)(a) and (b).
5-sulfo-1,3-benzenedicarboxylic acid, monosodium salt
(CAS Reg. No. 6362–79–4).
Tetrahydrophthalic acid.
Alcohols:
1,4-Cyclohexanedimethanol.
2,2-Dimethyl-1,3-propanediol.
1,6-Hexanediol (CAS Reg. No. 629–11–8).
Polyhydric and monohydric alcohols identified in
§ 175.300(b)(3)(vii)(c) and (d).
Polyethyleneadipate modified with ethanolamine with the molar ratio of For use only in the preparation of polyurethan resins.
the amine to the adipic acid less than 0.1 to 1.
Polyethylene glycol (molecular weight 200–6,000).
Polyethylene glycol mono-isotridecyl ether sulfate, sodium salt (CAS
Reg. No. 150413–26–6).
Polyethyleneglycol alkyl(C10-C12)ether sulfosuccinate, disodium salt (CAS
Reg. No. 68954–91–6).
Polyethylene, oxidized.
Polyethylene resins, carboxyl modified, identified in § 177.1600 of this
chapter.
Polyethylenimine.
Polyethylenimine-epichlorohydrin resins.
Poly(ethyloxazoline) (CAS Reg. No. 25805-17-8).
Polyisoprene.
Polymeric esters of polyhydric alcohols and polycarboxylic acids pre-
pared from glycerin and phthalic anhydride and modified with benzoic
acid, castor oil, coconut oil, linseed oil, rosin, soybean oil, styrene, and
vinyl toluene.
Polymers: Homopolymers and copolymers of the following monomers:.
Acrylamide.
Acrylic acid.
Acrylonitrile.
Allylmethacrylate (CAS Reg. No. 00096–05–09).
Butadiene.
Butene.
N-tert-Butylacrylamide.
Butyl acrylate.
173
§ 175.105 21 CFR Ch. I (4–1–23 Edition)
1,3-Butylene glycol dimethacrylate.

Butyl methacrylate.
Crotonic acid.
Decyl acrylate.
Diallyl fumarate.
Diallyl maleate.
Diallyl phthalate.
Dibutyl fumarate.
Dibutyl itaconate.
Dibutyl maleate.
Di(2-ethylhexyl) maleate.
Dimethyl-a-methylstyrene.
Dioctyl fumarate.
Dioctyl maleate.
Divinylbenzene.
Ethyl acrylate.
Ethylene.
Ethylene cyanohydrin.
2-Ethylhexyl acrylate.
Ethyl methacrylate.
Fatty acids, C10-13-branched, vinyl esters (CAS Reg. No. 184785–
38–4).
Fumaric acid and/or its methyl, ethyl, propyl, butyl, amyl hexyl,
heptyl and octyl esters.
Glycidyl methacrylate.
1–Hexene (CAS Reg. No. 592–41–6).
2-Hydroxyethyl acrylate.
2-Hydroxyethyl methacrylate.
2-Hydroxypropyl methacrylate.
Isobutyl acrylate.
Isobutylene.
Itaconic acid.
Maleic acid, diester with 2-hydroxyethanesulfonic acid, sodium salt.
Maleic anhydride.
Methacrylic acid.
Methyl acrylate.
N,N′-Methylenebisacrylamide.
Methyl methacrylate.
N-Methylolacrylamide.
Methyl styrene.
-Methyl styrene.
Monoethyl maleate.
Monomethyl maleate.
Mono (2-ethylhexyl) maleate.
5-Norbornene-2 3-dicarboxylic acid, mono-n-butyl ester.
1-Octene (CAS Reg. No. 111–66–0).
Propyl acrylate.
Propylene.
Styrene.
Triallyl cyanurate.
Vinyl acetate.
Vinyl alcohol (from alcoholysis or hydrolysis of vinyl acetate units).
Vinyl butyrate.
Vinyl chloride.
Vinyl crotonate.
Vinyl ethyl ether.
Vinyl hexoate.
Vinylidene chloride.
Vinyl methyl ether.
Vinyl pelargonate.
Vinyl propionate.
Vinyl pyrrolidone.
Vinyl stearate.
Polyoxyalkylated-phenolic resin (phenolic resin obtained from formalde-
hyde plus butyl- and/or amylphenols, oxyalkylated with ethylene oxide
and/or propylene oxide).
Poly(oxycaproyl) diols and triols (minimum molecular weight 500).
Polyoxyethylated (40 moles) tallow alcohol sulfate, sodium salt.
Polyoxyethylene (20 mol)—anhydrous lanolin adduct.
Polyoxyethylene (molecular weight 200) dibenzoate.
Polyoxyethylene (molecular weight 200–600) esters of fatty acids derived
from animal or vegetable fats and oils (including tall oil).

Polyoxyethylene (15 moles) ester of rosin.
Polyoxyethylene (4–5 moles) ether of phenol.
174
Polyoxyethylene (25 moles)—glycerol adduct.

Polyoxyethylene (40 moles) stearate.
Polyoxyethylene (5–15 moles) tridecyl alcohol.
Polyoxypropylene (3 moles) tridecyl alcohol sulfate.
Polyoxypropylene (20 moles) butyl ether.
Polyoxypropylene (40 moles) butyl ether.
Polyoxypropylene (20 moles) oleate butyl ether.
Polyoxypropylene-polyoxyethylene condensate (minimum molecular
weight 1,900).
Polypropylene glycol (minimum molecular weight 150).
Polypropylene glycol (3–4 moles) triether with 2-ethyl-2-(hydroxymethyl)-
1,3-propane-diol, average molecular weight 730.
Polypropylene glycol dibenzoate (CAS Reg. No. 72245–46–6) ................. For use as a plasticizer at levels not to exceed 20
percent by weight of the finished adhesive.
Polypropylene, noncrystalline.
Polysiloxanes:
Diethyl polysiloxane.
Dihydrogen polysiloxane.
Dimethyl polysiloxane.
Diphenyl polysiloxane.
Ethyl hydrogen polysiloxane.
Ethyl phenyl polysiloxane.
Methyl ethyl polysiloxane.
Methyl hydrogen polysiloxane.
Methyl phenyl polysiloxane.
Phenyl hydrogen polysiloxane.
Polysorbate 60.
Polysorbate 80.
Polysorbate 20 (polyoxyethylene (20) sorbitan monolaurate).
Polysorbate 40 (polyoxyethylene (20) sorbitan monopalmitate).
Poly[styrene-co-disodium maleate-co-a-(p-nonyl-phenyl)-omega-(p-vinyl-
benzyl)poly(oxyethylene)] terpolymer.
Polytetrafluoroethylene..
Polyurethane resins produced by: (1) reacting diisocyanates with one or
more of the polyols or polyesters named in this paragraph, or (2) re-
acting the chloroformate derivatives of one or more of the polyols or
polyesters named in this paragraph with one or more of the
polyamines named in this paragraph, or (3) reacting toluene
diisocyanate or 4,4′ methylenebis(cyclohexylisocyanate) (CAS Reg.
No. 5124–30–1) with: (i) one or more of the polyols or polyesters
named in this paragraph and with either N-methyldiethanolamine (CAS
Reg. No. 105–59–9) and dimethyl sulfate (CAS Reg. No. 77–78–1) or
dimethylolpropionic acid (CAS Reg. No. 4767–03–7) and triethylamine
(CAS Reg. No. 121–44–8), or (ii) a fumaric acid-modified poly-
propylene glycol or fumaric acid-modified tripropylene glycol),
triethylamine (CAS Reg. No. 107–15–3), and ethylenediamine (CAS
Reg. No. 121–44–8), or (4) reacting meta-tetramethylxylene
diisocyanate (CAS Reg. No. 2778–42–9) with one or more of the
polyols and polyesters listed in this paragraph and with
dimethylolpropionic acid (CAS Reg. No. 4767–03–7) and triethylamine
(CAS Reg. No. 121–44–8), N-methyldiethanolamine (CAS Reg. No.
105–59–9), 2–dimethylaminoethanol (CAS Reg. No. 108–01–0), 2–
dimethylamino–2–methyl–1–propanol (CAS Reg. No. 7005–47–2),
and/or 2–amino–2–methyl–1–propanol (CAS Reg. No. 124–68–5).
Polyvinyl alcohol modified so as to contain not more than 3 weight per-
cent of comonomer units derived from 1-alkenes having 12 to 20 car-
bon atoms.
Polyvinyl butyral.
Polyvinyl formal.
Potassium ferricyanide ................................................................................ For use only as polymerization-control agent.
Potassium N-methyldithiocarbamate.
Potassium pentachlorophenate ................................................................... For use as preservative only.
Potassium permanganate.
Potassium persulfate.
Potassium phosphates (mono-, di-, tribasic).
Potassium tripolyphosphate.
a, a′, a″-1,2,3-Propanetriyltris [omega-(2,3-epoxypropoxy) poly
(oxypropylene) (24 moles)].
b-Propiolactone.
Propyl alcohol (propanol).
Propylene carbonate.
Propylene glycol and p-p′-isopropylidenediphenol diether.

Propylene glycol dibenzoate (CAS Reg. No. 19224–26–1) ....................... For use as a plasticizer at levels not to exceed 20
percent by weight of the finished adhesive.
175
§ 175.105 21 CFR Ch. I (4–1–23 Edition)
Propylene glycol esters of coconut fatty acids.

Propylene glycol monolaurate.
Propylene glycol monomethyl ether.
Propylene glycol monostearate.
a, a′, a″-[Propylidynetris (methylene)] tris [omega-hydroxypoly
(oxypropylene) (1.5 moles minimum)], minimum molecular weight 400.
Quaternary ammonium chloride (hexadecyl, octadecyl derivative) ............ For use as preservative only.
Rosin (wood, gum, and tall oil rosin), rosin dimers, decarboxylated rosin
(including rosin oil, disproportionated rosin, and these substances as
modified by one or more of the following reactants:.
Alkyl (C1-C9) phenolformaldehyde.
Ammonia.
Ammonium caseinate-p-Cyclohexylphenolformaldehyde.
Diethylene glycol.
Dipentaerythritol.
Ethylene glycol.
Formaldehyde.
Fumaric acid.
Glycerin.
Hydrogen.
Isophthalic acid.
4,4′-Isopropylidenediphenol-epichlorohydrin (epoxy).
4,4′-Isopropylidenediphenol-formaldehyde.
Maleic anhydride.
Methyl alcohol.
Pentaerythritol.
Phthalic anhydride.
Polyethylene glycol.
Phenol-formaldehyde.
Phenyl μ-cresol-formaldehyde.
p-Phenylphenol-formaldehyde.
Sulfuric acid.
Triethylene glycol.
Xylenol-formaldehyde.
Rosin salts (salts of wood, gum, and tall oil rosin, and the dimers there-
of, decarboxylated rosin disproportionated rosin, hydrogenated rosin):
Aluminum.
Ammonium.
Calcium.
Magnesium.
Potassium.
Sodium.
Zinc.
Rosin, gasoline-insoluble fraction.
Rubber hydrochloride polymer.
Rubber latex, natural.
Salicylic acid ................................................................................................ For use as preservative only.
Sandarac.
Sebacic acid.
Shellac.
Silicon dioxide as defined in § 172.480(a) of this chapter.
Sodium alkyl (C2-C13.5 aliphatic) benezenesulfonate.
Sodium aluminum pyrophosphate.
Sodium aluminum sulfate.
Sodium bisulfate.
Sodium calcium silicate.
Sodium capryl polyphosphate.
Sodium carboxymethylcellulose.
Sodium chlorate.
Sodium chlorite.
Sodium chromate.
Sodium decylsulfate.
Sodium dehydroacetate .............................................................................. For use as preservative only.
Sodium di-(2-ethylhexoate).
Sodium di-(2-ethylhexyl) pyrophosphate.
Sodium dihexylsulfosuccinate.
Sodium dissobutylphenoxydiethoxyethyl sulfonate.
Sodium diisobutylphenoxymonoethoxyethyl sulfonate.
Sodium diisopropyl- and triisopropylnaphthalenesulfonate.
Sodium dimethyldithiocarbamate.
Sodium dioctylsulfosuccinate.
Sodium n-dodecylpolyethoxy (50 moles) sulfate.

Sodium ethylene ether of nonylphenol sulfate.
Sodium 2-ethylhexyl sulfate.
176
Sodium fluoride ........................................................................................... For use only as bonding agent for aluminum foil, sta-
bilizer, or preservative. Total fluoride for all sources
not to exceed 1 percent by weight of the finished
adhesive.
Sodium formaldehyde sulfoxylate.
Sodium formate.
Sodium heptadecylsulfate.
Sodium hypochlorite.
Sodium isododecylphenoxypolyethoxy (40 moles) sulfate.
Sodium N-lauroyl sarcosinate.
Sodium metaborate.
Sodium a-naphthalene sulfonate.
Sodium nitrate.
Sodium nitrite.
Sodium oleoyl isopropanolamide sulfosuccinate.
Sodium pentachlorophenate ....................................................................... For use as preservative only.
Sodium perborate.
Sodium persulfate.
Sodium μ-phenylphenate ............................................................................ For use as preservative only.
Sodium polyacrylate.
Sodium polymethacrylate.
Sodium polystyrene sulfonate.
Sodium salicylate ........................................................................................ For use as preservative only.
Sodium salt of 1-hydroxy 2(1H)-pyridine thione ......................................... Do.
Sodium tetradecylsulfate.
Sodium thiocyanate.
Sodium bis-tridecylsulfosuccinate.
Sodium xylene sulfonate.
Sorbitan monooleate.
Sorbitan monostearate.
Soybean oil, epoxidized.
Spermaceti wax.
Sperm oil wax.
Stannous 2-ethylhexanoate ........................................................................ For use only as a catalyst for polyurethane resins.
Stannous stearate.
Starch hydrolysates.
Starch or starch modified by one or more of the treatments described in
§§ 172.892 and 178.3520 of this chapter.
Starch, reacted with a urea-formaldehyde resin.
Starch, reacted with formaldehyde.
Stearamide (stearic acid amide).
Stearic acid.
Stearic acid-chromic chloride complex.
Stearyl-cetyl alcohol, technical grade, approximately 65 percent–80 per-
cent stearyl and 20 percent–35 percent cetyl.
Strontium salicylate.
Styrenated phenol.
Styrene block polymers with 1,3-butadiene.
Styrene-maleic anhydride copolymer, ammonium or potassium salt.
Styrene-maleic anhydride copolymer (partially methylated) sodium salt.
Styrene-methacrylic acid copolymer, potassium salt.
Sucrose acetate isobutyrate.
Sucrose benzoate.
Sucrose octaacetate.
2–sulfoethyl methacrylate (CAS Registry No. 10595–80–9) ...................... For use at levels not to exceed 2 percent by weight
of the dry adhesive.
a-Sulfo-omega-(dodecyloxy)poly (oxyethylene), ammonium salt.
Sulfonated octadecylene (sodium form).
Sulfosuccinic acid 4-ester with polyethylene glycol dodecyl ether diso-
dium salt (alcohol moiety produced by condensation of 1 mole of n-
dodecyl alcohol and an average of 5–6 moles of ethylene oxide,
Chemical Abstracts Service Registry No. 039354–45–5).
Sulfosuccinic acid 4-ester with polyethylene glycol nonylphenyl ether, di-
sodium salt (alcohol moiety produced by condensation of 1 mole of
nonylphenol and an average of 9–10 moles of ethylene oxide) (CAS
Reg. No. 9040–38–4).
Sulfur.
Synthetic primary linear aliphatic alcohols whose weight average molec-
ular weight is greater than 400 (CAS Reg. No. 71750–71–5).
Synthetic wax polymer as described in § 176.170(a)(5) of this chapter.
Tall oil.
Tall oil fatty acids, linoleic and oleic.

Tall oil fatty acid methyl ester.
Tall oil, methyl ester.
177
§ 175.105 21 CFR Ch. I (4–1–23 Edition)
Tall oil pitch.

Tall oil soaps.
Tallow alcohol (hydrogenated).
Tallow amine, secondary (hexadecyl, octadecyl), of hard tallow.
Tallow, blown (oxidized).
Tallow, propylene glycol ester.
Terpene resins (a-and b-pinene) homopolymers, copolymers, and con-
densates with phenol, formaldehyde, coumarone, and/or indene.
Terphenyl.
Terphenyl, hydrogenated.
Terpineol.
Tetraethylene pentamine.
Tetraethylthiuram disulfide.
Tetrahydrofuran.
Tetrahydrofurfuryl alcohol.
Tetra-isopropyl titanate.
Tetrakis[methylene (3,5-di-tert-butyl-4-hydroxy-hydro-cinnamate)] meth-
ane.
A[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-hydroxypoly-(oxyethylene)
produced by the condensation of 1 mole of p-(1,1,3,3-tetramethylbutyl)
phenol with an average of 1–40 moles of ethylene oxide.
A-[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-hydroxy-poly(oxyethylene)
mixture of dihydrogen phosphate and monohydrogen phosphate esters
and their sodium, potassium, and ammonium salts having a
poly(oxyethylene) content averaging 6–9 or 40 moles.
Tetramethyl decanediol.
Tetramethyl decynediol.
Tetramethyl decynediol plus 1–30 moles of ethylene oxide.
Tetramethylthiuram monosulfide.
Tetrasodium N-(1,2-dicarboxyethyl)N-octadecylsulfosuccinamate.
4,4′-Thiobis-6-tert-butyl-m-cresol.
Thiodiethylene-bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamate).
2,2′-(2,5-Thiophenediyl) bis[5-tert-butylbenzoxazole].
Thiram.
Thymol ......................................................................................................... For use as preservative only.
Titanium dioxide.
Titanium dioxide-barium sulfate.
Titanium dioxide-calcium sulfate.
Titanium dioxide-magnesium silicate.
Toluene.
Toluene 2,4-diisocyanate.
Toluene 2,6-diisocyanate.
o- and p-Toluene ethyl sulfonamide.
o- and p-Toluene sulfonamide.
p-Toluene sulfonic acid.
p-(p′-Toluene-sulfonylamide)-diphenylamide.
Triazine-formaldehyde resins as described in § 175.300(b)(3)(xiii).
Tributoxyethyl phosphate.
Tributylcitrate.
Tri-tert-butyl-p-phenyl phenol ...................................................................... For use as preservative only.
Tributyl phosphate.
Tributyltin chloride complex of ethylene oxide condensate of For use as preservative only.
dehydroabietylamine.
Tri-n-butyltin acetate ................................................................................... For use as preservative only.
Tri-n-butyltin neodecanoate ........................................................................ Do.
1,1,1-Trichloroethane.
1,1,2-Trichloroethane.
Trichloroethylene.
Tri-b-chloroethylphosphate.
Tridecyl alcohol.
Triethanolamine.
3-(Triethoxysilyl) propylamine.
Triethylene glycol.
Triethylene glycol dibenzoate.
Triethylene glycol di(2-ethylhexoate).
Triethylene glycol polyester of benzoic acid and phthalic acid.
Triethylhexyl phosphate.
Triethylphosphate.
2,4,5-Trihydroxy butyrophenone.
Triisopropanolamine.
Trimethylol propane.
2,2,4-Trimethylpentanediol-1,3-diisobutyrate.
Trimeric aromatic amine resin from diphenylamine and acetone of mo-
lecular weight approximately 500.
178
Tri(nonylphenyl) phosphite-formaldehyde resins ........................................ As identified in § 177.2600(c)(4)(iii) of this chapter.

For use only as a stabilizer.
Triphenylphosphate.
Tripropylene glycol monomethyl ether.
1,3,5-Tris (3,5-di-tert-butyl-4-hydroxy-benzyl)-triazine-2,4,6 (1H,3H,5H)-
trione.
Tris (p-tertiary butyl phenyl) phosphate.
Tris(2-methyl-4-hydroxy-5-tert-butyl-phenyl)butane.
Trisodium N-hydroxyethylethylenediaminetriacetate (CAS Reg. No. 139–
89–9).
Turpentine.
Urea-formaldehyde resins as described in § 175.300(b)(3)(xii).
Vegetable oil, sulfonated or sulfated, potassium salt.
Vinyl acetate-maleic anhydride copolymer, sodium salt.
Waxes, petroleum.
Wax, petroleum, chlorinated (40% to 70% chlorine).
Waxes, synthetic paraffin (Fischer-Tropsch process).
3-(2-Xenolyl)-1,2-epoxypropane.
Xylene.
Xylene (or toluene) alkylated with dicyclopentadiene.
Zein.
Zinc acetate.
Zinc ammonium chloride.
Zinc dibenzyl dithiocarbamate.
Zinc dibutyldithiocarbamate.
Zinc diethyldithiocarbamate.
Zinc di(2-ethylhexoate).
Zinc formaldehyde sulfoxylate.
Zinc naphthenate and dehydroabietylamine mixture.
Zinc nitrate.
Zinc orthophosphate.
Zinc resinate.
Zinc sulfide.
Zineb (zinc ethylenebis-dithiocarbamate).
Ziram (zinc dimethyldithiocarbamate).
[42 FR 14534, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977]

EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 175.105, see the List of CFR
Sections Affected, which appears in the Finding Aids section of the printed volume and at
www.govinfo.gov.
§ 175.125 Pressure-sensitive adhesives. (4) Substances identified in § 172.615 of

this chapter other than substances
Pressure-sensitive adhesives may be
used in accordance with paragraph
safely used as the food-contact surface (a)(2) of this section.
of labels and/or tapes applied to food, (5) Polyethylene, oxidized; complying
in accordance with the following pre- with the identity prescribed in
scribed conditions: § 177.1620(a) of this chapter.
(a) Pressure-sensitive adhesives pre- (6) 4-[[4, 6-Bis(octylthio)-s-triazin-2-
pared from one or a mixture of two or yl]amino]-2,6-di-tert-butylphenol (CAS
more of the substances listed in this Reg. No. 991–84–4) as an antioxidant/
paragraph may be used as the food-con- stabilizer at a level not to exceed 1.5
tact surface of labels and/or tapes ap- percent by weight of the finished pres-
plied to poultry, dry food, and proc- sure-sensitive adhesive.
essed, frozen, dried, or partially dehy- (7) 2,2′-(2,5-Thiophenediyl)-bis(5-tert-
drated fruits or vegetables. butylbenzoxazole) (CAS Reg. No. 7128–
(1) Substances generally recognized 64–5) as an optical brightener at a level
not to exceed 0.05 percent by weight of
as safe in food.
the finished pressure-sensitive adhe-
(2) Substances used in accordance
sive.
with a prior sanction or approval. (8) 2-Hydroxy-1-[4-(2-hydroxyethoxy)
(3) Color additives listed for use in or
phenyl]-2-methyl-1-propanone (CAS
on food in parts 73 and 74 of this chap- Reg. No. 106797–53–9) as a photoinitiator
ter. at a level not to exceed 5 percent by
179
§ 175.210 21 CFR Ch. I (4–1–23 Edition)
weight of the pressure-sensitive adhe- Tri(mixed mono- and dinonylphenyl)

sive. phosphite (which may contain not more
(9) Butanedioic acid, sulfo-1,4-di-(C9- than 1 percent by weight of
triisopropanolamine).
C11 alkyl) ester, ammonium salt (also
known as butanedioic acid sulfo-1, 4- (c) Acrylonitrile copolymers identi-
diisodecyl ester, ammonium salt [CAS fied in this section shall comply with
Reg. No. 144093–88–9]) as a surface ac- the provisions of § 180.22 of this chap-
tive agent at a level not to exceed 3.0 ter.
percent by weight of the finished pres- [42 FR 14534, Mar. 15, 1977, as amended at 42
sure-sensitive adhesive. FR 15674, Mar. 22, 1977; 48 FR 15617, Apr. 12,
(b) Pressure-sensitive adhesives pre- 1983; 63 FR 3464, Jan. 23, 1998; 63 FR 51528,
pared from one or a mixture of two or Sept. 28, 1998; 64 FR 48291, Sept. 3, 1999]
more of the substances listed in this
paragraph may be used as the food-con- Subpart C—Substances for Use as
tact surface of labels and/or tapes ap- Components of Coatings
plied to raw fruit and raw vegetables.
(1) Substances listed in paragraphs § 175.210 Acrylate ester copolymer
(a)(1), (a)(2), (a)(3), (a)(5), (a)(6), (a)(7), coating.
(a)(8), and (a)(9) of this section, and Acrylate ester copolymer coating
those substances prescribed by para- may safely be used as a food-contact
graph (a)(4) of this section that are not surface of articles intended for pack-
identified in paragraph (b)(2) of this aging and holding food, including heat-
section. ing of prepared food, subject to the pro-
(2) Substances identified in this sub- visions of this section:
paragraph and subject to the limita- (a) The acrylate ester copolymer is a
tions provided: fully polymerized copolymer of ethyl
BHA. acrylate, methyl methacrylate, and
BHT. methacrylic acid applied in emulsion
Butadiene-acrylonitrile copolymer. form to molded virgin fiber and heat-
Butadiene-acrylonitrile-styrene copolymer. cured to an insoluble resin.
Butadiene-styrene copolymer.
Butyl rubber. (b) Optional substances used in the
Butylated reaction product of p-cresol and preparation of the polymer and in the
dicyclopentadiene produced by reacting p- preparation and application of the
cresol and dicyclopentadiene in an approxi- emulsion may include substances
mate mole ratio of 1.5 to 1.0, respectively, named in this paragraph, in an amount
followed by alkylation with isobutylene so not to exceed that required to accom-
that the butyl content of the final product plish the desired technical effect and
is not less than 18 percent, for use at levels
subject to any limitation prescribed:
not to exceed 1.0 percent by weight of the
adhesive formulation. Provided, however, That any substance
Chlorinated natural rubber. named in this paragraph and covered
Isobutylene-styrene copolymer. by a specific regulation in subchapter
Petrolatum. B of this chapter must meet any speci-
Polybutene-1. fications in such regulation.
Polybutene, hydrogenated; complying with
the identity prescribed under § 178.3740(b) of List of substances Limitations
this chapter.
Aluminum stearate.
Polyisobutylene. Ammonium lauryl sulfate.
cis-1,4-Polyisoprene. Borax ............................................ Not to exceed the
Polystyrene. amount required as a
Propyl gallate. preservative in emul-
Rapeseed oil, vulcanized. sion defoamer.
Rosins and rosin derivatives as provided in Disodium hydrogen phosphate ..... Do.
§ 178.3870 of this chapter. Formaldehyde.
Glyceryl monostearate.
Rubber hydrochloride. Methyl cellulose.
Rubber (natural latex solids or crepe, Mineral oil.
smoked or unsmoked). Paraffin wax.
Terpene resins (a- and b-pinene), Potassium hydroxide.
homopolymers, copolymers, and conden- Potassium persulfate.
sates with phenol, formaldehyde, cou- Tallow.

Tetrasodium pyrophosphate.
marone, and/or indene. Titanium dioxide.
Tetrasodium ethylenediaminetetraacetate.
180
(c) The coating in the form in which into its components by a solvent sepa-
it contacts food meets the following ration method, using synthetic
tests: isoparaffinic petroleum hydrocarbons
(1) An appropriate sample when ex- complying with § 178.3530 of this chap-
posed to distilled water at 212 °F for 30 ter.
minutes shall yield total chloroform- (b) Synthetic paraffin shall conform
soluble extractables not to exceed 0.5 to the following specifications:
milligram per square inch. (1) Congealing point. There is no speci-
(2) An appropriate sample when ex- fication for the congealing point of
posed to n-heptane at 120 °F for 30 min- synthetic paraffin components, except
utes shall yield total chloroform-solu- those components that have a con-
ble extractables not to exceed 0.5 milli- gealing point below 50 °C when used in
gram per square inch. contact with food Types III, IVA, V,
VIIA, and IX identified in table 1 of
§ 175.230 Hot-melt strippable food § 176.170(c) of this chapter and under
coatings.
conditions of use E, F, and G described
Hot-melt strippable food coatings in table 2 of § 176.170(c) of this chapter
may be safely applied to food, subject shall be limited to a concentration not
to the provisions of this section. exceeding 15 percent by weight of the
(a) The coatings are applied to and finished coating. The congealing point
used as removable coatings for food. shall be determined by ASTM method
(b) The coatings may be prepared, as D938–71 (Reapproved 1981), ‘‘Standard
mixtures, from the following sub- Test Method for Congealing Point of
stances: Petroleum Waxes, Including Petro-
(1) Substances generally recognized latum,’’ which is incorporated by ref-
as safe in food. erence. Copies may be obtained from
(2) Substances identified in this sub- the American Society for Testing Ma-
paragraph. terials, 100 Barr Harbor Dr., West
List of substances Limitations Conshohocken, Philadelphia, PA 19428-
2959, or may be examined at the Na-
Acetylated monoglycerides ........... Complying with 172.828 tional Archives and Records Adminis-
of this chapter.
Cellulose acetate butyrate. tration (NARA). For information on
Cellulose acetate propionate. the availability of this material at
Mineral oil, white ........................... For use only as a com- NARA, call 202–741–6030, or go to: http://
ponent of hot-melt
strippable food coat-
ings applied to frozen code_of_federal_regulations/
meats and complying ibr_locations.html.
with § 172.878 of this (2) Oil content. The substance has an
chapter.
oil content not exceeding 2.5 percent as
determined by ASTM method D721–56T,
§ 175.250 Paraffin (synthetic). ‘‘Tentative Method of Test for Oil Con-
Synthetic paraffin may be safely tent of Petroleum Waxes’’ (Revised
used as an impregnant in, coating on, 1956), which is incorporated by ref-
or component of coatings on articles erence. See paragraph (b)(1) of this sec-
used in producing, manufacturing, tion for availability of the incorpora-
packing, processing, preparing, treat- tion by reference.
ing, packaging, transporting, or hold- (3) Absorptivity. The substance has an
ing food in accordance with the fol- absorptivity at 290 millimicrons in
lowing prescribed conditions: decahydronaphthalene at 88 °C not ex-
(a) The additive is synthesized by the ceeding 0.01 as determined by ASTM
Fischer-Tropsch process from carbon method E131–81a, ‘‘Standard Defini-
monoxide and hydrogen, which are cat- tions of Terms and Symbols Relating
alytically converted to a mixture of to Molecular-Spectroscopy,’’ which is
paraffin hydrocarbons. Lower molec- incorporated by reference. See para-
ular-weight fractions are removed by graph (b)(1) of this section for avail-
distillation. The residue is hydro- ability of the incorporation by ref-
genated and may be further treated by erence.

percolation through activated char- (c) The provisions of this section are
coal. This mixture can be fractionated not applicable to synthetic paraffin
181
§ 175.260 21 CFR Ch. I (4–1–23 Edition)
used in food-packaging adhesives com- (b) The poly(vinyl fluoride) basic res-
plying with § 175.105. ins have an intrinsic viscosity of not
[42 FR 14534, Mar. 15, 1977, as amended at 47 less than 0.75 deciliter per gram as de-
FR 11839, Mar. 19, 1982; 49 FR 10106, Mar. 19, termined by ASTM method D1243–79,
1984; 51 FR 47010, Dec. 30, 1986; 60 FR 39645, ‘‘Standard Test Method for Dilute So-
Aug. 3, 1995] lution Viscosity of Vinyl Chloride
Polymers,’’ which is incorporated by
§ 175.260 Partial phosphoric acid
esters of polyester resins. reference. Copies may be obtained from
the American Society for Testing Ma-
Partial phosphoric acid esters of pol- terials, 100 Barr Harbor Dr., West
yester resins identified in this section Conshohocken, Philadelphia, PA 19428-
and applied on aluminum may be safely
used as food-contact coatings, in ac-
conditions: tration (NARA). For information on
(a) For the purpose of this section, the availability of this material at
partial phosphoric acid esters of poly- NARA, call 202–741–6030, or go to: http://
ester resins are prepared by the reac- www.archives.gov/federal_register/
tion of trimellitic anhydride with 2,2- code_of_federal_regulations/
dimethyl-1,3-propanediol followed by ibr_locations.html.
reaction of the resin thus produced (1) Solvent. N,N-Dimethylacetamide,
with phosphoric acid anhydride to technical grade.
produce a resin having an acid number (2) Solution. Powdered resin and sol-
of 81 to 98 and a phosphorus content of vent are heated at 120 °C until the resin
4.05 to 4.65 percent by weight. is dissolved.
(b) The coating is chemically bonded (3) Temperature. Flow times of the
to the metal and cured at temperatures solvent and solution are determined at
exceeding 450 °F. 110 °C.
(c) The finished food-contact coating, (4) Viscometer. Cannon-Ubbelohde size
when extracted with the solvent or sol-
50 semimicro dilution viscometer (or
vents characterizing the type of food
equivalent).
and under the conditions of time and
temperature characterizing the condi- (5) Calculation. The calculation meth-
tions of its intended use, as determined od used is that described in appendix X
from tables 1 and 2 of § 175.300(d), yields 1.3 (ASTM method D1243–79, ‘‘Standard
total extractives in each extracting Test Method for Dilute Solution Vis-
solvent not to exceed 0.3 milligrams cosity of Vinyl Chloride Polymers,’’
per square inch of food-contact surface, which is incorporated by reference; see
as determined by the methods de- paragraph (b) of this section for avail-
scribed in § 175.300(e), and the coating ability of the incorporation by ref-
yields 2,2-dimethyl-1,3-propanediol in erence) with the reduced viscosity de-
each extracting solvent not to exceed termined for three concentration levels
0.3 micrograms per square inch of food- not greater than 0.5 gram per deciliter
contact surface. In testing the finished and extrapolated to zero concentration
food-contact articles, a separate test for intrinsic viscosity. The following
sample is to be used for each required formula is used for determining re-
extracting solvent. duced viscosity:
§ 175.270 Poly(vinyl fluoride) resins. Reduced viscosity in terms t − to
Poly(vinyl fluoride) resins identified of deciliters per gram = to × c
in this section may be safely used as
components of food-contact coatings where:
for containers having a capacity of not t = Solution efflux time.
less than 5 gallons, subject to the pro- to = Solvent efflux time.
visions of this section. c = Concentration of solution in terms of
(a) For the purpose of this section, grams per deciliter.
poly(vinyl fluoride) resins consist of [42 FR 14534, Mar. 15, 1977, as amended at 47
basic resins produced by the polym- FR 11839, Mar. 19, 1982; 49 FR 10107, Mar. 19,
erization of vinyl fluoride. 1984]
182
ER01JA93.387</GPH>
§ 175.300 Resinous and polymeric coat- Pumpkinseed.

ings. Safflower.
Sesame.
Resinous and polymeric coatings Soybean.
may be safely used as the food-contact Sunflower.
surface of articles intended for use in Tall oil.
producing, manufacturing, packing, Walnut.
processing, preparing, treating, pack-
aging, transporting, or holding food, in The oils may be raw, heat-bodied, or
accordance with the following pre- blown. They may be refined by filtra-
scribed conditions: tion, degumming, acid or alkali wash-
(a) The coating is applied as a contin- ing, bleaching, distillation, partial de-
uous film or enamel over a metal sub- hydration, partial polymerization, or
strate, or the coating is intended for solvent extraction, or modified by com-
repeated food-contact use and is ap- bination with maleic anhydride.
plied to any suitable substrate as a (ii) Reconstituted oils from
continuous film or enamel that serves triglycerides or fatty acids derived
as a functional barrier between the from the oils listed in paragraph
food and the substrate. The coating is (b)(3)(i) of this section to form esters
characterized by one or more of the fol- with:
lowing descriptions: Butylene glycol.
(1) Coatings cured by oxidation. Ethylene glycol.
(2) Coatings cured by polymerization, Pentaerythritol.
condensation, and/or cross-linking Polyethylene glycol.
without oxidation. Polypropylene glycol.
(3) Coatings prepared from prepoly- Propylene glycol.
merized substances. Sorbitol.
(b) The coatings are formulated from Trimethylol ethane.
optional substances that may include: Trimethylol propane.
(1) Substances generally recognized
(iii) Synthetic drying oils, as the
as safe in food.
basic polymer:
(2) Substances the use of which is
permitted by regulations in this part Butadiene and methylstyrene copolymer.
or which are permitted by prior sanc- Butadiene and styrene copolymer, blown or
tion or approval and employed under unblown.
the specific conditions, if any, of the Maleic anhydride adduct of butadiene sty-
prior sanction or approval. rene.
(3) Any substance employed in the Polybutadiene.
production of resinous and polymeric (iv) Natural fossil resins, as the basic
coatings that is the subject of a regula- resin:
tion in subchapter B of this chapter
Copal.
and conforms with any specification in
Damar.
such regulation. Substances named in
Elemi.
this paragraph (b)(3) and further identi- Gilsonite.
fied as required: Glycerol ester of damar, copal, elemi, and
(i) Drying oils, including the sandarac.
triglycerides or fatty acids derived Sandarac.
therefrom: Shellac.
Beechnut. Utah coal resin.
Candlenut. (v) Rosins and rosin derivatives, with
Castor (including dehydrated). or without modification by polymeriza-
Chinawood (tung).
Coconut. tion, isomerization, incidental
Corn. decarboxylation, and/or hydrogenation,
Cottonseed. as follows:
Fish (refined). (a) Rosins, refined to color grade of K
Hempseed. or paler:
Linseed.
Oiticica. Gum rosin.

Perilla. Tall oil rosin.
Poppyseed. Wood rosin.
183
§ 175.300 21 CFR Ch. I (4–1–23 Edition)
(b) Rosin esters formed by reacting Fumaric.

rosin (paragraph (b)(3)(v)(a) of this sec- Isophthalic.
tion) with: Maleic.
2,6-Naphthalenedicarboxylic.
4,4′-sec-Butylidenediphenol-epichlorohydrin 2,6-Naphthalenedicarboxylic, dimethyl ester.
(epoxy). Orthophthalic.
Diethylene glycol. Sebacic.
Ethylene glycol. Terephthalic.
Glycerol. Terpene-maleic acid adduct.
4,4′-Isopropylidenediphenol-epichlorohydrin Trimellitic.
(epoxy).
Methyl alcohol. (b) Monobasic acids:
Pentaerythritol. Benzoic acid.
(c) Rosin esters (paragraph (b)(3)(v)(b) 4,4-Bis(4′-hydroxyphenyl)-pentanoic acid.
tert-Butyl benzoic acid.
of this section) modified by reaction Fatty acids derived from oils listed in para-
with: graph (b)(3)(i) of this section.
Maleic anhydride. Rosins listed in paragraph (b)(3)(v)(a) of this
o-, m-, and p-substituted phenol-formalde- section, for use only as reactants in oil-
hydes listed in paragraph (b)(3)(vi) of this based or fatty acid-based alkyd resins.
section. (c) Polyhydric alcohols:
Phenol-formaldehyde.
Butylene glycol.
(d) Rosin salts: Diethylene glycol.
Calcium resinate (limed rosin). 2,2-Dimethyl-1,3-propanediol for use only in
Zinc resinate. forming polyester resins for coatings in-
tended for use in contact with non-alco-
(vi) Phenolic resins as the basic poly- holic foods.
mer formed by reaction of phenols with Ethylene glycol.
formaldehyde: Glycerol.
(a) Phenolic resins formed by reac- Mannitol.
tion of formaldehyde with: a-Methyl glucoside.
Pentaerythritol.
Alkylated (methyl, ethyl, propyl, isopropyl, Propylene glycol.
butyl) phenols. Sorbitol.
p-tert-Amylphenol. Triethylene glycol, for use as a component in
4,4′-sec-Butylidenediphenol. polyester resins for coatings not exceeding
p-tert-Butylphenol. a coating weight of 4 milligrams per square
o-, m-, and p-Cresol. inch and that are intended for contact
p-Cyclohexylphenol. under conditions of use D, E, F or G de-
4,4′-Isopropylidenediphenol. scribed in table 2 of paragraph (d) of this
p-Nonylphenol. section with alcoholic beverages con-
p-Octylphenol. taining less than 8 percent alcohol.
3-Pentadecyl phenol mixture obtained from Trimethylol ethane.
cashew nut shell liquid. Trimethylol propane.
Phenol.
Phenyl o-cresol. (d) Monohydric alcohols:
p-Phenylphenol. Cetyl alcohol.
Xylenol. Decyl alcohol.
(b) Adjunct for phenolic resins: Alu- Lauryl alcohol.
minum butylate. Myristyl alcohol.
Octyl alcohol.
(vii) Polyester resins (including Stearyl alcohol.
alkyd-type), as the basic polymers,
formed as esters of acids listed in para- (e) Catalysts:
graph (b)(3)(vii)(a) and (b) of this sec- Dibutyltin oxide (CAS Reg. No. 818–08–6), not
tion by reaction with alcohols in para- to exceed 0.2 percent of the polyester resin.
graph (b)(3)(vii)(c) and (d) of this sec- Hydroxybutyltin oxide (CAS Reg. No. 2273–
tion. 43–0), not to exceed 0.2 percent of the poly-
(a) Polybasic acids: ester resin.
Monobutyltin tris(2-ethylhexoate) (CAS Reg.
Adipic. No. 23850–94–4), not to exceed 0.2 percent of
1,4-cyclohexanedicarboxylic (CAS Reg. No. the polyester resin.
1076–97–7).
Dimerized fatty acids derived from oils listed (viii) Epoxy resins, catalysts, and ad-
in paragraph (b)(3)(i) of this section. juncts:
184
(a) Epoxy resins, as the basic poly- peated use in contact with foods only of
mer: the types identified in paragraph (d) of this
section, table 1, under Types I, II, and III,
(Alkoxy C10-C16)-2,3-epoxypropane, in which under conditions of use C, D, E, or F as de-
the alkyl groups are even numbered and scribed in table 2 of paragraph (d) of this
consist of a maximum of 1 percent C10 car- section; or when such coatings are in-
bon atoms and a minimum of 48 percent C12 tended for repeated use in contact with
carbon atoms and a minimum of 18 percent foods of the types identified in paragraph
C14 carbon atoms, for use only in coatings (d) of this section, table 1, under Types V,
that are intended for contact with dry bulk VI, VII, and VIII, under conditions of use E
foods at room temperature. or F as described in table 2 of paragraph (d)
4,4′-sec-Butylidenediphenol-epichlorohydrin. of this section. Use shall be limited to
4,4′-sec-Butylidenediphenol-epichlorohydrin coatings for tanks of capacity greater than
reacted with one or more of the drying oils 530,000 gallons.
or fatty acids listed in paragraph (b)(3)(i) Benzyl alcohol (CAS Reg. No. 100–51–6), for
of this section. use only in coatings at a level not to ex-
4,4′-sec-Butylidenediphenol-epichlorohydrin ceed 4 percent by weight of the resin when
chemically treated with one or more of such coatings are intended for repeated use
the following substances: in contact with foods only of the types
Allyl ether of mono-, di-, or trimethylol
identified in paragraph (d) of this section,
phenol.
table 1, under Types I, II, and III, under
4,4′-sec-Butylidenediphenol-formaldehyde.
conditions of use C, D, E, or F as described
4,4′-Isopropylidenediphenol-formaldehyde.
in table 2 of paragraph (d) of this section;
Melamine-formaldehyde.
Phenol-formaldehyde. or when such coatings are intended for re-
Urea-formaldehyde. peated use in contact with foods of the
Epoxidized polybutadiene. types identified in paragraph (d) of this
Glycidyl ethers formed by reacting section, table 1, under Types V, VI, VII,
phenolnovolak resins with and VIII, under conditions of use E or F as
epichlorohydrin. described in table 2 of paragraph (d) of this
4,4′-Isopropylidenediphenol-epichlorohydrin. section. Use shall be limited to coatings
4,4′-Isopropylidenediphenol-epichlorohydrin for tanks of capacity greater than 530,000
reacted with one or more of the drying oils gallons.
or fatty acids listed in paragraph (b)(3)(i) Catalysts and cross-linking agents for epoxy
of this section. resins:
4,4′-Isopropylidenediphenol-epichlorohydrin 3-Aminomethyl-3,5,5-
chemically treated with one or more of trimethylcyclohexylamine (CAS Reg. No.
the following substances: 2855–0913–092).
Allyl ether of mono-, di-, or trimethylol Cyanoguanidine.
phenol. 3-Diethylaminopropylamine (CAS Reg. No.
4,4′-sec-Butylidenediphenol-formaldehyde. 104–78–9), for use in coatings at a level not
4,4′-Isopropylidenediphenol-formaldehyde. to exceed 6 percent by weight of the resin
Melamine-formaldehyde. when such coatings are intended for re-
2,2′-[(1-methylethylidene)bis[4,1- peated use in contact with foods only of
phenyleneoxy[1-(butoxymethyl)-2,1- the types identified in paragraph (d) of this
ethanediyl]oxymethylene]]bisoxirane, section, table 1, under Types I, II, and III,
CAS Reg. No. 71033–08–4, for use only in under conditions of use C, D, E, or F as de-
coatings intended for contact with bulk scribed in table 2 of paragraph (d) of this
dry foods at temperatures below 100 °F. section; or when such coatings are in-
Phenol-formaldehyde. tended for repeated use in contact with
Urea-formaldehyde. foods of the types identified in paragraph
(d) of this section, table 1, under Types V,
(b) Catalysts and cross-linking agents
VI, VII, and VIII, under conditions of use E
for epoxy resins: or F as described in table 2 of paragraph (d)
3-(Aminomethyl)-3,5,5-trimethylcyclohexyl- of this section. Use shall be limited to
amine reacted with phenol and formalde- coatings for tanks of capacity greater than
hyde in a ratio of 2.6:1.0:2.0, for use only in 530,000 gallons.
coatings intended for repeated use in con- Diethylenetriamine.
tact with foods only of the types identified Diphenylamine.
in paragraph (d) of this section, table 1, Ethylenediamine.
under Category I and Category VIII, at Isophthalyl dihydrazide for use only in coat-
temperatures not exceeding 88 °C (190 °F). ings subject to the provisions of paragraph
N-Beta-(aminoethyl)-gamma-aminopropyltri- (c)(3) or (4) of this section.
methoxysilane (CAS Reg. No. 1760–24–3), for 4,4′-Methylenedianiline, for use only in coat-
use only in coatings at a level not to ex- ings for containers having a capacity of
ceed 1.3 percent by weight of the resin 1,000 gallons or more when such containers
when such coatings are intended for re- are intended for repeated use in contact
185
§ 175.300 21 CFR Ch. I (4–1–23 Edition)
with alcoholic beverages containing up to 8 Triethylenetetramine.
percent of alcohol by volume. Trimellitic anhydride (CAS Reg. No. 552–30–
N-Oleyl-1,3-propanediamine with not more 7) for use only as a cross-linking agent at
than 10 percent by weight of a level not to exceed 15 percent by weight
diethylaminoethanol. of the resin in contact with food under all
3-Pentadecenyl phenol mixture (obtained conditions of use, except that resins in-
from cashew nutshell liquid) reacted with tended for use with foods containing more
formaldehyde and ethylenediamine in a than 8 percent alcohol must contact such
ratio of 1:2:2 (CAS Reg. No. 68413–28–5). food only under conditions of use D, E, F,
Polyamine produced when 1 mole of the and G described in table 2 of paragraph (d)
chlorohydrin diether of polyethylene gly- of this section.
col 400 is made to react under Trimellitic anhydride adducts of ethylene
dehydrohalogenating conditions with 2 glycol and glycerol, prepared by the reac-
moles of N-octadecyltrimethylenediamine tion of 1 mole of trimellitic anhydride with
for use only in coatings that are subject to 0.4–0.6 mole of ethylene glycol and 0.04–0.12
the provisions of paragraph (c)(3) or (4) of mole of glycerol, for use only as a cross-
this section and that contact food at tem- linking agent at a level not to exceed 10
peratures not to exceed room temperature. percent by weight of the cured coating,
Polyethylenepolyamine (CAS Reg. No. 68131– provided that the cured coating only con-
73–7), for use only in coatings intended for tacts food containing not more than 8 per-
repeated use in contact with food, at tem- cent alcohol.
peratures not to exceed 180 °F (82 °C). Meta-Xylylenediamine (1,3-benzenedi-
Salicylic acid, for use only in coatings for methanamine, CAS Reg. No. 1477–55–0), for
containers having a capacity of 1,000 gal- use only in coatings at a level not to ex-
lons or more when such containers are in- ceed 3 percent by weight of the resin when
tended for repeated use in contact with al- such coatings are intended for repeated use
coholic beverages containing up to 8 per- in contact with foods only of the types
cent of alcohol by volume. identified in paragraph (d) of this section,
Salicylic acid (CAS Reg. No. 69–72–7), for use table 1, under Types I, II, and III, under
only in coatings at a level not to exceed conditions of use C, D, E or F as described
0.35 percent by weight of the resin when in table 2 of paragraph (d) of this section;
such coatings are intended for repeated use or when such coatings are intended for re-
in contact with foods only of the types peated use in contact with foods of the
identified in paragraph (d) of this section, types identified in paragraph (d) of this
table 1, under Types I, II, and III, under section, table 1, under Types V, VI, VII,
conditions of use C, D, E, or F as described and VIII, under conditions of use E or F as
in table 2 of paragraph (d) of this section; described in table 2 of paragraph (d) of this
or when such coatings are intended for re- section. Use shall be limited to coatings
peated use in contact with foods of the for tanks of capacity greater than 530,000
types identified in paragraph (d) of this gallons.
section, table 1, under Types V, VI, VII, Para-Xylylenediamine (1,4 benzenedimethan-
and VIII, under conditions of use E or F as amine, CAS Reg. No. 539–48–0), for use only
described in table 2 of paragraph (d) of this in coatings at a level not to exceed 0.6 per-
section. Use shall be limited to coatings cent by weight of the resin when such coat-
for tanks of capacity greater than 530,000 ings are intended for repeated use in con-
gallons. tact with foods only of the types identified
Stannous 2-ethylhexanoate for use only as a in paragraph (d) of this section, table 1,
catalyst at a level not to exceed 1 percent under Types I, II, III, under conditions of
by weight of the resin used in coatings that use C, D, E, or F as described in table 2 of
are intended for contact with food under paragraph (d) of this section; or when such
conditions of use D, E, F, and G described coatings are intended for repeated use in
in table 2 of paragraph (d) of this section. contact with foods of the types identified
Styrene oxide, for use only in coatings for in paragraph (d) of this section, table 1,
containers having a capacity of 1,000 gal- under Types V, VI, VII, and VIII, under
lons or more when such containers are in- conditions of use E and F as described in
tended for repeated use in contact with al- table 2 of paragraph (d) of this section. Use
coholic beverages containing up to 8 per- shall be limited to coatings for tanks of ca-
cent of alcohol by volume. pacity greater than 530,000 gallons.
Tetraethylenepentamine. (c) Adjuncts for epoxy resins:
Tetraethylenepentamine reacted with
equimolar quantities of fatty acids. Aluminum butylate.
Tri(dimethylaminomethyl) phenol and its Benzoic acid, for use as a component in
salts prepared from the fatty acid moieties epoxy resins for coatings not exceeding a
of the salts listed in paragraph coating weight of 4 milligrams per square
(b)(3)(xxii)(b) of this section, for use only inch and that are intended for contact
in coatings subject to the provisions of under conditions of use D, E, F or G de-
paragraph (c)(3) or (4) of this section. scribed in table 2 of paragraph (d) of this
186
section with alcoholic beverages con- Benzoguanamine-formaldehyde.
taining less than 8 percent alcohol. Melamine-formaldehyde.
Polyamides from dimerized vegetable oils Melamine-formaldehyde chemically modified
and the amine catalysts listed in para- with one or more of the following amine
graph (b)(3)(viii)(b) of this section, as the catalysts:
basic polymer. Amine catalysts listed in paragraph
Silane coupled silica, prepared from the re- (b)(3)(viii)(b) of this section.
action of microcrystalline quartz with N- Dimethylamine-2-methyl-1-propanol.
beta-(N-vinylbenzylamino) ethyl-gamma- Methylpropanolamine.
aminopropyltrimethoxy silane, mono- Triethanolamine.
hydrogen chloride, for use only in coatings Melamine-formaldehyde chemically modified
intended for repeated use in contact with with methyl, ethyl, propyl, isopropyl,
foods only of the types identified in para- butyl, or isobutyl alcohol.
graph (d) of this section, table 1, under
Category I and Category VIII, at tempera- (b) Curing (cross-linking) catalyst for
tures not exceeding 88 °C (190 °F). triazine-formaldehyde resins:
Succinic anhydride, for use as a component Dodecyl benzenesulfonic acid (C.A. Registry
in epoxy resins for coatings not exceeding No. 27176–87–0).
a coating weight of 4 milligrams per square
inch, and that are intended for contact (xiv) Modifiers (for oils and alkyds,
under conditions of use D, E, F or G de- including polyesters), as the basic poly-
scribed in table 2 of paragraph (d) of this mer:
section with alcoholic beverages con-
taining less than 8 percent alcohol. Butyl methacrylate.
Cyclopentadiene.
(ix) Coumarone-indene resin, as the Methyl, ethyl, butyl, or octyl esters of acryl-
basic polymer. ic acid.
(x) Petroleum hydrocarbon resin Methyl methacrylate.
(cyclopentadiene type), as the basic Styrene.
polymer. Vinyl toluene.
(xi) Terpene resins, as the basic poly- (xv) Vinyl resinous substance, as the
mer, from one or more of the following: basic polymers:
Dipentene. Polyvinyl acetate.
Hydrogenated dipentene resin (CAS Reg. No. Polyvinyl alcohol.
106168–39–2). For use only with coatings in Polyvinyl butyral.
contact with acidic and aqueous foods. Polyvinyl chloride.
Hydrogenated-beta-pinene-alpha-pinene- Polyvinyl formal.
dipentene copolymer resin (CAS Reg. No. Polyvinylidene chloride.
106168–37–0). For use only with coatings in Polyvinyl pyrrolidone.
contact with acidic and aqueous foods. Polyvinyl stearate.
a-Pinene. Vinyl chloride-acetate-2,3-epoxypropyl meth-
b-Pinene. acrylate copolymers containing not more
than 10 weight percent of total polymer
(xii) Urea-formaldehyde, resins and units derived from 2,3-epoxypropyl meth-
their curing catalyst: acrylate and not more than 0.1 weight per-
(a) Urea-formaldehyde resins, as the cent of unreacted 2,3-epoxypropyl meth-
basic polymer: acrylate monomer for use in coatings for
containers.
Urea-formaldehyde.
Vinyl chloride-acetate, hydroxyl-modified
Urea-formaldehyde chemically modified with
copolymer.
methyl, ethyl, propyl, isopropyl, butyl, or
Vinyl chloride-acetate, hydroxyl-modified
isobutyl alcohol.
copolymer, reacted with trimellitic anhy-
Urea-formaldehyde chemically modified with dride.
one or more of the amine catalysts listed Vinyl chloride copolymerized with acryl-
in paragraph (b)(3)(viii)(b) of this section. amide and ethylene in such a manner that
(b) Curing (cross-linking) catalyst for the finished copolymers have a minimum
urea-formaldehyde resins: weight average molecular weight of 30,000
and contain not more than 3.5 weight per-
Dodecyl benzenesulfonic acid (C.A. Registry cent of total polymer units derived from
No. 27176–87–0). acrylamide; the acrylamide portion may or
may not be subsequently partially
(xiii) Triazine-formaldehyde resins hydrolyzed.
and their curing catalyst: Vinyl chloride copolymerized with one or

(a) Triazine-formaldehyde resins, as more of the following substances:
the basic polymer: Acrylonitrile.
187
§ 175.300 21 CFR Ch. I (4–1–23 Edition)
Fumaric acid and/or its methyl, ethyl, tent of 0.8 percent and a minimum intrin-
propyl, butyl, amyl, hexyl, heptyl, or octyl sic viscosity of 0.9, determined at 135 °C on
esters. a 0.1 percent solution of the modified poly-
Maleic acid and/or its methyl, ethyl, propyl, propylene in decahydronaphthalene as de-
butyl, amyl, hexyl, heptyl, or octyl esters. termined by a method titled ‘‘Method for
5-Norbornene-2,3-dicarboxylic acid, mono-n- Determination of Intrinsic Viscosity of
butyl ester; for use such that the finished Maleic Anhydride Adduct of Poly-
vinyl chloride copolymers contain not propylene,’’ which is incorporated by ref-
more than 4 weight percent of total poly- erence. Copies are available from the Cen-
mer units derived from this comonomer. ter for Food Safety and Applied Nutrition
Vinyl acetate. (HFS–200), Food and Drug Administration,
Vinylidene chloride. 5001 Campus Dr., College Park, MD 20740,
Vinyl chloride-vinylidene chloride-2,3- or available for inspection at the National
epoxypropyl methacrylate copolymers con- Archives and Records Administration
taining not more than 10 weight percent of (NARA). For information on the avail-
total polymer units derived from 2,3- ability of this material at NARA, call 202–
epoxypropyl methacrylate and not more 741–6030, or go to: http://www.archives.gov/
than 0.05 weight percent of unreacted 2,3- federal_register/code_of_federal_regulations/
epoxypropyl methacrylate monomer based ibr_locations.html.
on polymer solids for use only in coatings
for containers intended for contact with (xx) Acrylics and their copolymers,
foods under conditions B, C, D, E, F, G, or as the basic polymer:
H described in table 2 of paragraph (d) of Acrylamide with ethylacrylate and/or sty-
this section. rene and/or methacrylic acid, subsequently
(xvi) Cellulosics, as the basic poly- reacted with formaldehyde and butanol.
mer: Acrylic acid and the following esters thereof:
Ethyl.
Carboxymethylcellulose. Methyl.
Cellulose acetate. Butyl acrylate-styrene-methacrylic acid-hy-
Cellulose acetate-butyrate. droxyethyl methacrylate copolymers con-
Cellulose acetate-propionate. taining no more than 20 weight percent of
Ethylcellulose. total polymer units derived from meth-
Ethyl hydroxyethylcellulose. acrylic acid and containing no more than 7
Hydroxyethylcellulose. weight percent of total polymer units de-
Hydroxypropyl methylcellulose. rived from hydroxyethyl methacrylate; for
Methylcellulose. use only in coatings that are applied by
Nitrocellulose. electrodeposition to metal substrates.
Butyl acrylate-styrene-methacrylic acid-
(xvii) Styrene polymers, as the basic
hydroxypropyl methacrylate copolymers
polymer: containing no more than 20 weight percent
Polystyrene. of total polymer units derived from meth-
a-Methyl styrene polymer. acrylic acid and containing no more than 7
Styrene copolymerized with one or more of weight percent of total polymer units de-
the following: rived from hydroxypropyl methacrylate;
Acrylonitrile. for use only in coatings that are applied by
a-Methylstyrene. electrodeposition to metal substrates and
that are intended for contact, under condi-
(xviii) Polyethylene and its copoly- tion of use D, E, F, or G described in table
mers as the basic polymer: 2 of paragraph (d) of this section, with food
containing no more than 8 percent of alco-
Ethylene-ethyl acrylate copolymer. hol.
Ethylene-isobutyl acrylate copolymers con- Ethyl acrylate-styrene-methacrylic acid co-
taining no more than 35 weight percent of polymers for use only as modifiers for
total polymer units derived from isobutyl epoxy resins listed in paragraph
acrylate. (b)(3)(viii)(a) of this section.
Ethylene-vinyl acetate copolymer. Ethyl acrylate-methyl methacrylate-sty-
Polyethylene. rene-methacrylic acid copolymers for use
(xix) Polypropylene as the basic poly- only as modifiers for epoxy resins listed in
mer: paragraph (b)(3)(viii)(a) of this section.
2-Ethylhexyl acrylate-ethyl acrylate copoly-
Polypropylene. mers prepared by copolymerization of 2-
Maleic anhydride adduct of polypropylene ethylhexyl acrylate and ethyl acrylate in a
The polypropylene used in the manufac- 7/3 weight ratio and having a number aver-
ture of the adduct complies with age molecular weight range of 5,800 to 6,500
§ 177.1520(c), item 1.1; and the adduct has a and a refractive index, nD25° (40 percent in
maximum combined maleic anhydride con- 2,2,4-trimethyl pentane) of 1.4130–1.4190; for
188
use as a modifier for nylon resins com- 2-Chloro-1,3-butadiene (neoprene).
plying with § 177.1500 of this chapter and for Natural rubber (natural latex or natural
phenolic and epoxy resins listed in para- latex solids, smoked or unsmoked).
graph (b)(3)(vi) and (viii) of this section, re- Polyisobutylene.
spectively, at a level not to exceed 1.5 per- Rubber hydrochloride.
cent of the coating. Styrene-isobutylene copolymer.
2-Ethylhexyl acrylate-methyl methacrylate-
acrylic acid copolymers for use only as
(xxii) Driers made by reaction of a
modifiers for epoxy resins listed in para- metal from paragraph (b)(3)(xxii)(a) of
graph (b)(3)(viii) of this section. this section with acid, to form the salt
Methacrylic acid and the following esters listed in paragraph (b)(3)(xxii)(b) of this
thereof: section:
Butyl. (a) Metals:
Ethyl.
Methyl. Aluminum.
Methacrylic acid or its ethyl and methyl Calcium.
esters copolymerized with one or more of Cerium.
the following: Cobalt.
Acrylic acid. Iron.
Ethyl acrylate. Lithium.
Methyl acrylate. Magnesium.
n-Butyl acrylate-styrene-methacrylic acid- Manganese.
hydroxyethyl methacrylate copolymers Zinc.
containing no more than 2 weight percent Zirconium.
of total polymer units derived from meth- (b) Salts:
acrylic acid and containing no more than
9.5 weight percent of total polymer units Caprate.
derived from hydroxyethyl methacrylate; Caprylate.
for use only in coatings in contact with dry Isodecanoate.
food (food type VIII in table 1 of paragraph Linoleate.
(d) of this section). 2-(Dimethylamino) eth- Naphthenate.
anol (C.A.S. Registry No. 108–01–0) may be Neodecanoate.
employed as an optional adjuvant sub- Octoate (2-ethylhexoate).
stance limited to no more than 2 weight Oleate.
percent based on polymer solids in the Palmitate.
coating emulsion. Resinate.
Styrene polymers made by the polymeriza- Ricinoleate.
tion of any combination of styrene or Soyate.
alpha methyl styrene with acrylic acid, Stearate.
methacrylic acid, 2-ethyl hexyl acrylate, Tallate.
methyl methacrylate, and butyl acrylate.
(xxiii) Waxes:
The styrene and alpha methyl styrene, in-
dividually, may constitute from 0 to 80 Paraffin, Type I.
weight percent of the polymer. The other Paraffin, Type II.
monomers, individually, may be from 0 to Polyethylene.
40 weight percent of the polymer. The poly- Sperm oil.
mer number average molecular weight (Mn) Spermaceti.
shall be at least 2,000 (as determined by gel
permeation chromatography). The acid (xxiv) Plasticizers:
number of the polymer shall be less than Acetyl tributyl citrate.
250. The monomer content shall be less Acetyl triethyl citrate.
than 0.5 percent. The polymers are for use Butyl stearate.
only in contact with food of Types IV-A, V, p-tert-Butyl phenyl salicylate.
VII in table 1 of paragraph (d) of this sec- Dibutyl sebacate.
tion, under use conditions E through G in Diisobutyl adipate.
table 2 of paragraph (d), and with food of Epoxidized soybean oil (iodine number max-
Type VIII without use temperature restric- imum 14; oxirane oxygen content 6% min-
tion. imum), as the basic polymer.
(xxi) Elastomers, as the basic poly- 2-Ethylhexyl diphenyl phosphate.
mer: di-2-Ethylhexyl phthalate.
Glycerol.
Butadiene-acrylonitrile copolymer. Glyceryl monooleate.
Butadiene-acrylonitrile-styrene copolymer. Glyceryl triacetate.
Butadiene-styrene copolymer. Monoisopropyl citrate.

Butyl rubber. Propylene glycol.
Chlorinated rubber. Sorbitol.
189
§ 175.300 21 CFR Ch. I (4–1–23 Edition)
Mono-, di-, and tristearyl citrate. containing dimethylpolysiloxane (CAS
Triethyl citrate. Reg. No. 68083–18–1 and CAS Reg. No. 68083–
Triethylene glycol. 19–2) with methylhydrogen polysiloxane
3-(2-Xenolyl)-1,2-epoxypropane. (CAS Reg. No. 63148–57–2) and
dimethylmethylhydrogen polysiloxane
(xxv) Release agents, as the basic (CAS Reg. No. 68037–59–2), where the plat-
polymer, when applicable: inum content does not exceed 150 parts per
million. The following substances may be
N,N′-Dioleoylethylenediamine (CAS Reg. No.
used as optional polymerization inhibitors:
110–31–6) for use only in ionomeric resins
3,5-Dimethyl-1-hexyne-3-ol (CAS Reg. No.
complying with § 177.1330 of this chapter
107–54–0), at a level not to exceed 0.53
and in ethylene vinyl acetate copolymers
weight-percent;
complying with § 177.1350 of this chapter at
1-Ethynylcyclohexene (CAS Reg. No. 931–49–
a level not to exceed 0.0085 milligram per
7), at a level not to exceed 0.64 weight-per-
square centimeter (0.055 milligram per cent;
square inch) in the finished food-contact Bis(methoxymethyl)ethyl maleate (CAS Reg.
article. No. 102054–10–4), at a level not to exceed 1.0
N,N′-Distearoyl ethylenediamine. weight-percent;
Linoleic acid amide. Methylvinyl cyclosiloxane (CAS Reg. No.
Oleic acid amide. 68082–23–5); and
Palmitic acid amide. Tetramethyltetravinylcyclotetrasiloxane
Petrolatum. (CAS Reg. No. 2554–06–5).
Polyethylene wax.
Polyoxyethylene glycol monooleate (mol. (b) Curing (cross-linking) catalysts
wt. of the polyoxyethylene glycol moiety for silicones (the maximum amount of
greater than 300). tin catalyst used shall be that required
Polytetrafluoroethylene. to effect optimum cure but shall not
Silicones (not less than 300 centistokes vis- exceed 1 part of tin per 100 parts of si-
cosity): Dimethylpolysiloxanes and/or
loxane resins solids):
methylphenylpolysiloxanes. The methyl-
phenylpolysiloxanes contain not more than Dibutyltin dilaurate.
2.0 percent by weight of cyclosiloxanes Stannous oleate.
having up to and including 4 siloxy units. Tetrabutyl titanate.
Silicones (not less than 100 centistokes vis-
cosity): Dimethylpolysiloxanes and/or (xxix) Surface active agents:
methylphenylpolysiloxanes limited to use Ethylene oxide adduct of 2,4,7,9-tetramethyl-
only on metal substrates. The 5-decyn-4,7-diol (CAS Reg. No. 9014–85–1).
methylphenylpolysiloxanes contain not Poly[2-(diethylamino) ethyl methacrylate]
more than 2.0 percent by weight of phosphate (minimum intrinsic viscosity in
cyclosiloxanes having up to and including 4 water at 25 °C is not less than 9.0 deciliters
siloxy units. per gram as determined by ASTM method
D1243–79, ‘‘Standard Test Method for Dilute
(xxvi) Colorants used in accordance Solution Viscosity of Vinyl Chloride Poly-
with § 178.3297 of this chapter. mers,’’ which is incorporated by reference
(xxvii) Surface lubricants: (Copies may be obtained from the Amer-
Cottonseed oil and other edible oils. ican Society for Testing Materials, 100
Dibutyl sebacate. Barr Harbor Dr., West Conshohocken,
Dioctyl sebacate. Philadelphia, PA 19428-2959, or may be ex-
Glyceryl monostearate. amined at the National Archives and
Lanolin. Records Administration (NARA). For in-
Mineral oil, white. formation on the availability of this mate-
Palm oil. rial at NARA, call 202–741–6030, or go to:
Paraffin, Type I. http://www.archives.gov/federal_register/
Paraffin, Type II. code_of_federal_regulations/
Petrolatum. ibr_locations.html.), for use only as a sus-
Stearic acid. pending agent in the manufacture of vinyl
chloride copolymers and limited to use at
(xxviii) Silicones and their curing levels not to exceed 0.1 percent by weight
catalysts: of the copolymers.
(a) Silicones as the basic polymer: Sodium dioctyl sulfosuccinate.
Sodium dodecylbenzenesulfonate
Siloxane resins originating from methyl hy- Sodium lauryl sulfate.
drogen polysiloxane, dimethyl 2,4,7,9-Tetramethyl-5-decyn-4,7-diol (C.A.S.
polysiloxane, and methylphenyl Reg. No. 126-86-3), for use only in can coat-
polysiloxane. ings which are subsequently dried and

Siloxane resins originating from the plat- cured at temperatures of at least 193 °C (380
inum-catalyzed reaction product of vinyl- °F) for 4 minutes.
190
(xxx) Antioxidants: epsilon-Caprolactam-(ethylene-ethyl acry-

late) graft polymer.
Butylated hydroxyanisole. Dicumyl peroxide for use only as polymeriza-
Butylated hydroxytoluene. tion catalyst.
Gum guaiac. 4–(Diiodomethylsulfonyl) toluene (CAS Reg.
Dilauryl thiodipropionate. No. 20018–09–1) for use as a preservative at
Nordihydroguaiaretic acid. a level not to exceed 0.3 percent by weight
Propyl gallate. in can-sealing cements.
Distearyl thiodipropionate. Diisodecyl phthalate for use only as plasti-
Thiodipropionic acid. cizer in side seam cements for containers
2,4,5-Trihydroxybutyrophenone. intended for use in contact with food only
of the types identified in paragraph (d) of
(xxxi) Can end cements (sealing com- this section, table 1, under Categories I, II,
pounds used for sealing can ends only): and VI.
In addition to the substances listed in 4,4′-Bis(alpha,alpha-dimethyl-
paragraph (b) of this section and those benzyl)diphenylamine, CAS Reg. No. 10081–
listed in § 177.1210(b)(5) of this chapter, 67–1.
the following may be used: Ethyl toluene sulfonamide.
N,N′-Hexamethylenebis(3,5-di-tert-butyl-4-
Butadiene-styrene-divinylbenzene copolymer hydroxyhydrocinnamide), CAS Reg. No.
(CAS Reg. No. 26471–45–4) for use only at 23128–74–7.
levels not to exceed 23.8 percent by weight Polyamides consisting of the following:
of the cement solids in can end cements. Copolymer of omega-laurolactam and
Butadiene-styrene-fumaric acid copolymer. espilon-caprolactam, CAS Reg. No. 25191–
4,4′-Butylidenebis (6-tert-butyl-m-cresol). 04–2 (Nylon 12/6).
Dibenzamido phenyl disulfide. Homopolymer of omega-aminododecanoic
Di-b-naphthyl phenylenediamine. acid, CAS Reg. No. 24937–16–4.
Dipentamethylene thiuram tetrasulfide. Homopolymer of omega-laurolactam, CAS
Isobutylene-isoprene-divinylbenzene copoly- Reg. No. 25038–74–8 (Nylon 12).
mers for use only at levels not to exceed 15 Polyamides derived from the following acids
percent by weight of the dry cement com- and amines:
position. Acids:
Naphthalene sulfonic acid-formaldehyde con- Adipic.
densate, sodium salt, for use only at levels Azelaic.
not to exceed 0.6 percent by weight of the Sebacic.
cement solids in can end cements for con- Vegetable oil acids (with or without
tainers having a capacity of not less than dimerization).
5 gallons. Amines:
Sodium decylbenzene sulfonate. Diethylenetriamine.
Sodium nitrite for use only at levels not to Diphenylamine.
exceed 0.3 percent by weight of the cement Ethylenediamine.
solids in can end cements for containers Hexamethylenediamine.
having a capacity of not less than 5 gal- Tetraethylenepentamine.
lons. Triethylenetetramine.
Sodium pentachlorophenate for use as a pre- Polypropylene glycol CAS Reg. No. 25322–69–
servative at 0.1 percent by weight in can- 4.
Sodium pentachlorophenate for use as a pre-
sealing compounds on containers having a
servative at 0.1 percent by weight in can-
capacity of 5 gallons or more.
sealing compounds on containers having a
Sodium phenylphenate.
capacity of 5 gallons or more.
Styrene-maleic anhydride resin, partial
Tetrakis [methylene(3,5-di-tert-butyl-4-
methyl and butyl (sec- or iso-) esters, for
hydroxyhydrocinnamate)]methane, CAS
use only at levels not in excess of 3 percent
Reg. No. 6683–19–8.
of the cement solids in can end cement for-
Toluene sulfonamide formaldehyde resin
mulations.
(basic polymer).
Tetrasodium EDTA (tetrasodium ethylene-
Triethylene glycol methacrylate for use only
diaminetetraacetate).
as polymerization cross-linking agent in
Tri (mixed mono- and dinonylphenyl)
side seam cements for containers intended
phosphite.
for use in contact with food only of the
Zinc dibutyldithiocarbamate.
types identified in paragraph (d) of this
(xxxii) Side seam cements: In addi- section, table 1, under Categories I, II, and
tion to the substances listed in para- VI.
graph (b)(3)(i) to (xxx), inclusive, of Urea.
this section, the following may be used. (xxxiii) Miscellaneous materials:
p-tert-Butyl perbenzoate as a catalyst for Ammonium citrate.

epoxy resin. Ammonium potassium phosphate.
191
§ 175.300 21 CFR Ch. I (4–1–23 Edition)
Bentonite, modified by reaction with benzyl Cyclohexanone-formaldehyde resin produced
dimethyl alkyl ammonium chloride, where when 1 mole of cyclohexanone is made to
the alkyl groups are derived from hydro- react with 1.65 moles of formaldehyde such
genated tallow (CAS Reg. No. 71011–24–0). that the finished resin has an average mo-
For use only as a rheological agent in coat- lecular weight of 600–610 as determined by
ings intended to contact food under re- ASTM method D2503–82, ‘‘Standard Test
peated use conditions. Method for Molecular Weight (Relative
Bentonite, modified by reaction with sodium Molecular Mass) of Hydrocarbons by Ther-
stearate and benzyl dimethyl alkyl ammo- moelectric Measurement of Vapor Pres-
nium chloride, where the alkyl groups are sure,’’ which is incorporated by reference.
derived from hydrogenated tallow (CAS Copies may be obtained from the American
Reg. No. 121888–68–4). For use as a Society for Testing Materials, 100 Barr
rheological agent only in coatings in- Harbor Dr., West Conshohocken, Philadel-
tended to contact dry food under repeated- phia, PA 19428-2959, or may be examined at
use conditions. the National Archives and Records Admin-
Calcium acetate. istration (NARA). For information on the
Calcium ethyl acetoacetate. availability of this material at NARA, call
Calcium glycerophosphate. 202–741–6030, or go to: http://
Calcium, sodium, and potassium oleates. www.archives.gov/federal_register/
Calcium, sodium, and potassium code_of_federal_regulations/
ricinoleates. ibr_locations.html. For use only in contact
Calcium, sodium, and potassium stearates. with nonalcoholic and nonfatty foods
Castor oil, hydrogenated. under conditions of use E, F, and G, de-
scribed in table 2 of paragraph (d) this sec-
Castor oil, hydrogenated polymer with ethyl-
tion.
enediamine, 12-hydroxyoctadecanoic acid
Decyl alcohol.
and sebacic acid (CAS Reg. No. 68604–06–8).
1,2-Dibromo-2,4-dicyanobutane (CAS Reg No.
The condensation product formed by the
35691–65–7). For use as an antimicrobial
reaction of hydrogenated castor oil with
agent at levels not to exceed 500 milli-
polyamide derived from ethylenediamine,
grams per kilogram in emulsion-based sili-
sebacic acid and 12-hydroxystearic acid, for
cone coatings.
use only in coatings at a level not to ex-
Disodium hydrogen phosphate.
ceed 3.2 percent by weight of the resin
Ethyl acetoacetate.
when such coatings are intended for re- Hectorite, modified by reaction with a mix-
peated use in contact with foods only of ture of benzyl methyl dialkyl ammonium
the types identified in paragraph (d) of this chloride and dimethyl dialkyl ammonium
section, table 1, under Types I, II, and III, chloride, where the alkyl groups are de-
under conditions of use C, D, E, or F as derived from hydrogenated tallow (CAS Reg.
scribed in table 2 of paragraph (d) of this No. 121888–67–3). For use as a rheological
section; or when such coatings are in- agent only in coatings intended to contact
tended for repeated use in contact with dry food under repeated-use conditions.
foods of the types identified in paragraph Lauryl alcohol.
(d) of this section, table 1, under Types V, Lecithin.
VI, VII, and VIII, under conditions of use E Magnesium, sodium, and potassium citrate.
or F as described in table 2 of paragraph (d) Magnesium glycerophosphate.
of this section. Use shall be limited to Magnesium stearate.
coatings for tanks of capacity greater than Mono-, di-, and tricalcium phosphate.
530,000 gallons. Monodibutylamine pyrophosphate as
Castor oil, sulfated, sodium salt (CAS Reg. sequestrant for iron.
No. 68187–76–8), for use only in coatings for Mono-, di-, and trimagnesium phosphate.
containers intended for repeated use. Myristyl alcohol.
Cetyl alcohol. Octyl alcohol.
5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Phosphoric acid.
Reg. No. 26172–55–4) and 2-methyl-4- Polybutene, hydrogenated; complying with
isothiazolin-3-one (CAS Reg. No. 2682–20–4) the identity and limitations prescribed by
mixture, at a ratio of 3 parts to 1 part, re- § 178.3740 of this chapter.
spectively, manufactured from methyl-3- Poly(ethylene oxide).
mercaptopropionate (CAS Reg. No. 2935–90– Siloxanes and silicones, dimethyl, 3-
2) and optionally containing magnesium hydroxypropyl group-terminated, diesters
nitrate (CAS Reg. No. 10377–60–3) at a con- with poly(2-oxepanone), diacetates (CAS
centration equivalent to the isothiazolone Reg. No. 116810–47–0) at a level not to ex-
active ingredients (weight/weight). For use ceed 0.025 weight percent of the finished
only as an antimicrobial agent in emul- coating having no greater than a 0.5 mil
sion-based silicone coatings at a level not thickness for use as a component of poly-
to exceed 50 milligrams per kilogram ester, epoxy, and acrylic coatings com-
(based on isothiazolone active ingredient) plying with paragraphs (b)(3)(vii), (viii),
in the coating formulations. and (xx) of this section, respectively.
192
Silver chloride-coated titanium dioxide for milligrams per square inch of food-con-
use only as a preservative in latex emul- tact surface.
sions at a level not to exceed 2.2 parts per (xxxvi) Methacrylonitrile grafted
million (based on silver ion concentration)
polybutadiene copolymers containing
in the dry coating.
Sodium pyrophosphate.
no more than 41 weight percent of total
Stannous chloride.
polymer units derived from
Stannous stearate. methacrylonitrile; for use only in coat-
Stannous sulfate. ings that are intended for contact,
Stearyl alcohol. under conditions of use D, E, F, or G
2-Sulfoethyl methacrylate, sodium salt (CAS described in table 2 of paragraph (d) of
Reg. No. 1804–87–1). For use only in copoly- this section, with food containing no
mer coatings on metal under conditions of more than 8 percent of alcohol.
use E, F, and G described in table 2 of para- (xxxvii) Polymeric resin as a coating
graph (d) of this section, and limited to use component prepared from terephthalic
at a level not to exceed 2.0 percent by acid, isophthalic acid, succinic anhy-
weight of the dry copolymer coating. dride, ethylene glycol, diethylene gly-
Tetrasodium pyrophosphate. col, and 2,2-dimethyl-1,3-propanediol
Tridecyl alcohol produced from
for use in contact with aqueous foods
tetrapropylene by the oxo process, for use
only as a processing aid in polyvinyl chlo- and alcoholic foods containing not
ride resins. more than 20 percent (by volume) of al-
Trimethylolpropane (CAS Reg. No. 77–99–6). cohol under conditions of use D, E, F,
For use as a pigment dispersant at levels and G described in table 2 of § 176.170 of
not to exceed 0.45 percent by weight of the this chapter. The resin shall contain no
pigment. more than 30 weight percent of 2,2-di-
Vinyl acetate-dibutyl maleate copolymers methyl-1,3-propanediol.
produced when vinyl acetate and dibutyl (c) The coating in the finished form
maleate are copolymerized with or without in which it is to contact food, when ex-
one of the monomers: Acrylic acid or
glycidyl methacrylate. For use only in
tracted with the solvent or solvents
coatings for metal foil used in contact with characterizing the type of food, and
foods that are dry solids with the surface under conditions of time and tempera-
containing no free fat or oil. The finished ture characterizing the conditions of
copolymers shall contain at least 50 its intended use as determined from ta-
weight-percent of polymer units derived bles 1 and 2 of paragraph (d) of this sec-
from vinyl acetate and shall contain no tion, shall yield chloroform-soluble ex-
more than 5 weight-percent of total poly- tractives, corrected for zinc extractives
mer units derived from acrylic acid or
glycidyl methacrylate.
as zinc oleate, not to exceed the fol-
lowing:
(xxxiv) Polyamide resins derived (1) From a coating intended for or
from dimerized vegetable oil acids employed as a component of a con-
(containing not more than 20 percent of tainer not to exceed 1 gallon and in-
monomer acids) and ethylenediamine, tended for one-time use, not to exceed
as the basic resin, for use only in coat- 0.5 milligram per square inch nor to ex-
ings that contact food at temperatures ceed that amount as milligrams per
not to exceed room temperature. square inch that would equal 0.005 per-
(xxxv) Polyamide resins having a cent of the water capacity of the con-
maximum acid value of 5 and a max- tainer, in milligrams, divided by the
imum amine value of 8.5 derived from area of the food-contact surface of the
dimerized vegetable oil acids (con- container in square inches. From a fab-
taining not more than 10 percent of ricated container conforming with the
monomer acids), ethylenediamine, and description in this paragraph (c)(1), the
4,4-bis (4-hydroxyphenyl) pentanoic extractives shall not exceed 0.5 milli-
acid (in an amount not to exceed 10 gram per square inch of food-contact
percent by weight of said polyamide surface nor exceed 50 parts per million
resins); as the basic resin, for use only of the water capacity of the container
in coatings that contact food at tem- as determined by the methods provided
peratures not to exceed room tempera- in paragraph (e) of this section.
ture provided that the concentration of (2) From a coating intended for or
the polyamide resins in the finished employed as a component of a con-
food-contact coating does not exceed 5 tainer having a capacity in excess of 1
193
§ 175.300 21 CFR Ch. I (4–1–23 Edition)
gallon and intended for one-time use, (d) Tables:

not to exceed 1.8 milligrams per square
inch nor to exceed that amount as mil- TABLE 1—TYPES OF FOOD
ligrams per square inch that would I. Nonacid (pH above 5.0), aqueous products;
equal 0.005 percent of the water capac- may contain salt or sugar or both, and in-
ity of the container in milligrams, di- cluding oil-in-water emulsions of low- or
vided by the area of the food-contact high-fat content.
surface of the container in square II. Acidic (pH 5.0 or below), aqueous prod-
inches. ucts; may contain salt or sugar or both,
(3) From a coating intended for or and including oil-in-water emulsions of
employed as a component of a con- low- or high-fat content.
tainer for repeated use, not to exceed III. Aqueous, acid or nonacid products con-
18 milligrams per square inch nor to taining free oil or fat; may contain salt,
exceed that amount as milligrams per and including water-in-oil emulsions of
low- or high-fat content.
square inch that would equal 0.005 per-
IV. Dairy products and modifications:
cent of the water capacity of the con-
A. Water-in-oil emulsion, high- or low-fat.
tainer in milligrams, divided by the
B. Oil-in-water emulsion, high- or low-fat.
area of the food-contact surface of the
V. Low moisture fats and oils.
container in square inches.
VI. Beverages:
(4) From coating intended for re-
A. Containing alcohol.
peated use, and employed other than as
B. Nonalcoholic.
a component of a container, not to ex-
VII. Bakery products.
ceed 18 milligrams per square inch of VIII. Dry solids (no end test required).
coated surface.
TABLE 2—TEST PROCEDURES FOR DETERMINING AMOUNT OF EXTRACTIVES FROM RESINOUS OR
POLYMERIC COATINGS, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES
Extractant
Types of food
Condition of use (see Table 1) Water Heptane1 2 8% alcohol
(time and temperature) (time and temperature) (time and temperature)
A. High temperature I, IV–B ................... 250 °F, 2 hr ................... .

heat-sterilized (e.g.,
over 212 °F).
III, IV–A, VII ........... do .................................. 150 °F, 2 hr.
B. Boiling water-sterilized II ............................ 212 °F, 30 min .............. .
III, VII ..................... do .................................. 120 °F, 30 min.
C. Hot filled or pasteur- II, IV–B .................. Fill boiling, cool to 100 .
ized above 150 °F. °F.
III, IV–A ................. do .................................. 120 °F, 15 min.
V ............................ ....................................... do.
D. Hot filled or pasteur- II, IV–B, VI–B ........ 150 °F, 2 hr ................... .
ized below 150 °F.
III, IV–A ................. do .................................. 100 °F, 30 min.
V ............................ ....................................... do.
VI–A ...................... ....................................... ....................................... 150 °F, 2 hr.
E. Room temperature II, IV–B, VI–B ........ 120 °F, 24 hr ................. .
filled and stored (no
thermal treatment in
the container).
III, IV–A ................. do .................................. 70 °F, 30 min.
V, VII ..................... ....................................... do.
VI–A ...................... ....................................... ....................................... 120 °F, 24 hr.
F. Refrigerated storage I, II, III, IV–A, IV–B, 70 °F, 48 hr ................... .
(no thermal treatment VI–B,VII.
in the container).
VI–A ...................... ....................................... ....................................... 70 °F, 48 hr.
G. Frozen storage (no I, II, III, IV–B, VII ... 70 °F, 24 hr ................... .
the container).
H. Frozen storage:
Ready-prepared foods
intended to be re-
heated in container at
time of use:
1. Aqueous or oil in I, II, IV–B ............... 212 °F, 30 min .............. .

water emulsion of
high or low fat.
194
TABLE 2—TEST PROCEDURES FOR DETERMINING AMOUNT OF EXTRACTIVES FROM RESINOUS OR

POLYMERIC COATINGS, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES—Contin-
ued
Extractant
Types of food
Condition of use (see Table 1) Water Heptane1 2 8% alcohol
(time and temperature) (time and temperature) (time and temperature)
2. Aqueous, high or III, IV–A, VII ........... do .................................. 120 °F, 30 min.
low free oil or fat.
1 Heptane extractant not to be used on wax-lined containers.
2 Heptane extractivity results must be divided by a factor of five in arriving at the extractivity for a food product.
(e) Analytical methods—(1) Selection of from coated containers. Quadruplicate

extractability conditions. First ascertain samples of representative containers
the type of food product (table 1, para- should be selected from the lot to be
graph (d) of this section) that is being examined and must be carefully rinsed
packed commercially in the test con- to remove extraneous material prior to
tainer and the normal conditions of the actual extraction procedure. Soda
thermal treatment used in packaging fountain pressure-type hot water rins-
the type of food involved. Using table 2 ing equipment, consisting in its sim-
(paragraph (d) of this section), select plest form of a 1⁄8-inch–1⁄4-inch internal
the food-simulating solvent or solvents diameter metal tube attached to a hot
(demineralized distilled water, water line and bent so as to direct a
heptane, and/or 8 percent ethyl alcohol) stream of water upward, may be used.
and the time-temperature exaggera- Be sure hot water has reached a tem-
tions of the container-use conditions. perature of 190 °F–200 °F before starting
Aqueous products (Types I, II, IV-B, to rinse the container. Invert the con-
and VI-B) require only a water- tainer over the top of the fountain and
extractability test at the temperature direct a strong stream of hot water
and time conditions shown for the against the bottom and all sides for 1
most severe ‘‘conditions of use.’’ Aque- minute, drain, and allow to dry.
ous products with free oil or fat, and (4) Exposure conditions—(i) Water (250
water-oil emulsions (types III, IV-A, °F for 2 hours), simulating high-tempera-
and VII) will require determinations of ture heat sterilization. Fill the container
both water extractability and heptane within 1⁄4-inch of the top with a meas-
extractability. Low-moisture fats and ured volume of demineralized distilled
oils (type V with no free water) require water. Cover the container with clean
only the heptane extractability. Alco- aluminum foil and place the container
holic beverages (type VI-A) require on a rack in a pressure cooker. Add a
only the 8 percent alcohol extractant. small amount of demineralized dis-
Having selected the appropriate ex- tilled water to the pressure cooker, but
tractant or extractants simulating var- do not allow the water to touch the
ious types of foods and beverages and bottom of the container. Close the
the time-temperature exaggerations cooker securely and start to heat over
over normal use, follow the applicable a suitable burner. When a steady
extraction procedure. Adapt the proce- stream of steam emerges from the
dure, when necessary, for containers vent, close the vent and allow the pres-
having a capacity of over 1 gallon. sure to rise to 15 pounds per square
(2) Selection of coated-container sam- inch (250 °F) and continue to maintain
ples. For consumer-sized containers up this pressure for 2 hours. Slowly re-
to 1 gallon, quadruplicate samples of lease the pressure, open the pressure
representative containers (using for cooker when the pressure reads zero,
each replicate sample the number of and composite the water of each rep-
containers nearest to an area of 180 licate immediately in a clean Pyrex
square inches) should be selected from flask or beaker. Proceed with the de-
the lot to be examined. termination of the amount of extrac-

(3) Cleaning procedure preliminary to tives by the method described in para-
determining the amount of extractables graph (e)(5) of this section.
195
§ 175.300 21 CFR Ch. I (4–1–23 Edition)
(ii) Water (212 °F for 30 minutes), simu- minum foil. Place the test container in
lating boiling water sterilization. Fill the an incubator or oven maintained at 120
container within 1⁄4-inch of the top °F. After 24 hours, remove the test con-
with a measured volume of boiling, tainer from the incubator and imme-
demineralized distilled water. Cover diately composite the water of each
the container with clean aluminum foil replicate in a clean Pyrex flask or
and place the container on a rack in a beaker. Proceed with the determina-
pressure cooker in which a small tion of the amount of extractives by
amount of demineralized distilled the method described in paragraph
water is boiling. Do not close the pres- (e)(5) of this section.
sure vent, but operate at atmospheric (vi) Water (70 °F for 48 hours), simu-
pressure so that there is a continuous lating refrigerated storage. Bring
escape of a small amount of steam.
demineralized distilled water to 70 °F
Continue to heat for 30 minutes, then
in a clean Pyrex flask. Fill the con-
remove the test container and com-
tainer within 1⁄4-inch of the top with a
posite the contents of each replicate
measured volume of the 70 °F water,
immediately in a clean Pyrex flask or
beaker. Proceed with the determina- and cover with clean aluminum foil.
tion of the amount of extractives by Place the test container in a suitable
the method described in paragraph room maintained at 70 °F. After 48
(e)(5) of this section. hours, immediately composite the
(iii) Water (from boiling to 100 °F), sim- water of each replicate in a clean
ulating hot fill or pasteurization above 150 Pyrex flask or beaker. Proceed with
°F. Fill the container within 1⁄4-inch of the determination of the amount of ex-
the top with a measured volume of tractives by the method described in
boiling, demineralized distilled water. paragraph (e)(5) of this section.
Insert a thermometer in the water and (vii) Water (70 °F for 24 hours), simu-
allow the uncovered container to stand lating frozen storage. Bring
in a room at 70 °F–85 °F. When the tem- demineralized distilled water to 70 °F
perature reads 100 °F, composite the in a clean Pyrex flask. Fill the con-
water from each replicate immediately tainer within 1⁄4-inch of the top with a
in a clean Pyrex flask or beaker. Pro- measured volume of the 70 °F water
ceed with the determination of the and cover with clean aluminum foil.
amount of extractives by the method Place the container in a suitable room
described in paragraph (e)(5) of this maintained at 70 °F. After 24 hours, im-
section. mediately composite the water of each
(iv) Water (150° for 2 hours), simulating replicate in a clean Pyrex flask or
hot fill or pasteurization below 150 °F. beaker. Proceed with the determina-
Preheat demineralized distilled water tion of the amount of extractives by
to 150 °F in a clean Pyrex flask. Fill the method described in paragraph
the container within 1⁄4-inch of the top (e)(5) of this section.
with a measured volume of the 150 °F
(viii) Water (212 °F for 30 minutes), sim-
water and cover with clean aluminum
ulating frozen foods reheated in the con-
foil. Place the test container in an
oven maintained at 150 °F. After 2 tainer. Fill the container to within 1⁄4-
hours, remove the test container from inch of the top with a measured volume
the oven and immediately composite of boiling, demineralized distilled
the water of each replicate in a clean water. Cover the container with clean
Pyrex flask or beaker. Proceed with aluminum foil and place the container
the determination of the amount of ex- on a rack in a pressure cooker in which
tractives by the method described in a small amount of demineralized dis-
paragraph (e)(5) of this section. tilled water is boiling. Do not close the
(v) Water (120 °F for 24 hours), simu- pressure vent, but operate at atmos-
lating room temperature filling and stor- pheric pressure so that there is a con-
age. Preheat demineralized distilled tinuous escape of a small amount of
water to 120 °F in a clean Pyrex flask. steam. Continue to heat for 30 minutes,
Fill the container within 1⁄4-inch of the then remove the test container and
top with a measured volume of the 120 composite the contents of each rep-
°F water and cover with clean alu- licate immediately in a clean Pyrex
196
flask or beaker. Proceed with the de- tractives by the method described in
termination of the amount of extrac- paragraph (e)(5) of this section.
tives by the method described in para- (xi) Heptane (120 °F for 15 minutes),
graph (e)(5) of this section. simulating hot fill or pasteurization above
(ix) Heptane (150 °F for 2 hours) simu- 150 °F for fatty foods only. Preheat re-
lating high-temperature heat sterilization distilled reagent-grade heptane (boiling
for fatty foods only. Preheat redistilled point 208 °F) carefully in a clean Pyrex
reagent-grade heptane (boiling point flask on a water bath or nonsparking
208 °F) carefully in a clean Pyrex flask hot plate in a well-ventilated hood to
on a water bath or nonsparking hot 120 °F. At the same time, preheat a
plate in a well-ventilated hood to 150 pressure cooker or equivalent to 120 °F
°F. At the same time preheat a pres- in an incubator. This pressure cooker
sure cooker or equivalent to 150 °F in is to serve only as a container for the
an incubator. This pressure cooker is heptane-containing test package inside
to serve only as a container for the the incubator in order to minimize the
heptane-containing test package inside danger of explosion. Fill the test con-
the incubator in order to minimize the tainer within 1⁄4-inch of the top with a
danger of explosion. Fill the test con- measured volume of the 120 °F heptane
tainer within 1⁄4-inch of the top with a and cover with clean aluminum foil.
measured volume of the 150 °F heptane Place the test container in the
and cover with clean aluminum foil. preheated pressure cooker and then put
Place the test container in the the assembly into a 120 °F incubator.
preheated pressure cooker and then put After 15 minutes, remove the pressure
the assembly into a 150 °F incubator. cooker from the incubator, open the as-
After 2 hours, remove the pressure sembly, and immediately composite
cooker from the incubator, open the as- the heptane of each replicate in a clean
sembly, and immediately composite Pyrex flask or beaker. Proceed with
the heptane of each replicate in a clean the determination of the amount of ex-
Pyrex flask or beaker. Proceed with tractives by the method described in
the determination of the amount of ex- paragraph (e)(5) of this section.
tractives by the method described in (xii) Heptane (100 °F for 30 minutes),
paragraph (e)(5) of this section. simulating hot fill or pasteurization below
(x) Heptane (120 °F for 30 minutes), sim- 150 °F for fatty foods only. Preheat re-
ulating boiling water sterilization of fatty distilled reagent-grade heptane (boiling
foods only. Preheat redistilled reagent- point 208 °F) carefully in a clean Pyrex
grade heptane (boiling point 208 °F) flask on a water bath or nonsparking
carefully in a clean Pyrex flask on a hot plate in a well-ventilated hood to
water bath or nonsparking hot plate in 100 °F. At the same time, preheat a
a well-ventilated hood to 120 °F. At the pressure cooker or equivalent to 100 °F
same time, preheat a pressure cooker in an incubator. This pressure cooker
or equivalent to 120 °F in an incubator. is to serve only as a container for the
This pressure cooker is to serve only as heptane-containing test package inside
a vented container for the heptane-con- the incubator in order to minimize the
taining test package inside the incu- danger of explosion. Fill the test con-
bator in order to minimize the danger tainer within 1⁄4-inch of the top with a
of explosion. Fill the test container measured volume of the 100 °F heptane
within 1⁄4-inch of the top with a meas- and cover with clean aluminum foil.
ured volume of the 120 °F heptane and Place the test container in the
cover with clean aluminum foil. Place preheated pressure cooker and then put
the test container in the preheated the assembly into a 100 °F incubator.
pressure cooker and then put the as- After 30 minutes, remove the pressure
sembly into a 120 °F incubator. After 30 cooker from the incubator, open the as-
minutes, remove the pressure cooker sembly and immediately composite the
from the incubator, open the assembly, heptane of each replicate in a clean
and immediately composite the Pyrex flask or beaker. Proceed with
heptane of each replicate in a clean the determination of the amount of ex-

Pyrex flask or beaker. Proceed with tractives by the method described in
the determination of the amount of ex- paragraph (e)(5) of this section.
197
§ 175.300 21 CFR Ch. I (4–1–23 Edition)
(xiii) Heptane (70 °F for 30 minutes), (xvi) Alcohol—8 percent (120 °F for 24
simulating room temperature filling and hours), simulating alcoholic beverages
storage of fatty foods only. Fill the test room-temperature filled and stored. Pre-
container within 1⁄4-inch of the top heat 8 percent (by volume) ethyl alco-
with a measured volume of the 70 °F hol in demineralized distilled water to
heptane and cover with clean alu- 120 °F in a clean Pyrex flask. Fill the
minum foil. Place the test container in test container within 1⁄4-inch of the top
a suitable room maintained at 70 °F. with a measured volume of the 8 per-
After 30 minutes, composite the cent alcohol, cover the container with
heptane of each replicate in a clean clean aluminum foil and place in an
Pyrex flask or beaker. Proceed with oven or incubator maintained at 120 °F.
the determination of the amount of ex- After 24 hours, remove the container
tractives by the method described in from the oven or incubator and imme-
paragraph (e)(5) of this section. diately composite the alcohol from
(xiv) Heptane (120 °F for 30 minutes), each replicate into a clean Pyrex flask.
simulating frozen fatty foods reheated in Proceed with the determination of the
the container. Preheat redistilled rea- amount of extractives by the method
gent-grade heptane (boiling point 208 described in paragraph (e)(5) of this
°F) carefully in a clean Pyrex flask on section.
a water bath or hot plate in a well-ven- (xvii) Alcohol—8 percent (70 °F for 48
tilated hood to 120 °F. At the same hours), simulating alcoholic beverages in
time, preheat a pressure cooker to 120 refrigerated storage. Bring 8 percent (by
°F in an incubator. This pressure cook- volume) ethyl alcohol in demineralized
er is to serve only as a container for distilled water to 70 °F in a clean Pyrex
the heptane-containing test package flask. Fill the test container within 1⁄4-
inside the incubator in order to mini- inch of the top with a measured volume
mize the danger of explosion. Fill the of the 8 percent alcohol. Cover the con-
test container within 1⁄4-inch of the top tainer with clean aluminum foil. Place
with a measured volume of the 120 °F the test container in a suitable room
heptane and cover with clean alu- maintained at 70 °F. After 48 hours, im-
minum foil. Place the test container in mediately composite the alcohol from
the preheated pressure cooker and then each replicate into a clean Pyrex flask.
put the assembly into a 120 °F incu- Proceed with the determination of the
bator. After 30 minutes, remove the amount of extractives by the method
pressure cooker from the incubator, described in paragraph (e)(5) of this
open the assembly and immediately section.
composite the heptane from each rep- NOTE: The tests specified in paragraph
licate into a clean Pyrex flask. Proceed (e)(4)(i) through (xvii) of this section are ap-
with the determination of the amount plicable to flexible packages consisting of
of extractives by the method described coated metal contacting food, in which case
in paragraph (e)(5) of this section. the closure end is double-folded and clamped
(xv) Alcohol—8 percent (150 °F for 2 with metal spring clips by which the package
can be suspended.
hours), simulating alcoholic beverages hot
filled or pasteurized below 150 °F. Pre- (5) Determination of amount of extrac-
heat 8 percent (by volume) ethyl alco- tives—(i) Total residues. Evaporate the
hol in demineralized distilled water to food-simulating solvents from para-
150 °F in a clean Pyrex flask. Fill the graph (e)(4)(i) to (xvii), inclusive, of
test container with within 1⁄4-inch of this section to about 100 milliliters in
the top with a measured volume of the the Pyrex flask and transfer to a clean,
8 percent alcohol. Cover the container tared platinum dish, washing the flask
with clean aluminum foil and place in three times with the solvent used in
an oven maintained at 150 °F. After 2 the extraction procedure, and evapo-
hours, remove the container from the rate to a few milliliters on a non-
oven and immediately composite the sparking low-temperature hotplate.
alcohol from each replicate in a clean The last few milliliters should be evap-
Pyrex flask. Proceed with the deter- orated in an oven maintained at a tem-
perature of 212 °F. Cool the platinum
mination of the amount of extractives

by the method described in paragraph dish in a desiccator for 30 minutes and
(e)(5) of this section. weigh the residue to the nearest 0.1
198
milligram (e). Calculate the extractives weighed residue, (e), in the platinum
in milligrams per square inch and in dish, obtained in paragraph (e)(5)(i) of
parts per million for the particular size this section. Warm carefully, and filter
of container being tested and for the through Whatman No. 41 filter paper in
specific food-simulating solvent used. a Pyrex funnel, collecting the filtrate
(a) Water and 8-percent alcohol. in a clean, tared platinum dish. Repeat
the chloroform extraction, washing the
Milligrams extractives e filter paper with this second portion of
=
per square inch s chloroform. Add this filtrate to the
original filtrate and evaporate the
Ex = ( e )( a )(1000) total down to a few milliliters on a
Extractives residue = low-temperature hotplate. The last few
( c )( s ) milliliters should be evaporated in an
(b) Heptane. oven maintained at 212 °F. Cool the
platinum dish in a desiccator for 30
Milligrams extractives e minutes and weigh to the nearest 0.1
= milligram to get the chloroform-solu-
per square inch ( s )( F ) ble extractives residue (e′). This e′ is
substituted for e in the equations in
Ex = ( e )( a )(1000) paragraph (e)(5)(i)(a) and (b) of this sec-
Extractives residue = tion. If the concentration of extrac-
( c )( s )( F ) tives (Ex) still exceeds 50 parts per mil-
where: lion or the extractives in milligrams
Ex = Extractives residue in ppm for any con- per square inch exceed the limitations
tainer size. prescribed in paragraph (c) of this sec-
e = Milligrams extractives per sample tested. tion for the particular container size,
a = Total coated area, including closure in
proceed as follows to correct for zinc
square inches.
c = Water capacity of container, in grams. extractives (‘‘C’’ enamels only): Ash
s = Surface of coated area tested, in square the residue in the platinum dish by
inches. heating gently over a Meeker-type
F = Five, the ratio of the amount of extrac- burner to destroy organic matter and
tives removed from a coated container by hold at red heat for about 1 minute.
heptane under exaggerated time-tempera- Cool in the air for 3 minutes, and place
ture test conditions compared to the
the platinum dish in the desiccator for
amount extracted by a fat or oil from a
container tested under exaggerated condi- 30 minutes and weigh to the nearest 0.1
tions of thermal sterilization and use. milligram. Analyze this ash for zinc by
e′ = Chloroform-soluble extractives residue. standard Association of Official Agri-
ee′ = Zinc corrected chloroform-soluble ex- cultural Chemists methods or equiva-
tractive residue. lent. Calculate the zinc in the ash as
e′ or ee′ is substituted for e in the above equa- zinc oleate, and subtract from the
tions when necessary.
weight of chloroform-soluble extrac-
If when calculated by the equations in tives residue (e′) to obtain the zinc-cor-
paragraph (e)(5)(i)(a) and (b) of this sec- rected chloroform-soluble extractives
tion, the concentration of extractives residue (ee′). This ee′ is substituted for
residue (Ex) exceeds 50 parts per mil- e in the formulas in paragraph
lion or the extractives in milligrams (e)(5)(i)(a) and (b) of this section. To ER01JA93.391</GPH>
per square inch exceed the limitations comply with the limitations in para-
prescribed in paragraph (c) of this sec- graph (c) of this section, the chloro-
tion for the particular container size, form-soluble extractives residue (but
proceed to paragraph (e)(5)(ii) of this after correction for the zinc extractives
section (method for determining the in case of ‘‘C’’ enamels) must not ex-
ER01JA93.389</GPH> ER01JA93.390</GPH>
amount of chloroform-soluble extrac- ceed 50 parts per million and must not
tives residue). exceed in milligrams per square inch
(ii) Chloroform-soluble extractives res- the limitations for the particular arti-
idue. Add 50 milliliters of chloroform cle as prescribed in paragraph (c) of
this section.
(freshly distilled reagent grade or a

grade having an established consist- (f) Equipment and reagent require-
ently low blank) to the dried and ments—(1) Equipment.
199
ER01JA93.388</GPH>
§ 175.320 21 CFR Ch. I (4–1–23 Edition)
Rinsing equipment, soda fountain pressure- the provisions of § 180.22 of this chap-
type hot water, consisting in simplest form ter.
of a 1⁄8-inch–1⁄4-inch inside diameter metal (i) Epoxy resins derived by the reac-
tube attached to a hot water line delivering
190 °F–200 °F water and bent so as to direct
tion of 4,4′-isopropylidenediphenol and
a stream of water upward. epichlorohydrin, as described in para-
Pressure cooker, 21-quart capacity with graph (b)(3)(viii)(a) of this section, may
pressure gage, safety release, and removable be used in accordance with this section
rack, 12.5 inches inside diameter × 11 inches except as coatings in packaging for
inside height, 20 pounds per square inch safe powdered and liquid infant formula.
operating pressure.
Oven, mechanical convection, range to in- [42 FR 14534, Mar. 15, 1977]
clude 120 °F–212 °F explosion-proof, inside di- EDITORIAL NOTE: For FEDERAL REGISTER ci-
mensions (minimum), 19″ × 19″ × 19″, constant tations affecting § 175.300, see the List of CFR
temperature to ±2 °F (water bath may be Sections Affected, which appears in the
substituted). Finding Aids section of the printed volume
Incubator, inside dimensions (minimum) and at www.govinfo.gov.
19″ × 19″ × 19″ for use at 100 °F±2 °F explosion
proof (water bath may be substituted). § 175.320 Resinous and polymeric coat-
Constant-temperature room or chamber 70 ings for polyolefin films.
°F±2 °F minimum inside dimensions 19″ × 19″
× 19″. Resinous and polymeric coatings
Hot plate, nonsparking (explosion proof), may be safely used as the food-contact
top 12″ × 20″, 2,500 watts, with temperature surface of articles intended for use in
control. producing, manufacturing, packing,
Platinum dish, 100-milliliter capacity min-
processing, preparing, treating, pack-
imum.
All glass, Pyrex or equivalent. aging, transporting, or holding food, in
(2) Reagents. scribed conditions:
Water, all water used in extraction proce- (a) The coating is applied as a contin-
dure should be freshly demineralized (deion- uous film over one or both sides of a
ized) distilled water. base film produced from one or more of
Heptane, reagent grade, freshly redistilled the basic olefin polymers complying
before use, using only material boiling at 208 with § 177.1520 of this chapter. The base
°F. polyolefin film may contain optional
Alcohol, 8 percent (by volume), prepared
from undenatured 95 percent ethyl alcohol adjuvant substances permitted for use
diluted with demineralized or distilled in polyolefin film by applicable regula-
water. tions in parts 170 through 189 of this
Chloroform, reagent grade, freshly redis- chapter.
tilled before use, or a grade having an estab- (b) The coatings are formulated from
lished, consistently low blank. optional substances which are:
Filter paper, Whatman No. 41 or equiva- (1) Substances generally recognized
lent.
as safe for use in or on food.
(g) In accordance with good manufac- (2) Substances the use of which is
turing practice, finished coatings in- permitted under applicable regulations
tended for repeated food-contact use in parts 170 through 189 of this chapter,
shall be thoroughly cleansed prior to by prior sanctions, or approvals.
their first use in contact with food. (3) Substances identified in this para-
(h) Acrylonitrile copolymers identi- graph (b)(3) and subject to such limita-
fied in this section shall comply with tions as are provided:
List of substances Limitations
(i) Resins and polymers:

Acrylic acid polymer and its ethyl or methyl esters.
Acrylamide copolymerized with ethyl acrylate and/or sty-
rene and/or methacrylic acid, and the copolymer subse-
quently reacted with formaldehyde and butanol.
Butadiene-acrylonitrile copolymer.
Butadiene-acrylonitrile-styrene terpolymer.
Butyl rubber.
N,N′-Diphenyl-p-phenylenediamine ...................................... For use only as a polymerization inhibitor in 2-sulfoethyl meth-

acrylate, sodium salt.
200
2-Ethylhexyl acrylate copolymerized with one or more of

the following:
Acrylonitrile.
Itaconic acid.
Methacrylonitrile.
Methyl acrylate.
Methyl methacrylate.
4,4′-Isopropylidenediphenolepichlorohydrin average molec-
ular weight 900.
Melamine-formaldehyde as the basic polymer or chemi-
cally modified with methyl alcohol.
Methacrylic acid and its ethyl or methyl esters copolym-
erized with one or more of the following:
Acrylic acid.
Ethyl acrylate.
Methyl acrylate.
a-Methyl styrene polymer.
a-Methylstyrene-vinyltoluene copolymer resins (molar ratio For use only in coatings that contact food under conditions of
1 a-methylstyrene to 3 vinyltoluene). use D, E, F, or G described in table 2 of § 176.170(c) of this
chapter, provided that the concentration of a-methylstyrene-
vinyltoluene copolymer resins in the finished food-contact
coating does not exceed 1.0 milligram per square inch of
food-contact surface.
Petroleum alicyclic hydrocarbon resins ................................ As defined in § 176.170 of this chapter. Blended with butyl rub-
ber for use as a component of coatings on polyolefin fabric
for bulk packaging of raw fruits and vegetables and used at
a level not to exceed 30 percent by weight of the total coat-
ing solids.
Polyamide resins (CAS Reg. No. 68139–70–8), as the For use only in coatings for polypropylene films that contact
basic resin, derived from: food at temperatures not to exceed room temperature.
Dimerized vegetable oil or tall oil acids containing not
more than 20 percent of monomer acids.
Azelaic acid (CAS Reg. No. 123–99–9) in an amount
not to exceed 3.7 percent by weight of the poly-
amide resin.
Ethylenediamine (CAS Reg. No. 107–15–3).
Piperazine (CAS Reg. No. 110–85–0) in an amount
not to exceed 6.4 percent by weight of the poly-
amide resin.
Polyamide resins, derived from dimerized vegetable oil For use only in coatings for polyolefin films that contact food at
acids (containing not more than 20% of monomer acids) temperatures not to exceed room temperature.
and ethylenediamine, as the basic resin.
Polyamide resins having a maximum acid value of 5 and a For use only in coatings that contact food at temperatures not
maximum amine value of 8.5 derived from dimerized to exceed room temperature provided that the concentration
vegetable oil acids (containing not more than 10 percent of the polyamide resins in the finished food-contact coating
of monomer acids), ethylenediamine, and 4,4-bis (4- does not exceed 5 milligrams per square inch of food-con-
hydroxyphenyl) pentanoic acids (in an amount not to ex- tact surface.
ceed 10 percent by weight of said polyamide resins); as
the basic resin.
Polyester resins formed by reaction of one or more of the
following polybasic acids and monobasic acids with one
or more of the following polyhydric alcohols:
Polybasic acids:
Adipic.
Azelaic .................................................................... For use in forming polyester resins intended for use in coatings
that contact food only of the type identified in § 176.170(c) of
this chapter, table 1, under Category VIII, and under condi-
tions of use E, F, or G, described in table 2 of § 176.170(c)
of this chapter.
Dimerized fatty acids derived from:
Animal, marine or vegetable fats and oils.
Tall oil.
Fumaric.
Isophthalic.
Maleic.
o-Phthalic.
Sebacic.
Terephthalic.
Trimellitic.
Monobasic acids:
Fatty acids derived from:
Animal, marine, or vegetable fats and oils.
201
§ 175.320 21 CFR Ch. I (4–1–23 Edition)
Gum rosin ....................................................... As defined in § 178.3870 of this chapter. For use in forming
polyester resins intended for use in coatings that contact
food only of the type identified in § 176.170(c) of this chap-
ter, table 1, under Category VIII, and under conditions of use
E, F, or G described in table 2 of § 176.170(c) of this chap-
ter.
Polyhydric alcohols:
1,3-Butylene glycol.
Diethylene glycol.
2,2-Dimethyl-1,3-propanediol.
Dipropylene glycol.
Ethylene glycol.
Glycerol.
Mannitol.
a-Methyl glucoside.
Pentaerythritol.
Propylene glycol.
Sorbitol.
Trimethylol ethane.
Polyethylenimine .................................................................. For use only as a primer subcoat to anchor epoxy surface
coatings to the base sheet.
Polystyrene.
Polyvinyl acetate.
Polyvinyl chloride ..................................................................
Siloxanes and silicones: platinum-catalyzed reaction product of Platinum content not to exceed 150 parts per million.
vinyl-containing dimethylpolysiloxane (CAS Reg. No. 68083–
18–1 and CAS Reg. No. 68083–19–2) with methylhydrogen
polysiloxane (CAS Reg. No. 63148–57–2) and
dimethylmethylhydrogen polysiloxane (CAS Reg. No. 68037–
59–2). The following substances may be used as optional
polymerization inhibitors:.
3,5-Dimethyl-1-hexyne-3-ol (CAS Reg. No. 107–54–0), at
a level not to exceed 0.53 weight percent;.
1-Ethynylcyclohexene (CAS Reg. No. 931–49–7), at a
level not to exceed 0.64 weight percent;.
Bis(methoxymethyl)ethyl maleate (CAS Reg. No.
102054–10–4), at a level not to exceed 1.0 weight
percent;.
Methylvinyl cyclosiloxane (CAS Reg. No. 68082–23–5);
and.
Tetramethyltetravinylcyclotetrasiloxane (CAS Reg. No.
2554–06–5)..
Siloxanes and silicones; platinum-catalyzed reaction product of Platinum content not to exceed 100 parts per million. For use
vinyl-containing dimethylpolysiloxane (CAS Reg. Nos. only as a surface coating under the following conditions:
68083–19–2 and 68083–18–1), with methyl hydrogen 1. In coatings for olefin polymers provided the coating contacts
polysiloxane (CAS Reg. No. 63148–57–2). Dimethyl maleate food only of the types identified in § 176.170(c) of this chap-
(CAS Reg. No. 624–48–6) and vinyl acetate (CAS Reg. No. ter, table 1, under Types I, II, VI, and VII-B when used under
108–05–4) may be used as optional polymerization inhibitors. conditions of use E, F, and G described in table 2 in
§ 176.170(c) of this chapter.
2. In coatings for olefin polymers provided the coating contacts
food only of the types identified in § 176.170(c) of this chap-
ter, table 1, under Types III, IV, V, VII-A, VIII, and IX when
used under conditions of use A through H described in table
2 in § 176.170(c) of this chapter.
vinyl-containing dimethylpolysiloxane (CAS Reg. Nos. only as a release coating for pressure sensitive adhesives.
68083–19–2 and 68083–18–1), with methyl hydrogen
polysiloxane (CAS Reg. No. 63148–57–2). Dimethyl maleate
(CAS Reg. No. 624–48–6), vinyl acetate (CAS Reg. No.
108–05–4), dibutyl maleate (CAS Reg. No. 105–76–0) and
diallyl maleate (CAS Reg. No. 999–21–3) may be used as
optional polymerization inhibitors. The polymer may also
contain C16-C18 olefins (CAS Reg. No. 68855–60–7) as a
control release agent.
Styrene copolymerized with one or more of the following:
Acrylonitrile.
a-Methyl styrene.
202
Styrene polymers made by the polymerization of any com- For use only in contact with foods of Types IV-A, V, and VII in
bination of styrene or alpha methyl styrene with acrylic table 1 of § 176.170(c) of this chapter, under use conditions
acid, methacrylic acid, 2-ethyl hexyl acrylate, methyl E through G in table 2 of § 176.170(c), and with foods of
methacrylate, and butyl acrylate. The styrene and alpha Types VIII and IX without use temperature restriction.
methyl styrene, individually, may constitute from 0 to 80
weight percent of the polymer. The other monomers, in-
dividually, may be from 0 to 40 weight percent of the
polymer. The polymer number average molecular weight
(Mn) shall be at least 2,000 (as determined by gel per-
meation chromatography). The acid number of the poly-
mer shall be less than 250. The monomer content shall
be less than 0.5 percent.
Styrene-isobutylene copolymer.
Terpene resins consisting of polymers of a-pinene, b-pi-
nene, and/or dipentene; acid value less than 5, saponi-
fication number less than 5, and color less than 4 on the
Gardner scale as measured in 50 percent mineral spirits
solution.
2-Sulfoethyl methacrylate, sodium salt Chemical Abstracts For use only in copolymer coatings under conditions of use E,
Service No. 1804–87–1]. F, and G described in table 2 of § 176.170(c) of this chapter
and limited to use at a level not to exceed 2.0 percent by
weight of the dry copolymer coating.
Vinyl chloride-acetate, hydroxyl-modified copolymer or ma-
leic acid-modified copolymer.
Vinyl chloride copolymerized with one or more of the fol-
lowing:
Acrvlonitrile.
Vinyl acetate.
Vinylidene chloride copolymerized with one or more of the
following:
Acrylic acid and its methyl, ethyl, propyl, butyl, or octyl
esters.
Acrylonitrile.
Itaconic acid.
Methacrylic acid and its methyl, ethyl, propyl, butyl, or
octyl esters.
Methacrylonitrile.
Vinyl chloride.
(ii) Plasticizers:
Acetyl tributyl citrate.
Acetyl triethyl citrate.
Butyl stearate.
Dibutyl sebacate.
2-Ethylhexyl diphenyl phosphate.
Glycerol monooleate ............................................................
Glycerol triacetate.
Triethyl citrate.
(iii) Adjuvants (release agents, waxes, and dispersants):
Acetone.
Amides (unsubstituted) of fatty acids from vegetable or
animal oils.
n-Butyl acetate.
n-Butyl alcohol.
Candelilla wax.
Carnauba wax.
5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. For use only as an antimicrobial agent in emulsion-based sili-
26172–55–4) and 2-methyl-4-isothiazolin-3-one (CAS cone coatings at a level not to exceed 50 milligrams per kilo-
Reg. No. 2682–20–4) mixture, at a ratio of 3 parts to 1 gram (based on isothiazolone active ingredient) in the coat-
part, respectively, manufactured from methyl-3- ing formulation.
mercaptopropionate (CAS Reg. No. 2935–90–2) and op-
tionally containing magnesium nitrate (CAS Reg. No.
10377–60–3) at a concentration equivalent to the
isothiazolone active ingredients (weight/weight)..
1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691–65– For use as an antimicrobial agent at levels not to exceed 500
7). milligrams per kilogram in emulsion-based silicone coating.
Ethyl acetate.
Fatty acids from vegetable or animal oils and their alu-
minum, ammonium, calcium, magnesium, and sodium
salts.
Hexane.
Methyl ethyl ketone.
203
§ 175.350 21 CFR Ch. I (4–1–23 Edition)
N,N′-Dioleoylethylenediamine (CAS Reg. No. 110–31–6) ... For use only in ionomeric resins complying with § 177.1330 of
this chapter and in ethylene vinyl acetate copolymers com-
plying with § 177.1350 of this chapter at a level not to ex-
ceed 0.0085 milligram per square centimeter (0.055 milli-
gram per square inch) in the finished food-contact article.
Petroleum waxes conforming to specifications included in
a regulation in subchapter B of this chapter.
Polyvinyl alcohol, minimum viscosity of 4% aqueous solu- For use only as a dispersing agent at levels not to exceed 6%
tion at 20 °C of 4 centipoises and percent alcoholysis of of total coating weight in coatings for pol-yolefin films pro-
87–100. vided the finished polyolefin films contact food only of the
types identified in § 176.170(c) of this chapter, table 1, under
Types V, VIII, and IX.
Sodium dioctyl sulfosuccinate.
Sodium dodecylbenzenesulfonate.
Sodium lauryl sulfate.
Sorbitan and sorbitol esters of fatty acids from vegetable
or animal oils.
Spermaceti wax.
Tetrahydrofuran.
Toluene.
(iv) Preservatives:
Silver chloride-coated titanium dioxide ................................ For use only as a preservative in latex emulsions at a level not
to exceed 2.2 parts per million (based on silver ion con-
centration) in the dry coating.
(c) The coating in the finished form (b) The quantity of any optional sub-
in which it is to contact food, when ex- stance does not exceed the amount rea-
tracted with the solvent or solvents sonably required to accomplish the in-
characterizing the type of food, and tended physical or technical effect nor
under conditions of time and tempera- any limitations further provided.
ture characterizing the conditions of (c) Any optional substance that is
its intended use as determined from ta- the subject of a regulation in parts 174,
bles 1 and 2 of § 176.170(c) of this chap- 175, 176, 177, 178, and § 179.45 of this
ter, shall yield net chloroform-soluble chapter conforms with any specifica-
extractives not to exceed 0.5 milligram tions in such regulation.
per square inch of coated surface. (d) Optional substances as provided
(d) Acrylonitrile copolymers identi- in paragraph (a) of this section include:
fied in this section shall comply with (1) Substances generally recognized
the provisions of § 180.22 of this chap- as safe in food.
ter. (2) Substances subject to prior sanc-
tion or approval for uses with a copoly-
mer of vinyl acetate and crotonic acid
FR 7206, Feb. 21, 1978; 45 FR 6541, Jan. 29,
1980; 47 FR 22512, May 25, 1982; 49 FR 36497, and used in accordance with such sanc-
Sept. 18, 1984; 50 FR 47209, Nov. 15, 1985; 56 FR tion or approval.
49674, Oct. 1, 1991; 61 FR 14246, Apr. 1, 1996; 63 (3) Substances identified in this sub-
FR 71017, Dec. 23, 1998; 64 FR 2568, Jan. 15, paragraph and subject to such limita-
1999; 65 FR 6892, Feb. 11, 2000; 65 FR 37041, tions as are provided:
June 13, 2000; 87 FR 31089, May 20, 2022]
§ 175.350 Vinyl acetate/crotonic acid
Silica.
copolymer.
Japan wax.
A copolymer of vinyl acetate and
crotonic acid may be safely used as a (e) Copolymer of vinyl acetate and
coating or as a component of a coating crotonic acid used as a coating or as a
which is the food-contact surface of component of a coating conforming
polyolefin films intended for packaging with the specifications of paragraph
food, subject to the provisions of this (e)(1) of this section are used as pro-
section. vided in paragraph (e)(2) of this sec-
(a) The copolymer may contain added tion.

optional substances to impart desired (1) Specifications. (i) The chloroform-
properties. soluble portion of the water extractives
204
of the coated film obtained with dis- (d) The coating in the finished form
tilled water at 120 °F for 24 hours does in which it is to contact food, when ex-
not exceed 0.5 milligram per square tracted with the solvent or solvents
inch of coated surface. characterizing the type of food, and
(ii) The chloroform-soluble portion of under conditions of time and tempera-
the n-heptane extractives of the coated ture characterizing the conditions of
film obtained with n-heptane at 70 °F its intended use as determined from ta-
for 30 minutes does not exceed 0.5 milli- bles 1 and 2 of § 176.170(c) of this chap-
gram per square inch of coated surface. ter, shall yield net chloroform-soluble
(2) Conditions of use. The copolymer extractives not to exceed 0.5 milligram
of vinyl acetate and crotonic acid is per square inch of coated surface when
used as a coating or as a component of tested by the methods described in
a coating for polyolefin films for pack- § 176.170(d) of this chapter.
aging bakery products and confec- (e) Acrylonitrile copolymers identi-
tionery. fied in this section shall comply with
the provisions of § 180.22 of this chap-
§ 175.360 Vinylidene chloride copoly- ter.
mer coatings for nylon film. [42 FR 14534, Mar. 15, 1977, as amended at 43
Vinylidene chloride copolymer coat- FR 7206, Feb. 21, 1978; 45 FR 76998, Nov. 21,
ings identified in this section and ap- 1980; 47 FR 54430, Dec. 3, 1982]
plied on nylon film may be safely used § 175.365 Vinylidene chloride copoly-
as food-contact surfaces, in accordance mer coatings for polycarbonate
with the following prescribed condi- film.
tions:
Vinylidene chloride copolymer coat-
(a) The coating is applied as a contin- ings identified in this section and ap-
uous film over one or both sides of a plied on polycarbonate film may be
base film produced from nylon resins safely used as food-contact surfaces, in
complying with § 177.1500 of this chap- accordance with the following pre-
ter. scribed conditions:
(b) The coatings are prepared from (a) The coating is applied as a contin-
vinylidene chloride copolymers pro- uous film over one or both sides of a
duced by copolymerizing vinylidene base film produced from polycarbonate
chloride with one or more of the mono- resins complying with § 177.1580 of this
mers acrylic acid, acrylonitrile, ethyl chapter.
acrylate, methacrylic acid, methyl ac- (b) The coatings are prepared from
rylate, methyl methacrylate (CAS Reg. vinylidene chloride copolymers pro-
No. 80–62–6; maximum use level 6 duced by copolymerizing vinylidene
weight percent) and 2-sulfoethyl meth- chloride with acrylonitrile, methyl ac-
acrylate (CAS Reg. No. 10595–80–9; max- rylate, and acrylic acid. The finished
imum use level 1 weight percent). The copolymers contain at least 50 weight-
finished copolymers contain at least 50 percent of polymer units derived from
weight percent of polymer units de- vinyldene chloride.
rived from vinylidene chloride. The fin- (c) Optional adjuvant substances em-
ished coating produced from vinylidene ployed in the production of the coat-
chloride copolymers produced by co- ings or added thereto to impart desired
polymerizing vinylidene chloride with properties may include sodium
methyl methacrylate and/or 2- dodecylbenzenesulfonate in addition to
sulfoethyl methacrylate, or with meth- substances described in § 174.5(d) of this
yl methacrylate and/or 2-sulfoethyl chapter.
methacrylate together with one or (d) The coating in the finished form
more of the other monomers from this in which it is to contact food, when ex-
section, is restricted to use at or below tracted with the solvent or solvents
room temperature. characterizing the type of food, and
(c) Optional adjuvant substances em- under the conditions of time and tem-
ployed in the production of the coat- perature characterizing the conditions
ings or added thereto to impart desired of its intended use as determined from
properties may include sodium tables 1 and 2 of § 176.170(c) of this chap-
dodecylbenzenesulfonate. ter, shall yield net chloroform-soluble
205
§ 175.380 21 CFR Ch. I (4–1–23 Edition)
extractives in each extracting solvent 0.05 milligram per square inch of food-
not to exceed 0.5 milligram per square contact surface.
inch of coated surface as determined by (c) The resins identified in paragraph
the methods described in § 176.170(d) of (a) of this section may be used as a
this chapter. In testing the finished food-contact coating for articles in-
food-contact articles, a separate test tended for contact at temperatures not
sample is to be used for each required to exceed room temperature with food
extracting solvent. of Type VI-C described in table 1 of
(e) Acrylonitrile copolymers identi- § 176.170(c) of this chapter provided the
fied in this section shall comply with coating in the finished form in which it
the provisons of § 180.22 of this chapter. is to contact food meets the following
extractives limitations when tested by
§ 175.380 Xylene-formaldehyde resins the methods provided in § 175.300(e):
condensed with 4,4′- (1) The coating when extracted with
isopropylidenediphenol- distilled water at 180 °F for 24 hours
epichlorohydrin epoxy resins.
yields total extractives not to exceed
The resins identified in paragraph (a) 0.05 milligram per square inch of food-
of this section may be safely used as a contact surface.
food-contact coating for articles in- (2) The coating when extracted with
tended for use in contact with food, in 50 percent (by volume) ethyl alcohol in
accordance with the following pre- distilled water at 180 °F for 24 hours
scribed conditions. yields total extractives not to exceed
(a) The resins are produced by the 0.05 milligram per square inch.
condensation of xylene-formaldehyde
resin and 4,4′-isopropylidenediphenol- § 175.390 Zinc-silicon dioxide matrix
epichlorohydrin epoxy resins, to which coatings.
may have been added certain optional Zinc-silicon dioxide matrix coatings
adjuvant substances required in the may be safely used as the food-contact
production of the resins or added to im- surface of articles intended for use in
part desired physical and technical producing, manufacturing, packing,
properties. The optional adjuvant sub- processing, preparing, treating, pack-
stances may include resins produced by aging, transporting, or holding food,
the condensation of allyl ether of subject to the provisions of this sec-
mono-, di-, or trimethylol phenol and tion;
capryl alcohol and also may include (a) The coating is applied to a metal
substances identified in § 175.300(b)(3), surface, cured, and washed with water
with the exception of paragraph to remove soluble substances.
(b)(3)(xxxi) and (xxxii) of that section. (b) The coatings are formulated from
(b) The resins identified in paragraph optional substances which include:
(a) of this section may be used as a (1) Substances generally recognized
food-contact coating for articles in- as safe.
tended for contact at temperatures not (2) Substances for which safe condi-
to exceed 160 °F with food of Types I, tions of use have been prescribed in
II, VI-A and B, and VIII described in § 175.300.
table 1 of § 176.170(c) of this chapter (3) Substances identified in para-
provided that the coating in the fin- graph (c) of this section, subject to the
ished form in which it is to contact limitations prescribed.
food meets the following extractives (c) The optional substances per-
limitations when tested by the meth- mitted are as follows:
ods provided in § 175.300(e):
(1) The coating when extracted with List of substances Limitations
distilled water at 180 °F for 24 hours Ethylene glycol ...................... As a solvent removed by
yields total extractives not to exceed water washing.
0.05 milligram per square inch of food- Iron oxide.
Lithium hydroxide .................. Removed by water washing.
contact surface. Methyl orange ........................ As an acid-base indicator.
(2) The coating when extracted with 8 Potassium dichromate ........... Removed by water washing.
percent (by volume) ethyl alcohol in Silica gel.

distilled water at 160 °F for 4 hours Sodium silicate.
Zinc, as particulate metal.
yields total extractives not to exceed
206
(d) The coating in the finished form Subpart A [Reserved]

in which it is to contact food, when ex-
characterizing the type of food, and
Subpart B—Substances for Use
under the conditions of its intended use Only as Components of Paper
as shown in table 1 and 2 of § 175.300(d) and Paperboard
(using 20 percent alcohol as the solvent
§ 176.110 Acrylamide-acrylic acid res-
when the type of food contains approxi- ins.
mately 20 percent alcohol) shall yield
total extractives not to exceed those Acrylamide-acrylic acid resins may
prescribed in § 175.300(c)(3); lithium ex- be safely used as components of arti-
tractives not to exceed 0.025 milligram cles intended for use in producing,
per square inch of surface; and chro- manufacturing, packing, processing,
mium extractives not to exceed 0.05 preparing, treating, packaging, trans-
microgram per square inch of surface. porting, or holding food, subject to the
(e) The coatings are used as food-con- provisions of this section.
tact surfaces for bulk reusable con- (a) Acrylamide-acrylic acid resins are
tainers intended for storing, handling, produced by the polymerization of ac-
and transporting food. rylamide with partial hydrolysis or by
the copolymerization of acrylamide
and acrylic acid.
PART 176—INDIRECT FOOD ADDI- (b) The acrylamide-acrylic acid res-
TIVES: PAPER AND PAPERBOARD ins contain less than 0.2 percent resid-
COMPONENTS ual monomer.
(c) The resins are used as adjuvants
Subpart A [Reserved] in the manufacture of paper and paper-
board in amounts not to exceed that
Subpart B—Substances for Use Only as necessary to accomplish the technical
Components of Paper and Paperboard effect and not to exceed 2 percent by
Sec. weight of the paper or paperboard.
176.110 Acrylamide-acrylic acid resins.
176.120 Alkyl ketene dimers.
§ 176.120 Alkyl ketene dimers.
176.130 Anti-offset substances. Alkyl ketene dimers may be safely
176.150 Chelating agents used in the manu- used as a component of articles in-
facture of paper and paperboard. tended for use in producing, manufac-
176.160 Chromium (Cr III) complex of N- turing, packing, processing, preparing,
ethyl-N-heptadecylfluoro-octane sulfonyl treating, packaging, transporting, or
glycine.
holding food, subject to the provisions
176.170 Components of paper and paperboard
in contact with aqueous and fatty foods.
of this section.
176.180 Components of paper and paperboard (a) The alkyl ketene dimers are man-
in contact with dry food. ufactured by the dehydrohalogenation
176.200 Defoaming agents used in coatings. of the acyl halides derived from the
176.210 Defoaming agents used in the manu- fatty acids of animal or vegetable fats
facture of paper and paperboard. and oils.
176.230 3,5-Dimethyl-1,3,5,2H- (b) The alkyl ketene dimers are used
tetrahydrothiadiazine-2-thione. as an adjuvant in the manufacture of
176.250 Poly-1,4,7,10,13-pentaaza-15- paper and paperboard under such condi-
hydroxyhexadecane. tions that the alkyl ketene dimers and
176.260 Pulp from reclaimed fiber. their hydrolysis products dialkyl
176.300 Slimicides.
ketones do not exceed 0.4 percent by
176.320 Sodium nitrate-urea complex.
176.350 Tamarind seed kernel powder.
weight of the paper or paperboard.
(c) The alkyl ketene dimers may be
AUTHORITY: 21 U.S.C. 321, 342, 346, 348, 379e. used in the form of an aqueous emul-
SOURCE: 42 FR 14554, Mar. 15, 1977, unless sion which may contain sodium
otherwise noted. lignosulfonate as a dispersant.
EDITORIAL NOTE: Nomenclature changes to § 176.130 Anti-offset substances.

FR 56035, Nov. 6, 2001; and 70 FR 72074, Dec. Substances named in paragraphs (b)
1, 2005. and (c) of this section may be safely
207
§ 176.150 21 CFR Ch. I (4–1–23 Edition)
used to prevent the transfer of inks to accomplish the intended technical

employed in printing and decorating effect nor greater than any specific
paper and paperboard used for food limitation, where such is provided.
packaging in accordance with the pro-
visions of this section: § 176.160 Chromium (Cr III) complex
(a) The substances are applied to the of N-ethyl-N-heptadecylfluoro-oc-
nonfood contact, printed side of the tane sulfonyl glycine.
paper or paperboard in an amount not The chromium (Cr III) complex of N-
greater than that required to accom- ethyl - N -heptadecylfluoro-octane
plish the technical effect nor greater sulfonyl glycine containing up to 20
than any specific limitations, where percent by weight of the chromium (Cr
such are provided. III) complex of heptadecylfluoro-octane
(b) Anti-offset powders are prepared sulfonic acid may be safely used as a
from substances that are generally rec- component of paper for packaging dry
ognized as safe in food, substances for food when used in accordance with the
which prior sanctions or approvals following prescribed conditions.
were granted and which are used in ac- (a) The food additive is used as a
cordance with the specific provisions of component of paper in an amount not
such sanction or approval, and sub- to exceed 0.5 percent by weight of the
stances named in paragraph (c) of this paper.
section. (b)(1) The food-contact surface of the
(c) The substances permitted are as paper is overcoated with a polymeric or
follows: resinous coating at least 1⁄3-mil in
Substances Limitations thickness, that meets the provision of
§ 176.170; or
Carbon tetrachloride.
Methyl hydrogen
(2) The treated paper forms one or
polysiloxanes. more plies of a paper in a multiwall
Industrial starch—modified .... Complying with § 178.3520 of bag and is separated from the food by
this chapter.
at least one ply of packaging films or
Stannous oleate.
Zinc-2-ethyl hexoate. grease-resistant papers which serves as
a functional barrier between the food
additive and the food. Such packaging
§ 176.150 Chelating agents used in the
manufacture of paper and paper- films or grease-resistant papers con-
board. form with appropriate food additive
regulations.
The substances named in paragraph
(c) The labeling of the food additive
(a) of this section may be safely used in
shall contain adequate directions for
the manufacture of paper and paper-
board, in accordance with the condi- its use to insure compliance with the
tions prescribed in paragraphs (b) and requirements of paragraphs (a) and (b)
(c) of this section: of this section.
(a) Chelating agents:
§ 176.170 Components of paper and pa-
List of substances Limitations perboard in contact with aqueous
and fatty foods.
Ammonium fructoheptonate.
Ammonium glucoheptonate. Substances identified in this section
Disodium ethylenediamine tetraacetate. may be safely used as components of
Pentasodium salt of diethylenetriamine the uncoated or coated food-contact
pentaacetate.
Sodium fructoheptonate. surface of paper and paperboard in-
Sodium glucoheptonate. tended for use in producing, manufac-
Tetrasodium ethylenediamine tetra- turing, packaging, processing, pre-
acetate.
Trisodium N-hydroxyethyl ethylene- paring, treating, packing, transporting,
diamine triacetate. or holding aqueous and fatty foods,
subject to the provisions of this sec-
(b) Any one or any combination of tion. Components of paper and paper-
the substances named is used or in- board in contact with dry food of the
tended for use as chelating agents. type identified under Type VIII of table
(c) The substances are added in an 1 in paragraph (c) of this section are
amount not greater than that required subject to the provisions of § 176.180.
208
(a) Substances identified in paragraph (a) are present in the food-con-
graph (a)(1) through (5) of this section tact surface of such paper or paper-
may be used as components of the food- board.
contact surface of paper and paper- (1) Substances generally recognized
board. Paper and paperboard products as safe in food.
shall be exempted from compliance (2) Substances generally recognized
with the extractives limitations pre- as safe for their intended use in paper
scribed in paragraph (c) of this section: and paperboard products used in food
Provided, That the components of the packaging.
food-contact surface consist entirely of (3) Substances used in accordance
one or more of the substances identi- with a prior sanction or approval.
fied in this paragraph: And provided fur- (4) Substances that by regulation in
ther, That if the paper or paperboard parts 170 through 189 of this chapter
when extracted under the conditions may be safely used without extractives
prescribed in paragraph (c) of this sec- limitations as components of the
tion exceeds the limitations on extrac- uncoated or coated food-contact sur-
tives contained in paragraph (c) of this face of paper and paperboard in contact
section, information shall be available with aqueous or fatty food, subject to
from manufacturing records from the provisions of such regulation.
which it is possible to determine that (5) Substances identified in this para-
only substances identified in this paragraph, as follows:
List of Substances Limitations
Acetyl peroxide ............................................................................ For use only as polymerization catalyst.

Acrylamide-methacrylic acid-maleic anhydride copolymers con- For use only as a retention aid employed prior to the sheet-
taining not more than 0.2 percent of residual acrylamide forming operation in the manufacture of paper and paper-
monomer and having an average nitrogen content of 14.9 board in such an amount that the finished paper and paper-
percent such that a 1 percent by weight aqueous solution board will contain the additive at a level not in excess of
has a minimum viscosity of 600 centipoises at 75 °F, as de- 0.05 percent by weight of dry fibers in the finished paper and
termined by LVG-series Brookfield viscometer (or equivalent) paperboard.
using a No. 2 spindle at 30 r.p.m.
Acrylamide-b-methacrylyloxyethyltrimethylammonium methyl For use only as a retention aid and flocculant employed prior
sulfate copolymer resins containing not more than 10 molar to the sheet-forming operation in the manufacture of paper
percent of b-methacrylyloxyethyltrimethylammonium methyl and paperboard.
sulfate and containing less than 0.2% of residual acrylamide
monomer.
Acrylic acid, sodium salt copolymer with polyethyleneglycol allyl For use only in paper mill boilers.
ether (CAS Reg. No. 86830–15–1).
Acrylic acid copolymer with 2-acrylamido-2-methylpropane-sul- For use only as a scale inhibitor prior to the sheet-forming op-
fonic acid (CAS Reg. No. 40623–75–4) and/or its ammo- eration in the manufacture of paper and paperboard and
nium/alkali metal mixed salts. The copolymer is produced by used at a level not to exceed 1.0 kilogram (2.2 pounds) of
poly-merization of acrylic acid and 2-acrylamido-2- copolymer per 907 kilograms (1 ton) of dry paper and paper-
methylpropane-sulfonic acid in a weight ratio of 60/40, such board fibers.
that a 28 percent by weight aqueous solution of the polymer
has a viscosity of 75–150 centipoises at 25 °C as deter-
mined by LV-series Brookfield viscometer (or equivalent)
using a No. 2 spindle at 60 r.p.m.
Acrylonitrile polymer, reaction product with ethylenediamine For use only as a size promoter and retention aid at a level not
sulfate having a nitrogen content of 22.5–25.0 percent (Kjel- to exceed 0.5 percent by weight of the dry paper and paper-
dahl dry basis) and containing no more than 0.075 percent board.
monomer as ethylenediamine. The finished resin in a 24 per-
cent by weight aqueous solution has a viscosity of 1,000–
2,000 centipoises at 25 °C as determined by LVT-series
Brookfield viscometer using a No. 4 spindle at 50 r.p.m. (or
by other equivalent method).
Acrylonitrile polymer with styrene, reaction product with ethyl- 1. For use only as a sizing material applied after the sheet-
enediamine acetate, having a nitrogen content of 7.4–8.3 forming operation in the manufacture of paper and paper-
percent (Kjeldahl dry basis) and containing no more than board in such amount that the paper and paperboard will
0.25 percent monomer as ethylenediamine. contain the additive at a level not in excess of 0.25 percent
by weight of the dry paper and paperboard.
2. For use only as a sizing material applied prior to the sheet-
forming operation in the manufacture of paper and paper-
board in such amount that the paper and paperboard will
contain the additive at a level not in excess of 1.0 percent by
weight of the dry paper and paperboard.
209
§ 176.170 21 CFR Ch. I (4–1–23 Edition)
1-Alkenyl olefins, containing not less than 72 percent of C30 For use only under the following conditions:
and higher olefins. 1. In coatings for paper and paperboard with food of Types I,
II, IV-B, and VII-B described in table 1 of paragraph (c) of
this section under conditions of use E, F, and G described in
table 2 of paragraph (c) of this section.
2. In coatings for paper and paperboard with food of Type VIII
described in table I of paragraph (c) of this section under
conditions of use A through H described in table 2 of para-
graph (c) of this section.
(2-Alkenyl) succinic anhydrides mixture, in which the alkenyl For use only as a sizing agent employed prior to the sheet-
groups are derived from olefins which contain not less than forming operation in the manufacture of paper and paper-
95 percent of C15-C21 groups. board and limited to use at a level not to exceed 1 percent
by weight of the finished dry paper and paperboard fibers.
Alkyl(C12-C20)methacrylatemethacrylic acid copolymers (CAS For use only as stabilizers employed prior to the sheet-forming
Reg. No. 27401–06–5). operation in the manufacture of paper and paperboard.
tert-Alkyl(C8-C16)mercaptans ....................................................... For use only as polymerization-control agent.
Aluminum acetate.
2-Amino-2-methyl-1-propanol (CAS Reg. No. 124–68–5) .......... For use as a dispersant for pigment suspension at a level not
to exceed 0.25 percent by weight of pigment. The suspen-
sion is used as a component of coatings for paper and pa-
perboard under conditions of use described in paragraph (c)
of this section, table 2, conditions of use E through G.
Ammonium thiosulfate.
Ammonium zirconium carbonate (CAS Reg. No. 32535–84–5) For use only as an insolubilizer for binders used in coatings for
and its tartaric acid adduct. paper and paperboard, and limited to use at a level not to
exceed 2.5 percent by weight of coating solids.
Ammonium zirconium citrate (CAS Reg. No. 149564–62–5), For use as insolubilizers with protein binders in coatings for
ammonium zirconium lactate-citrate (CAS Reg. No. 149564– paper and paperboard, at a level not to exceed 1.4 percent
64–7), ammonium zirconium lactate (CAS Reg. No. 149564– by weight of coating solids.
63–6).
Anionic polyurethane, produced by reacting the preliminary For use only as a surface sizing agent at a level not to exceed
adduct formed from the reaction of glyceryl monostearate 0.1 percent by weight of dry paper and paperboard.
and 2,4-toluenediisocyanate with not more than 10 mole per-
cent N-methyldiethanolamine and not less than 90 mole per-
cent dimethylolpropionic acid. The final product is a 15 to 20
percent by weight aqueous solution, having a Brookfield vis-
cosity of 25 to 100 centipoises at 24 °C (75 °F).
9,10–Anthraquinone (Chemical Abstracts Service Registry No. For use only as a pulping aid in the alkaline pulping of
84–65–1) which has a purity of not less than 98 percent. lignocellulosic material at levels not to exceed 0.1 percent by
weight of the raw lignocellulosic material.
Aromatic petroleum hydrocarbon resin, hydrogenated (CAS For use only as modifiers in wax polymer blend coatings for
Reg. No. 88526–47–0), produced by the catalytic polym- paper and paperboard at a level not to exceed 50 weight-
erization of aromatic substituted olefins from low boiling dis- percent of the coating solids under conditions of use E, F,
tillates of cracked petroleum stocks with a boiling point no and G identified in table 2 of paragraph (c) of this section.
greater than 220 °C (428 °F), and the subsequent catalytic
reduction of the resulting aromatic petroleum hydrocarbon
resin. The resin meets the following specifications: softening
point 85 °C (185 °F) minimum, as determined by ASTM
Method E 28–67 (Reapproved 1982), ‘‘Standard Test Meth-
od for Softening Point by Ring-and-Ball Apparatus,’’ and ani-
line point 70 °C (158 °F) minimum, as determined by ASTM
Method D 611–82, ‘‘Standard Test Methods for Aniline Point
and Mixed Aniline Point of Petroleum Products and Hydro-
carbon Solvents,’’ which are incorporated by reference in ac-
cordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
may be obtained from the American Society for Testing and
Materials, 100 Barr Harbor Dr., West Conshohocken, Phila-
delphia, PA 19428-2959, or may be examined at the Na-
tional Archives and Records Administration (NARA). For in-
formation on the availability of this material at NARA, call
202–741–6030, or go to: http://www.archives.gov/fed-
eral_register/code_of_federal_regulations/ibr_locations.html..
Azo-bisisobutyronitrile .................................................................. For use only as polymerization catalyst.
1,2-Benzisothiazolin-3-one (CAS Registry No. 2634–33–5) ....... For use only as a preservative in paper coating compositions
and limited to use at a level not to exceed 0.01 mg/in2
(0.0016 mg/cm2) of the finished paper and paperboard.
Benzoyl peroxide ......................................................................... Do.
N,N-Bis(2-hydroxyethyl)alkyl (C12-C18)amide .............................. For use only as an adjuvant to control pulp absorbency and
pitch content in the manufacture of paper and paperboard
prior to the sheet forming operation.
210
Bis(methoxymethyl)tetrakis-[(octadecyloxy)-methyl]melamine For use only under the following conditions:

resins having a 5.8–6.5 percent nitrogen content (CAS Reg. 1. As a water repellant employed prior to the sheet-forming op-
No. 68412–27–1). eration in the manufacture of paper and paperboard in such
amount that the finished paper and paperboard will contain
the additive at a level not in excess of 1.6 percent by weight
of the finished dry paper and paperboard fibers.
2. The finished paper and paperboard will be used in contact
with nonalcoholic foods only.
3. As a water repellant employed after the sheet-forming oper-
ation in the manufacture of paper and paperboard in such
amount that the finished paper and paperboard will contain
the additive at a level not to exceed 1.6 percent by weight of
the finished dry paper and paperboard fibers. The finished
paper and paperboard will be used only in contact with food
of Types I, II, IV-B, VI, VII-B, and VIII described in table 1 of
paragraph (c) of this section.
2-Bromo-2-nitro-1,3-propanediol (CAS Reg. No. 52–51–7) ........ For use only as an antimicrobial/preservative in fillers, pigment
slurries, starch sizing solutions, and latex coatings at levels
not to exceed 0.01 percent by weight of those components.
Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium For use as a surface active agent in package coating inks at
salt (also known as butanedioic acid, sulfo-1,4-diisodecyl levels not to exceed 3 percent by weight of the coating ink.
ester, ammonium salt [CAS Reg. No. 144093–88–9])..
tert-Butyl hydroperoxide .............................................................. For use only as polymerization catalyst.
tert-Butyl peroxide ....................................................................... Do.
Calcium isostearate ..................................................................... For use only with n-decyl alcohol as a stabilizing material for
aqueous calcium stearate dispersions intended for use as
components of coatings for paper and paperboard.
Carrageenan and salts of carrageenan as described in
§§ 172.620 and 172.626 of this chapter.
Castor oil, hydrogenated.
Castor oil, sulfated, ammonium, potassium, or sodium salt.
Cellulose, regenerated.
Chloracetamide ............................................................................ For use only as polymerization-control agent.
Cobaltous acetate ........................................................................ For use only as polymerization catalyst.
Cumene hydroperoxide ............................................................... Do.
Cyanoguanidine ........................................................................... For use only:
1. As a modifier for amino resins.
2. As a fluidizing agent in starch and protein coatings for paper
and paperboard.
n-Decyl alcohol ............................................................................ For use only with calcium isostearate as a stabilizing material
for aqueous calcium stearate dispersions intended for use as
components of coatings for paper and paperboard.
Dialdehyde guar gum .................................................................. For use only as a wet-strength agent employed prior to the
sheet-forming operation in the manufacture of paper and pa-
perboard and used at a level not to exceed 1% by weight of
the finished dry paper and paperboard fibers.
Dialdehyde locust bean gum ....................................................... Do.
Dialkyl(C16-C18)carbamoyl chloride (CAS Reg. No. 41319–54– For use as a sizing agent at a level not to exceed 0.2 percent
4) manufactured by the reaction of secondary amines de- by weight of the dry fiber.
rived from fatty acids of animal or vegetable sources with
phosgene.
Diallyldimethyl ammonium chloride polymer with acrylamide For use only as a retention and/or drainage aid employed prior
and potassium acrylate, produced by copolymerizing either to the sheet-forming operations in the manufacture of paper
(1) diallyldimethyl ammonium chloride and acrylamide in a and paperboard and limited to use at a level not to exceed
weight ratio of 50/50, with 4.4 percent of the acrylamide sub- 0.05 percent by weight of the finished paper and paper-
sequently hydrolyzed to potassium acrylate or (2) polym- board.
erized diallyldimethyl ammonium chloride, acrylamide and
potassium acrylate (as acrylic acid) in a weight ratio of 50/
47.8/2.2, respectively, so that the finished resin in a 1 per-
cent by weight aqueous solution (active polymer) has a vis-
cosity of more than 22 centipoises at 22 °C (72 °F) as deter-
mined by LVF series, Brookfield Viscometer using No. 1
spindle at 60 RPM (or by other equivalent method) (CAS
Reg. No. 25136–75–8).
Diallyldimethylammonium chloride with acrylamide (CAS Reg. For use only as a drainage and/or retention aid employed prior
No. 26590–05–6). The copolymer is produced by copolym- to the sheet-forming operation in the manufacture of paper
erizing diallyldimethylammonium chloride with acrylamide in and paperboard and limited to use at a level not to exceed
a weight ratio of 50–50 so that the finished resin in a 1 per- 0.05 percent by weight of the finished paper and paper-
cent by weight aqueous solution (active polymer) has a vis- board.
cosity of more than 22 centipoises at 22 °C (71.6 °F), as de-

termined by LVF-series Brookfield viscometer using a No. 1
spindle at 60 r.p.m. (or by other equivalent method).
211
§ 176.170 21 CFR Ch. I (4–1–23 Edition)
Diallyldiethylammonium chloride polymer with acrylamide, and

diallyldimethylammonium chloride, produced by copolym-
erizing acrylamide, diallyldiethylammonium chloride, and
diallyldimethylammonium chloride, respectively, in the fol-
lowing weight ratios and having viscosities determined at 22
°C, by LVF-series Brookfield viscometer using a No. 1 spin-
dle at 60 r.p.m. (or by other equivalent method), as follows:.
1. Weight ratio: 50–2.5–47.5. The finished resin in a 1 per- For use only as a retention aid employed prior to the sheet-
cent by weight aqueous solution has a minimum vis- forming operation in the manufacture of paper and paper-
cosity of 22 centipoises. board and limited to use at a level not to exceed 0.05 per-
cent by weight of the finished paper and paperboard.
2. Weight ratio: 25–2.5–72.5. The finished resin in a 0.20 For use only as a drainage and/or retention aid employed prior
percent by weight aqueous solution has a minimum vis- to the sheet-forming operation in the manufacture of paper
cosity of 20 centipoises. and paperboard and limited to use at a level not to exceed
0.075 percent by weight of the finished paper and paper-
board.
3. Weight ratio: 80–2.5–17.5. The finished resin in a 0.30 For use only as a drainage and/or retention aid employed prior
percent by weight aqueous solution has a minimum vis- to the sheet-forming operation in the manufacture of paper
cosity of 50 centipoises. and paperboard and limited to use at a level not to exceed
0.075 percent by weight of the finished paper and paper-
board.
Diallyldiethylammonium chloride polymer with acrylamide, po- For use only as a retention aid employed prior to the sheet-
tassium acrylate, and diallyldimethylammonium chloride. The forming operation in the manufacture of paper and paper-
polymer is produced by copolymerizing either: (1) acryl- board and limited to use at a level not to exceed 0.05 per-
amide, diallyldiethylammonium chloride, and cent by weight of the finished paper and paperboard.
diallyldimethylammonium chloride in a weight ratio of 50–
2.5–47.5, respectively, with 4.4 percent of the acrylamide
subsequently hydrolyzed to potassium acrylate, or (2) acryl-
amide, potassium acrylate (as acrylic acid),
diallyldiethylammonium chloride, and
diallyldimethylammonium chloride in a weight ratio of 47.8–
2.2–2.5–47.5, so that the finished resin in a 1 percent by
weight aqueous solution has a minimum viscosity of 22 cen-
tipoises at 22 °C, as determined by LVF-series Brookfield
viscometer using a No. 1 spindle at 60 r.p.m. (or by other
equivalent method).
Diallyldimethylammonium chloride polymer with acrylamide, re- For use only as a dry and wet strength agent employed prior
action product with glyoxal, produced by copolymerizing not to the sheet-forming operation in the manufacture of paper
less than 90 weight percent of acrylamide and not more than and paperboard in such an amount that the finished paper
10 weight percent of diallyldimethylammonium chloride, and paperboard will contain the additive at a level not in ex-
which is then cross-linked with not more than 30 weight per- cess of 2 percent by weight of the dry fibers in the finished
cent of glyoxal, such that a 10 percent aqueous solution has paper and paperboard.
a minimum viscosity of 25 centipoises at 25 °C as deter-
mined by Brookfield viscometer Model RVF, using a No. 1
spindle at 100 r.p.m.
2,2-Dibromo-3-nitrilopropionamide (CAS Reg. No.10222–01–2). For use as a preservative at a level not to exceed 100 parts
per million in coating formulations and in component slurries
and emulsions, used in the production of paper and paper-
board and coatings for paper and paperboard.
2,5-Di-tert-butyl hydroquinone ..................................................... For use only as an antioxidant for fatty based coating adju-
vants provided it is used at a level not to exceed 0.005% by
weight of coating solids.
Diethanolamine ............................................................................ For use only:
1. As an adjuvant to control pulp absorbency and pitch content
in the manufacture of paper and paperboard prior to the
sheet-forming operation.
2.In paper mill boilers.
Diethyl(2-hydroxyethyl) methylammonium methyl sulfate, acry- For use only as a retention aid and drainage aid employed
late, polymer with acrylamide, chemical abstract service reg- prior to the sheet-forming operation in the manufacture of
istry No. [26796–75–8] having 90–95 mole pct. acrylamide, a paper and paperboard at a level not to exceed 0.15 pct. by
nitrogen content of not more than 19.7 pct. (Kjeldahl, dry weight of finished dry paper and paperboard fibers.
basis), and a residual acrylamide monomer content of not
more than 0.1 pct. The finished polymer in a 1 pct. by weight
aqueous solution has a minimum viscosity of 900 centipoises
at 25 °C as determined by LVT-series Brookfield viscometer
using a No. 2 spindle at 12 r.p.m. (or by equivalent method).
Diethylenetriamine ....................................................................... For use only as a modifier for amino resins.
N,N-Diisopropanolamide of tallow fatty acids ............................. For use only as an adjuvant to control pulp absorbency and
prior to the sheet-forming operation.
212
Dimethylamine-epichlorohydrin copolymer in which not more For use only:

than 5 mole-percent of dimethylamine may be replaced by 1. As a retention aid employed before the sheet-forming oper-
an equimolar amount of ethylenediamine and in which the ation in the manufacture of paper and paperboard and lim-
ratio of total amine to epichlorohydrin does not exceed 1:1. ited to use at a level not to exceed 1 percent by weight of
The nitrogen content of the copolymer shall be 9.4 to 10.8 the finished paper and paperboard.
weight percent on a dry basis and a 10 percent by weight 2. At the size press at a level not to exceed 0.017 percent by
aqueous solution of the final product has a minimum vis- weight of the finished paper and paperboard.
cosity of 5.0 centipoises at 25 °C, as determined by LVT-se-
ries Brookfield viscometer using a No. 1 spindle at 60 r.p.m.
(or by other equivalent method).
N-[(Dimethylamino)methyl]-acrylamide polymer with acrylamide For use only as a dry-strength agent employed prior to the
and styrene having a nitrogen content of not more than 16.9 sheet-forming operation in the manufacture of paper and pa-
percent and a residual acrylamide monomer content of not perboard and used at a level not to exceed 1 percent by
more than 0.2 percent on a dry basis. weight of finished dry paper or paperboard fibers.
N,N′-Dioleoylethylenediamine.
Diphenylamine ............................................................................. For use only as an antioxidant for fatty based coating adju-
vants provided it is used at a level not to exceed 0.005% by
Dipropylene glycol.
Disodium salt of 1,4-dihydro-9,10-dihydroxyanthracene (CAS For use only as a catalyst in the alkaline pulping of
Reg. No. 73347–80–5). lignocellulosic materials at levels not to exceed 0.1 percent
by weight of the raw lignocellulosic materials.
n-Dodecylguanidine acetate ........................................................ For use only as an antimicrobial agent in paper and paper-
board under the following conditions:
1. For contact only with nonalcoholic food having a pH above 5
and provided it is used at a level not to exceed 0.4 percent
by weight of the paper and paperboard.
2. For use in the outer ply of multiwall paper bags for contact
with dry food of Type VIII described in table I of paragraph
(c) of this section and provided it is used at a level of 0.8
percent by weight of the paper.
n-Dodecylguanidine hydrochloride .............................................. For use only as an antimicrobial agent in paper and paper-
board under the following conditions:
1. For contact only with nonalcoholic food having a pH above 5
and provided it is used at a level not to exceed 0.4 percent
by weight of the paper and paperboard.
2. For use in the outer ply of multiwall paper bags for contact
with dry food of Type VIII described in table I of paragraph
(c) of this section and provided it is used at a level of 0.8
percent by weight of the paper.
Fatty acids derived from animal and vegetable fats and oils
and salts of such acids, single or mixed, as follows:
Aluminum.
Ammonium.
Calcium.
Magnesium.
Potassium.
Sodium.
Zinc.
Ferric chloride.
Ferrous ammonium sulfate.
Fish oil, hydrogenated.
Fish oil, hydrogenated, potassium salt.
Furcelleran and salts of furcelleran as described in §§ 172.655
and 172.660 of this chapter.
Glutaraldehyde (CAS Reg. No. 111–30–8) ................................. For use only as an antimicrobial agent in pigment and filler
slurries used in the manufacture of paper and paperboard at
levels not to exceed 300 parts per million by weight of the
slurry solids.
Glyceryl lactostearate.
Glyceryl mono-1,2-hydroxystearate.
Glyceryl monoricinoleate.
Guar gum modified by treatment with b-diethylaminoethyl For use only as a retention aid and/or drainage aid employed
chloride hydrochloride. prior to the sheet-forming operation in the manufacture of
paper and paperboard.
213
§ 176.170 21 CFR Ch. I (4–1–23 Edition)
Guar gum modified by treatment with not more than 25 weight For use only as a retention aid and/or internal size employed
percent of 2,3-epoxypropyltri-methylammonium chloride such prior to the sheet-forming operation in the manufacture of
that the finished product has a maximum chlorine content of paper and paperboard, and limited to use at a level: (1) Not
4.5 percent, a maximum nitrogen content of 3.0 percent, and to exceed 0.15 percent by weight of the finished dry paper
a minimum viscosity in 1-percent-by-weight aqueous solution and paperboard fibers intended for use in contact with all
of 1,000 centipoises at 77 °F, as determined by RV-series types of foods, except (2) not to exceed 0.30 pct. by weight
Brookfield viscometer (or equivalent) using a No. 3 spindle at of the finished dried paper and paperboard fibers for use
20 r.p.m. with nonalcoholic and nonfatty food of types identified under
Types I, II, IV-B, VI-B, VII-B, and VIII of table I in par. (c) of
this section.
N,N,N′,N′,N″,N″-Hexakis (methoxymethyl)-1,3,5-triazine-2,4,6- For use only as a water-repellent applied to the surface of
triamine polymer with stearyl alcohol, a-octadecenyl-omega- paper and paperboard at levels not to exceed 1 percent by
hydroxypoly(oxy-1,2-ethanediyl), and alkyl (C20 + ) alcohols weight of the finished dry paperboard fibers. The finished
(CAS Reg. No. 130328–24–4). paper and paperboard will be used in contact with aqueous
foods under conditions of use B through G as described in
table 2 of paragraph (c) of this section.
Hexamethylenetetramine ............................................................. For use only as polymerization cross-linking agent for protein,
including casein.
Hydroquinone and the monomethyl or monoethyl ethers of hy- For use only as an inhibitor for monomers.
droquinone.
Hydroxymethyl-5,5-dimethylhydantoin (CAS Reg. No. 27636– For use only as a preservative in clay-type fillers at a level not
82–4), mixture with 1,3-bis(hydroxymethyl)-5,5- to exceed a combined total of 1,200 milligrams/kilograms
dimethylhydantoin (CAS Reg. No. 6440–58–0). hydroxymethyl-5,5-dimethylhydantoin and 1,3-
bis(hydroxymethyl)-5,5-dimethylhydantoin in the filler.
Hydroxypropyl guar gum having a minimum viscosity of 5,000 For use only as a dry strength and formation aid agent em-
centipoises at 25 °C., as determined by RV-series Brookfield ployed prior to the sheet-forming operation in the manufac-
viscometer using a No. 4 spindle at 20 r.p.m. (or other suit- ture of paper and paperboard and used at a level not to ex-
able method) and using a test sample prepared by dissolving ceed 1.5 percent by weight of finished dry paper or paper-
5 grams of moisture-free hydroxypropyl guar gum in 495 mil- board fibers.
liliters of a 70 percent by weight aqueous propylene glycol
solution.
12-Hydroxystearic acid-polyethylene glycol block copolymers For use only as a surfactant for dispersions of polyacrylamide
(CAS Reg. No. 70142–34–6) produced by the reaction of retention and drainage aids employed prior to the sheet
polyethylene glycol (minimum molecular weight 200) with 12- forming operation in the manufacture of paper and paper-
hydroxystearic acid. board.
Imidazolium compounds, 2–(C17 and C17-unsaturated alkyl)-1– For use only at a level not to exceed 0.5 percent by weight of
[2–(C18 and C18-unsaturated amido)ethyl]-4,5-dihydro-1- the dry paper and paperboard.
methyl, methyl sulfates (CAS Reg. No. 72749–55–4)..
Isopropyl m- and p-cresols (thymol derived) ............................... For use only as an antioxidant for fatty based coating adju-
vants provided it is used as a level not to exceed 0.005% by
Isopropyl peroxydicarbonate ....................................................... For use only as polymerization catalyst.
Japan wax.
Lanolin.
Lauryl peroxide ............................................................................ For use only as polymerization catalyst.
Lauryl sulfate salts:
Ammonium.
Magnesium.
Potassium.
Sodium.
Lecithin, hydroxylated.
Lignin sulfonate and its calcium, potassium, and sodium salts.
Maleic anhydride, polymer with ethyl acrylate and vinyl acetate, For use only as a deposit control additive prior to the sheet
hydrolyzed (CAS Reg. No. 113221–69–5) and/or its ammo- forming operation to prevent scale buildup in the manufac-
nium, potassium, and sodium salts. ture of paper and paperboard in contact with food, at a level
not to exceed 0.075 percent (as the acid) by weight of the
dry paper and paperboard.
Methacrylic acid-acrylic acid copolymer (CAS Reg. No. 25751– For use only as a boiler water additive at a level not to exceed
21–7). 50 parts per million in the boiler water.
N-methyldiallylamine hydrochloride polymer with For use only as a retention aid, flocculating agent, and wet-
epichlorohydrin having a nitrogen content of 4.8 to 5.9 per- strength agent employed in the manufacture of paper and
cent (Kjeldahl dry basis) such that a 20 percent by weight paperboard prior to the sheet-forming operation and limited
aqueous solution has a minimum viscosity of 30 centipoises to use at a level not to exceed 1.5 percent by weight of the
and maximum viscosity of 100 centipoises at 25 °C, as de- dry paper and paperboard.
termined by LVF Model Brookfield viscometer using a No. 1
spindle at 60 r.p.m. (or equivalent method).
Methyl naphthalene sulfonic acid-formaldehyde condensate, For use only as an adjuvant to control pulp absorbency and
sodium salt. pitch content in the manufacture of paper and paperboard
N-methyl-N-(tall oil acyl) taurine, sodium salt (CAS Reg. No. For use only to control scale formation in the manufacture of
61791–41–1). paper and paperboard prior to the sheetforming operation at
a level not to exceed 0.015 percent by weight of the dry

paper and paperboard.
Mineral oil, white.
214
Mono-, di-, tri-(1-methyl-1-phenylethyl)-phenol, ethoxylated, For use only as an emulsifier for rosin based sizing at a level
sulfated, ammonium salt with an average of 12 to 16 moles not to exceed 0.03 percent by weight of the finished dry
of ethylene oxide (CAS Reg. No. 68130–71–2). paper and paperboard.
Monoglyceride citrate.
Monoisopropanolamine (CAS Reg. No. 78–96–6) ...................... For use as a dispersant for titanium dioxide suspensions at a
level not to exceed 0.68 percent by weight of titanium diox-
ide. The finished paper and paperboard will be used in con-
tact with all food types under conditions of use E through G
described in table 2 of paragraph (c) of this section.
Mustardseed oil, sulfated, ammonium, potassium, or sodium
salt.
Naphthalene sulfonic acid-formaldehyde condensate, sodium For use only as an adjuvant to control pulp absorbency and
salt. pitch content in the manufacture of paper and paperboard
Nitrocellulose, 10.9–12.2% nitrogen.
Oleic acid, sulfated, ammonium, potassium, or sodium salt.
N-Oleoyl-N′-stearoylethylenediamine.
Oxystearin.
Paraformaldehyde ....................................................................... For use only as setting agent for protein.
Petrolatum ................................................................................... Complying with § 178.3700 of this chapter.
Petroleum asphalt, steam and vacuum refined to meet the fol- For use only as a component of internal sizing of paper and
lowing specifications: Softening point 88 °C to 93 °C, as de- paperboard intended for use in contact only with raw fruits,
termined by ASTM method D36–76, ‘‘Standard Test Method raw vegetables, and dry food of the type identified under
for Softening Point of Bitumen (Ring-and-Ball Apparatus);’’ Type VIII of table 1 in paragraph (c) of this section, and pro-
penetration at 25 °C not to exceed 0.3 mm, as determined vided that the asphalt is used at a level not to exceed 5% by
by ASTM method D5–73 (Reapproved 1978), ‘‘Standard weight of the finished dry paper and paperboard fibers.
Test Method for Penetration of Bituminous Materials,’’ which
are incorporated by reference (Copies may be obtained from
the American Society for Testing Materials, 100 Barr Harbor
Dr., West Conshohocken, Philadelphia, PA 19428-2959, or
may be examined at the National Archives and Records Ad-
ministration (NARA). For information on the availability of this
material at NARA, call 202–741–6030, or go to: http://
code_of_federal_regulations/ibr_locations.html.); and max-
imum weight loss not to exceed 3% when distilled to 371 °C,
nor to exceed an additional 1.1% when further distilled be-
tween 371 °C and thermal decomposition.
Petroleum wax, synthetic ............................................................ Complying with § 178.3720 of this chapter.
Phenothiazine .............................................................................. For use only as antioxidant in dry rosin size.
Phenyl acid phosphate ................................................................ For use only as polymerization catalyst in melamine-formalde-
hyde modified alkyd coatings and limited to use at a level
not to exceed 2% by weight of the coating solids.
Phenyl-b-naphthylamine .............................................................. For use only as antioxidant in dry rosin size and limited to use
at a level not to exceed 0.4% by weight of the dry rosin size.
Phosphoric acid esters and polyesters (and their sodium salts) For use as an adjuvant prior to the sheet forming operation to
of triethanolamine formed by the reaction of triethanolamine control pitch and scale formation in the manufacture of paper
with polyphosphoric acid to produce a mixture of esters hav- and paperboard intended for use in contact with food only of
ing an average nitrogen content of 1.5 percent and an aver- the types identified in paragraph (c) of this section, table 1,
age phosphorus content of 32 percent (as PO4). under Types I, IV, V, VII, VIII, and IX, and used at a level
not to exceed 0.075 percent by weight of dry paper or pa-
perboard fibers.
Poly[acrylamide-acrylic acid-N-(dimethyl-aminomethyl)acryl- For use only as a drainage aid and retention aid employed
amide], produced by reacting 2.40 to 3.12 parts by weight of prior to the sheet-forming operation in the manufacture of
polyacrylamide with 1.55 parts dimethylamine and 1 part paper and paperboard for use in contact with fatty foods
formaldehyde, and containing no more than 0.2 percent under conditions of use described in paragraph (c) of this
monomer as acrylamide. section, table 2, conditions of use E, F, and G.
Poly(2-aminoethyl acrylate nitrate-co-2-hydroxypropyl acrylate) For use only as a retention and drainage aid employed prior to
produced when one mole of hydroxypropyl acrylate and the sheet-forming operation in the manufacture of paper and
three moles of acrylic acid are reacted with three moles of paperboard at a level not to exceed 0.2 percent by weight of
ethylenimine and three moles of nitric acid, such that a 35 dry paper or paperboard fiber.
percent by weight aqueous solution has a minimum viscosity
of 150 centipoises at 72 °F., as determined by RVF-series
Brookfield viscometer (or equivalent) using a No. 2 spindle at
20 r.p.m.
Polyacrolein (1 part) -sodium bisulfite (0.7 part) adduct, con- For use only as an agent in modifying starches and starch
taining excess bisulfite (ratio of excess bisulfite to adduct not gums used in the production of paper and paperboard and
to exceed 1.5 to 1). limited to use at a level not to exceed 0.09 mg/in2 of the fin-
ished paper and paperboard.
215
§ 176.170 21 CFR Ch. I (4–1–23 Edition)
Poly[acrylamide-acrylic acid-N-(dimethylaminomethyl) acryl- For use only as a drainage aid, retention aid, or dry-strength
amide] (C.A. Registry No. 53800–41–2), produced by react- agent employed prior to the sheet-forming operation in the
ing 9.6–16.4 parts by weight of polyacrylamide with 1.6 parts manufacture of paper and paperboard at a level not to ex-
dimethylamine and 1 part formaldehyde, and containing no ceed 0.25 percent by weight of finished dry paper and pa-
more than 0.2% monomer as acrylamide, such that a 20% perboard fibers, when such paper or paperboard is used in
aqueous solution has a minimum viscosity of 4,000 cP at 25 contact with fatty foods under conditions of use described in
°C., as determined by Brookfield viscometer model RVT, paragraph (c) of this section, table 2, conditions of use E, F,
using a No. 5 spindle at 20 r/min (or equivalent method). and G.
Polyamide-epichlorohydrin modified resin produced by reacting For use only as a retention aid and flocculant employed prior
adipic acid with diethylene triamine to produce a basic poly- to the sheet-forming operation in the manufacture of paper
amide which is modified by reaction with formic acid and and paperboard and used at a level not to exceed 0.2 per-
formaldehyde and further reacted with epichlorohydrin in the cent dry resin by weight of finished dry paper or paperboard
presence of ammonium hydroxide to form a water-soluble fibers.
cationic resin having a nitrogen content of 13–16 percent
(Kjeldahl, dry basis) such that a 35 percent by weight aque-
ous solution has a minimum viscosity of 75 centipoises at 25
°C, as determined by Brookfield viscometer using a No. 1
spindle at 12 r.p.m.
Polyamide-epichlorohydrin water-soluble thermosetting resins For use only under the following conditions:
[CAS Reg. No. 68583–79–9] prepared by reacting adipic 1. As a retention aid employed prior to the sheet-forming oper-
acid with diethylenetriamine to form a basic polyamide and ation in the manufacture of paper and paperboard and lim-
further reacting the polyamide with an epichlorohydrin and ited to use at a level not to exceed 0.12 percent by weight of
dimethylamine mixture such that the finished resins have a dry paper or paperboard.
nitrogen content of 17.0 to 18.0 percent of a dry basis, and 2. The finished paper or paperboard will be used in contact
that a 30-percent-by-weight aqueous solution has a minimum with food only of the types identified in paragraph (c) of this
viscosity of 350 centipoises at 20 °C, as determined by a section, table 1, under types I and IV-B and under conditions
Brookfield viscometer using a No. 3 spindle at 30 r.p.m. (or of use described in paragraph (c) of this section, table 2,
equivalent method). conditions of use F and G.
Polyamide-epichlorohydrin water-soluble thermosetting resin For use only as a wet strength agent and/or retention aid em-
(CAS Reg. No. 96387–48–3) prepared by reacting N-methyl- ployed prior to the sheet-forming operation in the manufac-
bis(3-aminopropyl) amine with oxalic acid and urea to form a ture of paper and paperboard and used at a level not to ex-
basic polyamide and further reacting the polyamide with ceed 1.5 percent by weight of dry paper and paperboard fi-
epichlorohydrin. bers.
Polyamide-epichlorohydrin water-soluble thermosetting resins For use only in the manufacture of paper and paperboard
prepared by reacting adipic acid, isophthalic acid, itaconic under conditions such that the resins do not exceed 1.5 per-
acid or dimethyl glutarate with diethylenetriamine to form a cent by weight of the paper or paperboard.
basic polyamide and further reacting the polyamide with one
of the following:
Epichlorohydrin.
Epichlorohydrin and ammonia mixture.
Epichlorohydrin and sodium hydrosulfite mixture.
Polyamidoamine-ethyleneimine-epichlorohydrin resin prepared For use only as a retention aid employed prior to the sheet-
by reacting hexanedioic acid, N-(2-aminoethyl)-1,2- forming operation in the manufacture of paper and paper-
ethanediamine, (chloromethyl)oxirane, ethyleneimine board at a level not to exceed 0.12 percent resin by weight
(aziridine), and polyethylene glycol, partly neutralized with of the finished dry paper or paperboard.
sulfuric acid (CAS Reg. No. 167678–45–7).
Polyamidol-epichlorohydrin modified resin produced by reacting For use only as a wet strength agent employed prior to the
glutaric acid dimethyl ester with diethylene-triamine to sheet-forming operation in the manufacture of paper and pa-
produce a basic polyamide which is modified by reaction perboard, and used at a level not to exceed 2.5 percent by
with formaldehyde and further reacted with epicholorohydrin weight of dry paper and paperboard fibers when such paper
to form a water soluble cationic resin having a nitrogen con- or paperboard is used in contact with food under conditions
tent of 10.9–11.9 percent and a chlorine content of 13.8– of use E through G described in table 2 of paragraph (c) of
14.8 percent, on a dry basis, and a minimum viscosity, in this section.
12.5 percent by weight aqueous solution, of 10 centipoises
at 25 °C, as determined by a Brookfield Model LVF viscom-
eter using a No. 1 spindle at 60 r.p.m. (or equivalent meth-
od).
Polyamine-epichlorohydrin resin produced by the reaction of For use only as a flocculant, drainage aid, formation aid, reten-
epichlorohydrin with monomethylamine to form a prepolymer tion aid, or strength additive employed prior to the sheet-
and further reaction of this prepolymer with N,N,N′,N′- forming operation in the manufacture of paper and paper-
tetramethylethylenediamine such that the finished resin hav- board, and used at a level not to exceed 0.12 percent by
ing a nitrogen content of 11.6 to 14.8 percent and a chlorine weight of dry paper and paperboard fibers.
content of 20.8 to 26.4 percent and a minimum viscosity, in
25 percent by weight aqueous solution, of 500 centipoises at
25 °C, as determined by LV-series Brookfield viscometer
using a No. 2 spindle at 12 r.p.m. (or by other equivalent
method).
216
Polyamine-epichlorohydrin resin produced by the reaction of For use only as a clarifier in the treatment of influent water to
N,N-dimethyl-1,3-propanediamine with epichlorohydrin and be used in the manufacture of paper and paperboard, and
further reacted with sulfuric acid, Chemical Abstracts Service used at a level not to exceed 20 parts per million of the influ-
Registry Number [27029–41–0], such that the finished resin ent water.
has a maximum nitrogen content of 14.4 percent (dry basis)
and a minimum viscosity in 30 percent by weight aqueous
solution (pH 4–6) of 50 centipoises at 25 °C, as determined
by Brookfield LVT model viscometer, using a No. 1 spindle
at 12 r.p.m. (or equivalent method).
Polyamine-epichlorohydrin water-soluble thermosetting resin For use only as a wetstrength agent and/or retention aid em-
produced by reacting epichlorohydrin with: (i) polyamines ployed prior to the sheet-forming operation in the manufac-
comprising at least 95 percent by weight C4 to C6 aliphatic ture of paper and paperboard, and used at a level not to ex-
diamines and/or their self-condensation products, and/or (ii) ceed 1 percent by weight of dry paper and paperboard fi-
prepolymers produced by reacting 1,2-dichloroethane with bers.
the polyamines in (i). The finished resin has a nitrogen con-
tent of 5.0 to 9.0 percent, a chlorine content of 18.0 to 35.0
percent on a dry basis, and a minimum viscosity, in a 25
percent by weight aqueous solution, of 50 centipoises at 20
°C (68 °F), as determined by Brookfield HAT model viscom-
eter using a No. 1H spindle at 50 r.p.m. (or equivalent meth-
od).
Polyamine-epichlorohydrin water-soluble thermosetting resin For use only as a wet-strength agent and/or retention aid em-
produced by reacting epichlorohydrin with: (i) polyamines ployed prior to the sheet-forming operation in the manufac-
comprising at least 95 percent by weight C4 to C6 aliphatic ture of paper and paperboard, and used at a level not to ex-
diamines and/or their self-condensation products and/or (ii) ceed 1 percent by weight of dry paper and paperboard fi-
hexamethylenediamine, and/or (iii) bis(hexamethylene) tri- bers.
amine and higher homologues, and/or (iv) prepolymers pro-
duced by reacting 1,2-dichloroethane with the polyamines in
(i) and/or (ii) and/or (iii). The finished resin has a nitrogen
content of 5.0 to 9.0 percent, a chlorine content of 18.0 to
35.0 percent on a dry basis, and a minimum viscosity, in a
25 percent by weight aqueous solution, of 50 centipoises at
20 °C (68 °F), as determined by Brookfield HAT model vis-
cometer using a No. 1H spindle at 50 r.p.m. (or equivalent
method).
Polyamine-epichlorohydrin water soluble thermosetting resin For use only as a wet-strength agent and/or retention aid em-
prepared by reacting hexamethylenediamine with 1,2-di- ployed prior to the sheet-forming operation in the manufac-
chloroethane to form a prepolymer and further reacting this ture of paper and paperboard, and used at a level not to ex-
prepolymer with epichlorohydrin. This resin is then reacted ceed 1 percent by weight of dry paper and paperboard fi-
with nitrilotris (methylene-phosphonic acid), pentasodium bers.
salt, such that the finished resin has a nitrogen content of
5.0–5.3 percent; a chlorine content of 29.7–31.3 percent;
and a phosphorus content of 2.0–2.2 percent, on a dry
basis, and a minimum viscosity, in 25 percent by weight
aqueous solution, of 50 centipoises at 25 °C., as determined
on a Brookfield HAT model viscometer using a No. 1H spin-
dle at 50 r.p.m. (or equivalent method).
Polyamine resin produced by the reaction of 1,2-dichloroethane For use only as a retention aid and/or flocculent employed
with bis(hexamethylene)triamine and higher homologues prior to the sheet-forming operation in the manufacture of
such that the finished resin has a nitrogen content of 13.0– paper and paperboard and used at a level not to exceed 0.1
15.0 percent on a dry basis, and a minimum viscosity in 25- percent by weight of dry paper or paperboard fibers.
percent-by-weight aqueous solution of 75 centipoises at 25
°C., as determined by Brookfield HAT model viscometer
using a No. 1 spindle at 50 r.p.m. (or equivalent method).
Polyaminoamide-epichlorohydrin modified resin produced by For use only as a wet-strength agent and/or retention aid em-
reacting adipic acid with diethylenetriamine to produce a pol- ployed prior to the sheet-forming operation in the manufac-
yamide which is modified by reaction with ture of paper and paperboard, and used at a level not to ex-
diethylaminopropylamine and further reacted with dichlor- ceed 0.5 percent by weight of the finished dry paper and pa-
oethyl ether to form a polyamide intermediate. This poly- perboard.
amide intermediate is then reacted with epichlorohydrin such
that the finished resins have a nitrogen content of 10.9–12.4
percent (Kjeldahl, dry basis) and a minimum viscosity in 40
percent-by-weight aqueous solution of 250 centipoises at 22
°C, as determined by a Brookfield Model LVT viscometer
using a No. 2 spindle at 30 r.p.m. (or equivalent method).
Polybutene, hydrogenated; complying with the identity pre- For use only as provided in §§ 175.300, 178.3740 and
scribed under § 178.3740(b) of this chapter. 178.3860 of this chapter.
217
§ 176.170 21 CFR Ch. I (4–1–23 Edition)
Poly(diallyldimethylammonium chloride) (CAS Reg. No. 26062– For use only:

79–3) produced by the polymerization of 1. As a pigment dispersant and/or retention aid prior to the
(diallyldimethylammonium chloride) so that the finished resin sheet-forming operation in the manufacture of paper and pa-
has a nitrogen content of 8.66±0.4 percent on a dry weight perboard, and used at a level not to exceed 10 pounds of
basis and a minimum viscosity in a 40 percent by weight active polymer per ton of finished paper and paperboard.
aqueous solution of 1,000 centipoises at 25 °C (77 °F), de- 2. As a pigment dispersant in coatings at a level not to exceed
termined by LVF Model Brookfield Viscometer using a No. 3 3.5 pounds of active polymer per ton of finished paper and
spindle at 30 r.p.m. (or equivalent method). The level of re- paperboard.
sidual monomer is not to exceed 1 percent by weight of the
polymer (dry basis).
Poly (diallyldimethylammonium chloride) (CAS Reg. No. For use only as a flocculant employed prior to the sheet-form-
26062–79–3) produced by the polymerization of ing operation in the manufacture of paper and paperboard,
diallyldimethylammonium chloride so that the finished resin and used at a level not to exceed 10 mg/L (10 parts per mil-
has a nitrogen content of 8.66±0.4 percent on a dry basis lion) of influent water.
and a minimum viscosity in a 15 weight-percent aqueous so-
lution of 10 centipoises at 25 °C (77 °F), as determined by
LVF Model Brookfield viscometer using a No. 1 spindle at 60
r/min (or equivalent method). The level of residual monomer
is not to exceed 1 weight-percent of the polymer (dry basis).
Poly(1,2-dimethyl-5-vinylpyridinium methyl sulfate) having a ni- For use only as an adjuvant employed in the manufacture of
trogen content of 5.7 to 7.3 percent and a sulfur content of paper and paperboard prior to the sheet-forming operation.
11.7 to 13.3 percent by weight on a dry basis and having a
minimum viscosity in 30-percent-by-weight aqueous solution
of 2,000 centipoises at 25 °C., as determined by LV-series
Brookfield viscometer (or equivalent) using a No. 4 spindle at
60 r.p.m.
Polyester resin produced by reacting dimethylolpropionic acid For use only as a surface-sizing compound applied after the
(CAS Registry No. 4767–03–7) as a comonomer, at no more sheet-forming operation in the manufacture of paper and pa-
than 30 percent by weight of total polymer solids in reaction perboard and limited to use at levels not to exceed 0.1 per-
with 2,2-dimethyl-1,3-propanediol, phthalic anhydride and cent by weight of finished dry paper or paperboard.
isophthalic acid, such that the polyester resin has a viscosity
of 200–600 centipoises at 80 °F as determined by a Brook-
field RVT viscometer using a number 3 spindle at 50 rpm (or
equivalent method).
Polyethylene, oxidized; complying with the identity prescribed For use only as component of coatings that contact food only
in § 177.1620(a) of this chapter. of the type identified under Type VII-B of table 1 in para-
graph (c) of this section, and limited to use at a level not to
exceed 50 percent by weight of the coating solids.
Polyethyleneamine mixture produced when 1 mole of ethylene For use only as a retention aid employed prior to the sheet-
dichloride, 1.05 moles of ammonia, and 2 moles of sodium forming operation in the manufacture of paper and paper-
hydroxide are made to react so that a 10 percent aqueous board.
solution has a minimum viscosity of 40 centipoises at 77 °F,
as determined by Brookfield viscometer using a No. 1 spin-
dle at 60 r.p.m.
Polyethylene glycol (200) dilaurate ............................................. For use only as an adjuvant employed in the manufacture of
paper and paperboard prior to the sheet-forming operation.
Polyethylene glycol (400) dioleate.
Polyethylene glycol (400) esters of coconut oil fatty acids.
Polyethylene glycol (600) esters of tall oil fatty acids.
Polyethylene glycol (400) monolaurate.
Polyethylene glycol (400) monooleate.
Polyethylene glycol (400) monostearate.
Polyethylene glycol (3,000) monostearate.
Polyethylenimine, produced by the polymerization of For use only as an adjuvant employed prior to sheet formation
ethylenimine. in paper-making systems operated at a pH of 4.5 or higher,
and limited to use at a level not to exceed 5% by weight of
finished dry paper or paperboard fibers.
Poly(isobutene)/maleic anhydride adduct, diethanolamine reac- For use only as a surfactant for dispersions of polyacrylamide
tion product. The mole ratio of poly(isobutene)/maleic retention and drainage aids employed prior to the sheet for-
anydride adduct to diethanolamine is 1:1. mation operation in the manufacture of paper and paper-
board.
Polymethacrylic acid, sodium salt, having a viscosity in 30-per- For use only as a coating adjuvant for controlling viscosity
cent-by-weight aqueous solution of 125–325 centipoises at when used at a level not to exceed 0.3% by weight of coat-
25 °C as determined by LV-series Brookfield viscometer (or ing solids.
equivalent) using a No. 2 spindle at 60 r.p.m.
Polymethacrylic acid, sodium salt, having a viscosity in 40-per- For use only as a coating adjuvant for controlling viscosity
cent-by-weight aqueous solution of 400–700 centipoises at when used at a level not to exceed 0.1% by weight of coat-
25 °C, as determined by LV-series Brookfield viscometer (or ing solids.
equivalent) using a No. 2 spindle at 30 r.p.m.
218
Poly[(methylimino)(2-hydroxytrimethylene)hydrochloride] pro- For use only as a retention aid employed prior to the sheet-
duced by reaction of 1:1 molar ratio of methylamine and forming operation in such an amount that finished paper and
epichlorohydrin so that a 31-percent aqueous solution at 25 paperboard will contain the additive at a level not in excess
°C has a Stokes viscosity range of 2.5-4.0 as determined by of 1 percent by weight of the dry paper and paperboard.
ASTM method D1545–76 (Reapproved; 1981), ‘‘Standard
Test Method for Viscosity of Transparent Liquids by Bubble
Time Method,’’ which is incorporated by reference. Copies
may be obtained from the American Society for Testing Ma-
terials, 100 Barr Harbor Dr., West Conshohocken, Philadel-
phia, PA 19428-2959, or may be examined at the National
Archives and Records Administration (NARA). For informa-
tion on the availability of this material at NARA, call 202–
741–6030, or go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html..
Poly[oxyethylene (dimethyliminio) ethylene (dimethyliminio) For use only to improve dry-strength of paper and paperboard
ethylene dichloride] produced by reacting equimolar quan- and as a retention and drainage aid employed prior to the
tities of N,N,N,N-tetramethylethylene-diamine and sheet-forming operation in the manufacture of paper and pa-
dichlorethyl ether to yield a solution of the solid polymer in perboard and limited to use at a level not to exceed 0.1 per-
distilled water at 25 °C with a reduced viscosity of not less cent by weight of the finished dry paper and paperboard fi-
than 0.15 deciliter per gram as determined by ASTM method bers.
D1243–79, ‘‘Standard Test Method for -Dilute Solution Vis-
cosity of Vinyl Chloride Polymers,’’ which is incorporated by
reference. Copies may be obtained from the American Soci-
ety for Testing Materials, 100 Barr Harbor Dr., West
Conshohocken, Philadelphia, PA 19428-2959, or may be ex-
amined at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call 202–741–6030, or go to: http://www.archives.gov/
federal_register/code_of_federal_regulations/
ibr_locations.html.). The following formula is used for deter-
mining reduced viscosity:.
Reduced viscosity in terms of deciliters per gram = (t ¥ t0)
/ (t ¥ C),
where:
t = Solution efflux time
to = Water efflux time
C = Concentration of solution in terms of grams per deci-
liter
Polypropylene glycol (minimum molecular weight 1,000).
Potassium persulfate.
2-Propenoic acid, telomer with sodium 2-methyl-2-[(1-oxo-2- For use only as a deposit control additive employed prior to
propenyl)amino]-1-propane sulfonate and sodium phos- the sheet forming operation in the manufacture of paper and
phinate (CAS Reg. No. 110224–99–2). paperboard and at a level not to exceed 0.15 percent by
weight of the dry paper and paperboard.
Propylene glycol alginate.
Protein hydrolysate from animal hides or soybean protein con-
densed with oleic and/or stearic acid.
Rapeseed oil, sulfated ammonium, potassium, or sodium salt.
Ricebran oil, sulfated ammonium, potassium, or sodium salt.
Rosin and rosin derivatives ......................................................... As provided in § 178.3870 of this chapter.
Siloxanes (silicones), dimethyl, isopropyl methyl, methyl 1- For use only as a component of polyolefin coatings with
methyl-C9-49-alkyl (CAS Reg. No. 144635–08–5). § 177.1520 of this chapter at a level not to exceed 3 percent
by weight. The finished coating will be used only for paper
and paperboard that contact food of types VI-A and VI-B of
table 1 in paragraph (c) of this section, and under conditions
of use C, D, and E, as described in table 2 in paragraph (c)
of this section, with a maximum hot fill temperature of 200 °F
(94 °C).
Silver chloride-coated titanium dioxide ........................................ For use only as a preservative in polymer latex emulsions at a
level not to exceed 2.2 parts per million (based on silver ion
concentration) in the dry coating.
Sodium carboxymethyl guar gum having a minimum viscosity For use only as a dry-strength and formation-aid agent em-
of 2,700 centipoises at 25 °C after 24 hours as determined ployed prior to the sheet-forming operation in the manufac-
by RV-series Brookfield viscometer (or equivalent) using a ture of paper and paperboard and used at a level not to ex-
No. 4 spindle at 20 r.p.m. and using a test sample prepared ceed 1% by weight of finished dry paper or paperboard fi-
by dissolving 8 grams of sodium carboxymethyl guar gum in bers.
392 milliliters of 0.2-percent-by-weight aqueous sodium o-
phenylphenate solution.
Sodium formaldehyde sulfoxylate ............................................... For use only as polymerization catalyst.
Sodium N-methyl-N-oleyltaurate ................................................. For use only as an adjuvant to control pulp absorbency and
219
§ 176.170 21 CFR Ch. I (4–1–23 Edition)
Sodium nitrite ............................................................................... For use only:

1. At levels not to exceed 0.2% by weight of lubricants or re-
lease agents applied at levels not to exceed 1 lb. per ton of
finished paper or paperboard.
2. As an anticorrosion agent at levels not to exceed 0.2% by
weight of wax emulsions used as internal sizing in the manu-
facture of paper and paperboard prior to the sheet-forming
operation.
Sodium persulfate.
Sodium polyacrylate .................................................................... For use only:
1. As a thickening agent for natural rubber latex coatings, pro-
vided it is used at a level not to exceed 2 percent by weight
of coating solids.
2. As a pigment dispersant in coatings at a level not to exceed
0.25 percent by weight of pigment.
Sodium poly(isopropenylphosphonate) (CAS Reg. No. 118632– For use only in paper mill boilers.
18–1).
Sodium zinc potassium polyphosphate (CAS Reg. No. 65997– For use only as a pigment dispersant in coatings at a level not
17–3). to exceed 1 percent by weight of pigment.
Sperm oil, sulfated, ammonium, potassium, or sodium salt.
Stannous oleate.
Stearyl-2-lactylic acid and its calcium salt.
Styrene-butadiene copolymers produced by copolymerizing sty-
rene-butadiene with one or more of the monomers: acryl-
amide, acrylic acid, fumaric acid, 2-hydroxyethyl acrylate,
itaconic acid, methacrylic acid, and N-methylolacrylamide
(CAS Reg. No. 53504–31–7). The finished copolymers shall
contain not more than 10 weight percent of total polymer
units derived from acrylic acid, fumaric acid, 2-hydroxyethyl
acrylate, itaconic acid, and methacrylic acid, and shall con-
tain not more than 3 weight percent of total polymer units
derived from N-methylolacrylamide, and shall contain not
more than 2 weight percent of polymer units derived from
acrylamide..
Styrene-maleic anhydride copolymer, amidated, ammonium so- For use only as a surface size at a level not to exceed 1 per-
dium salt; having, in a 25 percent by weight aqueous solu- cent by weight of paper or paperboard substrate.
tion at pH 8.8, a minimum viscosity of 600 centipoises at 25
°C as determined by Brookfield model LVT viscometer using
a No. 3 spindle at 60 r.p.m. (or equivalent method).
Styrene-maleic anhydride copolymer, sodium salt (minimum For use only:
molecular weight 30,000). 1. As a coating thickening agent at a level not to exceed 1%
by weight of coating solids.
2. As surface size at a level not to exceed 1% by weight of
paper or paperboard substrate.
Styrene-methacrylic acid copolymer, potassium salt (minimum For use only as a coating thickening agent at a level not to ex-
molecular weight 30,000). ceed 1% by weight of coating solids.
Synthetic wax polymer prepared by the catalytic polymerization For use only as a component of petroleum wax and/or syn-
of alpha olefins such that the polymer has a maximum iodine thetic petroleum wax complying with § 178.3710 or
number of 18 and a minimum number average molecular § 178.3720 of this chapter at levels not to exceed 5 percent
weight of 2,400. by weight of the wax:
1. Under conditions of use F and G described in table 2 of
paragraph (c) of this section for all foods.
2. Under conditions of use E described in table 2 of paragraph
(c) of this section for food Types I, II, IV-B, VI, VII-B and VIII
as described in table 1 of paragraph (c) of this section.
Tallow.
Tallow alcohol.
Tallow alcohol, hydrogenated.
Tallow fatty acid, hydrogenated.
Tallow hydrogenated.
Tallow sulfated, ammonium, potassium, or sodium salt.
Tetraethylenepentamine .............................................................. For use only as a modifier for amino resins.
1,4,4a,9a-Tetrahydro-9, 10-anthracenedione (CAS Reg. No. For use only as a catalyst in the alkaline pulping of
56136–14–2). lignocellulosic materials at levels not to exceed 0.1 percent
by weight of the raw lignocellulosic materials.
N,N,N′, N′-Tetramethylethylenediamine polymer with bis-(2- For use only as a flocculent, drainage aid or retention aid em-
chloroethyl) ether, first reacted with not more than 5 percent ployed prior to the sheet forming operation in the manufac-
by weight 1-chloro-2,3-epoxypropane and then reacted with ture of paper and paperboard and limited to use at a level
not more than 5 percent by weight poly (acrylic acid) such not to exceed 0.2 percent by weight of the finished dry paper
that a 50 percent by weight aqueous solution of the product and paperboard fibers.
has a nitrogen content of 4.7–4.9 percent and viscosity of
350–700 centipoises at 25 °C as determined by LV series

Brookfield viscometer using a No. 2 spindle at 60 r.p.m. (or
by other equivalent method).
220
Tetrasodium N- (1,2-dicarboxyethyl) - N - octadecylsulfo-suc- For use only as an emulsifier in aqueous dispersions of rosin
cinamate. sizes complying with § 178.3870(a)(4) of this chapter and
limited to use prior to the sheet-forming operation in the
manufacture of paper and paperboard at a level not to ex-
ceed 0.02 pct by weight of finished paper and paperboard.
Triethanolamine ........................................................................... For use only to adjust pH during the manufacture of amino res-
ins permitted for use as components of paper and paper-
board.
Triethylene glycol adipic acid monoester produced by reacting For use only as a curl-control agent at a level not to exceed
equimolar quantities of triethylene glycol and adipic acid. 2% by weight of coated or uncoated paper and paperboard.
Triethylenetetramine .................................................................... For use only as a modifier for amino resins.
1,3,5-Triethylhexahydro-1,3,5-triazine (CAS Registry No. 7779– For use only as an antimicrobial agent for coating, binder, pig-
27–3). ment, filler, sizing, and similar formulations added prior to
the heat drying step in the manufacture of paper and paper-
board and limited to use at a level between 0.05 and 0.15
percent by weight of the formulation.
Undecafluorocyclohexanemethanol ester mixture of dihydrogen For use only as an oil repellent at a level not to exceed 0.087
phosphate, compound with 2,2′ iminodiethanol (1:1); hydro- lb (0.046 lb of fluorine) per 1,000 ft2 of treated paper or pa-
gen phosphate, compound with 2,2′-iminodiethanol (1:1); and perboard, as determined by analysis for total fluorine in the
P,P′-dihydrogen pyrophosphate, compound with 2,2′- treated paper or paperboard without correction for any fluo-
iminodiethanol (1:2); where the ester mixture has a fluorine rine which might be present in the untreated paper or paper-
content of 48.3 pct to 53.1 pct as determined on a solids board, when such paper or paperboard is used in contact
basis. with food only of the types identified in paragraph (c) of this
section, table 1, under Types IVA, V, VIIA, VIII, and IX, and
under the conditions of use B through G described in table 2
of paragraph (c) of this section.
Viscose rayon fibers.
Wax, petroleum ........................................................................... Complying with § 178.3710 of this chapter.
Xanthan gum, conforming to the identity and specifications pre- For use only at a maximum level of 0.125 percent by weight of
scribed in § 172.695 of this chapter, except that the residual finished paper as a suspension aid or stabilizer for aqueous
isopropyl alcohol shall not exceed 6,000 parts per million. pigment slurries employed in the manufacture of paper and
paperboard.
Xylene sulfonic acid-formaldehyde condensate, sodium salt ..... For use only as an adjuvant to control pulp absorbency and
Zeolite Na-A (CAS Reg. No. 68989–22–0) ................................. For use as a pigment extender at levels not to exceed 5.4 per-
cent by weight of the finished paper and paperboard.
Zinc formaldehyde sulfoxylate ..................................................... For use only as polymerization catalyst.
Zinc octoate.
Zirconium oxide ........................................................................... For use only as a component of waterproof coatings where the
zirconium oxide is present at a level not to exceed 1 percent
by weight of the dry paper or paperboard fiber and where
the zirconium oxide is produced by hydrolysis of zirconium
acetate.
(b) Substances identified in para- (1) Substances identified in

graphs (b)(1) and (2) of this section may § 175.300(b)(3) of this chapter with the
be used as components of the food-con- exception of those identified in para-
tact surface of paper and paperboard, graphs (b)(3)(v), (xv), (xx), (xxvi),
provided that the food-contact surface (xxxi), and (xxxii) of that section and
of the paper or paperboard complies paragraph (a) of this section.
with the extractives limitations pre- (2) Substances identified in this para-
scribed in paragraph (c) of this section. graph (b)(2) follow:
Acrylamide copolymerized with ethyl acrylate and/or stryene

and/or methacrylic acid, subsequently reacted with formalde-
hyde and butyl alcohol.
Acrylamide copolymerized with ethylene and vinyl chloride in For use only as coatings or components of coatings.
such a manner that the finished copolymers have a minimum
weight average molecular weight of 30,000 and contain not
more than 3.5 weight percent of total polymer units derived
from acrylamide, and in such a manner that the acrylamide
portion may or may not be subsequently partially hydrolyzed.
2-Acrylamido-2-methyl-propanesulfonic acid, homopolymer, so- For use only in coatings at a level not to exceed 0.01 mg/in2
dium salt (CAS Reg. No. 35641–59–9).

Acrylic and modified acrylic polymers ......................................... Complying with § 177.1010 of this chapter.
221
§ 176.170 21 CFR Ch. I (4–1–23 Edition)
Acrylic copolymers produced by copolymerizing 2 or more of

the acrylate monomers butyl acrylate, ethyl acrylate, ethyl
methacrylate, methyl acrylate, methyl methacrylate, and n-
propyl methacrylate, or produced by copolymerizing one or
more of such acrylate monomers together with one or more
of the monomers acrylic acid, acrylonitrile, butadiene, 2-
ethyl-hexyl acrylate, fumaric acid, glycidyl methacrylate, n-
hexyl-methacrylate, itaconic acid, methacrylic acid, styrene,
vinyl acetate, vinyl chloride, and vinylidene chloride. The fin-
ished copolymers shall contain at least 50 weight percent of
polymer units derived from one or more of the monomers
butyl acrylate, ethyl acrylate, ethyl methacrylate, methyl acry-
late, methyl methacrylate, and n-propyl methacrylate; and
shall contain not more than 5 weight percent of total polymer
units derived from acrylic acid, fumaric acid, glycidyl meth-
acrylate, n-hexyl methacrylate, itaconic acid, and methacrylic
acid. The provision limiting the finished acrylic copolymers to
not more than 5 units derived from acrylic acid, fumaric acid,
glycidyl methacrylate, n-hexyl methacrylate, itaconic acid,
and methacrylic acid is not applicable to finished acrylic co-
polymers used as coating adjuvants at a level not exceeding
2 weight percent of total coating solids.
Alkyl mono- and disulfonic acids, sodium salts (produced from For use only:
n-alkanes in the range of C10-C18 with not less than 50 per- 1. As emulsifiers for vinylidene chloride copolymer coatings
cent C14-C16).. and limited to use at levels not to exceed 2 percent by
weight of the coating solids.
2. As emulsifiers for vinylidene chloride copolymer or
homopolymer coatings at levels not to exceed a total of
2.6 percent by weight of coating solids. The finished poly-
mer contacts food only of types identified in paragraph (c)
of this section, table 1, under Types I, II, III, IV, V, VIA,
VIB, VII, VIII, and IX and under conditions of use E, F,
and G described in table 2 of paragraph (c) of this section.
2-Bromo-4′-hydroxyacetophenone .............................................. For use only as a preservative for coating formulations, bind-
ers, pigment slurries, and sizing solutions at a level not to
exceed 0.006 percent by weight of the coating, solution, slur-
ry or emulsion.
Butyl oleate, sulfated, ammonium, potassium, or sodium salt.
Butyraldehyde.
Captan (N-trichloromethylmercapto-4-cyclohexene-1, 2- For use only as a mold- and mildew-proofing agent in coatings
dicarboximide). intended for use in contact with food only of the types identi-
fied in paragraph (c) of this section, table 1, under Type I, II,
VI-B, and VIII.
Castor Oil, polyoxyethylated (42 moles ethylene oxide) ............. For use only as an emulsifier in nitrocellulose coatings for
paper and paperboard intended for use in contact with food
only of the types identified in paragraph (c) of this section,
table 1, under Types IV A, V, VII A, VIII, and IX; and limited
to use at a level not to exceed 8 percent by weight of the
coating solids.
1-(3-Chloroallyl)-3,5,7-triaza-1- azoniaadamantane chloride For use only:
(CAS Reg. No. 4080–31–3). 1. As a preservative at a level of 0.3 weight percent in
latexes used as pigment binders in paper and paperboard
intended for use in contact with nonacidic, nonalcoholic
food and under the conditions of use described in para-
graph (c) of this section, table 2, conditions of use E, F,
and G.
2. As a preservative at a level not to exceed 0.07 weight
percent in latexes and 0.05 weight percent in pigment
slurries used as components of coatings for paper and pa-
perboard intended for use in contact with food.
222
5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. 26172– For use only:

55–4) and 2-methyl-4-isothiazolin-3-one (CAS Reg. No. 1. As an antimicrobial agent for polymer latex emulsions in
2682–20–4) mixture at a ratio of 3 parts to 1 part, manufac- paper coatings at a level not to exceed 50 parts per mil-
tured from methyl-3-mercaptopropionate (CAS Reg. No. lion (based on isothiazolone active ingredients) in the
2935–90–2). The mixture may contain magnesium nitrate coating formulation.
(CAS Reg. No. 10377–60–3) at a concentration equivalent to 2. As an antimicrobial agent for finished coating formulations
the isothiazolone active ingredients (weight/weight). and for additives used in the manufacture of paper and
paperboard including fillers, binders, pigment slurries, and
sizing solutions at a level not to exceed 25 parts per mil-
lion (based on isothiazolone active ingredients) in the
coating formulations and additives.
Copper 8-quinolinolate ................................................................ For use only as preservative for coating formulations.
Cyclized rubber produced when natural pale crepe rubber dis- For use only in coatings for paper and paperboard intended for
solved in phenol is catalytically cyclized so that the finished use in contact with food only of the types identified in para-
cyclized rubber has a melting point of 145 °C to 155 °C as graph (c) of this section, table 1, under Types VIII and IX.
determined by ASTM method E28–67 (Reapproved 1982),
‘‘Standard Test Method for Softening Point by Ring-and-Ball
Apparatus,’’ which is incorporated by reference (Copies may
be obtained from the American Society for Testing Materials,
100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA
19428-2959, or may be examined at the National Archives
and Records Administration (NARA). For information on the
availability of this material at NARA, call 202–741–6030, or
go to: http://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.), and contains
no more than 4000 ppm of residual-free phenol as deter-
mined by a gas liquid chromatographic procedure titled ‘‘De-
termination of Free Phenol in Cyclized Rubber Resin,’’ which
is incorporated by reference. Copies are available from the
Center for Food Safety and Applied Nutrition (HFS–200),
Food and Drug Administration, 5001 Campus Dr., College
Park, MD 20740, or available for inspection at the National
1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691–65–7) .. For use only as a preservative at levels not more than 0.05
weight percent and not less than 0.01 weight percent: in
latexes used as pigment binders in coatings; in pigment
slurries used in coatings; and/or in coatings themselves. The
total level of the preservative in the finished coating shall not
exceed 0.04 weight percent of the finished coating solids.
Dibutyl sebacate.
Di(C7,C9-alkyl) adipate ................................................................. Complying with § 178.3740 of this chapter.
Dicyclohexyl phthalate.
Diethylene glycol dibenzoate (CAS Reg. No. 120–55–8) ........... For use only as a plasticizer for polyvinyl acetate coatings at a
level not to exceed 5 percent by weight of the coating solids
under conditions described in paragraph (c) of this section,
table 2, conditions of use E, F, and G.
Diethylene glycol ester of the adduct of terpene and maleic an-
hydride.
Dihydroxy dichlorodiphenyl methane .......................................... For use only as preservative for coating formulations.
Dimethylpolysiloxane, 100 centistokes viscosity.
Dimethylpolysiloxane-beta-phenylethyl methyl polysiloxane co-
polymer (2:1), 200 to 400 centistokes viscosity.
N,N′-Diphenyl-p-phenylenediamine ............................................. For use only as polymerization inhibitor in 2-sulfoethyl meth-
acrylate, sodium salt.
Dipropylene glycol dibenzoate (CAS Reg. No. 27138–31–4) ..... 1. For use only as a plasticizer for polyvinyl acetate coatings at
a level not to exceed 5 percent by weight of the coating sol-
ids under conditions described in paragraph (c) of this sec-
tion, table 2, condition of use E.
2. For use only as a plasticizer for polyvinyl acetate coatings at
a level not to exceed 10 percent by weight of the coating
solids under conditions described in paragraph (c) of this
section, table 2, conditions of use F and G.
Disodium N-octadecylsulfosuccinamate ...................................... For use only as an emulsifier in resin latex coatings and limited
to use at a level not to exceed 0.05% by weight of the coat-
ing solids.
EDTA (ethylenediaminetetraacetic acid) and its sodium and/or
calcium salts.
Ethanedial, polymer with tetrahydro-4-hydroxy-5-methyl- For use only as an insolubilizer for starch-based coatings and
2(1H)pyrimidinone, propoxylated (CAS Reg. No. 118299-90- limited to use at a level not to exceed 5.0 percent by weight
4). of the coating.
223
§ 176.170 21 CFR Ch. I (4–1–23 Edition)
Ethylene-acrylic acid copolymers produced by the copolym-

erization of ethylene and acrylic acid and/or their partial am-
monium salts. The finished copolymer shall contain no more
than 25 weight percent of polymer units derived from acrylic
acid and no more than 0.35 weight percent of residual
monomeric acrylic acid, and have a melt index not to exceed
350 as determined by ASTM method D1238–82, ‘‘Standard
Test Method for Flow Rates of Thermoplastics by Extrusion
Plastometer,’’ which is incorporated by reference. Copies
may be obtained from the American Society for Testing Ma-
terials, 100 Barr Harbor Dr., West Conshohocken, Philadel-
phia, PA 19428-2959, or may be examined at the National
Formaldehyde .............................................................................. For use only as preservative for coating formulations.
Glyoxal ......................................................................................... For use only as an insolubilizing agent in starch- and protein-
based coatings that contact nonalcoholic foods, and limited
to use at a level not to exceed 6 percent by weight of the
starch or protein fraction of the coating solids.
Glyceryl monobutyl ricinoleate.
Hydroxymethyl derivatives (mixture of mono and poly) of [N-(1, For use only as a comonomer in polyvinyl acetate latex coat-
1-dimethyl-3-oxobutyl) acrylamide] produced by reacting 1 ings and limited to use at a level not to exceed 1 percent by
mole of the [N-(1,1-dimethyl-3-oxobutyl) acrylamide] with 3 weight of dry polymer solids.
moles of formaldehyde such that the finished product has a
maximum nitrogen content of 6.2 percent and a maximum
hydroxyl content of 15 percent by weight on a dry basis.
Isobutyl oleate, sulfated, ammonium, potassium, or sodium salt.
Maleic anhydride adduct of butadiene-styrene copolymer.
a-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1a-
Modified kaolin clay (CAS Reg. No. 1344–00–9) is produced For use only as a component of coatings in paper and paper-
by the reaction of sodium silicate (CAS Reg. No. 1344–09– board products at a level not to exceed 9 percent by weight
8) and kaolinite clay (CAS Reg. No. 1332–58–7) under hy- of the coating intended for use in contact with food of Types
drothermal conditions. The reaction product has a molecular I through IX described in table 1 of paragraph (c) of this sec-
weight between 246 and 365 and consists of 46 to 55 per- tion under conditions of use C through H described in table
cent silicon dioxide (Si02), 28 to 42 percent aluminum oxide 2 of paragraph (c) of this section.
(A1203), and 2 to 7 percent of sodium oxide (Na20). The re-
action product will not consist of more than 70 percent modi-
fied kaolin clay.
Naphthalene sulfonic acid-formaldehyde condensate, sodium
salt.
Oleyl alcohol.
Oxazolidinylethylmethacrylate (CAS Registry No. 46236–15–1) For use only as a binder for pigment coatings as a binder level
copolymer with ethyl acrylate and methyl methacrylate, and not to exceed 4.0 percent by weight of dry paper or paper-
containing not more than 6 percent by weight of board.
oxazolidinylethylmethacrylate. Maximum nitrogen content
shall be 0.5 percent and number average molecular weight
of that portion of the copolymer soluble in tetrahydrofuran
shall be not less than 50,000.
Pentaerythritol tetrastearate.
224
Petroleum alicyclic hydrocarbon resins, or the hydrogenated For use only as modifiers in waxpolymer blend coatings for
product thereof, meeting the following specifications: Soft- corrugated paperboard intended for use in bulk packaging or
ening point 97 °C minimum, as determined by ASTM method raw fruits, raw vegetables, iced meat, iced fish, and iced
E28–67 (Reapproved 1982), ‘‘Standard Test Method for Soft- poultry; and limited to use at a level not to exceed 30
ening Point by Ring and Ball Apparatus;’’ aniline point 120 weight-percent of the coating solids.
°C minimum, as determined by ASTM method D611–82,
‘‘Standard Test Methods for Aniline Point and Mixed Aniline
Point of Petroleum Products and Hydrocarbon Solvents,’’
which are incorporated by reference (Copies may be ob-
tained from the American Society for Testing Materials, 100
Barr Harbor Dr., West Conshohocken, Philadelphia, PA
19428-2959, or may be examined at the National Archives
code_of_federal_regulations/ibr_locations.html.). Specific
gravity 0.96–0.99 (20 °C/20 °C). Such petroleum hydro-
carbon resins are produced by the catalytic polymerization of
dienes and olefins from low-boiling distillates of cracked pe-
troleum stocks that contain no material boiling over 200 °C
and that meet the ultraviolet absorbance limits prescribed in
§ 172.880(b) of this chapter when subjected to the analytical
procedure described in § 172.886(b) of this chapter, modified
as follows: Treat the product as in the first paragraph under
‘‘Procedure’’ in § 172.250(b)(3) of this chapter. Then proceed
with § 172.886(b) of this chapter, starting with the paragraph
commencing with ‘‘Promptly complete transfer of the sample
* * *’’.
Polyester resin formed by the reaction of the methyl ester of
rosin, phthalic anhydride, maleic anhydride and ethylene gly-
col, such that the polyester resin has an acid number of 4 to
11, a drop-softening point of 70 °C–92 °C., and a color of K
or paler.
Polyester resin produced by reacting the acid groups in
montan wax with ethylene glycol.
Polyethylene, oxidized ................................................................. Complying with § 177.1620 of this chapter.
Polyethylene reacted with maleic anhydride such that the modi-
fied polyethylene has a saponification number not in excess
of 6 after Soxhlet extraction for 24 hours with anhydrous
ethyl alcohol.
Polyoxyethylated (40 moles) tallow alcohol sulfate, sodium salt Not to exceed 300 p.p.m. in finished coated paper or paper-
board.
Polyoxypropylene-polyoxyethylene block polymers (minimum
molecular weight 6,800).
Polyvinyl acetate.
Polyvinyl alcohol (minimum viscosity of 4% aqueous solution at
20 °C. of 4 centipoises).
Polyvinyl butyral.
Polyvinyl formal.
Polyvinylidene chloride.
Polyvinyl pyrrolidone.
Polyvinyl stearate.
Propylene glycol mono- and diesters of fats and fatty acids.
Siloxanes and silicones; platinum-catalyzed reaction product of For use only as a surface coating. Platinum content not to ex-
vinyl-containing dimethyl polysiloxane (CAS Reg. Nos. ceed 200 parts per million.
68083–19–2 and 68083–18–1) with methyl hydrogen 1. In coatings for paper and paperboard provided the coating
polysiloxane (CAS Reg. No. 63148–57–2) or dimethyl (meth- contacts food only of the types identified in paragraph (c) of
yl hydrogen) polysiloxane (CAS Reg. No. 68037–59–2). this section, table 1, under Types I, II, VI, and VII-B when
Diallyl maleate (CAS Reg No. 999–21–3), dimethyl maleate used under conditions of use E, F, and G described in table
(CAS Reg. No. 624–48–6), 1-ethynyl-1-cyclohexanol (CAS 2 of paragraph (c) of this section.
Reg. No. 78–27–3) and vinyl acetate (CAS Reg. No. 108– 2. In coatings for paper and paperboard provided the coating
05–4) may be used as optional polymerization inhibitors. contacts food only of the types identified in paragraph (c) of
this section, table 1, under Types III, IV, V, VII-A, VIII, and
IX when used under conditions of use A through H de-
scribed in table 2 of paragraph (c) of this section.
225
§ 176.170 21 CFR Ch. I (4–1–23 Edition)
vinyl-containing dimethylpolysiloxane (CAS Reg. Nos. only as a release coating for pressure sensitive adhesives.
68083–19–2 and 68083–18–1), with methyl hydrogen
polysiloxane (CAS Reg. No. 63148–57–2). Dimethyl maleate
(CAS Reg. No. 624–48–6), vinyl acetate (CAS Reg. No.
108–05–4), dibutyl maleate (CAS Reg. No. 105–76–0) and
diallyl maleate (CAS Reg. No. 999–21–3) may be used as
optional polymerization inhibitors. The polymer may also
contain C16-C18 olefins (CAS Reg. No. 68855–60–7) as a
control release agent.
Sodium decylbenzenesulfonate.
Sodium dihexyl sulfosuccinate.
Sodium n-dodecylpolyethoxy (50 moles) sulfate-sodium For use only as an emulsifier in coatings that contact food only
isododecylphenoxypolyethoxy (40 moles) sulfate mixtures. of the types identified in paragraph (c) of this section, table
1, under Types IV-A, V, VII, VIII, and IX; and limited to use
at levels not to exceed 0.75 percent by weight of the coating
solids.
Sodium 2-ethylhexyl sulfate.
Sodium oleoyl isopropanolamide sulfosuccinate.
Sodium pentachlorophenate ........................................................ For use only as preservative for coating formulations.
Sodium o-phenylphenate ............................................................. Do.
Sodium vinyl sulfonate polymerized.
Sodium xylenesulfonate (CAS Reg. No. 1300–72–7) ................. For use only in paper and paperboard coatings at levels not to
exceed 0.01 percent by weight of the finished paper and pa-
perboard.
Styrene copolymers produced by copolymerizing styrene with For use only as a coating or component of coatings and limited
maleic anhydride and its methyl and butyl (sec- or iso-) to use at a level not to exceed 1% by weight of paper or pa-
esters. Such copolymers may contain b-nitrostyrene as a po- perboard substrate.
lymerization chain terminator.
Styrene polymers made by the polymerization of any combina- For use only in contact with foods of Types IV-A, V, and VII in
tion of styrene or alpha methyl styrene with acrylic acid, table 1 of paragraph (c) of this section, under use conditions
methacrylic acid, 2-ethyl hexyl acrylate, methyl methacrylate, E through G in table 2 of paragraph (c), and with foods of
and butyl acrylate. The styrene and alpha methyl styrene, in- Types VIII and IX without use temperature restriction.
dividually, may constitute from 0 to 80 weight percent of the
polymer. The other monomers, individually, may be from 0 to
40 weight percent of the polymer. The polymer number aver-
age molecular weight (Mn) shall be at least 2,000 (as deter-
mined by gel permeation chromatography). The acid number
of the polymer shall be less than 250. The monomer content
shall be less than 0.5 percent.
Styrene-acrylic copolymers (CAS Reg. No. 25950–40–7 pro- For use only as a component of coatings and limited to use at
duced by polymerizing 77 to 83 parts by weight of styrene a level not to exceed 20 percent by weight of the coating
with 13 to 17 parts of methyl methacrylate, 3 to 4 parts of solids.
butyl methacrylate, 0.5 to 2.5 parts of methacrylic acid, and
0.1 to 0.3 part of butyl acrylate such that the finished copoly-
mers have a minimum number average molecular weight
greater than 100,000 and a level of residual styrene mon-
omer in the polymer not to exceed 0.1 percent by weight.
Styrene-butadiene copolymers produced by copolymerizing sty-
rene-butadiene with one or more of the monomer: acryl-
amide, acrylic acid, fumaric acid, 2-hydroxyethyl acrylate,
itaconic acid, and methacrylic acid. The finished copolymers
shall contain not more than 10 weight percent of total poly-
mer units derived from acrylic acid, fumaric acid, 2-hydroxy-
ethyl acrylate, itaconic acid and methacrylic acid, and shall
contain not more than 2 weight percent of polymer units de-
rived from acrylamide.
Styrene-butadiene copolymers with 2-hydroxyethyl acrylate and
acrylic acid containing not more than 15 weight percent
acrylic acid and no more than 20 weight percent of a com-
bination of 2-hydroxyethyl acrylate and acrylic acid.
Styrene-butadiene-vinylidene chloride copolymers containing For use only as coatings or components of coatings.
not more than 40 weight percent of vinylidene chloride in the
finished copolymers. The finished copolymers may contain
not more than 10 weight percent of total polymer units de-
rived from acrylic acid, fumaric acid, 2-hydroxyethyl acrylate,
itaconic acid, and/or methacrylic acid.
226
Styrene-dimethylstyrene-a-methylstyrene copolymers produced For use only in coatings for paper and paperboard intended for
by polymerizing equimolar ratios of the three comonomers use in contact with nonfatty food and limited to use at a level
such that the finished copolymers have a minimum average not to exceed 50% by weight of the coating solids.
molecular weight of 835 as determined by ASTM method
D2503–82, ‘‘Standard Test Method for Molecular Weight
(Relative Molecular Mass) of Hydrocarbons by Thermo-
electric Measurement of Vapor Pressure,’’ which is incor-
porated by reference. Copies may be obtained from the
American Society for Testing Materials, 100 Barr Harbor Dr.,
West Conshohocken, Philadelphia, PA 19428-2959, or may
be examined at the National Archives and Records Adminis-
tration (NARA). For information on the availability of this ma-
terial at NARA, call 202–741–6030, or go to: http://
Styrene-isobutylene copolymers (weight average molecular For use only in coatings for paper and paperboard intended for
weight not less than 6,300). use in contact under conditions of use D G described in
table 2 of paragraph (c) of this section, with food of Types I,
II, IV-B, VI-B, VII-B, and VIII described in table 1 of para-
graph (c) of this section; and limited to use at a level not to
exceed 40 percent by weight of the coating solids.
Styrene-maleic anhydride copolymers ........................................ For use only as a coating or component of coatings and limited
for use at a level not to exceed 2 percent by weight of paper
or paperboard substrate.
Styrene-methacrylic acid copolymers containing no more than
5 weight percent of polymer units derived from methacrylic
acid.
Styrene-vinylidene chloride copolymers containing not more For use only as coatings or components of coatings.
than 40 weight percent of vinylidene chloride in the finished
copolymers. The finished copolymers may contain not more
than 5 weight percent of total polymer units derived from
acrylic acid, fumaric acid, itaconic acid, and/or methacrylic
acid.
2-Sulfoethyl methacrylate, sodium salt [Chemical Abstracts For use only in copolymer coatings under conditions of use E,
Service No. 1804–87–1]. F, and G described in paragraph (c) of this section, table 2,
and limited to use at a level not to exceed 2.0 percent by
weight of the dry copolymer coating.
a[p-(1,1,3,3-Tetramethylbutyl) phenyl]-omega-hydroxypoly (oxy- For use only as a surface-active agent at levels not to exceed
ethylene) hydrogen sulfate, sodium salt mixture with a-[p- 3 percent by weight of vinyl acetate polymer with ethylene
(1,1,3,3-tetramethylbutyl)-phenyl]-omega-hydroxypoly (oxy- and N-(hydroxymethyl) acrylamide intended for use in coat-
ethylene) with both substances having a poly(oxyethylene) ings for paper and paperboard intended for use in contact
content averaging 3 moles. with foods:
1. Of the types identified in paragraph (c) of this section, table
1, under Types I, II, III, IV, VI-B, and VII, and under the con-
ditions of use described in paragraph (c) of this section,
1, under Types V, VIII and IX and under the conditions of
use described in paragraph (c) of this section, table 2, condi-
tions of use C, D, E, F, and G.
Tetrasodium N-(1,2-dicarboxyethyl)-N-octadecylsulfo-succina- For use only as an emulsifier in resin latex coatings, and lim-
mate. ited to use at a level not to exceed 0.05% by weight of the
coating solids.
Toluenesulfonamide-formaldehyde resins.
227
§ 176.170 21 CFR Ch. I (4–1–23 Edition)
Vinyl acetate copolymers produced by copolymerizing vinyl ac-

etate with one or more of the monomers acrylamide, acrylic
acid, acrylonitrile, bicyclo-[2.2.1]hept-2-ene-6-methylacrylate,
butyl acrylate, crotonic acid, decyl acrylate, diallyl fumarate,
diallyl maleate, diallyl phthalate, dibutyl fumarate, dibutyl
itaconate, dibutylmaleate, di(2-ethylhexyl) maleate, divinyl
benzene, ethyl acrylate, 2-ethyl-hexyl acrylate, fumaric acid,
itaconic acid, maleic acid, methacrylic acid, methyl acrylate,
methyl methacrylate, mono(2-ethylhexyl) maleate, monoethyl
maleate, styrene, vinyl butyrate, vinyl crotonate, vinyl
hexoate, vinylidene chloride, vinyl pelargonate, vinyl propio-
nate, vinyl pyrrolidone, vinyl stearate, and vinyl sulfonic acid.
The finished copolymers shall contain at least 50 weight per-
cent of polymer units derived from vinyl acetate and shall
contain no more than 5 weight percent of total polymer units
derived from acrylamide, acrylic acid, crotonic acid, decyl ac-
rylate, dibutyl itaconate, di(2-ethylhexyl) maleate, fumaric
acid, itaconic acid, maleic acid, methacrylic acid, mono(2-
ethylhexyl) maleate, monoethyl maleate, vinyl butyrate, vinyl
hexoate, vinyl pelargonate, vinyl propionate, vinyl stearate,
and vinyl sulfonic acid.
Vinyl acetate polymer with ethylene and N-(hydroxymethyl) ac- For use only in coatings for paper and paperboard intended for
rylamide containing not more than 6 weight percent of total use in contact with foods:
polymer units derived from N-(hydroxymethyl) acrylamide. 1. Of the types identified in paragraph (c) of this section, table
1, under Types I, II, III, IV, VI B, and VII and under the con-
ditions of use described in paragraph (c) of this section,
1, under Types V, VIII, and IX and under the conditions of
use described in paragraph (c) of this section, table 2, condi-
tions of use C, D, E, F, and G.
Vinyl chloride copolymers produced by copolymerizing vinyl
chloride with one or more of the monomers acrylonitrile; fu-
maric acid and its methyl, ethyl, propyl, butyl, amyl, hexyl,
heptyl, or octyl esters; maleic acid and its methyl, ethyl,
propyl, butyl, amyl, hexyl, heptyl, or octyl esters; maleic an-
hydride; 5-norbornene-2, 3-dicarboxylic acid, mono-n-butyl
ester; vinyl acetate-and vinylidene chloride. The finished co-
polymers shall contain at least 50 weight percent of polymer
units derived from vinyl chloride: shall contain no more than
5 weight percent of total polymer units derived from fumaric
and/or maleic acid and/or their methyl, ethyl, propyl, butyl,
amyl, heptyl, or octyl monoesters or from maleic anhydride
or from mono-n-butyl ester of 5-norbornene-2, 3-dicarboxylic
acid (however, in any case the finished copolymers shall
derived from mono-n-butyl ester of 5-norbornene-2,3-
dicarboxylic acid).
Vinyl chloride-vinyl acetate hydroxyl-modified copolymers.
Vinyl chloride-vinyl acetate hydroxyl-modified copolymers re-
acted with trimellitic anhydride.
Vinylidene chloride copolymers produced by copolymerizing vi-
nylidene chloride with one or more of the monomers acryl-
amide acrylic acid, acrylonitrile, butyl acrylate, butyl meth-
acrylate ethyl acrylate, ethyl methacrylate, fumaric acid,
itaconic acid, methacrylic acid, methyl acrylate, methyl meth-
acrylate, octadecyl methacrylate, propyl acrylate, propyl
methacrylate, vinyl chloride and vinyl sulfonic acid. The fin-
ished copolymers shall contain at least 50 weight percent of
polymer units derived from vinylidene chloride; and shall
derived from acrylamide, acrylic acid, fumaric acid, itaconic
acid, methacrylic acid, octadecyl methacrylate, and vinyl sul-
fonic acid.
Colorants:.
Aluminum .............................................................................. For use as a colorant only.
Aluminum hydrate ................................................................ Do.
Aluminum and potassium silicate (mica) ............................. Do.
Aluminum mono-, di-, and tristearate ................................... Do.
Aluminum silicate (China clay) ............................................. Do.
Barium sulfate ...................................................................... Do.
Bentonite .............................................................................. Do.

Bentonite, modified with dimethyldioctadecylammonium ion Do.
Burnt umber .......................................................................... Do.
228
Calcium carbonate ............................................................... Do.

Calcium silicate .................................................................... Do.
Calcium sulfate ..................................................................... Do.
Carbon black (channel process) .......................................... Do.
Cobalt aluminate .................................................................. Do.
Diatomaceous earth ............................................................. Do.
Iron oxides ............................................................................ Do.
Magnesium oxide ................................................................. Do.
Magnesium silicate (talc) ...................................................... Do.
Phthalocyanine blue (C.I. pigment blue 15, 15:1, 15:2, Do.
15:3, and 15:4; C.I. No. 74160; CAS Reg. No. 147–14–
8).
Raw sienna ........................................................................... Do.
Silica ..................................................................................... Do.
Tartrazine lake (certified FD&C Yellow No. 5 only) ............. Do.
Titanium dioxide ................................................................... Do.
Titanium dioxide-barium sulfate ........................................... Do.
Titanium dioxide-magnesium ............................................... Do.
silicate.
Zinc carbonate ...................................................................... Do.
Zinc oxide ............................................................................. Do.
(c) The food-contact surface of the II. Acid, aqueous products; may contain salt
paper and paperboard in the finished or sugar or both, and including oil-in-water
emulsions of low- or high-fat content.
form in which it is to contact food,
III. Aqueous, acid or nonacid products con-
when extracted with the solvent or sol- taining free oil or fat; may contain salt,
vents characterizing the type of food, and including water-in-oil emulsions of
and under conditions of time and tem- low- or high-fat content.
perature characterizing the conditions IV. Dairy products and modifications:
of its intended use as determined from A. Water-in-oil emulsions, high- or low-fat.
B. Oil-in-water emulsions, high- or low-fat.
tables 1 and 2 of this paragraph, shall V. Low-moisture fats and oil.
yield net chloroform-soluble extrac- VI. Beverages:
tives (corrected for wax, petrolatum, A. Containing up to 8 percent of alcohol.
mineral oil and zinc extractives as zinc B. Nonalcoholic.
oleate) not to exceed 0.5 milligram per C. Containing more than 8 percent alcohol.
square inch of food-contact surface as VII. Bakery products other than those in-
cluded under Types VIII or IX of this table:
determined by the methods described A. Moist bakery products with surface con-
in paragraph (d) of this section. taining free fat or oil.
B. Moist bakery products with surface con-
TABLE 1—TYPES OF RAW AND PROCESSED taining no free fat or oil.
FOODS VIII. Dry solids with the surface containing
I. Nonacid, aqueous products; may contain no free fat or oil (no end test required).
salt or sugar or both (pH above 5.0). IX. Dry solids with the surface containing
free fat or oil.
TABLE 2—TEST PROCEDURES WITH TIME TEMPERATURE CONDITIONS FOR DETERMINING AMOUNT OF
EXTRACTIVES FROM THE FOOD-CONTACT SURFACE OF UNCOATED OR COATED PAPER AND PAPER-
BOARD, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES
Food-simulating solvents
8 percent al- 50 percent al-

Types of food Water Heptane 1
Condition of use cohol cohol
(see table 1)
Time and Time and Time and Time and tem-
temperature temperature temperature perature
A. High temperature heat-sterilized (e.g., I, IV-B, VII-B ...... 250 °F, 2 hr ..................... ..................... ........................
over 212 °F).
III, IV-A, VII-A .... ......do .......... 150 °F, 2 hr ..................... ........................
B. Boiling water sterilized .............................. II, VII-B ............... 212 °F, 30
min.
III, VII-A .............. ......do .......... 120 °F, 30 ..................... ........................

min.
229
§ 176.170 21 CFR Ch. I (4–1–23 Edition)
TABLE 2—TEST PROCEDURES WITH TIME TEMPERATURE CONDITIONS FOR DETERMINING AMOUNT OF
EXTRACTIVES FROM THE FOOD-CONTACT SURFACE OF UNCOATED OR COATED PAPER AND PAPER-
BOARD, USING SOLVENTS SIMULATING TYPES OF FOODS AND BEVERAGES—Continued
Food-simulating solvents
8 percent al- 50 percent al-

Types of food Water Heptane 1
Condition of use cohol cohol
(see table 1)
Time and Time and Time and Time and tem-
temperature temperature temperature perature
C. Hot filled or pasteurized above 150 °F .... II, IV-B, VII-B ..... Fill boiling, ..................... ..................... ........................
cool to
100 °F.
III, IV-A, VII-A .... ......do .......... 120 °F, 15 ..................... ........................
min.
V, IX ................... ..................... ......do .......... ..................... ........................
D. Hot filled or pasteurized below 150 °F ..... II, IV-B, VI-B, ..... ..................... ..................... ..................... ........................
VII-B ................... 150 °F, 2 hr ..................... ..................... ........................
III, IV-A, VII-A .... ......do .......... 100 °F, 30 ..................... ........................
min.
V, IX ................... ..................... ......do .......... ..................... ........................
VI-A .................... ..................... ..................... 150 °F, 2 hr ........................
VI-C .................... ..................... ..................... ..................... 150 °F, 2 hr.
E. Room temperature filled and stored (no I, II, IV-B, VI-B, 120 °F, 24 hr ..................... ..................... ........................
thermal treatment in the container). VII-B.
III, IV-A, VII-A .... ......do .......... 70 °F, 30 ..................... ........................
min.
V, IX ................... ..................... ......do .......... ..................... ........................
VI-A .................... ..................... ..................... 120 °F, 24 hr ........................
VI-C .................... ..................... ..................... ..................... 120 °F, 24 hr.
F. Refrigerated storage (no thermal treat- III, IV-A, VII-A .... 70 °F, 48 hr 70 °F, 30 ..................... ........................
ment in the container). min.
I, II, IV-B, VI-B, ......do .......... ..................... ..................... ........................
VII-B.
VI-A .................... ..................... ..................... 70 °F, 48 hr ........................
VI-C .................... ..................... ..................... ..................... 70 °F, 48 hr.
G. Frozen storage (no thermal treatment in I, II, IV-B, VII-B .. 70 °F, 24 hr ..................... ..................... ........................
the container).
III, VII-A .............. ......do .......... 70 °F, 30 ..................... ........................
min.
H. Frozen or refrigerated storage: Ready-
prepared foods intended to be reheated in
container at time of use:
1. Aqueous or oil-in-water emulsion of I, II, IV-B, VII-B .. 212 °F, 30 ..................... ..................... ........................
high- or low-fat. min.
2. Aqueous, high- or low-free oil or fat .. III, IV-A, VII-A, IX ......do .......... 120 °F, 30 ..................... ........................
min.
1 Heptane extractability results must be divided by a factor of five in arriving at the extractability for a food product having
water-in-oil emulsion or free oil or fat. Heptane food-simulating solvent is not required in the case of wax-polymer blend coatings
for corrugated paperboard containers intended for use in bulk packaging of iced meat, iced fish, and iced poultry.
(d) Analytical methods—(1) Selection of aggeration over normal use, follow the
extractability conditions. First ascertain applicable extraction procedure.
the type of food product (table 1, para- (2) Reagents—(i) Water. All water used
graph (c) of this section) that is being in extraction procedures should be
packed commercially in the paper or freshly demineralized (deionized) dis-
paperboard and the normal conditions tilled water.
of thermal treatment used in pack- (ii) n-Heptane. Reagent grade, freshly
aging the type of food involved. Using redistilled before use, using only mate-
table 2, paragraph (c) of this section, rial boiling at 208 °F.
select the food-simulating solvent or (iii) Alcohol. 8 or 50 percent (by vol-
solvents and the time-temperature ex- ume), prepared from undenatured 95
aggerations of the paper or paperboard percent ethyl alcohol diluted with
use conditions. Having selected the ap- demineralized (deionized) distilled
propriate food-simulating solvent or water.

solvents and the time-temperature ex- (iv) Chloroform. Reagent grade, fresh-
ly redistilled before use, or a grade
230
having an established consistently low holding at least one 800-milliliter beak-

blank. er partially submersed in bath.
(3) Selection of test method. Paper or (b) Analytical balance sensitive to 0.1
paperboard ready for use in packaging milligram with an approximate capac-
shall be tested by use of the extraction ity of 100 grams.
cell described in ‘‘Official Methods of (c) Tongs.
Analysis of the Association of Official (d) Hood and hot-plate facilities.
Analytical Chemists,’’ 13th Ed. (1980), (e) Forced draft oven.
sections 21.010–21.015, under ‘‘Exposing For each extraction, the following ad-
Flexible Barrier Materials for Extrac- ditional apparatus is necessary:
tion,’’ which is incorporated by ref- (f) One No. 2 paper clip.
erence (Copies may be obtained from (g) One 800-milliliter beaker with
the AOAC INTERNATIONAL, 481 North watch-glass cover.
Frederick Ave., suite 500, Gaithersburg, (h) One 250-milliliter beaker.
MD 20877, or may be examined at the (i) Five 21⁄2-inch-square aluminum
National Archives and Records Admin- screens (standard aluminum window
istration (NARA). For information on screening is acceptable).
the availability of this material at (j) One wire capable of supporting
NARA, call 202–741–6030, or go to: http:// sample stack.
www.archives.gov/federal_register/ (ii) Procedure. (a) For each extrac-
code_of_federal_regulations/ tion, accurately cut eight 21⁄2-inch-
ibr_locations.html.); also described in square samples from the formed paper
ASTM method F34–76 (Reapproved or paperboard product to be tested.
1980), ‘‘Standard Test Method for Liq- (b) Carefully stack the eight 21⁄2-inch-
uid Extraction of Flexible Barrier Ma- square samples and the five 21⁄2-inch-
terials,’’ which is incorporated by ref- square aluminum screens in sandwich
erence (copies may be obtained from form such that the food-contact side of
the American Society for Testing Ma- each sample is always next to an alu-
terials, 100 Barr Harbor Dr., West minum screen, as follows: Screen, sam-
Conshohocken, Philadelphia, PA 19428- ple, sample, screen, sample, sample,
2959, or may be examined at the Na- screen, etc. Clip the sandwich together
tional Archives and Records Adminis- carefully with a No. 2 paper clip, leav-
tration (NARA). For information on ing just enough space at the top to slip
the availability of this material at a wire through.
NARA, call 202–741–6030, or go to: http:// (c) Place an 800-milliliter beaker con-
www.archives.gov/federal_register/ taining 100-milliliters of the appro-
code_of_federal_regulations/ priate food-simulating solvent into the
ibr_locations.html.), except that formed constant temperature bath, cover with
paper and paperboard products may be a watch glass and condition at the de-
tested in the container by adapting the sired temperature.
in-container methods described in (d) After conditioning, carefully
§ 175.300(e) of this chapter. Formed lower the sample sandwich with tongs
paper and paperboard products such as into the beaker.
containers and lids, that cannot be (e) At the end of the extraction pe-
tested satisfactorily by any of the riod, using the tongs, carefully lift out
above methods may be tested in spe- the sample sandwich and hang it over
cially designed extraction equipment, the beaker with the wire.
usually consisting of clamping devices (f) After draining, pour the food-sim-
that fit the closure or container so ulating solvent solution into a tared
that the food-contact surface can be 250-milliliter beaker. Rinse the 800-mil-
tested, or, if flat samples can be cut liliter beaker three times, using a total
from the formed paper or paperboard of not more than 50 milliliters of the
products without destroying the integ- required solvent.
rity of the food-contact surface, they (g) Determine total nonvolatile ex-
may be tested by adapting the fol- tractives in accordance with paragraph
lowing ‘‘sandwich’’ method: (d)(5) of this section.
(i) Apparatus. (a) Thermostated (±1.0 (4) Selection of samples. Quadruplicate

°F) water bath, variable between 70 °F samples should be tested, using for
and 120 °F water bath cover capable of each replicate sample the number of
231
§ 176.170 21 CFR Ch. I (4–1–23 Edition)
cups, containers, or preformed or con- (freshly distilled reagent grade or a

verted products nearest to an area of grade having an established consist-
100 square inches. ently low blank) to the dried and
(5) Determination of amount of extrac- weighed residue, (e), in the evaporating
tives—(i) Total residues. At the end of dish obtained in paragraph (d)(5)(i) of
the exposure period, remove the test this section. Warm carefully, and filter
container or test cell from the oven through Whatman No. 41 filter paper
and combine the solvent for each rep- (or equivalent) in a Pyrex (or equiva-
licate in a clean Pyrex (or equivalent) lent) funnel, collecting the filtrate in a
flask or beaker being sure to rinse the clean, tared evaporating dish (platinum
test container or cell with a small or Pyrex). Repeat the chloroform ex-
quantity of clean solvent. Evaporate traction, washing the filter paper with
the food-simulating solvents to about this second portion of chloroform. Add
100 milliliters in the flask or beaker, this filtrate to the original filtrate and
and transfer to a clean, tared
evaporate the total down to a few mil-
evaporating dish (platinum or Pyrex),
liliters on a low-temperature hotplate.
washing the flask three times with
The last few milliliters should be evap-
small portions of solvent used in the
extraction procedure, and evaporate to orated in an oven maintained at ap-
a few milliliters on a nonsparking, low- proximately 221 °F. Cool the
temperature hotplate. The last few evaporating dish in a desiccator for 30
milliliters should be evaporated in an minutes and weigh to the nearest 0.1
oven maintained at a temperature of milligram to get the chloroform-solu-
approximately 221 °F. Cool the ble extractives residue (′). This ′ is sub-
evaporating dish in a desiccator for 30 stituted for e in the equations in para-
minutes and weigh the residue to the graph (d)(5)(i)(a) and (b) of this section.
nearest 0.1 milligram, (e). Calculate the If the chloroform-soluble extractives in
extractives in milligrams per square milligrams per square inch still ex-
inch of the container or sheeted paper ceeds the limitation prescribed in para-
or paperboard surface. graph (c) of this section, proceed to
(a) Water and 8- and 50-percent alcohol. paragraph (d)(5)(iii) of this section
Milligrams extractives per square inch (method for determining corrected
= (e)/(s). chloroform-soluble extractives res-
(b) Heptane. Milligrams extractives idue).
per square inch=(e)/(s)(F) (iii) Corrected chloroform-soluble ex-
where: tractives residue—(a) Correction for zinc
e = Milligrams extractives per sample tested. extractives. Ash the residue in the
s = Surface area tested, in square inches. evaporating dish by heating gently
F = Five, the ratio of the amount of extrac- over a Meker-type burner to destroy
tives removed by heptane under exagger- organic matter and hold at red heat for
ated time-temperature test conditions about 1 minute. Cool in the air for 3
compared to the amount extracted by a fat
or oil under exaggerated conditions of
minutes, and place the evaporating
thermal sterilization and use. dish in the desiccator for 30 minutes
e′ = Chloroform-soluble extractives residue. and weigh to the nearest 0.1 milligram.
ee′ = Corrected chloroform-soluble extrac- Analyze this ash for zinc by standard
tives residue. Association of Official Agricultural
e′ or ee′ is substituted for e in the above equa- Chemists methods or equivalent. Cal-
tions when necessary.
culate the zinc in the ash as zinc ole-
If when calculated by the equations in ate, and subtract from the weight of
paragraph (d)(5)(i)(a) and (b) of this sec- chloroform-soluble extractives residue
tion, the extractives in milligrams per (′) to obtain the zinc-corrected chloro-
square inch exceeds the limitations form-soluble extractives residue (e′).
prescribed in paragraph (c) of this sec- This e′ is substituted for e in the equa-
tion, proceed to paragraph (d)(5)(ii) of tions in paragraph (d)(5)(i)(a) and (b) of
this section (method for determining this section.
the amount of chloroform-soluble ex- (b) Correction for wax, petrolatum, and
tractives residues). mineral oil—(1) Apparatus. Standard 10

(ii) Chloroform-soluble extractives res- millimeter inside diameter × 60 centi-
idue. Add 50 milliliters of chloroform meter chromatographic column (or
232
standard 50-milliliter buret with an in- through the column into a clean, tared
side diameter of 10–11 millimeters) evaporating dish (platinum or Pyrex)
with a stopcock of glass, at a dropwise rate of about 2 milliliters
perfluorocarbon resin, or equivalent per minute until the liquid surface
material. The column (or buret) may reaches the top glass wool plug; then
be optionally equipped with an integral close the stopcock temporarily. Rinse
coarse, fritted glass disc and the top of the Pyrex flask which contained the
the column (or buret) may be option- filtrate with an additional 10–15 milli-
ally fitted with a 100-millimeter sol- liters of heptane and add to the col-
vent reservoir. umn. Wash (elute) the column with
(2) Preparation of column. Place a more heptane collecting about 100 mil-
snug pledget of fine glass wool in the liliters of total eluate including that
bottom of the column (or buret) if the already collected in the evaporating
column (or buret) is not equipped with dish. Evaporate the combined eluate in
integral coarse, fritted glass disc. Over- the evaporating dish to dryness on a
lay the glass wool pledget (or fritted steam bath. Dry the residue for 15 min-
glass disc) with a 15–20 millimeter deep utes in an oven maintained at a tem-
layer of fine sand. Measure in a grad- perature of approximately 221 °F. Cool
uated cylinder 15 milliliters of the evaporating dish in a desiccator for
chromatographic grade aluminum 30 minutes and weigh the residue to the
oxide (80–200 mesh) that has been tight- nearest 0.1 milligram. Subtract the
ly settled by tapping the cylinder.
weight of the residue from the weight
Transfer the aluminum oxide to the
of chloroform-soluble extractives res-
chromatographic tube, tapping the
idue (′) to obtain the wax-, petrolatum-
tube during and after the transfer so as
, and mineral oil-corrected chloroform-
to tightly settle the aluminum oxide.
soluble extractives residue (e′). This e′
Overlay the layer of aluminum oxide
with a 1.0–1.5 centimeter deep layer of is substituted for e in the equations in
anhydrous sodium sulfate and on top of paragraph (d)(5)(i)(a) and (b) of this sec-
this place an 8–10 millimeter thick plug tion.
of fine glass wool. Next carefully add (ii) For chloroform residues weighing
about 25 milliliters of heptane to the more than 0.5 gram. Redissolve the
column with stopcock open, and allow dried and weighed chloroform-soluble
the heptane to pass through the col- extract residue as described in para-
umn until the top level of the liquid graph (d)(5)(iii)(b)(3)(i) of this section
just passes into the top glass wool plug using proportionately larger quantities
in the column, and close stopcock. of heptane. Transfer the heptane solu-
(3) Chromatographing of sample ex- tion to an appropriate-sized volumetric
tract—(i) For chloroform residues weigh- flask (i.e., a 250-milliliter flask for
ing 0.5 gram or less. To the dried and about 2.5 grams of residue) and adjust
weighed chloroform-soluble extract to volume with additional heptane. Pi-
residue in the evaporating dish, ob- pette out an aliquot (about 50 milli-
tained in paragraph (d)(5)(ii) of this liters) calculated to contain 0.1–0.5
section, add 20 milliliters of heptane gram of the chloroform-soluble extract
and stir. If necessary, heat carefully to residue and analyze
dissolve the residue. Additional chromatographically as described in
heptane not to exceed a total volume of paragraph (d)(5)(iii)(b)(3)(i) of this sec-
50 milliliters may be used if necessary tion. In this case the weight of the
to complete dissolving. Cool to room dried residue from the heptane eluate
temperature. (If solution becomes must be multiplied by the dilution fac-
cloudy, use the procedure in paragraph tor to obtain the weight of wax, petro-
(d)(5)(iii)(b)(3)(ii) of this section to ob- latum, and mineral oil residue to be
tain an aliquot of heptane solution cal- subtracted from the weight of chloro-
culated to contain 0.1–0.5 gram of chlo- form-soluble extractives residue (′) to
roform-soluble extract residue.) Trans- obtain the wax-, petrolatum-, and min-
fer the clear liquid solution to the col- eral oil-corrected chloroform-soluble
umn (or buret). Rinse the dish with 10 extractives residue (e′). This e′ is sub-
millimeters of additional heptane and stituted for e in the equations in para-
add to column. Allow the liquid to pass graph (d)(5)(i)(a) and (b) of this section.
233
§ 176.180 21 CFR Ch. I (4–1–23 Edition)
(Note: In the case of chloroform-solu- surface of paper and paperboard in-

ble extracts which contain high melt- tended for use in producing, manufac-
ing waxes (melting point greater than turing, packing, processing, preparing,
170 °F), it may be necessary to dilute treating, packaging, transporting, or
the heptane solution further so that a holding dry food of the type identified
50-milliliter aliquot will contain only in § 176.170(c), table 1, under Type VIII,
0.1–0.2 gram of the chloroform-soluble subject to the provisions of this sec-
extract residue.) tion.
(e) Acrylonitrile copolymers identi- (a) The substances are used in
fied in this section shall comply with
amounts not to exceed that required to
accomplish their intended physical or
ter, except where the copolymers are
restricted to use in contact with food technical effect, and are so used as to
only of the type identified in paragraph accomplish no effect in food other than
(c), table 1 under Category VIII. that ordinarily accomplished by pack-
aging.
[42 FR 14554, Mar. 15, 1977] (b) The substances permitted to be
EDITORIAL NOTE: For FEDERAL REGISTER ci- used include the following:
tations affecting § 176.170, see the List of CFR (1) Substances that by § 176.170 and
Sections Affected, which appears in the
other applicable regulations in parts
and at www.govinfo.gov. 170 through 189 of this chapter may be
safely used as components of the
§ 176.180 Components of paper and pa- uncoated or coated food-contact sur-
perboard in contact with dry food. face of paper and paperboard, subject
The substances listed in this section to the provisions of such regulation.
may be safely used as components of (2) Substances identified in the fol-
the uncoated or coated food-contact lowing list:
Acrylamide polymer with sodium 2-acrylamido-2- For use at a level not to exceed 0.015 weight percent of dry
methylpropane-sulfonate (CAS Reg. No. 38193–60–1). fiber.
(2-Alkenyl) succinic anhydrides in which the alkenyl groups are
derived from olefins which contain not less than 78 percent
C30 and higher groups (CAS Reg. No. 70983–55–0)..
4-[2-[2-(2-Alkoxy(C12-C15) ethoxy) ethoxy]ethyl]disodium sulfo- For use as a polymerization emulsifier and latex emulsion sta-
succinate. bilizer at levels not to exceed 5 percent by weight of total
emulsion solids.
Alkyl mono- and disulfonic acids, sodium salts (produced from
n-alkanes in the range of C10-C18 with not less than 50 per-
cent C14-C16)..
Aluminum and calcium salts of FD & C dyes on a substrate of Colorant.
alumina.
Ammonium nitrate..
Amylose..
Barium metaborate ...................................................................... For use as preservative in coatings and sizings.
1,2-Benzisothiazolin-3-one (CAS Registry No. 2634–33–5) ....... For use only as a preservative in paper coating compositions
and limited to use at a level not to exceed 0.02 mg/in2
(0.0031 mg/cm2) of finished paper and paperboard.
N,N′-Bis(hydroxyethyl)lauramide.
Bis(trichloromethyl) sulfone C.A. Registry No. 3064–70–8 ......... For use only as a preservative in coatings.
Borax ........................................................................................... For use as preservative in coatings.
Boric acid ..................................................................................... Do.
sec-Butyl alcohol..
Candelilla wax..
Carbon tetrachloride..
Castor oil, polyoxyethylated (42 moles ethylene oxide)..
Cationic soy protein hydrolyzed (hydrolyzed soy protein isolate For use only as a coating adhesive, pigment structuring agent,
modified by treatment with 3-chloro-2-hydroxypropyl- and fiber retention aid.
trimethylammonium chloride).
Cationic soy protein (soy protein isolate modified by treatment For use only as a coating adhesive, pigment structuring agent,
with 3-chloro-2-hydroxypropyltrimethyl-ammonium chloride). and fiber retention aid.
Chloral hydrate ............................................................................ Polymerization reaction-control agent.

N-Cyclohexyl-p-toluene sulfonamide..
2,5-Di-tert-butyl hydroquinone.
234
Diethanolamine..
Diethylene glycol dibenzoate (CAS Reg. No. 120–55–8) ........... For use only as a plasticizer in polymeric substances.
Diethylene glycol monobutyl ether..
Diethylene glycol monoethyl ether..
Diethylenetriamine..
N,N-Diisopropanolamide of tallow fatty acids..
N-[(dimethylamino)methyl]acrylamide polymer with acrylamide
and styrene..
N,N-Dioleoylethylenediamine, N,N-dilinoeoyl-ethylenediamine,
and N-oleoyl-N-linoleoyl-ethylenediamine mixture produced
when tall oil fatty acids are made to react with ethylene-
diamine such that the finished mixture has a melting point of
212°–228 °F, as determined by ASTM method D127–60, and
an acid value of 10 maximum. ASTM Method D127–60
‘‘Standard Method of Test for Melting Point of Petrolatum
and Microcrystalline Wax’’ (Revised 1960) is incorporated by
reference. Copies are available from University Microfilms
International, 300 N. Zeeb Rd., Ann Arbor, MI 48106, or
available for inspection at the National Archives and Records
Administration (NARA). For information on the availability of
this material at NARA, call 202–741–6030, or go to: http://
Diphenylamine..
Dipropylene glycol dibenzoate (CAS Reg. No. 27138–31–4) ..... For use only as plasticizer in polymeric substances.
Disodium N-octadecylsulfosuccinamate..
tert-Dodecyl thioether of polyethylene glycol..
Erucamide (erucylamide)..
Ethanedial, polymer with tetrahydro-4-hydroxy-5-methyl-
2(1H)pyrimidinone, propoxylated..
Ethylene oxide ............................................................................. Fumigant in sizing.
Ethylene oxide adduct of mono-(2-ethylhexyl) o-phosphate..
Fatty acid (C12-C18) diethanolamide..
Fish oil fatty acids, hydrogenated, potassium salt..
Formaldehyde..
Glyceryl monocaprate..
Glyceryl tribenzoate (CAS Reg. No. 614–33–5) ......................... For use only as a plasticizer in polymeric coatings.
Glyoxal..
Glyoxal-urea-formaldehyde condensate (CAS Reg. No. 27013– For use as an insolubilizer for starch in coatings.
01–0) formed by reaction in the molar ratio of approximately
47:33:15, respectively. The reaction product has a number
average molecular weight of 278±14 as determined by a
suitable method.
Glyoxal-urea polymer (CAS Reg. No. 53037–34–6) ................... For use as an insolubilizer for starch.
Hexamethylenetetramine ............................................................. Polymerization crosslinking agent for protein, including casein.
As neutralizing agent with myristochromic chloride complex
and stearato-chromic chloride complex.
Hexylene glycol (2-methyl-2,4-pentanediol)..
Hydroabietyl alcohol..
5-Hydroxymethoxymethyl-1-aza-3,7-dioxabicyclo[3.3.0] octane, For use only as an antibacterial preservative.
5-hydroxymethyl-1-aza-3,7-dioxabicyclo[3.3.0]octane, and 5-
hydroxypoly-[methyleneoxy]methyl-1-aza-3,7-
dioxabicyclo[3.3.0] octane mixture.
Imidazolium compounds, 2–(C17 and C17-unsaturated alkyl)-1– For use only at levels not to exceed 0.5 percent by weight of
[2–(C18 and C18-unsaturated amido)ethyl]-4,5-dihydro-1- the dry paper and paperboard.
methyl, methyl sulfates (CAS Reg. No. 72749–55–4)..
Isopropanolamine hydrochloride..
Isopropyl m- and p-cresol (thymol derived)..
Itaconic acid..
Maleic anhydride-diisobutylene copolymer, ammonium or so-
dium salt..
Melamine-formaldehyde modified with: Basic polymer.
Alcohols (ethyl, butyl, isobutyl, propyl, or isopropyl).
Diethylenetriamine.
Imino-bis-butylamine.
Imino-bis-ethyleneimine.
Imino-bis-propylamine.
Polyamines made by reacting ethylenediamine or
trimethylenediamine with dichloroethane or dichloropropane.
Sulfanilic acid.
Methyl alcohol..
Methyl ethers of mono-, di-, and tripropylene glycol..
235
§ 176.180 21 CFR Ch. I (4–1–23 Edition)
Methyl naphthalene sulfonic acid-formaldehyde condensate,

sodium salt..
Methylated poly(N-1,2-dihydroxyethylene-1,3-imidazolidin-2- For use only as an in solubilizer for starch.
one).
Modified polyacrylamide resulting from an epichlorohydrin addi- For use only as a dry strength and pigment retention aid agent
tion to a condensate of formaldehyde-dicyandiamide- employed prior to the sheetforming operation in the manu-
diethylene triamine and which product is then reacted with facture of paper and paperboard and used at a level not to
polyacrylamide and urea to produce a resin having a nitro- exceed 1 percent by weight of dry fibers.
gen content of 5.6 to 6.3 percent and having a minimum vis-
cosity in 56 percent-by-weight aqueous solution of 200 centi-
poises at 25 °C, as determined by LVT-series Brookfield vis-
cometer using a No. 4 spindle at 60 r.p.m. (or equivalent
method).
Mono- and di(2-alkenyl)succinyl esters of polyethylene glycol For use only as an emulsifier.
containing not less than 90 percent of the diester product
and in which the alkenyl groups are derived from olefins that
contain not less than 95 percent of C15-C21 groups.
Monoglyceride citrate..
Myristo chromic chloride complex..
Naphthalene sulfonic acid-formaldehyde condensate, sodium
salt..
Nickel..
b-Nitrostyrene .............................................................................. Basic polymer.
Octadecanoic acid, reaction products with 2-[(2- For use prior to sheet forming at levels not to exceed 12
aminoethyl)amino]ethanol and urea (CAS Reg. No. 68412– pounds per ton of paper.
14–6), and the acetate salts thereof (CAS Reg. No. 68784–
21–4), which may be emulsified with ethoxylated tallow alkyl
amines (CAS Reg. No. 61791–26–2).
a-cis-9-Octadecenyl-omega-hydroxypoly (oxyethylene); the
octadecenyl group is derived from oleyl alcohol and the
poly(oxyethylene) content averages not less than 20 moles..
a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) sulfate,
ammonium salt; the nonyl group is a propylene trimer isomer
and the poly (oxyethylene) content averages 9 or 30 moles..
Oleic acid reacted with N-alkyl-(C16-C18) trimethylenediamine..
Oxidized soy isolate having 50 to 70 percent of its cystine resi- For use as a binder adhesive component of coatings.
dues oxidized to cysteic acid.
Petroleum alicyclic hydrocarbon resins, or the hydrogenated For use as modifiers at levels up to 30 weight-percent of the
product thereof, complying with the identity prescribed in solids content of wax-polymer blend coatings.
§ 176.170(b)(2).
Petroleum hydrocarbon resins (produced by the catalytic po-
lymerization and subsequent hydrogenation of styrene,
vinyltoluene, and indene types from distillates of cracked pe-
troleum stocks)..
Petroleum hydrocarbons, light and odorless..
o-Phthalic acid modified hydrolyzed soy protein isolate..
Pine oil..
Poly(2-aminoethyl acrylate nitrate-co-2-hydroxypropyl acrylate)
complying with the identity described in § 176.170(a)..
Polyamide-epichloro hydrin modified resins resulting from the
reaction of the initial caprolactam-itaconic acid product with
diethylenetriamine and then condensing this prepolymer with
epichlorohydrin to form a cationic resin having a nitrogen
content of 11–15 percent and chlorine level of 20–23 percent
on a dry basis..
Polyamide-ethyleneimine-epichlorohydrin resin is prepared by
reacting equimolar amounts of adipic acid and three amines
(21 mole percent of 1,2-ethanediamine, 51 mole percent of
N-(2-aminoethyl)-1,3-propanediamine, and 28 mole percent
of N, N′-1,2-ethanediylbis(1,3-propanediamine)) to form a
basic polyamidoamine which is modified by reaction with
ethyleneimine (5.5:1.0 ethyleneimine:polyamidoamine). The
modified polyamidoamine is reacted with a crosslinking
agent made by condensing approximately 34 ethylene glycol
units with (chloromethyl)oxirane, followed by pH adjustment
with formic acid or sulfuric acid to provide a finished product
as a formate (CAS Reg. No. 114133–44–7) or a sulfate
(CAS Reg. No. 167678–43–5), having a weight-average mo-
lecular weight of 1,300,000 and a number-average molecular

weight of 16,000..
236
Polyamide-ethyleneimine-epichlorohydrin resin (CAS Reg. No.

115340–77–7), prepared by reacting equimolar amounts of
adipic acid and N-(2-aminoethyl)-1,2-ethanediamine to form
a basic polyamidoamine which is modified by reaction with
ethyleneimine, and further reacted with formic acid and
(chloromethyl)oxirane-a-hydro-omega-hydroxypoly(oxy-1,2-
ethanediyl)..
Polybutene, hydrogenated; complying with the identity pre-
scribed under § 178.3740(b) of this chapter..
Poly [2-(diethylamino) ethyl methacrylate] phosphate..
Polyethylene glycol (200) dilaurate..
Polyethylene glycol monoisotridecyl ether sulfate, sodium salt For use only as a surfactant at levels not to exceed 3 percent
(CAS Reg. No. 150413–26–6). in latex formulations used in pigment binders for paper and
paperboard.
Polymers: Homopolymers and copolymers of the following Basic polymer.
monomers:
Acrylamide.
Acrylic acid and its methyl, ethyl, butyl, propyl, or octyl
esters.
Acrylonitrile.
Butadiene.
Crotonic acid.
Cyclol acrylate.
Decyl acrylate.
Diallyl fumarate.
Diallyl maleate.
Diallyl phthalate.
Dibutyl fumarate.
Dibutyl itaconate.
Dibutyl maleate.
Di(2-ethylhexyl) maleate.
Dioctyl fumarate.
Dioctyl maleate.
Divinylbenzene.
Ethylene.
2-Ethylhexyl acrylate.
Fumaric acid.
Glycidyl methacrylate.
2-Hydroxyethyl acrylate.
N-(Hydroxymethyl) acrylamide.
Isobutyl acrylate.
Isobutylene.
Isoprene.
Itaconic acid.
Maleic anhydride and its methyl or butyl esters.
Methacrylic acid and its methyl, ethyl, butyl, or propyl esters.
Methylstyrene.
Mono(2-ethylhexyl) maleate.
Monoethyl maleate.
5-Norbornene-2,3-dicarboxylic acid, mono-n-butyl ester.
Styrene.
Vinyl acetate.
Vinyl butyrate.
Vinyl chloride.
Vinyl crotonate.
Vinyl hexoate.
Vinyl pelargonate.
Vinyl propionate.
Vinyl pyrrolidone.
Vinyl stearate.
Vinyl sulfonic acid.
Polymer prepared from urea, ethanedial, formaldehyde, and For use only as a starch and protein reactant in paper and pa-
propionaldehyde (CAS Reg. No. 106569–82–8). perboard coatings.
Polyoxyethylene (minimum 12 moles) ester of tall oil (30%–
40% rosin acids)..
Polyoxypropylene-polyoxyethylene glycol (minimum molecular
weight 1,900)..
Polyvinyl alcohol..
Potassium titanate fibers produced by calcining titanium diox-
ide, potassium chloride, and potassium carbonate, such that
the finished crystalline fibers have a nominal diameter of
0.20–0.25 micron, a length-to-diameter ratio of approximately

25:1 or greater, and consist principally of K2Ti4O9 and K2Ti
6O13..
237
§ 176.200 21 CFR Ch. I (4–1–23 Edition)
Sodium diisobutylphenoxy diethoxyethyl sulfonate..

Sodium diisobutylphenoxy monoethoxy ethylsulfonate..
Sodium n-dodecylpolyethoxy (50 moles) sulfate..
Sodium isododecylphenoxypolyethoxy (40 moles) sulfate..
Sodium N-methyl-N-oleyl taurate..
Sodium methyl siliconate..
Sodium nitrite..
Sodium polyacrylate..
Sodium bis-tridecylsulfosuccinate..
Sodium xylene sulfonate..
Stearato chromic chloride complex..
Styrene-allyl alcohol copolymers..
Styrene-methacrylic acid copolymer, potassium salt..
Tetraethylenepentamine .............................................................. Polymerization cross-linking agent.
a-[p-(1,1,3,3-Tetramethylbutyl)phenyl]-omega
hydroxypoly(oxyethylene) mixture of dihydrogen phosphate
and monohydrogen phosphate esters and their sodium, po-
tassium, and ammonium salts having a poly(oxyethylene)
content averaging 6–9 or 40 moles..
a-[p-(1,1,3,3-Tetramethylbutyl)phenyl or p-nonylphenyl]-omega-
hydroxypoly (oxyethylene) where nonyl group is a propylene
trimer isomer..
Tetrasodium N-(1,2-dicarboxyethyl)-N-octadecyl
sulfosuccinamate..
Toluene..
Triethanolamine..
Triethylenetetramine .................................................................... Polymerization cross-linking agent.
Triethylenetetramine monoacetate, partially stearoylated..
Urea-formaldehyde chemically modified with:
Alcohol (methyl, ethyl, butyl, isobutyl, propyl, or isopropyl).
Aminomethylsulfonic acid.
Diaminobutane.
Diaminopropane.
Diethylenetriamine.
N,N′-Dioleoylethylenediamine.
Diphenylamine.
Ethylenediamine.
Guanidine.
Imino-bis-butylamine.
Imino-bis-ethylamine.
Imino-bis-propylamine.
N-Oleoyl-N′-stearoylethylenediamine.
Polyamines made by reacting ethylenediamine or
triethylenediamine with dichloroethane or dichloropropane.
Xylene..
Xylene sulfonic acid-formaldehyde condensate, sodium salt..
Zinc stearate..
[42 FR 14554, Mar. 15, 1977]

www.govinfo.gov.
§ 176.200 Defoaming agents used in (a) The defoaming agents are pre-
coatings. pared as mixtures of substances de-
The defoaming agents described in scribed in paragraph (d) of this section.
this section may be safely used as com- (b) The quantity of any substance
ponents of articles intended for use in employed in the formulation of de-
producing, manufacturing, packing, foaming agents does not exceed the
processing, preparing, treating, pack- amount reasonably required to accom-
aging, transporting, or holding food, plish the intended physical or technical
subject to the provisions of this sec- effect in the defoaming agents or any
tion. limitation further provided.
238
(c) Any substance employed in the (1) Substances generally recognized

production of defoaming agents and as safe in food.
which is the subject of a regulation in (2) Substances subject to prior sanc-
parts 174, 175, 176, 177, 178 and § 179.45 of tion or approval for use in defoaming
this chapter conforms with any speci- agents and used in accordance with
fication in such regulation. such sanction or approval.
(d) Substances employed in the for- (3) Substances identified in this para-
mulation of defoaming agents include: graph (d)(3) and subject to such limita-
tions as are provided:
n-Butyl alcohol.
tert-Butyl alcohol.
Butyl stearate.
Castor oil, sulfated, ammonium, potassium, or sodium salt.
Cetyl alcohol.
Cyclohexane.
Cyclohexanol.
Diethylene glycol monolaurate.
Diethylene glycol monostearate.
Dimers and trimers of unsaturated C18 fatty acids derived from: For use only at levels not to exceed 0.1% by weight of total
coating solids.
Animal and vegetable fats and oils.
Tall oil.
Dimethylpolysiloxane.
a-(Dinonylphenyl)-w-hydroxy-poly(oxy-1,2-ethanediyl), con- For use only in defoaming agents for the production of styrene-
taining 7 to 24 moles of ethylene oxide per mole of butadiene coatings at a level not to exceed 0.05 percent by
dinonylphenol (CAS Reg. No. 9014–93–1). weight of the finished coating.
Dipropylene glycol.
Ethyl alcohol.
Fats and oils derived from animal, marine, or vegetable
sources:
Fatty acids derived from animal, marine, or vegetable
fats and oils, and salts of such acids, single or
mixed, as follows:
Aluminum..
Ammonium..
Calcium..
Magnesium..
Potassium..
Sodium..
Zinc..
Formaldehyde .............................................................................. For use as preservative of defoamer only.
Glyceryl mono-12-hydroxystearate.
Glyceryl monostearate.
Hexane.
Hexylene glycol (2-methyl-2,4-pentanediol).
Isobutyl alcohol.
Isopropyl alcohol.
Kerosene.
Lecithin hydroxylated.
Methyl alcohol.
Methylcellulose.
Methyl esters of fatty acids derived from animal, marine, or
vegetable fats and oils.
Methyl oleate.
Methyl palmitate.
Mineral oil.
Mustardseed oil, sulfated, ammonium, potassium, or sodium
salt.
Myristyl alcohol.
Naphtha.
b-Naphthol ................................................................................... For use as preservative of defoamer only.
Nonylphenol.
Odorless light petroleum hydrocarbons ...................................... As defined in § 178.3650 of this chapter.
Oleic acid, sulfated, ammonium, potassium, or sodium salt.
Parachlorometacresol .................................................................. For use as preservative of defoamer only.
Peanut oil, sulfated, ammonium, potassium, or sodium salt.
Petrolatum.
Pine oil.
Polyacrylic acid, sodium salt ....................................................... As a stabilizer and thickener in defoaming agents containing
dimethylpolysiloxane.
Polyethylene.
239
§ 176.210 21 CFR Ch. I (4–1–23 Edition)
Polyethylene, oxidized.
Polyethylene glycol (200) dilaurate.
Polyethylene glycol (400) esters of coconut oil fatty acids.
Polyethylene glycol (600) monoricinoleate.
Polyoxybutylene-polyoxypropylene-polyoxyethylene glycol (min.
mol. wt. 3,700).
Polyoxyethylated (min. 3 mols) cetyl alcohol.
Polyoxyethylated (min. 5 mols) oleyl alcohol.
Polyoxyethylated (min. 1.5 mols) tridecyl alcohol.
Polyoxyethylene (min. 15 mols) ester of rosin.
Polyoxyethylene (min. 8 mols) monooleate.
Polyoxyethylene (40) stearate.
Polyoxypropylated (min. 20 mols) butyl alcohol.
Polyoxypropylene glycol (min. mol. wt. 200).
Polyoxypropylene (min. 20 mols) oleate butyl ether.
Polyoxypropylene-polyoxyethylene glycol (min. mol. wt. 1,900).
Polyoxypropylene (min. 40 mols) stearate butyl ether.
Potassium pentachlorophenate ................................................... For use as preservative of defoamer only.
Potassium trichlorophenate ......................................................... Do.
Propylene glycol monoester of soybean oil fatty acids.
Propylene glycol monoester of tallow fatty acids.
Ricebran oil, sulfated, ammonium, potassium, or sodium salt.
Rosins and rosin derivatives ....................................................... As provided in § 178.3870 of this chapter.
Silica.
Sodium 2-mercaptobenzothiazole ............................................... For use as preservative of defoamer only.
Sodium pentachlorophenate ........................................................ Do.
Sodium trichlorophenate .............................................................. Do.
Sperm oil, sulfated, ammonium, potassium, or sodium salt.
Stearyl alcohol.
Tall oil fatty acids.
Tallow fatty acids, hydrogenated or sulfated.
Tallow, sulfated, ammonium, potassium, or sodium salt.
Triethanolamine.
Triisopropanolamine.
Waxes, petroleum.
(e) The defoaming agents are used as (a) The defoaming agents are pre-
follows: pared from one or more of the sub-
(1) The quantity of defoaming agent stances named in paragraph (d) of this
or agents used shall not exceed the section, subject to any prescribed limi-
amount reasonably required to accom- tations.
plish the intended effect, which is to (b) The defoaming agents are used to
prevent or control the formation of prevent or control the formation of
foam. foam during the manufacture of paper
(2) The defoaming agents are used in and paperboard prior to and during the
the preparation and application of sheet-forming process.
coatings for paper and paperboard. (c) The quantity of defoaming agent
or agents added during the manufac-
[42 FR 14554, Mar. 15, 1977, as amended at 62 turing process shall not exceed the
FR 39772, July 24, 1997] amount necessary to accomplish the
intended technical effect.
§ 176.210 Defoaming agents used in the (d) Substances permitted to be used
manufacture of paper and paper- in the formulation of defoaming agents
board. include substances subject to prior
Defoaming agents may be safely used sanctions or approval for such use and
in the manufacture of paper and paper- employed subject to the conditions of
board intended for use in packaging, such sanctions or approvals, substances
transporting, or holding food in accord- generally recognized as safe for use in

ance with the following prescribed con- food, substances generally recognized
ditions: as safe for use in paper and paperboard,
240
and substances listed in this para- Triethanolamine (amides and soaps).

graph, subject to the limitations, if Triisopropanolamine (amides and soaps).
any, prescribed. Trimethylolethane (esters).
Zinc hydroxide (soaps).
(1) Fatty triglycerides, and the fatty
acids, alcohols, and dimers derived (3) Miscellaneous:
therefrom: Alcohols and ketone alcohols mixture (still-
Beef tallow. bottom product from C12-C18 alcohol manu-
Castor oil. facturing process).
Coconut oil. Amyl alcohol.
Corn oil. Butoxy polyethylene polypropylene glycol
Cottonseed oil. molecular weight 900–4,200.
Fish oil. Butoxy-polyoxypropylene molecular weight
Lard oil. 1,000–2,500.
Linseed oil. Butylated hydroxyanisole.
Mustardseed oil. Butylated hydroxytoluene.
Palm oil. Calcium lignin sulfonate.
Peanut oil. Capryl alcohol.
p-Chlorometacresol.
Rapeseed oil.
Cyclohexanol.
Ricebran oil.
Diacetyltartaric acid ester of tallow mono-
Soybean oil.
glyceride.
Sperm oil.
1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No.
Tall oil.
35691–65–7), for use as a preservative at a
(2) Fatty triglycerides, and marine level not to exceed 0.05 weight-percent of
oils, and the fatty acids and alcohols the defoaming agent.
derived therefrom (paragraph (d)(1) of Diethanolamine.
Diethylene triamine.
this section) reacted with one or more Di-(2-ethylhexyl) phthalate.
of the following, with or without dehy- 2,6-Dimethyl heptanol-4 (nonyl alcohol).
dration, to form chemicals of the cat- Dimethylpolysiloxane.
egory indicated in parentheses: Di-tert-butyl hydroquinone.
Dodecylbenzene sulfonic acids.
Aluminum hydroxide (soaps). Ethanol.
Ammonia (amides). 2-Ethylhexanol.
Butanol (esters). Ethylenediamine tetraacetic acid tetra-
Butoxy-polyoxypropylene, molecular weight sodium salt.
1,000–2,500 (esters). Formaldehyde.
Butylene glycol (esters). Heavy oxo-fraction (a still-bottom product of
Calcium hydroxide (soaps). iso-octyl alcohol manufacture, of approxi-
Diethanolamine (amides). mate composition: Octyl alcohol 5 percent
Diethylene glycol (esters). nonyl alcohol 10 percent, decyl and higher
Ethylene glycol (esters). alcohols 35 percent, esters 45 percent, and
Ethylene oxide (esters and ethers). soaps 5 percent).
Glycerin (mono- and diglycerides). 2-Heptadecenyl-4-methyl-4-hydroxymethyl-2-
Hydrogen (hydrogenated compounds). oxazoline.
Hydrogen (amines). Hexylene glycol (2-methyl-2-4-pentanediol).
Isobutanol (esters). 12-Hydroxystearic acid.
Isopropanol (esters). Isobutanol.
Magnesium hydroxide (soaps). Isopropanol.
Methanol (esters). Isopropylamine salt of dodecylbenzene sul-
Morpholine (soaps). fonic acid.
Oxygen (air-blown oils). Kerosine.
Pentaerythritol (esters). Lanolin.
Polyoxyethylene, molecular weights 200, 300, Methanol.
400, 600, 700, 1,000, 1,540, 1,580, 1,760, 4,600 Methyl 12-hydroxystearate.
(esters). Methyl taurine-oleic acid condensate, molec-
Polyoxypropylene, molecular weight 200– ular weight 486.
2,000 (esters). a,a′-[Methylenebis[4-(1,1,3,3-tetramethylbu-
Potassium hydroxide (soaps). tyl)-o-phenylene]]bis[omega-hydroxypoly
Propanol (esters). (oxyethylene)] having 6–7.5 moles of ethyl-
Propylene glycol (esters). ene oxide per hydroxyl group.
Propylene oxide (esters). Mineral oil.
Sodium hydroxide (soaps). Mono-, di-, and triisopropanolamine.
Sorbitol (esters). Mono- and diisopropanolamine stearate.

Sulfuric acid (sulfated and sulfonated com- Monobutyl ether of ethylene glycol.
pounds). Monoethanolamine.
241
§ 176.230 21 CFR Ch. I (4–1–23 Edition)
Morpholine. a-[p-(1,1,3,3-Tetramethylbutyl) phenyl-, p-
Myristyl alcohol. nonylphenyl-, or p-dodecylphenyl]-omega-
Naphtha. hydroxypoly(oxyethylene) produced by the
b-Naphthol. condensation of 1 mole of p-alkylphenol
Nonylphenol. (alkyl group is 1,1,3,3-tetramethylbutyl, a
Odorless light petroleum hydrocarbons. propylene trimer isomer, or a propylene
Oleyl alcohol. tetramer isomer) with an average of 1.5–15
Petrolatum. moles of ethylene oxide.
o-Phenylphenol. Tetrahydrofurfuryl alcohol.
Pine oil. Tributoxyethyl phosphate.
Polybutene, hydrogenated; complying with Tributyl phosphate.
the identity prescribed under § 178.3740(b) of Tridecyl alcohol.
this chapter. Triethanolamine.
Polyethylene. Triethylene glycol di(2-ethyl hexanoate).
Polyethylene, oxidized (air-blown). Tri-(2-ethylhexyl) phosphate.
Polymer derived from N-vinyl pyrrolidone Tristearyl phosphate.
and copolymers derived from the mixed Wax, petroleum, Type I and Type II.
alkyl (C12-C15, C16, C18, C20, and C22) meth- Wax, petroleum (oxidized).
acrylate esters, butyl methacrylate (CAS Wax (montan).
Reg. No. 97–88–1), isobutyl methacrylate
(CAS Reg. No. 97–86–9) and methyl meth-
FR 17986, Apr. 27, 1982; 47 FR 46495, Oct. 19,
acrylate (CAS Reg. No. 80–62–6); the com-
1982; 47 FR 56845, Dec. 21, 1982; 54 FR 24897,
bined polymer contains no more than 5
June 12, 1989; 57 FR 31313, July 15, 1992; 61 FR
weight percent of polymer units derived
14246, Apr. 1, 1996]
from N-vinyl pyrrolidone and is present at
a level not to exceed 7 parts per million by
weight of the finished dry paper and paper-
§ 176.230 3,5-Dimethyl-1,3,5,2H-
board fibers.
tetrahydrothiadiazine-2-thione.
Polyoxyethylene (4 mols) decyl phosphate. 3,5-Dimethyl-1,3,5,2H-tetrahydrothi-
Polyoxyethylene (4 mols) di(2-ethyl hexano- adiazine-2-thione may safely be used as
ate). a preservative in the manufacture and
Polyoxyethylene (15 mols) ester of rosin. coating of paper and paperboard in-
Polyoxyethylene (3–15 mols) tridecyl alcohol.
tended for use in contact with food in
Polyoxypropylene, molecular weight 200–
2,000. accordance with the following pre-
Polyoxypropylene-polyoxethylene conden- scribed conditions:
sate, minimum molecular weight 950. (a) It is used as follows:
Polyoxypropylene-ethylene oxide condensate (1) In the manufacture of paper and
of ethylene diamine, molecular weight paperboard as a preservative for sub-
1,700–3,800. stances added to the pulp suspension
Polyvinyl pyrrolidone, molecular weight prior to the sheet-forming operation
40,000.
provided that the preservative is vola-
Potassium distearyl phosphate.
Potassium pentachlorophenate.
tilized by heat in the drying and fin-
Potassium trichlorophenate. ishing of the paper and paperboard.
Rosins and rosin derivatives identified in (2) As a preservative for coatings for
§ 175.105(c)(5) of this chapter. paper and paperboard, Provided, That
Silica. the preservative is volatilized by heat
Siloxanes and silicones, dimethyl, methylhy- in the drying and finishing of the coat-
drogen, reaction products with poly- ed paper or paperboard.
ethylene-polypropylene glycol monoallyl (b) The quantity used shall not ex-
ether (CAS Reg. No. 71965–38–3).
Sodium alkyl (C9-C15) benzene-sulfonate.
ceed the least amount reasonably re-
Sodium dioctyl sulfosuccinate. quired to accomplish the intended
Sodium distearyl phosphate. technical effect and shall not be in-
Sodium lauryl sulfate. tended to nor, in fact, accomplish any
Sodium lignin sulfonate. physical or technical effect in the food
Sodium 2-mercaptobenzothiazole. itself.
Sodium naphthalenesulfonic acid (3 mols) (c) The use of a preservative in any
condensed with formaldehyde (2 mols). substance or article subject to any reg-
Sodium orthophenylphenate.
ulation in parts 174, 175, 176, 177, 178
Sodium pentachlorophenate.
Sodium petroleum sulfonate, molecular and § 179.45 of this chapter must comply
weight 440–450. with any specifications and limitations

Sodium trichlorophenate. prescribed by such regulation for the
Stearyl alcohol. substance or article.
242
§ 176.250 Poly-1,4,7,10,13-pentaaza-15- or contains any poisonous or delete-

hydroxyhexadecane. rious substance which is retained in
Poly-1,4,7,10,13-pentaaza-15-hydrox- the recovered pulp and that migrates
yhexadecane may be safely used as a to the food, except as provided in regu-
retention aid employed prior to the lations promulgated under sections 406
sheet-forming operation in the manu- and 409 of the act or (ii) has been used
facture of paper and paperboard infor shipping or handling any such sub-
tended for use in contact with food in stance.
an amount not to exceed that nec-
essary to accomplish the intended § 176.300 Slimicides.
physical or technical effect and not to (a) Slimicides may be safely used in
exceed 6 pounds per ton of finished the manufacture of paper and paper-
paper or paperboard. board that contact food, in accordance
§ 176.260 Pulp from reclaimed fiber.
tions:
(a) Pulp from reclaimed fiber may be (1) Slimicides are used as anti-
safely used as a component of articles microbial agents to control slime in
used in producing, manufacturing, the manufacture of paper and paper-
packing, processing, preparing, treat- board.
ing, packaging, transporting, or hold- (2) Subject to any prescribed limita-
ing food, subject to the provisions of tions, slimicides are prepared from one
paragraph (b) of this section.
or more of the slime-control substances
(b) Pulp from reclaimed fiber is pre-
named in paragraph (c) of this section
pared from the paper and paperboard
to which may be added optional adju-
products described in paragraphs (b)(1)
vant substances as provided for under
and (2) of this section, by repulping
with water to recover the fiber with paragraph (d) of this section.
the least possible amount of nonfibrous (3) Slimicides are added to the proc-
substances. ess water used in the production of
(1) Industrial waste from the manu- paper or paperboard, and the quantity
facture of paper and paperboard prod- added shall not exceed the amount nec-
ucts excluding that which bears or con- essary to accomplish the intended
tains any poisonous or deleterious sub- technical effect.
stance which is retained in the recov- (b) To insure safe usage, the label or
ered pulp and that migrates to the labeling of slimicides shall bear ade-
food, except as provided in regulations quate directions for use.
promulgated under sections 406 and 409 (c) Slime-control substances per-
of the Federal Food, Drug, and Cos- mitted for use in the preparation of
metic Act. slimicides include substances subject
(2) Salvage from used paper and pa- to prior sanction or approval for such
perboard excluding that which (i) bears use and the following:
Acrolein.
Alkenyl (C16-C18) dimethylethyl-ammonium bromide.
n-Alkyl (C12-C18) dimethyl benzyl ammonium chloride.
1,2-Benzisothiazolin-3-one .......................................................... At a level of 0.06 pound per ton of dry weight fiber.
Bis(1,4-bromoacetoxy)-2-butene.
5,5-Bis(bromoacetoxymethyl) m-dioxane.
2,6-Bis(dimethylaminomethyl) cyclohexanone.
1,2-Bis(monobromoacetoxy) ethane [CA Reg. No. 3785–34–0] At a maximum level of 0.10 pound per ton of dry weight fiber.
Bis(trichloromethyl)sulfone.
4-Bromoacetoxymethyl-m-dioxolane.
2-Bromo-4′-hydroxyacetophenone.
2-Bromo-2-nitropropane-1,3-diol (CAS Reg. No. 52–51–7) ........ At a maximum level of 0.6 pound per ton of dry weight fiber.
b-Bromo-b-nitrostyrene ................................................................ At a maximum level of 1 pound per ton of dry weight fiber.
Chloroethylenebisthiocyanate.
5-Chloro-2 - methyl - 4 - isothiazolin-3-one calcium chloride At a level of 2.5 pounds per ton of dry weight fiber.
and 2-methyl-4-isothiazolin-3-one calcium chloride mixture at
a ratio of 3 parts to 1 part.
Chlorinated levulinic acids.

Chloromethyl butanethiolsulfonate.
Cupric nitrate.
243
§ 176.300 21 CFR Ch. I (4–1–23 Edition)
n-Dialkyl (C12-C18) benzylmethylammonium chloride.

1,2-Dibromo-2,4-dicyanobutane (CAS Reg. No. 35691–65–7) .. At a maximum level of 0.005% of dry weight fiber.
2,2-Dibromo-3-nitrilopropionamide .............................................. At a maximum level of 0.1 lb/ton of dry weight fiber.
2,3-Dibromopropionaldehyde.
4,5-dichloro-1, 2-dithiol-3-one (CAS Reg. No. 1192–52–5) ........ For use only at levels not to exceed 10 milligrams per kilogram
in the pulp slurry.
1,3-Dihalo-5,5-dimethylhydantoin (where the dihalo (halogen) At a maximum level of 1.0 kilogram (kg) per 1,000 kg of dry
may be bromine and/or chlorine) that may contain no more weight fiber.
than 20 weight percent 1,3-dihalo-5-ethyl-5-methylhydantoin
(where the dihalo (halogen) may be bromine and/or chlo-
rine)..
4-(Diiodomethylsulfonyl) toluene (CAS Reg. No. 20018–09–1). At a maximum level of 0.2 pound per ton (100 grams/1,000
kilograms) of dry weight fiber.
3,5-Dimethyl 1,3,5,2H-tetrahydrothiadiazine-2-thione.
Dipotassium and disodium ethylenebis(dithiocarba-mate).
Disodium cyanodithioimidocarbonate.
n-Dodecylguanidine hydrochloride .............................................. At a maximum level of 0.20 pound per ton of dry weight fiber.
Glutaraldehyde (CAS Reg. No. 111-30-8).
2-(p-hydroxyphenyl) glyoxylohydroximoyl chloride (CAS Reg- At a level of 0.02 pound per ton of dry weight fiber.
istry No. 34911–46–1).
2-Hydroxypropyl methanethiol sulfonate.
2-Mercaptobenzothiazole.
Methylenebisbutanethiolsulfonate.
Methylenebisthiocyanate.
2-Nitrobutyl bromoacetate [CA Reg. No. 32815–96–6] .............. At a maximum level of 0.15 pound per ton of dry weight fiber.
N-[a-(Nitroethyl)benzyl] ethylenediamine.
Potassium 2-mercaptobenzothiazole.
Potassium N-hydroxymethyl-N-methyldithiocarba-mate.
Potassium N-methyldithiocarbamate.
Potassium pentachlorophenate.
Potassium trichlorophenate.
Silver fluoride ............................................................................... Limit of addition to process water not to exceed 0.024 pound,
calculated as silver fluoride, per ton of paper produced.
Silver nitrate.
Sodium dimethyldithiocarbamate.
Sodium 2-mercaptobenzothiazole.
Sodium pentachlorophenate.
Sodium trichlorophenate.
1,3,6,8-Tetraazatricyclo[6.2.1.13,6] dodecane.
3,3,4,4-Tetrachlorotetrahydrothiophene-1,1-dioxide.
Tetrakis(hydroxymethyl)phosphonium sulfate (CAS Reg. No. Maximum use level of 84 mg/kg in the pulp slurry. The additive
55566–30–8). may also be added to water, which when introduced into the
pulp slurry, results in a concentration in the pulp slurry not to
exceed 84 mg/kg.
2-(Thiocyanomethylthio) benzothiazole.
Vinylene bisthiocyanate.
(d) Adjuvant substances permitted to (oxyethylene)] having 6–7.5 moles of ethyl-

be used in the preparation of slimicides ene oxide per hydroxyl group.
include substances generally recog- Monomethyl ethers of mono-, di-, and tri-
nized as safe for use in food, substances propylene glycol.
generally recognized as safe for use in Nonylphenol reaction product with 9 to 12
paper and paperboard, substances per- molecules of ethylene oxide.
mitted to be used in paper and paper- Octylphenol reaction product with 25 mol-
ecules of propylene oxide and 40 molecules
board by other regulations in this
of ethylene oxide.
chapter, and the following:
Acetone. FR 41854, Aug. 19, 1977; 44 FR 75627, Dec. 21,
Butlylene oxide. 1979; 46 FR 36129, July 14, 1981; 49 FR 5748,
N,N-Dimethylformamide. Feb. 15, 1984; 51 FR 19059, May 27, 1986; 51 FR
Ethanolamine. 43734, Dec. 4, 1986; 54 FR 18103, Apr. 27, 1989;
Ethylene glycol. 55 FR 31825, Aug. 6, 1990; 64 FR 46130, Aug. 24,
Ethylenediamine. 1999; 64 FR 69900, Dec. 15, 1999; 65 FR 40497,
N-methyl-2-pyrrolidone (CAS Reg. No. 872– June 30, 2000; 65 FR 70790, Nov. 28, 2000; 69 FR
50–4). 24512, May 4, 2004; 87 FR 31089, May 20, 2022]

a,a′-[Methylenebis[4-(1,1,3,3-tetramethyl-
butyl)-o-phenylene]] bis[omega-hydroxypoly
244
§ 176.320 Sodium nitrate-urea complex. 177.1040 Acrylonitrile/styrene copolymer.

177.1050 Acrylonitrile/styrene copolymer
Sodium nitrate-urea complex may be modified with butadiene/styrene elas-
safely used as a component of articles tomer.
intended for use in producing, manu- 177.1060 n-Alkylglutarimide/acrylic copoly-
facturing, packing, processing, pre- mers.
paring, treating, packaging, trans- 177.1200 Cellophane.
porting, or holding food, subject to the 177.1210 Closures with sealing gaskets for
food containers.
provisions of this section. 177.1211 Cross-linked polyacrylate copoly-
(a) Sodium nitrate-urea complex is a mers.
clathrate of approximately two parts 177.1240 1,4-Cyclohexylene dimethylene
urea and one part sodium nitrate. terephthalate and 1,4-cyclohexylene
(b) Sodium nitrate-urea complex con- dimethylene isophthalate copolymer.
forming to the limitations prescribed 177.1310 Ethylene-acrylic acid copolymers.
in paragraph (b)(1) of this section is 177.1312 Ethylene-carbon monoxide copoly-
used as provided in paragraph (b)(2) of mers.
177.1315 Ethylene-1,4-cyclohexylene
this section. dimethylene terephthalate copolymers.
(1) Limitations. (i) It is used as a plas- 177.1320 Ethylene-ethyl acrylate copoly-
ticizer in glassine and greaseproof mers.
paper. 177.1330 Ionomeric resins.
(ii) The amount used does not exceed 177.1340 Ethylene-methyl acrylate copoly-
that required to accomplish its in- mer resins.
tended technical effect or exceed 15 177.1345 Ethylene/1,3-phenylene oxyethylene
percent by weight of the finished paper. isophthalate/terephthalate copolymer.
177.1350 Ethylene-vinyl acetate copolymers.
(2) Conditions of use. The glassine and 177.1360 Ethylene-vinyl acetate-vinyl alco-
greaseproof papers are used for pack- hol copolymers.
aging dry food or as the food-contact 177.1380 Fluorocarbon resins.
surface for dry food. 177.1390 Laminate structures for use at tem-
peratures of 250 °F and above.
§ 176.350 Tamarind seed kernel pow- 177.1395 Laminate structures for use at tem-
der. peratures between 120 °F and 250 °F.
Tamarind seed kernel powder may be 177.1400 Hydroxyethyl cellulose film, water-
insoluble.
safely used as a component of articles 177.1420 Isobutylene polymers.
intended for use in producing, manu- 177.1430 Isobutylene-butene copolymers.
facturing, packing, processing, pre- 177.1440 4,4′-Isopropylidenediphenol-
paring, treating, packaging, trans- epichlorohydrin resins minimum molec-
porting, or holding food, subject to the ular weight 10,000.
provisions of this section. 177.1460 Melamine-formaldehyde resins in
(a) Tamarind seed kernel powder is molded articles.
177.1480 Nitrile rubber modified acrylo-
the ground kernel of tamarind seed
nitrile-methyl acrylate copolymers.
(Tamarindus indica L.) after removal of 177.1500 Nylon resins.
the seed coat. 177.1520 Olefin polymers.
(b) It is used in the manufacture of 177.1550 Perfluorocarbon resins.
paper and paperboard. 177.1555 Polyarylate resins.
177.1556 Polyaryletherketone resins.
177.1560 Polyarylsulfone resins.
PART 177—INDIRECT FOOD 177.1570 Poly-1-butene resins and butene/
ADDITIVES: POLYMERS ethylene copolymers.
177.1580 Polycarbonate resins.
Subpart A [Reserved] 177.1585 Polyestercarbonate resins.
177.1590 Polyester elastomers.
Subpart B—Substances for Use as Basic 177.1595 Polyetherimide resin.
Components of Single and Repeated 177.1600 Polyethylene resins, carboxyl modi-
Use Food Contact Surfaces fied.
177.1610 Polyethylene, chlorinated.
Sec. 177.1615 Polyethylene, fluorinated.
177.1010 Acrylic and modified acrylic plas- 177.1620 Polyethylene, oxidized.
tics, semirigid and rigid. 177.1630 Polyethylene phthalate polymers.
177.1020 Acrylonitrile/butadiene/styrene co- 177.1632 Poly(phenyleneterephthalamide)
polymer. resins.
177.1030 Acrylonitrile/butadiene/styrene/ 177.1635 Poly(p-methylstyrene) and rubber-
methyl methacrylate copolymer. modified poly(p-methylstyrene).
245
§ 177.1010 21 CFR Ch. I (4–1–23 Edition)
177.1637 Poly(oxy-1,2- 177.2800 Textiles and textile fibers.
ethanediyloxycarbonyl-2,6- 177.2910 Ultra-filtration membranes.
naphthalenediylcarbonyl) resins.
AUTHORITY: 21 U.S.C. 321, 342, 348, 379e.
177.1640 Polystyrene and rubber-modified
polystyrene. SOURCE: 42 FR 14572, Mar. 15, 1977, unless
177.1650 Polysulfide polymer-polyepoxy res- otherwise noted.
ins.
177.1655 Polysulfone resins. EDITORIAL NOTE: Nomenclature changes to
177.1660 Poly(tetramethylene part 177 appear at 61 FR 14482, Apr. 2, 1996; 66
terephthalate). FR 56035, Nov. 6, 2001; 66 FR 66742, Dec. 27,
177.1670 Polyvinyl alcohol film. 2001; 68 FR 15355, Mar. 31, 2003; 70 FR 72074,
177.1680 Polyurethane resins. Dec. 1, 2005; and 81 FR 49896, July 29, 2016.
177.1810 Styrene block polymers.
177.1820 Styrene-maleic anhydride copoly- Subpart A [Reserved]
mers.
177.1830 Styrene-methyl methacrylate co-
polymers. Subpart B—Substances for Use as
177.1850 Textryls. Basic Components of Single
177.1900 Urea-formaldehyde resins in molded and Repeated Use Food Con-
articles.
177.1950 Vinyl chloride-ethylene copoly-
tact Surfaces
mers.
177.1960 Vinyl chloride-hexene-1 copoly-
§ 177.1010 Acrylic and modified acrylic
mers.
plastics, semirigid and rigid.
177.1970 Vinyl chloride-lauryl vinyl ether Semirigid and rigid acrylic and modi-
copolymers. fied acrylic plastics may be safely used
177.1980 Vinyl chloride-propylene copoly- as articles intended for use in contact
mers. with food, in accordance with the fol-
177.1990 Vinylidene chloride/methyl acry-
late copolymers. lowing prescribed conditions. The
177.2000 Vinylidene chloride/methyl acry- acrylic and modified acrylic polymers
late/methyl methacrylate polymers. or plastics described in this section
also may be safely used as components
Subpart C—Substances for Use Only as of articles intended for use in contact
Components of Articles Intended for with food.
Repeated Use (a) The optional substances that may
be used in the formulation of the
177.2210 Ethylene polymer,
chlorosulfonated. semirigid and rigid acrylic and modi-
177.2250 Filters, microporous polymeric. fied acrylic plastics, or in the formula-
177.2260 Filters, resin-bonded. tion of acrylic and modified acrylic
177.2280 4,4′-Isopropylidenediphenol- components of articles, include sub-
epichlorohydrin thermosetting epoxy stances generally recognized as safe in
resins. food, substances used in accordance
177.2355 Mineral reinforced nylon resins. with a prior sanction or approval, sub-
177.2400 Perfluorocarbon cured elastomers.
177.2410 Phenolic resins in molded articles.
stances permitted for use in such plas-
177.2415 Poly(aryletherketone) resins. tics by regulations in parts 170 through
177.2420 Polyester resins, cross-linked. 189 of this chapter, and substances
177.2430 Polyether resins, chlorinated. identified in this paragraph. At least 50
177.2440 Polyethersulfone resins. weight-percent of the polymer content
177.2450 Polyamide-imide resins. of the acrylic and modified acrylic ma-
177.2460 Poly(2,6-dimethyl-1,4-phenylene) terials used as finished articles or as
oxide resins.
177.2465 Polymethylmethacrylate/poly(tri
components of articles shall consist of
methoxysilylpropyl) methacrylate copolymer units derived from one or
polymers. more of the acrylic or methacrylic
177.2470 Polyoxymethylene copolymer. monomers listed in paragraph (a)(1) of
177.2480 Polyoxymethylene homopolymer. this section.
177.2490 Polyphenylene sulfide resins. (1) Homopolymers and copolymers of
177.2500 Polyphenylene sulfone resins. the following monomers:
177.2510 Polyvinylidene fluoride resins.
177.2550 Reverse osmosis membranes. n-Butyl acrylate.
177.2600 Rubber articles intended for re- n-Butyl methacrylate.
peated use. Ethyl acrylate.

177.2710 Styrene-divinylbenzene resins, 2-Ethylhexyl acrylate.
cross-linked. Ethyl methacrylate.
246
Methyl acrylate. Methacryloxyacetamidoethylethylene urea.
Methyl methacrylate. Methacryloxyacetic acid.
n-Propyl methacrylate.
(2) Copolymers produced by copolym- 3,5,5-Trimethylcyclohexyl methacrylate.
erizing one or more of the monomers
listed in paragraph (a)(1) of this section (4) Polymers identified in paragraphs
with one or more of the following (a)(1), (2), and (3) of this section are
monomers: mixed together and/or with the fol-
lowing polymers, provided that no
Acrylonitrile. chemical reactions, other than addi-
Methacrylonitrile. tion reactions, occur when they are
a-Methylstyrene.
Styrene.
mixed:
Vinyl chloride. Butadiene-acrylonitrile copolymers.
Vinylidene chloride. Butadiene-acrylonitrile-styrene copolymers.
Butadiene-acrylonitrile-styrene-methyl
(3) Polymers identified in paragraphs methacrylic copolymers.
(a)(1) and (2) of this section containing Butadiene-styrene copolymers.
no more than 5 weight-percent of total Butyl rubber.
polymer units derived by copolym- Natural rubber.
erization with one or more of the Polybutadiene.
monomers listed in paragraph (a)(3)(i) Poly (3-chloro-1,3-butadiene).
and (ii) of this section. Monomers list- Polyester identified in § 175.300(b)(3)(vii) of
this chapter.
ed in paragraph (a)(3)(ii) of this section Polyvinyl chloride.
are limited to use only in plastic arti- Vinyl chloride copolymers complying with
cles intended for repeated use in con- § 177.1980.
tact with food. Vinyl chloride-vinyl acetate copolymers.
(i) List of minor monomers: (5) Antioxidants and stabilizers iden-
Acrylamide. tified in § 175.300(b)(3)(xxx) of this chap-
Acrylic acid ter and the following:
1,3-Butylene glycol dimethacrylate.
1,4-Butylene glycol dimethacrylate. Di-tert-butyl-p-cresol.
Diethylene glycol dimethacrylate. 2-Hydroxy-4-methoxybenzophenone.
Diproplylene glycol dimethacrylate. 2-Hydroxy-4-methoxy-2-
Divinylbenzene. carboxybenzophenone.
Ethylene glycol dimethacrylate. 3-Hydroxyphenyl benzoate.
Itaconic acid. p-Methoxyphenol.
Methacrylic acid. Methyl salicylate.
N-Methylolacrylamide. Octadecyl 3,5-di-tert-butyl-4-hydroxyhydro-
N-Methylolmethacrylamide. cinnamate (CAS Reg. No. 2082–79–3): For
4-Methyl-1,4-pentanediol dimethacrylate. use only: (1) At levels not exceeding 0.2
Propylene glycol dimethacrylate. percent by weight in semirigid and rigid
Trivinylbenzene. acrylic and modified acrylic plastics,
where the finished articles contact foods
(ii) List of minor monomers limited containing not more than 15 percent alco-
to use only in plastic articles intended hol; and (2) at levels not exceeding 0.01 per-
for repeated use in contact with food: cent by weight in semirigid and rigid
acrylic and modified acrylic plastics in-
Allyl methacrylate [Chemical Abstracts tended for repeated food-contact use where
Service Registry No. 96–05–9] the finished article may be used for foods
tert-Butyl acrylate. containing more than 15 percent alcohol.
tert-Butylaminoethyl methacrylate. Phenyl salicylate.
sec-Butyl methacrylate.
tert-Butyl methacrylate. (6) Release agents: Fatty acids de-
Cyclohexyl methacrylate. rived from animal and vegetable fats
Dimethylaminoethyl methacrylate. and oils, and fatty alcohols derived
2-Ethylhexyl methacrylate. from such acids.
Hydroxyethyl methacrylate. (7) Surface active agent: Sodium
Hydroxyethyl vinyl sulfide. dodecylbenzenesulfonate.
Hydroxypropyl methacrylate. (8) Miscellaneous materials:
Isobornyl methacrylate.
Isobutyl methacrylate. Di(2-ethylhexyl) phthalate, for use only as a
Isopropyl acrylate. flow promoter at a level not to exceed 3
Isopropyl methacrylate. weight-percent based on the monomers.

Methacrylamide. Oxalic acid, for use only as a polymerization
Methacrylamidoethylene urea. catalyst aid.
247
§ 177.1010 21 CFR Ch. I (4–1–23 Edition)
Tetraethylenepentamine, for use only as a condenser. The 8 and 50 percent (by vol-
catalyst activator at a level not to exceed ume) alcohol solvents shall be prepared
0.5 weight-percent based on the monomers. from ethyl alcohol meeting the speci-
Toluene.
fications of the United States Pharma-
Xylene.
copeia XX and diluted with double-dis-
(b) The semirigid and rigid acrylic tilled water that has been prepared in a
and modified acrylic plastics, in the still using a tin block condenser. The
finished form in which they are to con- n-heptane shall be spectrophotometric
tact food, when extracted with the sol- grade. Adequate precautions must be
vent or solvents characterizing the taken to keep all solvents dust-free.
type of food and under the conditions (4) Blank values on solvents. (i) Dupli-
of time and temperature as determined cate determinations of residual solids
from tables 1 and 2 of § 176.170(c) of this shall be run on samples of each solvent
chapter, shall yield extractives not to that have been exposed to the tempera-
exceed the following, when tested by ture-time conditions of the extraction
the methods prescribed in paragraph test without the plastic sample. Sixty
(c) of this section. The acrylic and milliliters of exposed solvent is
modified acrylic polymers or plastics pipetted into a clean, weighed plat-
intended to be used as components of inum dish, evaporated to 2–5 milliliters
articles also shall yield extractives not on a nonsparking, low-temperature hot
to exceed the following limitations plate and dried in 212 °F oven for 30
when prepared as strips as described in minutes. The residue for each solvent
paragraph (c)(2) of this section: shall be determined by weight and the
(1) Total nonvolatile extractives not average residue weight used as the
to exceed 0.3 milligram per square inch blank value in the total solids deter-
of surface tested. mination set out in paragraph (c)(6) of
(2) Potassium permanganate oxidiz- this section. The residue for an accept-
able distilled water and 8 and 50 per- able solvent sample shall not exceed 0.5
cent alcohol extractives not to exceed milligram per 60 milliliters.
an absorbance of 0.15. (ii) For acceptability in the ultra-
(3) Ultraviolet-absorbing distilled violet absorbers test, a sample of each
water and 8 and 50 percent alcohol ex- solvent shall be scanned in an ultra-
tractives not to exceed an absorbance violet spectrophotometer in 5-centi-
of 0.30. meter silica spectrophotometric ab-
(4) Ultraviolet-absorbing n-heptane sorption cells. The absorbance of the
extractives not to exceed an absorb- distilled water when measured versus
ance of 0.10. air in the reference cell shall not ex-
(c) Analytical methods—(1) Selection of ceed 0.03 at any point in the wave-
extractability conditions. These are to be length region of 245 to 310 mμ. The ab-
chosen as provided in § 176.170(c) of this sorbance of the 8 percent alcohol when
chapter. measured versus distilled water in the
(2) Preparation of samples. Sufficient reference cell shall not exceed 0.01 at
samples to allow duplicates of all ap- any point in the wavelength region of
plicable tests shall be cut from the ar- 245 to 310 mμ. The absorbance of the 50
ticles or formed from the plastic com- percent alcohol when measured versus
position under tests, as strips about 2.5 distilled water in the reference cell
inches by about 0.85-inch wide by about shall not exceed 0.05 at any point in the
0.125-inch thick. The total exposed sur- wavelength region of 245 to 310 mμ. The
face should be 5 square inches ±0.5- absorbance of the heptane when meas-
square inch. The samples, after prepa- ured versus distilled water in the ref-
ration, shall be washed with a clean erence cell shall not exceed 0.15 at 245,
brush under hot tapwater, rinsed under 0.09 at 260, 0.04 at 270, and 0.02 at any
running hot tapwater (140 °F min- point in the wavelength region of 280 to
imum), rinsed with distilled water, and 310 mμ.
air-dried in a dust-free area or in a des- (iii) Duplicate ultraviolet blank de-
iccator. terminations shall be run on samples of
(3) Preparation of solvents. The water each solvent that has been exposed to
used shall be double-distilled water, the temperature-time conditions of the
prepared in a still using a block tin extraction test without the plastic
248
sample. An aliquot of the exposed sol- tents to room temperature if nec-

vent shall be measured versus the un- essary.
exposed solvent in the reference cell. (6) Determination of total nonvolatile
The average difference in the extractives. Remove the plastic strip
absorbances at any wavelength in the from the solvent with a pair of clean
region of 245 to 310 mμ shall be used as forceps and wash the strip with 5 milli-
a blank correction for the ultraviolet liters of the appropriate solvent, add-
absorbers measured at the same wave- ing the washings to the contents of the
length according to paragraph (c)(8)(ii) test tube. Pour the contents of the test
of this section. tube into a clean, weighed platinum
(iv) The acceptability of the solvents dish. Wash the tube with 5 milliliters
for use in the permanganate test shall of the appropriate solvent and add the
solvent to the platinum dish. Evapo-
be determined by preparing duplicate
rate the solvent to 2–5 milliliters on a
permanganate test blanks according to
nonsparking, low-temperature
paragraph (c)(7)(iv) of this section. For
hotplate. Complete the evaporation in
this test, the directions referring to a 212 °F oven for 30 minutes. Cool the
the sample extract shall be dis- dish in a desiccator for 30 minutes and
regarded. The blanks shall be scanned weigh to the nearest 0.1 milligram. Cal-
in 5-centimeter silica culate the total nonvolatile extractives
spectrophotometric cells in the spec- as follows:
trophotometer versus the appropriate
solvent as reference. The absorbance in Milligrams extractives e − b
distilled water in the wavelength re- =
gion of 544 to 552 mμ should be 1.16 but
per square inch s
must not be less than 1.05 nor more
than 1.25. The absorbance in the 8 and Extractives in parts eb
50 percent alcohol must not be less = × 100
per million s
than 0.85 nor more than 1.15.
where:
(v) Duplicate permanganate test de-
terminations shall be run on samples of e = Total increase in weight of the dish, in
milligrams.
distilled water and 8 and 50 percent al- b = Blank value of the solvent in milligrams,
cohol solvents that have been exposed as determined in paragraph (c)(4)(i) of
to the temperature-time conditions of this section.
the extraction test without the plastic s = Total surface of the plastic sample in
sample. The procedure shall be as de- square inches.
scribed in paragraph (c)(7)(iv) of this (7) Determination of potassium per-
section, except that the appropriate ex- manganate oxidizable extractives. (i) Pi-
posed solvent shall be substituted pette 25 milliliters of distilled water
where the directions call for sample ex- into a clean 125-milliliter Erlenmeyer
tract. The average difference in the flask that has been rinsed several
absorbances in the region of 544 to 552 times with aliquots of distilled water.
mμ shall be used as a blank correction This is the blank. Prepare a distilled
for the determination of permanganate water solution containing 1.0 part per
oxidizable extractives according to million of p-methoxyphenol (melting
paragraph (c)(7)(iv) of this section. point 54–56 °C, Eastman grade or equiv-
(5) Extraction procedure. For each ex- alent). Pipette 25 milliliters of this p-
traction, place a plastic sample in a methoxyphenol solution into a rinsed
clean 25 millimeters × 200 millimeters Erlenmeyer flask. Pipette exactly 3.0
hard-glass test tube and add solvent milliliters of 154 parts per million
equal to 10 milliliters of solvent per aqueous potassium permanganate solu-
square inch of plastic surface. This tion into the p-methoxyphenol and ex-
amount will be between 45 milliliters actly 3.0 milliliters into the blank, in
and 55 milliliters. The solvent must be that order. Swirl both flasks to mix the
preequilibrated to the temperature of contents and then transfer aliquots
the extraction test. Close the test tube from each flask into matched 5-centi-
with a ground-glass stopper and expose meter spectrophotometric absorption

ER01JA93.393</GPH>
to the specified temperature for the cells. The cells are placed in the spec-
specified time. Cool the tube and con- trophotometer cell compartment with
249
ER01JA93.392</GPH>
§ 177.1010 21 CFR Ch. I (4–1–23 Edition)
the p-methoxyphenol solution in the pose of ascertaining compliance with

reference beam. Spectrophotometric the limitations in paragraph (b)(2) of
measurement is conducted as in para- this section, the absorbance measure-
graph (c)(7)(iv) of this section. The ab- ments obtained on the distilled water
sorbance reading in the region 544–552 extracts according to paragraph
mμ should be 0.24 but must be not less (c)(7)(iv) of this section shall be multi-
than 0.12 nor more than 0.36. This test plied by a correction factor, calculated
shall be run in duplicate. For the pur- as follows:
0.24
= Correction factor for water extracts.
Average of duplicate ρ-methoxyphenol
absorbance determinations according to
this paragraph (c)(7)(i) of this section
(ii) The procedure in paragraph ascertaining compliance with the limi-

(c)(7)(i) of this section is repeated ex- tations prescribed in paragraph (b)(2) of
cept that, in this instance, the solvent this section, the absorbance measure-
shall be 8 percent alcohol. The absorb- ments obtained on the 8 percent alco-
ance in the region 544–552 mμ should be hol extracts according to paragraph
0.26 but must be not less than 0.13 nor (c)(7)(iv) of this section shall be multi-
more than 0.39. This test shall be run in plied by a correction factor, calculated
duplicate. For the purpose of as follows:
0.26 Correction factor for aqueous

=
Average of duplicate ρ-methoxyphenol 8 percent alcohol extracts.
absorbance determination according to
this paragraph (c)(7)(ii) of this section
(iii) The procedure in paragraph ascertaining compliance with the limi-

(c)(7)(i) of this section is repeated ex- tations prescribed in paragraph (b)(2) of
cept that, in this instance, the solvent this section, the absorbance measure-
shall be 50 percent alcohol. The absorb- ments obtained on the 50 percent alco-
ance in the region 544–552 mμ should be hol extracts according to paragraph
0.25 but must be not less than 0.12 nor (c)(7)(iv) of this section shall be multi-
more than 0.38. This test shall be run in plied by a correction factor, calculated
duplicate. For the purpose of as follows:
0.25 Correction factor for 50 percent

=
Average of duplicate ρ-methoxyphenol aqueous alcohol extracts.
paragraph (c)(7)(ii) of this section
ER01JA93.395</GPH> ER01JA93.396</GPH>
(iv) Water and 8 and 50 percent alcohol the same solvent. This is the blank.
extracts. Pipette 25 milliliters of the ap- Into another similarly rinsed flask, pi-
propriate solvent into a clean, 125-mil- pette 25 milliliters of the sample ex-
liliter Erlenmeyer flask that has been tract that has been exposed under the
rinsed several times with aliquots of conditions specified in paragraph (c)(5)
250
ER01JA93.394</GPH>
of this section. Pipette exactly 3.0 mil- propriate correction factor determined
liliters of 154 parts per million aqueous according to paragraph (c)(7)(i), (ii),
potassium permanganate solution into and (iii) of this section. This test shall
the sample and exactly 3.0 milliliters be run in duplicate and the two results
into the blank, in that order. Before averaged.
use, the potassium permanganate solu- (8) Determination of ultraviolet-absorb-
tion shall be checked as in paragraph ing extractives. (i) A distilled water so-
(c)(7)(i) of this section. Both flasks are lution containing 1.0 part per million
swirled to mix the contents, and then of p-methoxyphenol (melting point 54
aliquots from each flask are trans-
°C–56 °C. Eastman grade or equivalent)
ferred to matched 5-centimeter
shall be scanned in the region 360 to 220
spectrophotometric absorption cells.
Both cells are placed in the spectro- mμ in 5-centimeter silica spectrophoto-
photometer cell compartment with the metric absorption cells versus a dis-
sample solution in the reference beam. tilled water reference. The absorbance
The spectrophotometer is adjusted for at the wavelength of maximum absorb-
0 and 100 percent transmittance at 700 ance (should be about 285 mμ) is about
mμ. The spectrum is scanned on the ab- 0.11 but must be not less than 0.08 nor
sorbance scale from 700 mμ to 500 mμ in more than 0.14. This test shall be run in
such a way that the region 544 mμ to duplicate. For the purpose of
552 mμ is scanned within 5 minutes to ascertaining compliance with the limi-
10 minutes of the time that permanga- tations prescribed in paragraph (b)(3)
nate was added to the solutions. The and (4) of this section, the absorbance
height of the absorbance peak shall be obtained on the extracts according to
measured, corrected for the blank as paragraph (c)(8)(ii) of this section shall
determined in paragraph (c)(4)(v) of be multiplied by a correction factor,
this section, and multiplied by the ap- calculated as follows:
0.11
= Correction factor for ultraviolet
Average of duplicate ρ-methoxyphenol absorbers test.
this paragraph (c)(8)(i) of this section
(ii) An aliquot of the extract that has (e) Acrylonitrile copolymers identi-
been exposed under the conditions fied in this section shall comply with
specified in paragraph (c)(5) of this sec- the provisions of § 180.22 of this chap-
tion is scanned in the wavelength re- ter.
gion 360 to 220 mμ versus the appro- (f) The acrylic and modified acrylic
priate solvent reference in matched 5- polymers identified in and complying
centimeter silica spectrophotometric with this section, when used as compo-
absorption cells. The height of any ab- nents of the food-contact surface of an
sorption peak shall be measured, cor- article that is the subject of a regula-
rected for the blank as determined in tion in this part and in parts 174, 175,
paragraph (c)(4)(iii) of this section, and 176, and 178 of this chapter, shall com-
multiplied by the correction factor de- ply with any specifications and limita-
termined according to paragraph tions prescribed by such regulation for
(c)(8)(i) of this section. the article in the finished form in
(d) In accordance with current good which it is to contact food.
manufacturing practice, finished
semirigid and rigid acrylic and modi- [42 FR 14572, Mar. 15, 1977; 42 FR 56728, Oct.
fied acrylic plastics, and articles con- 28, 1977, as amended at 43 FR 54927, Nov. 24,
1978; 45 FR 67320, Oct. 10, 1980; 46 FR 46796,
taining these polymers, intended for
Sept. 22, 1981; 49 FR 10108, Mar. 19, 1984; 49 FR
repeated use in contact with food shall 13139, Apr. 3, 1984; 50 FR 31045, July 24, 1985;
be thoroughly cleansed prior to their 87 FR 31089, May 20, 2022]
first use in contact with food.
251
ER01JA93.397</GPH>
§ 177.1020 21 CFR Ch. I (4–1–23 Edition)
§ 177.1020 Acrylonitrile/butadiene/sty- (2) Residual acrylonitrile monomer

rene co-polymer. content of the finished copolymer arti-
Acrylonitrile/butadiene/styrene co- cles is not more than 11 parts per mil-
polymer identified in this section may lion as determined by a gas
be safely used as an article or compo- chromatographic method titled ‘‘De-
nent of articles intended for use with termination of Residual Acrylonitrile
all foods, except those containing alco- and Styrene Monomers-Gas
hol, under conditions of use E, F, and G Chromatographic Internal Standard
described in table 2 of § 176.170(c) of this Method,’’ which is incorporated by ref-
chapter. erence. Copies are available from the
(a) Identity. For the purpose of this Center for Food Safety and Applied Nu-
section, the acrylonitrile/butadiene/ trition (HFS–200), Food and Drug Ad-
styrene copolymer consists of: ministration, 5001 Campus Dr., College
(1) Eighty-four to eighty-nine parts Park, MD 20740, or available for inspec-
by weight of a matrix polymer con- tion at the National Archives and
taining 73 to 78 parts by weight of acry- Records Administration (NARA). For
lonitrile and 22 to 27 parts by weight of information on the availability of this
styrene; and
(2) Eleven to sixteen parts by weight
of a grafted rubber consisting of (i) 8 to
13 parts of butadiene/styrene elastomer eral_register/code_of_federal_regulations/
containing 72 to 77 parts by weight of ibr_locations.html.
butadiene and 23 to 28 parts by weight (d) Extractive limitations. (1) Total
of styrene and (ii) 3 to 8 parts by nonvolatile extractives not to exceed
weight of a graft polymer having the 0.0005 milligram per square inch sur-
same composition range as the matrix face area when the finished food con-
polymer. tact article is exposed to distilled
(b) Adjuvants. The copolymer identi- water, 3 percent acetic acid, or n-
fied in paragraph (a) of this section heptane for 8 days at 120 °F.
may contain adjuvant substances re- (2) The finished food-contact article
quired in its production. Such adju- shall yield not more than 0.0015 milli-
vants may include substances gen- gram per square inch of acrylonitrile
erally recognized as safe in food, sub- monomer when exposed to distilled
stances used in accordance with prior water and 3 percent acetic acid at 150
sanction, substances permitted in this °F for 15 days when analyzed by a po-
part, and the following: larographic method titled ‘‘Extracted
Substance Limitations Acrylonitrile by Differential Pulse Po-
larography,’’ which is incorporated by
2-Mercapto- ethanol The finished copolymer shall contain
not more than 100 ppm 2- reference. Copies are available from
mercaptoethanol acrylonitrile adduct the Center for Food Safety and Applied
as determined by a method titled Nutrition (HFS–200), Food and Drug
‘‘Analysis of Cycopac Resin for Re-
sidual b-(2-Hydroxyethylmercapto) Administration, 5001 Campus Dr., Col-
propionitrile,’’ which is incorporated lege Park, MD 20740, or available for in-
by reference. Copies are available spection at the National Archives and
from the Bureau of Foods (HFS–
200), Food and Drug Administra- Records Administration (NARA). For
tion, 5001 Campus Dr., College information on the availability of this
Park, MD 20740, or available for in- material at NARA, call 202–741–6030, or
spection at the National Archives
and Records Administration go to: http://www.archives.gov/fed-
(NARA). For information on the eral_register/code_of_federal_regulations/
availability of this material at NARA, ibr_locations.html.
call 202–741–6030, or go to: http://
www.archives.gov/federal_register/ (e) Acrylonitrile copolymers identi-
code_of_federal_regulations/ fied in this section shall comply with
ibr_locations.html.
ter.
(c) Specifications. (1) Nitrogen content
(f) Acrylonitrile copolymers identi-
of the copolymer is in the range of 16

to 18.5 percent as determined by Micro- fied in this section are not authorized
Kjeldahl analysis.
252
to be used to fabricate beverage con- Substances Limitations

tainers. 2–Mercaptoethanol .. The finished copolymer shall contain
[42 FR 14572, Mar. 15, 1977, as amended at 42 not more than 800 ppm 2–
mercaptoethanol acrylonitrile adduct
FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, as determined by a method titled
1982; 54 FR 24897, June 12, 1989] ‘‘Analysis of Cycopac Resin for Re-
sidual b–(2–Hydroxyethylmercapto)
§ 177.1030 Acrylonitrile/butadiene/sty- propionitrile,’’ which is incorporated
rene/methyl methacrylate copoly- by reference. Copies are available
from the Bureau of Foods (HFS–
mer. 200), Food and Drug Administra-
tion, 5001 Campus Dr., College
Acrylonitrile/butadiene/styrene/ Park, MD 20740, or available for in-
methyl methacrylate copolymer iden- spection at the National Archives
tified in this section may be safely and Records Administration
(NARA). For information on the
used as an article or component of arti- availability of this material at NARA,
cles intended for use with food identi- call 202–741–6030, or go to: http://
fied in table 1 of § 176.170(c) of this www.archives.gov/federal_register/
chapter as Type I, II, III, IVA, IVB, V, ibr_locations.html.
VIB, (except bottles intended to hold
carbonated beverages), VIIA, VIIB, VIII (c) Specifications. (1) Nitrogen content
and IX, under conditions of use C, D, E, of the copolymer is in the range of 13.0
F, and G described in table 2 of to 16.0 percent as determined by Micro-
§ 176.170(c) of this chapter with a high Kjeldahl analysis.
temperature limitation of 190 °F. (2) Residual acrylonitrile monomer
(a) Identity. For the purpose of this content of the finished copolymer arti-
section, acrylonitrile/butadiene/sty- cles is not more than 11 parts per mil-
rene/methyl methacrylate copolymer lion as determined by a gas
consists of: (1) 73 to 79 parts by weight chromatographic method titled ‘‘De-
of a matrix polymer containing 64 to 69 termination of Residual Acrylonitrile
parts by weight of acrylonitrile, 25 to and Styrene Monomers-Gas
Chromatographic Internal Standard
30 parts by weight of styrene and 4 to
Method,’’ which is incorporated by ref-
6 parts by weight of methyl methacry-
late; and (2) 21 to 27 parts by weight of Center for Food Safety and Applied Nu-
a grafted rubber consisting of (i) 16 to trition (HFS–200), Food and Drug Ad-
20 parts of butadiene/styrene/elastomer ministration, 5001 Campus Dr., College
containing 72 to 77 parts by weight of Park, MD 20740, or available for inspec-
butadiene and 23 to 28 parts by weight tion at the National Archives and
of styrene and (ii) 5 to 10 parts by Records Administration (NARA). For
weight of a graft polymer having the information on the availability of this
same composition range as the matrix material at NARA, call 202–741–6030, or
polymer. go to: http://www.archives.gov/fed-
(b) Adjuvants. The copolymer identi- eral_register/code_of_federal_regulations/
fied in paragraph (a) of this section ibr_locations.html.
may contain adjuvant substances re- (d) Extractive limitations. (1) Total
quired in its production. Such adju- nonvolatile extractives not to exceed
vants may include substances gen- 0.0005 milligram per square inch sur-
erally recognized as safe in food, sub- face area of the food-contact article
stances used in accordance with prior when exposed to distilled water, 3 per-
sanction, substances permitted under cent acetic acid, 50 percent ethanol,
applicable regulations in this part, and and n-heptane for 10 days at 120 °F.
(2) The finished food-contact article
the following:
shall yield not more than 0.0025 milli-
gram per square inch of acrylonitrile
monomer when exposed to distilled
water, 3 percent acetic acid and n-
heptane at 190 °F for 2 hours, cooled to
120 °F (80 to 90 minutes) and main-
tained at 120 °F for 10 days when ana-

lyzed by a polarographic method titled
253
§ 177.1040 21 CFR Ch. I (4–1–23 Edition)
‘‘Extracted Acrylonitrile by Differen- terials subject to the provisions of this

tial Pulse Polarography,’’ which is in- section.
corporated by reference. Copies are (a) Identity. For the purposes of this
available from the Center for Food section acrylonitrile/styrene copoly-
Safety and Applied Nutrition (HFS– mers are basic copolymers meeting the
200), Food and Drug Administration, specifications prescribed in paragraph
5001 Campus Dr., College Park, MD (c) of this section.
20740, or available for inspection at the (b) Adjuvants. (1) The copolymers
National Archives and Records Admin- identified in paragraph (c) of this sec-
istration (NARA). For information on tion may contain adjuvant substances
the availability of this material at required in their production, with the
NARA, call 202–741–6030, or go to: http:// exception that they shall not contain
www.archives.gov/federal_register/ mercaptans or other substances which
code_of_federal_regulations/ form reversible complexes with acryl-
ibr_locations.html. onitrile monomer. Permissible adju-
(e) Acrylonitrile copolymers identi- vants may include substances gen-
fied in this section shall comply with erally recognized as safe in food, sub-
the provisions of § 180.22 of this chap- stances used in accordance with prior
ter. sanction, substances permitted under
(f) Acrylonitrile copolymers identi- applicable regulations in this part, and
fied in this section are not authorized those authorized in paragraph (b)(2) of
to be used to fabricate beverage con- this section.
tainers. (2) The optional adjuvants for the ac-
[42 FR 14572, Mar. 15, 1977, as amended at 42 rylonitrile/styrene copolymer identi-
FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, fied in paragraphs (c)(1) and (3) of this
1982; 54 FR 24898, June 12, 1989] section are as follows:
§ 177.1040 Acrylonitrile/styrene copoly- Substances Limitation
mer.
Condensation polymer of toluene 0.15 pct maximum.
Acrylonitrile/styrene copolymers sulfonamide and formaldehyde.
identified in this section may be safely
used as a component of packaging ma- (c) Specifications.
Maximum re-
sidual acrylo- Nitrogen con-
nitrile mon- Maximum extractable fractions at Conformance with
Acrylonitrile/styrene copolymers tent of co-
omer content specified temperatures and times certain specifications
polymer
of finished
article
1. Acrylonitrile/styrene copolymer 80 ppm1 ...... 17.4 to 19 Total nonvolatile extractives not to Minimum number av-
consisting of the copolymer pro- pct. exceed 0.01 mg/in 2 surface erage molecular
duced by polymerization of 66– area of the food contact article weight is 30,000. 1
72 parts by weight of acrylo- when exposed to distilled water
nitrile and 28–34 parts by weight and 3 pct acetic acid for 10 d at
of styrene; for use with food of 66 °C (150 °F).
Type VI-B identified in table 1 of The extracted copolymer shall not
§ 176.170(c) of this chapter exceed 0.001 mg/in 2 surface
under conditions of use C, D, E, area of the food contact article
F, G described in table 2 of when exposed to distilled water
§ 176.170(c) of this chapter. and 3 pct acetic acid for 10 d at
66 °C (150 °F) 1.
2. Acrylonitrile/styrene copolymer 50 ppm1 ...... 12.2 to 17.2 Extracted copolymer not to exceed Minimum 10 pct solu-
consisting of the copolymer pro- pct. 2.0 ppm in aqueous extract or n- tion viscosity at 25
duced by polymerization of 45– heptane extract obtained when °C (77 °F) is
65 parts by weight of acrylo- 100 g sample of the basic co- 10cP. 1
nitrile and 35–55 parts by weight polymer in the form of particles
of styrene; for use with food of of a size that will pass through a
Types, I, II, III, IV, V, VI (except U.S. Standard Sieve No. 6 and
bottles), VII, VIII, and IX identi- that will be held on a U.S.
fied in table 1 of § 176.170(c) of Standard Sieve No. 10 is ex-
this chapter under conditions B tracted with 250 mil of deionized
(not to exceed 93 °C (200 °F)), water or reagent grade n-
C, D, E, F, G described in table heptane at reflux temperature
2 of § 176.170(c) of this chapter. for 2 h.1
254
Maximum re-
sidual acrylo- Nitrogen con-
nitrile mon- Maximum extractable fractions at Conformance with
Acrylonitrile/styrene copolymers tent of co-
omer content specified temperatures and times certain specifications
polymer
of finished
article
3. Acrylonitrile/styrene copolymer 0.10 ppm 17.4 to 19 Total nonvolatile extractives not to Maximum carbon di-
consisting of the copolymer pro- (calculated pct. exceed 0.01 mg/in 2 surface oxide permeability
duced by polymerization of 66– on the area of the food contact article at 23 °C (73 °F) for
72 parts by weight of acrylo- basis of when exposed to distilled water the finished article
nitrile and 28–34 parts by weight the weight and 3 pct acetic acid for 10 d at is 0.04 barrer. 3
of styrene; for use with food of of the ac- 66 °C (150 °F).
Types VI-A and VI-B identified in rylonitrile The extracted copolymer shall not
table 1 of § 176.170(c) of this copolymer exceed 0.001 mg/in 2 surface
chapter under conditions of use resin in the area of the food contact article
C, D, E, F, G described in table finished ar- when exposed to distilled water
2 of § 176.170(c) of this chapter. ticles). 2 and 3 pct acetic acid for 10 d at
66 °C (150 °F). 1.
1 Use methods for determination of residual acrylonitrile monomer content, maximum extractable fraction, number average mo-
lecular weight, and solution viscosity, titled: ‘‘Determination of Residual Acrylonitrile and Styrene Monomers-Gas
Chromatographic Internal Standard Method’’; ‘‘Infrared Spectrophotometric Determination of Polymer Extracted from Barex 210
Resin Pellets’’; ‘‘Procedure for the Determination of Molecular Weights of Acrylonitrile/Styrene Copolymers,’’ and ‘‘Analytical
Method for 10% Solution Viscosity of Tyril,’’ which are incorporated by reference. Copies are available from the Center for Food
Safety and Applied Nutrition (HFS–200), 5001 Campus Dr., College Park, MD 20740, or may be examined at the National Ar-
chives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or
go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
2 As determined by the method titled ‘‘Headspace Sampling and Gas-Solid Chromatographic Determination of Residual Acrylo-
nitrile in Acrylonitrile Copolyemr Solutions,’’ which is incorporated by reference. Copies are available from the Center for Food
Safety and Applied Nutrition (HFS–200), 5001 Campus Dr., College Park, MD 20740, or may be examined at the National Ar-
chives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or
go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
3 As determined on appropriately shaped test samples of the article or acrylonitrile copolymer layer in a multilayer construction
by ASTM method D–1434–82, ‘‘Standard Method for Determining Gas Permeability Characteristics of Plastic Film and Sheeting,’’
which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS–200), 5001
Campus Dr., College Park, MD 20740, and the American Society for Testing Materials, 100 Barr Harbor Dr., West
Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/
(d) Interim listing. Acrylonitrile co- mer modified with butadiene/styrene

polymers identified in this section elastomer consists of a blend of:
shall comply with the provisions of (1) 82–88 parts by weight of a matrix
§ 180.22 of this chapter. copolymer produced by polymerization
(e) Acrylonitrile copolymer identified of 77–82 parts by weight of acrylonitrile
in this section may be used to fabricate and 18–23 parts of styrene; and
beverage containers only if they com- (2) 12–18 parts by weight of a grafted
ply with the specifications of item 3 in rubber consisting of (i) 8–12 parts of bu-
paragraph (c) of this section. tadiene/styrene elastomer containing
[42 FR 14572, Mar. 15, 1977, as amended at 42 77–82 parts by weight of butadiene and
FR 48543, Sept. 23, 1977; 47 FR 11841, Mar. 19, 18–23 parts by weight of styrene and (ii)
1982; 49 FR 36643, Sept. 19, 1984; 52 FR 33803, 4–6 parts by weight of a graft copoly-
Sept. 8, 1987] mer consisting of 70–77 parts by weight
of acrylonitrile and 23–30 parts by
§ 177.1050 Acrylonitrile/styrene copoly- weight of styrene.
mer modified with butadiene/sty-
rene elastomer. (b) Adjuvants. The modified copoly-
mer identified in paragraph (a) of this
Acrylonitrile/styrene copolymer section may contain adjuvant sub-
modified with butadiene/styrene elas- stances required in its production.
tomer identified in this section may be Such adjuvants may include substances
safely used as a component of bottles generally recognized as safe in food,
intended for use with foods identified substances used in accordance with
in table I of § 176.170(c) of this chapter prior sanction, substances permitted
as Type VI-B under conditions for use
under applicable regulations in this
E, F, or G described in table 2 of
part, and the following:
(a) Identity. For the purpose of this

section, acrylonitrile/styrene copoly-
255
§ 177.1050 21 CFR Ch. I (4–1–23 Edition)
Substances Limitations go to: http://www.archives.gov/fed-

n-Dodecylmercaptan The finished copolymer shall contain
not more than 500 parts per million ibr_locations.html.
(ppm) dodecylmercaptan as (d) Extractives limitations. The fol-
dodecylmercapto-propionitrile as de- lowing extractives limitations are de-
termined by the method titled, ‘‘De-
termination of b-Dodecyl-
termined by an infrared spectrophoto-
mercaptopropionitrile in NR–16 metric method titled ‘‘Infrared
Polymer,’’ which is incorporated by Spectrophotometric Determination of
reference. Copies are available Polymer Extracted from Borex ® 210
from the Center for Food Safety
and Applied Nutrition (HFS–200), Resin Pellets,’’ which is incorporated
Food and Drug Administration, 5001 by reference. Copies are available from
Campus Dr., College Park, MD the Center for Food Safety and Applied
20740, or available for inspection at
the National Archives and Records
Nutrition (HFS–200), Food and Drug
Administration (NARA). For informa- Administration, 5001 Campus Dr., Col-
tion on the availability of this mate- lege Park, MD 20740, or available for in-
rial at NARA, call 202–741–6030, or spection at the National Archives and
eral_register/ Records Administration (NARA). For
code_of_federal_regulations/ information on the availability of this
ibr_locations.html. material at NARA, call 202–741–6030, or
(c) Specifications. (1) Nitrogen content eral_register/code_of_federal_regulations/
of the modified copolymer is in the ibr_locations.html. Copies are applicable
range of 17.7–19.8 percent. to the modified copolymers in the form
(2) Intrinsic viscosity of the matrix of particles of a size that will pass
copolymer in butyrolactone is not less through a U.S. Standard Sieve No. 6
than 0.5 deciliter/gram at 35 °C, as de- and that will be held on a U.S. Stand-
termined by the method titled ‘‘Molec- ard Sieve No. 10:
ular Weight of Matrix Copolymer by (1) The extracted copolymer shall not
Solution Viscosity,’’ which is incor- exceed 2.0 ppm in aqueous extract ob-
porated by reference. Copies are avail- tained when a 100-gram sample of co-
able from the Center for Food Safety polymer is extracted with 250 milli-
and Applied Nutrition (HFS–200), Food liters of freshly distilled water at
and Drug Administration, 5001 Campus reflux temperature for 2 hours.
Dr., College Park, MD 20740, or avail- (2) The extracted copolymer shall not
able for inspection at the National Ar- exceed 0.5 ppm in n-heptane when a 100-
chives and Records Administration gram sample of the basic copol-ymer is
(NARA). For information on the avail- extracted with 250 milliliters spectral
ability of this material at NARA, call grade n-heptane at reflux temperature
202–741–6030, or go to: http:// for 2 hours.
www.archives.gov/federal_register/ (e) Accelerated extraction end test. The
code_of_federal_regulations/ modified copolymer shall yield acrylo-
ibr_locations.html. nitrile monomer not in excess of 0.4
(3) Residual acrylonitrile monomer ppm when tested as follows:
content of the modified copolymer ar- (1) The modified copolymer shall be
ticles is not more than 11 ppm as deter- in the form of eight strips 1⁄2 inch by 4
mined by a gas chromatographic meth- inches by .03 inch.
od titled ‘‘Determination of Residual (2) The modified copolymer strips
Acrylonitrile and Styrene Monomers- shall be immersed in 225 milliliters of 3
Gas Chromatographic Internal Stand- percent acetic acid in a Pyrex glass
ard Method,’’ which is incorporated by pressure bottle.
reference. Copies are available from (3) The pyrex glass pressure bottle is
the Center for Food Safety and Applied then sealed and heated to 150 °F in ei-
Nutrition (HFS–200), Food and Drug ther a circulating air oven or a thermo-
Administration, 5001 Campus Dr., Col- stat controlled bath for a period of 8
lege Park, MD 20740, or available for in- days.
spection at the National Archives and (4) The Pyrex glass pressure bottle is
Records Administration (NARA). For then removed from the oven or bath
information on the availability of this and cooled to room temperature. A
material at NARA, call 202–741–6030, or sample of the extracting solvent is
256
then withdrawn and analyzed for acry- (c) Specifications. Maximum nitrogen
lonitrile monomer by a gas content of the copolymer determined
chromatographic method titled ‘‘Gas- by micro-Kjeldahl analysis, shall not
Solid Chromatographic Procedure for exceed 8 percent.
Determining Acrylonitrile Monomer in (d) Limitations. (1) The n-alkylglutar-
Acrylonitrile-Containing Polymers and imide/acrylic copolymers in the fin-
Food Simulating Solvents,’’ which is ished form in which they shall contact
incorporated by reference. Copies, are food, when extracted with the solvent
available from the Center for Food or solvents characterizing the type of
Safety and Applied Nutrition (HFS– food and under the conditions of time
200), Food and Drug Administration, and temperature described in tables 1
5001 Campus Dr., College Park, MD and 2 of § 176.170(c) of this chapter,
20740, or available for inspection at the shall yield extractives not to exceed
National Archives and Records Admin- the limitations of § 177.1010(b) of this
istration (NARA). For information on chapter, when prepared as strips, as de-
the availability of this material at scribed in § 177.1010(c)(2) of this chapter.
NARA, call 202–741–6030, or go to: http:// (2) The n-alkylglutarimide/acrylic co-
www.archives.gov/federal_register/ polymers shall not be used as polymer
code_of_federal_regulations/ modifiers in vinyl chloride homo- or
copolymers.
ibr_locations.html.
(e) Conditions of use. The n-
(f) Acrylonitrile copolymers identi- alkylglutarimide/acrylic copolymers
fied in this section shall comply with are used as articles or components of
the provisions of § 180.22 of this chap- articles (other than articles composed
ter. of vinyl chloride homo- or copolymers)
(g) Acrylonitrile copolymers identi- intended for use in contact with all
fied in this section are not authorized foods except beverages containing
to be used to fabricate beverage con- more than 8 percent alcohol under con-
tainers. ditions of use D, E, F, and G as de-
[42 FR 14572, Mar. 15, 1977, as amended at 42 scribed in table 2 of § 176.170(c) of this
FR 48544, Sept. 23, 1977; 47 FR 11841, Mar. 19, chapter.
1982; 47 FR 16775, Apr. 20, 1982; 54 FR 24898,
June 12, 1989]
FR 17098, Apr. 1, 1993]
§ 177.1060 n-Alkylglutarimide/acrylic § 177.1200 Cellophane.
copolymers.
Cellophane may be safely used for
n-Alkylglutarimide/acrylic copoly- packaging food in accordance with the
mers identified in this section may be following prescribed conditions:
safely used as articles or components (a) Cellophane consists of a base
of articles intended for use in contact sheet made from regenerated cellulose
with food subject to provisions of this to which have been added certain op-
section and part 174 of this chapter. tional substances of a grade of purity
(a) Identity. For the purpose of this suitable for use in food packaging as
section, n-alkylglutarimide/acrylic co- constituents of the base sheet or as
polymers are copolymers obtained by coatings applied to impart desired
reaction of substances permitted by technological properties.
§ 177.1010(a)(1), (2), and (3) with the fol- (b) Subject to any limitations pre-
lowing substance: Monomethylamine scribed in this part, the optional sub-
(CAS Reg. No. 74–89–5), to form n- stances used in the base sheet and
methylglutarimide/acrylic copolymers. coating may include:
(b) Adjuvants. The copolymers identi- (1) Substances generally recognized
fied in paragraph (a) of this section as safe in food.
may contain adjuvant substances re- (2) Substances for which prior ap-
quired in their production. The op- proval or sanctions permit their use in
tional adjuvant substances required in cellophane, under conditions specified
the production of the basic polymer in such sanctions and substances listed
may include substances permitted for in § 181.22 of this chapter.

such use by applicable regulations, as (3) Substances that by any regulation
set forth in part 174 of this chapter. promulgated under section 409 of the
257
§ 177.1200 21 CFR Ch. I (4–1–23 Edition)
act may be safely used as components (4) Substances named in this section
of cellophane. and further identified as required.
(c) List of substances:
Limitations (residue and limits of addition expressed as percent
List of substances by weight of finished packaging cellophane)
Acrylonitrile-butadiene copolymer resins ..................................... As the basic polymer.

Acrylonitrile-butadiene-styrene copolymer resins ........................ Do.
Acrylonitrile-styrene copolymer resins ......................................... Do.
Acrylonitrile-vinyl chloride copolymer resins ............................... Do.
N-Acyl sarcosines where the acyl group is lauroyl or stearoyl ... For use only as release agents in coatings at levels not to ex-
ceed a total of 0.3 percent by weight of the finished pack-
aging cellophane.
Alkyl ketene dimers identified in § 176.120 of this chapter.
Aluminum hydroxide.
Aluminum silicate.
Ammonium sulfate.
Behenamide.
Butadiene-styrene copolymer ...................................................... As the basic polymer.
1,3-Butanediol.
n-Butyl acetate ............................................................................. 0.1 percent.
n-Butyl alcohol ............................................................................. Do.
Calcium ethyl acetoacetate.
Calcium stearoyl-2-lactylate identified in § 172.844 of this chap- Not to exceed 0.5 percent weight of cellophane.
ter.
Carboxymethyl hydroxyethylcellulose polymer.
Castor oil, sulfonated, sodium salt.
Cellulose acetate butyrate.
Cellulose acetate propionate.
Cetyl alcohol.
Clay, natural.
Coconut oil fatty acid (C12-C18) diethanolamide, coconut oil For use only as an adjuvant employed during the processing of
fatty acid (C12-C18) diethanolamine soap, and diethanolamine cellulose pulp used in the manufacture of cellophane base
mixture having total alkali (calculated as potassium hydrox- sheet.
ide) of 16–18% and having an acid number of 25–35.
Copal resin, heat processed ....................................................... As basic resin.
Damar resin.
Defoaming agents identified in § 176.200 of this chapter.
Dialkyl ketones where the alkyl groups are lauryl or stearyl ...... Not to exceed a total of 0.35 percent.
Dicyclohexyl phthalate ................................................................. Do.
Diethylene glycol ester of the adduct of terpene and maleic an-
hydride.
Di(2-ethylhexyl) adipate.
Di(2-ethylhexyl) phthalate ............................................................ Alone or in combination with other phthalates where total
phthalates do not exceed 5 percent.
Dimethyldialkyl (C8-C18) ammonium chloride .............................. 0.005 percent for use only as a flocculant for slip agents.
Di-n-ocyltin bis (2-ethylhexyl maleate) ........................................ For use only as a stabilizer at a level not to exceed 0.55 per-
cent by weight of the coating solids in vinylidene chloride co-
polymer waterproof coatings prepared from vinylidene chlo-
ride copolymers identified in this paragraph, provided that
such vinylidene chloride copolymers contain not less than 90
percent by weight of polymer units derived from vinylidene
chloride.
N,N′-Dioleoyethylenediamine, N,N′-dilinoleoylethylene-diamine 0.5 percent.
and N-oleoyl-N′linoleoylethylene-diamine mixture produced
when tall oil fatty acids are made to react with ethylene-
diamine such that the finished mixture has a melting point of
212°–228 °F., as determined by ASTM method D127–60
(‘‘Standard Method of Test for Melting Point of Petrolatum
and Microcrystalline Wax’’ (Revised 1960), which is incor-
porated by reference; copies are available from University
Microfilms International, 300 N. Zeeb Rd., Ann Arbor, MI
48106, or available for inspection at the National Archives
code_of_federal_regulations/ibr_locations.html.), and an acid
value of 10 maximum.
N,N′-Dioleoylethylenediamine (N,N′-ethylenebisoleamide).
Disodium EDTA.
Distearic acid ester of di(hydroxyethyl) diethylenetriamine 0.06 percent.

monoacetate.
N,N′-Distearoylethylenediamine (N,N′-ethylenebis stearamide).
258

Epoxidized polybutadiene ............................................................ For use only as a primer subcoat to anchor surface coatings to
the base sheet.
Erucamide.
Ethyl acetate.
Ethylene-vinyl acetate copolymers complying with § 177.1350.
2-Ethylhexyl alcohol ..................................................................... 0.1 percent for use only as lubricant.
Fatty acids derived from animal and vegetable fats and oils,
and the following salts of such acids, single or mixed: Alu-
minum, ammonium, calcium, magnesium, potassium, sodium.
Ferrous ammonium sulfate.
Fumaric acid.
Glycerin-maleic anhydride ........................................................... As the basic polymer.
Glycerol diacetate.
Glycerol monoacetate.
Hydroxyethyl cellulose, water-insoluble.
Hydroxypropyl cellulose identified in § 172.870 of this chapter.
Isopropyl acetate ......................................................................... Residue limit 0.1 percent
Isopropyl alcohol .......................................................................... Do.
Itaconic acid.
Lanolin.
Lauryl alcohol.
Lauryl sulfate salts: ammonium, magnesium, potassium, so-
dium.
Maleic acid ................................................................................... 1 percent.
Maleic acid adduct of butadienestyrene copolymer.
Melamine formaldehyde .............................................................. As the basic polymer.
Melamine-formaldehyde modified with one or more of the fol- As the basic polymer, and used as a resin to anchor coatings
lowing: Butyl alcohol, diaminopropane, diethylenetriamine, to substrate.
ethyl alcohol, guanidine, imino-bis-butylamine, imino-bis-eth-
ylamine, imino-bis-propylamine, methyl alcohol, polyamines
made by reacting ethylenediamine or trimethylenediamine
with dichloroethane or dichloropropane, sulfanilic acid,
tetraethylenepentamine, triethanolamine, triethylenetetra-
mine.
Methyl ethyl ketone ..................................................................... Residue limit 0.1 percent
Methyl hydrogen siloxane ............................................................ 0.1 percent as the basic polymer.
a-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1a-
Mineral oil, white.
Mono- and bis-(octadecyldiethylene oxide) phosphates (CAS For use only as a release agent at a level not to exceed 0.6
Reg. No. 62362–49–6). percent by weight of coatings for cellophane.
Naphthalenesulfonic acid-formaldehyde condensate, sodium 0.1 percent, for use only as an emulsifier.
salt.
Nitrocellulose, 10.9 percent–12.2 percent nitrogen.
Nylon resins complying with § 177.1500.
n-Octyl alcohol ............................................................................. For use only as a defoaming agent in the manufacture of cello-
phane base sheet.
Olefin copolymers complying with § 177.1520.
Oleic acid reacted with N-alkyl trimethylenediamine (alkyl C16
to C18).
Oleic acid, sulfonated, sodium salt.
Oleyl palmitamide.
N,N′-Oleoyl-stearylethylenediamine (N-(2-stearoyl-
aminoethyl)oleamide).
Paraffin, synthetic, complying with § 175.250 of this chapter.
Pentaerythritol tetrastearate ........................................................ 0.1 percent.
Polyamide resins derived from dimerized vegetable oil acids For use only in cellophane coatings that contact food at tem-
(containing not more than 20 percent of monomer acids) and peratures not to exceed room temperature.
ethylenediamine as the basic resin.
Polyamide resins having a maximum acid value of 5 and a As the basic resin, for use only in coatings that contact food at
maximum amine value of 8.5 derived from dimerized vege- temperatures not to exceed room temperature provided that
table oil acids (containing not more than 10 percent mon- the concentration of the polyamido resins in the finished
omer acids), ethylenediamine, and 4,4-bis(4- food-contact coating does not exceed 5 milligrams per
hydroxyphenyl)pentanoic acid (in an amount not to exceed square inch of food-contact surface.
10 percent by weight of said polyamide resins).
Polybutadiene resin (molecular weight range 2,000–10,200; For use only as an adjuvant in vinylidene chloride copolymer
bromine number range 210–320). coatings.
Polycarbonate resins complying with § 177.1580.
Polyester resin formed by the reaction of the methyl ester of
rosin, phthalic anhydride, maleic anhydride, and ethylene
glycol, such that the polyester resin has an acid number of 4

to 11, a drop-softening point of 70 °C–92 °C, and a color of
K or paler.
259
§ 177.1200 21 CFR Ch. I (4–1–23 Edition)

Polyethylene.
Polyethyleneaminostearamide ethyl sulfate produced when ste- 0.1 percent.
aric acid is made to react with equal parts of
diethylenetriamine and triethylenetetramine and the reaction
product is quaternized with diethyl sulfate.
Polyethylene, oxidized: complying with the identity prescribed
in § 177.1620(a).
Polyethylenimine .......................................................................... As the basic polymer, for use as a resin to anchor coatings to
the substrate and for use as an impregnant in the food-con-
tact surface of regenerated cellulose sheet in an amount not
to exceed that required to improve heat-sealable bonding
between coated and uncoated sides of cellophane.
Polyisobutylene complying with § 177.1420.
Polyoxypropylene-polyoxyethylene block polymers (molecular For use as an adjuvant employed during the processing of cel-
weight 1,900–9,000). lulose pulp used in the manufacture of cellophane base
sheet.
Polypropylene complying with § 177.1520.
Polystyrene .................................................................................. As the basic polymer.
Polyvinyl acetate .......................................................................... Do.
Polyvinyl alcohol (minimum viscosity of 4 percent aqueous so-
lution at 20 °C of 4 centipoises).
Polyvinyl chloride ......................................................................... As the basic polymer.
Polyvinyl stearate ........................................................................ Do.
n-Propyl acetate .......................................................................... Residue limit 0.1 percent.
n-Propyl alcohol ........................................................................... Do.
Rapeseed oil, blown.
Rosins and rosin derivatives as provided in § 178.3870 of this
chapter.
Rubber, natural (natural latex solids).
Silica.
Silicic acid.
Sodium m-bisulfite.
Sodium lauroyl sarcosinate ......................................................... 0.35 percent; for use only in vinylidene chloride copolymer
coatings.
Sodium oleyl sulfate-sodium cetyl sulfate mixture ...................... For use only as an emulsifier for coatings; limit 0.005 percent
where coating is applied to one side only and 0.01 percent
where coating is applied to both sides.
Sodium silicate.
Sodium stearoyl-2-lactylate identified in § 172.846 of this chap- Not to exceed 0.5 percent weight of cellophane.
ter.
Sodium sulfate.
Sodium sulfite.
Spermaceti wax.
Stannous oleate.
2-Stearamido-ethyl stearate.
Stearyl alcohol.
Styrene-maleic anhydride resins ................................................. As the basic polymer.
Terpene resins identified in § 172.615 of this chapter.
Tetrahydrofuran ........................................................................... Residue limit of 0.1 percent.
Titanium dioxide.
Toluene ........................................................................................ Residue limit of 0.1 percent.
Toluene sulfonamide formaldehyde ............................................ 0.6 percent as the basic polymer.
Triethylene glycol.
Triethylene glycol diacetate, prepared from triethylene glycol
containing not more than 0.1 percent of diethylene glycol.
2,2,4-Trimethyl-1,3 pentanediol diisobutyrate ............................. For use only in cellophane coatings and limited to use at a
level not to exceed 10 percent by weight of the coating sol-
ids except when used as provided in § 178.3740 of this
chapter
Urea (carbamide).
Urea formaldehyde ...................................................................... As the basic polymer.
260

Urea formaldehyde modified with methanol, ethanol, butanol As the basic polymer, and used as a resin to anchor coatings
diethylenetriamine, triethylenetetramine, tetraethylenepenta- to the substrate.
mine, guanidine, sodium sulfite, sulfanilic acid, imino-bis-eth-
ylamine, imino-bis-propylamine, imino-bis-butylamine,
diaminopropane, diaminobutane, aminomethylsulfonic acid,
polyamines made by reacting ethylenediamine or
trimethylenediamine with dichlorethane or dichloropropane.
Vinyl acetate-vinyl chloride copolymer resins ............................. As the basic polymer.
Vinyl acetate-vinyl chloride-maleic acid copolymer resins .......... Do.
Vinylidene chloride copolymerized with one or more of the fol- Do.
lowing: Acrylic acid, acrylonitrile, butyl acrylate, butyl meth-
acrylate, ethyl acrylate, 2-ethylhexyl acrylate, 2-ethylhexyl
methacrylate, ethyl methacrylate, itaconic acid, methacrylic
acid, methyl acrylate, methyl methacrylate, propyl acrylate,
propyl methacrylate, vinyl chloride.
Vinylidene chloride-methacrylate decyloctyl copolymer .............. Do.
Wax, petroleum, complying with § 178.3710 of this chapter.
(d) Any optional component listed in stances identified in § 175.300(b) of this

this section covered by a specific food chapter, with the exception of para-
additive regulation must meet any graph (b)(3)(v), (xxxi), and (xxxii) of
specifications in that regulation. that section, and from other optional
(e) Acrylonitrile copolymers identi- substances, including the following:
fied in this section shall comply with (1) Substances generally recognized
the provisions of § 180.22 of this chap- as safe in food.
ter. (2) Substances used in accordance
[42 FR 14572, Mar. 15, 1977, as amended at 47 with the provisions of a prior sanction
FR 11842, Mar. 19, 1982; 64 FR 57978, Oct. 28, or approval within the meaning of sec-
1999; 87 FR 31089, May 20, 2022] tion 201(s) of the act.
§ 177.1210 Closures with sealing gas- (3) Substances that are the subject of
kets for food containers. regulations in parts 174, 175, 176, 177, 178
and § 179.45 of this chapter and used in
Closures with sealing gaskets may be
accordance with the conditions pre-
safely used on containers intended for
scribed.
use in producing, manufacturing, pack-
ing, processing, preparing, treating, (4) Substances identified in para-
packaging, transporting, or holding graph (b)(5) of this section, used in
food in accordance with the following amounts not to exceed those required
prescribed conditions: to accomplish the intended physical or
(a) Closures for food containers are technical effect and in conformance
manufactured from substances gen- with any limitation provided; and fur-
erally recognized as safe for contact ther provided that any substance em-
with food; substances that are subject ployed in the production of closure-
to the provisions of prior sanctions; sealing gasket compositions that is the
substances authorized by regulations subject of a regulation in parts 174, 175,
in parts 174, 175, 176, 177, 178 and § 179.45 176, 177, 178 and § 179.45 of this chapter
of this chapter; and closure-sealing conforms with the identity or speci-
gaskets, as further prescribed in this fications prescribed.
section. (5) Substances that may be employed
(b) Closure-sealing gaskets and over- in the manufacture of closure-sealing
all discs are formulated from sub- gaskets include:
TABLE 1
Limitations (expressed as percent by weight of closure-sealing
List of substances gasket composition)
Arachidy-l-behenyl amide (C20-C22fatty acid amides) ................. 5 percent.

Azodicarbonamide ....................................................................... 1. 2 percent.

2. 5 percent; for use only in the manufacture of polyethylene
complying with item 2.1 in § 177.1520(c) of this chapter.
261
§ 177.1210 21 CFR Ch. I (4–1–23 Edition)
TABLE 1—Continued
Balata rubber.
Benzyl alcohol ............................................................................. 1 percent.
Brominated isobutylene-isoprene copolymers, produced when
isobutylene-isoprene copolymers complying with
§ 177.1420(a)(2) are modified by bromination with not more
than 2.3 weight-percent of bromine and having a Mooney
Viscosity (ML 1 + 8 (125 °C)) of 27 or higher. The viscosity
is determined by the American Society for Testing and Mate-
rials (ASTM) method D 1646–81, ‘‘Standard Test Method for
Rubber—Viscosity and Vulcanization Characteristics (Moon-
ey Viscometer),’’ which is incorporated by reference in ac-
cordance with 5 U.S.C. 522(a) and 1 CFR part 51. Copies
are available from the AOAC INTERNATIONAL, 481 North
Frederick Ave., Suite 500, Gaithersburg, MD 20877-2504
and the Center for Food Safety and Applied Nutrition (HFS–
200), Food and Drug Administration, 5001 Campus Dr., Col-
lege Park, MD 20740, or available for inspection at the Na-
1,3-Butanediol.
Calcium tin stearate ..................................................................... 2 percent.
Calcium zinc stearate .................................................................. Do.
Carbon, activated ........................................................................ 1 percent.
Castor oil, hydrogenated ............................................................. 2 percent.
Chlorinated isobutylene-isoprene copolymers complying with
§ 177.1420.
Coco amide (coconut oil fatty acids amides) .............................. 2 percent.
Cork (cleaned, granulated).
Diebenzamide phenyl disulfide .................................................... 1 percent; for use only in vulcanized natural or synthetic rubber
gasket compositions.
Di(C7, C9-alkyl) adipate ............................................................... Complying with § 178.3740 of this chapter; except that, there is
no limitation on polymer thickness.
Di-2-ethylhexyl adipate.
Di-2-ethylhexyl sebacate ............................................................. 2 percent.
Di-2-ethylhexyl terephthalate (CAS Reg. No. 006422–86–2). .... For use as a plasticizer at levels not exceeding 75 parts per
hundred by weight of permitted vinyl chloride homo- and/or
copolymer resins used in contact with food of Types I, II, IV-
B, VI-A, VI-B, VI-C (up to 15 percent alcohol by volume), VII-
B, and VIII described in § 176.170(c) of this chapter, table 1,
and under conditions of use A through H described in
§ 176.170 (c) of this chapter, table 2.
Dihexyl ester of sodium sulfosuccinate ....................................... 1 percent.
Diisodecyl phthalate .................................................................... No limitation on amount used but for use only in closure-seal-
ing gasket compositions used in contact with non-fatty foods
containing no more than 8 percent of alcohol.
Di-b-naphthyl-p-phenylenediamine .............................................. 1 percent.
Dipentamethylenethiurametetrasulfide ........................................ 0.4 percent; for use only in vulcanized natural or synthetic rub-
ber gasket compositions.
Eicosane (technical grade) (water-white mixture of predomi-
nantly straight-chain paraffin hydrocarbons averaging 20 car-
bon atoms per molecule).
Epoxidized linseed oil.
Epoxidized linseed oil modified with trimellitic anhydride.
Epoxidized safflower oil.
Epoxidized safflower oil modified with trimellitic anhydride.
Epoxidized soybean oil modified with trimellitic anhydride.
Erucylamide ................................................................................. 5 percent.
Ethylene-propylene copolymer.
Ethylene-propylene modified copolymer elastomers produced
when ethylene and propylene are copolymerized with 5-
methylene-2-norbornene and/or 5-ethylidine-2-norbornene.
The finished copolymer elastomers so produced shall con-
tain not more than 5 weight-percent of total polymer units
derived from 5-methylene-2-norbornene and/or 5-ethylidine-
2-norbornene, and shall have a minimum viscosity average
molecular weight of 120,000 as determined by the method
described in § 177.1520(d)(5), and a minimum Mooney vis-

cosity of 35 as determined by the method described in
§ 177.1520(d)(6).
262
TABLE 1—Continued
Ethylene-vinyl acetate copolymer.

Glyceryl mono-12-hydroxystearate (hydrogenated glyceryl 2 percent.
ricinoleate).
Gutta-percha.
Hexamethylenetetramine ............................................................. 1 percent.
Hexylene glycol ........................................................................... 0.5 percent.
Isobutylene-isoprene copolymers complying with § 177.1420.
Maleic anhydride-polyethylene copolymer .................................. 5 percent.
Maleic anhydride-styrene copolymer ........................................... Do.
2,2′-Methylenebis[6-(1-methylcylcohexyl)-p-cresol] ..................... 1 percent.
Mixed octylated diphenylamine (CAS Reg. No. 68411–46–1) ... 0.1 percent in isobutylene-isoprene and chlorinated
isobutylene-isoprene copolymers complying with § 177.1420,
and brominated isobutylene-isoprene copolymers complying
with this section.
Naphthalene sulfonic acid-formaldehyde condensate, sodium 0.2 percent.
salt.
Natural rubber (crepe, latex, mechanical dispersions).
a-cis-9-Octadecenyl-omega-hydroxypoly (oxyethylene); the 0.5 percent.
octadecenyl group is derived from oleyl alcohol and the poly
(oxyethylene) content averages 20 moles.
Oleyl alcohol ................................................................................ 1 percent.
4,4′-Oxybis (benzene sulfonyl hydrazide) ................................... 0.5 percent.
Paraformaldehyde ....................................................................... 1 percent.
Polybutadiene.
Poly-p-dinitroso benzene (activator for butyl rubber) .................. 1 percent; for use only in vulcanized natural or synthetic rubber
gasket compositions.
Polyethylene glycol 400 esters of fatty acids derived from ani- 1 percent.
mal and vegetable fats and oils.
Polyisobutylene complying with § 177.1420.
Polyoxypropylene-polyoxyethylene condensate, average mol. 0.05 percent.
wt. 2750–3000.
Polyurethane resins manufactured from diphenylmethane For use only:
diisocyanate, 1,4-butanediol, and adipic acid (CAS Reg. No. No limitation on amount used, but for use only in closure
26375–23–5).. gasket compositions used in contact with food types VI-A
and VI-C (up to 15 percent alcohol) under conditions of use
D, E, F, and G, as described in § 176.170(c) of this chapter,
tables 1 and 2, respectively.
Potassium benzoate .................................................................... 1 percent.
Potassium propionate .................................................................. 2 percent.
Potassium and sodium persulfate ............................................... 1 percent.
Resorcinol .................................................................................... 0.24 percent; for use only as a reactive adjuvant substance
employed in the production of gelatin-bonded cord composi-
tions for use in lining crown closures. The gelatin so used
shall be technical grade or better.
Rosins and rosin derivatives as defined in § 175.300(b)(3)(v) of
this chapter for use only in resinous and polymeric coatings
on metal substrates; for all other uses as defined in
Sodium cetyl sulfate .................................................................... 1 percent.
Sodium decylbenzenesulfonate ................................................... Do.
Sodium decyl sulfate ................................................................... Do.
Sodium formaldehyde sulfoxylate ............................................... 0.05 percent.
Sodium lauryl sulfate ................................................................... 1 percent.
Sodium lignin sulfonate ............................................................... 0.2 percent.
Sodium myristyl sulfate (sodium tetradecyl sulfate) .................... 0.6 percent.
Sodium nitrite ............................................................................... 0.2 percent; for use only in annular ring gaskets applied in
aqueous dispersions to closures for containers having a ca-
pacity of not less than 5 gallons.
Sodium o-phenylphenate ............................................................. 0.05 percent.
Sodium polyacrylate .................................................................... 5 percent.
Sodium and potassium pentachlorophenate ............................... 0.05 percent.
Sodium salt of trisopropyl naphthalenesulfonic acid ................... 0.2 percent.
Sodium tridecylsulfate ................................................................. 0.6 percent.
Stearic acid amide ....................................................................... 5 percent.
Sulfur ........................................................................................... For use only as a vulcanizing agent in vulcanized natural or
synthetic rubber gasket compositions at a level not to ex-
ceed 4 percent by weight of the elastomer content of the
rubber gasket composition.
Tallow, sulfated ............................................................................ 1 percent.

Tin-zinc stearate .......................................................................... 2 percent.
Tri(mixed mono- and dinonylphenyl) phosphite .......................... 1 percent.
263
§ 177.1210 21 CFR Ch. I (4–1–23 Edition)
TABLE 1—Continued
Vinyl chloride-vinyl stearate copolymer.

Zinc dibutyldithiocarbamate ......................................................... 0.8 percent; for use only in vulcanized natural or synthetic rub-
ber gasket compositions.
TABLE 2—MAXIMUM EXTRACTIVES TOLERANCES when extracted on a suitable glass con-

[In parts per million] tainer with a solvent or solvents char-
acterizing the type of foods, and under
Chloro-
Chloro- form Chloro- conditions of time and temperature
form form
Type of closure-sealing gas- fraction fraction fraction characterizing the conditions of its use
of
ket composition of water heptane of alco- as determined from tables 3 and 4 shall
extrac- hol ex-
tives extrac- tractives yield net chloroform-soluble extrac-
tives
tives (corrected for zinc as zinc oleate)
1. Plasticized polymers, in- not to exceed the tolerances specified
cluding unvulcanized or in table 2, calculated on the basis of
vulcanized or otherwise
cured natural and syn-
the water capacity of the container on
thetic rubber formed in which the closure is to be used. Employ
place as overall discs or the analytical method described in
annular rings from a hot § 175.300 of this chapter, adapting the
melt, solution, plastisol,
organisol, mechanical dis- procedural details to make the method
persion, or latex ............... 50 500 50 applicable to closures; such as, for ex-
2. Preformed overall discs ample, placing the closed glass con-
or annular rings of plasti-
cized polymers, including tainer on its side to assure contact of
unvulcanized natural or the closure’s food-contacting surface
synthetic rubber ............... 50 250 50 with the solvent.
3. Preformed overall discs
or annular rings of vulcan- TABLE 3—TYPES OF FOOD
ized plasticized polymers,
including natural or syn- I. Nonacid (pH above 5.0), aqueous products;
thetic rubber ..................... 50 50 50 may contain salt or sugar or both, and in-
4. Preformed overall discs cluding oil-in-water emulsions of low- or
or annular rings of poly- high-fat content.
meric or resinous-coated
paper, paperboard, plas-
II. Acidic (pH 5.0 or below), aqueous prod-
tic, or metal foil substrates 50 250 50 ucts; may contain salt or sugar or both,
5. Closures with sealing and including oil-in-water emulsions of
gaskets or sealing com- low- or high-fat content.
positions as described in III. Aqueous, acid or nonacid products con-
1, 2, 3, and 4, and includ- taining free oil or fat; may contain salt,
ing paper, paperboard,
and including water-in-oil emulsions of
and glassine used for dry
foods only ........................ (1) (1) (1) low- or high-fat content.
IV. Dairy products and modifications:
1 Extractability tests not applicable. A. Water-in-oil emulsions, high- or low-fat.
(c) The closure assembly to include B. Oil-in-water emulsions, high- or low-fat.
V. Low-moisture fats and oils.
the sealing gasket or sealing com-
VI. Beverages:
pound, together with any polymeric or A. Containing alcohol.
resinous coating, film, foil, natural B. Nonalcoholic.
cork, or glass that forms a part of the VII. Bakery products.
food-contact surface of the assembly, VIII. Dry solids (no end-test required).
TABLE 4—TEST PROCEDURES WITH TIME-TEMPERATURE CONDITIONS FOR DETERMINING AMOUNT OF
EXTRACTIVES FROM CLOSURE-SEALING GASKETS, USING SOLVENTS SIMULATING TYPES OF FOODS
AND BEVERAGES
Extractant
Types of food
Conditions of use (see Table 3) Water (time and tem- Heptane1 (time and 8% alcohol
perature) temperature) (time and temperature)
A. High temperature I, IV–B ................... 250 °F, 2 hr ................... .

heat-sterilized (e.g.,
over 212 °F).
III, IV–A, VII ........... do .................................. 150 °F, 2 hr.
264
TABLE 4—TEST PROCEDURES WITH TIME-TEMPERATURE CONDITIONS FOR DETERMINING AMOUNT OF

EXTRACTIVES FROM CLOSURE-SEALING GASKETS, USING SOLVENTS SIMULATING TYPES OF FOODS
AND BEVERAGES—Continued
Extractant
Types of food
Conditions of use (see Table 3) Water (time and tem- Heptane1 (time and 8% alcohol
perature) temperature) (time and temperature)
B. Boiling water-sterilized II ............................ 212 °F, 30 min .............. .

III, VII ..................... do .................................. 120 °F, 30 min.
C. Hot filled or pasteur- II, IV–B .................. Fill boiling, cool to 100 .
ized above 150 °F. °F.
III, IV–A ................. do .................................. 120 °F, 15 min.
V ............................ ....................................... do.
D. Hot filled or pasteur- II, IV–B, VI–B ........ 150 °F, 2 hr ................... .
ized below 150 °F.
III, IV–A ................. do .................................. 100 °F, 30 min.
V ............................ ....................................... do.
VI–A ...................... ....................................... ....................................... 150 °F, 2 hr.
E. Room temperature II, IV–B, VI–B ........ 120 °F, 24 hr ................. .
filled and stored (no
the container).
III, IV–A ................. do .................................. 70 °F, 30 min.
V ............................ ....................................... do.
VI–A ...................... ....................................... ....................................... 120 °F, 24 hr.
F. Refrigerated storage I, II, III, IV–A, IV–B, 70 °F, 48 hr ................... 70 °F, 30 min.
(no thermal treatment). VI–B,VII.
VI–A ...................... ....................................... ....................................... 70 °F, 48 hr.
G. Frozen storage (no I, II, III, IV–B, VII ... 70 °F, 24 hr ................... .
the container).
1Heptane extractant not applicable to closure-sealing gaskets overcoated with wax.
[42 FR 14572, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended at 47 FR 22090, May 21, 1982;
49 FR 5748, Feb. 15, 1984; 55 FR 34555, Aug. 23, 1990; 61 FR 14480, Apr. 2, 1996; 65 FR 26745, May
9, 2000; 65 FR 52908, Aug. 31, 2000; 70 FR 67651, Nov. 8, 2005; 76 FR 59249, Sept. 26, 2011; 78 FR
14665, Mar. 7, 2013; 82 FR 20832, May 4, 2017]
§ 177.1211 Cross-linked polyacrylate (b) Adjuvants. The copolymers identi-

copolymers. fied in paragraph (a) of this section
Cross-linked polyacrylate copoly- may contain optional adjuvant sub-
stances required in the production of
mers identified in paragraph (a) of this
such copolymers. The optional adju-
section may be safely used as articles
vant substances may include sub-
or components of articles intended for
stances permitted for such use by regu-
use in contact with food in accordance
lations in parts 170 through 179 of this
chapter, substances generally recog-
tions:
nized as safe in food, and substances
(a) Identity. For the purpose of this used in accordance with a prior sanc-
section, the cross-linked polyacrylate tion or approval.
copolymers consist of: (c) Extractives limitations. The copoly-
(1) The grafted copolymer of cross- mers identified in paragraph (a) of this
linked sodium polyacrylate identified section, in the finished form in which
as 2-propenoic acid, polymers with N,N- they will contact food, must yield low
di-2-propenyl-2-propen-1-amine and molecular weight (less than 1,000 Dal-
hydrolyzed polyvinyl acetate, sodium tons) extractives of no more than 0.15
salts, graft (CAS Reg. No. 166164–74–5); percent by weight of the total polymer
or when extracted with 0.2 percent by
(2) 2-propenoic acid, polymer with 2- weight of aqueous sodium chloride so-
ethyl-2-(((1-oxo-2-pro- lution at 20 °C for 24 hours. The low
penyl)oxy)methyl)-1,3-propanediyl di-2- molecular weight extractives shall be

propenoate and sodium 2-propenoate determined using size exclusion chro-
(CAS Reg. No. 76774–25–9). matography or an equivalent method.
265
§ 177.1240 21 CFR Ch. I (4–1–23 Edition)
When conducting the extraction test, 176, 177, 178 and § 179.45 of this chapter
the copolymer, with no other absorp- conforms with any specification in
tive media, shall be confined either in such regulation.
a finished absorbent pad or in any suit- (d) Substances employed in the pro-
able flexible porous article, (such as a duction of the copolymer include:
‘‘tea bag’’ or infuser), under an applied (1) Substances generally recognized
pressure of 0.15 pounds per square inch as safe in food.
(for example, a 4 × 6 inch square pad is (2) Substances subject to prior sanc-
subjected to a 1.6 kilograms applied tion or approval for use in the copoly-
mass). The solvent used shall be at mer and used in accordance with such
least 60 milliliters aqueous sodium sanction or approval.
chloride solution per gram of copoly- (3) Substances which by regulation in
mer. parts 174, 175, 176, 177, 178 and § 179.45 of
(d) Conditions of use. The copolymers this chapter may be safely used as
identified in paragraph (a)(1) of this components of resinous or polymeric
section are limited to use as a fluid ab- coatings and film used as food-contact
sorbent in food-contact materials used surfaces, subject to the provisions of
in the packaging of frozen or refrig- such regulation.
erated poultry. The copolymers identi- (e) The copolymer conforms with the
fied in paragraph (a)(2) of this section following specifications:
are limited to use as a fluid absorbent (1) The copolymer, when extracted
in food-contact materials used in the with distilled water at reflux tempera-
packaging of frozen or refrigerated ture for 2 hours, yields total extrac-
meat and poultry. tives not to exceed 0.05 percent.
(2) The copolymer, when extracted
with ethyl acetate at reflux tempera-
FR 16817, Mar. 30, 2000]
ture for 2 hours, yields total extrac-
§ 177.1240 1,4-Cyclohexylene tives not to exceed 0.7 percent.
dimethylene terephthalate and 1,4- (3) The copolymer, when extracted
cyclohexylene dimethylene with n-hexane at reflux temperature
isophthalate copolymer. for 2 hours, yields total extractives not
Copolymer of 1,4-cyclohexylene to exceed 0.05 percent.
dimethylene terephthalate and 1,4- [42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15,
cyclohexylene dimethylene isophtha- 1984, as amended at 55 FR 34555, Aug. 23, 1990]
late may be safely used as an article or
component of articles used in pro- § 177.1310 Ethylene-acrylic acid co-
ducing, manufacturing, packing, proc- polymers.
essing, preparing, treating, packaging, The ethylene-acrylic acid copolymers
transporting, or holding food, subject identified in paragraph (a) of this sec-
to the provisions of this section: tion may be safely used as components
(a) The copolymer is a basic poly- of articles intended for use in contact
ester produced by the catalytic con- with food subject to the provisions of
densation of dimethyl terephthalate this section.
and dimethyl isophthalate with 1,4- (a) The ethylene-acrylic acid copoly-
cyclohexanedimethanol, to which may mers consist of basic copolymers pro-
have been added certain optional sub- duced by the copolymerization of
stances required in its production or ethylene and acrylic acid such that the
added to impart desired physical and finished basic copolymers contain no
technical properties. more than:
(b) The quantity of any optional sub- (1) 10 weight-percent of total polymer
stance employed in the production of units derived from acrylic acid when
the copolymer does not exceed the used in accordance with paragraph (b)
amount reasonably required to accom- of this section; and
plish the intended physical or technical (2) 25 weight-percent of total polymer
effect or any limitation further pro- units derived from acrylic acid when
vided. used in accordance with paragraph (c)
(c) Any substance employed in the of this section.

production of the copolymer that is the (b) The finished food-contact articles
subject of a regulation in parts 174, 175, made with no more than 10 percent
266
total polymer units derived from acryl- this section may be safely used as com-
ic acid, when extracted with the sol- ponents of articles intended for use in
vent or solvents characterizing the contact with food subject to the provi-
type of food and under the conditions sions of this section.
of its intended use as determined from (a) Identity. For the purposes of this
tables 1 and 2 of § 176.170(c) of this chap- section, ethylene-carbon monoxide co-
ter, yield net acidified chloroform-solu- polymers (CAS Reg. No. 25052–62–4) con-
ble extractives not to exceed 0.5 milli- sist of the basic polymers produced by
gram per square inch of food-contact the copolymerization of ethylene and
surface when tested by the methods
carbon monoxide such that the copoly-
prescribed in § 177.1330(e)(1), (3)(i)
mers contain not more than 30 weight-
through (iv), (4), (5), and (6), except
that percent of polymer units derived from
(1) The total residue method using 3 carbon monoxide.
percent acetic acid, as prescribed in (b) Conditions of use. (1) The polymers
§ 177.1330(e)(6)(i)(a), does not apply, and may be safely used as components of
(2) The net acidified chloroform-solu- the food-contact or interior core layer
ble extractives from paper and paper- of multilaminate food-contact articles.
board complying with § 176.170 of this (2) The polymers may be safely used
chapter may be corrected for wax, pet- as food-contact materials at tempera-
rolatum, and mineral oil as provided in tures not to exceed 121 °C (250 °F).
§ 176.170(d)(5)(iii)(b) of this chapter. (c) Specifications. (1) Food-contact
If the finished food-contact article is layers formed from the basic copoly-
itself the subject of a regulation in mer identified in paragraph (a) of this
parts 174, 175, 176, 177, 178, and § 179.45 of section shall be limited to a thickness
this chapter, it shall also comply with of not more than 0.01 centimeter (0.004
any specifications and limitations pre- inch).
scribed for it by that regulation. (2) The copolymers identified in para-
(c) The finished food-contact layer graph (a) of this section shall have a
made with basic copolymers containing melt index not greater than 500 as de-
more than 10 weight-percent but no termined by ASTM method D1238–82,
more than 25 weight-percent of total condition E ‘‘Standard Test Method for
polymer units derived from acrylic
Flow Rates of Thermoplastics by Ex-
acid and with a maximum thickness of
trusion Plastometer,’’ which is incor-
0.0025 inch (2.5 mils) may be used in
porated by reference in accordance
contact with food types I, II, IVB, VIA,
VIB, VIIB, and VIII identified in table
1 of § 176.170(c) of the chapter under Copies may be obtained from the Amer-
conditions of use B through H as de- ican Society for Testing Materials, 100
scribed in table 2 of § 176.170(c) of this Barr Harbor Dr., West Conshohocken,
chapter, and in contact with food types Philadelphia, PA 19428-2959, or may be
III, IVA, V, VIIA, and IX identified in examined at the Center for Food Safety
table 1 of § 176.170(c) of this chapter and Applied Nutrition (HFS–200), Food
under conditions of use E through G as and Drug Administration, 5001 Campus
described in table 2 of § 176.170(c) of this Dr., College Park, MD 20740, or at the
chapter. National Archives and Records Admin-
(d) The provisions of this section are istration (NARA). For information on
not applicable to ethylene-acrylic acid the availability of this material at
copolymers used in food-packaging ad- NARA, call 202–741–6030, or go to: http://
hesives complying with § 175.105 of this www.archives.gov/federal_register/
chapter. code_of_federal_regulations/
ibr_locations.html.
FR 19060, May 27, 1986; 53 FR 44009, Nov. 1, (3) The basic copolymer identified in
1988] paragraph (a) of this section, when ex-
§ 177.1312 Ethylene-carbon monoxide characterizing the type of food and
copolymers.
under the conditions of time and tem-

The ethylene-carbon monoxide co- perature characterizing the conditions
polymers identified in paragraph (a) of of its intended use, as determined from
267
§ 177.1315 21 CFR Ch. I (4–1–23 Edition)
tables 1 and 2 of § 176.170(c) of this chap- contact with food subject to provisions
ter, yields net chloroform-soluble ex- of this section and of part 174 of this
tractives in each extracting solvent chapter.
not to exceed 0.5 milligram per square (a) Identity. For the purposes of this
inch of food-contact surface when test- section, ethylene-1,4-cyclohexylene
ed by methods described in § 176.170(d) dimethylene terephthalate copolymers
of this chapter. (1,4-benzene dicarboxylic acid, di-
(4) The provisions of this section are methyl ester, polymerized with 1,4-
not applicable to ethylene-carbon mon- cyclohexanedimethanol and 1,2-
oxide copolymers complying with ethanediol) (CAS Reg. No. 25640–14–6) or
§ 175.105 of this chapter. (1,4-benzenedicarboxylic acid, polym-
erized with 1,4-cyclohexanedimethanol
[57 FR 32422, July 22, 1992] and 1,2-ethanediol) (CAS Reg. No.
25038–91–9) are basic copolymers meet-
§ 177.1315 Ethylene-1, 4-cyclohexylene ing the specifications prescribed in
dimethylene terephthalate copoly- paragraph (b) of this section, to which
mers.
may have been added certain optional
Ethylene-1, 4-cyclohexylene substances required in their production
dimethylene terephthalate copolymer or added to impart desired physical or
may be safely used as articles or com- technical properties.
ponents of articles intended for use in (b) Specifications:
Maximum extractable fractions
of the copolymer in the fin-
Ethylene-1,4- ished form at specified tem-
cyclohexylene peratures and times (ex- Test for
Inherent viscosity Conditions of use
dimethylene pressed in micrograms of the orientability
terephthalate copolymers terephthaloyl moletles/square
centimeter of food-contact sur-
face)
1. Non-oriented ethyl- Inherent viscosity (1) 0.23 microgram per square No test required ... In contact with foods, in-
ene-1,4-cyclohexylene of a 0.50 per- centimeter (1.5 micrograms cluding foods con-
dimethylene cent solution of per square inch) of food-containing not more than
terephthalate copoly- the copolymer in tact surface when extracted 25 percent (by vol-
mer is the reaction phenol- with water added at 82.2 °C ume) aqueous alcohol,
product of dimethyl tetrachloroetha- (180 °F) and allowed to cool excluding carbonated
terephthalate or ter- ne (60:40 ratio to 48.9 °C (120 °F) in con- beverages and beer.
ephthalic acid with a wt/wt) solvent is tact with the food-contact ar- Conditions of hot fill
mixture containing 99 not less than ticle. not to exceed 82.2 °C
to 66 mole percent of 0.669 as deter- (180 °F), storage at
ethylene glycol and 1 mined by using temperatures not in
to 34 mole percent of a Wagner vis- excess of 48.9 °C
1,4-cyclo- cometer (or (120 °F). No thermal
hexanedimethanol (70 equivalent) and treatment in the con-
percent trans isomer, calculated from tainer.
30 percent cls isomer). the following
equation: Inher-
ent viscosity =
(Natural loga-
rithm of (Nr)/(c)
where: Nr =
Ratio of flow
time of the poly-
mer solution to
that of the sol-
vent, and c =
concentration of
the test solution
expressed in
grams per 100
milliliters.
268

face)
......do ................... (2) 0.23 microgram per square ......do ................... Do.
centimeter (1.5 micrograms
per square inch) of food-con-
tact surface when extracted
with 3 percent (by volume)
aqueous acetic acid added
at 82.2 °C (180 °F) and al-
lowed to cool to 48.9 °C
(120 °F) in contact with the
food-contact article.
centimeter (0.5 microgram
for 2 hours with n-heptane at
48.9 °C (120 °F). The
heptane extractable results
are to be divided by a factor
of 5.
for 24 hours with 25 percent
(by volume) aqueous ethanol
at 48.9 °C (120 °F).
2. Oriented ethylene-1,4- ......do ................... (1) 0.23 microgram per square When extracted In contact with non-
cyclohexylene centimeter (1.5 micrograms with heptane at alcoholic foods includ-
dimethylene per square inch) of food-con- 65.6 °C (150 °F) ing carbonated bev-
terephthalate copoly- tact surface of the oriented for 2 hours: erages. Conditions of
mer is the reaction copolymer when extracted terephthaloyl hot fill not exceeding
product of dimethyl with water added at 87.8 °C moieties do not 87.8 °C (190 °F), stor-
terephthalate or ter- (190 °F) and allowed to cool exceed 0.09 age at temperatures
ephthalic acid with a to 48.9 °C (120 °F) in con- microgram per not in excess of 48.9
mixture containing 99 tact with the food-contact ar- square centi- °C (120 °F). No ther-
to 85 mole percent ticle. meter (0.60 mal treatment in the
ethylene glycol and 1 microgram per container.
to 15 mole percent of square inch) of
1,4-cyclohexane-di- food-contact
methanol (70 percent surface.
trans isomer, 30 per-
cent cls isomer).
centimeter (1.5 micrograms
tact surface of oriented co-
polymer when extracted with
3 percent (by volume) aque-
ous acetic acid added at
87.8 °C (190 °F) and al-
lowed to cool to 48.9 °C
(120 °F) in contact with the
tact surface of oriented co-
polymer when extracted for
2 hours with n-heptane at
48.9 °C (120 °F). The
heptane extractable results
are to be divided by a factor
of 5.
269
§ 177.1320 21 CFR Ch. I (4–1–23 Edition)

face)
......do ................... (4) 0.23 microgram per square ......do ................... In contact with foods and
centimeter (1.5 micrograms beverages containing
per square inch) of food-con- up to 20 percent (by
tact surface of oriented co- volume) alcohol. Con-
polymer when extracted with ditions of thermal
20 percent (by volume) treatment in the con-
aqueous ethanol heated to tainer not exceeding
65.6 °C (150 °F) for 20 min- 65.6 °C (150 °F) for
utes and allowed to cool to 20 minutes. Storage at
48.9 °C (120 °F) in contact temperatures not in
with the food-contact article. excess of 48.9 °C
(120 °F).
......do ................... (5) 0.23 microgram per square ......do ................... In contact with foods and
centimeter (1.5 micrograms beverages containing
per square inch) of food-con- up to 50 percent (by
tact surface of oriented co- volume) alcohol. Con-
polymer when extracted with ditions of fill and stor-
50 percent (by volume) age not exceeding
aqueous ethanol at 48.9 °C 48.9 °C (120 °F). No
(120 °F) for 24 hours. thermal treatment in
the container.
3. Ethylene-1,4- No test required ... For each corresponding condi- No test required ... For each corresponding
cyclohexylene tion of use, must meet speci- specification, may be
dimethylene fications described in used as a base sheet
terephthalate copoly- § 177.1630(f), (g), (h), or (j). and base polymer in
mer is the reaction accordance with con-
product of dimethyl ditions of use de-
terephthalate or ter- scribed in
ephthalic acid with a § 177.1630(f), (g), (h),
mixture containing 99 or (j).
to 95 mole percent of
ethylene glycol and 1
to 5 mole percent of
1,4-
cyclohexanedimethan-
ol (70 percent trans
isomer, 30 percent cis
isomer).
(c) Analytical method for determination standards prepared in 95:5 percent (v/v)
of extractability. The total extracted heptane: tetrahydrofuran.
terephthaloyl moieties can be deter-
[45 FR 39252, June 10, 1980, as amended at 47
mined in the extracts, without evapo- FR 24288, June 4, 1982; 49 FR 25629, June 22,
ration of the solvent, by measuring the 1984; 51 FR 22929, June 24, 1986; 60 FR 57926,
ultraviolet (UV) absorbance at 240 Nov. 24, 1995]
nanometers. The spectrophotometer
(Varian 635–D, or equivalent) is zeroed § 177.1320 Ethylene-ethyl acrylate co-
with a sample of the solvent taken polymers.
from the same lot used in the extrac- Ethylene-ethyl acrylate copolymers
tion tests. The concentration of the may be safely used to produce pack-
total terephthaloyl moieties in water, 3 aging materials, containers, and equip-
percent acetic acid, and in 8 percent ment intended for use in producing,
aqueous alcohol is calculated as bis(2- manufacturing, packing, processing,
hydroxyethyl terephthalate) by ref- preparing, treating, packaging, trans-
erence to standards prepared in the ap- porting, or holding food, in accordance
propriate solvent. Concentration of the with the following prescribed condi-
tions:
terephthaloyl moieties in heptane is

calculated as cyclic trimer (a) Ethylene-ethyl acrylate copoly-
(C6H4CO2C2H4CO2)3, by reference to mers consist of basic resins produced
270
by the catalytic copolymerization of Plastics by the Density-Gradient Tech-

ethylene and ethyl acrylate, to which nique,’’ which is incorporated by ref-
may have been added certain optional erence. Copies may be obtained from
substances to impart desired techno- the American Society for Testing Ma-
logical properties to the resin. Subject terials, 100 Barr Harbor Dr., West
to any limitations prescribed in this Conshohocken, Philadelphia, PA 19428-
section, the optional substances may 2959, or may be examined at the Na-
include: tional Archives and Records Adminis-
(1) Substances generally recognized tration (NARA). For information on
as safe in food and food packaging. the availability of this material at
(2) Substances the use of which is NARA, call 202–741–6030, or go to: http://
permitted under applicable regulations www.archives.gov/federal_register/
in parts 170 through 189 of this chapter, code_of_federal_regulations/
prior sanction, or approvals. ibr_locations.html.
(b) The ethyl acrylate content of the (2) Limitations. Ethylene-ethyl acry-
copolymer does not exceed 8 percent by late copolymers or the blend may be
weight unless it is blended with poly- used in contact with food except as a
ethylene or with one or more olefin co- component of articles used for pack-
polymers complying with § 177.1520 or aging or holding food during cooking
with a mixture of polyethylene and one provided they meet the following
or more olefin copolymers, in such pro- extractability limits:
portions that the ethyl acrylate con- (i) Maximum soluble fraction of 11.3
tent of the blend does not exceed 8 per- percent in xylene after refluxing and
cent by weight, or unless it is used in subsequent cooling to 25 °C.
a coating complying with § 175.300 or (ii) Maximum extractable fraction of
§ 176.170 of this chapter, in such propor- 5.5 percent when extracted with n-
tions that the ethyl acrylate content hexane at 50 °C.
does not exceed 8 percent by weight of (d) The provisions of paragraphs (b)
the finished coating. and (c)(2) of this section are not appli-
(c) Ethylene-ethyl acrylate copoly- cable to ethylene-ethyl acrylate co-
mers or the blend shall conform to the polymers used in the formulation of ad-
specifications prescribed in paragraph hesives complying with § 175.105 of this
(c)(1) of this section and shall meet the chapter.
ethyl acrylate content limits pre- [42 FR 14572, Mar. 15, 1977, as amended at 49
scribed in paragraph (b) of this section, FR 10108, Mar. 19, 1984]
and the extractability limits pre-
scribed in paragraph (c)(2) of this sec- § 177.1330 Ionomeric resins.
tion, when tested by the methods pre- Ionomeric resins manufactured from
scribed for polyethylene in § 177.1520. either ethylene-methacrylic acid co-
(1) Specifications—(i) Infrared identi- polymers (and/or their ammonium, cal-
fication. Ethylene-ethyl acrylate co- cium, magnesium, potassium, sodium,
polymers can be identified by their and/or zinc partial salts), ethylene-
characteristic infrared spectra. methacrylic acid-vinyl acetate copoly-
(ii) Quantitative determination of ethyl mers (and/or their ammonium, cal-
acrylate content. The ethyl acrylate can cium, magnesium, potassium, sodium,
be determined by the infrared spectra. and/or zinc partial salts,), or meth-
Prepare a scan from 10.5 microns to 12.5 acrylic acid polymers with ethylene
microns. Obtain a baseline absorbance and isobutyl acrylate (and/or their po-
at 11.6 microns and divide by the tassium, sodium and/or zinc partial
plaque thickness to obtain absorbance salts) may be safely used as articles or
per mil. From a previously prepared components of articles intended for use
calibration curve, obtain the amount of in contact with food, in accordance
ethyl acrylate present. with the following prescribed condi-
(iii) Specific gravity. Ethylene-ethyl tions:
acrylate copolymers have a specific (a) For the purpose of this section,
gravity of not less than 0.920 nor more the ethylene-methacrylic acid copoly-
than 0.935, as determined by ASTM mers consist of basic copolymers pro-

method D1505–68 (Reapproved 1979), duced by the copolymerization of
‘‘Standard Test Method for Density of ethylene and methacrylic acid such
271
§ 177.1330 21 CFR Ch. I (4–1–23 Edition)
that the copolymers contain no more determined from table I of paragraph

than 20 weight percent of polymer (f) of this section, shall yield net acidi-
units derived from methacrylic acid, fied chloroform-soluble extractives as
and the ethylene-methacrylic acid- follows:
vinyl acetate copolymers consist of (1) For fatty food use. (i) For films of
basic copolymers produced by the co- 2 mil (0.002 inches) thickness or less,
polymerization of ethylene, meth- extractives shall not exceed 0.70 milli-
acrylic acid, and vinyl acetate such gram/square inch 1 (0.109 milligram/
that the copolymers contain no more square centimeter) of food-contact sur-
than 15 weight percent of polymer face (n-heptane extractions) when ex-
units derived from methacrylic acid. tracted by the abbreviated method
(b) For the purpose of this section, cited in paragraph (e)(2)(i) of this sec-
the methacrylic acid copolymers with tion.
ethylene and isobutyl acrylate consist (ii) For films of greater than 2 mils
of basic copolymers produced by the (0.002 inch) thickness, extractives shall
copolymerization of methacrylic acid, not exceed 0.40 milligram/square inch 1
ethylene, and isobutyl acrylate such (0.062 milligram/square centimeter) of
that the copolymers contain no less food-contact surface (n-heptane extrac-
than 70 weight percent of polymer tions) when extracted by the abbre-
units derived from ethylene, no more viated method cited in paragraph
than 15 weight percent of polymer (e)(2)(i) of this section, or
units derived from methacrylic acid, (iii) Alternatively, for films of great-
and no more than 20 weight percent of er than 2 mils thickness, extractives
polymer units derived from isobutyl shall not exceed 0.70 milligram/square
acrylate. From 20 percent to 70 percent inch 1 (0.109 milligram/square centi-
of the carboxylic acid groups may op- meter) of food-contact surface (n-
tionally be neutralized to form sodium heptane extractions) when extracted by
or zinc salts. the equilibrium method cited in para-
(c) The finished food-contact article graph (e)(2)(ii) of this section.
described in paragraph (a) of this sec- (2) For aqueous foods. (i) The net
tion, when extracted with the solvent acidified chloroform-soluble extrac-
or solvents characterizing the type of tives shall not exceed 0.02 milligram/
food and under the conditions of time square inch 2(0.003 milligram/square
and temperature characterizing the centimeter) of food-contact surface
conditions of its intended use as deter- (water, acetic acid, or ethanol/water
mined from tables 1 and 2 of § 176.170(c) extractions) when extracted by the ab-
of this chapter, yields net acidified breviated method cited in paragraph
chloroform-soluble extractives in each (e)(2)(i) of this section.
extracting solvent not to exceed 0.5 (ii) Alternatively, the net acidified
milligram per square inch of food-con- chloroform-soluble extractives shall
tact surface when tested by the meth- not exceed 0.05 milligram/square inch 3
ods described in paragraph (e)(1) of this (0.078 mg/square centimeter) of food-
section, and if the finished food-con- contact surface (water, acetic acid, or
tact article is itself the subject of a ethanol/water extractions) when ex-
regulation in parts 174, 175, 176, 177, 178 tracted by the equilibrium method
and § 179.45 of this chapter, it shall also cited in paragraph (e)(2)(ii) of this sec-
comply with any specifications and tion. If when exposed to n-heptane, a
limitations prescribed for it by that particular film splits along die lines,
regulation. thus permitting exposure of both sides
NOTE: In testing the finished food-contact of the film to the extracting solvent,
article, use a separate test sample for each
required extracting solvent.
1 Average of four separate values, no single
(d) The finished food-contact article
described in paragraph (b) of this sec- value of which differs from the average of
those values by more then ±10 percent.
tion, when extracted according to the 2 Average of four separate values, no single
methods listed in paragraph (e)(2) of value of which differs from the average of
this section and referenced in this those values by more than ±50 percent.
paragraph (d), using the solvent or sol- 3 See footnote 2 to paragraph (d)(2)(i) of
vents characterizing the type of food as this section.
272
the results for that film sample are in- lating solvent is to contact the food-
valid and the test must be repeated for contact film at a temperature of 120 °F
that sample until no splitting by the until equilibrium is demonstrated.
solvent occurs. If the finished food-con-
tact article is itself the subject of a Minimum
extraction
regulation in parts 174, 175, 176, 177, 178 Solvent times
and § 179.45 of this chapter, it shall also (hours)
comply with any specifications and n-Heptane ............................................................ 8, 10, 12
limitations prescribed for it by that Water, 3% acetic acid, or 8%/50% ethanol ........ 72, 96,
regulation. 120
NOTE: In testing the finished food-contact
article, use a separate test sample for each The results from a series of extraction
required extracting solvent. times demonstrate equilibrium when
(e) Analytical methods—(1) Selection of the net chloroform-soluble extractives
extractability conditions for ionomeric res- are unchanging within experimental
ins. First ascertain the type of food error appropriate to the method as de-
(table 1 of § 176.170(c) of this chapter) scribed in paragraphs (d)(1)(i) and (2)(i)
that is being packed or used in contact of this section. Should equilibrium not
with the finished food-contact article be demonstrated over the above time
described in paragraph (a) of this sec-
series, extraction times must be ex-
tion, and also ascertain the normal
tended until three successive unchang-
conditions of thermal treatment used
ing values for extractives are obtained.
in packaging or contacting the type of
In the case where intended uses involve
food involved. Using table 2 of § 176.170
temporary food contact above 120 °F,
(c) of this chapter, select the food-sim-
the food-simulating solvent is to be
ulating solvent or solvents and the
contacted with the food-contact article
time-temperature test conditions that
under conditions of time and tempera-
correspond to the intended use of the
ture that duplicate the actual condi-
finished food-contact article. Having
tions in the intended use. Subsequently
selected the appropriate food-simu-
lating solvent or solvents and time- the extraction is to be continued for
temperature exaggeration over normal the time period and under the condi-
use, follow the applicable extraction tions specified in the above table.
procedure. (3) Reagents—(i) Water. All water used
(2) Selection of extractability conditions in extraction procedures should be
for ionomeric resins. Using table I of freshly demineralized (deionized) dis-
paragraph (f) of this section ascertain tilled water.
the type of food that is being packed or (ii) n-Heptane. Reagent grade, freshly
used in contact with the finished food- redistilled before use, using only mate-
contact article described in paragraph rial boiling at 208 °F (97.8 °C).
(b) of this section, and also ascertain (iii) Alcohol. 8 or 50 percent (by vol-
the food-simulating solvent or solvents ume), prepared from undenatured 95
that correspond to the intended use of percent ethyl alcohol diluted with
the finished food-contact article. demineralized (deionized), distilled
(i) Abbreviated test. For intended use water.
involving food contact at or below 120 (iv) Chloroform. Reagent grade, fresh-
°F (49 °C), the appropriate food-simu- ly redistilled before use, or a grade
lating solvent is to contact the food- having an established, consistently low
contact film for the time and tempera- blank.
tures as follows: (v) Acetic acid. 3 percent (by weight),
Solvent Time Temperature
prepared from glacial acetic acid di-
luted with demineralized (deionized),
n-Heptane ................................. 12 120 °F (49 °C). distilled water.
Water, 3% acetic acid, or 8%/ 1 48 120 °F (49 °C).
50% ethanol.
(4) Selection of test method. The fin-
1 Hours
ished food-contact articles shall be
tested either by the extraction cell de-
(ii) Equilibrium test. For intended use scribed in the Journal of the Association
involving food contact at or below 120 of Official Agricultural Chemists, Vol. 47,
°F (49 °C), the appropriate food-simu- No. 1, p. 177–179 (February 1964), also
273
§ 177.1330 21 CFR Ch. I (4–1–23 Edition)
described in ASTM method F34–76 (Re- where:

approved 1980), ‘‘Standard Test Method e = Milligrams extractives per sample tested.
for Liquid Extraction of Flexible Bar- s = Surface area tested, in square inches.
rier Materials,’’ which are incorporated F = Five, the ratio of the amount of extrac-
by reference, or by adapting the in-con- tives removed by heptane under exagger-
tainer methods described in § 175.300(e) ated time-temperature test conditions
of this chapter. Copies of the material compared to the amount extracted by a
incorporated by reference are available fat or oil under exaggerated conditions of
thermal sterilization and use.
from the Center for Food Safety and
e′ = Acidified chloroform-soluble extractives
Applied Nutrition (HFS–200), Food and residue. e′ is substituted for e in the
Drug Administration, 5001 Campus Dr., above equations when necessary (See
College Park, MD 20740, and the Amer- paragraph (e)(6)(ii) of this section for
ican Society for Testing Materials, 100 method to obtain e′).
Philadelphia, PA 19428-2959, respec- If when calculated by the equations in
tively, or may be examined at the Na- paragraphs (e)(6)(i)(a) and (b) of this
tional Archives and Records Adminis- section, the extractives in milligrams
tration (NARA). For information on per square inch exceed the limitations
the availability of this material at prescribed in paragraphs (c) or (d) of
NARA, call 202–741–6030, or go to: http:// this section, proceed to paragraph
www.archives.gov/federal_register/ (e)(6)(ii) of this section (method for de-
code_of_federal_regulations/ termining the amount of acidified chlo-
ibr_locations.html. roform-soluble extractives residue).
(5) Selection of samples. Quadruplicate (ii) Acidified chloroform-soluble extrac-
samples should be tested, using for tives residue. Add 3 milliliters of 37 per-
each replicate sample the number of cent ACS reagent grade hydrochloric
finished articles with a food-contact acid and 3 milliliters of distilled water
surface nearest to 100 square inches. to the evaporating dish containing the
(6) Determination of amount of extrac- dried and weighed residue, e, obtained
tives—(i) Total residues. At the end of in paragraph (e)(6)(i) of this section.
the exposure period, remove the test Mix well so every portion of the residue
container or test cell from the oven, if is wetted with the hydrochloric acid
any, and combine the solvent for each solution. Then add 50 milliliters of
replicate in a clean Pyrex (or equiva- chloroform. Warm carefully, and filter
lent) flask or beaker, being sure to through Whatman No. 41 filter paper
rinse the test container or cell with a (or equivalent) in a Pyrex (or equiva-
small quantity of clean solvent. Evapo- lent) funnel, collecting the filtrate in a
rate the food-simulating solvents to clean separatory funnel. Shake for 1
about 100 milliliters in the flask, and minute, then draw off the chloroform
transfer to a clean, tared evaporating layer into a clean tared evaporating
dish (platinum or Pyrex), washing the dish (platinum or Pyrex). Repeat the
flask three times with small portions chloroform extraction, washing the
of solvent used in the extraction proce- dish, the filter paper, and the sepa-
dure, and evaporate to a few milliliters ratory funnel with this second portion
on a nonsparking, low-temperature of chloroform. Add this filtrate to the
hotplate. The last few milliliters original filtrate and evaporate the
should be evaporated in an oven main- total down to a few milliliters on a
tained at a temperature of 221 °F (105 low-temperature hotplate. The last few
°C). Cool the evaporating dish in a des- milliliters should be evaporated in an
iccator for 30 minutes and weigh the oven maintained at 221 °F. Cool the
residues to the nearest 0.1 milligram, e. evaporating dish in a desiccator for 30
Calculate the extractives in milligrams minutes and weigh to the nearest 0.1
per square inch of the container or ma- milligram to get the acidified chloro-
terial surface. form-soluble extractives residue, e′.
(a) Water, 3 percent acetic acid, and 8 This e′ is substituted for e in the equa-
percent and 50 percent alcohol. Milli- tions in paragraphs (e)(6)(i)(a) and (b)
grams extractives per square inch=e/s. of this section.

(b) Heptane. Milligrams extractives (f) The types of food and appropriate
per square inch=(e)/(s)(F) solvents are as follows:
274
TABLE 1 temperature characterizing the condi-

tions of its intended use as determined
Types of food Appropriate solvent
from tables 1 and 2 of § 176.170(c) of this
1. Nonacid (pH above 5.0), aque- Water, n-heptane. chapter, yields net chloroform-soluble
ous products; may contain salt extractives (corrected for zinc extrac-
or sugar or both, and including
oil-in-water emulsions of low- or
tives as zinc oleate) in each extracting
high-fat content. solvent not to exceed 0.5 milligram per
2. Acidic (pH 5.0 or below), aque- n-heptane, water, 3% square inch of food-contact surface
ous products; may contain salt acetic acid. when tested by the methods described
or sugar or both, and including
oil-in-water emulsions of low- or
in § 176.170(d) of this chapter. If the fin-
high-fat content. ished food-contact article is itself the
3. Aqueous, acid or nonacid prod- Water, n-heptane, 3% subject of a regulation in parts 174, 175,
ucts containing free oil or fat; acetic acid. 176, 177, 178 and § 179.45 of this chapter,
may contain salt, and including
water-in-oil emulsions of low- or it shall also comply with any specifica-
high-fat content. tions and limitations prescribed for it
4. Dairy products and modifica- by that regulation.
tions:
NOTE: In testing the finished food-contact
Water, n-heptane.
i. Water-in-oil emulsions, high article, use a separate test sample for each
or low fat. required extracting solvent.
ii. Oil-in-water emulsions, high (c) The provisions of this section are
or low fat. not applicable to ethylene-methyl ac-
5. Low moisture fats and oils ........ n-heptane.
6. Beverages: rylate copolymer resins used in food-
i. Containing up to 8% alcohol 8% ethanol/water. packaging adhesives complying with
ii. Nonalcoholic ........................ 3% acetic acid. § 175.105 of this chapter.
iii. Containing more than 8% 50% ethanol/water.
alcohol.
7. Bakery products ........................ Water, n-heptane.
§ 177.1345 Ethylene/1,3-phenylene oxy-
8. Dry solids (without free fat or No extraction test re- ethylene isophthalate/
oil). quired. terephthalate copolymer.
9. Dry solids (with free fat or oil) .. n-heptane.
Ethylene/1,3-phenylene oxyethylene
isophthalate/terephthalate copolymer
(g) The provisions of paragraphs (c) (CAS Reg. No. 87365–98–8) identified in
and (d) of this section are not applica- paragraph (a) of this section may be
ble to the ionomeric resins that are safely used, subject to the provisions of
used in food-packaging adhesives com- this section, as the non-food-contact
plying with § 175.105 of this chapter. layer of laminate structures subject to
[45 FR 22916, Apr. 4, 1980, as amended at 49 the provisions of § 177.1395, and in
FR 10108, Mar. 19, 1984; 49 FR 37747, Sept. 26, blends with polyethylene terephthalate
1984; 53 FR 44009, Nov. 1, 1988; 54 FR 24898, polymers complying with § 177.1630.
June 12, 1989] (a) Identity. For the purpose of this
section, ethylene/1,3-phenylene oxy-
§ 177.1340 Ethylene-methyl acrylate co- ethylene isophthalate/terephthalate
polymer resins.
copolymer consists of the basic copoly-
Ethylene-methyl acrylate copolymer mer produced by the catalytic
resins may be safely used as articles or polycondensation of isophthalic acid
components of articles intended for use and terephthalic acid with ethylene
in contact with food, in accordance glycol and 1,3-bis(2-
with the following prescribed condi- hydroxyethoxy)benzene such that the
tions: finished resin contains between 42 and
(a) For the purpose of this section, 48 mole-percent of isophthalic
the ethylene-methyl acrylate copoly- moieties, between 2 and 8 mole-percent
mer resins consist of basic copolymers of terephthalic moieties, and not more
produced by the copolymerization of than 10 mole-percent of 1,3-bis(2-
ethylene and methyl acrylate such hydroxyethoxy)benzene moieties.
that the copolymers contain no more (b) Specifications—(1) Density. Ethyl-
than 25 weight percent of polymer ene/1,3-phenylene oxyethylene
units derived from methyl acrylate. isophthalate/terephthalate copolymer
(b) The finished food-contact article, identified in paragraph (a) of this sec-
when extracted with the solvent or sol- tion has a density of 1.33±0.02 grams per
vents characterizing the type of food cubic centimeter measured by ASTM
and under the conditions of time and Method D 1505–85 (Reapproved 1990),
275
§ 177.1350 21 CFR Ch. I (4–1–23 Edition)
‘‘Standard Test Method for Density of of use C at temperatures not to exceed

Plastics by the Density-Gradient Tech- 160 °F (71 °C).
nique,’’ which is incorporated by ref- [57 FR 43399, Sept. 21, 1992, as amended at 59
erence in accordance with 5 U.S.C. FR 62318, Dec. 5, 1994; 61 FR 14481, Apr. 2,
552(a) and 1 CFR part 51. Copies may be 1996; 62 FR 34628, June 27, 1997; 81 FR 5593,
obtained from the American Society Feb. 3, 2016]
for Testing and Materials, 100 Barr
Harbor Dr., West Conshohocken, Phila- § 177.1350 Ethylene-vinyl acetate co-
delphia, PA 19428-2959, or may be exam- polymers.
ined at the Food and Drug Administra- Ethylene-vinyl acetate copolymers
tion’s Main Library, 10903 New Hamp- may be safely used as articles or com-
shire Ave., Bldg. 2, Third Floor, Silver ponents of articles intended for use in
Spring, MD 20993, 301–796–2039, and at producing, manufacturing, packing,
the National Archives and Records Ad- processing, preparing, treating, pack-
ministration (NARA). For information aging, transporting, or holding food in
on the availability of this material at accordance with the following pre-
NARA, call 202–741–6030, or go to: http:// scribed conditions:
www.archives.gov/federal_register/ (a)(1) Ethylene-vinyl acetate copoly-
code_of_federal_regulations/ mers consist of basic resins produced
ibr_locations.html. by the catalytic copolymerization of
ethylene and vinyl acetate to which
(2) Softening point. Ethylene/1,3–phen-
may have been added certain optional
ylene oxyethylene isophthalate/
substances to impart desired techno-
terephthalate copolymer identified in logical or physical properties to the
paragraph (a) of this section has a soft- resin. Subject to any limitations pre-
ening point of 63±5 °C as measured by scribed in this section, the optional
ASTM Method D 1525–87, ‘‘Standard substances may include:
Test Method for VICAT Softening Tem- (i) Substances generally recognized
perature of Plastics,’’ which is incor- as safe in food and food packaging.
porated by reference in accordance (ii) Substances the use of which is
with 5 U.S.C. 552(a) and 1 CFR part 51. permitted under applicable regulations
The availability of this material is pro- in parts 170 through 189 of this chapter,
vided in paragraph (b)(1) of this sec- prior sanction, or approvals.
tion. (iii) Substances identified in
(c) Optional adjuvant substances. § 175.300(b)(3)(xxv), (xxvii), (xxx), and
Ethylene/1,3–phenylene oxyethylene (xxxiii) of this chapter, and colorants
isophthalate/terephthalate copolymer, used in accordance with § 178.3297 of
identified in paragraph (a) of this sec- this chapter.
tion, may contain optional adjuvant (iv) Erucamide as identified in
substances required in their produc- § 178.3860 of this chapter.
tion. The optional adjuvants may in- (v) Xanthan gum as identified in
clude substances used in accordance § 172.695 for use as a thickening agent
with § 174.5 of this chapter. at a level not to exceed 1 percent by
(d) Limitations. Copolymer blends de- weight of coating solids in aqueous dis-
scribed above shall not exceed 30 per- persions of ethylene-vinyl acetate co-
cent by weight of ethylene/1,3-phen- polymers, where such copolymers are
ylene oxyethylene isophthalate/ used only as coatings or a component
terephthalate copolymer. The finished of coatings.
blend may be used in contact with food (vi) The copolymer of vinylidene flu-
only under conditions of use C through oride and hexafluoropropene (CAS Reg.
G, as described in table 2 of § 176.170(c) No. 9011–17–0), containing 65 to 71 per-
of this chapter, except that with food cent fluorine and having a Mooney Vis-
cosity of at least 28, for use as a proc-
identified as Type III, IV-A, V, VII-A,
essing aid at a level not to exceed 0.2
and IX in § 176.170(c), table 1, the co-
percent by weight of ethylene-vinyl ac-
polymer may be used under condition
etate copolymers.
(2) Maleic anhydride-grafted ethyl-
ene-vinyl acetate copolymers (CAS
276
Reg. No. 28064–24–6) consist of basic res- National Archives and Records Admin-
ins produced by the catalytic copolym- istration (NARA). For information on
erization of ethylene and vinyl acetate, the availability of this material at
followed by reaction with maleic anhy- NARA, call 202–741–6030, or go to: http://
dride. Such polymers shall contain not www.archives.gov/federal_register/
more than 11 percent of polymer units code_of_federal_regulations/
derived from vinyl acetate by weight of ibr_locations.html. Compliance of the
total polymer prior to reaction with melt flow index specification shall be
maleic anhydride, and not more than 2 determined using conditions and proce-
percent of grafted maleic anhydride by dures corresponding to those described
weight of the finished polymer. Op- in the method as Condition E, Proce-
tional adjuvant substances that may be dure A). The copolymers shall be used
added to the copolymers include sub- in blends with other polymers at levels
stances generally recognized as safe in not to exceed 17 percent by weight of
food and food packaging, substances total polymer, subject to the limita-
the use of which is permitted under ap- tion that when contacting food of types
plicable regulations in parts 170 III, IV-A, V, VI-C, VII-A, and IX, iden-
through 189 of this chapter, and sub- tified in § 176.170(c) of this chapter,
stances identified in § 175.300(b)(3)(xxv), Table 1, the polymers shall be used
(xxvii), (xxxiii), and (xxx) of this chap- only under conditions of use C, D, E, F,
ter and colorants for polymers used in and G, described in § 176.170(c) of this
accordance with the provisions of chapter, Table 2.
§ 178.3297 of this chapter. (c) The provisions of paragraph (b) of
(b)(1) Ethylene-vinyl acetate copoly- this section are not applicable to ethyl-
mers, with or without the optional sub- ene-vinyl acetate copolymers used in
stances described in paragraph (a) of food-packaging adhesives complying
this section, when extracted with the with § 175.105 of this chapter.
solvent or solvents characterizing the
(d) Ethylene-vinyl acetate copoly-
type of food, and under conditions of
mers may be irradiated under the fol-
time and temperature characterizing
lowing conditions to produce molecular
the conditions of their intended use as
crosslinking of the polymers to impart
determined from tables 1 and 2 of
desired properties such as increased
§ 176.170(c) of this chapter, shall yield
strength and increased ability to
net chloroform-soluble extractives cor-
shrink when exposed to heat:
rected for zinc as zinc oleate not to ex-
ceed 0.5 milligram per square inch of an (1) Electron beam source of ionizing
appropriate sample. radiation at a maximum energy of 3
(2) Maleic anhydride grafted ethyl- million electron volts: Maximum ab-
ene-vinyl acetate copolymers shall sorbed dose not to exceed 150 kiloGray
have a melt flow index not to exceed 2.1 (15 megarads).
grams per 10 minutes as determined by (2) The finished food-contact film
ASTM method D 1238–82, ‘‘Standard shall meet the extractives limitations
Test Method for Flow Rates of Thermo- prescribed in paragraph (e)(2) of this
plastics by Extrusion Plastometer,’’ section.
which is incorporated by reference in (3) The ethylene-vinyl acetate co-
accordance with 5 U.S.C. 552(a). Copies polymer films may be further irradi-
may be obtained from the American ated in accordance with the provisions
Society for Testing Materials, 100 Barr of paragraph (e)(1) of this section: Pro-
Harbor Dr., West Conshohocken, Phila- vided, That the total accumulated radi-
delphia, PA 19428-2959, or at the Office ation dose from both electron beam
of Food Additive Safety (HFS–200), and gamma ray radiation does not ex-
Center for Food Safety and Applied Nu- ceed 150 kiloGray (15 megarads).
trition, Food and Drug Administration, (e) Ethylene-vinyl acetate copolymer
5001 Campus Dr., College Park, MD films intended for contact with food
20740, 240–402–1200, or may be examined may be irradiated to control the
at the Food and Drug Administration’s growth of microorganisms under the
Main Library, 10903 New Hampshire following conditions:

Ave., Bldg. 2, Third Floor, Silver (1) Gamma photons emitted from a
Spring, MD 20993, 301–796–2039, or at the cobalt–60 sealed source in the dose
277
§ 177.1360 21 CFR Ch. I (4–1–23 Edition)
range of 5–50 kiloGray (0.5–5.0 F34–76 (Reapproved 1980), ‘‘Standard

megarads). Test Method for Liquid Extraction of
(2) The irradiated ethylene-vinyl ace- Flexible Barrier Materials,’’ which is
tate copolymer films, when extracted incorporated by reference. Copies may
with reagent grade n-heptane (freshly be obtained from the American Society
redistilled before use) according to for Testing Materials, 100 Barr Harbor
methods described under § 176.170(d)(3) Dr., West Conshohocken, Philadelphia,
of this chapter, at 75 °F for 30 minutes PA 19428-2959, or may be examined at
shall yield total extractives not to ex- the National Archives and Records Ad-
ceed 4.5 percent by weight of the film. ministration (NARA). For information
FR 29287, July 7, 1978; 54 FR 35874, Aug. 30, NARA, call 202–741–6030, or go to: http://
1989; 55 FR 18595, May 3, 1990; 56 FR 42932, www.archives.gov/federal_register/
Aug. 30, 1991; 64 FR 47108, Aug. 30, 1999; 78 FR code_of_federal_regulations/
14665, Mar. 7, 2013; 81 FR 5593, Feb. 3, 2016] ibr_locations.html.
(1) The film when extracted with dis-
§ 177.1360 Ethylene-vinyl acetate-vinyl tilled water at 21 °C (70 °F) for 48 hours
alcohol copolymers. yields total extractives not to exceed
Ethylene-vinyl acetate-vinyl alcohol 0.0047 milligram per square centimeter
copolymers (CAS Reg. No. 26221–27–2) (0.03 milligram per square inch) of
may be safely used as articles or com- food-contact surface.
ponents of articles intended for use in (2) The film when extracted with 50
contact with food, in accordance with percent ethyl alcohol at 21 °C (70 °F) for
the following prescribed conditions: 48 hours yields total extractives not to
(a) Ethylene-vinyl acetate-vinyl alco- exceed 0.0062 milligram per square cen-
hol copolymers are produced by the timeter (0.04 milligram per square
partial or complete alcoholysis or hy- inch) of food-contact surface.
drolysis of those ethylene-vinyl acetate (c) The finished food-contact article
copolymers complying with § 177.1350. shall not exceed 0.0076 centimeter (0.003
(1) Those copolymers containing a inch) thickness and shall contact foods
minimum of 55 percent ethylene and a only of the types identified in table 1 of
maximum of 30 percent vinyl alcohol § 176.170(c) of this chapter in Categories
units by weight may be used in contact III, IV-A, VII-A, and IX under condi-
with foods as described in paragraph (b) tions of use F and G described in table
of this section. 2 of § 176.170(c) of this chapter. Film
(2) Those copolymers containing a samples of 0.0076 centimeter (0.003 inch)
minimum of 55 percent ethylene and a thickness representing the finished ar-
maximum of 15 percent vinyl alcohol ticles shall meet the following extrac-
units by weight may be used in contact tive limitation when tested by ASTM
with foods as described in paragraph (c) method F34–76 (Reapproved 1980),
of this section. ‘‘Standard Test Method for Liquid Ex-
(3) Those copolymers containing 17 to traction of Flexible Barrier Materials,’’
40 percent ethylene and 60 to 83 percent which is incorporated by reference. The
vinyl alcohol units by weight may be availability of this incorporation by
used in contact with foods as described reference is given in paragraph (b) of
in paragraph (d) of this section. this section. The film when extracted
(b) The finished food-contact article with n-heptane at 38 °C (100 °F) for 30
shall not exceed 0.013 centimeter (0.005 minutes yields total extractives not to
inch) thickness and shall contact foods exceed 0.0078 milligram per square cen-
only of the types identified in table 1 of timeter (0.05 milligram per square
§ 176.170(c) of this chapter in Categories inch) of food-contact surface, after cor-
I, II, IV-B, VI, VII-B, and VIII under recting the total extractives by divid-
conditions of use D through G de- ing by a factor of five.
scribed in table 2 of § 176.170(c) of this (d) The finished food-contact article
chapter. Film samples of 0.013 centi- shall not exceed 0.018 centimeter (0.007
meter (0.005) inch thickness rep- inch) thickness and may contact all
resenting the finished article shall foods, except those containing more
meet the following extractive limita- than 8 percent alcohol, under condi-
tion when tested by ASTM method tions of use B through H described in
278
table 2 of § 176.170(c) of this chapter. (a) For the purpose of this section,
Film samples of 0.018 centimeter (0.007 fluorocarbon resins consist of basic res-
inch) thickness representing the fin- ins produced as follows:
ished articles shall meet the following (1) Chlorotrifluoroethylene resins
extractive limitation when tested by produced by the homopolymerization
ASTM method F34–76 (Reapproved of chlorotrifluoroethylene.
1980), ‘‘Standard Test Methods for Liq- (2) Chlorotrifluoroethylene-1,1-
uid Extraction of Flexible Barrier Ma- difluoroethylene copolymer resins pro-
terials,’’ which is incorporated by ref- duced by copolymerization of
erence. The availability of this incor- chlorotrifluoroethylene and 1,1-
poration by reference is given in para- difluoroethylene.
graph (b) of this section. The film when (3) Chlorotrifluoroethylene-1,1-
extracted with distilled water at 100 °C difluoroethylene-tetrafluoroethylene
(212 °F) for 30 minutes yields ethylene- co-polymer resins produced by co-
vinyl acetate-vinyl alcohol oligomers polymerization of
not to exceed 0.093 milligram per chlorotrifluoroethylene, 1,1-
square centimeter (0.6 milligram per difluoroethylene, and tetrafluoro-
square inch) of food contact surface as ethylene.
determined by a method entitled ‘‘An- (4) Ethylene-chlorotrifluoroethylene
alytical Method of Determining the copolymer resins produced by copolym-
Amount of EVOH in the Extractives erization of nominally 50 mole percent
Residue of EVOH Film,’’ dated March of ethylene and 50 mole percent of
23, 1987, as developed by the Kuraray chlorotrifluoroethylene. The copoly-
Co., Ltd., which is incorporated by ref- mer shall have a melting point of 239 to
erence in accordance with 5 U.S.C. 243 °C and a melt index of less than or
552(a) and 1 CFR part 51. Copies may be equal to 20 as determined by ASTM
obtained from the Office of Food Addi- Method D 3275–89 ‘‘Standard Specifica-
tive Safety (HFS–200)), Center for Food tion for E-CTFE-Fluoroplastic Mold-
Safety and Applied Nutrition, Food and ing, Extrusion, and Coating Mate-
Drug Administration, 5001 Campus Dr., rials,’’ which is incorporated by ref-
College Park, MD 20740, 240–402–1200, or erence in accordance with 5 U.S.C.
may be examined at the Food and Drug 552(a) and 1 CFR part 51. Copies may be
Administration’s Main Library, 10903 obtained from the American Society
New Hampshire Ave., Bldg. 2, Third for Testing and Materials, 1916 Race
Floor, Silver Spring, MD 20993, 301–796– St., Philadelphia, PA 19013, or may be
2039, or at the National Archives and examined at the National Archives and
Records Administration (NARA). For Records Administration (NARA). For
information on the availability of this information on the availability of this
material at NARA, call 202–741–6030, or material at NARA, call 202–741–6030, or
go to: http://www.archives.gov/fed- go to: http://www.archives.gov/fed-
eral_register/code_of_federal_regulations/ eral_register/code_of_federal_regulations/
ibr_locations.html. ibr_locations.html.
(b) Fluorocarbon resins that are iden-
(e) The provisions of this section are
tified in paragraph (a) of this section
not applicable to ethylene-vinyl ace-
and that comply with extractive limi-
tate-vinyl alcohol copolymers used in
tations prescribed in paragraph (c) of
the food-packaging adhesives com-
this section may be used as articles or
plying with § 175.105 of this chapter.
components of articles intended for use
[47 FR 41531, Sept. 21, 1982, as amended at 49 in contact with food as follows:
FR 10108, Mar. 19, 1984; 65 FR 17135, Mar. 31, (1) Fluorocarbon resins that are iden-
2000; 78 FR 14665, Mar. 7, 2013; 81 FR 5593, Feb. tified in paragraphs (a)(1), (a)(2), and
3, 2016] (a)(3) of this section and that comply
only with the extractive limitations
§ 177.1380 Fluorocarbon resins. prescribed in paragraphs (c)(1) and
Fluorocarbon resins may be safely (c)(2) of this section may be used when
used as articles or components of arti- such use is limited to articles or com-
cles intended for use in contact with ponents of articles that are intended
food, in accordance with the following for repeated use in contact with food or
prescribed conditions: that are intended for one-time use in
279
§ 177.1390 21 CFR Ch. I (4–1–23 Edition)
contact with foods only of the types functional barrier, such as aluminum
identified in § 176.170(c) of this chapter, foil. Upon review of the physical prop-
table 1, under Types I, II, VI, VII-B, erties of a particular construction, the
and VIII. Food and Drug Administration may
(2) Fluorocarbon resins that are iden- consider other layers to serve as func-
tified in paragraph (a)(4) of this section tional barriers. This regulation is not
and that comply with the extractive intended to limit these constructions
limitations prescribed in paragraphs as to shape, degree of flexibility, thick-
(c)(1) and (c)(2) of this section may be ness, or number of layers. These layers
used only when such use is limited to may be laminated, extruded, co-
articles or components of articles that extruded, or fused.
are intended for repeated use in con- (b) When containers subject to this
tact with food. regulation undergo heat sterilization
(3) In accordance with current good to produce shelf-stable foods, certain
manufacturing practice, those food- control measures (in addition to the
contact articles intended for repeated food additive requirements in para-
use shall be thoroughly cleansed prior graphs (c) and (d) of this section) are
to their first use in contact with food. necessary to ensure proper food steri-
(c) Extractives limitations are appli- lization and package integrity. Refer
cable to the basic resins in the form of to parts 108, 110, 113, and 114 of this
pellets that have been ground or cut chapter for details.
into small particles that will pass (c) Subject to the provisions of this
through a U.S. Standard Sieve No. 6 paragraph, food-contact articles pro-
and that will be held on a U.S. Stand- duced from high-temperature lami-
ard Sieve No. 10. nates may be safely used to package all
(1) A 100-gram sample of the resin food types except those containing
pellets, when extracted with 100 milli- more than 8 percent ethyl alcohol.
liters of distilled water at reflux tem- (1) Polymeric films/layers. Films or lay-
perature for 8 hours, shall yield total ers not separated from food by a func-
extractives not to exceed 0.003 percent tional barrier must meet the following
by weight of the resins. requirements:
(2) A 100-gram sample of the resin (i) Films/layers may consist of the
pellets, when extracted with 100 milli- following:
liters of 50 percent (by volume) ethyl (a) Polyolefin resins complying with
alcohol in distilled water at reflux item 2.2 or 3.2 of the table in
temperature for 8 hours, shall yield § 177.1520(c).
total extractives not to exceed 0.003 (b) Polymeric resin blends formu-
percent by weight of the resins. lated from a base polymer complying
(3) A 100-gram sample of the resin with item 2.2 or 3.2 of the table in
pellets, when extracted with 100 milli- § 177.1520(c) blended with no more than
liters of n-heptane at reflux tempera- 10 percent by weight of a copolymer of
ture for 8 hours, shall yield total ex- ethylene and vinyl acetate complying
tractives not to exceed 0.01 percent by with § 177.1350.
weight of the resins. (c) Polymeric resin blends formulated
[42 FR 14572, Mar. 15, 1977, as amended at 57 from a base polymer complying with
FR 185, Jan. 3, 1992] item 2.2 or 3.2 of the table in
§ 177.1520(c) blended with no more than
§ 177.1390 Laminate structures for use 38 percent by weight of a homopolymer
at temperatures of 250 ≥F and of isobutylene complying with
above. § 177.1420(a)(1).
(a) The high-temperature laminates (d) Polyethylene phthalate resins
identified in this section may be safely complying with § 177.1630(e)(4)(i) and
used for food contact at temperatures (ii).
not exceeding 135 °C (275 °F) unless oth- (e) Nylon MXD–6 resins that comply
erwise specified. These articles are lay- with item 10.3 of the table in
ered constructions that are optionally § 177.1500(b) of this chapter when ex-
bonded with adhesives. The interior tracted with water and heptane under
(food-contact) layer(s) may be sepa- the conditions of time and temperature
rated from the exterior layer(s) by a specified for condition of use A, as set
280
forth in Table 2 of § 176.170(c) of this Reg. No. 4098–71–9) and optional

chapter. trimethoxysilane coupling agents con-
(f) Nylon 6⁄12 resins (CAS Reg. No. taining amino, epoxy, ether, and/or
25191–04–2) complying with item 13.3 of mercapto groups not to exceed 3 per-
the table in § 177.1500(b), for use as cent by weight of the cured adhesive.
nonfood-contact layers of laminated (b) Urethane cross-linking agent
films and in rigid multilaminate con- comprising not more than 25 percent
structions with polypropylene outer by weight of the cured adhesive and
layers. Laminate structures with au- formulated from 3-isocyanatomethyl-
thorized food-contact materials yield 3,5,5-trimethylcyclohexyl isocyanate
no more than 0.15 milligrams of epsilon- (CAS Reg. No. 4098–71–9) adduct of
caprolactam and 0.04 milligrams of trimethylol propane (Cas Reg. No. 77–
omega-laurolactam per square inch 99–6) and/or 1,3-bis(isocyanatomethyl)
when extracted with 95 percent ethanol benzene (CAS Reg. No. 25854–16–4)
at 121 °C (250 °F) for 2 hours. adduct of trimethylol propane.
(g) Polymeric resins that comply (v) Polyester-epoxy-urethane adhe-
with an applicable regulation in this sives formulated from the following:
chapter which permits food type and (a) Polyester resin formed by the re-
time/temperature conditions to which action of polybasic acids and
the container will be exposed, includ- polyhydric alcohols listed in
ing sterilization processing. § 175.300(b)(3)(vii) of this chapter. Aze-
(ii) Adjuvants used in these layers laic acid may also be used as a
must comply with an applicable regu- polybasic acid.
lation that permits food type and time/ (b) Epoxy resin listed in
temperature conditions to which the § 175.300(b)(3)(viii)(a) of this chapter and
container will be exposed, including comprising no more than 30 percent by
sterilization processing. weight of the cured adhesive.
(2) Adhesives. The use of adhesives in (c) Urethane cross-linking agent com-
these containers is optional. Adhesives prising no more than 14 percent weight
may be formulated from the following of the cured adhesive and formulated
substances, subject to the prescribed from 3-isocyanatomethyl-3,5.5-
limitations: trimethylcyclohexyl isocyanate
(i) Any substance suitable for use in cyanurate (CAS Reg. No. 53880–05–0).
formulating adhesives that complies (vi) Polyurethane-polyester resin-
with an applicable regulation of this epoxy adhesives formulated from the
chapter which permits food type and following mixture:
time/temperature conditions to which (a)(1) Polyester-polyurethanediol res-
the container will be exposed, includ- ins prepared by the reaction of a mix-
ing sterilization processing. ture of polybasic acids and polyhydric
(ii) Substances complying with alcohols listed in § 175.300(b)(3)(vii) of
§ 175.105 of this chapter may be used in this chapter and 3-isocyanatomethyl-
these constructions, provided they are 3,5,5-trimethylcyclohexyl isocyanate
separated from the interior (food-con- (CAS Reg. No. 4098–71–9).
tact) layer(s) by a functional barrier as (2) Polyester resin formed by the re-
discussed under paragraph (a) of this action of polybasic acids and
section. polyhydric alcohols listed in
(iii) Maleic anhydride adduct of poly- § 175.300(b)(3)(vii) of this chapter. Addi-
propylene complying with § 175.300 of tionally, azelaic acid and 1,6-
this chapter. hexanediol may also be used as
(iv) Polyester-urethane adhesive for reactants in lieu of a polyhydric alco-
use at temperatures not exceeding 121 hol.
°C (250 °F) and formulated from the fol- (3) Epoxy resin listed in
lowing: § 175.300(b)(3)(viii)(a) of this chapter and
(a) Polyester-urethanediol resin pre- comprising not more than 5 percent by
pared by the reaction of a mixture of weight of the cured adhesive.
polybasic acids and polyhydric alcohols (4) Optional trimethoxy silane curing
listed in § 175.300(b)(3)(vii) of this chap- agents, containing amino, epoxy, ether,

ter, 3-isocyanatomethyl-3,5,5- or mercapto groups not in excess of 3
trimethylcyclohexyl isocyanate (CAS percent of the cured adhesive.
281
§ 177.1390 21 CFR Ch. I (4–1–23 Edition)
(b) Urethane cross-linking agent, (250 °F): The container interior (food-
comprising not more than 20 percent contact side) shall be extracted with
by weight of the cured adhesive, and deionized distilled water at 121 °C (250
formulated from trimethylol propane °F) for 2 hours.
(CAS Reg. No. 77–99–6) adducts of 3– (1) The chloroform-soluble fraction of
isocyanatomethyl–3,5,5– the total nonvolatile extractives for
trimethylcyclohexyl isocyanate (CAS containers using adhesives listed in
Reg. No. 4098–71–9) or 1,3- paragraphs (c)(2)(i), (c)(2)(ii), (c)(2)(iii),
bis(isocyanatomethyl)benzene (CAS (c)(2)(iv), and (c)(2)(vii) of this section
Reg. No. 25854–16–4). shall not exceed 0.0016 milligram per
(vii) Polyester-polyurethane resin- square centimeter (0.01 milligram per
acid dianhydride adhesives for use at square inch) as determined by a meth-
temperatures not to exceed 121 °C (250 od entitled ‘‘Determination of Non-
°F), in contact only with food Types I, Volatile Chloroform Soluble Residues
II, VIA, VIB, VIIB, and VIII as de- in Retort Pouch Water Extracts,’’
scribed in Table I of § 176.170 of this which is incorporated by reference.
chapter, and formulated from the fol- Copies are available from the Center
lowing mixture: for Food Safety and Applied Nutrition
(a)(1) Polyesterpolyurethanediol res- (HFS–200), Food and Drug Administra-
ins prepared by the reaction of a mix- tion, 5001 Campus Dr., College Park,
ture of polybasic acids and polyhydric MD 20740, and may be examined at the
alcohols listed in § 175.300(b)(3)(vii) of Food and Drug Administration’s Main
this chapter and 3-isocyanatomethyl- Library, 10903 New Hampshire Ave.,
3,5,5-trimethylcyclohexyl isocyanate Bldg. 2, Third Floor, Silver Spring, MD
(CAS Reg. No. 4098–71–9). Additionally, 20993, 301–796–2039, or at the National
dimethylol propionic acid and 1,6- Archives and Records Administration
hexanediol may be used alone or in (NARA). For information on the avail-
combination as reactants in lieu of a ability of this material at NARA, call
polybasic acid and a polyhydric alco- 202–741–6030, or go to: http://
hol. www.archives.gov/federal_register/
(2) Acid dianhydride formulated from code_of_federal_regulations/
3a,4,5,7a-tetrahydro-7-methyl-5- ibr_locations.html.
(tetrahydro-2,5-dioxo-3-furanyl)-1,3- (2) The chloroform-soluble fraction of
isobenzofurandione (CAS Reg. No. the total nonvolatile extractives for
73003–90–4), comprising not more than containers using adhesives listed in
one percent of the cured adhesive. paragraph (c)(2)(v) of this section shall
(b) Urethane cross-linking agent, not exceed 0.016 milligram per square
comprising not more than twelve per- centimeter (0.10 milligram per square
cent by weight of the cured adhesive, inch) as determined by a method titled
and formulated from trimethylol pro- ‘‘Determination of Non-volatile Chlo-
pane (CAS Reg. No. 77–99–6) adducts of roform Soluble Residues in Retort
3-isocyanatomethyl-3,5,5- Pouch Water Extracts,’’ which is incor-
trimethylcyclohexyl isocyanate (CAS porated by reference in paragraph
Reg. No. 4098–71–9) and/or 1,3- (c)(3)(i)(a)(1) of this section.
bis(isocyanatomethyl)benzene (CAS (b) For use at temperatures not to ex-
Reg. No. 363–48–31). ceed 135 °C (275 °F): The container inte-
(3) Test specifications. These specifica- rior (food-contact side) shall be ex-
tions apply only to materials on the tracted with deionized distilled water
food-contact side of a functional bar- at 135 °C (275 °F) for 1 hour.
rier, if present. All tests must be per- (1) The chloroform-soluble fraction of
formed on containers made under pro- the total nonvolatile extractives for
duction conditions. Laminated struc- containers using no adhesive, or adhe-
tures submitted to extraction proce- sives listed in paragraphs (c)(2)(i), (ii),
dures must maintain complete struc- and (iii) of this section shall not exceed
tural integrity (particularly with re- 0.0020 milligram per square centimeter
gard to delamination) throughout the (0.013 milligram per square inch) as de-
test. termined by a method titled ‘‘Deter-

(i) Nonvolatile extractives. (a) For use mination of Non-volatile Chloroform
at temperatures not to exceed 121 °C Soluble Residues in Retort Pouch
282
Water Extracts,’’ which is incorporated (2) Nylon 12 resin complying with

by reference. The availability of this § 177.1500 and having an average thick-
incorporation by reference is given in ness not to exceed 0.0016 inch (41 mi-
paragraph (c)(3)(i)(a)(1) of this section. crons) may be used as the food-contact
(2) The chloroform-soluble fraction of surface of the container.
the total nonvolatile extractives for (3) Container test specifications. On
containers using adhesives listed in exposure to distilled water at 250 °F
paragraph (c)(2)(v) of this section shall (121 °C) for 2 hours, extractives from
not exceed 0.016 milligram per square the food-contact side of the nylon 12
centimeter (0.10 milligram per square multilayered construction shall not ex-
inch) as determined by a method titled ceed 0.05 milligram per square inch
‘‘Determination of Non-volatile Chlo- (0.0078 milligram per square centi-
roform Soluble Residues in Retort meter) as total nonvolatile extractives.
Pouch Water Extracts,’’ which is incor-
porated by reference. The availability [45 FR 2843, Jan. 15, 1980, as amended at 47
FR 49639, Nov. 2, 1982; 48 FR 236, Jan. 4, 1983;
of this incorporation by reference is
48 FR 15242, Apr. 8, 1983; 48 FR 17347, Apr. 22,
given in paragraph (c)(3)(i)(a)(1) of this 1983; 49 FR 7558, Mar. 1, 1984; 52 FR 33575,
section. Sept. 4, 1987; 53 FR 39084, Oct. 5, 1988; 54 FR
(3) The chloroform-soluble fraction of 24898, June 12, 1989; 61 FR 14481, Apr. 2, 1996;
the total nonvolatile extractives for 63 FR 55943, Oct. 20, 1998; 64 FR 4785, Feb. 1,
containers using adhesives listed in 1999; 64 FR 46272, Aug. 25, 1999; 69 FR 15668,
paragraph (c)(2)(vi) of this section shall Mar. 26, 2004; 81 FR 5593, Feb. 3, 2016]
not exceed 0.008 milligram per square
centimeter (0.05 milligram per square § 177.1395 Laminate structures for use
at temperatures between 120 ≥F and
inch) as determined by a method enti- 250 ≥F.
tled, ‘‘Determination of Non-volatile
Chloroform Soluble Residues in Retort (a) The laminates identified in this
Pouch Water Extracts,’’ which is incor- section may be safely used at the speci-
porated by reference in paragraph fied temperatures. These articles are
(c)(3)(i)(a)(1) of this section. layered structures that are optionally
(ii) Volatiles. Volatile substances em- bonded with adhesives. In these arti-
ployed in the manufacture of high-tem- cles, the food-contact layer does not
perature laminates must be removed to function as a barrier to migration of
the greatest extent possible in keeping components from non-food-contact lay-
with good manufacturing practice pre- ers. The layers may be laminated, ex-
scribed in § 174.5(a) of this chapter. truded, coextruded, or fused.
(d) Nylon 12/aluminum foil high-tem- (b) Laminate structures may be man-
perature laminates: Subject to the pro- ufactured from:
visions of this paragraph, containers (1) Polymers and adjuvants com-
constructed of nylon 12 laminated to plying with § 177.1390 of this chapter.
aluminum foil may be safely used at (2) Any polymeric resin listed in
temperatures no greater than 250 °F these regulations so long as the use of
(121 °C) in contact with all food types the resin in the structure complies
except those containing more than 8 with the conditions of use (food type
percent alcohol. and time/temperature) specified in the
(1) The container is constructed of regulation for that resin.
aluminum foil to which nylon 12 film is (3) Optional adjuvant substances used
fused. Prior to fusing the nylon 12, the in accordance with § 174.5 of this chap-
aluminum foil may be optionally ter.
precoated with a coating complying (4) The following substances in non-
with § 175.300 of this chapter. food-contact layers only:
283
§ 177.1400 21 CFR Ch. I (4–1–23 Edition)
Substances Limitations Substances Limitations
Ethylene/1,3–phenylene oxy- For use only with poly- Nylon 6/69 resins complying For use with nonalcoholic
ethylene isophthalate/ ethylene terephthalate as with § 177.1500(b), item 14, foods under conditions of
terephthalate copolymer the food-contact layer, of this chapter (CAS Reg. use B, C, D, E, F, G, and
(CAS Reg. No. 87365–98–8) complying with No. 51995–62–1). H described in table 2 of
complying with § 177.1345. § 177.1630 under condi- § 176.170 of this chapter.
tions of use C through G Laminate structures with
described in table 2 of authorized food-contact
§ 176.170(c) of this chap- materials may contain
ter. Laminate structures, nylon 6/69 resins pro-
when extracted with 8 vided that the nitrogen
percent ethanol at 150 °F content of aqueous ex-
for 2 hours shall not yield tracts of a representative
m-pheny lenedioxy-O,O′- laminate (obtained at 100
diethyl isophthalate or cy- °C (212 °F) for 8 hours)
clic bis(ethylene does not exceed 15
isophthalate) in excess of micrograms per square
7.8 micrograms/square centimeter (100
decimeter (0.5 micrograms per square
microgram/square inch) of inch).
food-contact surface.
Nylon 6/12 resins complying For use with nonalcoholic
with § 177.1500(b), item foods at temperatures not [52 FR 33575, Sept. 4, 1987, as amended at 53
13.2, of this chapter (CAS to exceed 100 °C (212 FR 19772, May 31, 1988; 57 FR 43399, Sept. 21,
Reg. No. 25191–04–2). °F). Laminate structures 1992; 58 FR 32610, June 11, 1993; 62 FR 53957,
with authorized food-con- Oct. 17, 1997]
tact materials yield no
more than 0.15 milligram § 177.1400 Hydroxyethyl cellulose film,
of epsilon-caprolactam water-insoluble.
and 0.04 milligram of
omega-laurolactam per Water-insoluble hydroxyethyl cel-
square inch when ex- lulose film may be safely used for
tracted with water at 100
°C (212 °F) for 5 hours. packaging food in accordance with the
Nylon 6/66 resins complying For use only with: following prescribed conditions:
with § 177.1500(b), item 4.2 1. Nonalcoholic foods at (a) Water-insoluble hydroxyethyl cel-
of this chapter (CAS Reg. temperatures not to ex- lulose film consists of a base sheet
24993–04–2). ceed 82.2 °C (180 °F).
Laminate structures with manufactured by the ethoxylation of
authorized food-contact cellulose under controlled conditions,
materials yield no more to which may be added certain optional
than 0.15 milligram of ep- substances of a grade of purity suitable
silon-caprolactam per
square inch when ex- for use in food packaging as constitu-
tracted with water at 82.2 ents of the base sheet or as coatings
°C (180 °F) for 5 hours. applied to impart desired technological
2. Nonalcoholic foods at
temperatures not to ex-
properties.
ceed 100 °C (212 °F). (b) Subject to any limitations pre-
Laminate films with au- scribed in parts 170 through 189 of this
thorized food-contact ma- chapter, the optional substances used
terials yield no more than
0.15 milligram of epsilon-
in the base sheet and coating may in-
caprolactam per square clude:
inch when extracted with (1) Substances generally recognized
water at 100 °C (212 °F) as safe in food.
for 5 hours.
(2) Substances permitted to be used
in water-insoluble hydroxyethyl cel-
lulose film by prior sanction or ap-
proval and under conditions specified
in such sanctions or approval, and sub-
stances listed in part 181, subpart B of
this chapter.
(3) Substances that by any regulation
promulgated under section 409 of the
act may be safely used as components
of water-insoluble hydroxyethyl cel-
lulose film.
(4) Substances identified in and used
in compliance with § 177.1200(c).
284
(c) Any substance employed in the (b) The polymers identified in para-
production of the water-insoluble hy- graph (a) of this section may contain
droxyethyl cellulose film described in optional adjuvant substances required
this section that is the subject of a reg- in the production of the polymers. The
ulation in parts 174, 175, 176, 177, 178 optional adjuvant substances required
and § 179.45 of this chapter conforms in the production of the polymers may
with any specification in such regula- include substances generally recog-
tion. nized as safe in food, substances used in
§ 177.1420 Isobutylene polymers. accordance with a prior sanction or ap-
proval, and aluminum chloride.
Isobutylene polymers may be safely
(c) The provisions of this section are
used as components of articles in-
tended for use in producing, manufac- not applicable to polyisobutylene used
turing, packing, processing, preparing, in food-packaging adhesives complying
treating, packaging, transporting, or with § 175.105 of this chapter.
holding food, in accordance with the
following prescribed conditions: § 177.1430 Isobutylene-butene copoly-
mers.
(a) For the purpose of this section,
isobutylene polymers are those pro- Isobutylene-butene copolymers iden-
duced as follows: tified in paragraph (a) of this section
(1) Polyisobutylene produced by the may be safely used as components of
homopolymerization of isobutylene articles intended for use in contact
such that the finished polymers have a with food, subject to the provisions of
molecular weight of 750,000 (Flory) or this section.
higher. (a) For the purpose of this section,
(2) Isobutylene-isoprene copolymers isobutylene-butene copolymers consist
produced by the copolymerization of
of basic copolymers produced by the
isobutylene with not more than 3
copolymerization of isobutylene with
molar percent of isoprene such that the
finished polymers have a molecular mixtures of n-butenes such that the
weight of 300,000 (Flory) or higher. finished basic copolymers contain not
(3) Chlorinated isobutylene-isoprene less than 45 weight percent of polymer
copolymers produced when units derived from isobutylene and
isobutylene-isoprene copolymers (mo- meet the specifications prescribed in
lecular weight 300,000 (Flory) or higher) paragraph (b) of this section when test-
are modified by chlorination with not ed by the methods described in para-
more than 1.3 weight-percent of chlo- graph (c) of this section.
rine. (b) Specifications:
Maximum
Molecular
Isobutylene-butene copolymers Viscosity (range) bromine
weight (range) value
1. Used as release agents in petroleum wax complying with 300 to 5,000 ... 40 to 20,000 seconds 40
§ 178.3710 of this chapter. Saybolt at 200 °F.
2. Used as plasticizers in polyethylene or polypropylene complying 300 to 5,000 ... 40 to 20,000 seconds 40
with § 177.1520, and in polystyrene complying with § 177.1640. Saybolt at 200 °F.
3. Used as components of nonfood articles complying with 300 to 5,000 ... 40 to 20,000 seconds 40
§§ 175.300, 176.170, 176.210, 177.2260(d)(2), 177.2800, and Saybolt at 200 °F.
178.3570 (provided that addition to food does not exceed 10 parts
per million), or § 176.180 of this chapter.
4. Used as production aids in the manufacture of expanded 150 to 5,000 ... Less than 20,000 seconds 90.
(foamed) polystyrene articles complying with § 177.1640 of this Saybolt at 200 °F.
chapter.
5. Used in release coatings on backings or linings for pressure-sen- 150 to 5,000 ... Less than 20,000 seconds 90
sitive adhesive labels complying with § 175.125 of this chapter. Saybolt at 200 °F.
(c) The analytical methods for deter- (1) Molecular weight. Molecular
mining whether isobutylene-butene co- weight shall be determined by Amer-
polymers conform to the specifications ican Society for Testing and Materials
in paragraph (b) are as follows: (ASTM) method D2503–82, ‘‘Standard
Test Method for Molecular Weight
285
§ 177.1440 21 CFR Ch. I (4–1–23 Edition)
(Relative Molecular Mass) of Hydro- tain optional adjuvant substances re-

carbons by Thermoelectric Measure- quired in the production of the resins.
ment of Vapor Pressure,’’ which is in- (b) The optional adjuvant substances
corporated by reference. Copies may be required in the production of the resins
obtained from the American Society may include substances generally rec-
for Testing Materials, 100 Barr Harbor ognized as safe in food, substances used
Dr., West Conshohocken, Philadelphia, in accordance with a prior sanction or
PA 19428-2959, or may be examined at approval, and the following:
the National Archives and Records Ad-
ministration (NARA). For information
on the availability of this material at Butyl alcohol ................... Not to exceed 300 p.p.m. as re-
NARA, call 202–741–6030, or go to: http:// sidual solvent in finished resin.
Ethyl alcohol.
www.archives.gov/federal_register/ Toluene ........................... Not to exceed 1,000 p.p.m. as re-
code_of_federal_regulations/ sidual solvent in finished resin.
ibr_locations.html.
(2) Viscosity. Viscosity shall be deter- (c) 4,4′-Isopropylidenediphenol-ep-
mined by ASTM method D445–74, ‘‘Test ichlorohydrin resins shall meet the fol-
for Kinematic Viscosity of Transparent lowing nonvolatile extractives limita-
and Opaque Liquids,’’ which is incor- tions:
porated by reference. The availability (1) Maximum extractable nonvolatile
of this incorporation by reference is fraction of 2 parts per million when ex-
given in paragraph (c)(1) of this sec- tracted with distilled water at 70 °C for
tion. 2 hours, using a volume-to-surface
(3) Maximum bromine value. Maximum ratio of 2 milliliters per square inch.
bromine value shall be determined by (2) Maximum extractable nonvolatile
ASTM method D1492–78, ‘‘Standard fraction of 3 parts per million when ex-
Test Method for Bromine Index of Aro- tracted with n-heptane at 70 °C for 2
matic Hydrocarbons by Coulometric hours, using a volume-to-surface ratio
Titration,’’ which is incorporated by of 2 milliliters per square inch.
reference. The availability of this in- (3) Maximum extractable nonvolatile
corporation by reference is given in fraction of 6 parts per million when ex-
paragraph (c)(1) of this section. tracted with 10 percent (by volume)
(d) The provisions of this section are ethyl alcohol in distilled water at 70 °C
not applicable to isobutylene-butene for 2 hours, using a volume-to-surface
copolymers used as provided under ratio of 2 milliliters per square inch.
§ 175.105 of this chapter. (d) The provisions of this section are
[52 FR 11641, Apr. 10, 1987, as amended at 63 not applicable to 4,4′-isopropylidene-
FR 36175, July 2, 1998] diphenol-epichlorohydrin resins listed
in other sections of subchapter B of
§ 177.1440 4,4′-Isopropylidenediphenol- this chapter.
epichlorohydrin resins minimum
molecular weight 10,000. § 177.1460 Melamine-formaldehyde res-
4,4′-Isopropylidenediphenol-epichlo- ins in molded articles.
rohydrin resins having a minimum mo- Melamine-formaldehyde resins may
lecular weight of 10,000 may be safely be safely used as the food-contact sur-
used as articles or components of arti- face of molded articles intended for use
cles intended for use in producing, in producing, manufacturing, packing,
manufacturing, packing, processing, processing, preparing, treating, pack-
preparing, treating, packaging, trans- aging, transporting, or holding food in
porting, or holding food in accordance accordance with the following pre-
with the following prescribed condi- scribed conditions:
tions: (a) For the purpose of this section,
(a) 4,4′-Isopropylidenediphenol-ep- melamine-formaldehyde resins are
ichlorohydrin resins consist of basic those produced when 1 mole of mel-
resins produced by the condensation of amine is made to react with not more
equimolar amounts of 4,4′- than 3 moles of formaldehyde in water
isopropylidenediphenol and solution.

epichlorohydrin terminated with phe- (b) The resins may be mixed with re-
nol, to which may have been added cer- fined woodpulp and the mixture may
286
contain other optional adjuvant sub- per gram as determined by ASTM

stances which may include the fol- method D1243–79, ‘‘Standard Test Meth-
lowing: od for Dilute Solution Viscosity of
Vinyl Chloride Polymers,’’ which is in-
corporated by reference. Copies may be
Colorants used in accord- obtained from the American Society
ance with § 178.3297 for Testing Materials, 100 Barr Harbor
of this chapter.
Dr., West Conshohocken, Philadelphia,
Hexamethylenetetramine For use only as polymerization
reaction control agent. PA 19428-2959, or may be examined at
Phthalic acid anhydride .. Do. the National Archives and Records Ad-
Zinc stearate ................... For use as lubricant. ministration (NARA). For information
(c) The molded melamine-formalde- NARA, call 202–741–6030, or go to: http://
hyde articles in the finished form in www.archives.gov/federal_register/
which they are to contact food, when code_of_federal_regulations/
extracted with the solvent or solvents ibr_locations.html.
characterizing the type of food and (iii) Residual acrylonitrile monomer
under the conditions of time and tem- content is not more than 11 parts per
perature as determined from tables 1 million as determined by gas chroma-
and 2 of § 175.300(d) of this chapter, tography.
shall yield net chloroform-soluble ex- (iv) Acetonitrile-soluble fraction
tractives not to exceed 0.5 milligram after refluxing the base polymer in ace-
per square inch of food-contact surface. tonitrile for 1 hour is not greater than
[42 FR 14572, Mar. 15, 1977, as amended at 56 95 percent by weight of the basic co-
FR 42933, Aug. 30, 1991; 87 FR 31089, May 20, polymers.
2022] (2) Extractives limitations. The fol-
lowing extractive limitations are de-
§ 177.1480 Nitrile rubber modified ac- termined by an infrared
rylonitrile-methyl acrylate copoly- spectrophotometric method titled,
mers. ‘‘Infrared Spectrophotometric Deter-
Nitrile rubber modified acrylonitrile- mination of Polymer Extracted from
methyl acrylate copolymers identified Borex ® 210 Resin Pellets,’’ which is in-
in this section may be safely used as corporated by reference. Copies are
components of articles intended for available from the Center for Food
food-contact use under conditions of Safety and Applied Nutrition (HFS–
use D, E, F, or G described in table 2 of 200), Food and Drug Administration,
§ 176.170(c) of this chapter, subject to 5001 Campus Dr., College Park, MD
the provisions of this section. 20740, or available for inspection at the
(a) For the purpose of this section, National Archives and Records Admin-
nitrile rubber modified acrylonitrile- istration (NARA). For information on
methyl acrylate copolymers consist of the availability of this material at
basic copolymers produced by the graft NARA, call 202–741–6030, or go to: http://
copolymerization of 73–77 parts by www.archives.gov/federal_register/
weight of acrylonitrile and 23–27 parts code_of_federal_regulations/
by weight of methyl acrylate in the ibr_locations.html.Copies are applicable
presence of 8–10 parts by weight of bu- to the basic copolymers in the form of
tadiene-acrylonitrile copolymers con- particles of a size that will pass
taining approximately 70 percent by through a U.S. standard sieve No. 6 and
weight of polymer units derived from that will be held on a U.S. standard
butadiene. sieve No. 10:
(b) The nitrile rubber modified acry- (i) Extracted copolymer not to ex-
lonitrile-methyl acrylate basic copoly- ceed 2.0 parts per million in aqueous
mers meet the following specifications extract obtained when a 100-gram sam-
and extractives limitations: ple of the basic copolymers is extracted
(1) Specifications. (i) Nitrogen content with 250 milliliters of demineralized
is in the range 16.5–19 percent as deter- (deionized) water at reflux temperature
mined by Kjeldahl analysis. for 2 hours.

(ii) Intrinsic viscosity in acetonitrile (ii) Extracted copolymer not to ex-
at 25 °C is not less than 0.29 deciliter ceed 0.5 part per million in n-heptane
287
§ 177.1500 21 CFR Ch. I (4–1–23 Edition)
extract obtained when a 100-gram sam- adipic acid, and 21.6±1.2 weight percent
ple of the basic copolymers is extracted terephthalic acid.
with 250 milliliters of reagent grade n- (8) Nylon 612 resins are manufactured
heptane at reflux temperature for 2 by the condensation of
hours. hexamethylenediamine and
(c) Acrylonitrile copolymers identi- dodecanedioic acid.
fied in this section shall comply with (9) Nylon 12 resins are manufactured
the provisions of § 180.22 of this chap- by the condensation of omega-
ter. laurolactam.
(d) Acrylonitrile copolymers identi- (10)(i) Impact modified Nylon MXD–6
fied in this section are not authorized resins (CAS Reg. No. 59655–05–9) manu-
to be used to fabricate beverage con- factured by the condensation of adipic
tainers. acid, 1,3-benzenedimethanamine, and
alpha-(3-aminopropyl)-omega-(3-amino-
[42 FR 14572, Mar. 15, 1977, as amended at 42 propoxy)polyoxyethylene under such
FR 48544, Sept. 23, 1977; 47 FR 11843, Mar. 19,
conditions that the alpha-(3-amino-
1982; 47 FR 16775, Apr. 20, 1982; 49 FR 10109,
Mar. 19, 1984; 54 FR 24898, June 12, 1989; 61 FR propyl)-omega-(3-aminopropoxy)
14481, Apr. 2, 1996] polyoxyethylene monomer content
does not exceed 7 percent by weight of
§ 177.1500 Nylon resins. the finished resin.
(ii) Nylon MXD–6 resins (CAS Reg.
The nylon resins listed in paragraph
No. 25718–70–1) manufactured by the
(a) of this section may be safely used to
condensation of adipic acid and 1,3-
produce articles intended for use in
benzenedimethanamine.
processing, handling, and packaging
(11) Nylon 12T resins are manufac-
food, subject to the provisions of this
tured by the condensation of omega-
section:
laurolactam (CAS Reg. No. 0947–04–6),
(a) The nylon resins are manufac-
isophthalic acid (CAS Reg. No. 0121–91–
tured as described in this paragraph so
5), and bis(4-amino-3-methylcycl-
as to meet the specifications prescribed
ohexyl)methane (CAS Reg. No. 6864–37–
in paragraph (b) of this section when
5) such that the composition in terms
tested by the methods described in
of ingredients is 34.4±1.5 weight percent
paragraph (d) of this section.
omega-laurolactam, 26.8±0.4 weight per-
(1) Nylon 66 resins are manufactured cent isophthalic acid, and 38.8±0.5
by the condensation of hexamethylene- weight percent bis(4-amino-3-
diamine and adipic acid. methylcyclohexyl)-methane.
(2) Nylon 610 resins are manufactured (12) Nylon 6I/6T resins (CAS Reg. No.
by the condensation of hexamethylene- 25750–23–6) are manufactured by the
diamine and sebacic acid. condensation of
(3) Nylon 66/610 resins are manufac- hexamethylenediamine, terephthalic
tured by the condensation of equal- acid, and isophthalic acid such that 65
weight mixtures of nylon 66 salts and to 80 percent of the polymer units are
nylon 610 salts. derived from hexamethylene
(4) Nylon 6/66 resins manufactured by isophthalamide.
the condensation and polymerization of (13)(i) Nylon 6/12 resins (CAS Reg. No.
Nylon 66 salts and epsilon-caprolactam. 25191–04–2) are manufactured by the co-
(5) Nylon 11 resins are manufactured polymerization of a 1 to 1 ratio by
by the condensation of 11- weight of epsilon-caprolactam and
aminoundecanoic acid. omega-laurolactam.
(6) Nylon 6 resins are manufactured (ii) Nylon 6/12 resins (CAS Reg. No.
by the polymerization of epsilon- 25191–04–2) are manufactured by the co-
caprolactam. polymerization of a ratio of at least 80
(7) Nylon 66T resins are manufac- weight percent of epsilon-caprolactam
tured by the condensation of and no more than 20 weight percent of
hexamethyl-enediamine, adipic acid, omega-laurolactam.
and terephthalic acid such that com- (14) Nylon 6/69 resins (CAS Reg. No.
position in terms of ingredients is 51995–62–1) are manufactured by the

43.1±0.2 weight percent hexamethyl- condensation of 49.5 + 0.5 weight per-
enediamine, 35.3±1.2 weight percent cent epsilon-caprolactam, 19.4 + 0.2
288
weight percent hexamethylenediamine by the condensation of 50 mol percent

and 31.2 + 0.3 weight percent azelaic 1,4-benzenedicarboxylic acid, dimethyl
acid. ester and 50 mol percent of an
(15) Nylon 46 resins (CAS Reg. No. equimolar mixture of 2,2,4-trimethyl-
50327–77–0) are manufactured by the 1,6-hexanediamine and 2,4,4-trimethyl-
condensation of 1,4-butanediamine and 1,6-hexanediamine.
adipic acid. (b) Specifications:
(16) Nylon resins PA 6–3–T (CAS Reg-
istry No. 26246–77–5) are manufactured
Maximum extractable fraction
in selected solvents
Melting (expressed in percent
point Solubility by weight of resin)
Specific Viscosity No.
Nylon resins (degrees in boiling
gravity (mL/g)
Fahr- 4.2N HC1 95 Ethyl
enheit) percent Ben-
Water ace-
ethyl zene
tate
alcohol
1. Nylon 66 resins .............. 1.14±.015 475–495 Dissolves in .................................. 1.5 1.5 0.2 0.2
1 h.
2. Nylon 610 resins ............ 1.09±.015 405–425 Insoluble .................................. 1.0 2.0 1.0 1.0
after 1 h.
3.1 Nylon 66/610 resins ..... 1.10±.015 375–395 Dissolves in .................................. 1.5 2.0 1.0 1.0
1 h.
4.1 Nylon 6/66 resins, ep- 1.13±.015 440–460 ......do ......... .................................. 2.0 2.0 1.5 1.5
silon-caprolactam mon-
omer content not to ex-
ceed 0.7 percent by
weight.
4.2 Nylon 6/66 resins with 1.14±.015 380–425 ......do ......... .................................. 0.8 1.0 0.5 0.5
combined caprolactam
content greater than 60
percent and residual ep-
silon-caprolactam mon-
omer content not to ex-
ceed 0.4 percent by
weight. For use only as
specified in § 177.1395 of
this chapter (CAS Reg.
No. 24993–04–2).
5.1 Nylon 11 resins for use 1.04±.015 355–375 Insoluble .................................. .30 .35 .25 .3
in articles intended for 1- after 1 h.
time use or repeated use
in contact with food.
5.2 Nylon 11 resins for use 1.04±.015 355–375 ......do ......... .................................. .35 1.60 .35 .40
only:
a. In articles intended for
repeated use in contact
with food.
b. In side-seam cements
for articles intended for
1-time use in contact
with food and which
are in compliance with
§ 175.300 of this chap-
ter.
6.1 Nylon 6 resins .............. 1.15±.015 392–446 Dissolves in .................................. 1.0 2.0 1.0 1.0
1 h.
6.2 Nylon 6 resins for use 1.15±.015 392–446 ......do ......... .................................. 1.5 2.0 1.0 1.0
only in food-contact films
having an average thick-
ness not to exceed 0.001
in.
7. Nylon 66T resins for use 1.16±.015 482–518 Insoluble .................................. 1.0 1.0 .25 .25
only in food-contact films after 1 h.
having an average thick-
ness not to exceed 0.001
in.
289
§ 177.1500 21 CFR Ch. I (4–1–23 Edition)

gravity (mL/g)
Water ace-
ethyl zene
tate
alcohol
8. Nylon 612 resins for use 1.06±.015 406–420 ......do ......... .................................. .50 1.50 .50 .50
only in articles intended
for repeated use in con-
tact with food at tempera-
tures not to exceed 212
°F.
9. Nylon 12 resins for use 1.01±.015 335–355 ......do ......... .................................. 1.0 2.0 1.50 1.50
only:.
a. In food-contact films hav-
ing an average thickness
not to exceed 0.0016
inch intended for use in
contact with nonalcoholic
food under the conditions
of use A (sterilization not
to exceed 30 minutes at
a temperature not to ex-
ceed 250 °F), and B
through H of table 2 of
§ 176.170(c) of this chap-
ter, except as provided in
§ 177.1390(d)
b. In coatings intended for
repeated use in contact
with all food types de-
scribed in table 1 of
ter, except those con-
taining more than 8 per-
cent alcohol, under con-
ditions of use B through
H described in table 2 of
ter.
10.1 Nylon MXD–6 and im- 1.21±0.02 437–491 Dissolves in .................................. 2.0 2.5 1.0 1.0
pact modified Nylon 1h.
MXD–6 film having an
average thickness not to
exceed 40 microns
(0.0016 inch) for use in
processing, handling, and
packaging of food of
types V and IX listed in
table 1 of § 176.170(c) of
this chapter under condi-
tions of use C, D, E, F,
G, and H in table 2 of
§ 176.170(C) of this
chapter.
290

gravity (mL/g)
Water ace-
ethyl zene
tate
alcohol
10.2 Impact modified Nylon 1.21±0.02 437–491 do ............... .................................. 2.0 2.5 1.0 1.0
MXD–6 resins for use as
polymer use as polymer
modifiers in Nylon 6 resin
films complying with
paragraph (a)(6) of this
section, at levels not to
exceed 13 percent by
weight of films whose av-
erage thickness will not
exceed 15 microns (0.6
mils). The finished film is
used for packaging,
transporting, or holding
food, excluding bev-
erages containing more
than 8 percent alcohol
(by volume) at tempera-
tures not to exceed 49
°C (120 °F) (conditions of
use E, F, and G in table
2 of § 176.170(c) of this
chapter).
10.3 Nylon MXD–6 resins 1.22±0.02 455–470 Dissolves in 1.0 1.5 0.2 0.2
for use only as nonfood- 1 h.
contact layers of: (1) Mul-
tilayer films and (2) rigid
plastic containers com-
posed of polypropylene
food-contact and exterior
layers, as defined in
§ 177.1520(c), item 1.1(a)
and 1.1(b), of this chap-
ter. The finished food-
contact laminate, in the
form in which it contacts
food, when extracted with
the food simulating sol-
vent or solvents charac-
terizing the conditions of
the intended use as de-
termined from Table 2 of
ter, shall yield not more
than 0.5 micrograms of
m-xylylenediamine-adipic
acid cyclic monomer per
square inch of food-con-
tact surface, when the
food simulating solvent is
analyzed by any appro-
priate, properly validated
method.
11. Nylon 12T resins for 1.06±0.015 N/A Insoluble .................................. 0.1 ............ 0.5 0.5
use in contact with all after 1
types of food except hour.
those containing more
than 8 percent alcohol.
12. Nylon 6I/6T resins for 1.207±0.1 N/A Insoluble .................................. 0.2 1.0 0.1 0.1
use in contact with all after 1
types of food except al- hour.
coholic beverages con-
cent alcohol.
291
§ 177.1500 21 CFR Ch. I (4–1–23 Edition)

gravity (mL/g)
Water ace-
ethyl zene
tate
alcohol
13.1 Nylon 6/12 resins for 1.06±0.015 260–285 Dissolves in Greater than 140 ..... 2.0 ............ 1.5 1.5
use only in food-contact 1 hour.
films having an average
thickness not to exceed
51 microns (0.002 inch).
The finished film is in-
tended to contact all
foods except those con-
cent ethanol under condi-
tions of use B, C, D, E,
F, G, and H listed in
table 2 of § 176.170(c) of
this chapter.
13.2 Nylon 6/12 resins with 1.10±0.15 380–400 Dissolves in Greater than 160 ..... 0.8 1.0 0.5 0.5
residual epsilon- 1 h.
caprolactam not to ex-
ceed 0.5 percent by
weight and residual
omega-laurolactam not to
exceed 0.1 percent by
this chapter.
13.3 Nylon 6/12 resins with 1.13 ±0.15 400–420 Dissolves in ............................. 1.0 1.5 0.5 0.5
residual epsilon- 1 h.
caprolactam not to ex-
ceed 0.8 percent by
weight and residual
omega-laurolactam not to
exceed 0.1 percent by
this chapter.
14. Nylon 6/69 resins for 1.09±0.02 270–277 .................... >140 using the meth- 3.0
use only as specified in od described in
21 CFR 177.1395 of this § 177.1500(c)(5)(ii)
chapter. of this chapter.
15. Nylon 46 resins for use 1.18±0.015 551–592 Dissolves in .................................. 0.3 0.2 0.2 0.3
only in food-contact 1 h.
membrane filters in-
tended for repeated use.
The finished membrane
filter is intended to con-
tact beverages containing
no more than 13 percent
alcohol, under conditions
of use E, F, and G listed
in table 2 of § 176.170(c)
of this chapter.
16. Nylon resins PA 6–3–T 1.12±0.03 NA Insoluble >110 ......................... 0.007 0.64 0.003 0
for repeated-use (exclud- after 1 h.
ing bottles) in contact
with food of type VIA and
VIB described in table 1
of § 176.170(c) of this
chapter under conditions
of use D through H de-
scribed in table 2 of
ter with a hot-fill tempera-
ture limitation of 40 °C.
292
(c) Nylon modifier—(1) Identity. Co- of Nylon modifiers listed in paragraph

polyester-graft-acrylate copolymer is (c)(1) of this section may include:
the substance 1,4-benzenedicarboxylic (A) Substances generally recognized
acid, polymer with 1,4-butanediol, (E)- as safe for use in food and food pack-
2-butenedioic acid, 1,2-ethanediol, aging;
ethyl 2-propenoate, hexanedioic acid (B) Substances subject to prior sanc-
and 2-propenoic acid, graft (CAS Reg. tion or approval for use in Nylon resins
No. 175419–23–5), and is derived from and used in accordance with such sanc-
grafting of 25 weight percent of acrylic tions or approval; and
polymer with 75 weight percent of co- (C) Optional substances required in
polyester. The copolyester is polym- the production of the additive identi-
erized terephthalic acid (55 mol%), fied in this paragraph and other op-
adipic acid (40 mol%), and fumaric acid tional substances that may be required
(5 mol%) with ethylene glycol (40 to accomplish the intended physical or
mol%) and 1,4-butanediol (60 mol%). technical effect.
The acrylic polymer is made from (d) Analytical methods—(1) Specific
acrylic acid (70 mol%) and ethyl acry- gravity. Specific gravity shall be deter-
late (30 mol%). mined by weighing a 1-gram to 5-gram
(2) Specifications. The finished copoly- sample first in air and then in freshly
ester-graft-acrylate copolymer shall boiled distilled water at 23 °C±2 °C.
meet the following specifications: (2) Melting point. The melting point
(i) Weight average molecular weight shall be determined as follows: Use a
15,000–35,000, hot-stage apparatus. The use of crossed
nicol prisms with a microscope hot
(ii) pH 7.2 to 8.2, and
stage and reading of the thermometer
(iii) Glass transition temperature when the birefringence disappears in-
¥15 to ¥25 °C. creases the accuracy. If the crossed
(3) Conditions of use. (i) Copolyester- nicol apparatus is not available, use
graft acrylate copolymer described in the lowest temperature at which the
paragraph (c)(1) of this section is in- sample becomes transparent or the
tended to improve the adhesive quali- sharp edges or corners of the sample
ties of film. It is limited for use as a become rounded as the melting point.
modifier of Nylon 6 and Nylon 6 modi- In case of doubt as to the onset of
fied with Nylon MXD–6 at a level not melting, the sample is prodded with a
to exceed 0.17 weight percent of the ad- sharp instrument. If it sticks to the
ditive in the finished film. heating block, it is considered to have
(ii) The finished film is used for pack- melted. If the melting point is low, dry
aging, transporting, or holding all the sample in an oven at 85 °C for 24
types of foods under conditions of use B hours in a nitrogen atmosphere then
through H, described in table 2 of repeat the test.
§ 176.170(c) of this chapter, except that (3) Solubility in boiling 4.2N HCl. The
in the case of Nylon 6 films modified test shall be run on a sample approxi-
with Nylon MXD–6 (complying with mately the size of a 1⁄8-inch cube in at
§ 177.1500, item 10.2), the use complies least 25 milliliters of 4.2 normal hydro-
with the conditions of use specified in chloric acid.
table 2. (4) Maximum extractable fraction in se-
(iii) Extractives. Food contact films lected solvents. The procedure for deter-
described in paragraphs (c)(1) of this mining the maximum extractable frac-
section, when extracted with solvent or tion of the nylon resins in selected sol-
solvents prescribed for the type of food vents is as follows:
and under conditions of time and tem- (i) Film should be cut with ordinary
perature specified for the intended use, scissors into pieces of a convenient size
shall yield total extractives not to ex- such as 1⁄4-inch squares, for the extrac-
ceed 0.5 milligram per inch squared of tion tests described in this section. The
food-contact surface when tested by granules of nylon molding powders are
the methods described in § 176.170(d) of in the proper form for the extraction
this chapter. tests. Samples of fabricated articles

(iv) Optional adjuvant substances. The such as pipe, fittings, and other similar
substances employed in the production articles must be cut to approximately
293
§ 177.1520 21 CFR Ch. I (4–1–23 Edition)
the size of the molding powder. This Copies are available from the Center
can be done conveniently by using a for Food Safety and Applied Nutrition
small-scale commercial plastics (HFS–200), Food and Drug Administra-
granulator and cutting the sample tion, 5001 Campus Dr., College Park,
through a screen having 1⁄4-inch mesh. MD 20740, or available for inspection at
Fine particles should be separated from the National Archives and Records Ad-
the cut resin by screening through a 20- ministration (NARA). For information
mesh screen. The material retained on on the availability of this material at
the screen is suitable for the extraction NARA, call 202–741–6030, or go to: http://
tests. www.archives.gov/federal_register/
(ii) The organic solvents must be of code_of_federal_regulations/
American Chemical Society analytical ibr_locations.html.
reagent grade; distilled water is used. (ii) The viscosity number (VN) for
Approximately 30 grams of the pre- Nylon 6/69 and Nylon PA–6–3–T resins
pared sample is weighed to the nearest in a 99 percent cresol solution (5 milli-
milligram. The weighed resin is trans- grams resin per milliliter) shall be de-
ferred to a 500-milliliter round-bottom termined at 25 °C (77 °F) by method ISO
flask equipped with a reflux condenser. 307–1984(E), ‘‘Plastics-Polyamides-De-
Approximately 300-milliliters of sol- termination of Viscosity Number,’’
vent is added to the flask and the con- which is incorporated by reference. The
tents refluxed gently for 8 hours with a availability of this incorporation by
heating mantle. The solvent is then fil- reference is given in paragraph (d)(5)(i)
tered off immediately while still hot, of this section.
using a Buchner funnel approximately
[42 FR 14572, Mar. 15, 1977]
5 inches in diameter, a suction flask,
and a hardened filter paper (Whatman EDITORIAL NOTE: For FEDERAL REGISTER ci-
No. 50 or equivalent). The paper is wet tations affecting § 177.1500, see the List of
with the solvent and a slight suction CFR Sections Affected, which appears in the
applied just before starting the filtra- Finding Aids section of the printed volume
tion. The resin is washed twice with
approximately 100-milliliter portions of § 177.1520 Olefin polymers.
solvent and the combined filtrate and
washings are reduced to approximately The olefin polymers listed in para-
25 milliliters by evaporation at reduced graph (a) of this section may be safely
pressure (50 millimeters to 100 millime- used as articles or components of arti-
ters of mercury, absolute), heating as cles intended for use in contact with
necessary. The contents of the flask food, subject to the provisions of this
are transferred to an evaporation dish section.
(which has been held in a vacuum des- (a) For the purpose of this section,
iccator over anhydrous calcium sulfate olefin polymers are basic polymers
until constant weight has been at- manufactured as described in this para-
tained) and carefully evaporated to graph, so as to meet the specifications
dryness. The weight of the solid residue prescribed in paragraph (c) of this sec-
is determined by difference after hold- tion, when tested by the methods de-
ing in a vacuum desiccator over anhy- scribed in paragraph (d) of this section.
drous calcium sulfate until constant (1)(i) Polypropylene consists of basic
weight has been attained. The percent polymers manufactured by the cata-
of solids extracted is calculated by di- lytic polymerization of propylene.
viding the weight of the solid residue (ii) Propylene homopolymer consists
by the weight of the sample and multi- of basic polymers manufactured by the
plying by 100. catalytic polymerization of propylene
(5) Viscosity number (VN). (i) The vis- with a metallocene catalyst.
cosity number (VN) for Nylon 6/12 resin (2)(i) Polyethylene consists of basic
in a 96 percent sulfuric acid solution (5 polymers manufactured by the cata-
milligrams resin per milliliter) shall be lytic polymerization of ethylene.
determined at 25 °C (77 °F) by method (ii) Fumaric acid-grafted poly-
ISO 307–1984(E), ‘‘Plastics-Polyamides- ethylene (CAS Reg. No. 26877–81–6) con-

Determination of Viscosity Number,’’ sists of basic polymers manufactured
which is incorporated by reference. by the catalytic polymerization of
294
ethylene followed by reaction with fu- units derived from butene-1 with the
maric acid in the absence of free rad- remainder being propylene.
ical initiators. Such polymers shall (d) Olefin basic terpolymers manufac-
contain grafted fumaric acid at levels tured by the catalytic copolymeriza-
not to exceed 2 percent by weight of tion of ethylene, hexene-1, and either
the finished polymer. propylene or butene-1, shall contain
(3) Olefin basic copolymers consist of not less than 85 weight percent poly-
basic copolymers manufactured by the mer units derived from ethylene.
catalytic copolymerization of: (e) Olefin basic copolymers manufac-
(i) Two or more of the 1-alkenes hav- tured by the catalytic polymerization
ing 2 to 8 carbon atoms. Such olefin of ethylene and octene-1, or ethylene,
basic copolymers contain not less than octene-1, and either hexene-1, butene-1,
96 weight-percent of polymer units de- propylene, or 4-methylpentene-1 shall
rived from ethylene and/or propylene, contain not less than 80 weight percent
except that: of polymer units derived from ethyl-
(a)(1) Olefin basic copolymers manu- ene.
factured by the catalytic copolym- (ii) 4-Methylpentene-1 and 1-alkenes
erization of ethylene and hexene-1 or having from 6 to 18 carbon atoms. Such
ethylene and octene-1 shall contain not olefin basic copolymers shall contain
less than 90 weight-percent of polymer not less than 95 molar percent of poly-
units derived from ethylene; mer units derived from 4-
(2) Olefin basic copolymers manufac- methylpentene-1, except that copoly-
tured by the catalytic copolymeriza- mers manufactured with 1-alkenes hav-
tion of ethylene and hexene-1 shall con- ing from 12 to 18 carbon atoms shall
tain not less than 80 but not more than contain not less than 97 molar percent
90 weight percent of polymer units de-
of polymer units derived from 4-
rived from ethylene.
methylpentene-1; or
(3) Olefin basic copolymers manufac-
(iii) Ethylene and propylene that
tured by the catalytic copolymeriza-
may contain as modifiers not more
tion of ethylene and pentene-1 shall
than 5 weight-percent of total polymer
contain not less than 90 weight-percent
of polymer units derived from ethyl- units derived by copolymerization with
ene. one or more of the following mono-
(4) Olefin basic copolymers manufac- mers:
tured by the catalytic polymerization 5-Ethylidine-2-norbornene.
of ethylene and octene-1 shall contain 5-Methylene-2-norbornene.
not less than 50 weight-percent of poly-
mer units derived from ethylene. (iv) Ethylene and propylene that may
contain as a modifier not more than 4.5
(b) Olefin basic copolymers manufac-
tured by the catalytic copolymeriza- weight percent of total polymer units
tion of ethylene and 4-methylpentene-1 derived by copolymerization with 1,4-
shall contain not less than 89 weight- hexadiene.
percent of polymer units derived from (v) Ethylene and butene-1 copolymers
ethylene; (CAS Reg. No. 25087–34–7) that shall
(c)(1) Olefin basic copolymers manu- contain not less than 80 weight percent
factured by the catalytic copolym- of polymer units derived from ethyl-
erization of two or more of the mono- ene.
mers ethylene, propylene, butene-1, 2- (vi) Olefin basic copolymers (CAS
methylpropene-1, and 2,4,4- Reg. No. 61615–63–2) manufactured by
trimethylpentene-1 shall contain not the catalytic copolymerization of
less than 85 weight-percent of polymer ethylene and propylene with 1,4-
units derived from ethylene and/or pro- hexadiene, followed by reaction with
pylene; fumaric acid in the absence of free rad-
(2) Olefin basic copolymers manufac- ical initiators. Such polymers shall
tured by the catalytic copolymeriza- contain not more than 4.5 percent of
tion of propylene and butene-1 shall polymer units deriving from 1,4-
contain greater than 15 but not greater hexadiene by weight of total polymer
than 35 weight percent of polymer prior to reaction with fumaric acid and
295
§ 177.1520 21 CFR Ch. I (4–1–23 Edition)
not more than 2.2 percent of grafted fu- (6) Ethylene-maleic anhydride co-
maric acid by weight of the finished polymers (CAS Reg. No. 9006–26–2) con-
polymer. taining no more than 2 percent by
(vii) Ethylene and 2-norbornene (CAS weight of copolymer units derived from
Reg. No. 26007–43–2) copolymers that maleic anhydride.
shall contain not less than 30 and not (b) The basic olefin polymers identi-
more than 70 mole percent of polymer fied in paragraph (a) of this section
units derived from 2-norbornene. may contain optional adjuvant sub-
(4) Poly(methylpentene) consists of
stances required in the production of
basic polymers manufactured by the
catalytic polymerization of 4- such basic olefin polymers. The op-
methylpentene-1. tional adjuvant substances required in
(5) Polyethylene graft copolymers the production of the basic olefin poly-
consist of polyethylene complying with mers or finished food-contact articles
item 2.2 of paragraph (c) of this section may include substances permitted for
which subsequently has 3a,4,7,7a- such use by applicable regulations in
tetrahydromethyl-4,7- parts 170 through 189 of this chapter,
methanoisobenzofuran-1,3-dione graft- substances generally recognized as safe
ed onto it at a level not to exceed 1.7 in food and food packaging, substances
percent by weight of the finished co- used in accordance with a prior sanc-
polymer. tion or approval, and the following:
Aromatic petroleum hydrocarbon resin, hydrogenated (CAS For use only as an adjuvant at levels not to exceed 25 percent
Reg. No. 88526–47–0), produced by the catalytic polym- by weight in blends with polypropylene complying with para-
erization of aromatic-substituted olefins from distillates of graph (c), item 1.1 of this section. The finished polymer may
cracked petroleum stocks with a boiling point no greater than be used in contact with food Types I, II, IV-B, VI-A through
220 °C (428 °F), and the subsequent catalytic hydrogenation VI-C, VII-B, and VIII identified in table 1 of § 176.170(c) of
of the resulting aromatic petroleum hydrocarbon resin, hav- this chapter and under conditions of use B through H de-
ing a minimum softening point of 110 °C (230 °F), as deter- scribed in table 2 of § 176.170(c) of this chapter; and with
mined by ASTM Method E 28–67 (Reapproved 1982), food Types III, IV-A, V, VII-A, and IX identified in table 1 of
‘‘Standard Test Method for Softening Point by Ring-and-Ball § 176.170(c) of this chapter and under conditions of use D
Apparatus,’’ and a minimum aniline point of 107 °C (225 °F), through G described in table 2 of § 176.170(c) of this chap-
as determined by ASTM Method D 611–82, ‘‘Standard Test ter.
Methods for Aniline Point and Mixed Aniline Point of Petro-
leum Products and Hydrocarbon Solvents,’’ both of which
are incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies are available from the
American Society for Testing and Materials, 100 Barr Harbor
Dr., West Conshohocken, Philadelphia, PA 19428-2959, or
from the Center for Food Safety and Applied Nutrition (HFS–
lege Park, MD 20740, or may be examined at the National
Colorants used in accordance with § 178.3297 of this chapter.
2,5-Dimethyl-2,5-di(tert-butylperoxy)hexane (CAS Reg. No. 78– For use as an initiator in the production of propylene
63–7). homopolymer complying with § 177.1520(c), item 1.1 and
olefin copolymers complying with § 177.1520(c), items 3.1
and 3.2 and containing not less than 75 weight percent of
polymer units derived from propylene, provided that the max-
imum concentration of tert-butyl alcohol in the polymer does
not exceed 100 parts per million, as determined by a method
titled ‘‘Determination of tert-Butyl Alcohol in Polypropylene,’’
which is incorporated by reference. Copies are available
from the Center for Food Safety and Applied Nutrition (HFS–
lege Park, MD 20740, or available for inspection at the Na-
eral_register/code_of_federal_regulations/ibr_locations.html.
296
Methyl methacrylate/butyl acrylate-grafted polypropylene co- For use only at levels not to exceed 6 percent by weight of
polymer containing methyl methacrylate/butyl acrylate-grafted olefin polymers complying with paragraph (c) of this section,
polypropylene (CAS Reg. No. 121510–09–6), methyl meth- items 1.1, 3.1a, 3.2a, and 3.2b, where the copolymers com-
acrylate/butyl acrylate copolymer (CAS Reg. No. 25852–37– plying with items 3.1a, 3.2a, and 3.2b contain not less than
3), methyl methacrylate homopolymer (CAS Reg. No. 9011– 85 weight-percent of polymer units derived from propylene.
14–7), and polypropylene (CAS Reg. No. 9003–07–0), re-
sulting from the reaction of a mixture of methyl methacrylate
and butyl acrylate with polypropylene. The finished product
contains no more than 55 percent by weight of polymer units
derived from methyl methacrylate and butyl acrylate as de-
termined by a method entitled, ‘‘Determination of the Total
Acrylic in PP–MMA/BA Polymers,’’ which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies are available from the Office of Food Addi-
tive Safety, Center for Food Safety and Applied Nutrition
(HFS–200), Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, or may be examined at the
Food and Drug Administration’s Main Library, 10903 New
Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD
20993, 301–796–2039, or at the National Archives and
Records Administration (NARA). For information on the avail-
ability of this material at NARA, call 202–741–6030, or go to:
http://www.archives.gov/federal_register/
Petroleum hydrocarbon resins (cyclopentadiene-type), hydro- For use only as an adjuvant at levels not to exceed 30 percent
genated (CAS Reg. No. 68132–00–3) produced by the ther- by weight in blends with: (1) Polypropylene complying with
mal polymerization of dicyclopentadiene and cyclodiene paragraph (c), item 1.1 of this section, or (2) a copolymer of
codimers (consisting of a mixture of cyclopentadiene, methyl propylene and ethylene containing not less than 94 weight
cyclopentadiene, and C4-C5 acyclic dienes), followed by hy- percent propylene and complying with paragraph (c), item
drogenation and having a ring-and-ball softening point of 119 3.2 of this section. The average thickness of the food-con-
°C minimum as determined by ASTM Method E 28–67 (Re- tact film is not to exceed 0.1 millimeter (0.004 inch). The fin-
approved 1982), ‘‘Standard Test Method for Softening Point ished polymer may be used in contact with (1) Food types I,
by Ring-and-Ball Apparatus,’’ and a minimum viscosity of II, IV-B, VI-A, VI-B, VII-B, and VIII identified in table 1 of
3,000 centipoise, measured at 160 °C, as determined by § 176.170(c) of this chapter and under conditions of use C
ASTM Method D 3236–88, ‘‘Standard Test Method for Ap- through G described in table 2 of § 176.170(c) of this chap-
parent Viscosity of Hot Melt Adhesives and Coating Mate- ter; and (2) food types III, IV-A, V, VI-C, VII-A, and IX identi-
rials,’’ both of which are incorporated by reference in accord- fied in table 1 of § 176.170(c) of this chapter and under con-
ance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are ditions of use D through G described in table 2 of
available from the American Society for Testing and Mate- § 176.170(c) of this chapter.
rials, 100 Barr Harbor Dr., West Conshohocken, Philadel-
phia, PA 19428-2959, or from the Center For Food Safety
and Applied Nutrition (HFS–200), Food and Drug Administra-
tion, 5001 Campus Dr., College Park, MD 20740, or may be
examined at the National Archives and Records Administra-
tion (NARA). For information on the availability of this mate-
rial at NARA, call 202–741–6030, or go to: http://
Polymethylsilsesquioxane (CAS Reg. No. 68554–70–1) ............ For use only as a surface lubricant or anti-blocking agent in
films.
Poly(vinylidene fluoride) homopolymer (CAS Reg. No. 24937– For use only as a processing aid in the production of olefin
79–9), having a melt viscosity of 6 to 37 kilopoise at a shear polymers complying with paragraph (c) of this section at lev-
rate of 100¥1 seconds at 232 °C as determined by ASTM els not to exceed 1.0 percent by weight of the polymer. The
Method D 3835–79 (Reapproved 1983), ‘‘Standard Test finished polymers may be used only under the conditions de-
Method for Rheological Properties of Thermoplastics with a scribed in § 176.170(c) of this chapter, table 2, under condi-
Capillary Rheometer’’ using a capillary of 15:1 L/D, which is tions of use B though H.
incorporated by reference in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies are available from the
Center for Food Safety and Applied Nutrition (HFS–200),
Food and Drug Administration, 5001 Campus Dr., College
Park, MD 20740, or may be examined at the National Ar-
chives and Records Administration (NARA). For information
on the availability of this material at NARA, call 202–741–
6030, or go to: http://www.archives.gov/federal_register/
Polyoxyethylene-grafted polydimethylsiloxane (CAS Reg. No. For use as an extrusion aid in the production of extruded olefin
68937–54–2). polymers that comply with § 177.1520(c) at levels not to ex-
ceed 0.3 percent by weight of the polymer. The finished
polymer is used in contact with foods under conditions of
use B through H described in table 2 of § 176.170 of this
chapter.
297
§ 177.1520 21 CFR Ch. I (4–1–23 Edition)
Triisopropanolamine (CAS Reg. No. 122–20–3) ........................ For use as a Zeigler-Natta-type catalyst deactivator and anti-
oxidant in the production of olefin polymers complying with
§ 177.1520(c), items 2.1, 2.2, and 2.3, and having a min-
imum density of 0.94 grams per cubic centimeter, and co-
polymers complying with § 177.1520(c), items 3.1 and 3.2,
for use in contact with all foods under the following condi-
tions of use: (a) films with a maximum thickness of 0.102
millimeter (0.004 inch) may be used under conditions A
through H defined in table 2 of § 176.170(c) of this chapter;
and (b) articles with thickness greater than 0.102 millimeter
(0.004 inch) may be used under conditions C through G de-
fined in table 2 of § 176.170(c) of this chapter.
Trimethylpyridine and dimethylpyridine mixture having percent For use only as an adjuvant substance in the production of
by weight composition as follows: 2,4,6-trimethylpyridine propylene homopolymers complying with items 1.1, 1.2, and
(CAS Reg. No. 108–75–8), not less than 60 percent; 2,3,6- 1.3, and propylene copolymers complying with items 3.1,
trimethylpyridine (CAS Reg. No. 1462–84–6), not more than and 3.2 of paragraph (c) of this section provided that the ad-
27 percent; 3,5-dimethylpyridine (CAS Reg. No. 591–22–0), juvant is used at a level not to exceed 20 parts per million
not more than 12 percent; and other dimethylpyridines, not by weight of the olefin polymers.
more than 6 percent.
Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. For use only as an extrusion aid in the production of extruded
No. 9011–17–0) having a fluorine content of 65 to 71 per- olefin polymers at levels not to exceed 0.2 percent by weight
cent and a Mooney viscosity of at least 28, as determined by of the polymer. The finished polymers may be used only
a method entitled ‘‘Mooney Viscosity,’’ which is incorporated under the conditions described in § 176.170(c) of this chap-
by reference in accordance with 5 U.S.C. 552(a). Copies are ter, table 2, under conditions of use B through H.
available from the Center for Food Safety and Applied Nutri-
tion (HFS–200), Food and Drug Administration, 5001 Cam-
pus Dr., College Park, MD 20740, or may be examined at
the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA,
call 202–741–6030, or go to: http://www.archives.gov/fed-
Vinylidene fluoride-hexafluoropropene copolymer (CAS Reg. For use only as a processing aid in the production of olefin
No. 9011–17–0), having a vinylidene fluoride content of not polymers complying with paragraph (c) of this section at lev-
less than 87 percent but less than 100 percent by weight els not to exceed 1.0 percent by weight of the polymer. The
and a melt viscosity of 12 to 27 kilopoise at a shear rate of finished polymers may be used only under the conditions de-
100¥1 seconds at 232 °C as determined by ASTM Method D scribed in § 176.170(c) of this chapter, table 2, under condi-
3835–79 (Reapproved 1983), ‘‘Standard Test Method for tions of use B though H.
Rheological Properties of Thermoplastics with a Capillary
Rheometer’’ using a capillary of 15:1 L/D, which is incor-
porated by reference in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. Copies are available from the Center for
Food Safety and Applied Nutrition (HFS–200), Food and
Drug Administration, 5001 Campus Dr., College Park, MD
20740, or may be examined at the National Archives and
Records Administration (NARA). For information on the avail-
ability of this material at NARA, call 202–741–6030, or go to:
(c) Specifications:
Maximum extract- Maximum soluble
Melting Point able fraction (ex- fraction (ex-
(MP) or softening pressed as per- pressed as per-
Olefin polymers Density point (SP) (De- cent by weight of cent by weight of
grees Centi- the polymer) in N- polymer) in xy-
grade)— hexane at speci- lene at specified
fied temperatures temperatures
1.1a. Polypropylene described in paragraph 0.880–0.913 MP: 160°–180 °C 6.4 pct at reflux 9.8 pct at 25 °C
(a)(1)(i) of this section temperature
1.1b. Propylene homopolymer described in 0.880–0.913– MP: 150°–180 °C 6.4 pct at reflux 9.8 pct at 25 °C
paragraph (a)(1)(ii) of this section temperature
1.2. Polypropylene, noncrystalline; for use 0.80–0.88
only to plasticize polyethylene described
under items 2.1 and 2.2 of this table, pro-
vided that such plasticized polymers meet
the maximum extractable fraction and max-
imum soluble fraction specifications pre-

scribed for such basic polyethylene
298

1.3. Polypropylene, noncrystalline, for use 0.80–0.88 SP:115°–138 °C.

only: To plasticize polypropylene described
by item 1.1 of this table, provided that such
plasticized polymers meet the maximum ex-
tractable fraction and maximum soluble
fraction specifications prescribed for such
basic polypropylene, and further provided
that such plasticized polypropylene contacts
food only of the types identified in
§ 176.170(c) of this chapter, table 1, under
Types I, II, IV-B, VI-B, VII-B, and VIII; and
for use at levels not to exceed 50 pct by
weight of any mixture employed as a food-
contact coating provided such coatings con-
tact food only of the types identified in
Types I, II, IV-B, VI-B, VII-B, and VIII
2.1. Polyethylene for use in articles that con- 0.85–1.00 ............................. 5.5 pct at 50 °C 11.3 pct at 25 °C
tact food except for articles used for pack-
ing or holding food during cooking
2.2. Polyethylene for use in articles used for 0.85–1.00 ............................. 2.6 pct at 50 °C Do.
packing or holding food during cooking
2.3. Polyethylene for use only as component 0.85–1.00 ............................. 53 pct at 50 °C 75 pct at 25 °C
of food-contact coatings at levels up to and
including 50 percent by weight of any mix-
ture employed as a food-contact coating
2.4. Olefin polymers described in paragraph
(a)(2)(ii) of this section, having a melt flow
index not to exceed 17 grams/per 10 min-
utes as determined by the method de-
scribed in paragraph (d)(7) of this section,
for use in blends with other polymers at lev-
els not to exceed 20 percent by weight of
total polymer, subject to the limitation that
when contacting food of types III, IV-A, V,
VI-C, VII-A, and IX identified in § 176.170(c)
of this chapter, Table 1, the polymers shall
be used only under conditions of use C, D,
E, F, and G, described in § 176.170(c) of
this chapter, Table 2.
3.1a. Olefin copolymers described in para- 0.85–1.00 ............................. 5.5 pct at 50 °C 30 pct at 25 °C
graph (a)(3)(i) of this section for use in arti-
cles that contact food except for articles
used for packing or holding food during
cooking; except olefin copolymers described
in paragraph (a)(3)(i)(a)(3) of this section
and listed in item 3.1c of this table and
olefin copolymers described in paragraph
(a)(3)(i)(e) of this section and listed in item
3.1b of this table
3.1b. Olefin copolymers described in para- 0.9–1.00 ............................. Do Do.
graph (a)(3)(i)(e) of this section for use in
contact with food only under conditions of
use D, E, F, G, and H described in
§ 176.170(c) of this chapter, table 2
3.1c. Olefin copolymers described in para- Not less than 0.92
graph (a)(3)(i)(a)(3) of this section for use in
contact with food only under conditions of
use B, C, D, E, F, G, and H described in
§ 176.170(c) of this chapter, table 2; except
that such copolymers when used in contact
with food of the types identified in
§ 176.170(c), table 1, under types III, IVA,
V, VIIA, and IX, shall be used only under
conditions of use D, E, F, and G described

in § 176.170(c) of this chapter, table 2
299
§ 177.1520 21 CFR Ch. I (4–1–23 Edition)

3.2a. Olefin copolymers described in para- 0.85–1.00 ............................. 2.6 pct at 50 °C Do.
graph (a)(3)(i) of this section for use in arti-
cles used for packing or holding food during
cooking; except olefin copolymers described
in paragraph (a)(3)(i)(c)(2) of this section
and listed in item 3.2b of this table; except
that olefin copolymers containing 89 to 95
percent ethylene with the remainder being
4-methyl-pentene-1 contacting food Types
III, IVA, V, VIIA, and IX identified in
§ 176.170(c) of this chapter, table 1, shall
not exceed 0.051 millimeter (mm) (0.002
inch (in)) in thickness when used under
conditions of use A and shall not exceed
0.102 mm (0.004 in) in thickness when
used under conditions of use B, C, D, E,
and H described in § 176.170(c) of this
chapter, table 2. Additionally, olefin copoly-
mers described in (a)(3)(i)(a)(2) of this sec-
tion may be used only under conditions of
use B, C, D, E, F, G, and H described in
§ 176.170(c) of this chapter, table 2, in con-
tact with all food types identified in
§ 176.170(c) of this chapter, table 1
3.2b. Olefin copolymers described in para- Do.
graph (a)(3)(i)(c)(2) of this section have a
melt flow index no greater than 10 grams
per 10 minutes as determined by the meth-
od described in paragraph (d)(7) of this sec-
tion, and the thickness of the finished poly-
mer contacting food shall not exceed 0.025
mm (0.001 in). Additionally, optional adju-
vants permitted for use in olefin copolymers
complying with item 3.2a of this table may
be used in the production of this copolymer
3.2c. Olefin copolymers described in para- 0.85–0.92
graph (a)(3)(i)(a)(4) of this section have a
melt flow index no greater than 50 grams
per 10 minutes as determined by the meth-
od described in paragraph (d)(7) of this sec-
tion. Articles manufactured using these
polymers may be used with all types of food
under conditions of use C through H as de-
scribed in table 2 of § 176.170(c) of this
chapter
3.3a. Olefin copolymers described in para-
graph (a)(3)(ii) of this section and manufac-
tured with 1-alkenes having from 6 to 10
carbon atoms
3.3b. Olefin copolymers described in para-
graph (a)(3)(ii) of this section, provided that
such olefin polymers have a melt tempera-
ture of 220 °C to 250 °C (428 °F to 482 °F)
as determined by the method described in
paragraph (d)(8) of this section and min-
imum intrinsic viscosity of 1.0 as determined
in paragraph (d)(9) of this section.
300

3.4. Olefin copolymers, primarily non-crys- 0.85–0.90

talline, described in par. (a)(3)(iii) of this
section provided that such olefin polymers
have a minimum viscosity average molec-
ular weight of 120,000 as determined by the
method described in par. (d)(5) of this sec-
tion and a minimum Mooney viscosity of 35
as determined by the method described in
par. (d)(6) of this section, and further pro-
vided that such olefin copolymers contact
food only of the types identified in
Types I, II, III, IV-B, VI, VII, VIII, and IX
3.5. Olefin copolymers, primarily non-crys- 0.85–0.90
talline, described in paragraph (a)(3)(iv) of
this section, provided that such olefin poly-
mers have a minimum viscosity average
molecular weight of 95,600 as determined
by the method described in paragraph
(d)(5) of this section, and further provided
that such olefin polymers are used only in
blends with olefin polymers described under
items 1.1, 2.1, and 2.2 of this table at a
maximum level of 25 pct by weight, and
provided that such olefin copolymers con-
tact food only of the types identified in
§ 176.170 (c) of this chapter, table 1, under
Types I, II, IV-B, VI, VII-B, and VIII at tem-
peratures not exceeding 190 °F
3.6. Olefin copolymers described in para- Not less than 0.88
graph (a)(3)(v) of this section for use in
blends with olefin polymer resins have a
melt flow index no greater than 5 grams/10
minutes as determined by the method de-
scribed in paragraph (d)(7) of this section
and the thickness of the finished blends
shall not exceed 0.1 millimeter (0.004 inch).
The ethylene/butene-1 copolymer may be
used subject to the following conditions: (1)
For use at a level not to exceed 20 weight
percent in polypropylene as described
under item 1.1 of this table. (2) For use at a
level not to exceed 40 weight percent in
polyethylene as described under items 2.1
and 2.2 of this table. (3) For use at a level
not to exceed 40 weight percent in olefin
copolymers as described under items 3.1
and 3.2 of this table
301
§ 177.1520 21 CFR Ch. I (4–1–23 Edition)

3.7. Ethylene/propylene copolymers, meeting Not less than 0.86

the identity described in paragraph (a)(3)(i)
of this section, containing not less than 80
mole-percent of polymer units derived from
ethylene and having a minimum viscosity
average molecular weight of 95,000 as de-
termined by the method described in para-
graph (d)(5) of this section, and a minimum
Mooney viscosity of 13 as determined by
the method described in paragraph (d)(6) of
this section. Ethylene/propylene copolymers
described in this item 3.7 are to be used
only in blends with other olefin polymers
complying with this section, at levels not to
exceed 30 percent by weight of the total
polymer blend, and in contact with food only
of types identified in § 176.170(c) of this
chapter, Table 1, under Types I, II, III, IV-B,
VI, VII, VIII, and IX. Additionally, optional
adjuvants permitted for use in olefin copoly-
mers complying with item 3.4 of this table
may be used in the production of this
copolymer
3.8. Olefin polymers described in paragraph
(a)(3)(vi) of this section, having a melt flow
index not to exceed 9.2 grams per 10 min-
utes as determined by the method de-
scribed in paragraph (d)(7) of this section,
for use in blends with other polymers at lev-
els not to exceed 8 percent by weight of
total polymer, subject to the limitation that
when contacting food of types III, IV-A, V,
VI-C, VII-A, and IX, identified in
§ 176.170(c) of this chapter, Table 1, the
polymers shall be used only under condi-
tions of use C, D, E, F, and G, described in
§ 176.170(c) of this chapter, Table 2.
3.9. Olefin copolymers described in paragraph Not less than 1.0
(a)(3)(vii) of this section may only be used
in contact with dry foods, Type VIII, as iden-
tified in § 176.170(c) of this chapter, Table 1
4. Poly(methylpentene) 0.82–0.85 MP: 235°–250 °C 6.6 pct at reflux 7.5 pct at 25 °C
temperature
5. Polyethylene copolymer described in para- Not less than 0.94 ............................. 0.45 pct at 15 °C 1.8 pct at 25 °C
graph (a)(5) of this section and having a
melt index not to exceed 2, for use, either
alone or in blends with other olefin poly-
mers, subject to the limitation that when
contacting foods of types III, IV-A, V, VI-C,
VII-A, VIII, and IX identified in § 176.170(c)
of this chapter, table 1, the thickness of the
film (in mils) containing the polyethylene
graft copolymer times the concentration of
the polyethylene graft copolymer shall not
exceed a value of 2
6. Ethylene-maleic anhydride copolymers de- 0.92 or greater ........................ 1.36 pct at 50 °C 2.28 pct at 25 °C
scribed in paragraph (a)(6) of this section
for use as the adhesive component in multi-
laminate structures, or as the sealant layer
in flexible packaging, in contact with food at
temperatures not exceeding 49 °C (120 °F)
(d) The analytical methods for deter- this section are as follows, and are ap-
mining whether olefin polymers con- plicable to the basic polymer in film
form to the specifications prescribed in form not exceeding 4 mils in thickness.
302
The film to be tested shall be cut into polypropylene, and poly(methylpentene).

approximately 1-inch squares by any A sample is refluxed in the solvent for
convenient method that avoids con- 2 hours and filtered at the boiling
tamination by dust, dirt, or grease point. The filtrate is evaporated and
(NOTE: Do not touch samples with bare the total residue weighed as a measure
fingers—use forceps to hold or transfer of the solvent extractable fraction.
samples). (a) Apparatus. (1) Erlenmeyer flasks,
(1) Density. Density shall be deter- 250-milliliter, with ground joint.
mined by ASTM method D1505–68 (Re- (2) Condensers, Allihn, 400-millimeter
approved 1979), ‘‘Standard Test Method jacket, with ground joint.
for Density of Plastics by the Density- (3) Funnels, ribbed 75-millimeter di-
Gradient Technique,’’ which is incor- ameter, stem cut to 40 millimeters.
porated by reference. Copies may be (4) Funnels, Buchner type, with
obtained from the American Society
coarse-porosity fritted disc, 60-milli-
for Testing Materials, 100 Barr Harbor
meter diameter.
Dr., West Conshohocken, Philadelphia,
(5) Bell jar for vacuum filtration into
PA 19428-2959, or may be examined at
the National Archives and Records Ad- beaker.
ministration (NARA). For information (b) Reagent. n-Hexane, commercial
on the availability of this material at grade, specific gravity 0.663–0.667 (20 °C/
NARA, call 202–741–6030, or go to: http:// 20 °C), boiling range 66 °C-69 °C, or
www.archives.gov/federal_register/ equivalent.
code_of_federal_regulations/ (c) Procedure. Weigh 1 gram of sample
ibr_locations.html. accurately and place in a 250-milliliter
(2) Melting point or softening point—(i) Erlenmeyer flask containing two or
Melting point. The melting point shall three boiling stones. Add 100 milliliters
be determined by ASTM method D2117– of solvent, attach the flask to the con-
82, ‘‘Standard Test Method for Melting denser (use no grease), and reflux the
Point of Semicrystalline Polymers by mixture for 2 hours. Remove the flask
the Hot Stage Microscopy Method,’’ from the heat, disconnect the con-
which is incorporated by reference. The denser, and filter rapidly, while still
availability of this incorporation by hot, through a small wad of glass wool
reference is given in paragraph (d)(1) of packed in a short-stem funnel into a
this section. tared 150-millimeter beaker. Rinse the
(ii) Softening point. The softening flask and filter with two 10-milliliter
point shall be determined by ASTM portions of the hot solvent, and add the
method E28–67 (Reapproved 1982), rinsings to the filtrate. Evaporate the
‘‘Standard Test Method for Softening filtrate on a stream bath with the aid
Point by Ring-and-Ball Apparatus,’’ of a stream of nitrogen. Dry the res-
which is incorporated by reference. The idue in a vacuum oven at 110 °C for 2
availability of this incorporation by hours, cool in a desiccator, and weigh
reference is given in paragraph (d)(1) of to the nearest 0.0001 gram. Determine
this section. the blank on 120 milliliters of solvent
(3) Maximum extractable fraction in n- evaporated in a tared 150-milliliter
hexane—(i) Olefin copolymers described beaker. Correct the sample residue for
in paragraph (a)(3)(ii) of this section, this blank if significant. Calculation:
Grams of residue
= Percent extractable with n-hexane.
Grams of sample × 100
(ii) Olefin copolymers described in para- residue weighed as a measure of the

graph (a)(3)(i) of this section and poly- solvent extractable fraction. Alter-
ethylene. A preweighed sample is ex- natively, the sample is reweighed after
tracted at 50 °C for 2 hours and filtered. the extraction period to give a measure
The filtrate is evaporated and the total of the solvent extractable fraction. The
303
ER01JA93.398</GPH>
§ 177.1520 21 CFR Ch. I (4–1–23 Edition)
maximum n-hexane-extractable frac- vent temperature has reached 50 °C,

tion may be determined by the meth- disconnect the heater, remove the resin
ods set forth in paragraphs (d)(3)(ii)(a) kettle from the heating jacket, and de-
through (d)(3)(ii)(i) of this section. cant the solvent, while still warm,
(a) Extraction apparatus. Two-liter, through a coarse filter paper placed on
straight-walled, Pyrex (or equivalent) top of a fritted-glass funnel, collecting
resin kettles, fitted with three-hole the filtrate in a tared, glass-stoppered
ground-glass covers are most conven- Erlenmeyer flask of 1-liter capacity.
ient for this purpose. The cover is Determine the weight of the filtrate re-
fitted with a thermometer, a gas-tight covered to the nearest gram. Recovery
stirrer driven by an air motor or explo- should be at least 90 percent of the
sion-proof electric motor, and a reflux original solvent. Losses due to evapo-
condenser. The kettle is fitted with an ration during heating and filtering
electric heating mantle of appropriate have been found not to exceed 10 per-
size and shape, which is controlled by a cent. Transfer about half of the solvent
variable-voltage transformer. filtrate to a 1-liter beaker placed on an
(b) Evaporating apparatus. Rapid opening in the steam bath and imme-
evaporation of large volumes of solvent diately cover with the special ‘‘gas’’
requires special precautions to prevent cover, the inlet tube of which has been
contamination by dust. This is facili- attached with flexible tetrafluoro-
tated by a special ‘‘gas’’ cover con- ethylene tubing to a source of high-pu-
sisting of an inverted flat Pyrex crys-
rity nitrogen in series with a stainless
tallizing dish of an appropriate size (190
steel heating coil immersed directly in
millimeters × 100 millimeters) to fit a
the body of the steam bath. Maintain a
1-liter beaker. Through the center of
positive flow of warm nitrogen gas
the dish are sealed an inlet tube for
throughout the evaporation of the sol-
preheated, oxygen-free nitrogen, and
an outlet tube located 1 inch off center. vent, adding the remainder of the fil-
Nitrogen is fed from the supply source trate from the Erlenmeyer flask as the
through a coil of 1⁄4-inch stainless steel evaporation proceeds. When the volume
tubing immersed in the same steam of the solvent has been reduced to
bath used to supply heat for solvent about 50 milliliters, transfer the con-
evaporation. All connections are made centrated liquid to a previously tared
with flexible tetrafluoroethylene tub- weighing dish of suitable size. Wash the
ing. beaker twice with 20–30 milliliter por-
(c) Reagents—(1) n-Hexane. Spectro- tions of warm solvent, adding the
grade n-hexane. washings to the weighing dish while
(2) Nitrogen. High-purity dry nitrogen continuing to evaporate the remainder
containing less than 10 parts per mil- of the solvent under the gas cover with
lion of oxygen. its flow of warm nitrogen directed to-
(d) Procedure. Transfer 2.5 grams (ac- ward the center of the dish. In the
curately weighed to nearest 0.001 gram) event that an insoluble residue that
of the polymer to the resin kettle. Add cannot be removed with warm solvent
1 liter of solvent and clamp top in posi- remains in the beaker, it may be nec-
tion. Start water flowing through jack- essary to heat with a small amount of
et of the reflux condenser and apply air a higher boiling solvent such as ben-
pressure to the stirring motor to zene or toluene, transferring these
produce vigorous agitation. Turn on washings to the weighing dish before
heating jacket with transformer set at final evaporation to dryness. Transfer
a predetermined voltage to bring the the weighing dish with its residue to a
temperature of the contents to 50 °C vacuum desiccator, and allow it to re-
within 20–25 minutes. As the thermom- main overnight (at least 12 hours),
eter reading approaches 45 °C–47 °C, re- after which the net weight of the dry
duce the voltage to the predetermined residue is determined to the nearest
setting that will just maintain the 0.0001 gram. Correct the result for any
temperature at 50 °C. Do not overshoot solvent blank equivalent to the non-
the prescribed temperature. Should volatile matter determined to be con-

this occur discard the test and start tained in the amount of solvents used
afresh. Exactly 2 hours after the sol- in the test.
304
(e) Extraction apparatus for alternate should be prepared by the same process
method. Two-liter extraction vessel, as will be used with the production
such as a resin kettle or round bottom resin. Using gloves and metal tweezers
flask, fitted with an Allihn condenser to avoid sample contamination, cut
(size C), a 45/50 male joint with a Teflon about 2.7 grams of the prepared film (4
sleeve, and a Teflon coated stir bar. mils or less in thickness) into about 1-
Water bath maintained at 49.5 °C ±0.5 inch squares using clean sharp scissors.
°C containing a submersible magnetic Proceed with Option 1 or 2.
stirrer motor with power supply. Other Option 1. Using tweezers and noting
suitable means of maintaining tem- the number of film pieces, transfer 2.5
perature control, such as electric heat- grams (accurately weighed to 0.1 milli-
ing mantles, may be used provided that
gram) of polymer to the extraction ves-
the temperature range can be strictly
sel. Extract the film sample for 2
maintained.
hours. Allow the vessel to cool and fil-
(f) Sample basket (Optional). A per-
ter the contents through a fritted por-
forated stainless steel cylindrical bas-
ket that is approximately 1.5 inches in celain funnel. Wash the film pieces
diameter, 1.6 inches high, and has per- with fresh n-hexane, aspirate to dry-
forations of 0.125 inches in diameter for ness, and transfer, using tweezers, to a
33 holes/in2, or 40 percent open area. beaker. Recount the film pieces to
The basket should pass freely through verify that none were lost during the
the 45/50 female joint of the extraction transfer. Place the beaker in the vacu-
flask. A No. 6–32 stainless steel eye- um oven for 2 hours at 80 °C ±5 °C. After
bolt is attached to the lid for posi- 2 hours, remove and place in a desic-
tioning the basket in the extraction cator to cool to room temperature
vessel. The positioning rod, approxi- (about 1 hour). After cooling, reweigh
mately 18 inches long and made from the film pieces to the nearest 0.1 milli-
1⁄16 inch outside diameter 316 stainless gram. Calculate the percent hexane-
steel welding rod or equivalent and extractables content from the weight
hooked at both ends, is used to position loss of the original sample. Multiply
the basket in the extraction apparatus. the result by 0.935 and compare with
(g) Vacuum oven. Capable of main- extraction limits in paragraph (c) of
taining 80 °C ±5 °C and a minimum of this section. Repeat the above proce-
635 millimeters of mercury pressure. dure for successive samples.
(h) Reagents. n-Hexane, reagent or Option 2. Transfer 2.5±0.05 grams of
spectrograde, aromatic free (less than 1 the prepared 1-inch film sections into a
milligram per liter), minimum 85 per- tared sample basket and accurately
cent n-hexane. This reagent may be reweigh to the nearest 0.1 milligram.
used until it contains a maximum of 1.5 Carefully raise the condenser until the
grams polyolefin extractables or has hook on the positioning rod is above
been used for 12 determinations. the neck of the 2-liter extraction ves-
(i) Procedure. Assemble the extraction
sel. The basket should be totally below
vessel, condenser, and magnetic stir
the level of n-hexane solvent. Extract
bar. Add n-hexane (1 liter) to the ex-
the sample resin film for 2 hours and
traction vessel and clamp the assembly
into a water bath set at 49.5 °C ±0.5 °C. then raise the basket above the solvent
Start the water flowing through the level to drain momentarily. Remove
jacket of the reflux condenser. Adjust the basket and rinse the contents by
the air flow through the stirring motor immersing several times in fresh n-
to give a smooth and uniform stir rate. hexane. Allow the basket to dry be-
Allow the n-hexane to preheat for 1 tween rinsings. Remove the excess sol-
hour to bring the temperature to 49.5 vent by briefly blowing the basket with
°C±0.5 °C. Temperature is a critical fac- a stream of nitrogen or dry air. Place
tor in this analysis and it must not the basket in the vacuum oven for 2
vary more than 1 °C. If the temperature hours at 80 °C ±5 °C. After 2 hours, re-
exceeds these limits, the test must be move and place in a desiccator to cool
discontinued and restarted. Blown, to room temperature (about 1 hour).

compression molded, or extrusion cast After cooling, reweigh the basket to
films can be tested. Ideally, the film the nearest 0.1 milligram. Calculate
305
§ 177.1520 21 CFR Ch. I (4–1–23 Edition)
the percent hexane extractables con- thylamine in 1 liter of industrial grade

tent from the weight loss of the origi- xylene having specific gravity 0.856–
nal sample. Multiply the result by 0.935 0.867 (20 °C/20 °C) and boiling range 123
and compare with extraction limits in °C–160 °C.
paragraph (c) of this section. Repeat (c) Procedure. Weigh 1 to 2 grams of
the above procedure for successive sample to the nearest 0.001 gram and
samples. The same solvent charge place in a 125-milliliter Pyrex reagent
should remain clear and can be used for bottle containing a 1-inch long tetra-
at least 12 determinations. Applica- fluoroethylene-resin-coated stirring
tions of solvent reuse should be con- bar. Add 100 milliliters of solvent, set
firmed for each resin type before use. the stopper in lightly, and place the
(4) Maximum soluble fraction in xy- bottle in the heating mantle or alu-
lene—(i) Olefin copolymers described in minum block maintained at a tempera-
paragraph (a)(3)(ii) of this section, poly- ture of 120 °C, and stir with a magnetic
propylene, and poly(methylpen-tene). A stirrer until the sample is completely
sample is dissolved completely in xy- dissolved. Remove the bottle from the
lene by heating and stirring in a bottle heat and allow it to cool 1 hour in the
with little free space. The solution is air, without stirring. Then place the
allowed to cool without stirring, bottle in a water bath maintained at 25
whereupon the insoluble portion pre- °C ±0.5 °C, and allow to stand 1 hour
cipitates and is filtered off; the total without stirring. Next, remove the bot-
solids content of the filtrate is then de- tle from the water bath, shake, and
termined as a measure of the soluble pour part of the contents into the
fraction. coarse-porosity fritted-glass funnel.
(a) Apparatus. (1) Pyrex (or equiva- Apply suction, and draw 30–40 milli-
lent) reagent bottle, 125-milliliter, liters of filtrate through, adding more
glass-stoppered. slurry to the funnel, and catching the
(2) Heating mantle of size for 150-mil- filtrate in a large test tube. (If the
liliter beaker (or suitable aluminum slurry is hard to filter, add 10 grams of
block to fit the 125-milliter bottle de- diatomaceous earth filter aid to the
scribed in paragraph (d)(4)(i)(a)(1) of bottle and shake vigorously just prior
this section. to the filtration.) Pipet a suitable ali-
(3) Magnetic stirrer for use under the quot (preferably 20 milliliters) of the
heating mantle (combination magnetic filtrate into a tared aluminum dispos-
stirrer and hotplate may be used if alu- able dish. Place the dish on a steam
minum block is used in place of heat- bath covered with a fresh sheet of alu-
ing mantle). minum foil and invert a short-stemmed
(4) Variable-voltage transformer, 7.5 4-inch funnel over the dish. Pass nitro-
amperes. gen (heated if desired) down through
(5) Tetrafluoroethylene-resin-coated the funnel at a rate sufficient to just
stirring bar, 1-inch long. ripple the surface of the solvent. When
(6) Constant temperature water bath the liquid has evaporated, place the
maintained at 25 °C±0.5 °C. dish in a vacuum oven at 140 °C and
(7) Aluminum dishes, 18 millimeters × less than 50 millimeters mercury pres-
60 millimeters, disposable. sure for 2 hours. Cool in a desiccator
(8) Funnel, Buchner type, with and weigh. (Note: If the residue value
coarse-porosity fritted disc, 30–60 milli- seems high, redry in the vacuum oven
meter diameter. for one-half hour to ensure complete
(b) Reagent. Xylene with antioxidant. removal of all xylene solvent.) Calcula-
Dissolve 0.020 gram of phenyl-b- naph- tion:
Grams of residue 100 milliters

× × 100 = Percent soluble in xylene
Grams of sample volume of aliquot in milliliters
306
ER01JA93.399</GPH>
(ii) Olefin copolymers described in para- reflux condenser and apply full voltage
graph (a)(3)(i) of this section and poly- (115 volts) to the heating mantle. When
ethylene. A sample is extracted in xy- the xylene starts to boil, reduce the
lene at reflux temperature for 2 hours voltage to a level just sufficient to
and filtered. The filtrate is evaporated maintain reflux. After refluxing for at
and the total residue weighed as a least 2 hours, disconnect the power
measure of soluble fraction. source to the mantle, remove the ket-
(a) Apparatus—(1) Extraction appa- tle, and allow to cool in air until the
ratus. Two-liter, straight-walled Pyrex temperature of the contents drops to 50
(or equivalent) resin kettles, fitted °C, after which the kettle may be rap-
with ground-glass covers, are most con- idly cooled to 25 °C–30 °C by immersing
venient for this purpose. The cover is in a cold water bath. Transfer the ket-
equipped with a thermometer and an tle to a constant temperature bath set
efficient reflux condenser. The kettle is to maintain 25 °C ±0.1 °C, and allow to
fitted with an electric heating mantle equilibrate for a least 1 hour (may be
of appropriate size and shape which is left overnight if convenient). Break up
controlled by a variable-voltage trans- any precipitated polymers that may
former. have formed, and decant the xylene so-
(2) Constant temperature water bath. It lution successively through a fast filter
must be large enough to permit immer- paper and then through a fritted-glass
sion of the extraction kettle and set to filter into a tared 1-liter Erlenmeyer
maintain 25 °C ±0.1 °C. flask, collecting only the first 450 mil-
(3) Evaporating apparatus. Gas cover liliters—500 milliliters of filtrate (any
consisting of a flat Pyrex crystallizing attempt to collect more of the xylene
dish (190 millimeters × 100 millimeters) solution usually results in clogging the
inverted to fit over a 1-liter beaker filter and risking losses). Reweigh the
with 8-millimeter gas inlet tube sealed Erlenmeyer flask and calculate the
through center and an outlet tube 1 weight of the filtrate obtained to the
inch off center. The beaker with gas nearest 0.1 gram. Transfer the filtrate,
cover is inserted in an electric heating quantitatively, from the Erlenmeyer
mantle equipped with a variable-volt- flask to the 1-liter beaker, insert the
age transformer. The outlet tube is at- beaker in its heating mantle, add a
tached to an efficient condenser glass-coated magnetic stirring bar, and
mounted on a receiving flask for sol- mount the gas cover in place, con-
vent recovery and having an outlet for necting the inlet tube to the nitrogen
connection to an aspirator pump. The source and the outlet to the condenser
heating mantle (with the beaker) is of the receiving flask. Start a flow of
mounted on a magnetic stirring device. nitrogen (2 to 3 liters per minute) into
An infrared heat lamp is mounted the gas cover and connect an aspirator
vertically 3–4 inches above the gas to the receiver using a free-flow rate
cover to prevent condensation of the equivalent to 6–7 liters of air per
solvent inside the cover. Make all con- minute. With the infrared lamp on, ad-
nections with flexible tetrafluoro- just the voltage to the heating mantle
ethylene tubing. to give a distillation rate of 12–13 milli-
(b) Reagents—(1) Xylene. American liters per minute when the magnetic
Chemical Society reagent grade that stirrer is revolving just fast enough to
has been redistilled through a promote good boiling. When the vol-
fractionating column to reduce the ume of solvent in the beaker has been
nonvolatile residue. reduced to 30–50 milliliters, transfer
(2) Nitrogen. High-purity dry nitrogen the concentrated extractive to a suit-
containing less than 104 parts per mil- able weighing dish that has been pre-
lion oxygen. viously tared (dry). Rinse the beaker
(c) Procedure. Transfer 5 grams ±0.001 twice with 10–20 milliliter portions of
gram of sample to the resin kettle, add fresh xylene, adding the rinsings to the
1,000 milliliters (840 grams) of xylene, weighing dish. Evaporate the remain-
and clamp top in position after insert- der of the xylene on an electric
ing a piece of glass rod to prevent hotplate set at low heat under the gas
bumping during reflux. Start water cover with a stream of nitrogen di-
flowing through the jacket of the rected toward the center of the dish.
307
§ 177.1520 21 CFR Ch. I (4–1–23 Edition)
Avoid any charring of the residue. termined at 100 °C. The apparatus con-
Transfer the weighing dish to a vacu- taining the sample is warmed for 1
um desiccator at room temperature minute, run for 8 minutes, and vis-
and allow to remain under reduced cosity measurements are then made.
pressure for at least 12 hours (over- (7) Melt flow index. The melt flow
night), after which determine the net index of olefin polymers described
weight of the residue to the nearest below shall be determined by ASTM
0.0001 gram. Correct the result for non- method D–1238–82, ‘‘Standard Test
volatile solvent blank obtained by Method for Flow Rates of Thermo-
evaporating the equivalent amount of plastics by Extrusion Plastometer,’’
xylene under identical conditions. Cal- which is incorporated by reference in
culate the weight of residue originally accordance with 5 U.S.C. 552(a). The
present in the total weight of solvent availability of this incorporation by
(840 grams), using the appropriate fac- reference is given in paragraph (d)(1) of
tor based on the weight of filtrate this section. The olefin polymers and
evaporated. test conditions and procedures are as
(5) Viscosity average molecular weight follows:
olefin copolymers described in paragraphs List of polymers Conditions/procedures
(a)(3)(iii) and (iv) of this section. The vis-
cosity average molecular weight shall Olefin copolymers described in para- Condition L, proce-
graph (a)(3)(i)(c)(2) of this section. dure A.
be determined from the kinematic vis- Olefin copolymers described in para- Condition E, proce-
cosity (using ASTM method D445–74, graph (a)(3)(v) of this section. dure A.
‘‘Test for Kinematic Viscosity of Olefin polymers described in para- Condition E, proce-
graph (a)(2)(ii) of this section. dure A.
Transparent and Opaque Liquids’’ (Re- Olefin polymers described in para- Condition E, proce-
vised 1974), which is incorporated by graph (a)(3)(vi) of this section. dure A.
reference; copies are available from
American Society for Testing and Ma- (8) Melting peak temperature. The melt
terials (ASTM), 100 Barr Harbor Dr., temperature of the olefin polymers de-
West Conshohocken, Philadelphia, PA scribed in paragraph (a)(3)(ii) of this
19428-2959, or available for inspection at section shall be determined by ASTM
the National Archives and Records Ad- method D 3418–82, ‘‘Standard Test
ministration (NARA). For information Method for Transition Temperatures of
on the availability of this material at Polymers by Thermal Analysis,’’ which
NARA, call 202–741–6030, or go to: http:// is incorporated by reference in accord-
www.archives.gov/federal_register/ ance with 5 U.S.C. 552(a). The avail-
code_of_federal_regulations/ ability of this incorporation by ref-
ibr_locations.html.) of solutions of the erence is given in paragraph (d)(1) of
copolymers in solvents and at tempera- this section.
tures as follows: (9) Intrinsic viscosity. The intrinsic
(i) Olefin polymers described in para- viscosity of the olefin polymers de-
graph (a)(3)(iii) of this section in scribed in paragraph (a)(3)(ii) of this
decahydronaphthalene at 135 °C. section shall be determined by ASTM
(ii) Olefin polymers described in method D 1601–78, ‘‘Standard Test
paragraph (a)(3)(iv) of this section in Method for Dilute Solution Viscosity
tetrachloroethylene at 30 °C. of Ethylene Polymers,’’ which is incor-
(6) Mooney viscosity—olefin copolymers porated by reference in accordance
described in paragraph (a)(3)(iii) of this with 5 U.S.C. 552(a). The availability of
section. Mooney viscosity is determined this incorporation by reference is given
by ASTM method D1646–81, ‘‘Standard in paragraph (d)(1) of this section.
Test Method for Rubber—Viscosity and (e) Olefin copolymers described in
Vulcanization Characteristics (Mooney paragraph (a)(3)(i) of this section and
Viscometer),’’ which is incorporated by polyethylene, alone or in combination,
reference (the availability of this in- may be subjected to irradiation bom-
corporation by reference is given in bardment from a source not to exceed
paragraph (d)(1) of this section), using 2.3 million volts intensity to cause mo-
the large rotor at a temperature of 100 lecular crosslinking of the polymers to
°C, except that a temperature of 127 °C
impart desired properties, such as in-

shall be used for those copolymers creased strength and increased ability
whose Mooney viscosity cannot be de- to shrink when exposed to heat.
308
(f) The olefin polymers identified in (3) Substances authorized under ap-
and complying with this section, when plicable regulations in this part and in
used as components of the food-contact parts 175 and 178 of this chapter and
surface of any article that is the sub- subject to any limitations prescribed
ject of a regulation in parts 174, 175, therein.
176, 177, 178, and § 179.45 of this chapter, (4) The following substances, subject
shall comply with any specifications to any limitations prescribed:
and limitations prescribed by such reg-
ulation for the article in the finished List of substances Limitations
form in which it is to contact food.
Lithium polysilicate containing For use only as a compo-
(g) The provisions of this section are not more than 20 weight per- nent of repeated-use
not applicable to olefin polymers iden- cent silica, not more than 2.1 coatings not exceeding
tified in § 175.105(c)(5) of this chapter percent lithium oxide and 0.030 millimeter (0.0012
having a maximum mole inch) in thickness where
and used in food-packaging adhesives ratio of Si02/Li20 of 8.5 to 1. the coatings are thermally
complying with § 175.105 of this chapter. cured at minimum sinter-
ing temperatures of 371
[42 FR 14572, Mar. 15, 1977] °C (700 °F). Lithium ex-
EDITORIAL NOTE: For FEDERAL REGISTER ci- tractives shall not exceed
tations affecting § 177.1520, see the List of 1.55 milligrams per
square decimeter (0.1
CFR Sections Affected, which appears in the milligram per square inch)
Finding Aids section of the printed volume of coating surface when
and at www.govinfo.gov. tested in accordance with
paragraph (e)(2) of this
§ 177.1550 Perfluorocarbon resins. section.
Naphthalene sulfonic acid For use only:
Perfluorocarbon resins identified in formaldehyde condensate, 1. As a component of re-
this section may be safely used as arti- sodium salt. peated-use coatings,
cles or components of articles intended based on the
to contact food, subject to the provi- perfluorocarbon resin
identified in paragraph
sions of this section: (a)(1) of this section, not
(a) Identity. For the purpose of this to exceed 0.030 milli-
section, perfluorocarbon resins are meter (0.0012 inch) in
thickness, and at a level
those produced by: (1) The not to exceed 0.4 weight
homopolymerization and/or copolym- percent of the coating.
erization of hexafluoropropylene and 2. As a component of re-
tetrafluoroethylene, and (2) the co- peated-use coatings,
based on the
polymerization of perfluorocarbon resin
perfluoropropylvinylether and tetra- identified in paragraph
fluoroethylene (CAS Reg. No. 26655–00– (a)(2) of this section, not
to exceed 0.10 millimeter
5). The resins shall meet the extrac- (0.004 inch) in thickness,
tives limitations in paragraph (d) of and at a level not to ex-
this section. ceed 0.4 weight percent
(b) Optional components. The of the coating.
perfluorocarbon resins identified in
paragraph (a) of this section as well as (c) Optional processing. Poly- tetra-
articles or coating made from these fluoroethylene resins may be irradi-
resins may include the following op- ated by either a cobalt-60 sealed
tional components except that the source, at a maximum dose of gamma
resin identified in paragraph (a)(2) of radiation not to exceed 7.5 megarads,
this section may not be used with the or an electron beam at energy levels
optional component, lithium not to exceed 2.5 million electron volts
polysilicate, mentioned in paragraph with a maximum dosage of 7.5
(b)(4) of this section. megarads, to produce lubricant pow-
(1) Substances generally recognized ders having a particle diameter of not
as safe (GRAS) in food or food pack- more than 20 microns for use only as
aging subject to any limitations cited components of articles intended for re-
on their use. peated use in contact with food.
(2) Substances used in accordance (d) Specifications—(1) Infrared identi-
with a prior sanction or approval, sub- fication. Perfluorocarbon resins can be

ject to any limitations cited in the identified by their characteristic infra-
prior sanction or approval. red spectra.
309
§ 177.1550 21 CFR Ch. I (4–1–23 Edition)
(2) Melt-viscosity. (i) The perfluoro- this material at NARA, call 202–741–
carbon resins identified in paragraph 6030, or go to: http://www.archives.gov/
(a)(1) of this section shall have a melt federal_register/
viscosity of not less than 104 poises at code_of_federal_regulations/
380 °C (716 °F) as determined by ASTM ibr_locations.html. The requirements of
method D1238–82, ‘‘Standard Test Meth- this paragraph do not apply to poly-
od for Flow Rates of Thermoplastics by tetrafluoroethylene resin lubricant
Extrusion Plastometer,’’ which is in- powders described in paragraph (c) of
corporated by reference. Copies may be this section.
obtained from the American Society (e) Limitations. 1 (1) Perfluorocarbon-
for Testing Materials, 100 Barr Harbor molded articles having a surface area
Dr., West Conshohocken, Philadelphia, of 6.45 square decimeters (100 square
PA 19428-2959, or may be examined at inches) or more and at least 1.27 milli-
the National Archives and Records Ad- meters (0.05 inch) thick shall be ex-
ministration (NARA). For information tracted at reflux temperatures for 2
on the availability of this material at hours separately with distilled water,
NARA, call 202–741–6030, or go to: http:// 50 percent ethanol, n-heptane, and
www.archives.gov/federal_register/ ethyl acetate.
(2) Perfluorocarbon resins identified
ibr_locations.html. The melt viscosity of
in paragraphs (a)(1) and (2) of this sec-
the perfluorocarbon resins identified in
paragraph (a)(1) of this section shall tion and intended for use as coatings or
not vary more than 50 percent within components of coatings shall meet
one-half hour at 380 °C (716 °F). extractability limits prescribed in
(ii) Perfluorocarbon resins identified paragraph (e)(3) of this section when
in paragraph (a)(2) of this section shall the resins in the form of coatings de-
have a melt viscosity of not less than scribed in paragraphs (e)(2)(i) and (ii) of
104 poises at 372 °C (702 °F) as deter- this section are extracted at reflux
mined by a more detailed method ti- temperatures for 2 hours separately
tled ‘‘Determination of Melt Viscosity, with distilled water, 8 percent ethanol,
Molecular Weight Distribution Index and n-heptane:
and Viscosity Stability,’’ which is in- (i) Perfluorocarbon resin coatings
corporated by reference. Copies are based on resins identified in paragraph
available from the Center for Food (a)(1) of this section shall be applied to
Safety and Applied Nutrition (HFS– both sides of a 0.025-millimeter (0.001
200), Food and Drug Administration, inch) thick aluminum foil to a thick-
5001 Campus Dr., College Park, MD ness of 0.025 millimeter (0.001 inch)
20740, or available for inspection at the after thermal curing at 399 °C (750 °F)
National Archives and Records Admin- for 10 minutes. If a primer is used, the
istration (NARA). For information on total thickness of the primer plus top-
the availability of this material at coat shall equal 0.025 millimeter (0.001
NARA, call 202–741–6030, or go to: http:// inch) after heat curing.
www.archives.gov/federal_register/ (ii) Perfluorocarbon resin coatings
code_of_federal_regulations/ based on resins identified in paragraph
ibr_locations.html. (a)(2) of this section shall be applied to
(3) Thermal instability index. The ther- both sides of a 0.025-millimeter (0.001
mal instability index of the tetra-
fluoroethylene homopolymer shall not 1 A more detailed procedure of extraction
exceed 50 as determined by ASTM conditions is entitled, ‘‘Preparation of Ex-
method D1457–56T, ‘‘Test for Thermal tracts,’’ which is incorporated by reference.
Instablility index of Tetrafluoro- Copies are available from the Center for
ethylene Homopolymer’’ (Revised 1956), Food Safety and Applied Nutrition (HFS–
which is incorporated by reference. 200), Food and Drug Administration, 5001
Copies are available from University Campus Dr., College Park, MD 20740, or
available for inspection at the National Ar-
Microfilms International, 300 N. Zeeb chives and Records Administration (NARA).
Rd., Ann Arbor, MI 48106, or available For information on the availability of this
for inspection at the National Archives material at NARA, call 202–741–6030, or go to:
and Records Administration (NARA). http://www.archives.gov/federal_register/
For information on the availability of code_of_federal_regulations/ibr_locations.html.
310
inch) thick aluminum foil to a thick- (250 °F) for 2 hours, shall yield total
ness of 0.10 millimeter (0.004 inch) after nonvolatile extractives not to exceed
thermal curing at 427 °C (800 °F) for 10 2.33 micrograms per square centimeter
minutes. If a primer is used, the total (15 micrograms per square inch) of the
thickness of the primer plus topcoat exposed resin surface.
shall equal 0.10 millimeter (0.004 inch) (d) Limitations. Polyarylate resin ar-
after heat curing. ticles may be used in contact with all
(3) The extracted surfaces shall meet foods except beverages containing
the following extractability limits: more than 8 volume percent ethanol
(i) Total extractives not to exceed 3.1 under conditions of use A through H,
milligrams per square decimeter (0.2 described in table 2 of § 176.170(c) of this
milligram per square inch). chapter.
(ii) Fluoride extractives calculated as [52 FR 35540, Sept. 22, 1987]
fluorine not to exceed 0.46 milligram
per square decimeter (0.03 milligram § 177.1556 Polyaryletherketone resins.
per square inch). The poly(oxy-1,4-phenylenecarbonyl-
(f) Conditions of use. Perfluorocarbon 1,4-phenyleneoxy-1,4-
resins identified in paragraph (a)(2) of phenylenecarbonyl-1,4-
this section are limited to use as coat- phenylenecarbonyl-1,4-phenylene) res-
ings or components of coatings for arti- ins (CAS Reg. No. 55088–54–5 and CAS
cles intended for repeated food-contact Reg. No. 60015–05–6 and commonly re-
use. ferred to as polyaryletherketone res-
[43 FR 44834, Sept. 29, 1978, as amended at 47 ins) identified in paragraph (a) of this
FR 11843, Mar. 19, 1982; 47 FR 14699, Apr. 6, section may be safely used as articles
1982; 49 FR 10109, Mar. 19, 1984; 50 FR 1502, or components of articles intended for
Jan. 11, 1985; 54 FR 24898, June 12, 1989; 61 FR repeated use in contact with food, sub-
14481, Apr. 2, 1996] ject to the provisions of this section.
(a) Identity. Polyaryletherketone res-
§ 177.1555 Polyarylate resins.
ins consist of basic resins produced by
Polyarylate resins (CAS Reg. No. reacting 4,4′-diphenoxy benzophenone
51706–10–6) may be safely used as arti- and terephthaloyl dichloride in such a
cles or components of articles intended way that the finished resins have a
for use in contact with food in accord- minimum weight average molecular
ance with the following prescribed con- weight of 20,000 grams per mole, as de-
ditions: termined by light scattering measure-
(a) Identity. Polyarylate resins (1, 3- ments in sulfuric acid at room tem-
benzenedicarboxylic acid, diphenyl perature.
ester, polymer with diphenyl 1,4- (b) Optional adjuvant substances. The
benzenedicarboxylate and 4-4′-(1- basic polyaryletherketone resins iden-
methylethylidine) bis(phenol)) are tified in paragraph (a) of this section
formed by melt polycondensation of may contain optional adjuvant sub-
bisphenol-A with diphenylisophthalate stances required in the production of
and diphenylterephthalate. such basic resins. These adjuvants may
(b) Specifications. (1) The finished co- include substances used in accordance
polymers shall contain from 70 to 80 with § 174.5 of this chapter and the fol-
weight percent of polymer units de- lowing:
rived from diphenylisophthalate and 20 (1) Benzoyl chloride, poly(tetrafluoro
to 30 weight percent of polymer units ethylene).
derived from diphenylterephthalate. (2) [Reserved]
(2) Polyarylate resins shall have a (c) Extractive limitations. The finished
minimum weight average molecular food-contact article yields net total ex-
weight of 20,000. tractives in each extracting solvent
(3) Polyarylate resins may be identi- not to exceed 0.052 milligram per
fied by their characteristic infrared square inch (corresponding to 0.008 mil-
spectra. ligram per square centimeter) of food-
(c) Extractive limitations. The finished contact surface, when extracted at
polyarylate resins in sheet form at reflux temperature for 2 hours with the
least 0.5 millimeter (0.020 inch) thick, following solvents: Distilled water, 50
when extracted with water at 121 °C percent (by volume) ethyl alcohol in
311
§ 177.1560 21 CFR Ch. I (4–1–23 Edition)
distilled water, 3 percent acetic acid paragraph and further identified as re-
(by weight) in distilled water, and n- quired:
heptane.
(d) In testing the finished food-con- Substances Limitations
tact article made of Sulfolane ..... Not to exceed 0.15 percent as residual sol-
polyaryletherketone resin, use a sepa- vent in the finished basic resin.
rate test sample for each required ex-
tracting solvent. (c) Extractive limitations. The finished
[61 FR 42381, Aug. 15, 1996] polyarylsulfone resin when extracted
for 2 hours with the following solvents
§ 177.1560 Polyarylsulfone resins. at the specified temperatures yields
total extractives in each extracting
Polyarylsulfone resins (CAS Reg. No.
79293–56–4) may be safely used as arti- solvent not to exceed 0.008 milligram
cles or components of articles intended per square centimeter of food-contact
for use in contact with food, at tem- surface: distilled water at 121 °C (250
peratures up to and including normal °F), 50 percent (by volume) ethyl alco-
baking temperatures, in accordance hol in distilled water at 71.1 °C (160 °F),
with the following prescribed condi- 3 percent acetic acid in distilled water
tions: at 100 °C (212 °F), and n-heptane at 65.6
(a) Identity. Polyarylsulfone resins °C (150 °F).
are copolymers containing not more NOTE: In testing the finished polyaryl-
than 25 percent of oxy-p-phenylene- sulfone resin use a separate test sample for
oxy-p-phenylenesulfonyl-p-phenylene each required extracting solvent.
polymer units and not less than 75 per- [50 FR 31046, July 24, 1985]
cent of oxy-p-phenylenesulfonyl-p-
phenylene-oxy-p-phenylenesulfonyl-p- § 177.1570 Poly-1-butene resins and
phenylene polymer units. The copoly- butene/ethylene copolymers.
mers have a minimum reduced vis-
The poly-1-butene resins and butene/
cosity of 0.40 deciliter per gram in 1-
ethylene copolymers identified in this
methyl-2-pyrrolidinone in accordance
with ASTM method D2857–70 (Re- section may be safely used as articles
approved 1977), ‘‘Standard Test Method or components of articles intended for
for Dilute Solution Viscosity of Poly- use in contact with food subject to the
mers,’’ which is incorporated by ref- provisions of this section.
erence. Copies may be obtained from (a) Identity. Poly-1-butene resins are
the American Society for Testing and produced by the catalytic polymeriza-
Materials, 100 Barr Harbor Dr., West tion of 1-butene liquid monomer.
Conshohocken, Philadelphia, PA 19428- Butene/ethylene copolymers are pro-
2959, or may be examined at the Na- duced by the catalytic polymerization
tional Archives and Records Adminis- of 1-butene liquid monomer in the pres-
tration (NARA). For information on ence of small amounts of ethylene
the availability of this material at monomer so as to yield no higher than
NARA, call 202–741–6030, or go to: http:// a 6-weight percent concentration of
www.archives.gov/federal_register/ polymer units derived from ethylene in
code_of_federal_regulations/ the copolymer.
ibr_locations.html. (b) Specifications and limitations. Poly-
(b) Optional adjuvant substances. The 1-butene resins and butene/ethylene co-
basic polyarylsulfone resins identified polymers shall conform to the speci-
in paragraph (a) of this section may fications prescribed in paragraph (b)(1)
contain optional adjuvant substances of this section, and shall meet the
required in the production of such extractability limits prescribed in
basic copolymers. These optional adju- paragraph (b)(2) of this section.
vant substances may include sub- (1) Specifications—(i) Infrared identi-
stances permitted for such use by regu- fication. Poly-1-butene resins and
lations in parts 170 through 179 of this butene/ethylene copolymers can be
chapter, substances generally recog- identified by their characteristic infra-
nized as safe in food, substances used in red spectra.

accordance with a prior sanction of ap- (ii) Viscosity. Poly-1-butene resins and
proval, and substances named in this the butene/ethylene copolymers have
312
an intrinsic viscosity 1.0 to 3.2 as deter- contact with food under conditions of
mined by ASTM method D1601–78, use B, C, D, E, F, G, or H described in
‘‘Standard Test Method for Dilute So- table 2 of § 176.170(c) of this chapter,
lution Viscosity of Ethylene Poly- subject to the provisions of this section
mers,’’ which is incorporated by ref- and provided that the maximum
erence. Copies may be obtained from extractables from test films 0.1 to 0.2
the American Society for Testing Ma- millimeter (0.004 to 0.008 inch) in thick-
terials, 100 Barr Harbor Dr., West ness do not exceed 0.80 percent by
Conshohocken, Philadelphia, PA 19428- weight of the polymer when extracted
2959, or may be examined at the Na- in a soxhlet extractor for 6 hours with
tional Archives and Records Adminis- refluxing 95 percent ethanol.
tration (NARA). For information on (iii) Poly-1-butene resins may be used
the availability of this material at as articles or components of articles
NARA, call 202–741–6030, or go to: http:// intended for packaging or holding food
www.archives.gov/federal_register/ during cooking, provided that the
code_of_federal_regulations/ thickness of such polymers in the form
ibr_locations.html. in which they contact food shall not
(iii) Density. Poly-1-butene resins exceed 0.1 millimeter (0.004 inch) and
have a density of 0.904 to 0.920 gms/cm3, yield maximum extractables of not
and butene/ethylene copolymers have a more than 2.5 percent by weight of the
density of 0.890 to 0.916 gms/cm3 as de- polymer when films are extracted for 2
termined by ASTM method D1505–68 hours at 50 °C (122 °F) in n-heptane.
(Reapproved 1979), ‘‘Standard Test [42 FR 14572, Mar. 15, 1977, as amended at 49
Method for Density of Plastics by the FR 10109, Mar. 19, 1984; 50 FR 31349, Aug. 2,
Density-Gradient Technique,’’ which is 1985]
incorporated by reference. The avail-
ability of this incorporation by ref- § 177.1580 Polycarbonate resins.
erence is given in paragraph (b)(1)(ii) of Polycarbonate resins may be safely
this section. used as articles or components of arti-
(iv) Melt index. Poly-1-butene resins cles intended for use in producing,
have a melt index of 0.1 to 24 and the manufacturing, packing, processing,
butene/ethylene copolymers have a preparing, treating, packaging, trans-
melt index of 0.1 to 20 as determined by porting, or holding food, in accordance
ASTM method D1238–82, condition E, with the following prescribed condi-
‘‘Standard Test Method for Flow Rates tions:
of Thermoplastics by Extrusion Plas- (a) Polycarbonate resins are poly-
tometer,’’ which is incorporated by ref- esters produced by:
erence. The availability of this incor- (1) The condensation of 4,4′-iso-
poration by reference is given in para- propylidenediphenol and carbonyl chlo-
graph (b)(1)(ii) of this section. ride to which may have been added cer-
(2) Limitations. Poly-1-butene resins tain optional adjuvant substances re-
and butene/ethylene copolymers for use quired in the production of the resins;
in articles that contact food, and for or by
articles used for packing or holding (2) The reaction of molten 4,4′-iso-
food during cooking shall yield no propylidenediphenol with molten di-
more than the following extractables: phenyl carbonate in the presence of the
(i) Poly-1-butene resins may be used disodium salt of 4,4′-isopro-
as articles or components of articles pylidenediphenol.
intended for use in contact with food, (3) The condensation of 4,4′-isopro-
provided that the maximum pylidenediphenol, carbonyl chloride,
extractables do not exceed 2.5 percent and 0.5 percent weight maximum of
by weight of the polymer when film or a2,a6-bis (6-hydroxy-m-tolyl) mesitol to
molded samples are tested for 2 hours which may have been added certain op-
at 50 °C (122 °F) in n-heptane. tional adjuvant substances required in
(ii) Butene/ethylene copolymers con- the production of branched
taining no more than 6 percent by polycarbonate resins.
weight of polymer units derived from (b) The optional adjuvant substances
ethylene may be used as articles or required in the production of resins
components of articles intended for produced by the methods described in
313
§ 177.1585 21 CFR Ch. I (4–1–23 Edition)
paragraph (a)(1) and (3) of this section in infant feeding bottles (baby bottles)
may include substances generally rec- and spill-proof cups, including their
ognized as safe in food, substances used closures and lids, designed to help train
in accordance with a prior sanction or babies and toddlers to drink from cups
approval, and the following: (sippy cups).
List of substances Limitations [42 FR 14572, Mar. 15, 1977, as amended at 46
FR 23227, Apr. 24, 1981; 49 FR 4372, Feb. 6,
p-tert-Butylphenol .................. 1984; 50 FR 14096, Apr. 10, 1985; 53 FR 29656,
Chloroform .............................
p-Cumylphenol (CAS Reg. For use only as a chain ter-
Aug. 8, 1988; 59 FR 43731, Aug. 25, 1994; 77 FR
No. 599–64–4). minator at a level not to ex- 41902, July 17, 2012]
ceed 5 percent by weight
of the resin. § 177.1585 Polyestercarbonate resins.
Ethylene dichloride.
Heptane. Polyestercarbonate resins may be
Methylene chloride. safely used as articles or components
Monochlorobenzene .............. Not to exceed 500 p.p.m. as of articles intended for use in pro-
residual solvent in finished
resin. ducing, manufacturing, packing, proc-
Pentaerythritol tetrastearate For use only as a mold re- essing, preparing, treating, packaging,
(CAS Reg. No. 115–83–3). lease agent, at a level not or holding food, in accordance with the
to exceed 0.5 percent by
weight of the finished resin.
Phenol (CAS Reg. No. 108– (a) Polyestercarbonate resins (CAS
95–2). Reg. No. 71519–80–7) are produced by the
Pyridine.
Toluene: (CAS Reg. No. Not to exceed 800 parts per
condensation of 4,4′-
108–88–3). million as residual solvent isopropylidenediphenol, carbonyl chlo-
in finished resin. ride, terephthaloyl chloride, and
Triethylamine. isophthaloyl chloride such that the fin-
ished resins are composed of 45 to 85
(c) Polycarbonate resins shall con- molepercent ester, of which up to 55
form to the specification prescribed in mole-percent is the terephthaloyl iso-
paragraph (c)(1) of this section and mer. The resins are manufactured
shall meet the extractives limitations using a phthaloyl chloride/carbonyl
prescribed in paragraph (c)(2) of this chloride mole ratio of 0.81 to 5.7/1 and
section. isophthaloyl chloride/terephthaloyl
(1) Specification. Polycarbonate resins chloride mole ratio of 0.81/1 or greater.
can be identified by their char- The resins are also properly identified
acteristic infrared spectrum. by CAS Reg. No. 114096–64–9 when pro-
(2) Extractives limitations. The duced with the use of greater than 2
polycarbonate resins to be tested shall but not greater than 5 weight percent
be ground or cut into small particles p-cumylphenol (CAS Reg. No. 599–64–4),
that will pass through a U.S. standard as an optional adjuvant substance in
sieve No. 6 and that will be held on a accordance with paragraph (b)(2) of
U.S. standard sieve No. 10. this section.
(i) Polycarbonate resins, when ex- (b) Optional adjuvants. The optional
tracted with distilled water at reflux adjuvant substances required in the
temperature for 6 hours, shall yield production of resins identified in para-
total extractives not to exceed 0.15 per- graph (a) of this section may include:
cent by weight of the resins.
(1) Substances used in accordance
(ii) Polycarbonate resins, when ex-
with § 174.5 of this chapter.
tracted with 50 percent (by volume)
(2) Substances identified in
ethyl alcohol in distilled water at
§ 177.1580(b).
reflux temperature for 6 hours, shall
(3) Substances regulated in
yield total extractives not to exceed
§ 178.2010(b) of this chapter for use in
0.15 percent by weight of the resins.
polycarbonate resins complying with
(iii) Polycarbonate resins, when ex-
§ 177.1580:
tracted with n-heptane at reflux tem-
perature for 6 hours, shall yield total Provided, That the substances are used
extractives not to exceed 0.15 percent in accordance with any limitation on
by weight of the resins. concentration, conditions of use, and

(d) Polycarbonate resins may be used food types specified in § 178.2010(b) of
in accordance with this section except this chapter.
314
(c) Polyestercarbonate resins shall reflux temperature for 6 hours, shall

conform to the specifications pre- yield total nonvolatile extractives not
scribed in paragraph (c)(1) of this sec- to exceed 0.005 percent by weight of the
tion and shall meet the extractive lim- resins.
itations prescribed in paragraph (c)(2) (iii) Polyestercarbonate resins, when
of this section. extracted with n-heptane at reflux
(1) Specifications. Polyestercarbonate temperature for 6 hours, shall yield
resins identified in paragraph (a) of total nonvolatile extractives not to ex-
this section can be identified by their ceed 0.002 percent by weight of the res-
characteristic infrared spectrum. The ins.
resins shall comply with either or both (3) Residual methylene chloride levels in
of the following specifications: polyestercarbonate resins. Polyester-
(i) The solution intrinsic viscosity of carbonate resin articles in the finished
the polyestercarbonate resins shall be form shall not contain residual meth-
a minimum of 0.44 deciliter per gram, ylene chloride in excess of 5 parts per
as determined by a method entitled million as determined by a method ti-
‘‘Intrinsic Viscosity (IV) of Lexan ® tled ‘‘Analytical Method for Deter-
Polyestercarbonate Resin by a Single mination of Residual Methylene Chlo-
Point Method Using Dichloromethane ride in Polyestercarbonate Resin,’’ de-
as the Solvent,’’ developed by the Gen- veloped by the General Electric Co.,
eral Electric Co., September 20, 1985, July 23, 1991, which is incorporated by
which is incorporated by reference in reference in accordance with 5 U.S.C.
accordance with 5 U.S.C. 552(a) and 1 552(a) and 1 CFR part 51. Copies are
CFR part 51. Copies are available from available from the Center for Food
the Office of Food Additive Safety, Safety and Applied Nutrition (HFS–
Center for Food Safety and Applied Nu- 200), Food and Drug Administration,
trition (HFS–215), Food and Drug Ad- 5001 Campus Dr., College Park, MD
ministration, 5001 Campus Dr., College 20740, or may be examined at the Na-
Park, MD 20740, or may be examined at tional Archives and Records Adminis-
the Food and Drug Administration’s tration (NARA). For information on
Main Library, 10903 New Hampshire the availability of this material at
Ave., Bldg. 2, Third Floor, Silver NARA, call 202–741–6030, or go to: http://
Spring, MD 20993, 301–796–2039, or at the www.archives.gov/federal_register/
National Archives and Records Admin- code_of_federal_regulations/
istration (NARA). For information on ibr_locations.html.
the availability of this material at [57 FR 3940, Feb. 3, 1992, as amended at 64 FR
NARA, call 202–741–6030, or go to: http:// 27178, May 19, 1999; 81 FR 5594, Feb. 3, 2015]
code_of_federal_regulations/ § 177.1590 Polyester elastomers.
ibr_locations.html. The polyester elastomers identified
(ii) A minimum weight-average mo- in paragraph (a) of this section may be
lecular weight of 27,000, as determined safely used as the food-contact surface
by gel permeation chromatography of articles intended for use in contact
using polystyrene standards. with bulk quantities of dry food of the
(2) Extractives limitations. The type identified in § 176.170(c) of this
polyestercarbonate resins to be tested chapter, table 1, under Type VIII, in ac-
shall be ground or cut into small par- cordance with the following prescribed
ticles that will pass through a U.S. conditions:
standard sieve No. 6 and that will be (a) For the purpose of this section,
held on U.S. standard sieve No. 10. polyester elastomers are those pro-
(i) Polyestercarbonate resins, when duced by the ester exchange reaction
extracted with distilled water at reflux when one or more of the following
temperature for 6 hours, shall yield phthalates—dimethyl terephthalate,
total nonvolatile extractives not to ex- and dimethyl isophthalate—is made to
ceed 0.005 percent by weight of the res- react with alpha-hydroomega-
ins. hydroxypoly (oxytetramethylene) and/
(ii) Polyestercarbonate resins, when or 1,4-butanediol such that the finished

extracted with 50 percent (by volume) elastomer has a number average molec-
ethyl alcohol in distilled water at ular weight between 20,000 and 30,000.
315
§ 177.1595 21 CFR Ch. I (4–1–23 Edition)
(b) Optional adjuvant substances em- contact articles. The optional adjuvant
ployed in the production of the poly- substances required in the production
ester elastomers or added thereto to of the basic polymer may include sub-
impart desired technical or physical stances permitted for such use by ap-
properties may include the following plicable regulations as set forth in part
substances: 174 of this chapter.
(c) Specifications and extractives limita-
tions—(1) Specifications. Polyetherimide
4,4′ - Bis (alpha, alpha-di- For use only as an anti- resin identified in paragraph (a) of this
methyl-benzyl) oxidant.
diphenylamine. section shall have an intrinsic vis-
Tetrabutyl titanate .................. For use only as a catalyst. cosity in chloroform at 25 °C (77 °F) of
not less than 0.35 deciliter per gram as
(c) An appropriate sample of the fin- determined by a method titled ‘‘In-
ished polyester elastomer in the form trinsic Viscosity of ULTEM
in which it contacts food when sub- Polyetherimide Using Chloroform as
jected to ASTM method D968–81, the Solvent,’’ which is incorporated by
‘‘Standard Test Methods for Abrasion reference. Copies are available from
Resistance of Organic Coatings by the the Center for Food Safety and Applied
Falling Abrasive Tester,’’ which is in- Nutrition (HFS–200), Food and Drug
corporated by reference (Copies may be Administration, 5001 Campus Dr., Col-
obtained from the American Society lege Park, MD 20740, or available for in-
for Testing Materials, 100 Barr Harbor spection at the National Archives and
Dr., West Conshohocken, Philadelphia, Records Administration (NARA). For
PA 19428-2959, or may be examined at information on the availability of this
the National Archives and Records Ad- material at NARA, call 202–741–6030, or
ministration (NARA). For information go to: http://www.archives.gov/fed-
on the availability of this material at eral_register/code_of_federal_regulations/
NARA, call 202–741–6030, or go to: http:// ibr_locations.html.
www.archives.gov/federal_register/ (2) Extractive limitations. Extractive
code_of_federal_regulations/ limitations are applicable to the basic
ibr_locations.html.), using No. 50 emery polyetherimide resin in the form of
abrasive in lieu of Ottawa sand, shall molded discs of thickness 0.16 centi-
exhibit an abrasion coefficient of not meter (0.063 inch). The resin discs when
less than 100 liters per mil of thickness. extracted with distilled water at 121 °C
[42 FR 14572, Mar. 15, 1977, as amended at 49 (250 °F) for 2 hours yield total nonvola-
FR 10109, Mar. 19, 1984; 87 FR 31089, May 20, tile extractives of not more than 12.3
2022] micrograms per square centimeter.
§ 177.1595 Polyetherimide resin. [50 FR 31351, Aug. 2, 1985; 50 FR 35535, Sept.
3, 1985]
The polyetherimide resin identified
in this section may be safely used as an
§ 177.1600 Polyethylene resins,
article or component of an article in- carboxyl modified.
tended for use in contact with food,
subject to the provisions of this sec- Carboxyl-modified polyethylene res-
tion. ins may be safely used as the food-con-
(a) Identity. For the purpose of this tact surface of articles intended for use
section, the polyetherimide resin is 1,3- in contact with food in accordance
isobenzofurandione, 5,5′[(1-methyl- with the following prescribed condi-
ethylidene)bis(4,1-phenyleneoxy)] bis- tions:
polymer with 1,3-benzenediamine (CAS (a) For the purpose of this section,
Reg. No. 61128–46–9), and is derived from carboxyl-modified polyethylene resins
the condensation reaction of m- consist of basic polymers produced
phenylenediamine and bisphenol A- when ethylene-methyl acrylate basic
dianhydride. copolymers, containing no more than
(b) Optional adjuvants. The basic 25 weight percent of polymer units de-
polymer identified in paragraph (a) of rived from methyl acrylate, are made
this section may contain optional adju- to react in an aqueous medium with
vant substances required in the produc- one or more of the following sub-
tion of basic resins or finished food- stances:
316
Ammonium hydroxide. Conshohocken, Philadelphia, PA 19428-
Calcium carbonate. 2959, or may be examined at the Na-
Potassium hydroxide.
Sodium hydroxide.
(b) The finished food-contact article, the availability of this material at
when extracted with the solvent or sol- NARA, call 202–741–6030, or go to: http://
vents characterizing the type of food www.archives.gov/federal_register/
and under the conditions of time and code_of_federal_regulations/
temperature characterizing the condi- ibr_locations.html.), and has a 7.0 per-
tions of its intended use as determined cent maximum extractable fraction in
from tables 1 and 2 of § 176.170(c) of this n-hexane at 50 °C, as determined by the
chapter, yields total extractives in method described in § 177.1520(d)(3)(ii).
each extracting solvent not to exceed (b) Chlorinated polyethylene may be
0.5 milligram per square inch of food- used in contact with all types of food,
contact surface as determined by the except that when used in contact with
methods described in § 176.170(d) of this fatty food of Types III, IV-A, V, VII-A,
chapter; and if the finished food-con- and IX described in table 1 of § 176.170(c)
tact article is itself the subject of a of this chapter, chlorinated poly-
regulation in parts 174, 175, 176, 177, 178, ethylene is limited to use only as a
and § 179.45 of this chapter, it shall also modifier admixed at levels not exceed-
comply with any specifications and ing 15 weight percent in plastic articles
limitations prescribed for it by that prepared from polyvinyl chloride and/
regulation. In testing the finished food- or from vinyl chloride copolymers com-
contact articles, a separate test sample plying with § 177.1980.
is to be used for each required extract-
ing solvent. [42 FR 14572, Mar. 15, 1977, as amended at 49
(c) The provisions of paragraph (b) of FR 10109, Mar. 19, 1984; 59 FR 14550, Mar. 29,
1994]
this section are not applicable to
carboxyl-modified polyethylene resins § 177.1615 Polyethylene, fluorinated.
used in food-packaging adhesives com-
plying with § 175.105 of this chapter. Fluorinated polyethylene, identified
in paragraph (a) of this section, may be
§ 177.1610 Polyethylene, chlorinated. safely used as food-contact articles in
Chlorinated polyethylene identified accordance with the following pre-
in this section may be safely used as scribed conditions:
articles or components of articles that (a) Fluorinated polyethylene food-
contact food, except for articles used contact articles are produced by modi-
for packing or holding food during fying the surface of polyethylene arti-
cooking, subject to the provisions of cles through action of fluorine gas in
this section. combination with gaseous nitrogen as
(a) For the purpose of this section, an inert diluent. Such modification af-
chlorinated polyethylene consists of fects only the surface of the polymer,
basic polymers produced by the direct leaving the interior unchanged.
chlorination of polyethylene con- Fluorinated polyethylene articles are
forming to the density, maximum n- manufactured from basic resins con-
hexane extractable fraction, and max- taining not less than 85 weight-percent
imum xylene soluble fraction specifica- of polymer units derived from ethylene
tions prescribed under item 2.1 of the and identified in § 177.1520 (a)(2) and
table in § 177.1520(c). Such chlorinated (3)(i).
polyethylene contains a maximum of 60 (b) Fluorinated polyethylene articles
percent by weight of total chlorine, as conform to the specifications and use
determined by ASTM 1method D1303–55 limitations of § 177.1520(c), items 2.1 and
(Reapproved 1979), ‘‘Standard Test 3.1.
Method for Total Chlorine in Vinyl (c) The finished food-contact article,
Chloride Polymers and Copolymers,’’ when extracted with the solvent or sol-
which is incorporated by reference vents characterizing the type of food
(Copies may be obtained from the and under conditions of time and tem-
American Society for Testing Mate- perature characterizing the conditions
rials, 100 Barr Harbor Dr., West of its intended use as determined from
317
§ 177.1620 21 CFR Ch. I (4–1–23 Edition)
tables 1 and 2 of § 176.170(c) of this chap- are not applicable to oxidized poly-
ter, yields fluoride ion not to exceed 5 ethylene used as provided in §§ 175.125
parts per million calculated on the and 176.170(a)(5) of this chapter and
basis of the volume of food held by the § 177.1200.
§ 177.1630 Polyethylene phthalate
[48 FR 39057, Aug. 29, 1983] polymers.
§ 177.1620 Polyethylene, oxidized. Polyethylene phthalate polymers
identified in this section may be safely
Oxidized polyethylene identified in
paragraph (a) of this section may be used as, or components of plastics
safely used as a component of food-con- (films, articles, or fabric) intended for
tact articles, in accordance with the use in contact with food in accordance
following prescribed conditions: with the following prescribed condi-
(a) Oxidized polyethylene is the basic tions:
resin produced by the mild air oxida- (a) Polyethylene phthalate films con-
tion of polyethylene conforming to the sist of a base sheet of ethylene
density, maximum n-hexane extract- terephthalate polymer, ethylene
able fraction, and maximum xylene terephthalate-isophthalate copolymer,
soluble fraction specifications pre- or ethylene-1,4-cyclohexylene
scribed under item 2.3 of the table in dimethylene terephthalate copoly-
§ 177.1520(c). Such oxidized polyethylene esters described in § 177.1315(b)(3), to
has a minimum number average molec- which have been added optional sub-
ular weight of 1,200, as determined by stances, either as constituents of the
high temperature vapor pressure os- base sheet or as constituents of coat-
mometry, contains a maximum of 5 ings applied to the base sheet.
percent by weight of total oxygen, and (b) Polyethylene phthalate articles
has an acid value of 9 to 19. consist of a base polymer of ethylene
(b) The finished food-contact article, terephthalate polymer, or ethylene-1,4-
when extracted with the solvent or sol- cyclohexylene dimethylene
vents characterizing the type of food terephthalate copolyesters described in
and under the conditions of time and § 177.1315(b)(3), to which have been
temperature characterizing the condi- added optional substances, either as
tions of its intended use as determined constituents of the base polymer or as
from tables 1 and 2 of § 176.170(c) of this constituents of coatings applied to the
chapter, yields net acidified chloro- base polymer.
form-soluble extractives not to exceed (c)(1) Polyethylene phthalate
0.5 milligram per square inch of food- spunbonded nonwoven fabric consist of
contact surface when tested by the continuous filaments of ethylene
methods described in § 177.1330(c), ex- terephthalate polymer and ethylene
cept that net acidified chloroform-solu- terephthalate-isophthalate copolymer
ble extractives from paper and paper- to which may have been added optional
board complying with § 176.170 of this adjuvant substances required in their
chapter may be corrected for wax, pet- preparation and finishing.
rolatum, and mineral oil as provided in (2) The ethylene terephthalate-
§ 176.170(d)(5)(iii)(b) of this chapter. If isophthalate copolymer component of
the finished food-contact article is the fabric shall not exceed 25 percent
itself the subject of a regulation in by weight. The filaments may be blend-
parts 174, 175, 176, 177, 178 and § 179.45 of ed with other fibers regulated for the
this chapter, it shall also comply with specific use and the spunbonded fabric
any specifications and limitations pre- may be further bonded by application
scribed for it by such regulations. of heat and/or pressure.
(NOTE: In testing the finished food-con- (3) The fabric shall be used only in
tact article, use a separate test sample accordance with paragraph (i) of this
for each extracting solvent.) section.
(c) The provisions of this section are (d) The quantity of any optional sub-
not applicable to oxidized polyethylene stance employed in the production of
used as provided in §§ 175.105 and 176.210 polyethylene phthalate plastics does

of this chapter, and § 177.2800. The pro- not exceed the amount reasonably re-
visions of paragraph (b) of this section quired to accomplish the intended
318
physical or technical effect or any lim- Ethylene terephthalate polymer: Prepared

itations further provided. Any sub- by the condensation of dimethyl
stance employed in the production of terephthalate and ethylene glycol.
Ethylene terephthalate polymer: Prepared
polyethylene phthalate plastics that is
by the condensation of terephthalic acid
the subject of a regulation in parts 174, and ethylene glycol.
175, 176, 177, 178 and 179 of this chapter
conforms with any specification in (iii) Coatings:
such regulation. Acrylic copolymers (CAS Reg. No. 30394–86–
(e) Substances employed in the pro- 6): Prepared by reaction of ethyl acrylate
(CAS Reg. No. 140–88–5), methyl methacry-
duction of polyethylene phthalate plas-
late (CAS Reg. No. 80–62–6), and
tics include: methacrylamide (CAS Reg. No. 79–39–0)
(1) Substances generally recognized blended with melamine-formaldehyde resin
as safe in food. (CAS Reg. No. 68002–20–0). For use in coat-
(2) Substances subject to prior sanc- ings for polyethylene phthalate films com-
tion or approval for use in poly- plying with paragraph (a) of this section.—
ethylene phthalate plastics and used in Ethylene azelate-terephthalate copolymer:
accordance with such sanction or ap- The copolymer, dissolved in 1,1,2-trichloro-
proval. ethane and/or methylene chloride, may be
used as a heat-activated sealant on poly-
(3) Substances which by regulation in
ethylene terephthalate film intended for
parts 174, 175, 176, 177, 178 and § 179.45 of sealing polyethylene terephthalate pouch-
this chapter may be safely used as es that are used as containers of either
components of resinous or polymeric nonalcoholic beverages or alcoholic bev-
food-contact surfaces subject to the erages containing not more than 15 percent
provisions of such regulation. ethyl alcohol. The copolymer has a
(4) Substances identified in this para- terephthalate/azelate molecular ratio of
graph (e)(4) subject to the limitations 1.25/1.00 and a relative viscosity of not less
prescribed: than 1.5 as determined by a method title
‘‘General Procedure of Determining the
LIST OF SUBSTANCES AND LIMITATIONS Relative Viscosity of Resin Polymers,’’
which is incorporated by reference. Copies
(i) Base sheet: are available from the Center for Food
Ethylene terephthalate copolymers: Pre- Safety and Applied Nutrition (HFS–200),
pared by the condensation of dimethyl Food and Drug Administration, 5001 Cam-
terephthalate or terephthalic acid with pus Dr., College Park, MD 20740, or avail-
ethylene glycol, modified with one or more able for inspection, at the National Ar-
of the following: Azelaic acid, dimethyl chives and Records Administration
azelate, dimethyl sebacate, sebacic acid. (NARA). For information on the avail-
Ethylene terephthalate copolymers: Pre- ability of this material at NARA, call 202–
pared by the condensation of dimethyl 741–6030, or go to: http://www.archives.gov/
terephthalate or terephthalic acid with federal_register/code_of_federal_regulations/
ethylene glycol, modified with one or more ibr_locations.html. Total residual copolymer
of the following: Azelaic acid, dimethyl solvent (1,1,2-trichloroethane and/or meth-
azelate, dimethyl sebacate, sebacic acid, ylene chloride) shall not exceed 0.13 milli-
pyromellitic dianhydride. The level of gram per square inch of film, and food con-
pyromellitic dianhydride shall not exceed tact of the film shall be limited to not
0.5 percent by weight of the finished co- more than 1 square inch per 250 grams of
polymer which may be used under condi- beverage.
tions of use E through H as described in 2-Ethylhexyl acrylate copolymerized with
table 2 of § 176.170(c) of this chapter. one or more of the following:
Ethylene terephthalate-isophthalate copoly- Acrylonitrile.
mers: Prepared by the condensation of Methacrylonitrile.
dimethyl terephthalate or terephthalic Methyl acrylate.
acid and dimethyl isophthalate or iso- Methyl methacrylate.
phthalic acid with ethylene glycol. The Itaconic acid.
finished copolymers contain either: Vinylidene chloride copolymerized with one
(a) 77 to 83 weight percent or or more of the following:
(b) At least 97 weight percent of polymer Methacrylic acid and its methyl, ethyl,
units derived from ethylene propyl, butyl, or octyl esters.
terephthalate. Acrylic acid and its methyl, ethyl, propyl,
butyl, or octyl esters.
(ii) Base sheet and base polymer: Acrylonitrile.
Ethylene-1,4-cyclohexylene dimethylene Methacrylonitrile.

terephthalate copolyesters described in Vinyl chloride.
§ 177.1315(b)(3). Itaconic acid.
319
§ 177.1630 21 CFR Ch. I (4–1–23 Edition)
Styrene-maleic anhydride resin, partial 2- code_of_federal_regulations/
butoxyethyl ester, ammonium salt (CAS ibr_locations.html.
Reg. No. 68890–80–2). For use only as a coat- The modifier is used at a level not to ex-
ing for polyethylene phthalate films com- ceed 5 percent by weight of polyethylene
plying with paragraph (a) of this section, terephthalate film. The average thick-
at levels not to exceed 0.025 gram per ness of the finished film shall not exceed
square meter (0.016 milligram per square 0.016 millimeter (0.0006 inch).
inch) of the film, in contact with food of Hexanedioic acid polymer with 1,3-
types VIII and IX in table 1 of § 176.170(c) of benzenedimethanamine (CAS Reg. No.
this chapter, under use conditions E, F, 25718–70–1) meeting the specifications in
and G in table 2 of § 176.170(c) of this chap- § 177.1500(b), item 10, when tested by the
ter. methods given in § 177.1500(c). The modi-
fier is used in polyethylene terephthalate
(iv) Emulsifiers: at a level not to exceed 30 percent by
Sodium dodecylbenzenesulfonate: As an ad- weight of the polyethylene
juvant in the application of coatings to the terephthalate.
base sheet or base polymer. Chloroform-soluble extractives shall not
Sodium lauryl sulfate: As an adjuvant in the exceed 0.08 milligram/centimeter2 (0.5
application of coatings to the base sheet or milligram/inch2) of food-contact surface
base polymer. of the modified polyethylene
2-Sulfoethyl methacrylate, sodium salt (CAS terephthalate article when exposed to
Reg. No. 1804–87–1). For use only in copoly- the following solvents at temperatures
mer coatings on polyethylene phthalate and times indicated:
film under conditions of use E, F, and G de- (a) Distilled water at 49 °C (120 °F) for 24
scribed in table 2 of § 175.300(d) of this chap- hours;
ter, and limited to use at a level not to ex- (b) n-Heptane at 49 °C (120 °F) for 24 hours;
ceed 2.0 percent by weight of the dry co- (c) 8 percent ethyl alcohol at 49 °C (120 °F)
polymer coating. for 24 hours.
For use in contact with all types of foods
(v) Modifier: except (a) those containing more than 8
1,4-Benzenedicarboxylic acid, dimethyl ester, percent alcohol, or (b) those at tempera-
polymer with 1,4-butanediol and a-hydro- tures over 49 °C (120 °F).
omega-hydroxypoly(oxy-1,4-butanediyl)
CAS Reg. No. 9078–71–1) meeting the fol-
(f) Polyethylene phthalate plastics
lowing specifications: conforming with the specifications pre-
Melting point: 200° to 215 °C as determined scribed in paragraph (f)(1) of this sec-
by ASTM method D2117–82, ‘‘Standard tion are used as provided in paragraph
Test Method for Melting Point of (f)(2) of this section:
Semicrystalline Polymers by the Hot (1) Specifications. (i) The food contact
Stage Microscopy Method,’’ which is in- surface, when exposed to distilled
corporated by reference. Copies may be water at 250 °F for 2 hours, yields chlo-
obtained from the American Society for
roform-soluble extractives not to ex-
Testing Materials, 100 Barr Harbor Dr.,
West Conshohocken, Philadelphia, PA ceed 0.5 mg/in2 of food contact surface
19428-2959, or may be examined at the Na- exposed to the solvent; and
tional Archives and Records Administra- (ii) The food contact surface, when
tion (NARA). For information on the exposed to n-heptane at 150 °F for 2
availability of this material at NARA, hours, yields chloroform-soluble ex-
call 202–741–6030, or go to: http:// tractives not to exceed 0.5 mg/in2 of
www.archives.gov/federal_register/ food contact surface exposed to the sol-
vent.
ibr_locations.html.
(2) Conditions of use. The plastics are
Density: 1.15 to 1.20 as determined by ASTM
method D1505–68 (Reapproved 1979), used for packaging, transporting, or
‘‘Standard Test Method for Density of holding food, excluding alcoholic bev-
Plastics by the Density-Gradient Tech- erages, at temperatures not to exceed
nique,’’ which is incorporated by ref- 250 °F.
erence. Copies may be obtained from the (g) Polyethylene phthalate plastics
American Society for Testing Materials, conforming with the specifications pre-
100 Barr Harbor Dr., West Conshohocken, scribed in paragraph (g)(1) of this sec-
Philadelphia, PA 19428-2959, or may be
tion are used as provided in paragraph
Records Administration (NARA). For in- (g)(2) of this section.
formation on the availability of this ma- (1) Specifications. (i) The food contact
terial at NARA, call 202–741–6030, or go surface meets the specifications in
to: http://www.archives.gov/federal_register/ paragraph (f)(1) of this section; and
320
(ii) The food contact surface when ex- (iii) Filtration of bulk alcoholic bev-
posed to 50 percent ethyl alcohol at 120 erages, not exceeding 50 percent alco-
°F for 24 hours, yields chloroform-solu- hol by volume, at temperatures not ex-
ble extractives not to exceed 0.5 mg/in2 ceeding 120 °F.
of food contact surface exposed to the (j) Polyethylene phthalate plastics,
solvent. composed of ethylene terephthalate-
(2) Conditions of use. The plastics are isophthalate containing a minimum of
used for packaging, transporting, or 98 weight percent of polymer units de-
holding alcoholic beverages that do not rived from ethylene terephthalate, or
exceed 50 percent alcohol by volume. ethylene-1,4-cyclohexylene
(h) Uncoated polyethylene phthalate dimethylene terephthalate copoly-
plastics consisting of a base sheet or esters described in § 177.1315(b)(3), con-
base polymer prepared as prescribed forming with the specifications pre-
from substances identified in para- scribed in paragraph (j)(1) of this sec-
graphs (e)(4)(i) and (ii) of this section tion, are used as provided in paragraph
and conforming with the specifications (j)(2) of this section.
prescribed in paragraph (h)(1) of this (1) Specifications. (i) The food contact
section are used as provided in para- surface meets the specifications in
graph (h)(2) of this section: paragraph (f)(1) of this section and
(1) Specifications. (i) The food contact (ii)(a) Containers with greater than 500
surface, when exposed to distilled mL capacity. The food-contact surface
water at 250 °F for 2 hours yields chlo- when exposed to 95 percent ethanol at
roform-soluble extractives not to ex- 120 °F for 24 hours should not yield
ceed 0.02 milligram/inch 2 of food con- chloroform-soluble extractives in ex-
tact surface exposed to the solvent; and cess of 0.005 mg/in 2.
(ii) The food contact surface, when (b) Containers with less than or equal to
exposed to n-heptane at 150 °F for 2 500 mL capacity. The food contact sur-
hours, yields chloroform-soluble ex- face when exposed to 95 percent eth-
tractives not to exceed 0.02 milligram/ anol at 120 °F for 24 hours should not
inch 2 of food contact surface exposed yield chloroform-soluble extractives in
to the solvent. excess of 0.05 mg/in 2.
(2) Conditions of use. The plastics are (2) Conditions of use. The plastics are
used to contain foods during oven bak- used for packaging, transporting, or
ing or oven cooking at temperatures holding alcoholic foods that do not ex-
above 250 °F. ceed 95 percent alcohol by volume.
(i) Polyethylene phthalate fabric, [42 FR 14572, Mar. 15, 1977]
identified in paragraph (c) of this sec-
tion and conforming with the specifica- EDITORIAL NOTE: For FEDERAL REGISTER ci-
tions prescribed in paragraph (i)(1) of tations affecting § 177.1630, see the List of
this section, is used only as provided in CFR Sections Affected, which appears in the
paragraph (i)(2) of this section. and at www.fdsys.gov.
(1) Specifications. Chloroform-soluble
extractives shall not exceed 0.2 milli- § 177.1632
gram/inch 2 of food-contact surface Poly(phenyleneterephthalamide)
when exposed to the following solvents resins.
at temperatures and times indicated: Poly(phenyleneterephthalamide) res-
(i) Distilled water at 212 °F for 2 ins identified in paragraph (a) of this
hours. section may be safely used as articles
(ii) n-Heptane at 150 °F for 2 hours. or components of articles intended for
(iii) 50 percent ethyl alcohol at 120 °F repeated contact with food.
for 24 hours. (a) Identity. For the purpose of this
(2) Conditions of use. The plastics are section, the poly(phenylene-
intended for: terephthalamide) resins (CAS Reg. No.
(i) Dry food contact. 26125–61–1) are produced by the polym-
(ii) Bulk food (excluding alcoholic erization of terephthalolyl chloride
beverages) repeated use applications, with p-phenylenediamine. The

including filtration, at temperatures poly(phenyleneterephthalamide) resin
not exceeding 212 °F. fibers and yarns may contain optional
321
§ 177.1635 21 CFR Ch. I (4–1–23 Edition)
adjuvant substances required in their (d) Conditions of use. (1)

preparation and finishing. Poly(phenyleneterephthalamide) resins
(b) Optional adjuvant substances. The in the form of continuous filament
poly(phenyleneterephthalamide) resins yarns and fibers may be used as compo-
identified in paragraph (a) of this sec- nents of articles intended for repeated
tion may contain the following op- use in contact with food at tempera-
tional adjuvant substances, subject to tures not to exceed 260 °C (500 °F). All
any limitation on their use: items are scoured prior to use by agita-
(1) Optional adjuvant substances au- tion in a water bath containing 0.5
thorized for this use in accordance with gram/liter of tetrasodium
§ 174.5 of this chapter. pyrophosphate and 0.5 percent deter-
(2) Optional finish components, total gent. The items are agitated at 80 °C
weight not to exceed 1 percent by (180 °F) for 20 minutes, and then sub-
weight of the base polymer, as follows: jected to a cold water rinse.
List of substances Limitations (2) Poly(phenyleneterephthalamide)
resins in the form of pulp may be used
Diundecylphthalate (CAS
Reg. No. 3648–20–2).
as gaskets and packing for food proc-
Mono- and dipotassium salts essing equipment at temperatures not
of lauryl phosphate (CAS to exceed 260 °C (500 °F).
Reg. No. 39322–78–6).
o-Phenylphenol (CAS Reg. For use as a fungicide for fin- [57 FR 3125, Jan. 28, 1992, as amended at 69
No. 90–43–7). ish coating materials. Not FR 24512, May 4, 2004]
to exceed 0.01 percent by
weight of the base poly-
mer. § 177.1635 Poly(p-methylstyrene) and
Poly(oxyethylene/ rubber-modified poly(p-methyl-
oxypropylen- styrene).
e)monobutylether (CAS
Reg. No. 9038–95–3). Poly(p-methylstyrene) and rubber-
Poly(oxyethylene) modified poly(p-methylstyrene) identi-
mono(nonylphenyl)ether fied in this section may be safely used
(CAS Reg. No. 9016–45–
9). as components of articles intended for
Polyvinyl methylether (CAS use in contact with food, subject to the
Reg. No. 9003–09–2). provisions of this section:
Poly(oxyethylene) sorbitol
monolaurate tetraoleate (a) Identity. For the purposes of this
(CAS Reg. No. 71243–28– section, poly(p-methylstyrene) and
2). rubber-modified poly(p-methylstyrene)
Poly(oxyethylene) sorbitol
hexaoleate (CAS Reg. No. are basic polymers, manufactured as
57171–56–9). described in this paragraph, meeting
4,4′-Butylidenebis (6-tert- For use only as an oxidation the specifications prescribed in para-
butyl-m-cresol) (CAS Reg. inhibitor for finish coating
No. 85–60–9). materials. Not to exceed
graph (c) of this section.
0.01 percent by weight of (1) Poly(p-methylstyrene) (CAS Reg.
the base polymer. No. 24936–41–2) polymer produced by the
polymerization of p-methylstyrene.
(c) Specifications. (1) (2) Rubber-modified poly(p-
Poly(phenyleneterephthalamide) resins
methylstyrene) (CAS Reg. No. 33520–88–
in the form of continuous filament
6) polymer produced by combining sty-
yarns or fibers that have been scoured
rene-butadiene copolymer and/or
in accordance with paragraph (d)(1) of
this section, when refluxed in a 50 per- polybutadiene with poly(p-
cent ethanol/water mixture for 24 methylstyrene), either during or after
hours, yields total extractables not ex- polymerization of the poly(p-
ceeding 0.5 percent by weight of the methylstyrene), such that the finished
sample. polymers contain not less than 75
(2) Poly(phenyleneterephthalamide) weight percent of total polymer units
resins in the form of pulp, when derived from p-methylstyrene) mon-
refluxed in a 50 percent ethanol/water omer.
(b) Optional adjuvants. The basic
mixture for 24 hours, yields total

extractables not exceeding 0.65 percent polymers identified in paragraph (a) of
by weight of the sample.
322
this section may contain optional adju- section shall be used in contact with
vant substances required in the produc- food only under conditions of use B
tion of such basic polymers. Such op- through H set forth in table 2 of
tional adjuvant substances may in- § 176.170(c) of this chapter.
clude substances permitted for such [48 FR 31384, July 8, 1983, as amended at 54
use by applicable regulations in this FR 24898, June 12, 1989; 55 FR 52989, Dec. 26,
chapter, substances generally recog- 1990]
nized as safe in food, substances gen-
erally recognized as safe in indirect ad- § 177.1637 Poly(oxy-1,2-
ditives, and substances used in accord- ethanediyloxycarbonyl-2,6-
ance with prior sanction or approval. naphthalenediylcarbonyl) resins.
(c) Specifications. (1) Poly(p- Poly(oxy-1,2-ethanediyloxycarbonyl-
methylstyrene) basic polymers identi- 2,6-naphthalenediylcarbonyl) resins
fied in paragraph (a)(1) of this section identified in paragraph (a) of this sec-
shall contain not more than 1 weight tion may be safely used as articles or
percent of total residual p- components of articles intended for use
methystyrene monomer, as determined in contact with food in accordance
by a gas chromatographic method ti- with the following conditions:
tled, ‘‘Gas Chromatographic Deter- (a) Identity. For the purpose of this
mination of PMS and PET in PPMS section, poly(oxy-1,2-
Basic Polymers,’’ which is incorporated ethanediyloxycarbonyl-2,6-
by reference. Copies are available from naphthalenediylcarbonyl) resins (CAS
the Center for Food Safety and Applied Reg. No. 24968–11–4) are polymers
Nutrition (HFS–200), Food and Drug formed by catalytic transesterification
Administration, 5001 Campus Dr., Col- of 2,6-dimethylnaphthalene
lege Park, MD 20740, or available for in- dicarboxylate with ethylene glycol fol-
spection at the National Archives and lowed by catalytic polycondensation.
Records Administration (NARA). For (b) Specifications—(1) Density. The
information on the availability of this density of poly(oxy-1,2-
material at NARA, call 202–741–6030, or ethanediyloxycarbonyl-2,6-
go to: http://www.archives.gov/fed- naphthalenediylcarbonyl) resins shall
eral_register/code_of_federal_regulations/ be between 1.33 and 1.40 grams per
ibr_locations.html. cubic centimeter.
(2) Rubber-modified poly(p- (2) Inherent viscosity. The finished
methylstyrene) basic polymers identi- food-contact article shall have a min-
fied in paragraph (a)(2) of this section imum inherent viscosity of 0.55 deci-
shall contain not more than 0.5 weight liter per gram in a solution of 0.1 gram
percent of total residual p- of polymer in 100 milliliters of a 25/40/
methylstyrene monomer, as deter- 35 (weight/weight/weight) solution of p-
mined by the method identified in chlorophenol/tetrachloroethane/phenol.
paragraph (c)(1) of this section The viscosity is determined by East-
(d) Other specifications and limitations. man Chemical Co.’s method ECD-A-AC-
The poly(p-methylstyrene) and rubber- G-V-1-5, ‘‘Determination of Dilute So-
modified poly(p-methylstyrene) identi- lution Viscosity of Polyesters,’’ dated
fied in and complying with this sec- May 31, 1988, which is incorporated by
tion, when used as components of the reference in accordance with 5 U.S.C.
food-contact surface of any article that 552(a) and 1 CFR part 51. Copies are
is the subject of a regulation in parts available from the Office of Food Addi-
175, 176, 177, 178 and § 179.45 of this chap- tive Safety (HFS–200), Center for Food
ter, shall comply with any specifica- Safety and Applied Nutrition, Food and
tions and limitations prescribed by Drug Administration, 5001 Campus Dr.,
such regulation for the article in the College Park, MD 20740, 240–402–1200, or
finished form in which it is to contact may be examined at the Food and Drug
food. Administration’s Main Library, 10903
(e) Conditions of use. Poly(p- New Hampshire Ave., Bldg. 2, Third
methylstyrene) basic polymers and Floor, Silver Spring, MD 20993, 301–796–
rubber-modified poly(p-methylstyrene) 2039, or at the National Archives and

basic polymers identified in paragraphs Records Administration (NARA). For
(a)(1) and (a)(2), respectively, of this information on the availability of this
323
§ 177.1640 21 CFR Ch. I (4–1–23 Edition)
material at NARA, call 202–741–6030, or polymer units derived from styrene

go to: http://www.archives.gov/fed- monomer.
eral_register/code_of_federal_regulations/ (b) Optional adjuvants. The basic
ibr_locations.html. polymers identified in paragraph (a) of
(c) Extraction limitations. A 0.5 milli- this section may contain optional adju-
meter (0.02 inch) thick sheet of resin vant substances required in the produc-
when extracted with water at 121 °C tion of such basic polymers. Such op-
(250 °F) for 2 hours shall yield total tional adjuvant substances may in-
nonvolatile extractives not exceeding clude substances permitted for such
2.0 micrograms per square inch of ex- use by regulations in parts 170 through
posed resin surface. 189 of this chapter, substances gen-
(d) Conditions of use. The finished erally recognized as safe in food, and
food contact article shall be: substances used in accordance with a
(1) Used in contact only with food of prior sanction or approval.
Types I, II, IVB, VIA, VIB, VIIB, and
(c) Specifications. (1) Polystyrene
VIII identified in table 1 of § 176.170(c)
basic polymers identified in paragraph
of this chapter, under conditions of use
(a)(1) of this section shall contain not
A through H described in table 2 of
more than 1 weight percent of total re-
§ 176.170(c) of this chapter; and with
sidual styrene monomer, as determined
food of Types III, IVA, V, VIC, VIIA,
by the method described in paragraph
and IX identified in table 1 of
§ 176.170(c) of this chapter, under condi- (d) of this section, except that when
tions of use C through H described in used in contact with fatty foods of
table 2 of § 176.170(c) of this chapter; Types III, IV-A, V, VII-A, and IX de-
and scribed in table 1 of § 176.170(c) of this
(2) Identified in a manner that will chapter, such polystyrene basic poly-
differentiate the article from articles mers shall contain not more than 0.5
made of other polymeric resins to fa- weight percent of total residual sty-
cilitate collection and sorting. rene monomer.
(2) Rubber-modified polystyrene
[61 FR 14965, Apr. 4, 1996, as amended at 78 basic polymers identified in paragraph
FR 14666, Mar. 7, 2013; 81 FR 5594, Feb. 3, 2016]
(a)(2) of this section shall contain not
§ 177.1640 Polystyrene and rubber- more than 0.5 weight percent of total
modified polystyrene. residual styrene monomer, as deter-
mined by the method described in para-
Polystyrene and rubber-modified pol-
graph (d) of this section.
ystyrene identified in this section may
be safely used as components of arti- (d) Analytical method for determination
cles intended for use in contact with of total residual styrene monomer con-
food, subject to the provisions of this tent—(1) Scope. This method is suitable
section. for the determination of residual sty-
(a) Identity. For the purposes of this rene monomer in all types of styrene
section, polystyrene and rubber-modi- polymers.
fied polystyrene are basic polymers (2) Principle. The sample is dissolved
manufactured as described in this para- in methylene chloride. An aliquot of
graph so as to meet the specifications the solution is injected into a gas chro-
prescribed in paragraph (c) of this sec- matograph. The amount of styrene
tion when tested by the method de- monomer present is determined from
scribed in paragraph (d) of this section. the area of the resulting peak.
(1) Polystyrene consists of basic poly- (3) Apparatus—(i) Gas chromatograph.
mers produced by the polymerization Beckman GC-2A gas chromatograph
of styrene. with hydrogen flame detector or appa-
(2) Rubber-modified polystyrene con- ratus of equivalent sensitivity.
sists of basic polymers produced by (ii) Chromatograph column. One-quar-
combining styrene-butadiene copoly- ter inch outside diameter stainless
mers and/or polybutadiene with poly- steel tubing (0.028 inch wall thickness),
styrene, either during or after polym- 4 feet in length, packed with 20 percent
erization of the polystyrene, such that polyethylene glycol (20,000 molecular

the finished basic polymers contain not weight) on alkaline treated 60–80 mesh
less than 75 weight percent of total firebrick.
324
(iii) Recorder. Millivolt range of 0–1, components of the food-contact surface

chart speed of 30 inches per hour. of any article that is the subject of a
(4) Reagents. Compressed air, purified; regulation in parts 174, 175, 176, 177, 178
helium gas; hydrogen gas; methylene and § 179.45 of this chapter, shall com-
chloride, redistilled; and styrene mon- ply with any specifications and limita-
omer, redistilled. tions prescribed by such regulation for
(5) Operating conditions for the gas the article in the finished form in
chromatograph. (i) The column is oper- which it is to contact food.
ated at a temperature of 100 °C with a (f) Nonapplicability. The provisions of
helium flow rate of 82 milliliters per this section are not applicable to poly-
minute. styrene and rubber-modified poly-
(ii) The hydrogen burner is operated styrene used in food-packaging adhe-
with 15 pounds per square inch of air sives complying with § 175.105 of this
pressure and 7 pounds per square inch chapter.
of hydrogen pressure.
(iii) The attenuation of the hydrogen § 177.1650 Polysulfide polymer-
flame detector is set at 2 × 102. polyepoxy resins.
(6) Standardization. (i) Prepare a Polysulfide polymer-polyepoxy res-
standard solution by weighing accu- ins may be safely used as the food-con-
rately 15 to 20 milligrams of styrene tact surface of articles intended for
monomer into a 2-ounce bottle con- packaging, transporting, holding, or
taining 25.0 milliliters of methylene otherwise contacting dry food, in ac-
chloride. Cap the bottle tightly and cordance with the following prescribed
shake to thoroughly mix the solution. conditions:
(ii) By means of a microliter syringe, (a) Polysulfide polymer-polyepoxy
inject 1 microliter of the standard solu- resins are the reaction products of liq-
tion into the gas chromatograph. Meas- uid polysulfide polymers and
ure the area of the styrene monomer polyfunctional epoxide resins, cured
peak which emerges after approxi- with the aid of
mately 12 minutes. tri(dimethylaminomethyl) phenol, to
(7) Procedure. (i) Transfer 1 gram of
which have been added certain optional
sample (accurately weighed to the
substances to impart desired techno-
nearest 0.001 gram to a 2-ounce bottle
logical properties to the resins. Subject
and add several glass beads. Pipette
to any limitations prescribed in this
25.0 milliliters of methylene chloride
section, the optional substances may
into the bottle. Cap the bottle tightly
include:
and place on a mechanical shaker.
Shake until the polymer is completely
as safe in food and food packaging.
dissolved. If any insoluble residue re-
(2) Substances the use of which is
mains, allow the bottle to stand (or
permitted under applicable regulations
centrifuge at a low speed) until a clear
in this part, prior sanctions, or approv-
supernatant layer appears.
als.
(ii) By means of a microliter syringe,
(3) Substances named in this subpara-
inject 3 microliters of the clear super-
graph and further identified as re-
natant liquid into the gas chro-
quired:
matograph.
(iii) Measure the area of the resulting List of substances Limitations
styrene monomer peak. Compare the
Bis(2-chloroethyl) formal.
sample peak area with the area pro- Bis(dichloropropyl) formal .................. Cross-linking agent.
duced by the standard styrene mon- Butyl alcohol ...................................... Solvent.
omer solution. Calculation: Carbon black (channel process).
Chlorinated paraffins ......................... Cross-linking agent.
Percent residual styrene monomer = Milli- Epoxidized linseed oil.
grams monomer in standard × peak area of Epoxidized soybean oil.
sample / Peak area of monomer standard × Epoxy resins (as listed in
sample weight in grams × 30 § 175.300(b)(3)(viii)(a) of this chap-
ter)..
(e) Other specifications and limitations. Ethylene glycol monobutyl ether ....... Solvent.
Magnesium chloride.
The polystyrene and rubber-modified Methyl isobutyl ketone ....................... Solvent.

polystyrene identified in and com- Naphthalene sulfonic acid-formalde-
plying with this section, when used as hyde condensate, sodium salt.
325
§ 177.1655 21 CFR Ch. I (4–1–23 Edition)
List of substances Limitations lecular weight of 15,000, as determined

by osmotic pressure in
Sodium dibutyl naphthalene Wetting agent.
sulfonate. monochlorobenzene; or
Sodium hydrosulfide. (2) 1,1′-Sulfonylbis[4-chlorobenzene]
Sodium polysulfide.
b,b′,g,g′-Tetrachloro normal propyl Cross-linking agent.
polymer with 4,4′-(1-
ether. methylethylidene)bis[phenol] (min-
Titanium dioxide. imum 92 percent) and 4,4′-
Toluene .............................................. Solvent.
Trichloroethane .................................. Cross-linking agent.
sulfonylbis[phenol] (maximum 8 per-
1,2,3-Trichloropropane ...................... Do. cent) (CAS Reg. No. 88285–91–0) pro-
Urea-formaldehyde resins. duced when a mixture of 4,4′-
Xylene ................................................ Solvent.
isopropylidenediphenol (minimum 92
(b) The resins are used as the food- percent) and 4,4′-sulfonylbis[phenol]
contact surface for dry food. (maximum 8 percent) is made to react
(c) An appropriate sample of the fin- with 4,4′-dichlorodiphenyl sulfone in
ished resin in the form in which it con- such a way that the finished resin has
tacts food, when subjected to ASTM a minimum number average molecular
method D968–81, ‘‘Standard Test Meth- weight of 26,000, as determined by os-
ods for Abrasion Resistance of Organic motic pressure in dimethylformamide.
Coatings by the Falling Abrasive (b) The basic polysulfone resins iden-
Tester,’’ which is incorporated by ref- tified in paragraph (a) of this section
erence (Copies may be obtained from may contain optional adjuvant sub-
the American Society for Testing Ma- stances required in the production of
terials, 100 Barr Harbor Dr., West such basic resins. The optional adju-
Conshohocken, Philadelphia, PA 19428- vant substances required in the produc-
2959, or may be examined at the Na- tion of the basic polysulfone resins
tional Archives and Records Adminis- may include substances described in
tration (NARA). For information on § 174.5(d) of this chapter and the fol-
the availability of this material at lowing:
www.archives.gov/federal_register/ List of substances Limitations
code_of_federal_regulations/ Dimethyl sulfoxide ..... Not to exceed 50 parts per million as
ibr_locations.html.), using No. 50 Emery residual solvent in finished basic
abrasive in lieu of Ottawa sand, shall resin in paragraph (a)(1) of this
section.
exhibit and abrasion coefficient of not
Monochlorobenzene .. Not to exceed 500 parts per million
less than 20 liters per mil of film thick- as residual solvent in finished
ness. basic resin in paragraph (a)(1) of
this section.
[42 FR 14572, Mar. 15, 1977, as amended at 49 N-methyl-2- Not to exceed 0.01 percent (100
FR 10110, Mar. 19, 1984] pyrrolidone. parts per million) as residual sol-
vent in finished basic resin in para-
§ 177.1655 Polysulfone resins. graph (a)(2) of this section.
Polysulfone resins identified in para-
graph (a) of this section may be safely (c) Polysulfone resins, when ex-
used as articles or components of arti- tracted at reflux temperatures for 6
cles intended for use in contact with hours with the solvents—distilled
food, in accordance with the following water, 50 percent (by volume) ethyl al-
prescribed conditions: cohol in distilled water, 3 percent ace-
(a) For the purpose of this section, tic acid in distilled water, and n-
polysulfone resins are: heptane, yield total extractives in each
(1) Poly(oxy-p-phenylenesulfonyl-p- extracting solvent not to exceed 0.0078
phenyleneoxy-p- milligram per square centimeter (0.05
phenyleneisopropylidene-p-phenylene) milligram per square inch) of resin sur-
resins (CAS Reg. No. 25154–01–2) con- face. Note: In testing the finished
sisting of basic resins produced when polysulfone resins, use a separate resin
the disodium salt of 4,4′- test sample for each required extract-
isopropylidenediphenol is made to ing solvent.
react with 4,4′-dichlorodiphenyl sulfone (d) Polysulfone resins intended for re-
in such a way that the finished resins peated use in contact with food may be
have a minimum number average mo- used under conditions of use A through
326
H in table 2 of § 176.170(c) of this chap- (2) Poly(tetramethylene

ter. The resins intended for single-serv- terephthalate) in the finished form in
ice food-contact use may be used only which it is to contact food shall yield
under condition of use H described in total extractives as follows:
table 2 of § 176.170(c) of this chapter. (i) Not to exceed 0.08 milligram per
square inch of food contact surface
[51 FR 882, Jan. 9, 1986; 51 FR 4165, Feb. 3, when extracted for 2 hours at 250 °F
1986; 61 FR 29475, June 11, 1996]
with distilled water.
(ii) Not to exceed 0.02 milligram per
§ 177.1660 Poly (tetramethylene
terephthalate). square inch of food contact surface
when extracted for 2 hours at 150 °F
Poly(tetramethylene terephthalate) with n-heptane.
(poly (oxytetramethyleneoxyter- (iii) Not to exceed 0.04 milligram per
ephthaloyl)) [Chemical Abstracts Serv- square inch of food contact surface
ice Registry No. 24968–12–5] identified when extracted for 2 hours at 212 °F
in this section may be safely used as with 3 percent aqueous acetic acid.
articles or components of articles in- (iv) Not to exceed 0.02 milligram per
tended to contact food, in accordance square inch of food contact surface
with the following prescribed condi- when extracted for 2 hours at 65.6 °C
tions: (150 °F) with 50 percent ethanol.
(a) Identity. For the purpose of this [42 FR 14572, Mar. 15, 1977, as amended at 50
section, poly (tetramethylene FR 20748, May 20, 1985; 52 FR 20069, May 29,
terephthalate) is the reaction product 1987]
of dimethyl terephthalate with 1,4-
butanediol to which may have been § 177.1670 Polyvinyl alcohol film.
added certain optional substances to Polyvinyl alcohol film may be safely
impart desired technological properties used in contact with food of the types
to the polymer. identified in § 176.170(c) of this chapter,
(b) Optional adjuvant substances. table 1, under Types V, VIII, and IX, in
Poly(tetramethylene terephthalate) accordance with the following pre-
identified in paragraph (a) of this sec- scribed conditions:
tion may contain optional adjuvant (a) The polyvinyl alcohol film is pro-
substances. The quantity of any op- duced from polyvinyl alcohol having a
tional adjuvant substance employed in minimum viscosity of 4 centipoises
the production of the polymer does not when a 4-percent aqueous solution is
exceed the amount reasonably required tested at 20 °C.
to accomplish the intended technical (b) The finished food-contact film for
or physical effect. Such adjuvants may use in contact with Food Types V or
include substances generally recog- IX, when extracted with the solvent
nized as safe in food, substances used in characterizing the type of food and
accordance with prior sanction, and under the conditions of time and tem-
substances permitted under applicable perature characterizing its intended
regulations in this part. use as determined from tables 1 and 2
(c) Specifications. (1) Inherent vis- of § 176.170(c) of this chapter, yields
cosity of a 0.50 percent solution of the total extractives not to exceed 0.078
polymer in phenol/tetrachloroethane milligram per square centimeter (0.5
(60/40 weight ratio) solvent is not less milligram per square inch) of food-con-
than 0.6 as determined using a Wagner tact surface when tested by ASTM
viscometer (or equivalent) and cal- method F34–76 (Reapproved 1980),
culated from the following equation: ‘‘Standard Test Method for Liquid Ex-
traction of Flexible Barrier Materials,’’
Inherent ( natural logarithm of N r ) which is incorporated by reference.
viscosity = Copies may be obtained from the Amer-
(c) ican Society for Testing Materials, 100
where: Barr Harbor Dr., West Conshohocken,
Nr = Ratio of flow time of the polymer solu- Philadelphia, PA 19428-2959, or may be
tion to that of the solvent and c = poly- examined at the National Archives and
mer concentration of the test solution in Records Administration (NARA). For
grams per 100 milliliters. information on the availability of this
327
ER01JA93.400</GPH>
§ 177.1680 21 CFR Ch. I (4–1–23 Edition)
material at NARA, call 202–741–6030, or 2,2-Dimethyl-1,3-propanediol.

go to: http://www.archives.gov/fed- Ethylene glycol.
eral_register/code_of_federal_regulations/ 1,6–Hexanediol (CAS Reg. No. 629–11–8).a–
ibr_locations.html. Hydro–w–hydroxypoly(oxy–1,4–butanediyl)
(c) The finished food-contact film (CAS Reg. No. 25190–06–1).
shall not be used as a component of a-Hydro-omega-hydroxypoly (oxytetra-
methylene).
food containers intended for use in con-
a,a′-(Isopropylidenedi-p-phenylene)bis[omega-
tact with water.
hydroxypoly (oxypropylene)(3–4 moles)],
[42 FR 14572, Mar. 15, 1977, as amended at 49 average molecular weight 675.
FR 10110, Mar. 19, 1984] Maleic anhydride.
Methyl oxirane polymer with oxirane (CAS
§ 177.1680 Polyurethane resins. Reg. No. 9003–11–6).
The polyurethane resins identified in Methyl oxirane polymer with oxirane, ether
paragraph (a) of this section may be with 1,2,3–propanetriol (CAS Reg. No. 9082–
00–2).
safely used as the food-contact surface
a,a′a″,a″′-Neopentanetetrayltetrakis [omega-
of articles intended for use in contact
hydroxypoly (oxypropylene) (1–2 moles)],
with bulk quantities of dry food of the average molecular weight 400.
type identified in § 176.170(c) of this Pentaerythritol-linseed oil alcoholysis prod-
chapter, table 1, under Type VIII, in ac- uct.
cordance with the following prescribed Phthalic anhydride.
conditions: Polybutylene glycol.
(a) For the purpose of this section, Polyethyleneadipate modified with ethanol-
polyurethane resins are those produced amine with the molar ratio of the amine to
when one or more of the isocyanates the adipic acid less than 0.1 to 1.
listed in paragraph (a)(1) of this section Poly(oxycarbonylpentamethylene).
is made to react with one or more of Polyoxypropylene ethers of 4.4′-isopropyl-
the substances listed in paragraph idenediphenol (containing an average of 2–
(a)(2) of this section: 4 moles of propylene oxide).
(1) Isocyanates: Polypropylene glycol.
a,a′,a″-1,2,3-Propanetriyltris [omega-
Bis(isocyanatomethyl) benzene (CAS Reg. hydroxypoly (oxypropylene) (15–18 moles)],
No. 25854–16–4). average molecular weight 3,000.
Bis(isocyanatomethyl) cyclohexane (CAS Propylene glycol.
Reg. No. 38661–72–2).
a,a′,a″-[Propylidynetris (methylene)] tris
4,4′-Diisocyanato-3,3′-dimethylbiphenyl (bi-
[omega-hydroxypoly (oxypropylene) (min-
tolylene diisocyanate).
imum 1.5 moles)], minimum molecular
Diphenylmethane diisocyanate.
weight 400.
Hexamethylene diisocyanate.
3-Isocyanatomethyl - 3,5,5 - trimethylcyclo- a-[r(1,1,3,3-Tetramethylbutyl) - phenyl]-
hexyl isocyanate. omega-hydroxypoly(oxyethylene) (5 moles),
4,4-Methylenebis(cyclohexyl isocyanate). average molecular weight 425.
Toluene diisocyanate. Trimethylol propane.
(2) List of substances: (b) Optional adjuvant substances em-

ployed in the production of the poly-
Adipic acid.
1,4-Butanediol. urethane resins or added thereto to im-
1,3-Butylene glycol. part desired technical or physical prop-
1,4–Cyclohexane dimethanol (CAS Reg. No. erties may include the following sub-
105–08–8). stances:
1-[(2-Aminoethyl)amino]2-propanol ............................................. As a curing agent.

1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride ....... As a preservative.
Colorants used in accordance with § 178.3297 of this chapter..
Dibutyltin diacetate ...................................................................... As a catalyst.
Dibutyltin dichloride ..................................................................... Do.
Dibutyltin dilaurate ....................................................................... Do.
N,N-Dimethyldodecylamine ......................................................... Do.
N-Dodecylmorpholine .................................................................. Do.
a,a′-[Isopropylidenebis[p-phenyleneoxy(2-hydroxytrimethylene) As a stabilizer.
]]bis[omega-hydroxypoly-(oxyethylene) (136–170 moles)], av-
erage molecular weight 15,000.

4,4′-Methylenedianiline ................................................................ As a curing agent.
1,1′,1″-Nitrilotri-2-propanol ........................................................... Do.
328
2,2′-(p-Phenylenedioxy) diethanol ............................................... Do.

Polyvinyl isobutyl ether.
Polyvinyl methyl ether.
Soyaalkyd resin ........................................................................... Conforming in composition with § 175.300 of this chapter and
containing litharge not to exceed that residual from its use
as the reaction catalyst and creosol not to exceed that re-
quired as an antioxidant.
Tetrakis [methylene–(2,5–di-tert-butyl-4-hydroxyhydrocinna- Stabilizer.
mate)]methane (CAS Reg. No. 6683–19–8).
N,N,N′N′-Tetrakis (2-hydroxypropyl)ethylenediamine ................. As a curing agent.
Triethanolamine ........................................................................... Do.
Trimethyleneglycol di (p-aminobenzoate) (CAS Reg. No. As a curing agent.
57609–64–0).
(c) An appropriate sample of the fin- § 177.1810 Styrene block polymers.

ished resin in the form in which it con- The styrene block polymers identi-
tacts food, when subjected to ASTM fied in paragraph (a) of this section
method D968–81, ‘‘Standard Test Meth- may be safely used as articles or as
ods for Abrasion Resistance of Organic components of articles intended for use
Coatings by the Falling Abrasive in contact with food, subject to provi-
Tester,’’ which is incorporated by ref- sions of this section.
erence (Copies may be obtained from (a) For the purpose of this section,
the American Society for Testing Ma- styrene block polymers are basic poly-
terials, 100 Barr Harbor Dr., West mers manufactured as described in this
Conshohocken, Philadelphia, PA 19428- paragraph, so that the finished poly-
2959, or may be examined at the Na- mers meet the specifications prescribed
tional Archives and Records Adminis- in paragraph (b) of this section, when
tration (NARA). For information on tested by the methods described in
the availability of this material at paragraph (c) of this section.
NARA, call 202–741–6030, or go to: http:// (1) Styrene block polymers with 1,3-
www.archives.gov/federal_register/ butadiene are those produced by the
code_of_federal_regulations/ catalytic solution polymerization of
ibr_locations.html.), using No. 50 Emery styrene and 1,3-butadiene.
abrasive in lieu of Ottawa sand, shall (2) Styrene block polymers with 2-
methyl-1,3-butadiene are those pro-
exhibit an abrasion coefficient of not
duced by the catalytic solution polym-
less than 20 liters per mil of film thick-
erization of styrene and 2-methyl-1,3-
ness.
butadiene.
[42 FR 14572, Mar. 15, 1977, as amended at 46 (3) Styrene block polymers with 1,3-
FR 57033, Nov. 20, 1981; 49 FR 10110, Mar. 19, butadiene, hydrogenated are those pro-
1984; 50 FR 51847, Dec. 20, 1985; 56 FR 15278, duced by the catalytic solution polym-
Apr. 16, 1991; 56 FR 42933, Aug. 30, 1991] erization of styrene and 1,3-butadiene,
and subsequently hydrogenated.
(b) Specifications:
Maximum extract- Maximum extract-
able fraction in dis- able fraction in 50
Molecular Glass transi- tilled water at spec- percent ethanol at
Styrene block polymers weight Solubility tion points ified temperatures, specified tempera-
(minimum) times, and tures, times, and
thicknesses thicknesses
1. (i) Styrene block polymers with 1,3- 29,000 Completely ¥98 °C 0.0039 mg/cm2 0.002 mg/cm2 (0.01
butadiene; for use as articles or as soluble in (¥144 °F) (0.025 mg/in2) of mg/in2) of sur-
components of articles that contact toluene. to ¥71 °C surface at reflux face at 66 °C
food of Types I, II, IV-B, VI, VII-B, (¥96 °F) temperature for (150 °F) for 2 hr
and VIII identified in table 1 in and 86 °C 30 min on a 0.19 on a 0.19 cm
§ 176.170(c) of this chapter under (187 °F) to cm (0.075 in) (0.075 in) thick
conditions of use D, E, F, and G de- 122 °C thick sample. sample.
scribed in table 2 in § 176.170(c) of (252 °F).
this chapter.
329
§ 177.1810 21 CFR Ch. I (4–1–23 Edition)

able fraction in dis- able fraction in 50
Molecular Glass transi- tilled water at spec- percent ethanol at
Styrene block polymers weight Solubility tion points ified temperatures, specified tempera-
(minimum) times, and tures, times, and
thicknesses thicknesses
(ii) Styrene block polymers with 1,3-bu- 29,000 ......do .......... ......do .......... ......do .................... Do.
tadiene; for use as components of
pressure-sensitive adhesives that
contact food of Types I, II, IV-B, VI,
VII-B, and VIII identified in table 1 in
§ 176.170(c) of this chapter under
conditions of use C, D, E, F and G
described in table 2 in § 176.170(c) of
this chapter, provided the pressure-
sensitive adhesives be applied only
to closure tapes for sealing con-
tainers having a capacity of not less
than 160 cc (5.5 fluid ounces) and
that the area of the adhesive ex-
posed to food shall not exceed 4.03
cm2 (0.625 in2). The pressure-sen-
sitive adhesive may contain terpene
resins as identified in § 175.125(b)(2)
of this chapter.
2. Styrene block polymers with 2-meth- 29,000 ......do .......... ¥65 °C 0.002 mg/cm2 (0.01 0.002 mg/cm2 (0.01
yl-1,3-butadiene; for use as articles (¥85 °F) mg/in2) of sur- mg/in2) of sur-
or as components of articles that to ¥47 °C face at reflux face at 66 °C
contact food of Types I, II, IV-B, VI, (¥53 °F) temperature for 2 (150 °F) for 2 hr
VII-B, and VIII identified in table 1 in and 86 °C hr on a 0.071 cm on a 0.071 cm
§ 176.170(c) of this chapter. (187 °F) to (0.028 in) thick (0.028 in) thick
122 °C sample. (Option- sample. (Option-
(252 °F). ally, maximum ally, maximum
net residue solu- net residue solu-
ble in chloroform ble in chloroform
shall not exceed shall not exceed
0.00020 mg/cm2 0.00040 mg/cm2
(0.0013 mg/in2) (0.0025 mg/in2)
of surface.). of surface.)
3. (i) Styrene block polymers with 1,3- 16,000 ......do .......... ¥50 °C 0.002 mg/cm2 (0.01 0.002 mg/cm2 (0.01
butadiene, hydrogenated (CAS Reg. (¥58 °F) mg/in2) of sur- mg/in2) of sur-
No. 66070–58–4): for use as articles to ¥30 °C face at reflux face at 66 °C
or as components of articles that (¥22 °F) temperature for 2 (150 °F) for 2 hr
contact food of Types I, II, IV-B, VI, and 92 °C hr on a 0.071 cm on a 0.071 cm
VII-B, and VIII identified in table 1 in (198 °F) to (0.028 in) thick (0.028 in) thick
§ 176.170(c) of this chapter. 98 °C (208 sample. sample.
°F).
(ii) Styrene block polymers with 1,3-bu- 16,000 ......do .......... ......do .......... ......do .................... Do.
tadiene, hydrogenated (CAS Reg.
No. 66070–58–4): for use at levels
not to exceed 42.4 percent by weight
as a component of closures with
sealing gaskets that would contact
food of Types III, IV-A, V, VII-A, VIII,
and IX identified in table 1 in
§ 176.170(c) of this chapter, and in
condition of use D as described
under table 2 in § 176.170(c) of this
chapter.
(c) The analytical methods for deter- (2) Glass transition points. The glass
mining whether styrene block poly- transition points shall be determined
mers conform to the specifications pre- by either of the following methods:
scribed in this section are as follows (i) ASTM method D2236–70 (‘‘Stand-
and are applicable to the finished poly- ard Method of Test for Dynamic Me-
mer. chanical Properties of Plastics by
(1) Molecular weight. Molecular Means of Torsional Pendulum,’’ which
weight shall be determined by intrinsic is incorporated by reference; copies are

viscosity (or other suitable method). available from American Society for
Testing and Materials (ASTM), 100
330
Barr Harbor Dr., West Conshohocken, (3) Maximum extractable fractions in

Philadelphia, PA 19428-2959, or avail- distilled water and 50 percent ethanol and
able for inspection at the National Ar- the maximum net residue solubles in chlo-
chives and Records Administration roform. The maximum extractable frac-
(NARA). For information on the avail- tions in distilled water and 50 percent
ability of this material at NARA, call ethanol, and the maximum net residue
202–741–6030, or go to: http:// solubles in chloroform, shall be deter-
www.archives.gov/federal_register/ mined in accordance with § 176.170(d)(3)
code_of_federal_regulations/ of this chapter using a sandwich form
ibr_locations.html.) modified by using a of the finished copolymer of the speci-
forced resonant vibration instead of a fied thickness and for the time and
fixed vibration and by using fre- temperature specified in paragraph (b)
quencies of 25 to 40 cycles per second of this section.
instead of 0.1 to 10 cycles per second.
(d) The provisions of this section are
(ii) Direct reading viscoelastometric
not applicable to butadiene-styrene co-
method titled ‘‘Direct Reading
Viscoelastrometric Method for Deter- polymers listed in other sections of
mining Glass Transition Points of Sty- this subpart.
rene Block Polymers’’ (which is incor- (e) The provisions of this section are
porated by reference; copies are avail- not applicable to styrene block poly-
able from the Center for Food Safety mers with 1,3-butadiene listed in
and Applied Nutrition (HFS–200), Food § 175.105 of this chapter.
and Drug Administration, 5001 Campus [42 FR 14572, Mar. 15, 1977, as amended at 42
Dr., College Park, MD 20740, or avail- FR 43621, Aug. 30, 1977; 47 FR 11844, Mar. 19,
able for inspection at the National Ar- 1982; 51 FR 16828, May 7, 1986; 54 FR 24898,
chives and Records Administration June 12, 1989; 58 FR 65546, Dec. 15, 1993]
ability of this material at NARA, call § 177.1820 Styrene-maleic anhydride
202–741–6030, or go to: http:// copolymers.
www.archives.gov/federal_register/ Styrene-maleic anhydride copoly-
ibr_locations.html.), by which the glass
section may be safely used as articles
transition points are determined in the
or components of articles intended for
tensile mode of deformation at a fre-
use in contact with food, subject to
quency of 35 hertz using a Rheovibron
Model DDV-II (or equivalent) Direct provisions of this section.
Reading Viscoelastometer. Take maxi- (a) For the purpose of this section,
ma in the out-of-phase component of styrene-maleic anhydride copolymers
the complex modulus as the glass tran- are those produced by the polymeriza-
sition points. For block polymers of tion of styrene and maleic anhydride so
low styrene content or for simple block that the finished polymers meet the
polymers, the polymer may be treated specifications prescribed in paragraph
with 0.3 part per hundred dicumyl per- (b) of this section, when tested by the
oxide and cured for 30 minutes at 153 °C methods described in paragraph (c) of
to accentuate the upper transition this section.
point. (b) Specifications:
331
§ 177.1830 21 CFR Ch. I (4–1–23 Edition)

Molecular Residual able fraction in dis- able fraction in n-
weight Residual sty- maleic anhy- tilled water at spec- heptane at speci-
Styrene-maleic copolymers (minimum rene mon- dride mon- ified temperatures, fied temperatures,
number omer omer times, and particle times, and particle
average) size size
1. Styrene-maleic anhydride copoly- 70,000 0.3 weight 0.1 weight 0.006 weight per- 0.02 weight percent
mers containing not more than 15 pct percent. percent. cent at reflux at 73 °F for 2 hr
maleic anhydride units by weight; for temperature for 1 utilizing particles
use as articles or as components of hr utilizing par- of a size that will
articles that contact food of Types I, ticles of a size pass through a
II, III, IV-A, IV-B, V, VI-B (except car- that will pass U.S. standard
bonated beverages), VII-A, VII-B, through a U.S. sieve No. 10 and
VIII, and IX identified in table 1 in standard sieve will be held on a
§ 176.170(c) of this chapter under No. 10 and will U.S. standard
conditions of use B, C, D, E, F, G, be held on a sieve No. 20.
and H described in table 2 in U.S. standard
§ 176.170(c) of this chapter. sieve No. 20.
2. Styrene-maleic anhydride copolymer .................. 0.3 ............... 0.1 ............... 0.015 weight per- 1.0 weight percent
modified with butadiene, (CAS Reg. cent at reflux at 23 °C (73 °F)
No. 27288–99–9) containing not temperature for 1 for 2 hours uti-
more than 15 percent maleic anhy- hour utilizing par- lizing particles of
dride units by weight and not more ticles of a size a size that will
than 20 percent styrene-butadiene that will pass pass through a
and/or butadiene rubber units by through a U.S. U.S. standard
weight; for use (except carbonated standard sieve sieve No. 10 and
beverage bottles) as articles or as No. 10 and will will be held on a
components of articles that contact be held on a U.S. standard
food of Types I, II, III, IV-A, IV-B, V, U.S. standard sieve No. 20.
VI, VII-A, VII-B, VIII, and IX identified sieve No. 20.
in table I in § 176.170(c) of this chap-
ter under conditions of use B, C, D,
E, F, G, and H described in table 2 in
(c) The analytical methods for deter- code_of_federal_regulations/

mining conformance with specifica- ibr_locations.html.
tions for styrene-maleic anhydride co- (d) The provisions of this section are
polymers prescribed in this section are not applicable to styrene-maleic anhy-
as follows: dride copolymers listed in other sec-
(1) Molecular weight. Molecular tions of this subpart.
weight shall be determined by mem-
brane osmometry. [42 FR 14572, Mar. 15, 1977, as amended at 47
(2) Residual styrene monomer content. FR 11844, Mar. 19, 1982; 47 FR 14698, Apr. 6,
1982; 54 FR 24898, June 12, 1989]
Residual styrene monomer content
shall be determined by the method de- § 177.1830 Styrene-methyl methacry-
scribed in § 177.1640(d). late copolymers.
(3) Residual maleic anhydride monomer
content. Residual maleic anhydride Styrene-methyl methacrylate co-
monomer content shall be determined polymers identified in this section may
by a gas chromatographic method ti- be safely used as components of plastic
tled ‘‘Determination of Residual Ma- articles intended for use in contact
leic Anhydride in Polymers by Gas with food, subject to the provisions of
Chromatography,’’ which is incor- this section.
porated by reference. Copies are avail- (a) For the purpose of this section,
able from the Center for Food Safety styrene-methyl methacrylate copoly-
and Applied Nutrition (HFS–200), Food mers consist of basic copolymers pro-
and Drug Administration, 5001 Campus duced by the copolymerization of sty-
Dr., College Park, MD 20740, or avail- rene and methyl methacrylate such
able for inspection at the National Ar- that the finished basic copolymers con-
chives and Records Administration tain more than 50 weight percent of
(NARA). For information on the avail- polymer units derived from styrene.
ability of this material at NARA, call (b) The finished plastic food-contact
202–741–6030, or go to: http:// article, when extracted with the sol-
www.archives.gov/federal_register/ vent or solvents characterizing the
332
type of food and under the conditions Substances Limitations

of time and temperature characterizing
(3) Adjuvant substance, As a solvent in the prepara-
the conditions of intended use as deter- dimethylformamide. tion of fibryl.
mined from tables 1 and 2 of § 176.170(c)
of this chapter, yields extractives not (d) Textryls meeting the conditions
to exceed the following when tested by of test prescribed in paragraph (d)(1) of
the methods prescribed in § 177.1010(c); this section are used as prescribed in
(1) Total nonvolatile extractives not paragraph (d)(2) of this section.
to exceed 0.3 milligram per square inch (1) Conditions of test. Textryls, when
of surface tested.
extracted with distilled water at reflux
(2) Potassium permanganate oxidiz-
temperature for 1 hour, yield total ex-
able distilled water and 8 and 50 per-
tractives not to exceed 1 percent.
cent alcohol extractives not to exceed
an absorbance of 0.15. (2) Uses. Textryls are used for pack-
(3) Ultraviolet-absorbing distilled aging or holding food at ordinary tem-
water and 8 and 50 percent alcohol ex- peratures and in the brewing of hot
tractives not to exceed an absorbance beverages.
of 0.30.
(4) Ultraviolet-absorbing n-heptane § 177.1900 Urea-formaldehyde resins in
molded articles.
extractives not to exceed an absorb-
ance of 0.40. Urea-formaldehyde resins may be
safely used as the food-contact surface
§ 177.1850 Textryls. of molded articles intended for use in
Textryls identified in this section contact with food, in accordance with
may be safely used as articles or com- the following prescribed conditions:
ponents of articles, intended for use in (a) For the purpose of this section,
producing, manufacturing, packing, urea-formaldehyde resins are those
processing, preparing, treating, pack- produced when 1 mole of urea is made
aging, transporting or holding food, to react with not more than 2 moles of
subject to the provisions of this sec- formaldehyde in water solution.
tion. (b) The resins may be mixed with re-
(a) Textryls are nonwoven sheets pre- fined wood pulp and the mixture may
pared from natural or synthetic fibers, contain other optional adjuvant sub-
bonded with fibryl (Fibryl consists of a stances which may include the fol-
polymeric resin in fibrous form com- lowing:
mingled with fiber to facilitate sheet
formation and subsequently heat cured List of substances Limitations
to fuse the fibryl and effect bonding).
Hexamethylenetetramine ....... For use only as polymeriza-
(b) Textryls are prepared from the fi- tion-control agent.
bers, fibryls, and adjuvants identified Tetrachlorophthalic acid an- Do.
in paragraph (c) of this section, and hydride.
subject to limitations prescribed in Zinc stearate .......................... For use as lubricant.
that paragraph, provided that any sub-
stance that is the subject of a regula- (c) The finished food-contact article,
tion in parts 174, 175, 176, 177, 178 and when extracted with the solvent or sol-
§ 179.45 of this chapter conforms with vents characterizing the type of food
any specifications in such regulation and under the conditions of time and
for that substance as a component of temperature characterizing the condi-
polymeric resins used as food contact tions of its intended use as determined
surfaces. from tables 1 and 2 of § 175.300(d) of this
(c) The fibers, fibryls, and adjuvants chapter, yields total extractives in
permitted are as follows: each extracting solvent not to exceed
0.5 milligram per square inch of food-
contact surface as determined by the
(1) Fibers prepared from pol- Conforming with § 177.1630. methods described in § 175.300(e) of this
yethylene terephthalate chapter.
resins.
(2) Fibryls prepared from As the basic polymer. NOTE: In testing the finished food-contact
vinyl chloride-vinyl acetate article, use a separate test sample for each
copolymer. required extracting solvent.
333
§ 177.1950 21 CFR Ch. I (4–1–23 Edition)
§ 177.1950 Vinyl chloride-ethylene co- eral_register/code_of_federal_regulations/

polymers. ibr_locations.html.
The vinyl chloride-ethylene copoly- (2) Extractives limitations. The fol-
lowing extractives limitations are de-
termined by the methods described in
section may be safely used as compo-
paragraph (d) of this section:
nents of articles intended for contact
(i) Total extractives do not exceed
with food, under conditions of use D, E,
0.10 weight-percent when extracted
F, or G described in table 2 of § 176.170
with n-heptane at 150 °F for 2 hours.
(c) of this chapter, subject to the provi-
(ii) Total extractives do not exceed
sions of this section.
(a) For the purpose of this section, with water at 150 °F for 2 hours.
vinyl chloride-ethylene copolymers (iii) Total extractives obtained by ex-
consist of basic copolymers produced tracting with water at 150 °F for 2
by the copolymerization of vinyl chlo- hours contain no more than 0.5 milli-
ride and ethylene such that the fin- gram of vinyl chloride-ethylene copol-
ished basic copolymers meet the speci- ymer per 100 grams of sample tested as
fications and extractives limitations determined from the organic chlorine
prescribed in paragraph (c) of this sec- content. The organic chlorine content
tion, when tested by the methods de- is determined as described in paragraph
scribed in paragraph (d) of this section. (d)(3) of this section.
(b) The basic vinyl chloride-ethylene (d) Analytical methods: The analyt-
copolymers identified in paragraph (a) ical methods for determining whether
of this section may contain optional vinyl chloride-ethylene basic copoly-
adjuvant substances required in the mers conform to the extractives limi-
production of such basic copolymers. tations prescribed in paragraph (c) of
The optional adjuvant substances re- this section are as follows and are ap-
quired in the production of the basic plicable to the basic copolymers in
vinyl chloride-ethylene copolymers powder form having a particle size such
may include substances permitted for that 100 percent will pass through a
such use by regulations in parts 170 U.S. Standard Sieve No. 40 and 80 per-
through 189 of this chapter, substances cent will pass through a U.S. Standard
generally recognized as safe in food, Sieve No. 80:
and substances used in accordance with (1) Reagents—(i) Water. All water used
a prior sanction or approval. in these procedures shall be
(c) The vinyl chloride-ethylene basic demineralized (deionized), freshly dis-
copolymers meet the following speci- tilled water.
fications and extractives limitations: (ii) n-Heptane. Reagent grade, freshly
(1) Specifications. (i) Total chlorine distilled n-heptane shall be used.
content is in the range of 53 to 56 per- (2) Determination of total amount of ex-
cent as determined by any suitable an- tractives. All determinations shall be
alytical procedure of generally accept- done in duplicate using duplicate
ed applicability. blanks. Approximately 400 grams of
(ii) Intrinsic viscosity in sample (accurately weighed) shall be
cyclohexanone at 30 °C is not less than placed in a 2-liter Erlenmeyer flask.
0.50 deciliter per gram as determined Add 1,200 milliliters of solvent and
by ASTM method D1243–79, ‘‘Standard cover the flask with aluminum foil.
Test Method for Dilute Solution Vis- The covered flask and contents are sus-
cosity of Vinyl Chloride Polymers,’’ pended in a thermostated bath and are
which is incorporated by reference. kept, with continual shaking at 150 °F
Copies may be obtained from the Amer- for 2 hours. The solution is then fil-
ican Society for Testing Materials, 100 tered through a No. 42 Whatman filter
Barr Harbor Dr., West Conshohocken, paper, and the filtrate is collected in a
Philadelphia, PA 19428-2959, or may be graduated cylinder. The total amount
examined at the National Archives and of filtrate (without washing) is meas-
Records Administration (NARA). For ured and called A milliliters. The fil-
information on the availability of this trate is transferred to a Pyrex (or

material at NARA, call 202–741–6030, or equivalent) beaker and evaporated on a
go to: http://www.archives.gov/fed- steam bath under a stream of nitrogen
334
to a small volume (approximately 50–60 aqueous extract or to a vacuum oven at

milliliters). The concentrated filtrate 150 °F in the case of the heptane ex-
is then quantitatively transferred to a tract. In the case of the aqueous ex-
tared 100-milliliter Pyrex beaker using tract, the evaporation to constant
small, fresh portions of solvent and a weight is completed in 15 minutes at
rubber policeman to effect the transfer. 230 °F; and in the case of heptane ex-
The concentrated filtrate is evaporated tract, it is overnight under vacuum at
almost to dryness on a hotplate under 150 °F. The residue is weighed and cor-
nitrogen, and is then transferred to a rected for the solvent blank. Calcula-
drying oven at 230 °F in the case of the tion:
Grams of corrected residue 1,200 milliliters Total extractives expressed as

× × 100 =
Grams of sample Volume of filtrate percent by weight of sample.
A in milliliters
(3) Vinyl chloride-ethylene copolymer extract and washings are collected in a

content of aqueous extract—(i) Principle. 1,500-milliliter beaker. The solution is
The vinyl chloride-ethylene copolymer evaporated carefully on a steam plate
content of the aqueous extract can be to a volume of approximately 50 milli-
determined by determining the organic liters and then transferred quan-
chlorine content and calculating the titatively, a little at a time, to a clean
amount of copolymer equivalent to the 22-milliliter Parr cup, also on the
organic chlorine content. steam plate. The solution is evaporated
(ii) Total organic chlorine content. A to dryness. Next 0.25 gram of sucrose
weighed sample of approximately 400 and 0.5 gram of benzoic acid are added
grams is extracted with 1,200 milliliters to the cup. One scoop (approximately
of water at 150 °F for 2 hours, filtered, 15 grams) of sodium peroxide is then
and the volume of filtrate is measured added to the cup. The bomb is assem-
(A milliliters) as described in para- bled and ignition is conducted in the
graph (d)(2) of this section. usual fashion.
(a) A slurry of Amberlite IRA–400, or (d) After the bomb has cooled, it is
equivalent, is made with distilled
rinsed thoroughly with distilled water
water in a 150-milliliter beaker. The
and disassembled. The top of the bomb
slurry is added to a chromatographic
is rinsed into a 250-milliliter beaker
column until it is filled to about half
with distilled water. The beaker is
its length. This should give a volume of
placed on the steam plate. The bomb
resin of 15–25 milliliters. The liquid
must not be allowed to drain below the cup is placed in the beaker and care-
top of the packed column. fully tipped over to allow the water to
(b) The column is regenerated to the leach out the combustion mixture.
basic (OH) form by slowly passing After the bubbling has stopped, the cup
through it (10–15 milliliters per minute) is removed from the beaker and rinsed
10 grams of sodium hydroxide dissolved thoroughly. The solution is cooled to
in 200 milliliters of water. The column room temperature and cautiously neu-
is washed with distilled water until the tralized with concentrated nitric acid
effluent is neutral to phenolphthalein. by slowly pouring the acid down a stir-
One drop of methyl red indicator is ring rod until the bubbling ceases. The
added to the A milliliters of filtered solution is cooled and an equal volume
aqueous extract and, if on the basic of acetone is added.
side (yellow), nitric acid is added drop (e) The solution is titrated with 0.005
by drop until the solution turns pink. N silver nitrate using standard poten-
(c) The extract is deionized by pass- tiometric titration techniques with a
ing it through the exchange column at silver electrode as indicator and a po-
a rate of 10–15 milliliters per minute. tassium nitrate modified calomel elec-
The column is washed with 200 milli- trode as a reference electrode. An ex-
liters of distilled water. The deionized panded scale recording titrimeter.
335
ER01JA93.401</GPH>
§ 177.1960 21 CFR Ch. I (4–1–23 Edition)
Metrohm Potentiograph 2336 or equiva- (iii) Calculations.

lent, should be used; a complete blank
must be run in duplicate.
Milligrams of aqueous extracted T × F × 64.3

= × 100
copolymer per 100-gram sample Weight of sample in grams
where: agent, respectively, in their produc-

T = Milliliters of silver nitrate (sample tion.
minus blank) × normality of silver ni- (b) Specifications and limitations. The
trate. vinyl chloride-hexene-1 basic copoly-
F = 1,200 / A (as defined above) mers meet the following specifications
(e) The vinyl chloride-ethylene co- and extractives limitations:
polymers identified in and complying (1) Specifications. (i) Total chlorine
with this section, when used as compo- content is 53 to 56 percent as deter-
nents of the food-contact surface of mined by any suitable analytical pro-
any article that is the subject of a reg- cedure of generally accepted applica-
ulation in parts 174, 175, 176, 177, 178 bility.
and § 179.45 of this chapter, shall com- (ii) Inherent viscosity in
ply with any specifications and limita- cyclohexanone at 30 °C is not less than
tions prescribed by such regulation for 0.59 deciliters per gram as determined
the article in the finished form in by ASTM method D1243–79, ‘‘Standard
which it is to contact food. Test Method for Dilute Solution Vis-
(f) The provisions of this section are cosity of Vinyl Chloride Polymers,’’
not applicable to vinyl chloride-ethyl- which is incorporated by reference.
ene copolymers used as provided in Copies may be obtained from the Amer-
§§ 175.105 and 176.180 of this chapter. ican Society for Testing Materials, 100
FR 10110, Mar. 19, 1984]
Philadelphia, PA 19428-2959, or may be
§ 177.1960 Vinyl chloride-hexene-1 co- Records Administration (NARA). For
polymers. information on the availability of this
The vinyl chloride-hexene-1 copoly-
section or as components of articles in-
tended for use in contact with food, ibr_locations.html.
under conditions of use D, E, F, or G (2) Extractives limitations. The fol-
described in table 2 of § 176.170(c) of this lowing extractives limitations are de-
chapter, subject to the provisions of termined by the methods prescribed in
this section. § 177.1970(d).
(a) Identity. For the purposes of this (i) Total extractives do not exceed
section vinyl chloride-hexene-1 copoly- 0.01 weight percent when extracted
mers consist of basic copolymers pro- with water at 150 °F for 2 hours.
duced by the copolymerization of vinyl (ii) Total extractives do not exceed
chloride and hexene-1 such that the fin- 0.30 weight percent when extracted
ished copolymers contain not more with n-heptane at 150 °F for 2 hours.
than 3 mole-percent of polymer units (c) Other specifications and limitations.
derived from hexene-1 and meet the The vinyl chloride-hexene-1 copoly-
specifications and extractives limita- mers identified in and complying with
tions prescribed in paragraph (b) of this this section, when used as components
section. The copolymers may option- of the food-contact surface of any arti-
ally contain hydroxypropyl methyl- cle that is subject to a regulation in

cellulose and trichloroethylene used as parts 174, 175, 176, 177, 178 and § 179.45 of
a suspending agent and chain transfer this chapter, shall comply with any
336
ER01JA93.402</GPH>
specifications and limitations pre- Conshohocken, Philadelphia, PA 19428-

scribed by such regulation for the arti- 2959, or may be examined at the Na-
cle in the finished form in which it is tional Archives and Records Adminis-
to contact food. tration (NARA). For information on
[42 FR 14572, Mar. 15, 1977, as amended at 49 the availability of this material at
FR 10110, Mar. 19, 1984] NARA, call 202–741–6030, or go to: http://
§ 177.1970 Vinyl chloride-lauryl vinyl code_of_federal_regulations/
ether copolymers. ibr_locations.html.
The vinyl chloride-lauryl vinyl ether (2) Extractives limitations. The fol-
copolymers identified in paragraph (a) lowing extractives limitations are de-
of this section may be used as an arti- termined by the method described in
cle or as a component of an article in- paragraph (d) of this section:
tended for use in contact with food sub- (i) Total extractives do not exceed
ject to the provisions of this section. 0.03 weight-percent when extracted
(a) Identity. For the purposes of this with water at 150 °F for 2 hours.
section vinyl chloride-lauryl vinyl (ii) Total extractives do not exceed
ether copolymers consist of basic co- 0.60 weight-percent when extracted
polymers produced by the copolym- with n-heptane at 150 °F for 2 hours.
erization of vinyl chloride and lauryl (d) Analytical methods. The analytical
vinyl ether such that the finished co- methods for determining total extrac-
polymers contain not more than 3 tives are applicable to the basic co-
weight-percent of polymer units de- polymers in powder form having a par-
rived from lauryl vinyl ether and meet ticle size such that 100 percent will
the specifications and extractives limi- pass through a U.S. Standard Sieve No.
tations prescribed in paragraph (c) of 40 and such that not more than 10 per-
this section. cent will pass through a U.S. Standard
(b) Optional adjuvant substances. The Sieve No. 200.
basic vinyl chloride-lauryl vinyl ether (1) Reagents—(i) Water. All water used
copolymers identified in paragraph (a) in these procedures shall be
of this section may contain optional demineralized (deionized), freshly dis-
adjuvant substances required in the tilled water.
production of such basic copolymers. (ii) n-Heptane. Reagent grade, freshly
These optional adjuvant substances distilled n-heptane shall be used.
may include substances permitted for (2) Determination of total amount of ex-
such use by regulations in parts 170 tractives. Place an accurately weighed
through 189 of this chapter, substances sample of suitable size in a clean
generally recognized as safe in food, borosilicate flask, and for each gram of
and substances used in accordance with sample add 3 milliliters of solvent pre-
a prior sanction or approval. viously heated to 150 °F. Maintain the
(c) Specifications and limitations. The temperature of the contents of the
vinyl chloride-lauryl vinyl ether basic flask at 150 °F for 2 hours using a hot
copolymers meet the following speci- plate while also maintaining gentle
fications and extractives limitations: mechanical agitation. Filter the con-
(1) Specifications. (i) Total chlorine tents of the flask rapidly through No.
content is 53 to 56 percent as deter- 42 Whatman filter paper with the aid of
mined by any suitable analytical pro- suction. Transfer the filtrate to flat
cedure of generally accepted applica- glass dishes that are warmed on a hot
bility. plate and evaporate the solvent with
(ii) Inherent viscosity in the aid of a stream of filtered air. When
cylcoHhexanone at 30 °C is not less the volume of the filtrate has been re-
than 0.60 deciliter per gram as deter- duced to 10 to 15 milliliters, transfer
mined by ASTM method D1243–79, the filtrate to tared 50-milliliter
‘‘Standard Test Method for Dilute So- borosilicate glass beakers and com-
lution Viscosity of Vinyl Chloride plete evaporation to a constant weight
Polymers,’’ which is incorporated by in a 140 °F vacuum oven. Carry out a
reference. Copies may be obtained from corresponding blank determination

the American Society for Testing Ma- with each solvent. Determine the
terials, 100 Barr Harbor Dr., West weight of the residue corrected for the
337
§ 177.1980 21 CFR Ch. I (4–1–23 Edition)
solvent blank and calculate the result (ii) Intrinsic viscosity in cyclo-
as percent of the initial weight of the hexanone at 30 °C is not less than 0.50
resin sample taken for analysis. deciliter per gram as determined by
(e) Other specifications and limitations. ASTM method D1243–79, ‘‘Standard
The vinyl chloride-lauryl vinyl ether Test Method for Dilute Solution Vis-
copolymers identified in and complying cosity of Vinyl Chloride Polymers,’’
with this section, when used as compo- which is incorporated by reference.
nents of the food-contact surface of Copies may be obtained from the Amer-
any article that is subject to a regula- ican Society for Testing Materials, 100
tion in parts 174, 175, 176, 177, 178 and Barr Harbor Dr., West Conshohocken,
§ 179.45 of this chapter, shall comply Philadelphia, PA 19428-2959, or may be
with any specifications and limitations examined at the National Archives and
prescribed by such regulation for the Records Administration (NARA). For
article in the finished form in which it information on the availability of this
is to contact food. material at NARA, call 202–741–6030, or
[42 FR 14572, Mar. 15, 1977, as amended at 49 go to: http://www.archives.gov/fed-
FR 10110, Mar. 19, 1984] eral_register/code_of_federal_regulations/
ibr_locations.html.
§ 177.1980 Vinyl chloride-propylene co- (2) Extractives limitations. The fol-
polymers.
lowing extractives limitations are de-
The vinyl chloride-propylene copoly- termined by the methods described in
mers identified in paragraph (a) of this paragraph (d) of this section:
section may be safely used as compo- (i) Total extractives do not exceed
nents of articles intended for contact 0.10 weight-percent when extracted
with food, subject to the provisions of with n-heptane at 150 °F for 2 hours.
this section. (ii) Total extractives do not exceed
(a) For the purpose of this section,
vinyl chloride-propylene copolymers
with water at 150 °F for 2 hours.
consist of basic copolymers produced
(iii) Total extractives obtained by ex-
by the copolymezation of vinyl chlo-
ride and propylene such that the fin- tracting with water at 150 °F for 2
ished basic copolymers meet the speci- hours contain no more than 0.17 milli-
fications and extractives limitations gram of vinyl chloride-propylene co-
prescribed in paragraph (c) of this sec- polymer per 100 grams of sample tested
tion, when tested by the methods de- as determined from the organic chlo-
scribed in paragraph (d) of this section. rine content. For the purpose of this
(b) The basic vinyl chloride-pro- section, the organic chlorine content is
pylene copolymers identified in para- the difference between the total chlo-
graph (a) of this section may contain rine and ionic chlorine contents deter-
optional adjuvant substances required mined as described in paragraph (d) of
in the production of such basic copoly- this section.
mers. The optional adjuvant sub- (d) Analytical methods: The analyt-
stances required in the production of ical methods for determining whether
the basic vinyl chloride-propylene co- vinyl chloride-propylene basic copoly-
polymers may include substances per- mers conform to the extractives limi-
mitted for such use by regulations in tations prescribed in paragraph (c) of
parts 170 through 189 of this chapter, this section are as follows and are ap-
substances generally recognized as safe plicable to the basic copolymers in
in food, and substances used in accord- powder form having a particle size such
ance with a prior sanction or approval. that 100 percent will pass through a
(c) The vinyl chloride-propylene U.S. Standard Sieve No. 40 and 80 per-
basic copolymers meet the following cent will pass through a U.S. Standard
specifications and extractives limita- Sieve No. 80:
tions: (1) Reagents—(i) Water. All water used
(1) Specifications. (i) Total chlorine in these procedures shall be
content is in the range of 53 to 56 per- demineralized (deionized), freshly dis-
cent as determined by any suitable an- tilled water.

alytical procedure of generally accept- (ii) n-Heptane. Reagent grade, freshly
ed applicability. distilled n-heptane shall be used.
338
(2) Determination of total amount of ex- to a small volume (approximately 50–60

tractives. All determinations shall be milliliters). The concentrated filtrate
done in duplicate using duplicate is then quantitatively transferred to a
blanks. Approximately 400 grams of tared 100-milliliter Pyrex beaker using
sample (accurately weighed) shall be small, fresh portions of solvent and a
placed in a 2-liter Erlenmeyer flask. rubber policeman to effect the transfer.
Add 1,200 milliliters of solvent and The concentrated filtrate is evaporated
cover the flask with aluminum foil. almost to dryness on a hotplate under
The covered flask and contents are sus- nitrogen, and is then transferred to a
pended in a thermostated bath and are drying oven at 230 °F in the case of the
kept, with continual shaking, at 150 °F aqueous extract or to a vacuum oven at
for 2 hours. The solution is then fil- 150 °F in the case of the heptane ex-
tered through a No. 42 Whatman filter tract. In the case of the aqueous ex-
paper, and the filtrate is collected in a tract the evaporation to constant
graduated cylinder. The total amount weight is completed in 15 minutes at
of filtrate (without washing) is meas- 230 °F; and in the case of heptane ex-
ured and called A milliliters. The fil- tract, it is overnight under vacuum at
trate is transferred to a Pyrex (or 150 °F. The residue is weighed and cor-
equivalent) beaker and evaporated on a rected for the solvent blank. Calcula-
steam bath under a stream of nitrogen tion:
Grams of corrected residue 1,200 milliliters Total extractives expressed as

× × 100 =
Grams of sample Volume of filtrate percent by weight of sample.
A in milliliters
(3) Vinyl chloride-propylene copolymer sembled, water is added to the recess at

content of aqueous extract—(i) Principle. the top of the bomb and ignition is con-
The vinyl chloride-propylene copoly- ducted in the usual fashion using a
mer content of the aqueous extract can Meeker burner. The heating is contin-
be determined by determining the or- ued for 1 minute after the water at the
ganic chlorine content and calculating top has evaporated. The bomb is
the amount of copolymer equivalent to quenched in water, rinsed with distilled
the organic chlorine content. The or- water, and placed in a 400-milliliter
ganic chlorine content is the difference beaker. The bomb cover is rinsed with
between the total chlorine content and water, catching the washings in the
the ionic chlorine content. same 400-milliliter beaker. The bomb is
(ii) Total chlorine content. A weighed covered with distilled water and a
sample is extracted with water at 150 watch glass and heated until the melt
°F for 2 hours, filtered, and the volume has dissolved. The bomb is removed,
of filtrate is measured (A milliliters) as rinsed, catching the rinsings in the
described in paragraph (d)(2) of this beaker, and the solution is acidified
section. Two drops of 50 percent by with concentrated nitric acid using
weight sodium hydroxide solution are methyl purple as an indicator. The
added to prevent loss of chloride from beaker is covered with a watch glass,
ammonium chloride, if present, and the and the contents are boiled gently for
solution is evaporated to approxi- 10–15 minutes. After cooling to room
mately 15 milliliters. The concentrated temperature the solution is made
filtrate is quantitatively transferred to slightly alkaline with 50 percent by
a 22-milliliter Parr bomb fusion cup weight sodium hydroxide solution,
and gently evaporated to dryness. To then acidified with dilute (1:5) nitric
the contents of the cup are added 3.5 acid. Then 1.5 milliliters of 2 N nitric
grams of granular sodium peroxide, 0.1 acid per 100 milliliters of solution is
gram of powdered starch, and 0.02 gram added and the solution is titrated with
potassium nitrate; and the contents 0.005 N silver nitrate to the equivalence
are mixed thoroughly. The bomb is as- potential end point using an expanded
339
ER01JA93.403</GPH>
§ 177.1980 21 CFR Ch. I (4–1–23 Edition)
scale pH meter (Beckman Model 76, or

equivalent). A complete blank must be
run in duplicate. Calculation:
Grams of sample 1,200 milliliters Milliequivalents of total chlorine in

× × 100 =
(B − C) Volume of filtrate aqueous extract of 100 grams of sample
A in milliliters
where: solution is evaporated to approxi-

A = volume of filtrate obtained in extraction. mately 150 milliliters. The solution is
B = milliliters of silver nitrate solution used quantitatively transferred to a 250-mil-
in sample titration × normality of silver
liliter beaker, methyl purple indicator
nitrate solution.
C = milliliters of silver nitrate solution used is added, and the solution is neutral-
in blank titration × normality of silver ized with 0.1 N nitric acid. For each 100
nitrate solution. milliliters of solution is added 1.5 mil-
(iii) Ionic chlorine content. A weighed liliters of 2 N nitric acid. The solution
sample is extracted with water at 150 is titrated with 0.005 N silver nitrate to
°F for 2 hours, filtered, and the volume the equivalence potential end point,
of filtrate is measured (A milliliters) as using the expanded scale pH meter de-
in paragraph (d)(2) of this section. Two scribed in paragraph (d)(3)(ii) of this
drops of 50 percent by weight sodium section. A complete blank must be run
hydroxide solution are added and the in duplicate. Calculation:
D−E 1,200 milliliters Milliequivalents of ionic chlorine in

× × 100 =
Grams of sample Volume of filtrate aqueous extract of 100 grams of sample.
A in milliliters
where: (b) Vinyl chloride-propylene copolymer

A = volume of filtrate obtained in extraction. content. Milligrams of vinyl chloride-
D = milliliters of silver nitrate solution used propylene copolymer in aqueous ex-
in sample titration × normality of silver tract of 100 grams of sample equal
nitrate solution. milliequivalents of organic chlorine in
E = milliliters of silver nitrate solution used aqueous extract of 100 grams of sample
in blank titration × normality of silver
nitrate solution.
(as calculated in paragraph (d)(3)(iv)(a)
of this section) multiplied by 84.5.
(iv) Organic chlorine content and vinyl NOTE: The conversion factor, 84.5, is de-
chloride-propylene copolymer content of rived from the equivalent weight of chlorine
aqueous extract. The organic chlorine divided by the chlorine content of the
content and the vinyl chloride pro- heptane extractable fraction.)
pylene copolymer content of the aque- (e) The vinyl chloride-propylene co-
ous extract is calculated as follows: polymers identified in and complying
(a) Organic chlorine content. Milli- with this section, when used as compo-
equivalents of organic chlorine in nents of the food-contact surface of
aqueous extract of 100 grams of sample any article that is the subject of a reg-
equal milliequivalents of total chlorine ulation in parts 174, 175, 176, 177, 178
in aqueous extract of 100 grams of sam- and § 179.45 of this chapter, shall com-
ple (as calculated in paragraph (d)(3)(ii) ply with any specifications and limita-
of this section) minus milliequivalents tions prescribed by such regulation for
of ionic chlorine in aqueous extract of the article in the finished form in

ER01JA93.405</GPH>
100 grams of sample (as calculated in which it is to contact food.

paragraph (d)(3)(iii) of this section).
340
ER01JA93.404</GPH>
(f) The provisions of this section are than 50,000 when determined by gel per-
not applicable to vinyl chloride-pro- meation chromatography using tetra-
pylene copolymers used in food-pack- hydrofuran as the solvent. The gel per-
aging adhesives complying with meation chromatograph is calibrated
§ 175.105 of this chapter. with polystyrene standards. The basic
[42 FR 14572, Mar. 15, 1977, as amended at 49 gel permeation chromatographic meth-
FR 10111, Mar. 19, 1984] od is described in ANSI/ASTM D3536–76,
‘‘Standard Test Method for Molecular
§ 177.1990 Vinylidene chloride/methyl Weight Averages and Molecular Weight
acrylate copolymers. Distribution of Polystyrene by Liquid
The vinylidene chloride/methyl acry- Exclusion Chromatography (Gel Per-
late copolymers (CAS Reg. No. 25038– meation Chromatography-GPC),’’
72–6) identified in paragraph (a) of this which is incorporated by reference.
section may be safely used as an article Copies are available from University
or as a component of an article in- Microfilms International, 300 North
tended for use in contact with food sub- Zeeb Rd., Ann Arbor, MI 48106, or avail-
ject to the provisions of this section. able for inspection at the National Ar-
(a) Identity. For the purposes of this chives and Records Administration
section vinylidene chloride/methyl ac- (NARA). For information on the avail-
rylate copolymers consist of basic co- ability of this material at NARA, call
polymers produced by the copolym- 202–741–6030, or go to: http://
erization of vinylidene chloride and www.archives.gov/federal_register/
methyl acrylate such that the copoly- code_of_federal_regulations/
mers contain not more than 15 weight- ibr_locations.html.
percent of polymer units derived from (3) Residual vinylidene chloride and
methyl acrylate. residual methyl acrylate in the copoly-
(b) Optional adjuvant substances. The mer in the form in which it will con-
basic vinylidene chloride/methyl acry- tact food (unsupported film, barrier
late copolymers identified in paragraph layer, or as a copolymer for blending)
(a) of this section may contain optional will not exceed 10 parts per million and
adjuvant substances required in the 5 parts per million, respectively, as de-
production of such basic copolymers. termined by either a gas
These optional adjuvant substances chromatographic method titled ‘‘De-
may include substances permitted for termination of Residual Vinylidene
such use by regulations in parts 170 Chloride and Methyl Acrylate in Vinyl-
through 179 of this chapter, substances idene Chloride/Methyl Acrylate Co-
generally recognized as safe in food, polymer Resins and Films,’’ or, alter-
and substances used in accordance with natively, ‘‘Residual Methyl Acrylate
a prior sanction or approval. and Vinylidene Chloride Monomers in
(c) Specifications. (1) The methyl acry- Saran MA/VDC Resins and Pellets by
late content is determined by an infra- Headspace Gas Chromatography,’’
red spectrophotometric method titled dated March 3, 1986, which are incor-
‘‘Determination of Copolymer Ratio in porated by reference in accordance
Vinylidene Chloride/Methyl Acrylate with 5 U.S.C. 552(a). Copies are avail-
Copolymers,’’ which is incorporated by able from the Center for Food Safety
reference. Copies are available from and Applied Nutrition (HFS–200), Food
the Center for Food Safety and Applied and Drug Administration, 5001 Campus
Nutrition (HFS–200), Food and Drug Dr., College Park, MD 20740, or avail-
Administration, 5001 Campus Dr., Col- able for inspection at the National Ar-
lege Park, MD 20740, or available for in- chives and Records Administration
spection at the National Archives and (NARA). For information on the avail-
Records Administration (NARA). For ability of this material at NARA, call
information on the availability of this 202–741–6030, or go to: http://
material at NARA, call 202–741–6030, or www.archives.gov/federal_register/
go to: http://www.archives.gov/fed- code_of_federal_regulations/
eral_register/code_of_federal_regulations/ ibr_locations.html.
ibr_locations.html. (d) Extractives limitations. The basic

(2) The weight average molecular copolymer resin in the form of granules
weight of the copolymer is not less that will pass through a U.S. Standard
341
§ 177.2000 21 CFR Ch. I (4–1–23 Edition)
Sieve No. 45 (350 microns) shall meet or the finished food-contact articles
the following extractives limitations: meet the specifications prescribed in
(1) 10-gram samples of the resin, paragraph (d) of this section.
when extracted separately with 100 (b) Optional adjuvant substances. The
milliliters of distilled water at 121 °C basic vinylidene chloride/methyl acry-
(250 °F) for 2 hours, and 100 milliliters late/methyl methacrylate polymers
of n-heptane at 66 °C (150 °F) for 2 identified in paragraph (a) of this sec-
hours, shall yield total nonvolatile ex- tion may contain optional adjuvant
tractives not to exceed 0.5 percent by substances required in the production
weight of the resin. of such basic polymers. These optional
(2) The basic copolymer in the form adjuvant substances may include sub-
of film when extracted separately with stances permitted for such use by regu-
distilled water at 121 °C (250 °F) for 2 lations in parts 170 through 179 of this
hours shall yield total nonvolatile ex- chapter, substances generally recog-
tractives not to exceed 0.047 milligram nized as safe in food, and substances
per square centimeter (0.3 milligram used in accordance with a prior sanc-
per square inch). tion of approval.
(e) Conditions of use. The copolymers (c) Conditions of use. The polymers
may be safely used as articles or com- may be safely used as articles or as
ponents of articles intended for use in components of articles intended for use
producing, manufacturing, processing, in producing, manufacturing, proc-
preparing, treating, packaging, trans- essing, preparing, treating, packaging,
porting, or holding food, including transporting, or holding food, including
processing of packaged food at tem- processing of packaged food at tem-
peratures not to exceed 135 °C (275 °F). peratures up to 121 °C (250 °F).
(f) Other specifications and limitations. (d) Specifications and limitations. The
The vinylidene chloride-methyl acry- vinylidene chloride/methyl acrylate/
late copolymers identified in and com- methyl methacrylate basic polymers
plying with this section, when used as and/or finished food-contact articles
components of the food contact surface meet the following specifications and
of any article that is subject to a regu- limitations:
lation in parts 174 through 178 and (1)(i) The basic vinylidene chloride/
§ 179.45 of this chapter, shall comply methyl acrylate/methyl methacrylate
with any specifications and limitations polymers contain not more than 2
prescribed by such regulation for the weight percent of polymer units de-
article in the finished form in which it rived from methyl acrylate monomer
is to contact food. and not more than 6 weight percent of
[48 FR 38605, Aug. 25, 1983; 48 FR 50077, Oct. polymer units derived from methyl
31, 1983, as amended at 53 FR 47185, Nov. 22, methacrylate monomer.
1988; 54 FR 24898, June 12, 1989] (ii) The basic polymers are limited to
a thickness of not more than 0.005 cen-
§ 177.2000 Vinylidene chloride/methyl timeter (0.002 inches).
acrylate/methyl methacrylate poly- (2) The weight average molecular
mers. weight of the basic polymer is not less
The vinylidene chloride/methyl acry- than 100,000 when determined by gel
late/methyl methacrylate polymers permeation chromatography using tet-
(CAS Reg. No. 34364–83–5) identified in rahydrofuran as the solvent. The gel
paragraph (a) of this section may be permeation chromatography is cali-
safely used as articles or as a compo- brated with polystyrene standards. The
nent of articles intended for use in con- basic gel permeation chromatographic
tact with food subject to the provisions method is described in ANSI/ASTM
of this section. D3536–76, which is incorporated by ref-
(a) Identity. For the purpose of this erence. Copies are available from the
section, vinylidene chloride/methyl ac- American Society for Testing Mate-
rylate/methyl methacrylate polymers rials, 100 Barr Harbor Dr., West
consist of basic polymers produced by Conshohocken, Philadelphia, PA 19428-
the copolymerization of vinylidene 2959, or available for inspection at the

chloride/methyl acrylate/methyl meth- National Archives and Records Admin-
acrylate such that the basic polymers istration (NARA). For information on
342
the availability of this material at od by Aminco Chloridometer,’’

NARA, call 202–741–6030, or go to: http:// ‘‘Hypolon ® Synthetic Rubber—Deter-
www.archives.gov/federal_register/ mination of Sulfur by Parr Bomb,’’ and
code_of_federal_regulations/ ASTM method D2857–70 (Reapproved
ibr_locations.html. 1977), ‘‘Standard Test Method for Di-
(3) The basic polymer or food-contact lute Solution Viscosity of Polymers,’’
article described in paragraph (a) of are incorporated by reference. Copies
this section, when extracted with the of the ASTM method may be obtained
solvent or solvents characterizing the from the American Society for Testing
type of food and under the conditions Materials, 100 Barr Harbor Dr., West
of time and temperature characterizing Conshohocken, Philadelphia, PA 19428-
the conditions of its intended use as de- 2959. Copies of the other two methods
termined from tables 1 and 2 of are available from the Center for Food
§ 176.170(c) of this chapter, yields net Safety and Applied Nutrition (HFS–
chloroform-soluble extractives in each 200), Food and Drug Administration,
extracting solvent not to exceed .08 5001 Campus Dr., College Park, MD
milligram per square centimeter (0.5 20740. Copies of all three methods may
milligram per square inch) of food-con- be examined at the National Archives
tact surface when tested by the meth- and Records Administration (NARA).
ods described in § 176.170(d). If the fin- For information on the availability of
ished food-contact article is itself the this material at NARA, call 202–741–
subject of a regulation in parts 174 6030, or go to: http://www.archives.gov/
through 178 and § 179.45 of this chapter, federal_register/
it shall also comply with any specifica- code_of_federal_regulations/
tions and limitations prescribed for it ibr_locations.html.
by the regulation. (c) The additive is used as the article,
[49 FR 29578, July 23, 1984] or a component of articles, intended for
use as liners and covers for reservoirs
intended for the storage of water for
Subpart C—Substances for Use drinking purposes.
Only as Components of Arti- (d) Substances permitted by § 177.2600
cles Intended for Repeated may be employed in the preparation of
Use ethylene polymers, chlorosulfonated,
subject to any limitations prescribed
§ 177.2210 Ethylene polymer, chloro- therein.
sulfonated.
(e) The finished ethylene copolymers,
Ethylene polymer, chlorosulfonated chlorosulfonated shall conform to
as identified in this section may be § 177.2600(e) and (g).
safely used as an article or component
of articles intended for use in contact
FR 10111, Mar. 19, 1984; 54 FR 24898, June 12,
with food, subject to the provisions of 1989]
this section.
(a) Ethylene polymer, chloro- § 177.2250 Filters, microporous poly-
sulfonated is produced by chloro- meric.
sulfonation of a carbon tetrachloride Microporous polymeric filters identi-
solution of polyethylene with chlorine fied in paragraph (a) of this section
and sulfuryl chloride. may be safely used, subject to the pro-
(b) Ethylene polymer, chloro- visions of this section, to remove par-
sulfonated shall meet the following ticles of insoluble matter in producing,
specifications: manufacturing, processing, and pre-
(1) Chlorine not to exceed 25 percent paring bulk quantities of liquid food.
by weight. (a) Microporous polymeric filters
(2) Sulfur not to exceed 1.15 percent consist of a suitably permeable, contin-
by weight. uous, polymeric matrix of polyvinyl
(3) Molecular weight is in the range chloride, vinyl chloride-propylene, or
of 95,000 to 125,000. vinyl chloride-vinyl acetate, in which
Methods for the specifications in this finely divided silicon dioxide is embed-
paragraph (b), titled ‘‘Chlorine and ded. Cyclohexanone may be used as a
Bromine—Coulometric Titration Meth- solvent in the production of the filters.
343
§ 177.2260 21 CFR Ch. I (4–1–23 Edition)
(b) Any substance employed in the 174, 175, 176, 177, 178 and § 179.45 of this
production of microporous polymeric chapter conforms with any specifica-
filters that is the subject of a regulation in such regulation.
tion in parts 170 through 189 of this (d) Substances employed in the pro-
chapter must conform with any speci- duction of resin-bonded filters include
fication in such regulation. the following, subject to any limita-
(c) Cyclohexanone when used as a sol- tions provided:
vent in the production of the filters
shall not exceed 0.35 percent by weight LIST OF SUBSTANCES AND LIMITATIONS
of the microporous polymeric filters. (1) Fibers:
(d) The microporous polymeric filters
may be colored with colorants used in Cellulose pulp.
accordance with § 178.3297 of this chap- Cotton.
ter. Nylon. (From nylon resins complying with
the provisions of applicable regulations in
(e) The temperature of food being
subchapter B of this chapter.
processed through the microporous pol- Polyethylene terephthalate complying in
ymeric filters shall not exceed 180 °F. composition with the provisions of
(f) The microporous polymeric filters § 177.1630; for use in inline filtration only as
shall be maintained in a sanitary man- provided for in paragraphs (e) and (f) of
ner in accordance with good manufac- this section.
turing practice so as to prevent poten- Rayon (viscose).
tial microbial adulteration of the food. (2) Substances employed in fiber fin-
(g) To assure safe use of the micro- ishing:
porous polymeric filters, the label or
labeling shall include adequate direc- BHT.
tions for a pre-use treatment, con- Butyl (or isobutyl) palmitate or stearate.
2,5-Di-tert-butyl hydroquinone for use only in
sisting of washing with a minimum of lubricant formulations for rayon fiber fin-
2 gallons of potable water at a tem- ishing and at a usage level not to exceed
perature of 180 °F for each square foot 0.1 percent by weight of the lubricant for-
of filter, prior to the filter’s first use in mulations.
contact with food. Dimethylpolysiloxane.
4-Ethyl-4-hexadecyl morpholinium ethyl sul-
[42 FR 14572, Mar. 15, 1977, as amended at 56 fate for use only as a lubricant in the man-
FR 42933, Aug. 30, 1991] ufacture of polyethylene terephthalate fi-
bers specified in paragraph (d)(1) of this
§ 177.2260 Filters, resin-bonded. section at a level not to exceed 0.03 percent
Resin-bonded filters may be safely by weight of the finished fibers.
used in producing, manufacturing, Fatty acid (C10-C18) diethanolamide conden-
processing, and preparing food, subject sates.
Fatty acids derived from animal or vegetable
to the provisions of this section. fats and oils, and salts of such acids, sin-
(a) Resin-bonded filters are prepared gle or mixed, as follows:
from natural or synthetic fibers to Aluminum.
which have been added substances re- Ammonium.
quired in their preparation and fin- Calcium.
ishing, and which are bonded with res- Magnesium.
ins prepared by condensation or polym- Potassium.
erization of resin-forming materials, Sodium.
Triethanolamine.
together with adjuvant substances re- Fatty acid (C10-C18) mono- and diesters of
quired in their preparation, applica- polyoxyethylene glycol (molecular weight
tion, and curing. 400–3,000).
(b) The quantity of any substance Methyl esters of fatty acids (C10-C18).
employed in the production of the Mineral oil.
resin-bonded filter does not exceed the Polybutene, hydrogenated; complying with
amount reasonably required to accom- the identity prescribed under § 178.3740 (b)
plish the intended physical or technical of this chapter.
Polyoxyethylene (4 mols) ethylenediamine
effect or any limitation further pro- monolauramide for use only in lubricant
vided. formulations for rayon fiber finishing and
(c) Any substance employed in the at a usage level not to exceed 10 percent by
production of resin-bonded filters that weight of the lubricant formulations.
is the subject of a regulation in parts Ricebran oil.
344
Titanium dioxide. (f)(1) of this section are used as pro-
(3) Resins: vided in paragraph (e)(2) of this sec-
tion:
Acrylic polymers produced by polymerizing (1) Total extractives. The finished fil-
ethyl acrylate alone or with one or more of ter, when exposed to distilled water at
the monomers: Acrylic acid, acrylonitrile,
N-methylolacrylamide, and styrene. The 145 °F for 2 hours, yields total extrac-
finished copolymers shall contain at least tives not to exceed 4 percent by weight
70 weight percent of polymer units derived of the filter.
from ethyl acrylate, no more than 2 weight (2) Conditions of use. It is used to fil-
percent of total polymer units derived ter milk or potable water at operating
from acrylic acid, no more than 10 weight temperatures not to exceed 145 °F.
percent of total polymer units derived (g) Resin-bonded filters conforming
from acrylonitrile, no more than 2 weight
percent of total polymer units derived
with the specifications of paragraph
from N-methylolacrylamide, and no more (g)(1) of this section are used as pro-
than 25 weight percent of total polymer vided in paragraph (g)(2) of this sec-
units derived from styrene. For use only as tion:
provided in paragraph (m) of this section. (1) Total extractives. The finished fil-
Melamine-formaldehyde. ter, when exposed to n-hexane at reflux
Melamine-formaldehyde chemically modified temperature for 2 hours, yields total
with one or more of the amine catalysts
identified in § 175.300(b)(3)(xiii) of this chap-
extractives not to exceed 0.5 percent by
ter. weight of the filter.
Melamine-formaldehyde chemically modified (2) Conditions of use. It is used to fil-
with methyl alcohol. ter edible oils.
Melamine-formaldehyde chemically modified (h) Resin-bonded filters conforming
with urea; for use only as provided for in with the specifications of paragraph
paragraphs (e), (f), (g), (h), and (i) of this (h)(1) of this section are used as pro-
section.
Phenol-formaldehyde resins.
vided in paragraph (h)(2) of this sec-
Polyvinyl alcohol. tion:
Polyvinyl alcohol with the copolymer of (1) Total extractives. The finished fil-
acrylic acid-allyl sucrose. ter, when exposed to distilled water at
Polyvinyl alcohol with melamine formalde- 212 °F for 2 hours, yields total extrac-
hyde. tives not to exceed 4 percent by weight
Polyvinyl acetate with melamine formalde- of the filter.
hyde.
p--Toluenesulfonamide-formaldehyde chemi-
(2) Conditions of use. It is used to fil-
cally modified with one or more of the ter milk, coffee, tea, and potable water
amine catalysts identified in § 175.300 at temperatures not to exceed 212 °F.
(b)(3)(xiii) of this chapter. (i) Resin-bonded filters conforming
(4) Adjuvant substances:
(i)(1) of this section are used as pro-
Dimethyl polysiloxane with methylcellulose vided in paragraph (i)(2) of this section:
and sorbic acid (as an antifoaming agent). (1) Total extractives. The finished fil-
Phosphoric acid. ter, when exposed to distilled water for
(5) Colorants: Colorants used in ac- 2 hours at a temperature equivalent to,
cordance with § 178.3297 of this chapter. or higher than, the filtration tempera-
(e) Resin-bonded filters conforming ture of the aqueous food, yields total
with the specifications of paragraph extractives not to exceed 4 percent, by
(e)(1) of this section are used as pro- weight, of the filter.
vided in paragraph (e)(2) of this sec- (2) Conditions of use. It is used in com-
tion: mercial filtration of bulk quantities of
(1) Total extractives. The finished fil- nonalcoholic, aqueous foods having a
ter, when exposed to distilled water at pH above 5.0.
100 °F for 2 hours, yields total extrac- (j) Resin-bonded filters conforming
tives not to exceed 2.8 percent by with the specifications of paragraph
weight of the filter. (j)(1) of this section are used as pro-
(2) Conditions of use. It is used to fil- vided in paragraph (j)(2) of this section:
ter milk or potable water at operating (1) Total extractives. The finished fil-
temperatures not to exceed 100 °F.
ter, when exposed to 5 percent (by

(f) Resin-bonded filters conforming weight) acetic acid for 2 hours at a
with the specifications of paragraph temperature equivalent to, or higher
345
§ 177.2280 21 CFR Ch. I (4–1–23 Edition)
than, the filtration temperature of the when exposed to distilled water at 145
aqueous food, yields total extractives °F for 2 hours yields total extractives
not to exceed 4 percent, by weight, of not to exceed 1.2 percent by weight of
the filter. the filter.
(2) Conditions of use. It is used in com- (n) Acrylonitrile copolymers identi-
mercial filtration of bulk quantities of fied in this section shall comply with
nonalcoholic, aqueous foods having a the provisions of § 180.22 of this chap-
pH of 5.0 or below. ter.
(k) Resin-bonded filters conforming
with the specifications of paragraph [42 FR 14572, Mar. 15, 1977, as amended at 56
(k)(1) of this section are used as pro- FR 42933, Aug. 30, 1991]
vided in paragraph (k)(2) of this sec-
tion: § 177.2280 4,4′-Isopropylidenediphenol-
(1) Total extractives. The finished fil- epichlorohydrin thermosetting
epoxy resins.
ter, when exposed to 8 percent (by vol-
ume) ethyl alcohol in distilled water 4,4′-Isopropylidenediphenol-epichlo-
for 2 hours at a temperature equivalent rohydrin thermosetting epoxy resins
to, or higher than, the filtration tem- may be safely used as articles or com-
perature of the alcoholic beverage, ponents of articles intended for re-
yields total extractives not to exceed 4 peated use in producing, manufac-
percent, by weight, of the filter. turing, packing, processing, preparing,
(2) Conditions of use. It is used in com- treating, packaging, transporting, or
mercial filtration of bulk quantities of holding food, in accordance with the
alcoholic beverages containing not following prescribed conditions:
more than 8 percent alcohol. (a) The basic thermosetting epoxy
(l) Resin-bonded filters conforming
resin is made by reacting 4,4′-
isopropylidenediphenol with epichloro-
(l)(1) of this section are used as pro-
hydrin.
vided in paragraph (l)(2) of this section:
(1) Total extractives. The finished fil- (b) The resin may contain one or
ter, when exposed to 50 percent (by vol- more of the following optional sub-
ume) ethyl alcohol in distilled water stances provided the quantity used
for 2 hours at a temperature equivalent does not exceed that reasonably re-
to, or higher than, the filtration tem- quired to accomplish the intended ef-
perature of the alcoholic beverage, fect:
yields total extractives not to exceed 4
Allyl glycidyl ether .................. As curing system additive.
percent, by weight, of the filter.
Di- and tri-glycidyl ester mix- As modifier at levels not to
(2) Conditions of use. It is used in com- ture resulting from the re- exceed equal parts by
mercial filtration of bulk quantities of action of epichlorohydrin weight of the 4,4′-
alcoholic beverages containing more with mixed dimers and isopropylidenediphenol-
trimers of unsaturated C18 epichlorohydrin basic resin
than 8 percent alcohol. monobasic fatty acids de- and limited to use in con-
(m) Resin-bonded filters fabricated rived from animal and veg- tact with alcoholic bev-
from acrylic polymers as provided in etable fats and oils. erages containing not more
paragraph (d)(3) of this section to- than 8 percent of alcohol.
1,2-Epoxy-3-phenoxypropane As curing system additive.
gether with other substances as pro-
Glyoxal ................................... Do.
vided in paragraph (d), (1), (2), and (4) 4,4′-Isopropylidenediphenol ... Do.
of this section may be used as follows: 4,4′-Methylenedianiline .......... Do.
(1) The finished filter may be used to m-Phenylenediamine ............. Do.
filter milk or potable water at oper- Tetrahydrophthalic anhydride Do.
ating temperatures not to exceed 100
°F, provided that the finished filter (c) In accordance with good manufac-
when exposed to distilled water at 100 turing practice, finished articles con-
°F for 2 hours yields total extractives taining the resins shall be thoroughly
not to exceed 1 percent by weight of cleansed prior to their first use in con-
the filter. tact with food.
(2) The finished filter may be used to (d) The provisions of this section are
filter milk or potable water at oper- not applicable to 4,4′-isopropylidenedi-

ating temperatures not to exceed 145 phenol-epichlorohydrin resins listed in
°F, provided that the finished filter
346
other sections of parts 174, 175, 176, 177, prior to their first use in contact with
178 and 179 of this chapter. food.
[42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, [42 FR 54533, Oct. 7, 1977, as amended at 42 FR
1984] 61594, Dec. 6, 1977]
§ 177.2355 Mineral reinforced nylon § 177.2400 Perfluorocarbon cured

resins. elastomers.
Mineral reinforced nylon resins iden- Perfluorocarbon cured elastomers
tified in paragraph (a) of this section identified in paragraph (a) of this sec-
may be safely used as articles or com- tion may be safely used as articles or
ponents of articles intended for re- components of articles intended for re-
peated use in contact with nonacidic peated use in contact with nonacid
food (pH above 5.0) and at use tempera- food (pH above 5.0), subject to the pro-
tures not exceeding 212 °F. in accord- visions of this section.
ance with the following prescribed con- (a) Identity. (1) For the purpose of
ditions: this section, perfluorocarbon cured
(a) For the purpose of this section elastomers are produced by
the mineral reinforced nylon resins terpolymerizing tetrafluorethylene
consist of nylon 66, as identified in and (CAS Reg. No. 116–14–3),
perfluoromethyl vinyl ether (CAS Reg.
complying with the specifications of
No. 1187–93–5), and perfluoro-2-
§ 177.1500, reinforced with up to 40
phenoxypropyl vinyl ether (CAS Reg.
weight percent of calcium silicate and
No. 24520–19–2) and subsequent curing of
up to 0.5 weight percent 3- the terpolymer (CAS Reg. No. 26658–70–
(triethoxysilyl) propylamine (Chemical 8) using the crosslinking agent, phenol,
Abstracts Service Registry No. 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl)
000919302) based on the weight of the ethylidene] bis-,dipotassium salt (CAS
calcium silicate. Reg. No. 25088–69–1) and accelerator,
(b) The mineral reinforced nylon res- 1,4,7,10,13,16-hexaoxacyclooctadecane
ins may contain up to 0.2 percent by (CAS Reg. No. 17455–13–9).
weight of titanium dioxide as an op- (2) The perfluorocarbon base polymer
tional adjuvant substance. shall contain no less than 40 weight-
(c) The mineral reinforced nylon res- percent of polymer units derived from
ins with or without the optional sub- tetrafluoroethylene, no less than 40
stance described in paragraph (b) of weight-percent of polymer units de-
this section, and in the form of 1⁄8-inch rived from perfluoromethyl vinyl ether
molded test bars, when extracted with and no more than 5 weight-percent
the solvents, i.e., distilled water and 50 polymer units derived from perfluoro-2-
percent (by volume) ethyl alcohol in phenoxy-propyl vinyl ether.
distilled water, at reflux temperature (3) The composition limitations of
for 24 hours using a volume-to-surface the cured elastomer, calculated as
ratio of 2 milliliters of solvent per parts per 100 parts of terpolymer, are
square inch of surface tested, shall as follows:
meet the following extractives limita- Phenol, 4,4′-[2,2,2-trifluoro-1-
tions: (trifluoromethyl)-ethylidene] bis-
(1) Total extractives not to exceed 5.0 ,dipotassium salt—not to exceed 5 parts.
milligrams per square inch of food-con- 1,4,7,10,13,16-Hexaoxacyclo-octadecane—not
tact surface tested for each solvent. to exceed 5 parts.
(2) The ash after ignition of the ex- (b) Optional adjuvant substances. The
tractives described in paragraph (c)(1) perfluorocarbon cured elastomer iden-
of this section, not to exceed 0.5 milli- tified in paragraph (a) of this section
gram per square inch of food-contact may contain the following optional ad-
surface tested. juvant substances, subject to any limi-
(d) In accordance with good manufac- tations cited on their use:
turing practice, finished articles con- (1) Substances generally recognized

taining the mineral reinforced nylon as safe (GRAS) in food or food pack-
resins shall be thoroughly cleansed aging.
347
§ 177.2410 21 CFR Ch. I (4–1–23 Edition)
(2) Substances used in accordance shall meet the following extractability

with a prior sanction. limits:
(3) Substances authorized under ap- (1) Total extractives not to exceed 3.1
plicable regulations in this part and in milligrams per square decimeter (0.2
parts 175 and 178 of this chapter and milligrams per square inch).
subject to any limitations prescribed (2) Fluoride extractives calculated as
therein. fluorine not to exceed 0.47 milligram
(4) Substances identified in this para- per square decimeter (0.03 milligram
graph (b)(4) subject to such limitations per square inch).
as are provided: (e) Conditions of use. In accordance
with current good manufacturing prac-
Substances Limitations tice, finished food contact articles con-
Carbon black (channel proc- Not to exceed 15 parts per taining the perfluorocarbon cured
ess of furnace combustion 100 parts of the elastomers shall be thoroughly cleaned
process) (CAS Reg. No. terpolymer. prior to their first use in contact with
1333–86–4).
Magnesium oxide (CAS Reg. Not to exceed 5 parts per
food.
No. 1309–48–4). 100 parts of the [49 FR 43050, Oct. 26, 1984]
terpolymer.
§ 177.2410 Phenolic resins in molded
(c) Specifications—(1) Infrared identi- articles.
fication. Perfluorocarbon cured Phenolic resins identified in this sec-
elastomers may be identified by the tion may be safely used as the food-
characteristic infrared spectra of the contact surface of molded articles in-
pyrolysate breakdown product that is tended for repeated use in contact with
obtained by heating and decomposing nonacid food (pH above 5.0), in accord-
the elastomer using the method enti- ance with the following prescribed con-
tled ‘‘Qualitative Identification of ditions:
Kalrez ® by Infrared Examination of (a) For the purpose of this section,
Pyrolysate.’’ This method is incor- the phenolic resins are those produced
porated by reference. Copies of the when one or more of the phenols listed
method are available from the Center in paragraph (a)(1) of this section are
for Food Safety and Applied Nutrition made to react with one or more of the
(HFS–200), Food and Drug Administra- aldehydes listed in paragraph (a)(2) of
tion, 5001 Campus Dr., College Park, this section, with or without aniline
MD 20740, or available for inspection at and/or anhydro-formaldehyde aniline
the National Archives and Records Ad- (hexahydro-1, 3,5-triphenyl-s-triazine):
ministration (NARA). For information (1) Phenols:
NARA, call 202–741–6030, or go to: http:// p-tert-Amylphenol.
www.archives.gov/federal_register/ p-tert-Butylphenol.
o-, m-, and p-Cresol.
code_of_federal_regulations/ p-Octylphenol.
ibr_locations.html. Phenol.
(2) Thermogravimetry. Perfluorocarbon o- and p-Phenylethylphenol mixture pro-
cured elastomers have a major decom- duced when phenol is made to react with
position peak occurring at 490° ±15 °C styrene in the presence of sulfuric acid cat-
(914 °F). Less than 1.5 percent of the alyst.
elastomers will volatilize below 400 °C (2) Aldehydes:
(752 °F) when run under nitrogen at a 10
°C or 18 °F per minute heating rate Acetaldehyde.
Formaldehyde.
using a Du Pont Thermal Analyzer Paraldehyde.
Model 1099 with Model 951 TGA unit or
the equivalent. (b) Optional adjuvant substances em-
(d) Extractive limitations. Articles fab- ployed in the production of the phe-
ricated from perfluorocarbon cured nolic resins or added thereto to impart
elastomers having a thickness of at desired technical or physical properties
least 1.0 millimeter (0.039 inch) when include the following:
extracted at reflux temperatures for 2

Asbestos fiber.
hours separately with distilled water, Barium hydroxide ................... For use as catalyst.
50 percent ethanol, and n-heptane, Calcium stearate .................... For use as lubricant.
348
Carbon black (channel proc- scribed in § 174.5(d) of this chapter and
ess).
Diatomaceous earth.
the following:
Glass fiber. Substance Limitations
Hexamethylenetetramine ....... For use as curing agent.
Mica. Diphenyl sulfone .................... Not to exceed 0.2 percent by
Oxalic acid ............................. For use as catalyst. weight as a residual sol-
Zinc stearate .......................... For use as lubricant. vent in the finished basic
resin.
(c) The finished food-contact article,
when extracted with distilled water at (c) Extractive limitations. The finished
reflux temperature for 2 hours, using a food contact article, when extracted at
volume-to-surface ratio of 2 milliliters reflux temperatures for 2 hours with
of distilled water per square inch of the following four solvents, yields in
surface tested, shall meet the following each extracting solvent net chloroform
extractives limitations: soluble extractives not to exceed 0.05
(1) Total extractives not to exceed milligrams per square inch of food con-
0.15 milligram per square inch of food- tact surface: Distilled water, 50 percent
contact surface. (by volume) ethanol in distilled water,
(2) Extracted phenol not to exceed 3 percent acetic acid in distilled water,
0.005 milligram per square inch of food- and n-heptane. In testing the final food
contact surface. contact article, a separate test sample
shall be used for each extracting sol-
(3) No extracted aniline when tested
vent.
by a spectrophotometric method sen-
sitive to 0.006 milligram of aniline per- [63 FR 20315, Apr. 24, 1998]
square inch of food-contact surface.
(d) In accordance with good manufac- § 177.2420 Polyester resins, cross-
linked.
turing practice, finished molded arti-
cles containing the phenolic resins Cross-linked polyester resins may be
shall be thoroughly cleansed prior to safely used as articles or components
their first use in contact with food. of articles intended for repeated use in
contact with food, in accordance with
§ 177.2415 Poly(aryletherketone) res- the following prescribed conditions:
ins. (a) The cross-linked polyester resins
Poly(aryletherketone) resins identi- are produced by the condensation of
fied in paragraph (a) of this section one or more of the acids listed in para-
may be safely used as articles or com- graph (a)(1) of this section with one or
ponents of articles intended for re- more of the alcohols or epoxides listed
peated use in contact with food subject in paragraph (a)(2) of this section, fol-
to the provisions of this section. lowed by copolymerization with one or
(a) Identity. For the purposes of this more of the cross-linking agents listed
section, poly(aryletherketone) resins in paragraph (a)(3) of this section:
are poly(p-oxyphenylene p- (1) Acids:
oxyphenylene p-carboxyphenylene) res- Adipic.
ins (CAS Reg. No. 29658–26–2) produced Fatty acids, and dimers thereof, from nat-
by the polymerization of hydroquinone ural sources.
and 4,4′-difluorobenzophenone, and Fumaric.
Isophthalic.
have a minimum weight-average mo- Maleic.
lecular weight of 12,000, as determined Methacrylic.
by gel permeation chromatography in Orthophthalic.
comparison with polystyrene stand- Sebacic.
ards, and a minimum mid-point glass Terephthalic.
transition temperature of 142 °C, as de- Trimellitic.
termined by differential scanning (2) Polyols and polyepoxides:
calorimetry.
(b) Optional adjuvant substances. The Butylene glycol.
Diethylene glycol.
basic resins identified in paragraph (a) 2,2-Dimethyl-1,3-propanediol.
may contain optional adjuvant sub- Dipropylene glycol.

stances used in their production. These Ethylene glycol.
adjuvants may include substances de- Glycerol.
349
§ 177.2420 21 CFR Ch. I (4–1–23 Edition)
4,4′-Isopropylidenediphenol-epichlorohydrin. Methyl methacrylate.
Mannitol. Styrene.
a-Methyl glucoside. Triglycidyl isocyanurate (CAS Reg. No. 2451–
Pentaerythritol. 62–9), for use only in coatings contacting
Polyoxypropylene ethers of 4,4′-isopropylide- bulk quantities of dry food of the type
nediphenol (containing an average of 2–7.5 identified in § 176.170(c) of this chapter,
moles of propylene oxide). table 1, under type VIII.
Propylene glycol. Vinyl toluene.
Sorbitol. (b) Optional adjuvant substances em-
Trimethylol ethane.
ployed to facilitate the production of
2,2,4-Trimethyl-1,3-pentanediol.
the resins or added thereto to impart
desired technical or physical properties
(3) Cross-linking agents: include the following, provided that
Butyl acrylate. the quantity used does not exceed that
Butyl methacrylate. reasonably required to accomplish the
Ethyl acrylate. intended physical or technical effect
Ethylhexyl acrylate. and does not exceed any limitations
Methyl acrylate. prescribed in this section:
Limitations (limits of addition expressed as percent by weight
List of substances of finished resin)
1. Inhibitors: Total not to exceed 0.08 percent.

Benzoquinone ....................................................................... 0.01 percent.
tert-Butyl catechol.
TBHQ.
Di-tert-butyl hydroquinone.
Hydroquinone.
2. Accelerators: Total not to exceed 1.5 percent.
Benzyl trimethyl ammonium chloride ................................... 0.05 percent.
Calcium naphthenate.
Cobalt naphthenate.
Copper naphthenate.
N, N-Diethylaniline ................................................................ 0.4 percent.
N, N-Dimethylaniline ............................................................. Do.
Ethylene guanidine hydrochloride ........................................ 0.05 percent.
3. Catalysts: Total not to exceed 1.5 percent, except that methyl ethyl ke-
tone peroxide may be used as the sole catalyst at levels not
to exceed 2 percent.
Azo-bis-isobutyronitrile.
Benzoyl peroxide.
tert-Butyl perbenzoate.
Chlorbenzoyl peroxide.
Cumene hydroperoxide.
Dibutyltin oxide (CAS Reg. No. 818–08–6) ......................... For use in the polycondensation reaction at levels not to ex-
ceed 0.2 percent of the polyester resin.
Dicumyl peroxide.
Hydroxybutyltin oxide (CAS Reg. No. 2273–43–0) ............. For use in the polycondensation reaction at levels not to ex-
ceed 0.2 percent of the polyester resin.
Lauroyl peroxide.
p-Menthane hydroperoxide.
Methyl ethyl ketone peroxide.
Monobutyltin tris(2-ethylhexoate) (CAS Reg. No. 23850– For use in the polycondensation reaction at levels not to ex-
94–4). ceed 0.2 percent of the polyester resin.
4. Solvents for inhibitors, accelerators, and catalysts:
Diethylene glycol .................................................................. As a solvent for benzyl trimethyl ammonium chloride or ethyl-
ene guanidine hydrochloride only.
Methyl alcohol.
Styrene.
Triphenyl phosphate.
5. Reinforcements:
Asbestos.
Glass fiber.
Polyester fiber produced by the condensation of one or
more of the acids listed in paragraph (a)(1) of this sec-
tion with one or more of the alcohols listed in paragraph
(a)(2) of this section.
6. Miscellaneous materials:
a-Methylstyrene.
Polyethylene glycol 6000.
Silicon dioxide.
350
Limitations (limits of addition expressed as percent by weight

List of substances of finished resin)
Wax, petroleum .................................................................... Complying with § 178.3710 of this chapter.
(c) The cross-linked polyester resins, § 177.2440 Polyethersulfone resins.

with or without the optional sub-
Polyethersulfone resins identified in
stances described in paragraph (b) of
this section, and in the finished form in paragraph (a) of this section may be
which they are to contact food, when safely used as articles or components
extracted with the solvent or solvents of articles intended for repeated use in
characterizing the type of food and contact with food in accordance with
under the conditions of time and tem- the following prescribed conditions:
perature characterizing the conditions (a) For the purpose of this section,
of their intended use, as determined polyethersulfone resins are:
from tables 1 and 2 of § 176.170(c) of this (1) Poly(oxy-p-phenylenesulfonyl-p-
chapter, shall meet the following ex- phenylene) resins (CAS Reg. No. 25667–
tractives limitations: 42–9), which have a minimum number
(1) Net chloroform-soluble extrac- average molecular weight of 16,000.
tives not to exceed 0.1 milligram per (2) 1,1′-sulfonylbis[4-chlorobenzene]
square inch of food-contact surface polymer with 4,4′-(1-methylethyl-
tested when the prescribed food-simu- idene)bis[phenol] (maximum 8 percent)
lating solvent is water or 8 or 50 per- and 4,4′-sulfonylbis[phenol] (minimum
cent alcohol. 92 percent) (CAS Reg. No. 88285–91–0),
(2) Total nonvolatile extractives not which have a minimum number aver-
to exceed 0.1 milligram per square inch age molecular weight of 26,000.
of food-contact surface tested when the
(3) In paragraphs (a)(1) and (a)(2) of
prescribed food-simulating solvent is
this section, the minimum number av-
heptane.
erage molecular weight is determined
(d) In accordance with good manufac-
turing practice, finished articles con- by reduced viscosity in dimethyl form-
taining the cross-linked polyester res- amide in accordance with ASTM meth-
ins shall be thoroughly cleansed prior od D2857–70 (Reapproved 1977), ‘‘Stand-
to their first use in contact with food. ard Test Method for Dilute Solution
Viscosity of Polymers,’’ which is incor-
[42 FR 14572, Mar. 15, 1977, as amended at 48 porated by reference. Copies may be
FR 37618, Aug. 19, 1983; 54 FR 48858, Nov. 28,
1989; 87 FR 31089, May 20, 2022]
obtained from the American Society
for Testing Materials, 100 Barr Harbor
§ 177.2430 Polyether resins, Dr., West Conshohocken, Philadelphia,
chlorinated. PA 19428-2959, or may be examined at
Chlorinated polyether resins may be the Office of Food Additive Safety
safely used as articles or components (HFS–200), Center for Food Safety and
of articles intended for repeated use in Applied Nutrition, Food and Drug Ad-
producing, manufacturing, packing, ministration, 5001 Campus Dr., College
processing, preparing, treating, pack- Park, MD 20740, 240–402–1200 or at the
aging, transporting, or holding food, in National Archives and Records Admin-
accordance with the following pre- istration (NARA). For information on
scribed conditions: the availability of this material at
(a) The chlorinated polyether resins NARA, call 202–741–6030, or go to: http://
are produced by the catalytic polym- www.archives.gov/federal_register/
erization of 3,3-bis(chloromethyl)- code_of_federal_regulations/
oxetane, and shall contain not more ibr_locations.html.
than 2 percent residual monomer. (b) The basic resins identified in
(b) In accordance with good manufac- paragraphs (a)(1) and (a)(2) of this sec-
turing practice, finished articles con- tion may contain optional adjuvant
taining the chlorinated polyether res- substances described in § 174.5(d) of this

ins shall be thoroughly cleansed prior
chapter and the following:
to their first use in contact with food.
351
§ 177.2450 21 CFR Ch. I (4–1–23 Edition)
List of substances Limitations tent of not less than 7.8 weight percent
Diphenylsulfone ................ Not to exceed 0.2 percent as re-
and not more than 8.2 weight percent.
sidual solvent in the finished Polyamide-imide resins identified in
basic resin described in para- paragraph (a)(2) of this section shall
graph (a)(1) of this section.
Dimethyl sulfoxide ............ Not to exceed 0.01 percent as
have a nitrogen content of not less
residual solvent in the finished than 7.5 weight percent and not more
basic resin described in para- than 7.8 weight percent. Nitrogen con-
N-methyl-2-pyrrolidone ..... Not to exceed 0.01 percent as
tent is determined by the Dumas Nitro-
residual solvent in the finished gen Determination as set forth in the
basic resin described in para- ‘‘Official Methods of Analysis of the
Association of Official Analytical
Chemists,’’ 13th Ed. (1980), sections
(c) The finished food-contact article,
7.016–7.020, which is incorporated by
when extracted at reflux temperatures
for 2 hours with the following four sol- reference in accordance with 5 U.S.C.
vents, yields net chloroform-soluble ex- 552(a). Copies may be obtained from the
tractives in each extracting solvent AOAC INTERNATIONAL, 481 North
not to exceed 0.02 milligram per square Frederick Ave., suite 500, Gaithersburg,
inch of food-contact surface: distilled MD 20877, or may be examined at the
water, 50 percent (by volume) ethyl al- National Archives and Records Admin-
cohol in distilled water, 3 percent ace- istration (NARA). For information on
tic acid in distilled water, and n- the availability of this material at
heptane. (Note: In testing the finished NARA, call 202–741–6030, or go to: http://
food-contact article, use a separate www.archives.gov/federal_register/
test sample for each required extract- code_of_federal_regulations/
ing solvent.) ibr_locations.html.
(d) In accordance with good manufac- (2) Polyamide-imide resins identified
turing practice, finished food-contact in paragraph (a)(1) of this section shall
articles containing the have a solution viscosity of not less
polyethersulfone resins shall be thor- than 1.200. Polyamide-imide resins
oughly cleansed before their first use identified in paragraph (a)(2) of this
in contact with food. section shall have a solution viscosity
[44 FR 34493, June 15, 1979, as amended at 47 of not less than 1.190. Solution vis-
FR 38885, Sept. 3, 1982; 49 FR 10111, Mar. 19, cosity shall be determined by a method
1984; 50 FR 47211, Nov. 15, 1985; 60 FR 48648, titled ‘‘Solution Viscosity’’ which is in-
Sept. 20, 1995; 78 FR 14666, Mar. 7, 2013] corporated by reference in accordance
with 5 U.S.C. 552(a). Copies are avail-
§ 177.2450 Polyamide-imide resins.
able from the Center for Food Safety
Polyamide-imide resins identified in and Applied Nutrition (HFS–200), Food
paragraph (a) of this section may be and Drug Administration, 5001 Campus
safely used as components of articles Dr., College Park, MD 20740, or avail-
intended for repeated use in contact able for inspection at the National Ar-
with food, in accordance with the fol- chives and Records Administration
lowing prescribed conditions:
(a) Identity. (1) For the purpose of
this section the polyamide-imide resins
are derived from the condensation re- 202–741–6030, or go to: http://
action of substantially equimolar parts www.archives.gov/federal_register/
of trimellitic anhydride and p,p′- code_of_federal_regulations/
diphenylmethane diisocyanate. ibr_locations.html.
(2) The polyamide-imide resins (CAS (3) The polyamide-imide resins iden-
Reg. No. 31957–38–7) derived from the tified in paragraph (a)(1) of this section
condensation reaction of equimolar are heat cured at 600 °F for 15 minutes
parts of benzoyl chloride-3,4- when prepared for extraction tests and
dicarboxylic anhydride and 4,4′- the residual monomers: p,p-
diphenylmethanediamine. diphenylmethane diisocyanate should
(b) Specifications. (1) Polyamide-imide not be present at greater than 100 parts
resins identified in paragraph (a)(1) of per million and trimellitic anhydride
this section shall have a nitrogen con- should not be present at greater than
352
500 parts per million. Residual mono- cleansed prior to their first use in con-
mers are determined by gas chroma- tact with food.
tography (the gas chromatography [42 FR 14572, Mar. 15, 1977, as amended at 47
method titled ‘‘Amide-Imide Polymer FR 11845, Mar. 19, 1982; 49 FR 10111, Mar. 19,
Analysis—Analysis of Monomer Con- 1984; 54 FR 24898, June 12, 1989; 54 FR 43170,
tent,’’ is incorporated by reference in Oct. 23, 1989; 61 FR 14481, Apr. 2, 1996; 70 FR
accordance with 5 U.S.C. 552(a). Copies 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005]
are available from the Center for Food § 177.2460 Poly(2,6-dimethyl-1,4-phen-
Safety and Applied Nutrition (HFS– ylene) oxide resins.
200), Food and Drug Administration,
The poly(2,6-dimethyl-1,4-phenylene)
oxide resins identified in paragraph (a)
20740, or available for inspection at the of this section may be used as an arti-
National Archives and Records Admin- cle or as a component of an article in-
istration (NARA). For information on tended for use in contact with food sub-
the availability of this material at ject to the provisions of this section.
NARA, call 202–741–6030, or go to: http:// (a) Identity. For the purposes of this
www.archives.gov/federal_register/ section, poly(2,6-dimethyl-1,4-phen-
code_of_federal_regulations/ ylene) oxide resins consist of basic res-
ibr_locations.html.). ins produced by the oxidative coupling
(c) Extractive limitations are appli- of 2,6-xylenol such that the finished
cable to the polyamide-imide resins basic resins meet the specifications
identified in paragraphs (a)(1) and (2) of and extractives limitations prescribed
this section in the form of films of 1 in paragraph (c) of this section.
mil uniform thickness after coating (b) Optional adjuvant substances. The
and heat curing at 600 °F for 15 minutes basic poly(2,6-dimethyl-1,4-phenylene)
on stainless steel plates, each having oxide resins identified in paragraph (a)
such resin-coated surface area of 100 of this section may contain optional
square inches. The cured-resin film adjuvant substances required in the
coatings shall be extracted in accord- production of such basic resins. The op-
tional adjuvant substances required in
ance with the method described in
the production of the basic poly(2,6-di-
§ 176.170(d)(3) of this chapter, using a
methyl-1,4-phenylene) oxide resins may
plurality of spaced, coated stainless
include substances permitted for such
steel plates, exposed to the respective use by regulations in parts 170 through
food simulating solvents. The resin 189 of this chapter, substances gen-
shall meet the following extractive erally recognized as safe in food, sub-
limitations under the corresponding stances used in accordance with a prior
extraction conditions: sanction or approval, and the fol-
(1) Distilled water at 250 °F for 2 lowing:
hours: Not to exceed 0.01 milligram per
Limitations (expressed as
square inch. List of substances percent by weight of finished
(2) Three percent acetic acid at 212 °F basic resin)
for 2 hours: Not to exceed 0.05 milli- Diethylamine .......................... Not to exceed 0.16 percent
gram per square inch. as residual catalyst.
Methyl alcohol ........................ Not to exceed 0.02 percent
(3) Fifty percent ethyl alcohol at 160
as residual solvent.
°F for 2 hours: Not to exceed 0.03 milli- Toluene .................................. Not to exceed 0.2 percent as
gram per square inch. residual solvent.
(4) n-Heptane at 150 °F for 2 hours:
Not to exceed 0.05 milligram per square (c) Specifications and extractives limita-
inch. tions. The poly(2,6-dimethyl-1,4-phen-
ylene) oxide basic resins meet the fol-
(d) In accordance with good manufac-
lowing:
turing practice, those food contact ar-
(1) Specifications. Intrinsic viscosity
ticles, having as components the poly- is not less than 0.30 deciliter per gram
amide-imide resins identified in para- as determined by ASTM method D1243–
graph (a) of this section and intended
79, ‘‘Standard Test Method for Dilute

for repeated use shall be thoroughly Solution Viscosity of Vinyl Chloride
Polymers,’’ which is incorporated by
353
§ 177.2465 21 CFR Ch. I (4–1–23 Edition)
reference, modified as follows. Copies section, when used as components of

of the incorporation by reference may the food-contact surface of any article
be obtained from the American Society that is the subject of a regulation in
for Testing Materials, 100 Barr Harbor parts 174, 175, 176, 177, 178 and § 179.45 of
Dr., West Conshohocken, Philadelphia, this chapter, shall comply with any
PA 19428-2959, or may be examined at specifications and limitations pre-
the National Archives and Records Ad- scribed by such regulation for the arti-
ministration (NARA). For information cle in the finished form in which it is
on the availability of this material at to contact food.
(e) Uses. The poly(2,6-dimethyl-1,4-
code_of_federal_regulations/ phenylene) oxide resins identified in
ibr_locations.html. and complying with the limitations in
(i) Solvent: Chloroform, reagent grade this section may be used as articles or
containing 0.01 percent tert- components of articles intended for re-
butylcatechol. peated food-contact use or as articles
(ii) Resin sample: Powdered resin ob- or components of articles intended for
tained from production prior to mold- single-service food-contact use only
ing or extrusion. under the conditions described in
(iii) Viscometer: Cannno-Ubbelohde se- § 176.170(c) of this chapter, table 2, con-
ries 25 dilution viscometer (or equiva- ditions of use H.
lent).
(iv) Calculation: The calculation [42 FR 14572, Mar. 15, 1977, as amended at 49
FR 10111, Mar. 19, 1984; 63 FR 8852, Feb. 23,
method used is that described in appen-
1998]
dix X.1.3 (ASTM method D1243–79, cited
and incorporated by reference in para- § 177.2465 Polymethylmethacrylate/
graph (c)(1) of this section) with the re- poly(trimethoxysilylpropyl)meth-
duced viscosity determined for three acrylate copolymers.
concentration levels (0.4, 0.2, and 0.1
gram per deciliter) and extrapolated to Polymethylmethacrylate/
zero concentration for intrinisic vis- poly(trimethoxysilylpropyl) methacry-
cosity. The following formula is used late copolymers (CAS Reg. No. 26936–
for determining reduced viscosity: 30–1) may be safely used as components
of surface primers used in conjunction
Reduced viscosity in terms t − t o with silicone polymers intended for re-
of deciliters per gram = t × c peated use and complying with § 175.300
of this chapter and § 177.2600, in accord-
o
where: ance with the following prescribed con-
t = Solution efflux time. ditions.
to = Solvent efflux time. (a) Identity. For the purpose of this
c = Concentration of solution in terms of section, polymethylmethacrylate/
grams per deciliter. poly(trimethoxysilylpropyl)methacry-
(2) Extractives limitations. Total resin late copolymers are produced by the
extracted not to exceed 0.02 weight-per- polymerization of methylmethacrylate
cent when extracted with n-heptane at and
160 °F for 2 hours as determined using trimethoxysilylpropylmethacrylate.
200 milliliters of reagent grade n- (b) Conditions of use. (1) The
heptane which has been freshly dis- polymethylmethacrylate/
tilled before use and 25 grams of poly poly(trimethoxysilylpropyl)methacry-
(2,-6-dimethyl-1,4-phenylene) oxide late copolymers are used at levels not
resin. The resin as tested is in pellet to exceed 6.0 percent by weight of the
form having a particle size such that primer formulation.
100 percent of the pellets will pass (2) The copolymers may be used in
through a U.S. Standard Sieve No. 6 food contact applications with all food
and 100 percent of the pellets will be types under conditions of use B
held on a U.S. Standard Sieve No. 10. through H as described in table 2 of
(d) Other limitations. The poly(2,6-di-

methyl-1,4-phenylene) oxide resins
identified in and complying with this [59 FR 5948, Feb. 9, 1994]
354
ER01JA93.406</GPH>
§ 177.2470 Polyoxymethylene copoly- (2) Minimum number average molec-

mer. ular weight of the copolymer is 15,000
Polyoxymethylene copolymer identi- as determined by a method titled
fied in this section may be safely used ‘‘Number Average Molecular Weight,’’
as an article or component of articles which is incorporated by reference.
intended for food-contact use in ac- Copies are available from the Center
cordance with the following prescribed for Food Safety and Applied Nutrition
conditions: (HFS–200), Food and Drug Administra-
(a) Identity. For the purpose of this tion, 5001 Campus Dr., College Park,
section, polyoxymethylene copolymers MD 20740, or available for inspection at
are identified as the following: The re- the National Archives and Records Ad-
action product of trioxane (cyclic ministration (NARA). For information
trimer of formaldehyde) and ethylene on the availability of this material at
oxide (CAS Reg. No. 24969–25–3) or the NARA, call 202–741–6030, or go to: http://
reaction product of trioxane (cyclic www.archives.gov/federal_register/
trimer of formaldehyde) and a max- code_of_federal_regulations/
imum of 5 percent by weight of ibr_locations.html.
butanediol formal (CAS Reg. No. 25214
(d) Extractive limitations. (1) Polyoxy-
85–1). Both copolymers may have cer-
methylene copolymer in the finished
tain optional substances added to im-
part desired technological properties to form in which it is to contact food,
the copolymer. when extracted with the solvent or sol-
(b) Optional adjuvant substances. The vents characterizing the type of food
polyoxymethylene copolymer identi- and under conditions of time and tem-
fied in paragraph (a) of this section perature as determined from tables 1
may contain optional adjuvant sub- and 2 of § 175.300(d) of this chapter,
stances required in its production. The shall yield net chloroform-soluble ex-
quantity of any optional adjuvant sub- tractives not to exceed 0.5 milligram
stance employed in the production of per square inch of food-contact surface.
the copolymer does not exceed the (2) Polyoxymethylene copolymer
amount reasonably required to accom- with or without the optional sub-
plish the intended technical or physical stances described in paragraph (b) of
effect. Such adjuvants may include this section, when ground or cut into
substances generally recognized as safe particles that pass through a U.S.A.
in food, substances used in accordance Standard Sieve No. 6 and that are re-
with prior sanction, substances per- tained on a U.S.A. Standard Sieve No.
mitted under applicable regulations in 10, shall yield total extractives as fol-
parts 170 through 189 of this chapter, lows:
and the following:
(i) Not to exceed 0.20 percent by
(1) Stabilizers (total amount of stabi-
weight of the copolymer when ex-
lizers not to exceed 2.0 percent and
amount of any one stabilizer not to extracted for 6 hours with distilled water
ceed 1.0 percent of polymer by weight) at reflux temperature.
(ii) Not to exceed 0.15 percent by
Calcium ricinoleate. weight of the copolymer when ex-
Cyanoguanidine.
Hexamethylene bis(3,5-di-tert-butyl-4-
tracted for 6 hours with n-heptane at
hydroxyhydrocinnamate) (CAS Reg. No. reflux temperature.
35074–77–2). (e) Conditions of use. (1) The
Melamine-formaldehyde resin. polyoxymethylene copolymer is for use
2,2′-Methylenebis(4-methyl-6-tert-butyl- as articles or components of articles
phenol).
Nylon 6/66, weight ratio 2/3.
intended for repeated use.
Tetrakis [methylene (3,5-di-tert-butyl-4- (2) Use temperature shall not exceed
hydroxyhydrocinnamate)] methane. 250 °F.
(2) Lubricant: N,N′Distearoylethyl- (3) In accordance with good manufac-
enediamine. turing practice, finished articles con-
taining polyoxymethylene copolymer
(c) Specifications. (1) Polyoxymeth-

ylene copolymer can be identified by
its characteristic infrared spectrum.
355
§ 177.2480 21 CFR Ch. I (4–1–23 Edition)
shall be thoroughly cleansed before Substances Limitations

their first use in contact with food.
Nylon 66/610/6 terpolymer, At a maximum level of 1.5
[42 FR 14572, Mar. 15, 1977, as amended at 48 respective proportions of percent by weight of
nylon polymers by weight homopolymer.
FR 56204, Dec. 20, 1983; 49 FR 5748, Feb. 15,
are: 3/2/4.
1984; 50 FR 1842, Jan. 14, 1985; 50 FR 20560, Nylon 612/6 copolymer (CAS Do.
May 17, 1985; 52 FR 4493, Feb. 12, 1987, 54 FR Reg. No. 51733-10-9),
24898, June 12, 1989] weight ratio 6/1.
Tetrakis[methylene(3,5-di-tert- At a maximum level of 0.5
§ 177.2480 Polyoxymethylene butyl-4-hydroxy-hydro- percent by weight of
cinnamate)] methane. homopolymer.
homopolymer.
Polyoxymethylene homopolymer (2) Lubricant. N,N′-Distearoylethyl-
identified in this section may be safely enediamine.
used as articles or components of arti- (3) Molding assistant. Polyethylene
cles intended for food-contact use in glycol 6,000.
accordance with the following pre- (c) Specifications. (1)
scribed conditions: Polyoxymethylene homopolymer can
(a) Identity. For the purpose of this be identified by its characteristic in-
section, polyoxymethylene homopoly- frared spectrum.
mer is polymerized formaldehyde (2) Minimum number average molec-
[Chemical Abstracts Service Registry ular weight of the homopolymer is
No. 9002–81–7]. Certain optional adju- 25,000.
vant substances, described in para- (3) Density of the homopolymer is be-
graph (b) of this section, may be added tween 1.39 and 1.44 as determined by
to impart desired technological prop- ASTM method D1505–68 (Reapproved
erties to the homopolymer. 1979), ‘‘Standard Test Method for Den-
(b) Optional adjuvant substances. The sity of Plastics by the Density-Gra-
polyoxymethylene homopolymer iden- dient Technique,’’ which is incor-
tified in paragraph (a) of this section porated by reference. Copies may be
may contain optional adjuvant sub- obtained from the American Society
stances in its production. The quantity for Testing Materials, 100 Barr Harbor
of any optional adjuvant substance em- Dr., West Conshohocken, Philadelphia,
ployed in the production of the PA 19428-2959, or may be examined at
homopolymer does not exceed the the National Archives and Records Ad-
amount reasonably required to accom- ministration (NARA). For information
plish the intended effect. Such adju- on the availability of this material at
vants may include substances gen- NARA, call 202–741–6030, or go to: http://
erally recognized as safe in food, sub- www.archives.gov/federal_register/
stances used in accordance with prior code_of_federal_regulations/
sanction, substances permitted under ibr_locations.html.
applicable regulations in this part, and (4) Melting point is between 172 °C
the following: and 184 °C as determined by ASTM
method D2133–66, ‘‘Specifications for
(1) Stabilizers. The homopolymer may
Acetal Resin Injection Molding and Ex-
contain one or more of the following
trusion Materials’’ (Revised 1966),
stabilizers. The total amount of stabi-
which is incorporated by reference.
lizers shall not exceed 1.9 percent of
Copies are available from American So-
homopolymer by weight, and the quan-
ciety for Testing and Materials
tity of individual stabilizer used shall
(ASTM), 100 Barr Harbor Dr., West
not exceed the limitations set forth
Conshohocken, Philadelphia, PA 19428-
below:
2959, or available for inspection at the
Substances Limitations National Archives and Records Admin-
Hexamethylenebis(3,5-di-tert- At a maximum level of 1 per- the availability of this material at
butyl-4-hydroxy-hydro- cent by weight of
cinnamate) (CAS Reg. No. homopolymer. The finished NARA, call 202–741–6030, or go to: http://
35074–77–2). articles shall not be used www.archives.gov/federal_register/
for foods containing more code_of_federal_regulations/
than 8 percent alcohol.
2,2′-Methylenebis(4-methyl-6- At a maximum level of 0.5

ibr_locations.html.
tert-butylphenol). percent by weight of (d) Extractive limitations. (1)
homopolymer. Polyoxymethylene homopolymer, in
356
the finished form which is to contact cleansed prior to first use in contact
food, when extracted with the solvent with food.
or solvents characterizing the type of [42 FR 14572, Mar. 15, 1977, as amended at 43
food and under conditions of time and FR 44835, Sept. 29, 1978; 47 FR 11846, Mar. 19,
temperature characterizing the condi- 1982; 47 FR 51562, Nov. 16, 1982; 49 FR 10111,
tions of intended use under paragraphs Mar. 19, 1984; 54 FR 24898, June 12, 1989]
(c)(3) and (d) of § 175.300 of this chapter
§ 177.2490 Polyphenylene sulfide res-
and as limited by paragraph (e) of this ins.
section, shall yield net chloroform-
soluble extractives not to exceed 0.5 Polyphenylene sulfide resins
milligram per square inch of food-con- (poly(1,4-phenylene sulfide) resins) may
tact surface. be safely used as coatings or compo-
nents of coatings of articles intended
(2) Polyoxymethylene homopolymer,
for repeated use in contact with food,
with or without the optional adjuvant in accordance with the following pre-
substances described in paragraph (b) scribed conditions.
of this section, when ground or cut into (a) Polyphenylene sulfide resins con-
particles that pass through a U.S.A. sist of basic resins produced by the re-
Standard Sieve No. 6 and that are reaction of equimolar parts of p-
tained on a U.S.A. Standard Sieve No. dichlorobenzene and sodium sulfide,
10, shall yield extractives as follows: such that the finished resins meet the
(i) Formaldehyde not to exceed 0.0050 following specifications as determined
percent by weight of homopolymer as by methods titled ‘‘Oxygen Flask Com-
determined by a method titled ‘‘Form- bustion-Gravimetric Method for Deter-
aldehyde Release and Formaldehyde mination of Sulfur in Organic Com-
Analysis,’’ which is incorporated by pounds,’’ ‘‘Determination of the Inher-
reference. Copies are available from ent Viscosity of Polyphenylene Sul-
Center for Food Safety and Applied Nu- fide,’’ and ‘‘Analysis for
trition (HFS–200) Food and Drug Ad- Dichlorobenzene in Ryton
ministration, 5001 Campus Dr., College Polyphenylene Sulfide,’’ which are in-
Park, MD 20740, or available for inspec- corporated by reference. Copies are
tion at the National Archives and available from the Center for Food
Records Administration (NARA). For Safety and Applied Nutrition (HFS–
200), Food and Drug Administration,
20740, or available for inspection at the
eral_register/code_of_federal_regulations/ istration (NARA). For information on
ibr_locations.html. the availability of this material at
(ii) Total extractives not to exceed NARA, call 202–741–6030, or go to: http://
0.20 percent by weight of homopolymer www.archives.gov/federal_register/
when extracted for 6 hours with dis- code_of_federal_regulations/
tilled water at reflux temperature and ibr_locations.html.
0.15 percent by weight of homopolymer (1) Sulfur content: 28.2–29.1 percent
when extracted for 6 hours with n- by weight of finished resin.
heptane at reflux temperature. (2) Minimum inherent viscosity: 0.13
(e) Conditions of use. (1) Polyoxy- deciliters per gram.
methylene homopolymer is for use as (3) Maximum residual p-
articles or components of articles in- dichlorobenzene: 0.8 ppm.
tended for repeated use. (b) Subject to any limitations pre-
(2) Use temperature shall not exceed scribed in parts 170 through 189 of this
250 °F. chapter, the following optional sub-
stances may be added to the
(3) In accordance with good manufac-
polyphenylene sulfide basic resins in an
turing practice, finished articles con-
amount not to exceed that reasonably
taining polyoxymethylene required to accomplish the intended
homopolymer shall be thoroughly
physical or technical effect.

as safe in food.
357
§ 177.2500 21 CFR Ch. I (4–1–23 Edition)
(2) Substances used in accordance acetic acid such that the finished res-
with prior sanction or approval. ins meet the specifications set forth in
(3) Substances the use of which is paragraph (c) of this section. The
permitted in coatings under regula- polyphenylene sulfide used to manufac-
tions in parts 170 through 189 of this ture polyphenylene sulfone is prepared
chapter. by the reaction of sodium sulfide and p-
(c) The finished coatings are ther- dichlorobenzene, and has a minimum
mally cured at temperatures of 700 °F weight average molecular weight of
and above. 5,000 Daltons.
(d) Polyphenylene sulfide resin coat- (b) Optional adjuvant substances. The
ings may be used in contact with food basic polyphenylene sulfone resins
at temperatures not to exceed the boil- identified in paragraph (a) of this sec-
ing point of water; provided that the tion may contain optional adjuvant
finished cured coating, when extracted substances required in the production
at reflux temperatures for 8 hours sepa- of such basic resins. These optional ad-
rately with distilled water, 50 percent juvant substances may include sub-
ethanol in water, and 3 percent acetic stances permitted for such use by regu-
acid, yields total extractives in each lations in parts 170 through 189 of this
extracting solvent not to exceed 0.02 chapter, substances generally recog-
milligram per square inch of surface nized as safe in food, or substances
and when extracted at reflux tempera- used in accordance with a prior sanc-
ture for 8 hours with heptane yields tion or approval.
total extractives not to exceed 0.1 mil- (c) Specifications. The glass transition
ligram per square inch of surface. temperature of the polymer is 360±5 °C
(e) Polyphenylene sulfide resin coat- as determined by the use of differential
ings containing perfluorocarbon resins scanning calorimetry.
complying with § 177.1550 may be used
in contact with food at temperatures [65 FR 15058, Mar. 21, 2000]
up to and including normal baking and
frying temperatures; provided that the § 177.2510 Polyvinylidene fluoride res-
finished cured coating, when extracted ins.
at reflux temperatures for 2 hours sepa- Polyvinylidene fluoride resins may
rately with distilled water, 50 percent be safely used as articles or compo-
ethanol in water, 3 percent acetic acid nents of articles intended for repeated
and heptane, yields total extractives in use in contact with food, in accordance
each extracting solvent not to exceed with the following prescribed condi-
0.2 milligram per square inch of surface tions:
and when extracted at reflux tempera- (a) For the purpose of this section,
ture for 1 hour with diphenyl ether the polyvinylidene fluoride resins con-
yields total extractives not to exceed sist of basic resins produced by the po-
4.5 milligrams per square inch of sur- lymerization of vinylidene fluoride.
face. (b) The finished food-contact article,
[42 FR 14572, Mar. 15, 1977, as amended at 47 when extracted at reflux temperatures
FR 11846, Mar. 19, 1982; 54 FR 24898, June 12, for 2 hours with the solvents distilled
1989] water, 50 percent (by volume) ethyl al-
cohol in distilled water, and n-heptane,
§ 177.2500 Polyphenylene sulfone res- yields total extractives in each ex-
ins. tracting solvent not to exceed 0.01 mil-
The polyphenylene sulfone resins ligram per square inch of food-contact
(CAS Reg. No. 31833–61–1) identified in surface tested; and if the finished food-
paragraph (a) of this section may be contact article is itself the subject of a
safely used as articles or components regulation in parts 174, 175, 176, 177, 178
of articles intended for repeated use in and § 179.45 of this chapter, it shall also
contact with food, subject to the provi- comply with any specifications and
sions of this section. limitations prescribed for it by that
(a) Identity. For the purpose of this regulation. (NOTE: In testing the fin-
section, polyphenylene sulfone resins ished food-contact article, use a sepa-

consist of basic resin produced by re- rate test sample for each required ex-
acting polyphenylene sulfide with per- tracting solvent.)
358
(c) In accordance with good manufac- dichloride (CAS Reg. No. 39443–76–0).
turing practice, finished food-contact The membrane is the food contact sur-
articles containing the polyvinylidene face and may be applied as a film on a
fluoride resins shall be thoroughly suitable support. Its maximum weight
cleansed prior to their first use in con- is 512 milligrams per square decimeter
tact with food. (33 milligrams per square inch).
(4) A cross-linked high molecular
§ 177.2550 Reverse osmosis mem-
branes. weight polyamide reaction product of
poly(N-vinyl-N-methylamine) (CAS
Substances identified in paragraph Reg. No. 31245–56–4), N,N′-bis(3-
(a) of this section may be safely used as aminopropyl)ethylenediamine (CAS
reverse osmosis membranes intended Reg. No. 10563–26–5), 1,3-
for use in processing bulk quantities of
benzenedicarbonyl dichloride (CAS
liquid food to separate permeate from
Reg. No. 99–63–8) and 1,3,5-
food concentrate or in purifying water
benzenetricarbonyl trichloride (CAS
for food manufacturing under the fol-
Reg. No. 4422–95–1). The membrane is
lowing prescribed conditions:
(a) Identity. For the purpose of this the food-contact surface. Its maximum
section, reverse osmosis membranes weight is 20 milligrams per square deci-
may consist of either of the following meter (1.3 milligrams per square inch)
formulations: as a thin film composite on a suitable
(1) A cross-linked high molecular support.
weight polyamide reaction product of (5) A polyamide reaction product of
1,3,5-benzenetricarbonyl trichloride 1,3,5-benzenetricarbonyl trichloride
with 1,3-benzenediamine (CAS Reg. No. polymer (CAS Reg. No. 4422–95–1) with
83044–99–9) or piperazine (CAS Reg. No. piperazine (CAS Reg. No. 110–85–0) and
110–85–0). The membrane is on the food- 1,2-diaminoethane (CAS Reg. No. 107–
contact surface, and its maximum 15–3). The membrane is the food-con-
weight is 62 milligrams per square deci- tact layer and may be applied as a film
meter (4 milligrams per square inch) as on a suitable support. Its maximum
a thin film composite on a suitable weight is 15 milligrams per square deci-
support. meter (1 milligram per square inch).
(2) A cross-linked polyetheramine (b) Optional adjuvant substances. The
(CAS Reg. No. 101747–84–6), identified as basic polymer identified in paragraph
the copolymer of epichlorohydrin, 1,2- (a) of this section may contain optional
ethanediamine and 1,2-dichloroethane, adjuvant substances required in the
whose surface is the reaction product production of such basic polymer.
of this copolymer with 2,4- These optional adjuvant substances
toluenediisocyanate (CAS Reg. No. of may include substances permitted for
the final polymer is 99811–80–0) for use such use by regulations in parts 170
as the food-contact surface of reverse
through 186 of this chapter, substances
osmosis membranes used in processing
generally recognized as safe in food,
liquid food. The composite membrane
and substances used in accordance with
is on the food-contact surface and its
maximum weight is 4.7 milligrams per a prior sanction or approval.
square decimeter (0.3 milligrams per (c) Supports. Suitable supports for re-
square inch) as a thin film composite verse osmosis membranes are mate-
on a suitable support. The maximum rials permitted for such use by regula-
weight of the 2,4-toluenediisocyanate tions in parts 170 through 186 of this
component of the thin film composite chapter, substances generally recog-
is 0.47 milligrams per square decimeter nized as safe in food, and substances
(0.03 milligrams per square inch). used in accordance with a prior sanc-
(3) For the purpose of this section, tion or approval.
the reverse osmosis membrane consists (d) Conditions of use. (1) Reverse os-
of a polyaramide identified as 2,4- mosis membranes described in para-
diaminobenzenesulfonic acid, calcium graphs (a)(1), (a)(2), (a)(3), and (a)(5) of
salt (2:1) polymer with 1,3- this section may be used in contact
benzenediamine, 1,3-benzenedicarbonyl with all types of liquid food at tem-
dichloride, and 1,4-benzenedicarbonyl peratures up to 80 °C (176 °F).
359
§ 177.2600 21 CFR Ch. I (4–1–23 Edition)
(2) Reverse osmosis membranes de- tion in parts 174, 175, 176, 177, 178 and
scribed in paragraph (a)(4) of this sec- § 179.45 of this chapter conforms with
tion may be used in contact with all any specification in such regulation.
types of liquid food, except food con- (i) Elastomers.
taining more than 8 percent alcohol, at Acrylonitrile-butadiene copolymer.
temperatures up to 80 °C (176 °F). Brominated isobutylene-isoprene copolymers
(3) Reverse osmosis membranes shall complying with § 177.1210.
be maintained in a sanitary manner in Butadiene-acrylonitrile-ethylene glycol
accordance with current good manufac- dimethacrylate copolymers containing not
turing practice so as to prevent micro- more than 5 weight percent of polymer
bial adulteration of food. units derived from ethylene glycol
dimethacrylate.
(4) To assure their safe use, reverse Butadiene-acrylonitrile-methacrylic acid co-
osmosis membranes and their supports polymer.
shall be thoroughly cleaned prior to Butadiene-styrene-methacrylic acid copoly-
their first use in accordance with cur- mer.
rent good manufacturing practice. Chloroprene polymers.
Chlorotrifluoroethylene-vinylidene fluoride
[49 FR 49448, Dec. 20, 1984, as amended at 52 copolymer.
FR 29668, Aug. 11, 1987; 53 FR 31835, Aug. 22, Ethylene-propylene copolymer elastomers
1988; 53 FR 32215, Aug. 24, 1988; 55 FR 8139, which may contain not more than 5
Mar. 7, 1990; 59 FR 9925, Mar. 2, 1994] weight-percent of total polymer units de-
rived from 5-methylene-2-norbornene and/
§ 177.2600 Rubber articles intended for or 5-ethylidine-2-norbornene.
repeated use. Ethylene-propylene-dicyclopentadiene co-
Rubber articles intended for repeated polymer.
Ethylene-propylene-1,4-hexadiene copoly-
use may be safely used in producing, mers containing no more than 8 weight
manufacturing, packing, processing, percent of total polymer units derived
preparing, treating, packaging, trans- from 1,4-hexadiene.
porting, or holding food, subject to the Hydrogenated butadiene/acrylonitrile co-
provisions of this section. polymers (CAS Reg. No. 88254–10–8) pro-
(a) The rubber articles are prepared duced when acrylonitrile/butadiene copoly-
from natural and/or synthetic polymers mers are modified by hydrogenation of the
olefinic unsaturation to leave either: (1)
and adjuvant substances as described Not more than 10 percent trans olefinic
in paragraph (c) of this section. unsaturation and no a, b-olefinic
(b) The quantity of any substance unsaturation as determined by a method
employed in the production of rubber entitled ‘‘Determination of Residual a, b-
articles intended for repeated use shall Olefinic and Trans Olefinic Unsaturation
not exceed the amount reasonably re- Levels in HNBR,’’ developed October 1,
quired to accomplish the intended ef- 1991, by Polysar Rubber Corp., 1256 South
Vidal St., Sarnia, Ontario, Canada N7T
fect in the rubber article and shall not
7MI; or (2) 0.4 percent to 20 percent olefinic
be intended to accomplish any effect in unsaturation and Mooney viscosities great-
food. er than 45 (ML 1 + 4 @ 100 °C), as deter-
(c) Substances employed in the prep- mined by ASTM Standard Method D1646–
aration of rubber articles include the 92, ‘‘Standard Test Method for Rubber—
following, subject to any limitations Viscosity and Vulcanization Characteris-
prescribed: tics (Mooney Viscometer),’’ which are both
(1) Substances generally recognized incorporated by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. Cop-
as safe for use in food or food pack- ies of these methods may be obtained from
aging. the Office of Food Additive Safety (HFS–
(2) Substances used in accordance 200), Center for Food Safety and Applied
with the provisions of a prior sanction Nutrition, Food and Drug Administration,
or approval. 5001 Campus Dr., College Park, MD 20740,
(3) Substances that by regulation in 240–402–1200, or may be examined at the
parts 170 through 189 of this chapter Food and Drug Administration’s Main Li-
may be safely used in rubber articles, brary, 10903 New Hampshire Ave., Bldg. 2,
Third Floor, Silver Spring, MD 20993, 301–
subject to the provisions of such regu-
796–2039, or at the National Archives and
lation. Records Administration (NARA). For in-
(4) Substances identified in this para- formation on the availability of this mate-
graph (c)(4), provided that any sub- rial at NARA, call 202–741–6030, or go to:
stance that is the subject of a regula- http://www.archives.gov/federal_register/
360
code_of_federal_regulations/ Silicone (Fsi) elastomers containing meth-
ibr_locations.html. A copy of ASTM Stand- yl and fluorine groups.
ard Method D1646–92 may also be obtained Silicone (PVsi) elastomers containing
from the American Society for Testing and phenyl, methyl, and vinyl groups.
Materials, 100 Barr Harbor Dr., West Styrene-butadiene copolymer.
Conshohocken, PA 19428–2959. Vinylidene fluoride-hexafluoropropylene co-
Isobutylene-isoprene copolymer. polymers (minimum number average mo-
Polyamide/polyether block copolymers (CAS lecular weight 70,000 as determined by os-
Reg. No. 77402–38–1 prepared by reacting a motic pressure in methyl ethyl ketone).
copolymer of omega-laurolactam and adipic Vinylidene fluoride-hexafluoropropylene-
acid with poly(tetramethylene ether gly- tetrafluoroethylene copolymers (minimum
col). The polyamide and polyether compo- number average molecular weight 100,000
nents are reacted in ratios such that the as determined by osmotic pressure in
polyamide component constitutes a min- methyl ethyl ketone).
imum of 30 weight-percent of total polymer
units. The copolymers may be used in con- (ii) Vulcanization materials—(a) Vul-
tact with foods of Types I, II, III, IV, V, VI, canizing agents.
VII, VIII, and IX identified in table 1 of
§ 176.170(c) of this chapter at temperatures 4,4′-Bis(aminocyclohexyl)methane carbamate
not to exceed 150 °F except that those co- for use only as cross-linking agent in the
polymers prepared with less than 50 vulcanization of vinylidene
weight-percent of polyamide are limited to fluoridehexafluoropropylene copolymer
use in contact with such foods at tempera- and vinylidene fluoride-
tures not to exceed 100 °F. hexafluoropropylene-tetrafluoroethylene
Polybutadiene. copolymer elastomers identified under
Polyester elastomers derived from the reac- paragraph (c)(4)(i) of this section and lim-
tion of dimethyl terephthalate, 1,4- ited to use at levels not to exceed 2.4 per-
butanediol, and a-hydro-omega- cent by weight of such copolymers.
hydroxypoly (oxytetramethylene). Addi- Diisopropyl xanthogen polysulfide (a 1:2:1
tionally, trimethyl trimellitate may be mixture of O,O-di(1-methylethyl)trithio-
used as a reactant. The polyester bis-thioformate, O,O-di(1-
elastomers may be used only in contact methylethyl)tetrathio-bis-thioformate,
with foods containing not more than 8 per- and O,O-di(1-methylethyl)pentathio-bis-
cent alcohol and limited to use in contact thioformate) for use as a cross linking
with food at temperatures not exceeding agent in the vulcanization of natural rub-
150 °F. ber, styrene-butadiene copolymer, acrylo-
Polyisoprene. nitrile-butadiene copolymer, and ethylene-
Polyurethane resins (CAS Reg. Nos. 37383–28– propylene terpolymers identified under
1 or 9018–04–6) derived from the reaction of paragraph (c)(4)(i) of this section and lim-
diphenylmethane diisocyanate with 1,4- ited to use at levels not to exceed 2.4 per-
butanediol and polytetramethylene ether cent by weight of such copolymers.
glycol. Hexamethylenediamine carbamate for use
Polyurethane resins derived from reactions only as cross-linking agent in the vul-
of diphenylmethane diisocyanate with canization of vinylidene fluoride-
adipic acid and 1,4-butanediol. hexafluoropropylene copolymer and vinyli-
Rubber, natural. dene fluoride-hexafluoropropylene-tetra-
Silicone basic polymer as described in ASTM fluoroethylene copolymer elastomers iden-
method D1418–81, ‘‘Standard Practice for tified under paragraph (c)(4)(i) of this sec-
Rubber and Rubber Latices—Nomen- tion and limited to use at levels not to ex-
clature,’’ which is incorporated by ref- ceed 1.5 percent by weight of such copoly-
erence. Copies may be obtained from the mers.
American Society for Testing Materials, Sulfur, ground.
100 Barr Harbor Dr., West Conshohocken,
Philadelphia, PA 19428-2959, or may be ex- (b) Accelerators (total not to exceed 1.5
amined at the National Archives and percent by weight of rubber product).
Records Administration (NARA). For in- 2-Benzothiazyl-N,N-diethylthiocarbamyl-sul-
formation on the availability of this mate- fide.
rial at NARA, call 202–741–6030, or go to: Benzoyl peroxide.
http://www.archives.gov/federal_register/ 1,3-Bis(2-benzothiazolylmercaptomethyl)
code_of_federal_regulations/ urea.
ibr_locations.html. N-tert-Butyl-2-benzothiazole sulfenamide.
Silicone (Si) elastomers containing methyl Butyraldehyde-aniline resin (iodine number
groups. 670–705).
Silicone (Psi) elastomers containing meth- Carbon disulfide-1,1′-methylenedipiperidine
yl and phenyl groups. reaction product.

Silicone (Vsi) elastomers containing meth- Copper dimethyldithiocarbamate.
yl and vinyl groups. N-Cyclohexyl-2-benzothiazole sulfenamide.
361
§ 177.2600 21 CFR Ch. I (4–1–23 Edition)
Dibenzoyl-p-quinone dioxime. (c) Retarders (total not to exceed 10 per-
Dibenzylamine. cent of weight of rubber product).
Diisopropyl xanthogen polysulfide (a 1:2:1
mixture of O,O-di(1-methylethyl)trithio- Cyanoguanidine.
bis-thioformate, O,O-di(1- Phthalic anhydride.
methylethyl)tetrathio-bis-thioformate, Salicylic acid.
and O,O-di(1-methylethyl)pentathio-bis-
thioformate).
(d) Activators (total not to exceed 5 per-
Di(4-methylbenzoyl) peroxide (CAS Reg. No. cent by weight of rubber product except
895–85–2) for use only as a crosslinking magnesium oxide may be used at higher
agent in silicone polymers and elastomers levels).
identified under paragraph (c)(4)(i) of this
Diethylamine.
section at levels not to exceed 1 percent by
Fatty acid amines, mixed.
weight of such polymers and elastomers
Fatty acids.
where the total of all accelerators does not
Magnesium carbonate.
exceed 1.5 percent by weight of rubber
product. Magnesium oxide, light and heavy.
Di-tert-butyl peroxide. Oleic acid, dibutylamine salt
(dibutylammonium oleate).
Dibutyl xanthogen disulfide.
Stannous chloride.
2,4-Dichlorobenzoyl peroxide.
Tall oil fatty acids.
Dicumyl peroxide.
Tetrachloro-p-benzoquinone.
N,N-Dimethylcyclohexylamine salt of
dibutyldithiocarbamic acid. Triethanolamine.
2,6-Dimethylmorpholine thiobenzothiazol. Zinc salts of fatty acids.
Dipentamethylenethiuram hexasulfide (CAS (iii) Antioxidants and antiozonants
Reg. No. 971–15–3). (total not to exceed 5 percent by weight of
Diphenylguanidine.
rubber product).
1,3-Diphenyl-2-thiourea.
2,2′-Dithiobis[benzothiazole]. Aldol-a-naphthylamine.
4,4′-Dithiodimorpholine. Alkylated (C4 and/or C8) phenols.
N,N′-Di-o-tolylguanidine. BHT (butylated hydroxytoluene).
Di-o-tolylguanidine salt of 4-[[4,6-bis(octylthio)-s-triazin-2-yl]amino]-
pyrocatecholborate. 2,6-di-tert-butylphenol (CAS Reg. No. 991–
Ethylenediamine carbamate. 84–4) for use only as a stabilizer at levels
Heptaldehyde-aniline resin (iodine number not to exceed 0.5 percent by weight of the
430–445). finished rubber product.
Hexamethylenetetramine. Butylated reaction product of p-cresol and
2-Mercaptobenzothiazole. dicyclopentadiene as identified in
2-Mercaptothiazoline. § 178.2010(b) of this chapter.
N-Oxydiethylene-benzothiazole-2- Butylated, styrenated cresols identified in
sulfenamide. § 178.2010(b) of this chapter.
Piperidinium pentamethylenedithiocarba- 4,4′-Butylidinebis(6-tert-butyl-m-cresol).
mate. N-Cyclohexyl-N′-phenylphenylenediamine.
Potassium pentamethylenedithiocarbamate. p,p′-Diaminodiphenylmethane.
p-Quinone dioxime. 2,5-Di-tert-amylhydroquinone.
Sodium dibutyldithiocarbamate. Diaryl-p-phenylenediamine, where the aryl
Sodium dimethyldithiocarbamate. group may be phenyl, tolyl, or xylyl.
Stannous oleate for use only as an accel- 2,6-Di-tert-butyl-p-phenylphenol.
erator for silicone elastomers. 1,2-Dihydro-2,2,4-trimethyl-6-
Tetrabutylthiuram monosulfide. dodecylquinoline.
Tetraethylthiuram disulfide. 1,2-Dihydro-2,2,4-trimethyl-6-
(1,1,4,4-Tetramethyltetramethylene)bis [tert- ethoxyquinoline.
butyl peroxide]. 1,2-Dihydro-2,2,4-trimethyl-6-
Tetramethylthiuram monosulfide. phenylquinoline.
Thiram (tetramethylthiuram disulfide). 4,4′-Dimethoxydiphenylamine.
Triallyl cyanurate. 4,6-Dinonyl-o-cresol.
Triethylenetetramine. N,N′-Dioctyl-p-phenylenediamine.
1,3,5-Triethyl-hexahydro-s-triazine Diphenylamine-acetone resin.
(triethyltrimethylenetriamine). Diphenylamine-acetone-formaldehyde resin.
Triphenylguanidine. N,N′-Diphenylethylenediamine.
Zinc butyl xanathate. N,N′-Disalicylalpropylenediamine.
Zinc dibenzyl dithiocarbamate. N,N′-Di-o-tolylethylenediamine.
Zinc dibutyldithiocarbamate. Hydroquinone monobenzyl ether.
Zinc diethyldithiocarbamate. Isopropoxydiphenylamine.

Zinc 2-mercaptobenzothiazole. N-Isopropyl-N′-phenyl-p-phenylenediamine.
Ziram (zinc dimethyldithiocarbamate). 2,2′-Methylenebis(6-tert-butyl-4-ethylphenol).
362
2,2′-Methylenebis(4-methyl-6-tert-butyl- Dipentene resin.
phenol). Fatty acids.
2,2′-Methylenebis(4-methyl-6-nonylphenol). Fatty acids, hydrogenated.
2,2′-Methylenebis(4-methyl-6-tert- Isooctyl ester of tall oil fatty acids.
octylphenol). Lanolin.
Monooctyl- and dioctyldiphenylamine. a-Methylstyrene-vinyltoluene copolymer
N,N′-Di-b-naphthyl-p-phenylenediamine. resins (molar ratio 1 a-methylstyrene to 3
Phenyl-a-naphthylamine. vinyltoluene).
Phenyl-b-naphthylamine. Mineral oil; (1) In rubber articles complying
Phenyl-b-naphthylamine-acetone aromatic with this section, not to exceed 30 percent
amine resin (average molecular weight 600; by weight; (2) Alone or in combination
nitrogen content 5.3 percent). with waxes, petroleum, total not to exceed
o- and p-Phenylphenol. 45 percent by weight of rubber articles that
Polybutylated (mixture) 4,4′- contain at least 20 percent by weight of
isopropylidenediphenol. ethylene-propylene copolymer elastomer
Sodium pentachlorophenate. complying with paragraph (c)(4)(i) of this
Styrenated cresols produced when 2 moles of section, in contact with foods of Types I,
styrene are made to react with 1 mole of a II, III, IV, VI, VII, VIII, and IX identified in
mixture of phenol and o-, m-, and p-cresols table 1 of § 176.170(c) of this chapter.
so that the final product has a Brookfield Montan wax.
viscosity at 25 °C of 1400 to 1700 centipoises. n-Octyl n-decyl adipate.
Styrenated phenol.
Petrolatum.
4,4′-Thiobis (6-tert-butyl-m-cresol).
Petroleum hydrocarbon resin
Toluene-2,4-diamine.
(cyclopentadiene type), hydrogenated.
N-o-Tolyl-N′-phenyl-p-phenylenediamine.
Petroleum hydrocarbon resin (produced by
p(p-Tolylsufanilamide) diphenylamine.
the homo- and copolymerization of dienes
Tri(mixed mono- and dinonylphenyl)
and olefins of the aliphatic, alicyclic, and
phosphite.
monobenzenoid arylalkene types from dis-
Tri(nonylphenyl) phosphite-formaldehyde
tillates of cracked petroleum stocks).
resins produced when 1 mole of
tri(nonylphenyl) phosphite is made to Petroleum hydrocarbon resin (produced by
react with 1.4 moles of formaldehyde or the catalytic polymerization and subse-
produced when 1 mole of nonylphenol is quent hydrogenation of styrene,
made to react with 0.36 mole of formalde- vinyltoluene, and indene types from dis-
hyde and the reaction product is then fur- tillates of cracked petroleum stocks).
ther reacted with 0.33 mole of phosphorus Petroleum oil, sulfonated.
trichloride. The finished resins have a min- Phenol-formaldehyde resin.
imum viscosity of 20,000 centipoises at 25 Pine tar.
°C, as determined by LV-series Brookfield Polybutene.
viscometer (or equivalent) using a No. 4 Polystyrene.
spindle at 12 r.p.m., and have an organic Propylene glycol.
phosphorus content of 4.05 to 4.15 percent n-Propyl ester of tall oil fatty acids.
by weight. Rapeseed oil vulcanized with rubber maker’s
sulfur.
(iv) Plasticizers (total not to exceed 30 Rosins and rosin derivatives identified in
percent by weight of rubber product un- § 175.105(c)(5) of this chapter.
less otherwise specified). Soybean oil vulcanized with rubber maker’s
sulfur.
Butylacetyl ricinoleate.
Styrene-acrylonitrile copolymer.
n-Butyl ester of tall oil fatty acids.
Terpene resins.
Butyl laurate.
Triethylene glycol dicaprate.
Butyl oleate.
Triethylene glycol dicaprylate.
Butyl stearate.
Waxes, petroleum.
Calcium stearate.
Castor oil. Xylene (or toluene) alkylated with
Coumarone-indene resins. dicyclopentadiene.
2,2′-Dibenzamidodiphenyl disulfide. Zinc 2-benzamidothiophenate.
Dibenzyl adipate. (v) Fillers.
Dibutoxyethoxyethyl adipate.
Dibutyl sebacate. Aluminum hydroxide.
Didecyl adipate. Aluminum silicate.
Diisodecyl adipate. Asbestos fiber, chrysotile or crocidolite.
Diisodecyl phthalate. Barium sulfate.
Diisooctyl adipate. Carbon black (channel process or furnace
Diisooctyl sebacate. combustion process; total carbon black not

Dioctyl adipate. to exceed 50 percent by weight of rubber
Dioctyl sebacate. product; furnace combustion black content
363
§ 177.2600 21 CFR Ch. I (4–1–23 Edition)
not to exceed 10 percent by weight of rub- Iodoform.
ber products intended for use in contact p-Menthane hydroperoxide.
with milk or edible oils). a-(p-Nonylphenyl)-omega-hydroxypoly (oxy-
Cork. ethylene) mixture of dihydrogen phosphate
Cotton (floc, fibers, fabric). and monohydrogen phosphate esters, bar-
Mica. ium salt; the nonyl group is a propylene
Nylon (floc, fibers, fabric). trimer isomer and the poly (oxyethylene)
Silica. content averages 9 moles; for use only as
Titanium dioxide. residual polymerization emulsifier at lev-
Zinc carbonate. els not to exceed 0.7 percent by weight of
Zinc sulfide. ethylene-propylene-1,4-hexadiene copoly-
(vi) Colorants. Colorants used in ac- mers identified under paragraph (c)(4)(i) of
this section.
cordance with § 178.3297 of this chapter. 4,4′-Oxybis (benzenesulfonhydrazide) as
(vii) Lubricants (total not to exceed 2 chemical blowing agent.
percent by weight of rubber product). Phenothiazine.
Polyethylene. Potassium persulfate.
Sodium stearate. Sodium formaldehyde sulfoxylate.
Sodium polysulfide.
(viii) Emulsifiers. Sodium nitrite.
Sodium salt of ethylenediamine tetraacetic
Fatty acid salts, sodium or potassium. acid and glycine.
Naphthalene sulfonic acid-formaldehyde con- Sodium sulfide.
densate, sodium salt. Styrene monomer.
Rosins and rosin-derivatives identified in Tall oil.
§ 175.105(c)(5) of this chapter. Thioxylenois as peptizing agents.
Sodium decylbenzenesulfonate Tridecyl mercaptan.
Sodium dodecylbenzenesulfonate Zinc 4-tert-butylthiophenate as peptizing
Sodium lauryl sulfate. agent.
Tall oil mixed soap (calcium, potassium, and
sodium). (d) Rubber articles intended for use
(ix) Miscellaneous (total not to exceed 5 with dry food are so formulated and
percent by weight of rubber product). cured under conditions of good manu-
facturing practice as to be suitable for
Animal glue as described in § 178.3120 of this repeated use.
chapter. (e) Rubber articles intended for re-
Azodicarbonamide as chemical blowing
peated use in contact with aqueous
agent.
2-Anthraquinone sulfonic acid sodium salt food shall meet the following specifica-
for use only as polymerization inhibitor in tions: The food-contact surface of the
chloroprene polymers and not to exceed rubber article in the finished form in
0.03 percent by weight of the chloroprene which it is to contact food, when ex-
polymers. tracted with distilled water at reflux
1,2-Benzisothiazolin-3-one (CAS Reg. No. temperature, shall yield total extrac-
2634–33–5) for use as a biocide in uncured tives not to exceed 20 milligrams per
liquid rubber latex not to exceed 0.02 per-
cent by weight of the latex solids, where
square inch during the first 7 hours of
the total of all items listed in paragraph extraction, nor to exceed 1 milligram
(c)(4)(ix) of this section does not exceed 5 per square inch during the succeeding 2
percent of the rubber product. hours of extraction.
n-Butyllithium for use only as polymeriza- (f) Rubber articles intended for re-
tion catalyst for polybutadiene. peated use in contact with fatty foods
4-tert-Butyl-o-thiocresol as peptizing agent. shall meet the following specifications:
tert-Butyl peracetate.
The food-contact surface of the rubber
p-tert-Butylpyrocatechol.
Dialkyl (C8–C18) dimethylammonium chlo- article in the finished form in which it
ride for use only as a flocculating agent in is to contact food, when extracted with
the manufacture of silica. n-hexane at reflux temperature, shall
Di- and triethanolamine. yield total extractives not to exceed
Diethyl xanthogen disulfide. 175 milligrams per square inch during
4-(Diiodomethylsulfonyl) toluene, Chemical the first 7 hours of extraction, nor to
Abstracts Service Registry No. 20018–09–01,
exceed 4 milligrams per square inch
for use as an antifungal preservative at
levels not to exceed 0.3 percent by weight during the succeeding 2 hours of ex-
of the sealants and caulking materials. traction.

Dodecyl mercaptan isomers, single or mixed. (g) In accordance with good manufac-
2-Ethoxyethanol. turing practice finished rubber articles
364
intended for repeated use in contact § 177.2800 Textiles and textile fibers.
with food shall be thoroughly cleansed
Textiles and textile fibers may safely
prior to their first use in contact with
food. be used as articles or components of ar-
(h) The provisions of this section are ticles intended for use in producing,
not applicable to rubber nursing-bottle manufacturing, packing, processing,
nipples. preparing, treating, packaging, trans-
(i) Acrylonitrile copolymers identi- porting, or holding food, subject to the
fied in this section shall comply with provisions of this section.
the provisions of § 180.22 of this chap- (a) The textiles and textile fibers are
ter. prepared from one or more of the fibers
[42 FR 14572, Mar. 15, 1977] identified in paragraph (d) of this sec-
tion and from certain other adjuvant
EDITORIAL NOTE: For FEDERAL REGISTER ci-
tations affecting § 177.2600, see the List of
substances required in the production
CFR Sections Affected, which appears in the of the textiles or textile fibers or added
Finding Aids section of the printed volume to impart desired properties.
and at www.govinfo.gov. (b) The quantity of any adjuvant sub-
stance employed in the production of
§ 177.2710 Styrene-divinylbenzene res- textiles or textile fibers does not ex-
ins, cross-linked.
ceed the amount reasonably required
Styrene-divinylbenzene cross-linked to accomplish the intended physical or
copolymer resins may be safely used as technical effect or any limitation fur-
articles or components of articles in- ther provided.
tended for repeated use in producing,
(c) Any substance employed in the
manufacturing, packing, processing,
production of textiles or textile fibers
preparing, treating, packaging, trans-
porting, or holding food, in accordance that is the subject of a regulation in
with the following prescribed condi- parts 174, 175, 176, 177, 178 and § 179.45 of
tions: this chapter conforms with any speci-
(a) The resins are produced by the co- fication in such regulation.
polymerization of styrene with (d) Substances employed in the pro-
divinylbenzene. duction of or added to textiles and tex-
(b) The resins meet the extractives tile fibers may include:
limitations prescribed in this para- (1) Substances generally recognized
graph: as safe in food.
(1) The resins to be tested are ground (2) Substances subject to prior sanc-
or cut into small particles that will tion or approval for use in textiles and
pass through a U.S. standard sieve No. textile fibers and used in accordance
3 and that will be held on a U.S. stand- with such sanction or approval.
ard sieve No. 20. (3) Substances generally recognized
(2) A 100-gram sample of the resins,
as safe for use in cotton and cotton fab-
when extracted with 100 milliliters of
rics used in dry-food packaging.
ethyl acetate at reflux temperature for
1 hour, yields total extractives not to (4) Substances that by regulation in
exceed 1 percent by weight of the res- this part may safely be used in the pro-
ins. duction of or as a component of tex-
(c) In accordance with good manufac- tiles or textile fibers and subject to
turing practice, finished articles con- provisions of such regulation.
taining the resins shall be thoroughly (5) Substances identified in this para-
cleansed prior to their first use in con- graph (d)(5), subject to such limitations
tact with food. as are provided:
(i) Fibers:
Cotton.
Polyethylene terephthalate complying in composition with For use only in the manufacture of items for repeated use.
the provisions of § 177.1630(e)(4)(ii).
Rayon.
(ii) Adjuvant substances:
Aluminum stearate.
365
§ 177.2800 21 CFR Ch. I (4–1–23 Edition)
Borax .................................................................................... For use as preservative only.

Butyl-acetyl ricinoleate.
Colorants used in accordance with § 178.3297 of this chapter..
Di-tert-butyl hydroquinone.
Dimethylpolysiloxane.
Ethylenediaminetetraacetic acid, sodium salt.
4-Ethyl-4-hexadecyl morpholinium ethyl sulfate .......................... For use only as a lubricant in the manufacture of polyethylene
terephthalate fibers specified in paragraph (d)(5)(i) of this
section at a level not to exceed 0.03 percent by weight of
the finished fibers.
Eugenol.
Fats, oils, fatty acids, and fatty alcohols derived from castor,
coconut, cottonseed, fish, mustardseed, palm, peanut,
rapeseed, ricebran, soybean, sperm, and tall oils and tallow.
Fats, oils, fatty acids, and fatty alcohols described in the pre-
ceding item reacted with one or more of the following sub-
stances:
n-Butyl and isobutyl alcohol.
Diethylene glycol.
Diethanolamine.
Glycerol.
Hexylene glycol (2-methyl-2,4-pentanediol).
Hydrogen.
Isopropyl alcohol.
Methyl alcohol.
Oxygen.
Polyethylene glycol (molecular weight 400–3,000).
Potassium hydroxide.
Propylene glycol.
Sodium hydroxide.
Sulfuric acid.
Formaldehyde .............................................................................. For use as preservative only.
Glyceryl mono-12-hydroxystearate.
2-(9-Heptadecenyl)-1-[2-(10-octadecenamido)ethyl-2-
imidazolinium ethyl sulfate.
Hexylene glycol (2-methyl,-2,4-pentanediol).
Isobutyl alcohol.
Isopropyl alcohol.
Kerosene.
Methyl ester of sulfated ricebran oil.
Mineral oil .................................................................................... For use only at a level not to exceed 0.15 percent by weight of
finished fibers.
Mono- and diisopropylated m- and p-cresols (isothymol deriva-
tive).
N-Oleyl, N′-acetyl, N′-b-hydroxy-ethylenediamine.
Petrolatum.
Petroleum sulfonate.
Pine oil.
Polybutene, hydrogenated; complying with the identity pre-
scribed under 21 CFR 178.3740(b) of this chapter.
Polyethylene, oxidized (air blown).
Polyvinyl acetate.
Polyvinyl alcohol.
Potassium soap of a saponified sulfated castor oil.
Sodium bis(2,6-dimethylheptyl-4) sulfosuccinate.
Sodium dodecyl benzenesulfonate.
Sodium fluoride ............................................................................ For use as preservative only.
Sodium hydrosulfite.
Sodium 2-mercaptobenzothiazole ............................................... Do.
Sodium pentachlorophenate ........................................................ Do.
Styrene-butadiene copolymer.
Sulfated butyl, isobutyl and propyl oleate.
Tallow.
Tallow, sulfonated.
Titanium dioxide.
Triethanolamine.
Ultramarine blue.
Waxes, petroleum.
Zinc hydrosulfite.
366
(e) Textile and textile fibers are used practice so as to prevent potential mi-
as articles or components of articles crobial adulteration of the food.
that contact dry food only. (e) Ultrafiltration membranes identi-
(f) The provisions of this section are fied in paragraph (a)(4) may be used to
not applicable to jute fibers used as filter aqueous or acidic foods con-
prescribed by § 178.3620(d)(2) of this taining up to 13 percent of alcohol at
chapter. temperatures not to exceed 21 °C (70
°F).
[42 FR 14572, Mar. 15, 1977, as amended at 46 (f) To assure safe use of the ultra-fil-
FR 37042, July 17, 1981; 49 FR 4372, Feb. 6,
1984; 49 FR 5748, Feb. 15, 1984; 56 FR 42933,
tration membranes, the label or label-
Aug. 30, 1991] ing shall include adequate directions
for a pre-use treatment, consisting of
§ 177.2910 Ultra-filtration membranes. conditioning and washing with a min-
imum of 8 gallons of potable water
Ultra-filtration membranes identi- prior to their first use in contact with
fied in paragraphs (a)(1), (a)(2), (a)(3), food.
and (a)(4) of this section may be safely (g) Acrylonitrile copolymers identi-
used in the processing of food, under fied in this section shall comply with
the following prescribed conditions; the provisions of § 180.22 of this chap-
(a)(1) Ultra-filtration membranes ter.
that consist of paper impregnated with
cured phenol-formaldehyde resin, [42 FR 14572, Mar. 15, 1977, as amended at 53
which is used as a support and is coat- FR 17925, May 19, 1988; 58 FR 48599, Sept. 17,
1993; 60 FR 54426, Oct. 24, 1995]
ed with a vinyl chloride-acrylonitrile
copolymer.
(2) Ultra-filtration membranes that PART 178—INDIRECT FOOD ADDI-
consist of a sintered carbon support TIVES: ADJUVANTS, PRODUCTION
that is coated with zirconium oxide AIDS, AND SANITIZERS
(CAS Reg. No. 1314–23–4) containing up
to 12 percent yttrium oxide (CAS Reg. Subpart A [Reserved]
No. 1314–36–9).
Subpart B—Substances Utilized To Control
(3) Ultra-filtration membranes that
the Growth of Microorganisms
consist of an aluminum oxide support
that is coated with zirconium oxide Sec.
(CAS Reg. No. 1314–23–4) containing up 178.1005 Hydrogen peroxide solution.
to 5 percent yttrium oxide (CAS Reg. 178.1010 Sanitizing solutions.
No. 1314–36–9).
Subpart C—Antioxidants and Stabilizers
(4) Ultrafiltration membranes that
consist of a microporous 178.2010 Antioxidants and/or stabilizers for
poly(vinylidene fluoride) membrane polymers.
with a hydrophilic surface modifier 178.2550 4-Hydroxymethyl-2,6-di-tert-butyl-
consisting of hydroxypropyl acrylate/ phenol.
178.2650 Organotin stabilizers in vinyl chlo-
tetraethylene glycol diacrylate copoly-
ride plastics.
mer.
(b) Any substance employed in the Subpart D—Certain Adjuvants and
production of ultra-filtration mem- Production Aids
branes that is the subject of a regula-
tion in parts 174, 175, 176, 177, 178 and 178.3010 Adjuvant substances used in the
manufacture of foamed plastics.
§ 179.45 of this chapter conforms with
178.3120 Animal glue.
the specifications of such regulation. 178.3125 Anticorrosive agents.
(c) Ultra-filtration membranes are 178.3130 Antistatic and/or antifogging
used in the physical separation of dis- agents in food-packaging materials.
solved or colloidally suspended varying 178.3280 Castor oil, hydrogenated.
molecular size components of liquids 178.3290 Chromic chloride complexes.
during the commercial processing of 178.3295 Clarifying agents for polymers.
178.3297 Colorants for polymers.
bulk quantities of food. 178.3300 Corrosion inhibitors used for steel
(d) Ultra-filtration membranes shall or tinplate.

be maintained in a sanitary manner in 178.3400 Emulsifiers and/or surface-active
accordance with good manufacturing agents.
367
§ 178.1005 21 CFR Ch. I (4–1–23 Edition)
178.3450 Esters of stearic and palmitic acids. Subpart B—Substances Utilized To
178.3480 Fatty alcohols, synthetic.
178.3500 Glycerin, synthetic.
Control the Growth of Micro-
178.3505 Glyceryl tri-(12-acetoxystearate). organisms
178.3520 Industrial starch-modified.
§ 178.1005 Hydrogen peroxide solution.
178.3530 Isoparaffinic petroleum hydro-
carbons, synthetic. Hydrogen peroxide solution identi-
178.3570 Lubricants with incidental food fied in this section may be safely used
contact. to sterilize polymeric food-contact sur-
178.3600 Methyl glucoside-coconut oil ester. faces identified in paragraph (e)(1) of
178.3610 a-Methylstyrene-vinyltoluene res- this section.
ins, hydrogenated. (a) Identity. For the purpose of this
178.3620 Mineral oil. section, hydrogen peroxide solution is
178.3650 Odorless light petroleum hydro- an aqueous solution containing not
carbons.
more than 35 percent hydrogen per-
178.3690 Pentaerythritol adipate-stearate.
oxide (CAS Reg. No. 7722–84–1) by
178.3700 Petrolatum.
weight, meeting the specifications pre-
178.3710 Petroleum wax.
scribed in paragraph (c) of this section.
178.3720 Petroleum wax, synthetic.
178.3725 Pigment dispersants. (b) Optional adjuvant substances. Hy-
178.3730 Piperonyl butoxide and pyrethrins drogen peroxide solution identified in
as components of bags. paragraph (a) of this section may con-
178.3740 Plasticizers in polymeric sub- tain substances generally recognized as
stances. safe in or on food, substances generally
178.3750 Polyethylene glycol (mean molec- recognized for their intended use in
ular weight 200–9,500). food packaging, substances used in ac-
178.3760 Polyethylene glycol (400) cordance with a prior sanction or ap-
monolaurate. proval, and substances permitted by
178.3770 Polyhydric alcohol esters of applicable regulations in parts 174
oxidatively refined (Gersthofen process) through 179 of this chapter.
montan wax acids. (c) Specifications. Hydrogen peroxide
178.3780 Polyhydric alcohol esters of long solution shall meet the specifications
chain monobasic acids. of the Food Chemicals Codex, 7th ed.
178.3790 Polymer modifiers in semirigid and (2010), pp. 496–497, which is incorporated
rigid vinyl chloride plastics.
by reference. Hydrogen peroxide solu-
178.3800 Preservatives for wood.
tion shall also meet the specifications
178.3850 Reinforced wax.
for ‘‘Acidity,’’ ‘‘Chloride,’’ and ‘‘Other
178.3860 Release agents.
requirements’’ for Hydrogen Peroxide
178.3870 Rosins and rosin derivatives.
Concentrate in the United States Phar-
178.3900 Sodium pentachlorophenate.
macopeia 36th Revision (2013), pp. 3848–
178.3910 Surface lubricants used in the man-
ufacture of metallic articles.
3849, which is incorporated by ref-
178.3930 Terpene resins. erence. The Director of the Office of
178.3940 Tetraethylene glycol di-(2-ethyl- the Federal Register approves this in-
hexoate). corporation by reference in accordance
178.3950 Tetrahydrofuran. with 5 U.S.C. 552(a) and 1 CFR part 51.
You may obtain copies from the United
AUTHORITY: 21 U.S.C. 321, 342, 348, 379e. States Pharmacopeial Convention,
SOURCE: 42 FR 14609, Mar. 15, 1977, unless 12601 Twinbrook Pkwy., Rockville, MD
otherwise noted. 20852 (Internet address http://
www.usp.org). Copies may be examined
EDITORIAL NOTE: Nomenclature changes to
at the Food and Drug Administration’s
FR 56035, Nov. 6, 2001; 66 FR 66742, Dec. 27, Main Library, 10903 New Hampshire
2001; 68 FR 15355, Mar. 31, 2003; 70 FR 72074, Ave., Bldg. 2, Third Floor, Silver
Dec. 1, 2005; and 81 FR 49896, July 29, 2016. Spring, MD 20993, 301–796–2039, or at the
Subpart A [Reserved] the availability of this material at
NARA, call 202–741–6030 or go to: http://

locations.html.
368
(d) Limitations. No use of hydrogen 108, 110, 113, and 114 of this chapter as
peroxide solution in the sterilization of applicable.
food packaging material shall be con-
[46 FR 2342, Jan. 9, 1981, as amended at 49 FR
sidered to be in compliance if more 10111, Mar. 19, 1984; 49 FR 32345, Aug. 14, 1984;
than 0.5 part per million of hydrogen 49 FR 37747, Sept. 26, 1984; 51 FR 45881, Dec.
peroxide can be determined in distilled 23, 1986; 52 FR 26146, July 13, 1987; 53 FR 47186,
water packaged under production con- Nov. 22, 1988; 54 FR 5604, Feb. 6, 1989; 54 FR
ditions (assay to be performed imme- 13167, Mar. 31, 1989; 54 FR 6365 Feb. 9, 1989; 55
diately after packaging). FR 47055, Nov. 9, 1990; 57 FR 32423, July 22,
(e) Conditions of use. (1) Hydrogen per- 1992; 78 FR 71467, Nov. 29, 2013]
oxide solution identified in and com-
plying with the specifications in this § 178.1010 Sanitizing solutions.
section may be used by itself or in Sanitizing solutions may be safely
combination with other processes to used on food-processing equipment and
treat food-contact surfaces to attain utensils, and on other food-contact ar-
commercial sterility at least equiva- ticles as specified in this section, with-
lent to that attainable by thermal in the following prescribed conditions:
processing for metal containers as pro- (a) Such sanitizing solutions are
vided for in part 113 of this chapter. used, followed by adequate draining,
Food-contact surfaces include the fol- before contact with food.
lowing: (b) The solutions consist of one of the
Substances Limitations following, to which may be added com-
ponents generally recognized as safe
Ethylene-acrylic acid Complying with § 177.1310 of this and components which are permitted
copolymers. chapter.
Ethylene-carbon mon- Complying with § 177.1312 of this by prior sanction or approval.
oxide copolymers. chapter. (1) An aqueous solution containing
Ethylene-methyl acry- Complying with § 177.1340 of this potassium, sodium, or calcium hypo-
late copolymer resins. chapter.
Ethylene-vinyl acetate Complying with § 177.1350 of this chlorite, with or without the bromides
copolymers. chapter. of potassium, sodium, or calcium.
Ionomeric resins ........... Complying with § 177.1330 of this (2) An aqueous solution containing
chapter.
Isobutylene polymers ... Complying with § 177.1420 (a)(1) dichloroisocyanuric acid,
and (a)(2) of this chapter. trichloroisocyanuric acid, or the so-
Olefin polymers ............ Complying with § 177.1520 of this dium or potassium salts of these acids,
chapter.
Polycarbonate resins ... Complying with § 177.1580 of this
with or without the bromides of potas-
chapter. sium, sodium, or calcium.
Polyethylene- Complying with § 177.1630 of this (3) An aqueous solution containing
terephthalate poly- chapter (excluding polymers de-
mers. scribed in § 177.1630(c)) of this
potassium iodide, sodium p-
chapter. toluenesulfonchloroamide, and sodium
Poly-l-butene resins Complying with § 177.1570 of this lauryl sulfate.
and butene/ethylene chapter.
copolymers.
(4) An aqueous solution containing
Polystryrene and rub- Complying with § 177.1640 of this iodine, butoxy monoether of mixed
ber-modified poly- chapter. (ethylene-propylene) polyalkylene gly-
styrene polymers. col having a cloudpoint of 90°–100 °C in
Vinylidene chloride/ Complying with § 177.1990 of this
methyl acrylate co- chapter.
0.5 percent aqueous solution and an av-
polymers. erage molecular weight of 3,300, and
ethylene glycol monobutyl ether. Addi-
(2) The packaging materials identi- tionally, the aqueous solution may
fied in paragraph (e)(1) of this section contain diethylene glycol monoethyl
may be used for packaging all commer- ether as an optional ingredient.
cially sterile foods except that the (5) An aqueous solution containing
olefin polymers may be used in articles elemental iodine, hydriodic acid, a-(p-
for packaging foods only of the types nonylphenyl)-omega-hydroxypoly-(oxy-
identified in § 176.170(c) of this chapter, ethylene) (complying with the identity
table 1, under Categories I, II, III, IV-B, prescribed in § 178.3400(c) and having a
V, and VI. maximum average molecular weight of
(3) Processed foods packaged in the 748) and/or polyoxyethylene-

materials identified in paragraph (e)(1) polyoxypropylene block polymers (hav-
of this section shall conform with parts ing a minimum average molecular
369
§ 178.1010 21 CFR Ch. I (4–1–23 Edition)
weight of 1,900). Additionally, the aque- n-alkyl (C12-C18) dimethyl ethylbenzyl

ous solution may contain isopropyl al- ammonium chloride (having an average
cohol as an optional ingredient. molecular weight of 384). In addition to
(6) An aqueous solution containing use on food-processing equipment and
elemental iodine, sodium iodide, so- utensils, this solution may be used on
dium dioctylsulfosuccinate, and food-contact surfaces in public eating
polyoxyethylene-polyoxypropylene places.
block polymers (having a minimum av- (12) An aqueous solution containing
erage molecular weight of 1,900). the sodium salt of sulfonated oleic
(7) An aqueous solution containing acid, polyoxyethylene-
dodecylbenzenesulfonic acid and either polyoxypropylene block polymers (hav-
isopropyl alcohol or polyoxyethylene- ing an average molecular weight of
polyoxypropylene block polymers (hav- 2,000 and 27 to 31 moles of
ing a minimum average molecular polyoxypropylene). In addition to use
weight of 2,800). In addition to use on on food-processing equipment and
food-processing equipment and uten- utensils, this solution may be used on
sils, this solution may be used on glass glass bottles and other glass containers
bottles and other glass containers in- intended for holding milk. All equip-
tended for holding milk. ment, utensils, glass bottles, and other
(8) An aqueous solution containing glass containers treated with this sani-
elemental iodine, butoxy monoether of tizing solution shall have a drainage
mixed (ethylene-propylene) period of 15 minutes prior to use in
polyalkylene glycol having a minimum contact with food.
average molecular weight of 2,400 and (13) An aqueous solution containing
a-lauroyl-omega-hydroxypoly (oxy- elemental iodine and alkyl (C12-C15)
ethylene) with an average 8–9 moles of monoether of mixed (ethylene-pro-
ethylene oxide and an average molec- pylene) polyalkylene glycol, having a
ular weight of 400. In addition to use on cloud-point of 70°–77 °C in 1 percent
food-processing equipment and uten- aqueous solution and an average mo-
sils, this solution may be used on bev- lecular weight of 807.
erage containers, including milk con- (14) An aqueous solution containing
tainers or equipment. Rinse water iodine, butoxy monoether of mixed
treated with this solution can be recir- (ethylene-propylene) polyalkylene gly-
culated as a preliminary rinse. It is not col, having a cloud-point of 90°–100 °C
to be used as final rinse. in 0.5 percent aqueous solution and an
(9) An aqueous solution containing n- average molecular weight of 3,300, and
alkyl (C12-C18) benzyldimethylam- polyoxyethylene-polyoxypropylene
monium chloride compounds having block polymers (having a minimum av-
average molecular weights of 351 to 380. erage molecular weight of 2,000).
The alkyl groups consist principally of (15) An aqueous solution containing
groups with 12 to 16 carbon atoms and lithium hypochlorite.
contain not more than 1 percent each (16) An aqueous solution containing
of groups with 8 and 10 carbon atoms. equal amounts of n-alkyl (C12-C18) ben-
Additionally, the aqueous solution may zyl dimethyl ammonium chloride and
contain either ethyl alcohol or iso- n-alkyl (C12-C14) dimethyl ethylbenzyl
propyl alcohol as an optional ingre- ammonium chloride (having average
dient. molecular weights of 377 to 384), with
(10) An aqueous solution containing the optional adjuvant substances
trichloromelamine and either sodium tetrasodium ethylenediaminetetra-
lauryl sulfate or dodecyl- acetate and/or alpha-(p-nonylphenol)-
benzenesulfonic acid. In addition to use omega-hydroxy poly (oxyethylene) hav-
on food-processing equipment and ing an average poly- (oxyethylene) con-
utensils and other food-contact arti- tent of 11 moles. Alpha-hydro-omega-
cles, this solution may be used on bev- hydroxypoly-(oxyethylene)
erage containers except milk con- poly(oxypropoylene) (15 to 18 mole
tainers or equipment. minimum) poly (oxyethylene) block co-
(11) An aqueous solution containing polymer, having a minimum molecular

equal amounts of n-alkyl (C12-C18) ben- weight of 1,900 (CAS Registry No. 9003–
zyl dimethyl ammonium chloride and 11–6) may be used in lieu of alpha- (p-
370
nonylphenol)-omega-hydroxy- The ratio of compound (1) to compound

poly(oxyethylene) having an average (2) is 60 to 40.
poly(oxyethylene) content of 11 moles. (23) An aqueous solution containing
In addition to use on food-processing n-alkyl (C12-C16) benzyl-
equipment and utensils, this solution dimethylammonium chloride and
may be used on food-contact surfaces didecyldimethylammonium chloride.
in public eating places. (24) An aqueous solution containing
(17) An aqueous solution containing elemental iodine (CAS Reg. No. 7553–56–
di-n-alkyl(C8-C10)dimethyl ammonium 2), alpha-[p-(1,1,3,3-tetramethylbutyl)-
chlorides having average molecular phenyl]-omega-hydroxypoly-(oxy-
weights of 332–361 and either ethyl al- ethylene) produced with one mole of
cohol or isopropyl alcohol. In addition the phenol and 4 to 14 moles ethylene
to use on food-processing equipment oxide, and alpha-alkyl(C12-C15)-omega-
and utensils, this solution may be used hydroxy[poly(oxyethylene)
on food-contact surfaces in public eat- poly(oxypropylene)] (having an average
ing places. molecular weight of 965).
(18) An aqueous solution containing (25) An aqueous solution containing
n-alkyl(C12-C18) benzyldimethylammo- elemental iodine (CAS Reg. No. 7553–56–
nium chloride, sodium metaborate, 2), potassium iodide (CAS Reg. No.
alpha-terpineol and alpha[p-(1,1,3,3- 7681–11–0), and isopropanol (CAS Reg.
tetramethylbutyl)phenyl] -omega-hy- No. 67–63–0). In addition to use on food
droxy-poly (oxyethylene) produced processing equipment and utensils, this
with one mole of the phenol and 4 to 14 solution may be used on beverage con-
moles ethylene oxide. tainers, including milk containers and
(19) An aqueous solution containing equipment and on food-contact sur-
sodium dichloroisocyanurate and faces in public eating places.
tetrasodium ethylenediaminetetra- (26) [Reserved]
acetate. In addition to use on food- (27) An aqueous solution containing
processing equipment and utensils, this decanoic acid (CAS Reg. No. 334–48–5),
solution may be used on food-contact octanoic acid (CAS Reg. No. 124–07–2),
surfaces in public eating places. and sodium 1-octanesulfonate (CAS
(20) An aqueous solution containing Reg. No. 5324–84–5). Additionally, the
ortho-phenylphenol, ortho-benzyl-para- aqueous solution may contain iso-
chlorophenol, para- propyl alcohol (CAS Reg. No. 67–63–0)
tertiaryamylphenol, sodium -alpha- as an optional ingredient.
alkyl(C12-C15)-omega-hydroxypoly (oxy- (28) An aqueous solution containing
ethylene) sulfate with the sulfonated 9-octadecenoic acid (CAS
poly(oxyethylene) content averaging Reg. No. 68988–76–1) and sodium
one mole, potassium salts of coconut xylenesulfonate (CAS Reg. No. 1300–72–
oil fatty acids, and isopropyl alcohol or 7).
hexylene glycol. (29) An aqueous solution containing
(21) An aqueous solution containing dodecyldiphenyloxidedisulfonic acid
sodium dodecylbenzenesulfonate. In ad- (CAS Reg. No. 30260–73–2), sulfonated
dition to use on food-processing equip- tall oil fatty acid (CAS Reg. No. 68309–
ment and utensils, this solution may 27–3), and neo-decanoic acid (CAS Reg.
be used on glass bottles and other glass No. 26896–20–8). In addition to use on
containers intended for holding milk. food-processing equipment and uten-
(22) An aqueous solution containing sils, this solution may be used on glass
(1) di-n-alkyl(C8-C10) bottles and other glass containers in-
dimethylammonium chloride com- tended for holding milk.
pounds having average molecular (30) An aqueous solution containing
weights of 332–361, (2) n-alkyl (C12-C18) hydrogen peroxide (CAS Reg. No. 7722–
benzyldimethylammonium chloride 84–1), peracetic acid (CAS Reg. No. 79–
compounds having average molecular 21–0), acetic acid (CAS Reg. No. 64–19–
weights of 351–380 and consisting prin- 7), and 1-hydroxyethylidene-1,1-
cipally of alkyl groups with 12 to 16 diphosphonic acid (CAS Reg. No. 2809–
carbon atoms with or without not over 21–4).

1 percent each of groups with 8 and 10 (31) An aqueous solution containing
carbon atoms, and (3) ethyl alcohol. elemental iodine, alpha-alkyl(C10-C14)-
371
§ 178.1010 21 CFR Ch. I (4–1–23 Edition)
omega-hydroxypoly(oxyethylene)poly- of oxychloro species (predominantly

(oxypropylene) of average molecular chlorite and chlorate) followed by dilu-
weight between 768 and 837, and alpha- tion with potable water to provide the
alkyl(C12-C18)-omega- concentration of available chlorine di-
hydroxypoly(oxyethylene) oxide described in paragraph (c)(29) of
poly(oxypropylene) of average molec- this section.
ular weight between 950 and 1,120. In (35) An aqueous solution containing
addition to use on food-processing decanoic acid (CAS Reg. No. 334–48–5),
equipment and utensils, this solution octanoic acid (CAS Reg. No. 124–07–2),
may be used on food-contact surfaces lactic acid (CAS Reg. No. 050–21–5),
in public eating places. phosphoric acid (CAS Reg. No. 7664–38–
(32) An aqueous solution containing 2) and a mixture of the sodium salt of
(i) di-n-alkyl(C8-C10)dimethyl- ammo- naphthalenesulfonic acid (CAS Reg.
nium chloride compounds having aver- No. 1321–69–3); the methyl, dimethyl,
age molecular weights of 332 to 361, (ii) and trimethyl dervatives of the sodium
n-alkyl(C12-C18)benzyldimethylammo- salt of naphthalenesulfonic acid; and a
nium chloride compounds having aver- mixture of the sodium salt of
age molecular weights of 351 to 380 and naphthalenesulfonic acid, and the
consisting principally of alkyl groups methyl, dimethyl, and trimethyl de-
with 12 to 16 carbon atoms with no rivatives of the sodium salt of
more than 1 percent of groups with 8 naphthalenesulfonic acid alkylated at 3
and 10, (iii) ethyl alcohol, and (iv) percent by weight with C6-C9 linear
alpha-(p-nonylphenyl)-omega- olefins, as components of a sanitizing
hydroxypoly(oxyethylene) produced by solution to be used on food-processing
the condensation of 1 mole of p- equipment and utensils. The methyl
nonylphenol with 9 to 12 moles of and dimethyl substituted derivatives
ethylene oxide. The ratio of compound (described within this paragraph
(i) to compound (ii) is 3 to 2. (b)(35)) constitute no less than 70 per-
(33) An aqueous solution containing cent by weight of the mixture of
(i) di-n-alkyl-(C8-C10)- naphthalenesulfonates.
dimethylammonium chloride com- (36) The sanitizing solution contains
pounds having average molecular decanoic acid (CAS Reg. No. 334–48–5);
weights of 332 to 361; (ii) n-alkyl(C12- octanoic acid (CAS Reg. No. 124–07–2);
C18) -benzyldimethylammonium chlo- lactic acid (CAS Reg. No. 050–21–5);
ride compounds having molecular phosphoric acid (CAS Reg. No. 7664–38–
weights of 351 to 380 and consisting 2); a mixture of 1-octanesulfonic acid
principally of alkyl groups with 12 to 16 (CAS Reg. No. 3944–72–7), and 1-
carbon atoms with no more than 1 per- octanesulfonic-2-sulfinic acid (CAS
cent of the groups with 8 to 10; and (iii) Reg. No. 113652–56–5) or 1,2-
tetrasodium ethylenediamine octanedisulfonic acid (CAS Reg. No.
tetraacetate. Additionally, the aqueous 113669–58–2); the condensate of four
solution contains either alpha-(p- moles of
nonylphenyl)-omega-hydroxypoly-(oxy- poly(oxyethylene)poly(oxypropylene)
ethylene) or alpha-alkyl(C11-C15)-omega- block copolymers with one mole of
hydroxypoly-(oxyethylene), each pro- ethylenediamine (CAS Reg. No. 11111–
duced with 9 to 13 moles of ethylene 34–5); and the optional ingredient
oxide. The ratio of compound (i) to FD&C Yellow No. 5 (CAS Reg. No.
compound (ii) is 3 to 2. 001934210). In addition to use on food-
(34) An aqueous solution of an equi- processing equipment and utensils, this
librium mixture of oxychloro species solution may be used on dairy-proc-
(predominantly chlorite, chlorate, and essing equipment.
chlorine dioxide) generated either (i) (37) The sanitizing solution contains
by directly metering a concentrated sodium hypochlorite (CAS Reg. No.
chlorine dioxide solution, prepared just 7681–52–9), trisodium phosphate (CAS
prior to use, into potable water to pro- Reg. No. 7601–54–9), sodium lauryl sul-
vide the concentration of available fate (CAS Reg. No. 151–21–3), and potas-
chlorine dioxide stated in paragraph sium permanganate (CAS Reg. No.

(c)(29) of this section, or (ii) by acidifi- 7722–64–7). Magnesium oxide (CAS Reg.
cation of an aqueous alkaline solution No. 1309–48–4) and potassium bromide
372
(CAS Reg. No. 7758–02–3) may be added dextrin, or both starch and dextrin
as optional ingredients to this sani- (CAS Reg. No. 9004–53–9); and the op-
tizing solution. In addition to use on tional ingredient methylene blue (CAS
food-processing equipment and uten- Reg. No. 61–73–4). In addition to use on
sils, this solution may be used on food- food-processing equipment and uten-
contact surfaces in public eating sils, this solution may be used on food-
places. contact surfaces in public eating
(38) An aqueous solution containing places.
hydrogen peroxide (CAS Reg. No. 7722– (42) An aqueous solution containing
84–1); peroxyacetic acid (CAS Reg. No. decanoic acid (CAS Reg. No. 334–48–5),
79–21–0); acetic acid (CAS Reg. No. 64– nonanoic acid (CAS Reg. No. 112–05–0),
19–7); sulfuric acid (CAS Reg. No. 7664– phosphoric acid (CAS Reg. No. 7664–38–
93–9); and 2,6-pyridinedicarboxylic acid 2), propionic acid (CAS Reg No. 79–09–
(CAS Reg. No. 499–83–2). In addition to 04), and sodium 1-octanesulfonate (CAS
use on food-processing equipment and Reg. No. 5324–84–5). Sulfuric acid (CAS
utensils, this solution may be used on Reg. No. 7664–93–9) may be added as an
dairy-processing equipment. optional ingredient. In addition to use
(39) An aqueous solution containing on food-processing equipment and
phosphoric acid (CAS Reg. No. 7664–38– utensils, this solution may be used on
2); octenyl succinic acid (CAS Reg. No. dairy-processing equipment.
28805–58–5); N,N-dimethyloctanamine (43) An aqueous solution of iodine
(CAS Reg. No. 7378–99–6); and a mixture and hypochlorous acid generated by
of n-carboxylic acids (C6-C12, consisting the dilution of an aqueous acidic (21.5
of not less than 56 percent octanoic percent nitric acid) solution of iodine
acid and not less than 40 percent deca- monochloride. In addition to use on
noic acid). This solution may be used food-processing equipment and uten-
on food-processing equipment and
sils, this solution may be used on
utensils, including dairy-processing
dairy-processing equipment.
equipment.
(44) An aqueous solution of citric
(40) An aqueous solution prepared by
combining elemental iodine (CAS Reg. acid, disodium ethylenediaminetetra-
No. 7553–56–2); hydriodic acid (CAS Reg. acetate, sodium lauryl sulfate, and
No. 10034–85–2); sodium N-cyclohexyl-N- monosodium phosphate. In addition to
palmitoyl taurate (CAS Reg. No. 132– use on food-processing equipment and
43–4); chloroacetic acid, sodium salt re- utensils, this solution may be used on
action products with 4,5-dihydro-2- dairy-processing equipment.
undecyl-1H-imidazole-1-ethanol and so- (45) An aqueous solution of hydrogen
dium hydroxide (CAS Reg. No. 68608–66– peroxide, acetic acid, peroxyacetic
2); dodecylbenzene sulfonic acid (CAS acid, octanoic acid, peroxyoctanoic
Reg. No. 27176–87–0); phosphoric acid acid, sodium 1-octanesulfonate, and 1-
(CAS Reg. No. 7664–38–2); isopropyl al- hydroxyethylidene-1,1-diphosphonic
cohol (CAS Reg. No. 67–63–0); and cal- acid. In addition to use on food-proc-
cium chloride (CAS Reg. No. 10043–52– essing equipment and utensils, this so-
4). In addition to use on food-proc- lution may be used on food-contact
essing equipment and utensils, this so- surfaces in public eating places, sub-
lution may be used on dairy-processing ject to the limitations in paragraph
equipment. (c)(39) of this section.
(41) An aqueous solution containing (46) An aqueous solution of chlorine
n-alkyl(C12- dioxide and related oxychloro species
C16)benzyldimethylammonium chlo- generated by acidification of an aque-
ride, having average molecular weights ous solution of sodium chlorite with a
ranging from 351 to 380 wherein the solution of sodium gluconate, citric
alkyl groups contain principally 12 to acid, phosphoric acid, and sodium
16 carbons and not more than 1 percent mono- and
each of the groups with 8 and 10 carbon didodecylphenoxybenzenedisulfonate.
atoms; ammonium chloride (CAS Reg. In addition to use on food-processing
No. 12125–02–9); calcium stearate (CAS equipment and utensils, this solution
Reg. No. 1592–23–0); sodium bicarbonate may be used on dairy-processing equip-
(CAS Reg. No. 144–55–8); starch or ment.
373
§ 178.1010 21 CFR Ch. I (4–1–23 Edition)
(c) The solutions identified in para- parts per million of active quaternary
graph (b) of this section will not exceed compound.
the following concentrations: (9) The solution identified in para-
(1) Solutions identified in paragraph graph (b)(12) of this section shall pro-
(b)(1) of this section will provide not vide not more than 200 parts per mil-
more than 200 parts per million of lion of sulfonated oleic acid, sodium
available halogen determined as avail- salt.
able chlorine. (10) Solutions identified in paragraph
(2) Solutions identified in paragraph (b)(15) of this section will provide not
(b)(2) of this section will provide not more than 200 parts per million of
more than 100 parts per million of available chlorine and not more than 30
available halogen determined as avail- ppm lithium.
able chlorine. (11) Solutions identified in paragraph
(3) Solution identified in paragraph (b)(16) of this section shall provide not
(b)(3) of this section will provide not more than 200 parts per million of ac-
more than 25 parts per million of ti- tive quaternary compound.
tratable iodine. The solutions will con- (12) Solutions identified in paragraph
tain the components potassium iodide, (b)(17) of this section shall provide,
sodium p-toluenesulfonchloramide and when ready to use, a level of 150 parts
sodium lauryl sulfate at a level not in per million of the active quaternary
excess of the minimum required to compound.
produce their intended functional ef- (13) Solutions identified in paragraph
fect. (b)(18) of this section shall provide not
(4) Solutions identified in paragraph more than 200 parts per million of ac-
(b)(4), (5), (6), (8), (13), and (14) of this tive quaternary compound and not
section will contain iodine to provide more than 66 parts per million of
not more than 25 parts per million of alpha[p-(1,1,3,3-tetramethylbutyl)
titratable iodine. The adjuvants used phenyl]-omega-hydroxypoly (oxy-
with the iodine will not be in excess of ethylene).
the minimum amounts required to ac- (14) Solutions identified in paragraph
complish the intended technical effect. (b)(19) of this section shall provide,
(5) Solutions identified in paragraph when ready to use, a level of 100 parts
(b)(7) of this section will provide not per million of available chlorine.
more than 400 parts per million (15) Solutions identified in paragraph
dodecylbenzenesulfonic acid and not (b)(20) of this section are for single use
more than 80 parts per million of applications only and shall provide,
polyoxyethylene-polyoxypropylene when ready to use, a level of 800 parts
block polymers (having a minimum av- per million of total active phenols con-
erage molecular weight of 2,800) or not sisting of 400 parts per million ortho-
more than 40 parts per million of iso- phenylphenol, 320 parts per million
propyl alcohol. ortho-benzyl-para-chlorophenol and 80
(6) Solutions identified in paragraph parts per million para-
(b)(9) of this section shall provide when tertiaryamylphenol.
ready to use no more than 200 parts per (16) Solution identified in paragraph
million of the active quaternary com- (b)(21) of this section shall provide not
pound. more than 430 parts per million and not
(7) Solutions identified in paragraph less than 25 parts per million of sodium
(b)(10) of this section shall provide not dodecylbenzenesulfonate.
more than sufficient (17) Solutions identified in paragraph
trichloromelamine to produce 200 parts (b)(22) of this section shall provide,
per million of available chlorine and ei- when ready to use, at least 150 parts
ther sodium lauryl sulfate at a level per million and not more than 400 parts
not in excess of the minimum required per million of active quaternary com-
to produce its intended functional ef- pound.
fect or not more than 400 parts per mil- (18) Solutions identified in paragraph
lion of dodecylbenzenesulfonic acid. (b)(23) of this section shall provide at
(8) Solutions identified in paragraph least 150 parts per million and not
(b)(11) of this section shall provide, more than 200 parts per million of the
when ready to use, not more than 200 active quaternary compound.
374
(19) Solutions identified in para- (27) Solutions identified in paragraph

graphs (b)(24), (b)(25), and (b)(43) of this (b)(32) of this section shall provide,
section shall provide at least 12.5 parts when ready to use, at least 150 parts
per million and not more than 25 parts per million and no more than 400 parts
per million of titratable iodine. The ad- per million of active quarternary com-
juvants used with the iodine shall not pounds in solutions containing no more
be in excess of the minimum amounts than 600 parts per million water hard-
required to accomplish the intended ness. The adjuvants used with the
technical effect. quarternary compounds will not exceed
(20)–(21) [Reserved] the amounts required to accomplish
(22) Solutions identified in paragraph the intended technical effect.
(b)(27) of this section shall provide, (28) Solutions identified in paragraph
when ready to use, at least 109 parts (b)(33) of this section shall provide,
per million and not more than 218 parts when ready to use, at least 150 parts
per million of total active fatty acids per million and not more than 400 parts
and at least 156 parts per million and per million of active quaternary com-
not more than 312 parts per million of pounds. The adjuvants used with the
the sodium 1-octanesulfonate. quaternary compounds shall not exceed
(23) Solutions identified in paragraph the amounts required to accomplish
(b)(28) of this section shall provide, the intended technical effect.
when ready to use, at least 156 parts Tetrasodium ethylenediamine
per million and not more than 312 parts tetraacetate shall be added at a min-
per million of sulfonated 9- imum level of 60 parts per million. Use
octadecenoic acid, at least 31 parts per of these sanitizing solutions shall be
million and not more then 62 parts per limited to conditions of water hardness
million of sodium xylenesulfonate. not in excess of 300 parts per million.
(24) Solutions identified in paragraph (29) Solutions identified in paragraph
(b)(29) of this section will provide at (b)(34) of this section should provide,
least 237 parts per million and not when ready to use, at least 100 parts
more than 474 parts per million per million and not more than 200 parts
dodecyldiphenyloxidedisulfonic acid, at per million available chlorine dioxide
least 33 parts per million and not more as determined by the method titled
than 66 parts per million sulfonated ‘‘Iodometric Method for the Deter-
tall oil fatty acid, and at least 87 parts mination of Available Chlorine Dioxide
per million and not more than 174 parts (50–250 ppm available ClO2),’’ which is
per million neo-decanoic acid. incorporated by reference. Copies are
(25) Solutions identified in paragraph available from the Center for Food
(b)(30) of this section shall provide, Safety and Applied Nutrition (HFS–
when ready to use, not less than 550 200), Food and Drug Administration,
parts per million and not more than 5001 Campus Dr., College Park, MD
1,100 parts per million hydrogen per- 20740, or available for inspection at the
oxide, not less than 100 parts per mil- National Archives and Records Admin-
lion and not more than 200 parts per istration (NARA). For information on
million peracetic acid, not less than 150 the availability of this material at
parts per million and not more than 300 NARA, call 202–741–6030, or go to: http://
parts per million acetic acid, and not www.archives.gov/federal_register/
less than 15 parts per million and not code_of_federal_regulations/
more than 30 parts per million 1- ibr_locations.html.
hydroxyethylidene-1,1-diphosphonic (30) Solutions identified in paragraph
acid. (b)(35) of this section shall provide,
(26) The solution identified in para- when ready for use, at least 117 parts
graph (b)(31) of this section shall proper million and not more than 234 parts
vide, when ready to use, at least 12.5 per million of total fatty acids and at
parts per million and not more than 25 least 166 parts per million and not
parts per million of titratable iodine. more than 332 parts per million of a
The adjuvants used with the iodine will mixture of naphthalenesulfonates. The
not be in excess of the minimum adjuvants phosphoric acid and lactic

amounts required to accomplish the in- acid, used with decanoic acid, octanoic
tended technical effect. acid, and sodium naphthalenesulfonate
375
§ 178.1010 21 CFR Ch. I (4–1–23 Edition)
and its alkylated derivatives, will not per million of sodium lauryl sulfate;
be in excess of the minimum amounts and at least 0.1 part per million and
required to accomplish the intended not more than 0.3 part per million of
technical effects. potassium permanganate.
(31) Solutions identified in paragraph (iii) Magnesium oxide when used in
(b)(36) of this section shall provide, paragraph (c)(32)(i) or (ii) of this sec-
when ready for use, at least 29 parts per tion shall not be used in excess of the
million and not more than 58 parts per minimum amount required to accom-
million decanoic acid; at least 88 parts plish its intended technical effect.
per million and not more than 176 parts (33) Solutions identified in paragraph
per million of octanoic acid; at least 69 (b)(38) of this section shall provide
parts per million and not more than 138 when ready for use not less than 300
parts per million of lactic acid; at least parts per million and not more than 465
256 parts per million and not more than parts per million of hydrogen peroxide;
512 parts per million of phosphoric not less than 200 parts per million and
acid; at least 86 parts per million and not more than 315 parts per million of
not more than 172 parts per million of peroxyacetic acid; not less than 200
1-octanesulfonic acid; at least 51 parts parts per million and not more than 340
per million and not more than 102 parts parts per million of acetic acid; not
per million of 1-octanesulfonic-2- less than 10 parts per million and not
sulfinic acid or 1,2-octanedisulfonic more than 20 parts per million of sul-
acid; and at least 10 parts per million furic acid; and not less than 0.75 parts
and not more than 20 parts per million per million and not more than 1.2 parts
of the condensate of four moles of per million of 2,6-pyridinedicarboxylic
poly(oxyethylene)poly(oxypropylene) acid.
block copolymers with one mole of (34) Solutions identified in paragraph
ethylenediamine. The colorant adju- (b)(39) of this section shall provide
vant FD&C Yellow No. 5 shall not be when ready for use not less than 460
used in excess of the minimum amount parts per million and not more than 625
required to accomplish the intended parts per million of phosphoric acid,
technical effect. and all components shall be present in
(32)(i) The solution identified in para- the following proportions: 1 part phos-
graph (b)(37) of this section without po- phoric acid to 0.25 octenyl succinic acid
tassium bromide shall provide, when to 0.18 part N,N-dimethyloctanamine to
ready to use, at least 100 parts per mil- 0.062 part of a mixture of n-carboxylic
lion and not more than 200 parts per acids (C6-C12, consisting of not less
million of available halogen deter- than 56 percent octanoic acid and not
mined as available chlorine; at least less than 40 percent decanoic acid).
2,958 parts per million and not more (35) Solutions identified in paragraph
than 5,916 parts per million of tri- (b)(40) of this section shall provide
sodium phosphate; at least 1 part per when ready for use not less than 12.5
million and not more than 3 parts per parts per million and not more than
million of sodium lauryl sulfate; and at 25.0 parts per million of titratable io-
least 0.3 part per million and not more dine; and not less than 2.7 parts per
than 0.7 part per million on potassium million and not more than 5.5 parts per
permanganate. million of dodecylbenzene sulfonic
(ii) The solution identified in para- acid. All components shall be present
graph (b)(37) of this section with potas- in the following proportions: 1.0 part
sium bromide shall provide, when dodecylbenzene sulfonic acid to 43
ready to use, at least 25 parts per mil- parts sodium N-cyclohexyl-N-palmitoyl
lion and not more than 200 parts per taurate to 7.7 parts chloroacetic acid,
million of available halogen deter- sodium salt, reaction products with 4,5-
mined as available chlorine; at least 15 dihydro-2-undecyl-1H-imidazole-1-eth-
parts per million and not more than 46 anol and sodium hydroxide to 114 parts
parts per million of potassium bro- phosphoric acid to 57 parts isopropyl
mide; at least 690 parts per million and alcohol to 3.0 parts calcium chloride.
not more than 2,072 parts per million of (36) Solutions identified in paragraph
trisodium phosphate; at least 0.3 part (b)(41) of this section shall provide,
per million and not more than 1 part when ready for use, not less than 150
376
parts per million and not more than 200 contact surfaces in public eating places
parts per million of n-alkyl(C12- and dairy and beverage containers,
C16)benzyldimethylammonium chlo- shall provide when ready for use at
ride; and not more than 0.4 part per least 72 parts per million and not more
million of the colorant methylene blue. than 216 parts per million of hydrogen
Components shall be present in the peroxide; at least 46 parts per million
product used to prepare the solution in and not more than 138 parts per million
the following proportions: 1 part n- of peroxyacetic acid; at least 40 parts
alkyl(C12- per million and not more than 122 parts
C16)benzyldimethylammonium chloride per million of octanoic acid (including
to 0.24 part ammonium chloride to 0.08 peroxyoctanoic acid); at least 281 parts
part calcium stearate to 0.60 part so- per million and not more than 686 parts
dium bicarbonate to 0.08 part starch or per million of acetic acid; at least 7
dextrin, or a combination of starch and parts per million and not more than 34
dextrin. parts per million of 1-
(37)(i) The solution identified in para- hydroxyethylidene-1,1-diphosphonic
graph (b)(42) of this section not con- acid; and at least 36 parts per million
taining sulfuric acid shall provide when and not more than 109 parts per million
ready for use not less than 45 parts per of sodium 1-octanesulfonate.
million and not more than 90 parts per (ii) The solution identified in para-
million of decanoic acid; and all com- graph (b)(45) of this section, when used
ponents shall be present in the fol- on food-contact equipment and utensils
lowing proportions (weight/weight (w/ in warewashing machines, including
w)): 1 part decanoic acid to 1 part nona- warewashing machines in public eating
noic acid to 9.5 parts phosphoric acid to places, at temperatures no less than 120
3.3 parts propionic acid to 3.3 parts so- °F (49 °C) shall provide when ready for
dium 1-octanesulfonate. use at least 30 parts per million and
(ii) The solution identified in para- not more than 91 parts per million of
graph (b)(42) of this section containing hydrogen peroxide; at least 19 parts per
sulfuric acid shall provide when ready million and not more than 58 parts per
for use not less than 45 parts per mil- million of peroxyacetic acid; at least 17
lion and not more than 90 parts per parts per million and not more than 52
million of decanoic acid; and all com- parts per million of octanoic acid (in-
ponents shall be present in the fol- cluding peroxyoctanoic acid); at least
lowing proportions (w/w): 1 part deca- 119 parts per million and not more than
noic acid to 1 part nonanoic acid to 2.8 290 parts per million of acetic acid; at
parts phosphoric acid to 3.3 parts propi- least 3 parts per million and not more
onic acid to 3.3 parts sodium 1- than 14 parts per million of 1-
octanesulfonate to 3.2 parts sulfuric hydroxyethylidene-1,1-diphosphonic
acid. acid; and at least 15 parts per million
(38) The solution identified in para- and not more than 46 parts per million
graph (b)(44) of this section shall proof sodium 1-octanesulfonate.
vide, when ready for use, at least 16,450 (iii) The solution identified in para-
parts per million and not more than graph (b)(45) of this section, when used
32,900 parts per million of citric acid; at on dairy or beverage containers, shall
least 700 parts per million and not provide when ready for use at least 36
more than 1,400 parts per million of di- parts per million and not more than 108
sodium ethylenediaminetetraacetate; parts per million of hydrogen peroxide;
at least 175 parts per million and not at least 23 parts per million and not
more than 350 parts per million of so- more than 69 parts per million of per-
dium lauryl sulfate; and at least 175 oxyacetic acid; at least 20 parts per
parts per million and not more than 350 million and not more than 61 parts per
parts per million of monosodium phos- million of octanoic acid (including
phate. peroxyoctanoic acid); at least 140 parts
(39)(i) The solution identified in para- per million and not more than 343 parts
graph (b)(45) of this section, when used per million of acetic acid; at least 3
on food processing equipment and uten- parts per million and not more than 17
sils, including dairy and beverage-proc- parts per million of 1-
essing equipment but excluding food- hydroxyethylidene-1,1-diphosphonic
377
§ 178.2010 21 CFR Ch. I (4–1–23 Edition)
acid; and at least 18 parts per million didodecylphenoxybenzenedisulfonate.

and not more than 55 parts per million Other components listed under para-
of sodium 1-octanesulfonate. graph (b)(46) of this section shall be
(40) The solution identified in para- used in the minimum amount nec-
graph (b)(46) of this section shall pro- essary to produce the intended effect.
vide, when ready for use, at least 100 (d) Sanitizing agents for use in ac-
parts per million and not more than 200 cordance with this section will bear la-
parts per million of chlorine dioxide as beling meeting the requirements of the
determined by the method developed Federal Insecticide, Fungicide, and
by Bio-cide International, Inc., enti- Rodenticide Act.
tled, ‘‘Iodometric Method for the De-
termination of Available Chlorine Di- [42 FR 14609, Mar. 16, 1977]
oxide (50–250 ppm Available ClO2),’’ EDITORIAL NOTE: For FEDERAL REGISTER ci-
dated June 11, 1987, which is incor- tations affecting § 178.1010, see the List of
porated by reference in accordance CFR Sections Affected, which appears in the
with 5 U.S.C. 552(a) and 1 CFR part 51. Finding Aids section of the printed volume
Copies of this method are available
from the Office of Food Additive Safety
(HFS–200), Center for Food Safety and Subpart C—Antioxidants and
Applied Nutrition, Food and Drug Ad- Stabilizers
Park, MD 20740, 240–402–1200, and may § 178.2010 Antioxidants and/or stabi-
be examined at the Food and Drug Ad- lizers for polymers.
ministration’s Main Library, 10903 New The substances listed in paragraph
Hampshire Ave., Bldg. 2, Third Floor, (b) of this section may be safely used as
Silver Spring, MD 20993, 301–796–2039, or antioxidants and/or stabilizers in poly-
at the National Archives and Records mers used in the manufacture of arti-
Administration (NARA). For informa- cles or components of articles intended
tion on the availability of this mate- for use in producing, manufacturing,
rial at NARA, call 202–741–6030, or go packing, processing, preparing, treat-
to: http://www.archives.gov/fed- ing, packaging, transporting, or hold-
eral_register/code_of_federal_regulations/ ing food, subject to the provisions of
ibr_locations.html; at least 380 parts per this section:
million and not more than 760 parts per (a) The quantity used shall not ex-
million of sodium gluconate; and at ceed the amount reasonably required
least 960 parts per million and not to accomplish the intended technical
more than 1,920 parts per million of so- effect.
dium mono- and (b) List of substances:
N-n-Alkyl-N′-(carboxymethyl)-N,N′- For use only:

trimethylenediglycine; the alkyl group is even 1. As component of nonfood articles complying with §§ 175.105 and
numbered in the range C14–C18 and the nitrogen 177.2600 of this chapter.
content is in the range 5.4–5.6 weight percent. 2. At levels not to exceed 1.35 percent by weight of natural rubber, buta-
diene-acrylonitrile, butadiene-acrylonitrile-styrene, and butadiene-styrene
polymers that are used in contact with nonalcoholic food at temperatures
not to exceed room temperature and that are employed in closure-sealing
gaskets complying with § 177.1210 of this chapter or in coatings com-
plying with § 175.300, § 176.170, or § 175.320 of this chapter. The aver-
age thickness of such coatings and closure-sealing gaskets shall not ex-
ceed 0.004 inch.
Alkylthiophenolics: ................................................... For use only:
1. Acid-catalyzed condensation reaction products 1. At levels not to exceed 2 percent by weight of adhesives complying with
of 4-nonylphenol, formaldehyde, and 1- § 175.105 of this chapter, of pressure-sensitive adhesives complying with
dodecanethiol (CAS Reg. No. 164907–73–7).. § 175.125 of this chapter, and of rubber articles complying with
2. Acid-catalyzed condensation reaction products 2. Do.
of branched 4-nonylphenol, formaldehyde, and
1-dodecanethiol (CAS Reg. No. 203742–97–6)..
378
p-tert-Amylphenolformaldehyde resins produced For use only at levels not to exceed 2.1 percent by weight of polyamide
when one mole of p-tert-amylphenol is made to resins that are:
react under acid conditions with one mole of 1. Derived from dimerized vegetable oil acids (containing not more than 20
formaldehyde. percent of monomer acids) and ethylenediamine.
2. Used in compliance with regulations in parts 174, 175, 176, 177, 178
and § 179.45 of this chapter.
1,4-Benzenedicarboxylic acid, bis[2-(1,1- For use only at levels not to exceed 0.075 percent by weight of olefin poly-
dimethylethyl)-6-[[3-(1,1-dimethylethyl)-2-hy- mers complying with § 177.1520 of this chapter.
droxy-5-methylphenyl]methyl]-4-methyl-
phenyl]ester (CAS Reg. No. 57569–40–1).
2-(2H-Benzotriazol-2-yl)-4,6-bis(1-methyl-1- For use only:
phenylethyl)phenol (CAS Reg. No. 70321–86–7). 1. At levels not to exceed 0.5 percent by weight of polyethylene phthalate
polymers complying with § 177.1630 of this chapter.
2. At levels not to exceed 3.0 percent by weight of polycarbonate resins
complying with § 177.1580 of this chapter.
2-(2H-Benzotriazol-2-yl)-4-(1, 1, 3, 3- For use only at levels not to exceed 0.5 percent by weight of polycarbonate
tetramethylbutyl) phenol (CAS Reg. No. 3147– resins complying with § 177.1580 of this chapter: Provided, That the fin-
75–9). ished resins contact food only under conditions of use E, F, and G de-
scribed in table 2 of § 176.170(c) of this chapter.
2-[4,6-Bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl]-5- For use only:
(octyloxy)phenol (CAS Reg. No. 2725–22–6).. 1. At levels not to exceed 0.3 percent by weight of olefin polymers com-
plying with § 177.1520(c) of this chapter in contact with food types I, II,
IV-B, VI, VII-B, and VIII described in § 176.170(c) of this chapter, table 1,
under conditions of use D through G as described in § 176.170(c), table
2, of this chapter.
2. At levels not to exceed 0.1 percent by weight of polypropylene complying
with § 177.1520(c) of this chapter, items 1.1a, 1.2, and 1.3 in contact with
food under conditions of use A through H as described in § 176.170(c),
table 2, of this chapter.
3. At levels not to exceed 0.04 percent by weight of polyethylene and olefin
copolymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2,
2.3, 3.1a, 3.1b, 3.1c, 3.2a, and 3.2b having a minimum density of 0.94
gram per cubic centimeter, in contact with food under conditions of use A
through H as described in § 176.170, table 2, of this chapter provided
that the finished articles used in contact with fatty food types III, IV-A, V,
VII-A, and IX as described in table 1 of § 176.170(c) of this chapter hold
a minimum of 2 gallons (7.6 liters) of food.
4. At levels not to exceed 0.4 percent by weight of ethylene copolymers
complying with § 177.1520(c) of this chapter, items 3.1a, 3.1b, 3.1c, 3.2a,
and 3.2b, having a density of less than 0.94 gram per cubic centimeter,
in contact with food under conditions of use B through H, as described in
§ 176.170(c), table 2, of this chapter provided that the finished articles
used in contact with fatty food types III, IV-A, V, VII-A, and IX hold a min-
imum of 5 gallons (18.9 liters) of food.
5. At levels not to exceed 0.04 percent by weight of polyethylene having a
density of less than 0.94 gram per cubic centimeter, and olefin polymers
complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.3a,
3.3b, 3.4, 3.5, 3.6, 4, 5, and 6, in contact with food under conditions of
use D through G as described in § 176.170(c) of this chapter, table 2,
provided that the finished articles used in contact with fatty food types III,
IV-A, V, VII-A, and IX hold a minimum of 5 gallons (18.9 liters) of food.
b, 3(or 4)-Bis(octadecylthio)cyclohexylethane (CAS For use only:
Reg. No. 37625–75–5); CAS synonym: 1-[(beta- 1. At levels not to exceed 0.3 percent by weight of all polymers for use in
(octadecylthio)ethyl]-3(or 4)- contact with foods of Types I, II, IV-B, VI, VII-B, and VIII under conditions
(octadecylthio)cyclohexane. of use B through H as described in tables 1 and 2 of § 176.170(c) of this
chapter.
2. At levels not to exceed 0.3 percent by weight of polyolefins complying
with § 177.1520 of this chapter, for use in contact with food of types III,
IV-A, V, VII-A, and IX under conditions of use C through G as described
in tables 1 and 2 of § 176.170(c) of this chapter.
Bis(2,2,6,6-tetramethyl-4-piperidinyl) sebacate For use only:
(CAS Reg. No. 52829–07–9). 1. In adhesives complying with § 175.105 of this chapter.
2. At levels not to exceed 0.1 percent by weight of pressure-sensitive adhe-
sives complying with § 175.125 of this chapter.
379
§ 178.2010 21 CFR Ch. I (4–1–23 Edition)
Bis(2,4-di-tert-butyl-6-methylphenyl) ethyl For use only:

phosphite (CAS Reg. No. 145650–60–8). 1. At levels not to exceed 0.3 percent by weight of olefin polymers com-
plying with § 177.1520(c) of this chapter. The finished polymers may only
be used with food of the types identified in § 176.170(c) of this chapter,
table 1, under Categories I, II, IV-B, VI-A, VI-B, VII-B, and VIII, and under
conditions of use B through H described in table 2 of § 176.170(c) of this
chapter.
2. At levels not to exceed 0.1 percent by weight of propylene polymers
complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 3.2b,
3.4, or 3.5, or 3.1a (where the density of this polymer is at least 0.85
gram per cubic centimeter and less than 0.91 gram per cubic centimeter).
The finished polymers may only be used in contact with food of the types
identified in § 176.170(c) of this chapter, table 1, under Categories III, IV-
A, V, VI-C, VII-A, and IX, and under conditions of use B through H de-
3. At levels not to exceed 0.1 percent by weight of high-density ethylene
polymers complying with § 177.1520(c) of this chapter, items 2.1, 2.2,
2.3, 3.1a, 3.1b, 3.2a, or 3.6 (where the density of each of these polymers
is at least 0.94 gram per cubic centimeter), or 5. The finished polymers
may only be used in contact with food of the types identified in
§ 176.170(c) of this chapter, table 1, under Categories III, IV-A, V, VI-C,
VII-A, and IX, and under conditions of use C (maximum temperature 70
°C) through G described in table 2 of § 176.170(c) of this chapter. Pro-
vided, that the finished food contact articles have a volume of at least
18.9 liters (5 gallons).
4. At levels not to exceed 0.01 percent by weight of low-density ethylene
2.3, 3.1a, 3.1b, 3.2a, 3.4, 3.5, or 3.6 (where the density of each of these
polymers is less than 0.94 gram per cubic centimeter). The finished poly-
mers may only be used in contact with food of the types identified in
§ 176.170(c) of this chapter, table 1, under Categories III, IV-A, V, VI-C,
VII-A, and IX, and under conditions of use B through H described in table
2 of § 176.170(c) of this chapter. Provided, that the average thickness of
such polymers in the form in which they contact food shall not exceed
0.001 inch.
1,2-Bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamoyl)- For use only:
hydrazine (CAS Reg. No. 32687–78–8). 1. As provided in § 175.105 of this chapter.
2. At levels not exceeding 0.1 percent by weight of acrylonitrile-butadiene-
styrene copolymers used in accordance with parts 175, 176, 177, and
181 of this chapter.
3. At levels not exceeding 0.1 percent by weight of polyoxymethylene co-
polymers complying with § 177.2470 of this chapter and of
polyoxymethylene homopolymers complying with § 177.2480 of this chap-
ter.
2,6-Bis(1-methylheptadecyl)-p-cresol ...................... For use only at levels not exceeding 0.3 percent by weight of olefin poly-
mers complying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3,
2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4. The average thickness of such polymers
in the form in which they contact fatty food or food containing more than
8 percent of alcohol shall not exceed 0.004 inch.
3,9-Bis[2,4-bis(1-methyl-1-phenylethyl)phenoxy]- For use only:
2,4,8,10-tetraoxa-3,9- 1. At levels not to exceed 0.15 percent by weight of all polymers, except as
diphosphaspiro[5.5]undecane (CAS Reg. No. specified below.
154862–43–8), which may contain not more 2. At levels not to exceed 0.2 percent by weight of polycarbonate resins
than 2 percent by weight of triisopropanolamine complying with § 177.1580 of this chapter.
(CAS Reg. No. 122–20–3). 3. At levels not to exceed 0.3 percent by weight of polyetherimide resins
380
5,7-Bis(1,1-dimethylethyl)-3-hydroxy-2(3H)- For use only:

benzofuranone, reaction products with o-xylene 1. At levels not to exceed 0.1 percent by weight of olefin polymers com-
(CAS Reg. No. 181314–48–7). plying with § 177.1520(c) of this chapter. The finished polymers may only
be used in contact with food of the types identified in § 176.170(c) of this
chapter, Table 1, under Categories I, II, IV-B, VI-A, VI-B, VII-B, and VIII,
and under conditions of use B through H described in Table 2 of
2. At levels not to exceed 0.02 percent by weight of:
(a) Propylene polymers and copolymers complying with § 177.1520(c) of
this chapter, items 1.1, 1.2, 3.1a, 3.2a, 3.2b, 3.4, or 3.5. The finished
polymer may only be used in contact with food of types identified in
§ 176.170(c) of this chapter, Table 1, under Categories III, IV-A, V, VI-C,
VII-A, and IX, and under conditions of use B through H described in
Table 2 of § 176.170(c) of this chapter; or
(b) Ethylene polymers and copolymers complying with § 177.1520(c) of this
chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, or 3.6 (where the density of
each of these polymers is at least 0.94 gram per cubic centimeter), or 5.
The finished polymers may only be used in contact with food of the types
identified in § 176.170(c) of this chapter, Table 1, under Categories III, IV-
A, V, VI-C, VII-A, and IX, and under conditions of use B through H de-
scribed in Table 2 of § 176.170(c) of this chapter; provided that the fin-
ished food-contact articles have a volume of at least 18.9 liters (5 gal-
lons).
3. At levels not to exceed 0.02 percent by weight of ethylene polymers and
polymers is less than 0.94 gram per cubic centimeter). The finished poly-
mers may only be used in contact with food of the types identified in
§ 176.170(c) of this chapter, Table 1, under Categories III, IV-A, V, VI-C,
VII-A, and IX, and under conditions of use B through H described in
Table 2 of § 176.170(c) of this chapter; provided that the average thick-
ness of such polymers in the form in which they contact food shall not
exceed 50 micrometers (0.002 inch).
3,9-Bis[2-{3-(3-tert-butyl-4-hydroxy-5- For use only:
methylphenyl)propionyloxy}-1,1-dimethylethyl]- 1. At levels not to exceed 0.2 percent by weight of polypropylene complying
2,4,8,10-tetraoxaspiro[5.5]undecane (CAS Reg. with § 177.1520(c), item 1.1 of this chapter. The finished polymer is to be
No. 90498–90–1). used in contact with food only under conditions of use D through H de-
2. At levels not to exceed 0.3 percent by weight of polyethylene complying
with § 177.1520(c) of this chapter, item 2.1, provided that the polymer
has a minimum density of 0.94 grams per cubic centimeter and is used in
contact with food only under conditions of use D through G described in
table 2 of § 176.170(c) of this chapter.
3. At levels not to exceed 0.3 percent by weight of olefin polymers com-
plying with § 177.1520(c) of this chapter, items 1.1, 3.1, and 3.2, where
the copolymers complying with items 3.1 and 3.2 contain not less than 85
weight percent of polymer units derived from propylene. The finished
polymer is to be used in contact with food of types I, II, IV-B, VI-A, VI-B,
VI-C, VII-B, and VIII under conditions of use A through H described in ta-
bles 1 and 2 of § 176.170(c) of this chapter.
381
§ 178.2010 21 CFR Ch. I (4–1–23 Edition)
4-[[4,6-Bis(octylthio)-s-triazin-2-yl]amino]-2,6-di- For use only:

tert-butylphenol (CAS Reg. No. 991–84–4). 1. At levels not to exceed 0.5 percent by weight: in styrene block copoly-
mers complying with § 177.1810 of this chapter; in rosins and rosin de-
rivatives complying with § 175.300(b)(3)(v) of this chapter; in can end ce-
ment formulations complying with § 175.300(b)(3)(xxxi) of this chapter; in
side seam cement formulations complying with § 175.300(b)(3)(xxxii) of
this chapter; in petroleum alicyclic hydrocarbon resins and terpene resins
complying with § 175.320(b)(3) of this chapter; in rosin and rosin deriva-
tives complying with § 176.170(a)(5) of this chapter; in petroleum alicyclic
hydrocarbon resins or their hydrogenated products complying with
§ 176.170(b)(2) of this chapter; in terpene resins complying with
§ 175.300(b)(2)(xi) of this chapter, when such terpene resins are used in
accordance with § 176.170(b)(1) of this chapter; in resins and polymers
complying with § 176.180(b) of this chapter; in closures with sealing gas-
kets complying with § 177.1210 of this chapter; in petroleum hydrocarbon
resin and rosins and rosin derivatives complying with § 178.3800(b) of
this chapter; and in reinforced wax complying with § 178.3850 of this
chapter.
2. At levels not to exceed 0.2 percent by weight of the finished cellophane
3. At levels not to exceed 0.1 percent by weight in polystyrene and rubber-
modified polystyrene complying with § 177.1640 of this chapter: Provided,
That the finished polystyrene and rubber-modified polystyrene polymer
contact food only under conditions of use B through G described in table
2 of § 176.170(c) of this chapter.
4. In adhesives complying with § 175.105 of this chapter; in pressure-sen-
sitive adhesives complying with § 175.125 of this chapter; and as pro-
vided in § 177.2600 of this chapter.
4,4′-Bis(a,a-dimethylbenzyl)diphenylamine (CAS For use at levels not to exceed 0.3 percent by weight of polypropylene
Reg. No. 10081–67–1). complying with § 177.1520(c) of this chapter. The polypropylene articles
are limited to use in contact with non-fatty foods only.
Boric acid (CAS Reg. No. 10043–35–3) ................. For use only at levels not to exceed 0.16 percent by weight of ethylene-
vinyl acetate-vinyl alcohol copolymers complying with § 177.1360(a)(3)
and (d) of this chapter.
1,3–Butanediol.
Butylated reaction product of p-cresol and For use only:
dicyclopentadiene produced by reacting p-cresol 1. As components of nonfood articles complying with §§ 175.105 and
and dicyclopentadiene in an approximate mole 177.2600(c)(4)(iii) of this chapter.
ratio of 1.5 to 1, respectively, followed by 2. At levels not to exceed 1.0 percent by weight of acrylonitrile/butadiene/
alkylation with isobutylene so that the butyl con- styrene copolymers. The finished copolymers may be used in contact
tent of the final product is not less than 18 per- with food of Types I, II, IV-B, VI-A, VI-B, VII-B, and VIII under conditions
cent. of use B through H, as described in tables 1 and 2 of § 176.170(c) of this
chapter, and with food of Types III, IV-A, V, VI-C, VII-A, and IX under
conditions of use C through G as described in tables 1 and 2 of
382
Butylated, styrenated cresols produced when For use only:

equal moles of isobutylene, styrene, and a 1. As provided in §§ 175.105 and 177.2600 of this chapter.
metacresol-paracresol mixture having a no more 2. At levels not to exceed 0.5 percent by weight of polystyrene, rubber-
than 3 °C distillation range including 202 °C are modified polystyrene, or olefin polymers complying with § 177.1520 (c) of
made to react so that the final product meets this chapter, items 1.1, 1.2, 1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4, or com-
the following specifications: Not less than 95 plying with other sections in parts 174, 175, 176, 177, 178 and § 179.45
percent by weight of total alkylated phenols con- of this chapter, used in articles that contact food only unded the condi-
sisting of 13–25 percent by weight of butylated tions described in § 176.170(c) of this chapter, table 2, under conditions
m- and p-cresols, 26–38 percent by weight of of use C through G.
styrenated m- and p-cresols, 37–49 percent by
weight of butylated styrenated m- and p-cresols,
and not more than 10 percent by weight total of
alkylated xylenols, alkylated o-cresol, alkylated
phenol, and alkylated ethylphenol; acidity not
more than 0.003 percent; and refractive index at
25 °C of 1.5550–1.5650, as determined by
ASTM method D1218–82, ‘‘Standard Test Meth-
od for Refractive Index and Refractive Disper-
sion of Hydrocarbon Liquids,’’ which is incor-
porated by reference. Copies may be obtained
from the American Society for Testing Materials,
100 Barr Harbor Dr., West Conshohocken,
Philadelphia, PA 19428-2959, or may be exam-
ined at the National Archives and Records Ad-
ministration (NARA). For information on the
availability of this material at NARA, call 202–
741–6030, or go to: http://www.archives.gov/fed-
ibr_locations.html..
2-tert-Butyl-a(3-tert-butyl-4-hydroxyphenyl)-p-cu- For use only:
menyl bis(p-nonylphenyl) phosphite; the nonyl 1. As components of nonfood articles complying with §§ 175.105 and
group is a propylene trimer isomer and the 177.2600 of this chapter.
phosphorus content is in the range 3.8–4.0 2. At levels not to exceed 1.35 percent by weight of natural rubber, buta-
weight percent. diene-acrylonitrile, butadiene-acrylonitrile-styrene, and butadiene-styrene
polymers that are used in contact with nonalcoholic food at temperatures
not to exceed room temperature and that are employed in closure-sealing
gaskets complying with § 177.1210 of this chapter or in coatings com-
plying with § 175.300, § 175.320, or § 176.170 of this chapter. The aver-
age thickness of such coatings and closure-sealing gaskets shall not ex-
ceed 0.004 inch.
2-(3′-tert-Butyl-2′-hydroxy-5′-methyl-phenyl)-5- For use only at levels not to exceed 0.5 percent by weight of olefin poly-
chlorobenzotriazole with a melting point of 137– mers complying with § 177.1520(c) of this chapter, provided that the fin-
141 °C. ished polymer contacts foods only of the types identified in Categories I,
II, IV-B, VI-A and B, VII-B, and VIII in table 1, § 176.170 of this chapter.
4,4′-Butylidenebis(6-tert-butyl-m-cresol) ................. For use only.
1. As provided in §§ 175.105 and 177.2600 of this chapter.
2. At levels not to exceed 0.5 percent by weight of polypropylene complying
with § 177.1520 of this chapter and for use at levels not to exceed 0.3
percent by weight of polyethylene complying with § 177.1520 of this
chapter, provided that the finished polypropylene and polyethylene con-
tact food only of the types identified in § 176.170(c) of this chapter, table
1, under Categories I, II, VI-B, and VIII.
Butyric acid, 3,3-bis(3-tert-butyl-4- For use only:
hydroxyphenyl)ethylene ester (CAS Reg. No. 1. At levels not to exceed 0.5 percent by weight of olefin copolymers com-
32509–66–3). plying with § 177.1520(c) of this chapter, items 3.1 and 3.2 except that
when used in contact with foods described as types III, IV-A, V, VII-A,
and IX in table 1 of § 176.170(c) of this chapter, the olefin copolymers
may only be used under conditions of use E, F, and G set forth in table 2
of § 176.170(c) of this chapter.
plying with § 177.1520(c) of this chapter, item 1.1, 3.1, or 3.2 (where the
copolymers complying with items 3.1 and 3.2 contain not less than 85
weight-percent of polymer units derived from propylene).
plying with § 177.1520(c) of this chapter, items 2.1, 2.2, 3.1, and 3.2.
Calcium benzoate..
383
§ 178.2010 21 CFR Ch. I (4–1–23 Edition)
Calcium bis[monoethyl(3,5-di-tert-butyl-4-hydroxy- For use only:

benzyl)phosphonate] (CAS Reg. No. 65140–91– 1. At levels not to exceed 0.25 percent by weight of polypropylene that
2). complies with § 177.1520(c) of this chapter, items 1.1, 1.2, and 1.3.
2. At levels not to exceed 0.2 percent by weight of polyethylene and olefin
copolymers that comply with § 177.1520(c) of this chapter, items 2.1, 2.2,
2.3, 3.1, 3.2, 3.3, 3.4, 3.5, and 3.6. Finished polymers having a density
less than 0.94 gram per cubic centimeter shall be used in contact with
food only under conditions of use B through H described in table 2 of
3. In adhesives complying with § 175.105 of this chapter.
4. At levels not to exceed 0.5 percent by weight of pressure-sensitive adhe-
5. At levels not to exceed 0.5 percent by weight of rosins and rosin deriva-
tives complying with § 175.300(b)(3)(v) of this chapter.
6. At levels not to exceed 0.5 percent by weight of can end cement formu-
lations complying with § 175.300(b)(3)(xxxi) of this chapter.
7. At levels not to exceed 0.5 percent by weight of side seam cement for-
mulations complying with § 175.300(b)(3)(xxxii) of this chapter.
8. At levels not to exceed 0.5 percent by weight of petroleum alicyclic hy-
drocarbon resins complying with § 175.320(b)(3) of this chapter.
9. At levels not to exceed 0.5 percent by weight of rosin and rosin deriva-
tives complying with § 176.170(a)(5) of this chapter; and petroleum alicy-
clic hydrocarbon resins, or the hydrogenated product thereof, complying
with § 176.170(b)(2) of this chapter.
10. At levels not to exceed 0.5 percent by weight of resins and polymers
used as components of paper and paperboard in contact with dry food in
compliance with § 176.180 of this chapter.
11. At levels not to exceed 0.5 percent by weight of closures with sealing
gaskets complying with § 177.1210 of this chapter.
12. At levels not to exceed 0.5 percent by weight of the finished rubber arti-
cle complying with § 177.2600 of this chapter.
13. At levels not to exceed 0.5 percent by weight of petroleum hydrocarbon
resin and rosins and rosin derivatives complying with § 178.3800(b).
14. At levels not to exceed 0.5 percent by weight of reinforced wax com-
plying with § 178.3850.
15. At levels not to exceed 0.3 percent by weight of polyethylene phthalate
polymers, complying with § 177.1630 of this chapter. Provided, that the
finished polymers contact food only under conditions of use B through H
described in Table 2 of § 176.170(c) of this chapter.
Calcium myristate..
Calcium ricinoleate .................................................. For use only at levels not to exceed 1 percent by weight of
polyoxymethylene copolymer as provided in § 177.2470(b)(1) of this
chapter.
Calcium stearate..
Carbethoxymethyl diethyl phosphonate (CAS Reg. At levels not to exceed 0.07 percent by weight of polyethylene phthalate
No. 867–13–0). polymers complying with § 177.1630 of this chapter.
Cerium stereate (CAS Reg. No. 10119–53–6) ....... For use only at levels not to exceed 0.5 percent by weight in rigid and
semirigid vinyl chloride homo- and copolymer articles modified in accord-
ance with § 178.3790(b)(1) of this chapter that contact food under condi-
tions of use B through H described in table 2 of § 176.170(c) of this chap-
ter.
Cupric acetate and lithium iodide ........................... For use at levels not exceeding 0.025 percent cupric acetate and 0.065
percent lithium iodide by weight of nylon 66 resins complying with
§ 177.1500 of this chapter; the finished resins are used or are intended to
be used to contain foods during oven baking or oven cooking at tempera-
tures above 250 °F. The average thickness of such resins in the form in
which they contact food shall not exceed 0.0012 inch.
Cuprous iodide ........................................................ For use at levels not exceeding 0.01 percent cuprous iodide by weight of
nylon 66T resins complying with § 177.1500 of this chapter; the finished
resins are used or are intended to be used to contain foods during oven
baking or oven cooking at temperatures above 250 °F. The average
thickness of such resins in the form in which they contact food shall not
exceed 0.001 inch.
Cuprous iodide and cuprous bromide ..................... For use at levels not exceeding 0.0025 percent cuprous iodide and 0.0175
percent cuprous bromide by weight of nylon 66 resins complying with
§ 177.1500 of this chapter; the finished resins are used or are intended to
be used to contain foods during oven baking or oven cooking at tempera-
tures above 250 °F. The average thickness of such resins in the form in
Cyanoguanidine ...................................................... For use only at levels not to exceed 1 percent by weight of
polyoxymethylene copolymer as provided in § 177.2470(b)(1) of this
chapter.
384
Cyclic neopentanetetrayl bis(octadecyl phosphite) For use only at levels not to exceed 0.1 percent by weight of ethylene-vinyl
(CAS Reg. No. 3806–34–6); the phosphorus acetate copolymers complying with § 177.1350 of this chapter that con-
content is in the range of 7.8 to 8.2 weight per- tact food under conditions of use E, F, and G described in table 2 of
cent. § 176.170(c) of this chapter.
Cyclic neopentanetetrayl bis(octadecyl phosphite) For use only:
(CAS Reg. No. 3806–34–6) (which may contain 1. At levels not to exceed 0.25 percent by weight of olefin polymers com-
not more than 1 percent by weight of plying with § 177.1520(c) of this chapter, items 1.1, 2.1, and 3.1.
triisopropanolamine (CAS Reg. No. 122–20–3)); 2. At levels not to exceed 0.25 percent by weight of olefin polymers com-
the phosphorus content is in the range of 7.8 to plying with § 177.1520(c) of this chapter, item 2.2, that contact food
8.2 weight percent. Types I, II, VI-A, VII-B, and VIII described in table 1 of § 176.170(c) of
this chapter under conditions of use B (for boil-in-bag applications), C, D,
E, F, G, and H described in table 2 of § 176.170(c) of this chapter.
plying with § 177.1520, items 1.1 and 3.2, that contact food Types I, II,
VI-A, VII-B, and VIII described in table 1 of § 176.170(c) of this chapter
under conditions of use B (for boil-in-bag applications), C, D, E, F, G,
and H described in table 2 of § 176.170(c) of this chapter.
4. At levels not to exceed 0.20 percent by weight of polystyrene and/or rub-
ber modified polystyrene complying with § 177.1640 of this chapter that
contact food under conditions of use E, F, and G described in table 2 of
4,4′-Cyclohexylidenebis(2-cyclohexylphenol) .......... For use only at levels not to exceed 0.1 percent by weight of olefin poly-
2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4: Provided, That the finished polymers
contact food only of the types identified in § 176.170(c) of this chapter,
table 1, under Categories I, II, IV-B, VI, VII-B, and VIII.
Dicetyl thiodipropionate having a melting point of The concentration of this additive and any other permitted antioxidants in
59°–62 °C as determined by ASTM method the finished food-contact article shall not exceed a total of 0.5 milligram
E324–79, ‘‘Standard Test Method for Relative per square inch of food-contact surface.
Initial and Final Melting Points and the Melting
Range of Organic Chemicals,’’ and a saponifica-
tion value in the range 176–183 as determined
by ASTM method D1962–67 (Reapproved
1979), ‘‘Standard Test Method for Saponification
Value of Drying Oils, Fatty Acids, and Polym-
erized Fatty Acids,’’ which are incorporated by
reference. Copies may be obtained from the
American Society for Testing Materials, 100
Barr Harbor Dr., West Conshohocken, Philadel-
phia, PA 19428-2959, or may be examined at
the National Archives and Records Administra-
tion (NARA). For information on the availability
of this material at NARA, call 202–741–6030, or
Didodecyl-1,4-dihydro-2,6-dimethyl-3,5- For use only at levels not to exceed 0.3 percent by weight in rigid polymer
pyridinedicarboxylate (CAS Reg. No. 36265–41– articles modified in accordance with § 178.3790 that contact food, under
5). conditions of use E, F, and G described in table 2 of § 176.170 of this
chapter.
2,6-Di(a-methyl benzyl)-4-methyl phenol [Chemical For use only at levels not to exceed 0.2 percent by weight of olefin poly-
Abstracts Service Registry No. 1817–68–1]. mers complying with item 3.4 in § 177.1520(c) of this chapter, provided
that such olefin polymers are limited to use at a level not to exceed 25
percent by weight in other olefin polymers complying with § 177.1520 of
this chapter; and the total amount in such finished olefin polymers not to
exceed 0.05 percent by weight, including the level that may be contrib-
uted by its presence at 6 percent in the item ‘‘butylated, styrenated
cresols * * * ’’ listed in this paragraph; and further provided that the fin-
ished olefin polymers are intended for contact with foods, except those
containing more than 8 percent alcohol.
2,4-Dimethyl-6-(1-methylpentadecyl)phenol (CAS For use only:
Reg. No. 134701–20–5). 1. At levels not to exceed 0.3 percent by weight of acrylonitrile-butadiene-
styrene copolymers used in accordance with applicable regulations in
parts 175, 176, 177, and 181 of this chapter, under conditions of use C
through H as described in table 2 of § 176.170(c) of this chapter.
2. At levels not to exceed 0.033 percent by weight of rigid polyvinyl chlo-
ride, under conditions of use A through H as described in table 2 of
385
§ 178.2010 21 CFR Ch. I (4–1–23 Edition)
Dimethyl succinate polymer with 4-hydroxy- For use only:

2,2,6,6-tetramethyl-1-piperidineethanol (CAS 1. At levels not to exceed 0.3 percent by weight of olefin polymers com-
Reg. No. 65447–77–0). plying with § 177.1520 of this chapter and under conditions of use B
through H described in table 2 of § 176.170(c) of this chapter.
2. At levels not to exceed 0.3 percent by weight of ethylene-vinyl acetate
copolymers complying with § 177.1350 of this chapter and under condi-
ter.
Dimethyltin/monomethyltin For use only at levels not to exceed 2 percent by weight:
isooctylmercaptoacetates consisting of 5 to 90 1. In rigid polyvinyl chloride used in the manufacture of pipes intended for
percent by weight of monomethyltin tris contact with water in food-processing plants, and
(isooctylmercaptoacetate) (CAS Reg. No. 2. In rigid polyvinyl chloride and in rigid vinyl chloride copolymers complying
54849–38–6) or monomethyltin tris(2- with § 177.1950 of this chapter or § 177.1980 of this chapter for use in
ethylhexylmercaptoacetate) (CAS Reg. No. contact with food of Types I, II, III, IV (except liquid milk), V, VI, VII, VIII,
57583–34–3) and 10 to 95 percent by weight of and IX described in table 1 of § 176.170(c) of this chapter under condi-
dimethyltin bis (isooctylmercaptoacetate) (CAS tions of use C through G described in table 2 of § 176.170(c) of this
Reg. No. 26636–01–1) or dimethyltin bis(2– chapter at temperatures not to exceed 88 °C (190 °F).
ethylhexylmercaptoacetate) (CAS Reg. No.
57583–35–4), and no more than 0.4 percent by
weight of trimethyltin compounds, and having
the following specifications: Tin content (as Sn)
in the range of 15 to 21 percent and
mercaptosulfur content in the range of 11 to
13.5 percent. Other alkyltin compounds are not
to exceed 20 ppm.
Dimyristyl thiodipropionate having a melting point Finished food-contact articles containing this additive shall meet the extrac-
of 48°–52 °C as determined by ASTM method tives limitations prescribed in § 176.170(c) of this chapter.
E324–79, ‘‘Standard Test Method for Relative
Initial and Final Melting Points and the Melting
Range of Organic Chemicals,’’ and a saponifica-
tion equivalent in the range 280–290 as deter-
mined by ASTM method D1962–67 (Re-
approved 1979), ‘‘Standard Test Method for Sa-
ponification Value of Drying Oils, Fatty Acids,
and Polymerized Fatty Acids,’’ which are incor-
porated by reference. Copies may be obtained
from the American Society for Testing Materials,
1916 Race St., Philadelphia PA 19103, or may
be examined at the National Archives and
Records Administration (NARA). For information
on the availability of this material at NARA, call
202–741–6030, or go to: http://
Di(n-octyl)tin bis(2-ethylhexyl maleate) [CAS Reg. For use only at levels not to exceed 0.5 percent by weight of acrylonitrile
No. 10039–33–5] having 12.5 to 15.0 percent by copolymers complying with §§ 177.1020 and 177.1030 of this chapter and
weight of tin (Sn) and having a saponification used in contact with all food types under conditions of use C through G
number of 260 to 280. The additive is made described in table 2 of § 176.170(c) of this chapter.
from di(n-octyl)tin oxide meeting the specifica-
tions of § 178.2650(a)(1).
N,N′-Diphenylthiourea ............................................. For use only:
1. At levels not to exceed 0.5 percent by weight of polyvinyl chloride and/or
vinyl chloride copolymers complying with § 177.1980 of this chapter.
2. At levels not to exceed 0.5 percent by weight of vinyl chloride-vinyl ace-
tate copolymers containing not more than 20 molar percent of vinyl ace-
tate.
2-(4,6-Diphenyl-1,3,5-triazin-2-yl)-5- For use only
hexyloxy)phenol (CAS Reg. No. 147315–50–2). 1. At levels not to exceed 0.5 percent by weight of polycarbonate resins
2. At levels not to exceed 0.5 percent by weight of polyester elastomers
3. At levels not to exceed 0.5 percent by weight of polyethylene phthalate
polymers complying with § 177.1630 of this chapter, in contact with food
under conditions of use A through H described in Table 2 of § 176.170(c)
of this chapter.
386
2,6-Di-tert-butyl-4-ethylphenol ................................. For use only in contact with nonalcoholic foods:

1. At levels not exceeding 0.04 mg/in 2 of food contact surface and not ex-
ceeding 0.1 percent by weight in ethylene polymers and copolymers
complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, 3.2,
and 3.3; § 177.1340; and § 177.1350 of this chapter. The average thick-
ness of such polymers and copolymers in the form in which they contact
food shall not exceed 0.0025 in.
2. At levels not exceeding 0.04 mg/in 2 of food contact surface in ethylene
polymers and copolymers complying with § 177.1520(c) of this chapter,
items 2.1, 2.2, 2.3, 3.1, 3.2, and 3.3; § 177.1340; and § 177.1350 of this
chapter. The average thickness of such polymers and copolymers in the
form in which they contact food shall be greater than 0.0025 in but shall
not exceed 0.025 in.
3,5-Di-tert-butyl-4-hydroxyhydrocinnamic acid For use only:
triester with 1,3,5-tris(2-hydroxyethyl)-s-triazine- 1. At levels not to exceed 0.5 percent by weight of polypropylene complying
2,4,6-(1H,3H,5H)-trione (CAS Reg. No. 34137- with § 177.1520 of this chapter in articles that contact food not in excess
09-2). of high temperature heat-sterilized condition of use A described in
§ 176.170(c) of this chapter, table 2.
with § 177.1520 of this chapter in articles that contact food not in excess
of high temperature heat-sterilized condition of use A described in
176.170(c) of this chapter, table 2.
4. At levels not to exceed 0.25 percent by weight of olefin copolymers com-
plying with § 177.1520(c) of this chapter, items 3.1, 3.2, 3.3, 3.4, 3.5, and
4.0.
5. At levels not to exceed 2 percent by weight of polyester elastomers,
complying with § 177.1590 of this chapter, in contact with dry food only,
and finished rubber articles for repeated use, complying with § 177.2600
of this chapter, in contact with all foods, at temperatures not to exceed
150 °F.
Di-tert-butyl-m-cresyl phosphonite condensation For use only:
product with biphenyl (CAS Reg. No. 178358– 1. At levels not to exceed 0.1 percent by weight of olefin polymers com-
58–2) produced by the condensation of 4,6-di- plying with § 177.1520(c) of this chapter, items 1.1, 2.1, 2.2, 3.1(a),
tert-butyl-m-cresol with the Friedel-Crafts addi- 3.1(b), 3.2(a), or 3.2(b).
tion product (phosphorus trichloride and
biphenyl) so that the food additive has a min-
imum phosphorus content of 5.0 percent.
Di-tert-butylphenyl phosphonite condensation For use only:
product with biphenyl (CAS Reg. No. 119345– 1. At levels not to exceed 0.1 percent by weight of olefin polymers com-
01–6) produced by the condensation of 2,4-di- plying with § 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 3.2b, 3.3a,
tert-butylphenol with the Friedel-Crafts addition 3.3b, 3.4, 3.5, and 3.1a (where the density is not less than 0.85 gram per
product (phosphorus trichloride and biphenyl) so cubic centimeter and not more than 0.91 gram per cubic centimeter); and
that the food additive has a minimum phos- 2.1, 2.2, 2.3, 3.1a, 3.1b, 3.2a, and 3.6 (where the density is not less than
phorus content of 5.4 percent, an acid value not 0.94 gram per cubic centimeter) and 5.
exceeding 10 mg KOH/gm, and a melting range 2. At levels not to exceed 0.1 percent by weight of polycarbonate resins
of 85 °C to 110 °C (185 °F to 230 °F). complying with § 177.1580 of this chapter.
3. At levels not to exceed 0.2 percent by weight of polystyrene and 0.3 per-
cent by weight of rubber-modified polystyrene complying with § 177.1640
of this chapter.
plying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b,
3.2a, 3.4, 3.5, and 3.6 (where the polyethylene component has a density
less than 0.94 gram per cubic centimeter).
5. At levels not to exceed 0.1 percent by weight of repeated use rubber ar-
ticles complying with § 177.2600 of this chapter.
387
§ 178.2010 21 CFR Ch. I (4–1–23 Edition)
2,4-Di-tert-butylphenyl-3,5-di-tert-butyl-4-hydroxy- For use only:

benzoate (CAS Reg. No. 4221–80–1). 1. At levels not to exceed 0.6 percent by weight of olefin polymers com-
plying with § 177.1520(c) of this chapter, item 1.1: (1) when used in sin-
gle-use articles that contact food of types I, II, IV-B, VI-A, VI-B, VII-B, and
VIII, identified in table 1 of § 176.170(c) of this chapter; and (2) when
used in repeated-use articles that contact food of types I, II, III, IV, V, VI,
VII, VIII, and IX identified in table 1 of § 176.170(c) of this chapter. The
additive is used under conditions of use B through H described in table 2
2. At levels not to exceed 0.25 percent by weight of olefin polymers having
a density of not less than 0.94 gram per cubic centimeter and complying
with § 177.1520(c) of this chapter, items 2.1, 2.2, 3.1, and 3.2: (1) when
used in single-use articles that contact food of types I, II, IV-B, VI-A, VI-
B, VII-B, and VIII, identified in table 1 of § 176.170(c) of this chapter; and
(2) when used in repeated-use articles that contact food of types I, II, III,
IV, V, VI, VII, VIII, and IX identified in table 1 of § 176.170(c) of this chap-
ter. The additive is used under conditions of use B through H described
in table 2 of § 176.170(c) of this chapter.
2,4-Di-tert-pentyl-6-[1-(3,5-di-tert-pentyl-2- For use only:
hydroxyphenyl)ethyl]phenyl acrylate (CAS Reg. 1. At levels not to exceed 0.2 percent by weight of polypropylene complying
No. 123968–25–2). with § 177.1520 of this chapter in contact with food under conditions of
use D through G as described in Table 2 of § 176.170(c) of this chapter,
except that polypropylene containing the additive at levels not to exceed
0.075 percent by weight may contact food under conditions of use A
through H described in Table 2 of § 176.170(c) of this chapter.
2. At levels not to exceed 1.0 percent by weight of styrene block polymers
complying with § 177.1810 of this chapter. The additive is used under
conditions of use D through G as described in Table 2 of § 176.170(c) of
this chapter.
3. At levels not to exceed 1.0 percent by weight of polystyrene and rubber
modified polystyrene complying with § 177.1640 of this chapter in contact
with food under conditions of use D through G as described in Table 2 of
N,N″–1,2–Ethanediylbis[N–[3–[[4,6- For use only:
bis[butyl(1,2,2,6,6-pentamethyl-4- 1. At levels not to exceed 0.06 percent by weight of olefin polymers com-
piperidinyl)amino]-1,3,5-triazin-2- plying with § 177.1520(c) of this chapter, items 1.1a, 1.1b, 1.2, or 1.3.
yl]amino]propyl]-N′,N″-dibutyl-N′,N″-bis(1,2,2,6,6- The finished polymers may only be used in contact with food of the
pentamethyl-4-piperidinyl)-1,3,5-triazine-2,4,6-tri- Types III, IV-A, V, VI-C, VII-A, and IX as described in table 1 of
amine] (CAS Reg. No. 106990–43–6). § 176.170(c) of this chapter, and under conditions of use A through H as
described in table 2 of § 176.170(c) of this chapter.
plying with § 177.1520(c) of this chapter. The finished polymers may only
be used in contact with food of the Types I, II, IV-B, VI-A, VI-B, VII-B,
and VIII as described in table 1 of § 176.170(c) of this chapter, and under
conditions of use A through H as described in table 2 of § 176.170(c) of
this chapter.
Ethylenebis(oxyethylene)-bis-(3-tert-butyl-4-hy- 1. At levels not to exceed 0.3 percent by weight of polystyrene and/or rub-
droxy-5-methylhydrocinnamate) (CAS Reg. No. ber modified polystyrene polymers complying with § 177.1640 of this
36443–68–2). chapter.
2. At levels not to exceed 0.3 percent by weight of acrylonitrile-butadiene-
styrene copolymers used in accordance with applicable regulations in
parts 175, 176, 177, and 181 of this chapter.
3. At levels not to exceed 0.75 percent by weight of polyoxymethylene co-
polymers used in accordance with § 177.2470 of this chapter. The fin-
ished articles shall not be used for foods containing more than 15 per-
cent alcohol.
4. At levels not to exceed 0.25 percent by weight of polyoxymethylene
homopolymers used in accordance with § 177.2480 of this chapter. The
finished articles shall not be used for foods containing more than 15 per-
cent alcohol.
5. At levels not to exceed 0.2 percent by weight of rigid vinyl chloride plas-
tics prepared from vinyl chloride homopolymers and/or vinyl chloride co-
polymers used in accordance with a prior sanction or applicable regula-
tions in parts 175, 176, and 177 of this chapter. The vinyl chloride co-
polymers shall contain not less than 50 weight percent of total polymer
units derived from vinyl chloride.
6. At levels not to exceed 0.1 percent by weight of vinylidene chloride
homopolymers and/or vinylidene chloride copolymers used in accordance
with a prior sanction or applicable regulations in parts 175, 176, and 177
of this chapter. The vinylidene chloride copolymers shall contain not less
than 50 weight percent of total polymer units derived from vinylidene

chloride.
7. In adhesives used in accordance with § 175.105 of this chapter.
388
2,2′-Ethylidenebis(4,6-di-tert-butylphenol) (CAS For use only:

Reg. No. 35958–30–6). 1. At levels not to exceed 0.1 percent by weight of olefin polymers com-
plying with § 177.1520(c) of this chapter, item 1.1, 1.2, 1.3, 3.1, or 3.2
(where the polymers complying with items 3.1 and 3.2 contain primarily
polymer units derived from propylene).
plying with § 177.1520(c) of this chapter, item 2.1, 2.2, or 2.3. The fin-
ished polymers are to be used only under conditions of use B through H
plying with § 177.1520(c) of this chapter, item 2.1, 2.2, or 2.3 (where the
density of each of these polymers is not less than 0.94 g/cc) and item 3.1
or 3.2 (where each of these polymers contains primarily polymer units
derived from ethylene).
plying with § 177.1520(c) of this chapter, item 3.3, 3.4, 3.5, or 4.
5. At levels not to exceed 0.1 percent by weight of ethylene vinyl acetate
copolymers complying with § 177.1350 of this chapter and under condi-
tions of use C through G described in table 2 of § 176.170(c) of this
chapter.
6. At levels not to exceed 0.1 percent by weight of rigid or semirigid poly-
vinyl chloride and under conditions of use B through H described in table
styrene copolymers containing less than 30 percent by weight of acrylo-
nitrile and under conditions of use D through G described in table 2 of
8. At levels not to exceed 0.1 percent by weight of polystyrene complying
with § 177.1640 of this chapter and under conditions of use D through G
9. At levels not to exceed 0.2 percent by weight of rubber-modified poly-
styrene complying with § 177.1640 of this chapter.
389
§ 178.2010 21 CFR Ch. I (4–1–23 Edition)
2,2′-Ethylidenebis(4,6-di-tert- For use only:

butylphenyl)fluorophosphonite (CAS Reg. No. 1. As provided in § 175.105 of this chapter.
118337–09–0). 2. In all polymers used in contact with food of types I, II, IV-B, VI-A, VI-B,
VII-B, and VIII, under conditions of use B through H described in Tables
1 and 2 of § 176.170(c) of this chapter at levels not to exceed 0.25 per-
cent by weight of polymers.
3. In polypropylene complying with § 177.1520(c) of this chapter, item 1.1,
in contact with food of types III, IV-A, V, VII-A, and IX, under:
(a) Conditions of use B through H described in Tables 1 and 2 of
§ 176.170(c) of this chapter at levels not to exceed 0.25 percent by
weight of the polymer; or
(b) Condition of use A, limited to levels not to exceed 0.1 percent by weight
of the polymer; provided that the food-contact surface has an average
thickness not exceeding 375 micrometers (0.015 inch).
4. In olefin copolymers complying with § 177.1520(c) of this chapter, items
3.1a or 3.2a, and containing not less than 85 percent by weight of poly-
mer units derived from propylene, in contact with food of types III, IV-A,
V, VII-A, and IX, and under:
(a) Conditions of use C through G, described in Tables 1 and 2 of
§ 176.170(c) of this chapter, limited to levels no greater than 0.2 percent
by weight of the copolymers; or
(b) Conditions of use A, B, and H, limited to levels no greater than 0.1 per-
cent by weight of the olefin copolymers; provided that the food-contact
surface has an average thickness not exceeding 375 micrometers (0.015
inch).
5. In olefin polymers complying with § 177.1520(c) of this chapter, items 1.2
or 1.3 in contact with food of types III, IV-A, V, VII-A, and IX, under con-
ditions of use A through H, described in Tables 1 and 2 of § 176.170(c)
of this chapter at levels not to exceed 0.1 percent by weight of the poly-
mers; provided that the food-contact surface has an average thickness
not exceeding 375 micrometers (0.015 inch).
6. In polyethylene complying with § 177.1520(c) of this chapter, items 2.1 or
2.2, having a density of not less than 0.94, in contact with food of types
III, IV-A, V, VII-A, and IX, and under:
(a) Conditions of use B through H, described in Tables 1 and 2 of
§ 176.170(c) of this chapter limited to levels not to exceed 0.2 percent by
weight of the polymers; or
(b) Condition of use A, described in Tables 1 and 2 of § 176.170(c) of this
chapter, limited to levels not to exceed 0.1 percent by weight of the poly-
mer; provided that the food-contact surface has an average thickness not
exceeding 125 micrometers (0.005 inch).
7. In olefin copolymers complying with § 177.1520(c) of this chapter, items
3.1a, 3.1b, 3.2a, or 3.2b, containing not less than 85 percent by weight of
polymer units derived from ethylene and having a density of not less than
0.94, in contact with food of types III, IV-A, V, VII-A, and IX, and under:
(a) Conditions of use C through G, described in Tables 1 and 2 of
§ 176.170(c) of this chapter limited to levels not to exceed 0.2 percent by
weight of the copolymers; or
(b) Conditions of use A, B, and H, limited to levels not to exceed 0.1 per-
cent by weight of the copolymers; provided that the food-contact surface
has an average thickness not exceeding 125 micrometers (0.005 inch).
8. In olefin polymers complying with § 177.1520(c) of this chapter, items
3.1a, 3.1b, 3.2a, or 3.2b containing not less than 85 percent by weight of
polymer units derived from ethylene, in contact with food of types III, IV-
A, V, VII-A, and IX, under conditions of use A through H, as described in
Tables 1 and 2 of § 176.170(c) of this chapter at levels not to exceed 0.1
percent by weight of the copolymer; provided that the food-contact sur-
face has an average thickness not exceeding 75 micrometers (0.003
inch).
9. In polyethylene phthalate polymers complying with § 177.1630 of this
chapter in contact with food of types III, IV-A, V, VI-C, VII-A, and IX, and
under:
(a) Conditions of use B through H, described in tables 1 and 2 of
§ 176.170(c) of this chapter, limited to levels not to exceed 0.3 percent by
weight of the polymers; or
(b) Condition of use A with food of types III, IV-A, V, VII-A, and IX, and lim-
ited to levels not to exceed 0.1 percent by weight of the polymers; pro-
vided that the film thickness does not exceed 875 micrometers (0.035
inch).
Hexadecyl 3,5-di-tert-butyl-4-hydroxybenzoate For use only at levels not to exceed 0.5 percent by weight of olefin poly-
(CAS Reg. No. 67845–93–6). mers complying with § 177.1520 of this chapter.
390
Hexamethylenebis (3,5-di-tert-butyl-4- For use only:

hydroxyhydrocinnamate) (CAS Reg. No. 35074- 1. As provided in § 177.2470(b)(1) and § 177.2480(b)(1) of this chapter.
77-2). 2. In adhesives complying with § 175.105 of this chapter.
3. At levels not to exceed 1 percent by weight in pressure-sensitive adhe-
4. At levels not to exceed 1 percent by weight in can end cement formula-
tions complying with § 175.300(b)(3)(xxxi) of this chapter.
5. At levels not to exceed 1 percent by weight in side seam cement formu-
lations complying with § 175.300(b)(3)(xxxii) of this chapter.
6. At levels not to exceed 1 percent by weight in petroleum alicyclic hydro-
carbon resins, polyamide resins, and terpene resins complying with
7. At levels not to exceed 1 percent by weight in rosin and rosin derivatives
when used in accordance with § 176.170(a)(5) of this chapter.
8. At levels not to exceed 1 percent by weight in petroleum alicyclic hydro-
carbon resins or their hydrogenated products complying with
§ 176.170(b)(2) of this chapter.
9. At levels not to exceed 1 percent by weight in terpene resins complying
with § 175.300(b)(3)(xi) of this chapter, when such terpene resins are
used in accordance with § 176.170(b)(1) of this chapter.
10. At levels not to exceed 1 percent by weight in resins and polymers au-
thorized for use in accordance with § 176.180 of this chapter.
11. At levels not to exceed 1 percent by weight in closures with sealing
12. At levels not to exceed 1 percent by weight in rubber articles intended
for repeated use complying with § 177.2600 of this chapter.
13. At levels not to exceed 1 percent by weight in petroleum hydrocarbon
resin and rosins and rosin derivatives used in accordance with
14. At levels not to exceed 1 percent by weight in reinforced wax complying
N,N′-Hexamethylenebis (3,5-di-tert-butyl-4- For use only:
hydroxyhydrocinnamamide) (CAS Reg. No. 1. At levels not to exceed 1 percent by weight of nylon resins complying
23128–74–7). with § 177.1500(b) of this chapter, items 1 through 8, that contact food
only of the types identified in categories in § 176.170(c) of this chapter,
table 1 except VI-A and VI-C.
2. At levels not to exceed 0.75 percent by weight of nylon 12 resins com-
plying with § 177.1500(b) of this chapter, item 9, that contact food only of
the types identified in categories in § 176.170(c) of this chapter, table 1,
except VI-A and VI-C.
3. At levels not to exceed 0.6 percent by weight of polyester resins com-
plying with § 175.300(b)(3)(vii) of this chapter.
5. At levels not to exceed 0.6 percent by weight of repeated use rubber ar-
ticles complying with § 177.2600 of this chapter.
6. At levels not to exceed 0.5 percent by weight of polyoxymethylene co-
polymer complying with § 177.2470 of this chapter.
homopolymer complying with § 177.2480 of this chapter.
1,6–Hexanediamine, N,N′-bis(2,2,6,6-tetramethyl- For use only as a stabilizer at levels not to exceed 0.3 percent by weight of
4-piperidinyl)-, polymers with morpholine-2,4,6- olefin polymers complying with § 177.1520(c) of this chapter. The finished
trichloro-1,3,5-triazine reaction products, polymers are to contact food only under conditions of use C, D, E, F, and
methylated (CAS Reg. No. 193098–40–7). G, as described in Table 2 of § 176.170(c) of this chapter. Provided that
the finished food-contact articles have a volume of at least 18.9 liters (5
gallons).
391
§ 178.2010 21 CFR Ch. I (4–1–23 Edition)
1,6-Hexanediamine, N,N’-bis(2,2,6,6-tetramethyl-4- For use only:

piperidinyl)-, polymer with 2,4,6-trichloro-1,3,5- 1. At levels not to exceed 0.5 percent by weight of propylene polymers and
triazine, reaction products with N-butyl-1- copolymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2,
butanamine and N-butyl-2,2,6,6-tetramethyl-4- 3.1a, 3.2a, 3.2b, 3.4, or 3.5. The finished polymers may contact food only
piperidinamine (CAS Reg. No. 192268–64–7). of the types identified in § 176.170(c) of this chapter, table 1, under cat-
egories I, II, IV-B, VI-A, VI-B, VII-B, and VIII, and under conditions of use
B through H described in table 2 of § 176.170(c) of this chapter.
2. At levels not to exceed 0.3 percent by weight of propylene polymers and
3.1a, 3.2a, 3.2b, 3.4, or 3.5. The finished polymers may contact food only
of the types identified in § 176.170(c) of this chapter, table 1, under cat-
egories III, IV-A, V, VI-C, VII-A, and IX, and under conditions of use B
through H described in table 2 of § 176.170(c) of this chapter.
may contact food only of the types identified in § 176.170(c) of this chap-
ter, table 1, under categories I, II, IV-B, VI-A, VI-B, VII-B, and VIII, and
under conditions of use B through H described in table 2 of § 176.170(c)
of this chapter.
may contact food only of the types identified in § 176.170(c) of this chap-
ter, table 1, under categories III, IV-A, V, VI-C, VII-A, and IX, and under
conditions of use B through H described in table 2 of § 176.170(c) of this
chapter.
polymers is less than 0.94 gram per cubic centimeter), or 5. The finished
polymers may contact food only of the types identified in § 176.170(c) of
this chapter, table 1, under categories I, II, IV-B, VI-A, VI-B, VII-B, and
VIII, and under conditions of use C through G described in table 2 of
polymers is less than 0.94 gram per cubic centimeter), or 5. The finished
polymers may contact food only of the types identified in § 176.170(c) of
this chapter, table 1, under categories III, IV-A, V, VI-C, VII-A, and IX,
and under conditions of use C through G described in table 2 of
2-Hydroxy-4-isooctoxy-benzophenone. Chemical For use only at levels not to exceed 0.5 percent by weight of olefin copoly-
Abstracts (CA) name: Methanone, [2-hydroxy-4- mers complying with § 177.1520(c) of this chapter: Items 1.1, 1.2, 1.3,
(isooctyloxy) phenyl]phenyl; CA Registry No. 2.1, 2.2, 2.3, 3.1, 3.2, 3.3 or 4: Provided, That the finished polymer con-
33059–05–1. tacts food only of the types identified in § 176.170(c) of this chapter, table
1, under Categories I, VII-B and VIII under conditions of use E, F, and G
392
2(2′-Hydroxy-5′-methylphenyl)benzotriazole meet- For use only:

ing the following specification: melting point 1. As component of nonfood articles complying with § 177.1010 of this
126°–132 °C (258.8°–269.6 °F) (CAS Reg. No. chapter.
2440–22–4). 2. At levels not to exceed 0.25 percent by weight of rigid polyvinyl chloride
and/or rigid vinyl chloride copolymers complying with § 177.1980 of this
chapter.
3. In polystyrene that complies with § 177.1640 of this chapter and that is
limited to use in contact with dry food of Type VIII described in table 1 of
4. At levels not to exceed 0.25 percent by weight of polystyrene and/or rub-
ber-modified polystyrene polymers complying with § 177.1640 of this
chapter intended to contact nonalcoholic food: Provided, That the finished
basic rubber-modified polystyrene polymers in contact with fatty foods
shall contain not less than 90 weight percent of total polymer units de-
rived from styrene monomer.
complying with § 177.1580 of this chapter. Provided, That the finished
polycarbonate resins contact food only of Types I, II, III, IV, V, VI-A, VI-B,
VII, VIII, and IX identified in table 1 of § 176.170(c) of this chapter and
under conditions of use E, F, and G described in table 2 of § 176.170(c)
of this chapter.
6. At levels not to exceed 0.5 percent by weight of ethylene-1,4-
cyclohexylene dimethylene terephthalate copolymers complying with
§ 177.1315 of this chapter and of ethylene phthalate polymers complying
with § 177.1630 of this chapter and that contact food only under condi-
tions of use D through G described in table 2, § 176.170(c) of this chap-
ter.
2-Hydroxy-4-n-octoxy-benzophenone ..................... For use only at levels not to exceed 0.5 percent by weight of olefin poly-
2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4: Provided, That the finished polymer con-
tacts food only of the types identified in § 176.170(c) of this chapter, table
1, under Categories I, IV-B, VII-B, and VIII , and under the conditions of
use B through H described in table 2 of § 176.170(c) of this chapter.
4,4′-Isopropylidenediphenol alkyl(C12-C15) For use only at levels not exceeding 1.0 percent by weight in rigid polyvinyl
phosphites; the phosphorus content is in the chloride and/or rigid vinyl chloride copolymers complying with
range of 5.2–5.6 weight percent. §§ 177.1950, 177.1970 or 177.1980 of this chapter, and used in contact
with food, except milk, only under the conditions described in
§ 176.170(c) of this chapter, table 2, under conditions of use D through
G.
Magnesium salicylate .............................................. For use only in rigid polyvinyl chloride and/or in rigid vinyl chloride copoly-
mers complying with § 177.1980 of this chapter: Provided, That total
salicylates (calculated as the acid) do not exceed 0.3 percent by weight
of such polymers.
2-Methyl-4,6-bis-[(octylthio)methyl] phenol (CAS For use only:
Reg. No. 110553–27–0). 1. In adhesives complying with § 175.105 of this chapter.
2. At levels not to exceed 0.5 percent by weight of can-end cements and
side-seam cements complying with § 175.300(b)(xxxi) and (xxxii) of this
chapter.
3. At levels not to exceed 1 percent by weight of pressure sensitive adhe-
sives complying with § 175.125 of this chapter petrolium alicyclic hydro-
carbon resins complying with § 176.170 of this chapter, resins and poly-
mers complying with § 176.180 of this chapter, and closures with sealing
4. At levels not to exceed 1.7 percent by weight of the finished rubber prod-
ucts complying with § 177.2600 of this chapter.
drocarbon resins complying with § 175.320 of this chapter; rubber-modi-
fied polystyrene complying with § 177.1640 of this chapter; and petroleum
hydrocarbon resins and rosins and rosins and rosin derivatives complying
6. At levels not to exceed 0.2 percent by weight of styrene block polymenrs
complying with § 177.1810 of this chapter that contact food of Types I, II,
IV-B, VI, VII-B, and VIII described in table 1, § 176.170(c) of this chapter,
only under conditions of use C through H described in table 2,
393
§ 178.2010 21 CFR Ch. I (4–1–23 Edition)
2,2′-Methylenebis(4,6-di-tert-butylphenyl)2- For use only at levels not to exceed 0.25 percent by weight of poly-
ethylhexyl phosphite (CAS Reg. No. 126050– propylene complying with § 177.1520 of this chapter. The finished poly-
54–2). mers may only be used in contact with food of the types identified in
§ 176.170(c) of this chapter, table 1, under Categories I, II, IV-B, VI-B,
VII-B, and VIII under conditions of use B through H described in table 2,
§ 176.170(c) of this chapter, and with food of the types identified in
§ 176.170(c) of this chapter, table 1, under Categories III, IV-A, V, VI-A,
VI-C, VII-A, and IX under conditions of use C through G described in
table 2, § 176.170(c) of this chapter.
2,2′-Methylenebis (6-tert-butyl-4-ethylphenol) ........ For use only:
1. In acrylonitrile-butadiene-styrene copolymers at levels not to exceed 0.6
percent by weight of the copolymer.
2. In semirigid and rigid acrylic and modified acrylic plastics complying with
§ 177.1010 of this chapter at levels not to exceed 0.1 percent by weight
of the plastic.
4,4′-Methylenebis (2,6-di-tert-butyl-phenol) ............ For use only:
1. As provided in § 175.105 of this chapter.
resins used in compliance with regulations in parts 174, 175, 176, 177,
178 and § 179.45 of this chapter.
3. At levels not to exceed 0.25 percent by weight of terpene resins used in
compliance with regulations in parts 174, 175, 176, 177, 178 and
with § 177.1520 of this chapter: Provided, That the polyethylene end
product contacts foods only of the types identified in Categories I, II, IV-
B, VI, VII-B, and VIII in table 1, § 176.170(c) of this chapter.
5. At levels not to exceed 0.5 percent by weight of polybutadiene used in
rubber articles complying with § 177.2600 of this chapter: Provided, That
the rubber end product contacts foods only of the types identified in Cat-
egories I, II, IV-B, VI, VII-B, and VIII in table 1, § 176.170(c) of this chap-
ter.
2,2′-Methylenebis(4-methyl-6-tert-butylphenol) ....... For use only:
plying with sec. 177.1520(c) of this chapter, items 1.1, 1.2, 1.3, 2.1, 2.2,
2.3, 3.1, 3.2, 3.3, or 4 used in articles that contact food of the types iden-
tified in sec. 176.170(c) of this chapter, table 1, under Categories I, II, IV-
B, VI, VII-B, and VIII.
2. At levels not to exceed 1 percent by weight of polyoxymethylene copoly-
mer as provided in sec. 177.2470(b)(1) of this chapter.
homopolymer as provided in § 177.2480(b)(1) of this chapter.
2,2′-Methylenebis(4-methyl-6-tert-butylphenol) For use only:
monoacrylate (CAS Reg. No. 61167–58–6). 1. At levels not to exceed 0.5 percent by weight of polystyrene and rubber-
modified polystyrene complying with § 177.1640 of this chapter.
2. At levels not to exceed 0.5 percent by weight of styrene block ploymers
3. At levels not to exceed 1 percent by weight of adhesives complying with
§ 175.105 of this chapter and pressure sensitive adhesives complying
styrene copolymers that comply with § 177.1020 of this chapter when
used in articles that contact food only under conditions of use E, F, and
G as described in table 2, § 176.170 (c) of this chapter.
2,2′-Methylenebis[6-(1-methylcyclo-hexyl)-p-cresol] For use only:
with § 177.1520 of this chapter: Provided, That the finished polyethylene
contacts foods only of the type identified in § 176.170(c) of this chapter,
table 1, under Categories I, II, VI-B, and VIII.
3. In polyethylene complying with § 177.1520 of this chapter: Provided, That
the finished polyethylene contacts foods only of the types identified in
§ 176.170(c) of this chapter, table 1, under Categories III, IV, V, VI-A, VII,
and IX, and only at temperatures not to exceed room temperature: And
further provided, That percentage concentration of the antioxidant in the
polyethylene, when multiplied by the thickness in inches of the finished
polyethylene, shall not be greater than 0.0005.
2,2′-Methylenebis(4-methyl-6-nonylphenol) and For use only in acrylonitrile-butadiene-styrene copolymers used in contact
2,6-bis(2-hydroxy-3-nonyl-5-methyl-benzyl)-p- with nonalcoholic foods.
cresol mixtures (varying proportions).
394
Methyltin-2-mercaptoethyloleate sulfide, which is For use only in rigid poly(vinyl chloride) and rigid vinyl chloride copolymers
defined as one or more of the following: complying with §§ 177.1950 and 177.1980 of this chapter, respectively,
used in the manufacture of pipes and pipe fittings intended for contact
with water in food processing plants, at levels not to exceed:
1. 1.0 percent by weight in pipes, and
2. 2.0 percent by weight in pipe fittings.
1. 9-Octadecenoic acid (Z)-, 2-mercaptoethyl
ester, reaction products with dichlorodime
thylstannane, sodium sulfide, and
trichloromethylstannane (CAS Reg. No.
68442–12–6);
2. Fatty acids, tall oil, 2-mercaptoethyl esters,
reaction products with
dichlorodimethylstannane, 2-mercaptoethyl
decanoate, 2-mercaptoethyl octanoate, so-
dium sulfide, and trichloromethylstannane
(CAS Reg. No. 151436–98–5); or
3. Fatty acids, tall oil, 2-mercaptoethyl esters,
reaction products with
dichlorodimethylstannane, sodium sulfide,
and trichloromethylstannane (CAS Reg. No.
201687–57–2);and which has the following
specifications: Tin content (as Sn) 5 to 21
percent by weight; mercaptosulfur content 5
to 13 percent by weight; acid value no
greater than 4.
Methyltin-2-Mercaptoethyloleate sulfide may
also be used with one or more of the fol-
lowing optional substances:
1.1a 2-Mercaptoethyl oleate (CAS Reg. No.
59118–78–4),
1.1b 2-Mercaptoethyl tallate (CAS Reg. No.
68440–24–4),
1.1c 2-Mercaptoethyl octanoate (CAS Reg.
No. 57813–59–9),
1.1d 2-Mercaptoethyl decanoate (CAS Reg.
No. 68928–33–6), alone or in combination;
not to exceed 40 percent by weight of the
stabilizer formulation;
2.1 2-Mercaptoethanol (CAS Reg. No. 60–24–
2): Not to exceed 2 percent by weight of
the stabilizer formulation.
3.1 Mineral oil (CAS Reg. No. 8012–95–1):
Not to exceed 40 percent by weight of the
stabilizer formulation.
4.1 Butylated hydroxytoluene (CAS Reg. No.
128–37–0): Not to exceed 5 percent by
weight of the stabilizer formulation.
The total of the optional substances (1.1a
through 4.1) shall not exceed 60 percent by
weight of the stabilizer formulation.
Nylon 66/610/6 terpolymer (see § 177.1500 of this For use only at levels not to exceed 1.5 percent by weight of
chapter for identification) polyoxymethylene homopolymer as provided in § 177.2480 (b)(1) of this
chapter.
Nylon 612/6 copolymer. (CAS Reg. No. 51733– For use only at levels not to exceed 1.5 percent by weight of
10–9), weight ratio 6/1. polyoxymethylene homopolymer as provided in § 177.2480(b)(1).
395
§ 178.2010 21 CFR Ch. I (4–1–23 Edition)
Octadecyl 3,5-di-tert-butyl-4- For use only:

hydroxyhydrocinnamate (CAS Reg. No. 2082– 1. At levels not exceeding 0.25 percent by weight of olefin polymers com-
79–3). plying with § 177.1520(c) of this chapter, item 1.1, 1.2, 1.3, 2.1, 2.2, 2.3,
3.1, 3.2, 3.3, or 4.
2. As provided in §§ 175.105 and 177.1010(a)(5) of this chapter.
3. At levels not exceeding 0.25 percent by weight of polystyrene and/or rub-
chapter, except that the finished basic rubber-modified polystyrene poly-
mers in contact with fatty foods shall contain not less than 85 weight per-
cent of total polymer units derived from styrene monomer.
styrene copolymers used in accordance with prior sanction or regulations
in parts 174, 175, 176, 177, 178 and § 179.45 of this chapter.
5. At levels not exceeding 0.25 percent by weight of olefin copolymers com-
plying with § 177.1520(c) of this chapter, items 3.4 and 3.5 as follows: (a)
item 3.4, Provided, That the finished copolymer contacts foods only of
types identified in § 176.170(c) of this chapter, table 1, under Categories
I, II, III, IV-B, VI, VII, VIII, and IX; (b) item 3.5, Provided, That the finished
copolymer contacts non-fatty foods only of types identified in § 176.170(c)
of this chapter, table 1, under Categories I, II, IV-B, VI, VII-B, and VIII.
6. At levels not exceeding 0.05 percent by weight of modified semi-rigid
and rigid vinyl chloride plastics modified with methacrylate-butadiene-sty-
rene copolymers in accordance with § 178.3790.
7. At levels not exceeding 0.2 percent by weight of rigid polyvinyl chloride.
that comply with § 177.1580 and that contact food only under conditions
of use E, F, and G described in table 2, § 176.170(c) of this chapter.
9. At levels not exceeding 0.1 percent by weight of ethylene-vinyl acetate
copolymers complying with § 177.1350 of this chapter.
10. At levels not to exceed 0.2 percent by weight of nitrile rubber-modified
acrylonitrile-methyl acrylate copolymers that comply with § 177.1480 of
this chapter when used in articles that contact food only under conditions
of use D, E, F, and G described in table 2, § 176.170(c) of this chapter.
11. At levels not exceeding 0.3 percent by weight of styrene block polymers
complying with § 177.1810 of this chapter when used in articles that con-
tact food only of the types identified in § 176.170(c) of this chapter, table
1, under Categories I, II, IV-B, VI, VII-B, and VIII, and under conditions of
use D, E, F, and G described in table 2 of § 176.170(c) of this chapter.
12. At levels not exceeding 0.2 percent by weight of vinylidene chloride
homopolymers and/or vinylidene chloride copolymers complying with ap-
plicable regulations in parts 175, 176, 177, 179, and 181 of this chapter.
The vinylidene chloride copolymers shall contain not less than 50 weight
percent of total polymer units derived from vinylidene chloride.
13. At levels not exceeding 0.025 percent by weight of chlorinated
isobutylene-isoprene copolymers complying with § 177.1420(a)(3) of this
chapter.
14. At levels not exceeding 0.5 percent by weight of the finished rubber ar-
ticle complying with § 177.2600 of this chapter.
396
7-Oxa-3,20-diazadispiro-[5.1.11.2]-heneicosan-21- For use only:

one,2,2,4,4-tetramethyl-,hydrochloride, reaction 1. At levels not to exceed 0.5 percent by weight of olefin polymers com-
products with epichlorohydrin, hydrolyzed, po- plying with § 177.1520 of this chapter, items 1.1, 3.1, and 3.2, where the
lymerized (CAS Reg. No. 202483–55–4). copolymers complying with items 3.1 and 3.2 contain not less than 85
weight percent of polymer units derived from propylene; in contact with
all types of food described in Table 1 of § 176.170 of this chapter, pro-
vided that the finished food-contact article will have a capacity of at least
18.9 liters (5 gallons) when in contact with food of types III, IV-A, V, VII-
A, and IX, described in Table 1 of § 176.170 of this chapter.
plying with § 177.1520 of this chapter, items 2.1, 2.2, 3.1, and 3.2, having
a density of not less than 0.94 gram/milliliter, where the copolymers com-
plying with items 3.1 and 3.2 contain not less than 85 weight percent of
polymer units derived from ethylene; in contact with food only under con-
ditions of use C, D, E, F, and G, described in Table 2 of § 176.170 of this
chapter, provided that the finished food-contact article will have a capac-
ity of at least 18.9 liters (5 gallons) when in contact with food of types III,
IV-A, V, VII-A, and IX, described in Table 1 of § 176.170 of this chapter.
plying with § 177.1520 of this chapter, items 2.1, 2.2, 3.1, 3.2, 3.3, 3.4,
3.5, 3.6, and 4.0, having a density of less than 0.94 gram/milliliter, in con-
tact with food only under conditions of use D, E, F, and G, described in
Table 2 of § 176.170 of this chapter, provided that the finished food-con-
tact article will have a capacity of at least 18.9 liters (5 gallons) except
that, films and molded articles containing not more than 0.2 percent by
weight of the stabilizer may contact aqueous food of types I, II, IV-B, VI,
and VIII, described in Table 1 of § 176.170 of this chapter with no restric-
tions on the amount of food contacted.
Oxidized bis(hydrogenated tallow alkyl)amines ...... For use only:
1. At levels not to exceed 0.1 percent by weight of polypropylene polymers
complying with § 177.1520(c) of this chapter, item 1.1, 1.2, 1.3, 3.1a
(density not less than 0.85 gram per cubic centimeter and less than 0.91
gram per cubic centimeter), 3.2b, 3.4, and 3.5. The finished polymers
may be used in contact with food types I, II, IV-B, VII-B and VIII de-
scribed in table 1 of § 176.170(c) of this chapter, under conditions of use
B through H described in table 2 of § 176.170(c) of this chapter and with
food types III, IV-A, V, VI, VII-A, and IX described in table 1 of
§ 176.170(c) of this chapter, under conditions of use D through H de-
2. At levels not to exceed 0.075 percent by weight of high-density poly-
ethylene polymers complying with § 177.1520(c) of this chapter, item 2.1,
2.2, 2.3, 3.1a, 3.1b, 3.2a, 3.6 (density not less than 0.94 gram per cubic
centimeter), and 5. The finished polymers may be used in contact with
food types I, II, IV-B, VII-B and VIII described in table 1 of § 176.170(c) of
this chapter, under conditions of use B through H described in table 2 of
§ 176.170(c) of this chapter, and with food types III, IV-A, V, VI, VII-A and
IX described in table 1 of § 176.170(c) of this chapter, under conditions of
use D through H described in table 2 of § 176.170(c) of this chapter.
2,2′-Oxamidobis[ethyl 3-(3,5-di-tert-butyl-4- For use only:
hydroxyphenyl)propionate] (CAS Reg. No. 1. At levels not to exceed 0.5 percent by weight of polystyrene and rubber-
70331–94–1). modified polystyrene complying with § 177.1640 of this chapter.
plying with § 177.1520(c) of this chapter, items 1.1, 1.2, and 1.3.
plying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, 3.2, 3.3,
3.4, 3.5, and 4.0 that contact food Types I, II, IV-B, VI, VII-B and VIII de-
plying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, 3.2, 3.3,
and 4.0 that contact food Types III, IV-A, V, VII-A, and IX described in
table 1 of § 176.170(c) of this chapter; except that olefin copolymers com-
plying with items 3.1 and 3.2 where the majority of polymer units are de-
rived from propylene may contain the additive at levels not to exceed 0.5
percent by weight.
plying with item 3.4 of § 177.1520(c) of this chapter, that contact food
Types III, VII-A, and IX described in table 1 of § 176.170(c) of this chap-
ter; except that olefin copolymers complying with item 3.4 where the ma-
jority of the polymer units are derived from propylene may contain the ad-
ditive at levels not to exceed 0.5 percent by weight.
397
§ 178.2010 21 CFR Ch. I (4–1–23 Edition)
Pentaerythritol and its stearate ester ...................... For use only in rigid polyvinyl chloride and/or in rigid vinyl chloride copoly-
mers complying with § 177.1980 of this chapter: Provided, That the total
amount of pentaerythritol and/or pentaerythritol stearate (calculated as
free pentaerythritol) does not exceed 0.4 percent by weight of such poly-
mers.
N-Phenylbenzenamine reaction products with For use at levels not to exceed 0.5 percent by weight of pressure-sensitive
2,4,4-trimethylpentenes (CAS Reg. No. 68411– adhesives complying with § 175.125 of this chapter.
46–1).
Phosphoric acid triesters with triethylene glycol At levels not to exceed 0.1 percent by weight of polyethylene phthalate
(CAS Reg. No. 64502–13–2). polymers complying with § 177.1630 of this chapter, such that the poly-
mers contact foods only of Type VI-B described in table 1 of § 176.170(c)
of this chapter.
Phosphorous acid, cyclic butylethyl propanediol, For use only:
2,4,6-tri-tert-butylphenyl ester (CAS Reg. No. 1. At levels not to exceed 0.2 percent by weight of olefin polymers com-
161717–32–4), which may contain not more plying with § 177.1520(c) of this chapter, items 1.1, 1.2, or 1.3, and items
than 1 percent by weight of triisopropanolamine 2.1, 2.2, or 2.3 (where the density of these polymers is not less than 0.94
(CAS Reg. No. 122–20–3). gram per cubic centimeter), and items 3.1 or 3.2, provided that the fin-
ished polymer contacts foods of types I, II, and VI-B as described in table
1 of § 176.170(c) of this chapter only under conditions of use B, C, D, E,
F, G, and H as described in table 2 of § 176.170(c) of this chapter.
plying with § 177.1520(c) of this chapter, items 1.1, 1.2, or 1.3, that con-
tact food of types III, IV, V, VI-A, VI-C, VII, VIII, and IX as described in
table 1 of § 176.170(c) of this chapter, only under conditions of use C, D,
E, F, and G as described in table 2 of § 176.170(c) of this chapter.
plying with § 177.1520(c) of this chapter, items 3.1a, 3.1b, 3.2a, or 3.2b,
having a density less than 0.94 grams per cubic centimeter, in contact
with food only of types III, IV, V, VI-A, VI-C, VII, VIII, and IX and under
conditions of use B, C, D, E, F, G, and H as described in tables 1 and 2
of § 176.170(c) of this chapter; provided that the food-contact surface
does not exceed 0.003 inch (0.076 mm) in thickness.
plying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1(a),
3.1(b), 3.1(c), 3.2 (a), or 3.2(b), having a density not less than 0.94
grams per cubic centimeter, in contact with foods only of types III, IV, V,
VI-A, VI-C, VII, VIII, and IX identified in Table 1 of § 176.170(c) of this
chapter, and under conditions of use B through H as described in Table
2 of § 176.170(c) of this chapter; provided that the food-contact surface
does not exceed 0.003 inch (0.076 mm) in thickness.
Phosphorous acid, cyclic neopentanetetrayl For use only at levels not to exceed 0.10 percent by weight of olefin poly-
bis(2,4-di-tert-butylphenyl) ester (CAS Reg. No. mers complying with § 177.1520(c) of this chapter, item 1.1, 1.2, 1.3, 2.1,
26741–53–7) which may contain not more than 2.2, 2.3, 3.1, or 3.2, and limited to use in contact with food only under
1 percent by weight of triisopropanolamine (CAS conditions of use B, C, D, E, F, G, and H described in table 2 of
Reg. No. 122–20–3). § 176.170(c) of this chapter. Olefin polymers that contain more than 50
weight-percent of polymer units derived from ethylene shall have a den-
sity equal to or greater than 0.94 gram per cubic centimeter.
Phosphorous acid, cyclic neopentanetetrayl bis For use only:
(2,6-di-tert-butyl-4-methylphenyl)ester (CAS 1. At levels not to exceed 0.25 percent by weight of polypropylene
Reg. No. 80693–00–1). homopolymer and copolymers complying with § 177.1520 of this chapter,
for use with all food types described in table 1 of § 176.170(c) of this
chapter only under conditions of use B through H described in table 2 of
2. At levels not to exceed 0.05 percent by weight of polymers complying
with § 177.1520(c) of this chapter, item 3.1 or 3.2, and with a maximum
thickness of 100 micrometers (0.004 inch) for use with all food types
under conditions of use B, C, D, E, F, G, and H described in table 2 of
398
Phosphorous acid, cyclic neopentanetetrayl For use only:

bis(2,4-di-tert-butylphenyl)ester (CAS Reg. No. 1. At levels not to exceed 0.86 percent by weight in polyvinyl chloride and/
26741–53–7). or vinyl chloride copolymers that comply with §§ 177.1950, 177.1960,
177.1970, or 177.1980 of this chapter for use with all food types de-
scribed in table 1 of § 176.170(c) of this chapter, except those containing
more than 15 percent alcohol, under conditions of use B, C, D, E, F, G,
that comply with § 177.1580 of this chapter for use with all food types de-
scribed in table 1 of § 176.170(c) of this chapter, except those containing
more than 15 percent alcohol, under conditions of use B, C, D, E, F, G,
3. At levels not to exceed 0.05 percent by weight in olefin polymers com-
plying with § 177.1520(c) of this chapter, item 3.1, that contain more than
50 weight percent of polymer units derived from ethylene and whose
density is less than 0.94 gram per cubic centimeter. The average thick-
ness of such polymers intended for use in contact with food types V and
VII-A described in table 1 of § 176.170(c) of this chapter shall not exceed
80 micrometers (0.003 inch).
Poly(1,4-cyclohexylenedimethylene-3,3′- For use only:
thiodipropionate) partially terminated with stearyl 1. In polypropylene complying with § 177.1520(c) of this chapter, item 1.1,
alcohol and produced when approximately equal and used in contact with nonfatty, nonalcoholic food.
moles of 1,4-cyclohexanedimethanol and 3,3′- 2. At levels not to exceed 0.5 percent by weight of polypropylene complying
thiodipropionic acid are made to react in the with § 177.1520(c) of this chapter, item 1.1, and used in contact with
presence of stearyl alcohol so that the final fatty, nonalcoholic food. The average thickness of such polymers in the
product has an average molecular weight in the form in which they contact fatty nonalcoholic food shall not exceed 0.005
range of 1,800–2,200, as determined by vapor inch.
pressure osmometry, and has a maximum acid
value of 2.5.
Poly[(1,3-dibutyldistannthianediylidene)-1,3-dithio] For use only at levels not to exceed 0.2 by percent weight in polyvinyl chlo-
having the formula [C8H18Sn2S3]n (where n aver- ride resin where such resin constitutes not less than 98.7 percent of a
ages 1.5–2) and produced so as to meet the fol- finished semirigid or rigid polyvinyl chloride food-contact surface, pro-
lowing specifications: Softening point, 130–145 vided that the finished food-contact article is employed only to package
°C; volatile components at 150 °C, less than 1.0 meat, cheese, and food Types I, VIII, and IX as described in table 1 of
percent; sulphur (sulfide) content in the range § 176.170(c) of this chapter. The finished food-contact article containing
20.5–22.0 percent; tin content in the range this stabilizer, when extracted with refined cottonseed oil at 120 °F for 48
52.0–53.2 percent. hours, using a volume-to-surface ratio of 2 milliliters per square inch of
surface tested, shall yield tin (Sn) not to exceed 0.0005 milligram per
square inch of food-contact surface.
Poly[(6-morpholino-s-triazine-2,4-diyl)[(2,2,6,6- For use only:
tetramethyl-4-piperidyl)imino]hexamethylene 1. At levels not to exceed 0.3 percent by weight of polypropylene complying
[(2,2,6,6-tetramethyl-4-piperidyl)imino]] (CAS with § 177.1520(c) of this chapter, items 1.1, 1.2, and 1.3, and of ethyl-
Reg. No. 82451–48–7). ene polymers complying with § 177.1520(c) of this chapter, items 2.1,
2.3, and 3.1, whose specific gravity is not less than 0.94. The finished
polymers are to contact food only under conditions of use D, E, F, and G
plying with § 177.1520(c) of this chapter, items 2.1, 2.3, and 3.1, whose
specific gravity is less than 0.94, and of olefin polymers complying with
items 3.3., 3.4, 3.5, and 4.0. The finished polymers are to contact food in
articles having a volume of at least 18.9 liters (5 gallons) only under con-
ditions of use D, E, F, and G described in table 2 of § 176.170(c) of this
chapter.
Poly[[6-[(1,1,3,3-tetramethybutyl) amino]-s-triazine- For use only:
2,4-diyl][2,2,6,6-tetramethyl-4- 1. At levels not to exceed 0.3 percent by weight of polypropylene complying
piperidyl)imino]hexamethylene[(2,2,6,6- with § 177.1520 of this chapter.
tetramethyl-4-piperidyl)imino]] (CAS Reg. No. 2. At levels not to exceed 0.2 percent by weight of polyethylene complying
70624–18–9). with § 177.1520 of this chapter, that has a density equal to or greater
than 0.94 gram per cubic centimeter.
3. At levels not to exceed 0.3 percent by weight of polyethylene that has a
density less than 0.94 gram per cubic centimeter complying with
§ 177.1520 of this chapter, items 2.1, 2.2, and 2.3, and of olefin polymers
and copolymers complying with items 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, and 4.
The finished polymers are to contact food only under conditions of use B
through H described in table 2 of § 176.170(c) of this chapter, and when
contacting fatty foods of Types III, IV-A, V, VII-A, and IX described in
table 1 of § 176.170(c) of this chapter, the finished articles are to have a
volume of at least 18.9 liters (5 gallons).
399
§ 178.2010 21 CFR Ch. I (4–1–23 Edition)
Potassium bromide and either cupric acetate or For use at levels not exceeding 0.18 percent potassium bromide and 0.005
cupric carbonate. percent copper as cupric acetate or cupric carbonate by weight of nylon
66 resins complying with § 177.1500 of this chapter; the finished resins
are used or are intended to be used to contain foods during oven baking
or oven cooking at temperatures above 250 °F. The average thickness of
such resins in the form in which they contact food shall not exceed
0.0015 inch.
1,3-propanediamine, N,N-1,2-ethanediylbis-, poly- For use only:
mer with 2,4,6-trichloro-1,3,5-triazine, reaction 1. At levels not to exceed 0.3 percent by weight of polypropylene complying
products with N-butyl-2,2,6,6-tetramethyl-4- with § 177.1520(c) of this chapter, items 1.1, 1.2, and 1.3.
piperidinamine (CAS Reg. No. 136504–96–6). 2. At levels not to exceed 0.2 percent by weight of olefin polymers having a
density greater than or equal to 0.94 grams per cubic centimeter and
complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, and
3.2.
3. At levels not to exceed 0.3 percent by weight of olefin polymers having a
density less than 0.94 grams per cubic centimeter and complying with
§ 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, 3.4, 3.5,
3.6, and 4.0. The finished polymers are to contact food only under condi-
tions of use B through H described in Table 2 of § 176.170(c) of this
chapter, and when used in contact with fatty foods of Types III, IV-A, V,
VII-A, and IX as described in Table 1 of § 176.170(c) of this chapter, the
finished articles are to have a volume of at least 18.9 liters (5 gallons).
N,N′-1,3-Propanediylbis (3,5-di-tert-butyl-4- For use only at levels not to exceed 0.6 percent by weight of rubber articles
hydroxyhydrocinnamamide) (CAS Reg. No. for repeated use complying with § 177.2600 of this chapter.
69851–61–2).
Siloxanes and silicones, methyl hydrogen, reaction For use as an ultraviolet (UV) stabilizer only at levels not to exceed 0.33
products with 2,2,6,6-tetramethyl-4-(2- percent by weight of polypropylene complying with § 177.1520(c) of this
propenyloxy)piperidine (CAS Reg. No. 182635– chapter, items 1.1a, 1.1b, 1.2, and 1.3, under conditions of use D, E, F,
99–0). and G, as described in Table 2 of § 176.170 of this chapter.
Stearoylbenzoylmethane (CAS Reg. No. 58446– For use only at levels not to exceed 0.5 percent by weight of vinyl chloride
52–9) consisting of a mixture of b–diketones homopolymers modified in accordance with § 178.3790(b)(1). The fin-
produced by the condensation of acetophenone ished polymers may be used in contact with food containing up to 50 per-
and technical methyl stearate.. cent alcohol under conditions of use B through H described in table 2 of
Styrenated diphenylamine (CAS Reg. No. 68442– For use only in adhesives complying with § 175.105 of this chapter and in
68–2). rubber articles intended for repeated use complying with § 177.2600 of
this chapter.
Tetradecanoic acid, lithium salt (CAS Reg. No. For use only at levels not to exceed 0.15 percent by weight of poly-
20336–96–3). propylene and polypropylene copolymers complying with § 177.1520(c) of
this chapter, items 1.1a, 1.1b, 3.1a, 3.1b, 3.1c, 3.2a, and 3.2b. The fin-
ished polymers may only be used in contact with food of Types I, II, IV-B,
VI-B, VII-B, and VIII as described in table 1 of § 176.170(c) of this chap-
ter under conditions of use B through H as described in table 2 of
§ 176.170(c) of this chapter, and with food of Types III, IV-A, V, VI-A, VI-
C, VII-A, and IX described in table 1 of § 176.170(c) of this chapter under
conditions of use C through G as described in table 2 of § 176.170(c) of
this chapter.
2-[[2,4,8,10-Tetrakis(1,1- For use only at levels not to exceed 0.075 percent by weight of olefin co-
dimethylethyl)dibenzo[d,f][1,3,2]- polymers complying with § 177.1520(c) of this chapter, items 1.1, 1.2,
dioxaphosphepin-6-yl]oxy]-N,N-bis[2-[[2,4,8,10- 1.3, 2.1, 2.2, or 2.3: Provided, That the density of the olefin polymers
tetrakis(1,1- complying with items 2.1, 2.2, or 2.3 is not less than 0.94 gram per cubic
dimethylethy- centimeter: And further provided, That the finished polymers contact food
l)dibenzo[d,f][1,3,2]dioxaphosphepin-6- only of Types I, II, IV-B, VI-A, VI-B, VII-B, and VIII described in table 1, of
yl]oxy]ethyl]ethanamine (CAS Reg. No. 80410– § 176.170(c) of this chapter, under conditions of use B through H de-
33–9). scribed in table 2 of § 176.170(c) of this chapter and food only of Types
III, IV-A, V, VI-C, VII-A, and IX described in table 1 of § 176.170(c) of this
chapter, under conditions of use C through G described in table 2 of
400
Tetrakis [methylene(3,5- di-tert-butyl-4- For use only:

hydroxyhydrocinnamate)] methane (CAS Reg. 1. At levels not to exceed 0.5 percent by weight of all polymers used as in-
No. 6683–19–8). direct additives in food packaging, except as specified below.
2. At levels not to exceed 0.1 percent by weight of petroleum wax or syn-
thetic petroleum wax complying with § 176.170(a)(5) of this chapter.
3. At levels not to exceed 1.0 percent by weight of:
(a) Pressure sensitive adhesives complying with § 175.125 of this chap-
ter.
(b) Can end cement formulations complying with § 175.300(b)(3)(xxxi) of
this chapter.
(c) Petroleum alicyclic hydrocarbon resins complying with § 175.320(b)(3)
of this chapter, § 176.170(b)(2) of this chapter, or their hydrogenated
products complying with § 176.170(b)(2) of this chapter.
(d) Rosin and rosin derivatives used in accordance with parts 175
through 178 of this chapter.
(e) Terpene resins complying with § 175.300(b)(2)(xi) of this chapter
when such terpene resins are used in accordance with § 176.170(b) of
this chapter.
(f) Resins and polymers complying with § 176.180 of this chapter.
(g) Closures with sealing gaskets complying with § 177.1210 of this chap-
ter.
(h) Polyoxymethylene copolymer as provided in § 177.2470(b)(1) of this
chapter.
(i) Petroleum hydrocarbon resin complying with § 178.3800.
(j) Reinforced wax complying with § 178.3850.
4,4-Thiobis(6-tert-butyl-m-cresol) ............................ For use only:
1. As provided in §§ 175.105 and 177.2600 of this chapter.
with § 177.1520 of this chapter: Provided, That the specific gravity of the
polyethylene is not less than 0.926: And further provided, That the fin-
ished polyethylene contacts food only of the types identified in
§ 176.170(c) of this chapter, table 1, under Categories I, II, VI-B, and VIII.
Thiodiethylene bis(3,5-di-tert-butyl-4- For use only:
hydroxyhydrocinnamate) (CAS Reg. No. 41484- 1. In adhesives complying with § 175.105 of this chapter.
35-9). 2. At levels not to exceed 0.5 percent by weight of pressure-sensitive adhe-
sives complying with § 175.125 of this chapter, petroleum alicyclic hydro-
carbon resins complying with § 176.170 of this chapter, resins and poly-
mers complying with § 176.180 of this chapter, closures with sealing gas-
kets complying with § 177.1210 of this chapter, and finished rubber prod-
ucts complying with § 177.2600 of this chapter.
Thiodipropionic acid.
1,3,5-Trimethyl-2,4,6-tris(3,5-di-tert-butyl-4- For use only:
hydroxybenzyl) benzene (CAS Reg. No. 1709– 1. At levels not to exceed 0.5 percent by weight of polymers except nylon
70–2). resins identified in § 177.1500 of this chapter.
2. At levels not to exceed 1 percent by weight of nylon resins identified in
Tri(mixed mono-and dinonylphenyl) phosphite
(which may contain not more than 1 percent by
weight of triisopropanolamine)..
1, 11-(3, 6, 9-Trioxaundecyl) bis-3-(dodecylthio) For use only as provided in § 175.300(b)(3)(xxxi) of this chapter at 4.0 parts
propionate (CAS Reg. No. 64253–30–1). per 100 parts rubber.
1,3,5-Tris(3,5-di-tert-butyl-4-hydroxybenzyl)-s-tri- For use only:
azine-2,4,6(1H,3H,5H)trione (CAS Reg. No. 1. At levels not to exceed 0.25 percent by weight of polypropylene com-
27676–62–6). plying with § 177.1520 of this chapter.
2. In polyethylene complying with § 177.1520 of this chapter:
(a) At levels not to exceed 0.1 weight percent.
(b) At levels not to exceed 0.5 weight percent in contact with nonfatty
food.
3. At levels not to exceed 0.5 percent by weight of ethylene-propylene-5-
ethylidine-2-norbornene terpolymers complying with § 177.1520 of this
chapter. The maximum thickness of such polymers in the form in which
they contact food shall not exceed 0.005 inch.
plying with § 177.1520(c) of this chapter, items 3.1, 3.2, 3.3, 3.4, or 3.5.
plying with § 177.1520(c) of this chapter, items 3.1 and 3.2, and also con-
taining not less than 85 weight percent of polymer units derived from pro-
pylene.
plying with § 177.1520(c)(4) of this chapter. The finished polymers may

be used in contact with food under conditions of use A through H de-
401
§ 178.2010 21 CFR Ch. I (4–1–23 Edition)
1,3,5-Tris(3,5-di-tert-butyl-4-hydro- For use only in contact with nonfatty foods:

xyhydrocinnamoyl) hexahydro-s-triazine. 1. At levels not to exceed 0.25 percent by weight of polypropylene com-
3. At levels not to exceed 0.5 percent by weight of ethylene-propylene-5-
ethylidine-2-norbornene terpolymers complying with § 177.1520 of this
chapter. The maximum thickness of such polymers in the form in which
1,3,5-Tris(4-tert-butyl-3-hydroxy-2,6-dimethyl- For use only:
benzyl)-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione. 1. At levels not to exceed 0.1 percent by weight of olefin polymers com-
[CAS Reg. No. 40601–76–1]. plying with § 177.1520 of this chapter, under conditions of use A through
H described in table 2 of § 176.170(c) of this chapter.
2. At levels not to exceed 0.1 percent by weight of polystyrene and rubber-
modified polystyrene that comply with § 177.1640 of this chapter, pro-
vided that the finished polystyrene and rubber-modified polystyrene con-
tact food only under the conditions described in § 176.170(c) of this chap-
ter, table 2, under conditions of use E through G.
402
Tris(2,4-di-tert-butylphenyl)phosphite. (CAS Reg. For use only:

No. 31570–04–4). 1. At levels not to exceed 0.5 percent by weight of elastomers used in rub-
ber articles complying with § 177.2600 of this chapter.
2. At levels not to exceed 1 percent by weight of nylon resins complying
with § 177.1500 of this chapter: Provided, That the finished polymer con-
tacts food only under conditions of use E, F, and G described in table 2
4. At levels not to exceeds 0.2 percent by weight of polystyrene and rub-
chapter: Provided, that the finished polymer contacts food only under
conditions of use B, C, D, E, F, G, and H described in table 2 of
plying with § 177.1520(c) of this chapter, item 1.1, 1.2, or 1.3.
plying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1(a),
3.1(b), 3.1(c), 3.2(a), or 3.2(b). The finished polymers complying with
items 2.1, 2.2, or 2.3 having a density less than 0.94 gram per cubic cen-
timeter and a thickness greater than 0.051 millimeter (0.002 inch), either
shall have a level of tris(2,4-di-tert-butylphenyl)phosphite that shall not
exceed 0.062 milligram per square inch of food-contact surface or shall
contact all food types identified in Table 1 of § 176.170(c) of this chapter
only under conditions of use E, F, and G described in Table 2 of
7. At levels not to exceed 0.2 percent by weight of ethylene-vinyl-acetate
copolymers complying with § 177.1350 of this chapter, and that are lim-
ited to use in contact with food only under conditions of use E, F, and G
described in table 2 of § 176.170(c) of this chapter. The average thick-
ness of such polymers in the form in which they contact fatty food shall
not exceed 0.1 millimeter (0.004 inch).
plying with § 177.1520(c) of this chapter, item 4. The finished polymers
having a thickness greater than 0.051 millimeter (0.002 inch), shall con-
tact food only under conditions of use E, F, and G described in table 2 of
9. At levels not to exceed 0.5 percent by weight of acrylic and modified
acrylic plastics, semirigid and rigid, complying with § 177.1010 of this
chapter.
10. At levels not to exceed 0.1 percent by weight of isobutylene polymers
12. At levels not to exceed 0.5 percent by weight of pressure sensitive ad-
hesives complying with § 175.125 of this chapter.
13. At levels not to exceed 0.5 percent by weight of can end cement formu-
lations complying with § 175.300(b)(3)(xxxi) of this chapter.
14. At levels not to exceed 0.5 percent by weight of side seam cement for-
mulations complying with § 175.300(b)(3)(xxxii) of this chapter.
drocarbon resins complying with § 175.320(b)(3) of this chapter.
drocarbon resins or their hydrogenated products complying with
§ 176.170(b)(2) of this chapter.
17. At levels not to exceed 0.5 percent by weight of resins and polymers
complying with § 176.180(b) of this chapter.
18. At levels not to exceed 0.5 percent by weight of rosins and rosin deriva-
tives complying with § 176.210(d)(3) of this chapter.
resin, and rosins and rosin derivatives complying with § 178.3800(b).
21. At levels not to exceed 0.5 percent by weight of reinforced wax com-
plying with § 178.3850.
plying with § 177.1520(c) of this chapter, item 3.3. The finished polymers
may be used in contact with food under conditions of use A through H
23. At levels not to exceed 0.15 percent by weight of poly-1-butene resins
and butene/ethylene copolymers complying with § 177.1570 of this chap-
ter: Provided, that the finished polymer contacts food only under condi-
ter.
403
§ 178.2550 21 CFR Ch. I (4–1–23 Edition)
Tris(2-methyl-4-hydroxy-5-tert-butylphenyl)butane For use only:

(CAS Reg. No. 1843–03–4). 1. At levels not to exceed 0.25 percent by weight of polymers used as pro-
vided in § 176.180 of this chapter.
2. At levels not to exceed 0.25 percent by weight of the following polymers
when used in articles that contact food of Types I, II, IV-B, VI-B, VII-B,
and VIII described in table 1 of § 176.170(c) of this chapter: Olefin poly-
2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4 or complying with other sections in parts
174, 175, 176, 177, 178 and § 179.45 of this chapter; vinyl chloride poly-
mers; and/or vinyl chloride copolymers complying with § 177.1980 of this
chapter.
3. At levels not to exceed 0.1 percent by weight of the following polymers
when used in articles that contact food of Types III, IV-A, V, VI-A, VI-C,
VII-A, and IX described in table 1 of § 176.170(c) of this chapter: Olefin
1.3, 2.1, 2.2, 2.3, 3.1, 3.2, 3.3, or 4 or complying with other sections in
parts 174, 175, 176, 177, 178 and § 179.45 of this chapter; vinyl chloride
polymers; and/or vinyl chloride copolymers complying with § 177.1980 of
this chapter.
5. At levels not to exceed 0.2 percent by weight of polystyrene and/or modi-
fied polystyrene polymers identified in § 177.1640 of this chapter.
styrene copolymers used in contact with nonalcoholic foods.
7. At levels not to exceed 1 percent by weight of closure-sealing gasket
compositions complying with § 177.1210(b) of this chapter.
Zinc dibutyldithiocarbamate (CAS Reg. No. 136– For use only:
23–2). 1. At levels not to exceed 0.2 percent by weight of isobutyleneisoprene co-
polymers complying with § 177.1420 of this chapter: Provided, That the
finished copolymers contact food only of the types identified in
§ 176.170(c) of this chapter, table 1, under Types V, VII, VIII, and IX.
2. At levels not to exceed 0.02 percent by weight of polypropylene poly-
mers complying with § 177.1520(c), item 1.1 of this chapter.
Zinc palmitate.
Zinc salicylate .......................................................... For use only in rigid polyvinyl chloride and/or in rigid vinyl chloride copoly-
mers complying with § 177.1980 of this chapter: Provided, That total
salicylates (calculated as the acid) do not exceed 0.3 percent by weight
of such polymers.
Zinc stearate.
1 Copies are available from the American Society for Testing and Materials, 1916 Race Street, Philadelphia, Pa. 19103.
[42 FR 14609, Mar. 15, 1977]

www.govinfo.gov.
§ 178.2550 4-Hydroxymethyl-2,6-di-tert- § 178.2650 Organotin stabilizers in

butylphenol. vinyl chloride plastics.
4-Hydroxymethyl-2,6-di-tert-butyl- The organotin chemicals identified in
phenol may be safely used as an anti- paragraph (a) of this section may be
oxidant in articles intended for use in safety used alone or in combination, at
contact with food, in accordance with levels not to exceed a total of 3 parts
the following prescribed conditions: per hundred of resin, as stabilizers in
(a) The additive has a solidification vinyl chloride homopolymers and co-
point of 140°–141 °C. polymers complying with the provi-
(b) The concentration of the additive sions of § 177.1950 or § 177.1980 of this
and any other permitted antioxidants chapter and that are identified for use
in the finished food-contact article in contact with food of types I, II, III,
does not exceed a total of 0.5 milligram IV (except liquid milk), V, VI (except
per square inch of food-contact surface. malt beverages and carbonated non-
alcoholic beverages), VII, VIII, and IX
described in table 1 of § 176.170(c) of this

chapter, except for the organotin
chemical identified in paragraph (a)(3)
404
of this section, which may be used in (3) C10-16-Alkyl mercaptoacetates re-

contact with food of types I through IX action products with
at temperatures not exceeding 75 °C dichlorodioctylstannane and
(167 °F), and further that the organotin trichlorooctylstannane (CAS Reg. No.
chemicals identified in paragraphs 83447–69–2) is an organotin chemical
(a)(5) and (6) of this section may be mixture having 10.8 to 11.8 percent by
used in contact with food of types I weight of tin (Sn) and having 8.0 to 8.6
through IX at temperatures not ex- percent by weight of mercapto sulfur.
ceeding 66 °C (150 °F), conditions of use It is made from a mixture of di(n-
D through G described in table 2 of octyl)tin dichloride and (n-octyl)tin
§ 176.170(c) of this chapter, and further trichloride which has an organotin
that dodecyltin chemicals identified in composition that is not less than 95
paragraph (a)(7) of this section which percent by weight di(n-octyl)tin dichlo-
may be used in contact with food of ride/(n-octyl)tin trichloride, and not
types I, II, III, IV (except liquid milk), more than 1.5 percent by weight of
V, VI (except malt beverages and car- tri(n-octyl)tin chloride. The alkyl rad-
bonated nonalcoholic beverages), VII, ical in the mercaptoacetate is derived
VIII, and IX described in table 1 of from a mixture of saturated n-alcohols
§ 176.170(c) of this chapter at tempera- which has a composition that is not
tures not exceeding 71 °C (160 °F), in ac- less than 50 percent by weight
cordance with the following prescribed tetradecyl alcohol, and that is not
conditions: more than 50 percent by weight total of
(a) For the purpose of this section, decyl alcohol and/or dodecyl alcohol,
the organotin chemicals are those list- and/or hexadecyl alcohol.
ed in paragraphs (a)(1), (2), (3), (4), (5), (4) (n-Octyl)tin S,S′S″ tris(isooctyl-
(6), and (7) of this section. mercaptoacetate) is an octyltin chem-
(1) Di(n-octyl)tin S,S′- ical having the formula n-
bis(isooctylmercaptoacetate) is an C8H17Sn(SCH2CO2C8H17)3 (CAS Reg. No.
octyltin chemical having 15.1 to 16.4 26401–86–5) having 13.4 to 14.8 percent by
percent by weight of tin (Sn) and hav- weight of tin (Sn) and having 10.9 to
ing 8.1 to 8.9 percent by weight of mer- 11.9 percent by weight of mercapto sul-
capto sulfur. It is made from di(n- fur. It is made from (n-octyl)tin tri-
octyl)tin dichloride or di(n-octyl)tin chloride. The isooctyl radical in the
oxide. The isooctyl radical in the mercaptoacetate is derived from oxo
mercaptoacetate is derived from oxo process isooctyl alcohol. The (n-
process isooctyl alcohol. Di(n-octyl)tin octyl)tin trichloride has an organotin
dichloride has an organotin composi- composition that is not less than 95
tion that is not less than 95 percent by percent by weight of (n-octyl)tin tri-
weight of di(n-octyl)tin dichloride and chloride and not more than 5 percent
not more than 5 percent by weight of by weight of tri(n-octyl)tin chloride.
tri(n-octyl)tin chloride. Di(n-octyl)tin (5) Bis(beta-carbobutoxyethyl)tin
oxide has an organotin composition bis(isooctylmercaptoacetate) (CAS
that is not less than 95 percent by Reg. No. 63397–60–4) is an estertin
weight of di(n-octyl)tin oxide and not chemical having 14.0 to 15.0 percent by
more than 5 percent by weight of weight of tin (Sn) and having 7.5 to 8.5
bis[tri(n-octyl)tin] oxide, and/or mono percent by weight of mercapto sulfur.
n-octyltin oxide. It is made from bis(beta-
(2) Di(n-octyl) tin maleate polymer is carbobutoxyethyl)tin dichloride. The
an octyltin chemical having the for- isooctyl radical in the mercaptoacetate
mula [(C8H17)2SnC4H2O4]n (where n is be- is derived from oxo process primary
tween 2 and 4 inclusive), having 25.2 to octyl alcohols. The bis(beta-
26.6 percent by weight of tin (Sn) and carbobutoxyethyl)tin dichloride has an
having a saponification number of 225 organotin composition that is not less
to 255. It is made from di(n-octyl)tin di- than 95 percent by weight of bis(beta-
chloride or di(n-octyl)tin oxide meet- carbobutoxyethyl)tin dichloride and
ing the specifications prescribed for not more than 5 percent by weight of
di(n-octyl) tin dichloride or di(n-octyl) bis(beta-carbobutoxyethyltin tri-

tin oxide in paragraph (a)(1) of this sec- chloride. The triestertin chloride con-
tion. tent of bis(beta-carbobutoxyethyltin)
405
§ 178.2650 21 CFR Ch. I (4–1–23 Edition)
dichloride shall not exceed 0.02 percent. cover at least three equilibrium peri-
p odic determinations, as follows:
(6) Beta-carbobutoxyethyltin (i) The exposure time for the first de-
tris(isooctylmercaptoacetate) (CAS termination shall be at least 72 hours
Reg. No. 63438–80–2) is an estertin for aqueous solvents, and at least 6
chemical having 13.0 to 14.0 percent by hours for heptane.
weight of tin (Sn) and having 10.5 to (ii) Subsequent determinations shall
11.5 percent by weight of mercapto sul- be at a minimum of 24-hour intervals
fur. It is made from beta- for aqueous solvents, and 2-hour inter-
carbobutoxyethyltin trichloride. The vals for heptane. These tests shall yield
isooctyl radical in the mercaptoacetate total octylin stabilizers not to exceed
is derived from oxo process primary
0.5 parts per million as determined by
octyl alcohol. The beta-
analytical method entitled ‘‘Atomic
carbobutoxyethyltin trichloride has an
Absorption Spectrometric Determina-
organotin composition that is not less
than 95 percent by weight of beta- tion of Sub-part-per-Million Quantities
carbobutoxyethyltin trichloride and of Tin in Extracts and Biological Mate-
not more than 5 percent total of rials with Graphite Furnace,’’ Analyt-
triestertin chloride and diestertin chlo- ical Chemistry, Vol. 49, p. 1090–1093
ride. (1977), which is incorporated by ref-
(7) The dodecyltin stabilizer is a mix- erence. Copies are available from the
ture of 50 to 60 percent by weight of n- Center for Food Safety and Applied Nu-
dodecyltin S,S′,S″- trition (HFS–200), Food and Drug Ad-
tris(isooctylmercaptoacetate) (CAS ministration, 5001 Campus Dr., College
Reg. No. 67649–65–4) and 40 to 50 percent Park, MD 20740, or available for inspec-
by weight of di(n-dodecyl)tin S,S′- tion at the National Archives and
di(isooctylmercaptoacetate) (CAS Reg. Records Administration (NARA). For
No. 84030–61–5) having 13 to 14 percent information on the availability of this
by weight of tin (Sn) and having 8 to 9 material at NARA, call 202–741–6030, or
percent by weight of mercapto sulfur. go to: http://www.archives.gov/fed-
It is made from a mixture of dodecyltin eral_register/code_of_federal_regulations/
trichloride and di(dodecyl)tin dichlo- ibr_locations.html.
ride which has not more than 0.2 per- (iii) Subsequent determinations for
cent by weight of dodecyltin tri- the dodecyltin mixture described in
chloride, not more than 2 percent by paragraph (a)(7) of this section shall be
weight of dodecylbutyltin dichloride at a minimum of 24-hour intervals for
and not more than 3 percent by weight aqueous solvents and 2-hour intervals
of tri(dodecyl)tin chloride. The for heptane. These tests shall yield
isooctyl radical in the mercaptoacetate di(n-octyl)tin S,S′-
is derived from oxo process primary bis(isooctylmercaptoacetate), or di(n-
octyl alcohols.
octyl)tin maleate polymer, or (C10-C16)-
(b) The vinyl chloride plastic con-
alkylmercaptoacetate reaction prod-
tainers, film or panels in the finished
ucts with dichlorodioctylstannane and
form in which they are to contact food,
shall meet the following limitations: trichlorooctylstannane, or n-octyltin
(1) The finished plastics intended for S,S′,S″-tris(isooctylmercaptoacetate),
contact with foods of the types listed tris(isooctylmercaptoacetate) and di(n-
in this section shall be extracted with dodecyl)tin
the solvent or solvents characterizing bis(isooctylmercaptoacetate) or any
those types of foods as determined combination thereof, not to exceed 0.5
from table 2 of § 176.170(c) of this chap- parts per million as determined by an
ter at the temperature reflecting the analytical method entitled ‘‘Atomic
conditions of intended use as deter- Absorption Spectrophotometric Deter-
mined therein. Additionally, extrac- mination of Sub-part-per-Million Quan-
tion tests for acidic foods shall be in- tities of Tin in Extracts and Biological
cluded and simulated by 3-percent ace- Materials with Graphite Furnace,’’ An-
tic acid at temperatures specified for alytical Chemistry, Vol. 49, pp. 1090–1093
water in table 2 of § 176.170(c) of this (1977), which is incorporated by ref-
chapter. The extraction tests shall erence in accordance with 5 U.S.C.
406
552(a). The availability of this incorpo- List of substances Limitations

ration by reference is given in para- 1,1,2,2-Tetra- For use only as a blowing agent ad-
graph (b)(1)(ii) of this section. chloroethylene. juvant in polystyrene at a level not
(2) In lieu of the tests prescribed in to exceed 0.3 percent by weight of
finished foamed polystyrene in-
paragraph (b)(1) of this section, the fin- tended for use in contact with food
ished plastics intended for contact with only of the types identified in
foods only of Types II, V, VI-A (except § 176.170(c) of this chapter, table
1, under Categories I, II, VI, and
malt beverages), and VI-C may be end- VIII.
tested with food-simulating solvents, Toluene ...................... For use only as a blowing agent ad-
under conditions of time and tempera- juvant in polystyrene at a level not
to exceed 0.35 percent by weight
ture, as specified below, whereby such of finished foamed polystyrene.
tests shall yield the octyltin residues
cited in paragraph (b)(1) of this section
not in excess of 0.5 ppm: [47 FR 22090, May 21, 1982, as amended at 58
FR 64895, Dec. 10, 1993]
Tem-
Time perature § 178.3120 Animal glue.
Food-simulating solvent (degrees
(hours) Fahr- Animal glue may be safely used as a
enheit)
component of articles intended for use
Type II ......... Acetic acid, 3 pct ......... 48 135 in producing, manufacturing, packing,
Type V ......... Heptane ....................... 2 100 processing, preparing, treating, pack-
Type VI-A .... Ethyl alcohol, 8 pct ...... 24 120
aging, transporting, or holding food,
Type VI-C .... Ethyl alcohol, 50 per- 24 120
cent. subject to the provisions of this sec-
tion.
(a) Animal glue consists of the pro-
FR 11847, Mar. 19, 1982; 48 FR 7170, Feb. 18, teinaceous extractives obtained from
1983; 48 FR 42972, Sept. 21, 1983; 48 FR 51612, hides, bones, and other collagen-rich
Nov. 10, 1983; 49 FR 8432, Mar. 7, 1984; 50 FR substances of animal origin (excluding
62, Jan. 2, 1985; 50 FR 3510, Jan. 25, 1985; 50 FR diseased or rotted animals), to which
37998, Sept. 19, 1985; 50 FR 47212, Nov. 15, 1985; may be added other optional adjuvant
54 FR 24898, June 12, 1989] substances required in its production
or added to impart desired properties.
Subpart D—Certain Adjuvants and (b) The quantity of any substance
Production Aids employed in the production of animal
glue does not exceed the amount rea-
§ 178.3010 Adjuvant substances used in sonably required to accomplish the in-
the manufacture of foamed plastics. tended physical or technical effect nor
The following substances may be any limitation further provided.
safely used as adjuvants in the manu- (c) Any substance employed in the
facture of foamed plastics intended for production of animal glue and which is
use in contact with food, subject to any the subject of a regulation in parts 174,
prescribed limitations: 175, 176, 177, 178 and § 179.45 of this chap-
ter conforms with any specification in
such regulation.
Azodicarbonamide ..... For use as a blowing agent in pol- (d) Optional adjuvant substances em-
yethylene complying with item 2.1 ployed in the production of animal glue
in § 177.1520(c) of this chapter at
a level not to exceed 5 percent by include:
weight of finished foamed poly- (1) Substances generally recognized
ethylene. as safe in food.
1,1-Difluoroethane For use as a blowing agent in poly-
(CAS Reg. No. 75– styrene. (2) Substances subject to prior sanc-
37–6). tion or approval for use in animal glue
Isopentane ................. For use as a blowing agent in poly- and used in accordance with such sanc-
styrene.
tion or approval.
n-Pentane .................. Do.
(3) Substances identified in this para-
graph (d)(3) and subject to such limita-

tions as are provided:
407
§ 178.3125 21 CFR Ch. I (4–1–23 Edition)
Alum (double sulfate of aluminum and ammonium, potassium, or sodium).

4-Chloro-3-methylphenol(p-chlorome-tacresol) ............................................ For use as preservative only.
Chromium potassium sulfate (chrome alum) ............................................... For use only in glue used as a colloidal flocculant
added to the pulp suspension prior to the sheet-
forming operation in the manufacture of paper and
paper board.
3,5-Dimethyl-1,3,5,H-tetrahydrothiadia-zine-2-thione .................................. For use as preservative only.
Disodium cyanodithioimidocarbonate .......................................................... Do.
Defoaming agents ........................................................................................ As provided in § 176.210 of this chapter.
Ethanolamine.
Ethylenediamine.
Formaldehyde .............................................................................................. For use as a preservative only.
Potassium N-methyldithiocarbamate ........................................................... Do.
Potassium pentachlorophenate .................................................................... Do.
Rosins and rosin derivatives ........................................................................ As provided in § 178.3870.
Sodium chlorate.
Sodium 2-mercaptobenzothiazole ................................................................ For use as preservative only.
Sodium pentachlorophenate ........................................................................ Do.
Sodium o-phenylphenate ............................................................................. Do.
Zinc dimethyldithiocarbamate ...................................................................... Do.
Zinc 2-mercaptobenzothiazole ..................................................................... Do.
(e) The conditions of use are as fol- food-contact materials subject to the
lows: provisions of this section:
(1) The use of animal glue in any sub-
stance or article that is the subject of
a regulation in this subpart conforms Zinc hydroxy For use only as a component of resinous
with any specifications or limitations phosphite and polymeric food-contact coatings in-
(CAS Reg. tended for repeated use in contact with
prescribed by such regulation for the No. 55799– dry foods.
finished form of the substance or arti- 16–1).
cle.
(2) It is used as an adhesive or compo- [50 FR 21835, May 29, 1985]
nent of an adhesive in accordance with
the provisions of § 175.105 of this chap- § 178.3130 Antistatic and/or anti-
ter. fogging agents in food-packaging
(3) It is used as a colloidal flocculant materials.
added to the pulp suspension prior to The substances listed in paragraph
the sheet-forming operation in the (b) of this section may be safely used as
manufacture of paper and paperboard. antistatic and/or antifogging agents in
(4) It is used as a protective colloid in food-packaging materials, subject to
resinous and polymeric emulsion coat- the provisions of this section:
ings. (a) The quantity used shall not ex-
§ 178.3125 Anticorrosive agents. to accomplish the intended technical
The substances listed in this section effect.
may be used as anticorrosive agents in (b) List of substances:
N-Acyl sarcosines where the acyl group is lauroyl, oleoyl, or For use only:
derived from the combined fatty acids of coconut oil. 1. As antistatic and/or antifogging agent at levels not to exceed
a total of 0.15 pct by weight of polyolefin film used for pack-
aging meat, fresh fruits, and fresh vegetables. The average
thickness of such polyolefin film shall not exceed 0.003 inch.
2. As antistatic and/or antifogging agent at levels not to exceed
a total of 0.15 pct by weight of ethylene-vinyl acetate copoly-
mer film complying with § 177.1350 of this chapter and used
for packaging meat, fresh fruits, fresh vegetables, and dry
food of Type VIII described in table 1 of § 176.170(c) of this
chapter. The average thickness of such ethylene-vinyl ace-
tate copolymer film shall not exceed 0.003 inch when used
for packaging meat, fresh fruits, and fresh vegetables.
408
Alpha-(Carboxymethyl)-omega-(tetradecyloxy)polyoxyethylene) For use only as an antistatic and/or antifogging agent at levels

not to exceed 0.2 pct by weight in polyolefin film not exceed-
ing 0.001 inch thickness.
n-alkanes in the range of C10-C18 with not less than 50 per- 1. As antistatic agents at levels not to exceed 0.1 percent by
cent C14-C16). weight of polyolefin films that comply with § 177.1520 of this
chapter: Provided, that the finished olefin polymers contact
foods of Types I, II, III, IV, V, VIA, VIB, VII, VIII, and IX de-
scribed in table 1 of § 176.170(c) of this chapter, and under
conditions of use E, F, and G described in table 2 of
2. As antistatic agents at levels not to exceed 3.0 percent by
weight of polystyrene or rubber-modified polystyrene com-
plying with § 177.1640(c) of this chapter under conditions of
use B through H described in table 2 of § 176.170(c) of this
chapter.
Aluminum Borate ((9Al2O3)·2(B2O3), CAS Reg. No. 11121–16– For use only:
7) produced by reaction between aluminum oxide and/or alu- 1. At levels not to exceed 1 percent by weight of poly-
minum hydroxide with boric acid and/or metaboric acid at propylene films complying with § 177.1520(c) of this chapter,
temperatures in excess of 1000 °C. item 1.1, of polyethylene films complying with § 177.1520(c)
of this chapter, items 2.1 and 2.2 and having a density
greater than 0.94 gram per cubic centimeter, and of
polyolefin copolymer films complying with § 177.1520(c) of
this chapter, items 3.1(a), 3.1(b), 3.2(a), and 3.2(b). The fin-
ished polymers may be used in contact with all food types
identified in Table 1 of § 176.170(c) of this chapter, under
conditions of use A through H as described in Table 2 of
§ 176.170(c) of this chapter. The thickness of the films shall
not exceed 0.005 inch.
2. At levels not to exceed 2 percent by weight of poly-
propylene films complying with § 177.1520(c) of this chapter,
item 1.1, of polyethylene films complying with § 177.1520(c)
of this chapter, items 2.1 and 2.2 and having a density
greater than 0.94 gram per cubic centimeter, and of
polyolefin copolymer films complying with § 177.1520(c) of
this chapter, items 3.1(a), 3.1(b), 3.2(a), and 3.2(b). The fin-
ished polymers may be used in contact with all food types
identified in Table 1 of § 176.170(c) of this chapter under
conditions of use B through H as described in Table 2 of
§ 176.170(c) of this chapter. The thickness of the films shall
N,N-Bis(2-hydroxyethyl)alkyl(C12-C18)amine ............................... For use only as an antistatic agent at levels not to exceed 0.1
pct by weight of polyolefin food-contact films.
N,N-bis(2-hydroxyethyl)alkyl (C13-C15) amine (CAS Reg. No. For use only:
70955–14–5). 1. As an antistatic agent at levels not to exceed 0.2 percent by
weight in molded or extruded high-density polyethylene (hav-
ing a density ≥0.95 g/cm3 and polypropylene containers that
contact food only of the types identified in § 176.170(c) of
this chapter, Table 1, under types I, VI-B, VII-B, and VIII,
under the conditions of use E through G described in Table
2 of § 176.170(c) of this chapter, provided such foods have a
pH above 5.0.
2. As an antistatic agent at levels not to exceed 0.1 percent by
weight in molded or extruded polypropylene homopolymers
and copolymers that contact food only of the types identified
in § 176.170(c) of this chapter, Table 1, under Types II, III,
IV, V, VII-A, and IX, under the conditions of use C through G
409
§ 178.3130 21 CFR Ch. I (4–1–23 Edition)
N,N-Bis(2-hydroxyethyl) alkylamine, where the alkyl groups For use only:

(C14–C18) are derived from tallow.. 1. As an antistatic agent at levels not to exceed 0.15 pct by
weight in molded or extruded polyethylene containers that
contact food only of the types identified in § 176.170(c) of
this chapter, table 1, under Types I, IV-B, VI-B, VII-B, and
VIII, under the conditions of use E through G described in
table 2 of § 176.170(c) of this chapter provided such foods
have a pH above 5.0.
2. As an antistatic agent at levels not to exceed 0.10 mg. per
square inch of food-contact surface in vinylidene chloride co-
polymer coatings complying with § 175.320, § 177.1200, or
§ 177.1630 of this chapter, provided that such coatings con-
tact food only of the types identified in § 176.170(c) of this
chapter, table 1, under Types I, IV, VII, VIII, and IX under
the conditions of use E through G described in table 2 of
§ 176.170(c) of this chapter. The finished copolymers shall
contain at least 70 weight pct of polymer units derived from
vinylidene chloride; and shall contain not more than 5 weight
pct of total polymer units derived from acrylamide, acrylic
acid, fumaric acid, itaconic acid, methacrylic acid, octadecyl
methacrylate, and vinyl sulfonic acid.
N,N-Bis(2-hydroxyethyl)dodecanamide produced when For use only:
diethanolamine is made to react with methyl laurate such 1. As an antistatic agent at levels not to exceed 0.5 percent by
that the finished product: Has a minimum melting point of 36 weight of molded or extruded polyethylene containers in-
°C; has a minimum amide assay of 90 percent; contains no tended for contact with honey, chocolate syrup, liquid sweet-
more than 2 percent by weight of free diethanolamine; and eners, condiments, flavor extracts and liquid flavor con-
contains no more than 0.5 percent by weight of N,N, bis(2- centrates, grated cheese, light and heavy cream, yogurt, and
hydroxyethyl)piperazine, as determined by paper chroma- foods of Type VIII as described in table 1 of § 176.170(c) of
tography method. this chapter.
2. As an antistatic agent at levels not to exceed 0.2 percent by
weight in polypropylene films complying with § 177.1520 of
this chapter, and used in contact with food of Types I, II, III,
IV, V, VI-B, VII, VIII, and IX described in table 1 of
§ 176.170(c) of this chapter, and under conditions of use B
through H described in table 2 of § 176.170(c) of this chap-
ter. The average thickness of such polypropylene film shall
not exceed 0.001 inches (30 micrometers).
N,N-Bis(2-hydroxyethyl) dodecanamide produced when For use only as an antistatic agent at levels not to exceed 0.5
diethanolamine is made to react with methyl laurate such percent by weight of molded or extruded polyethylene con-
that the finished product: Has a minimum melting point of 36 tainers intended for contact with honey, chocolate syrup, liq-
°C; has a minimum amide assay of 90 percent; contains no uid sweeteners, condiments, flavor extracts and liquid flavor
more than 2 percent by weight of free diethanolamine; and concentrates, grated cheese, light and heavy cream, yogurt,
contains no more than 0.5 percent by weight of N,N′-bis(2- and foods of Type VIII as described in table 1 of
hydroxyethyl) piperazine, as determined by paper chroma- § 176.170(c) of this chapter.
tography method.
N,N-Bis(2-hydroxyethyl) octadecylamine, Chemical Abstracts For use only as an antistatic agent at levels not to exceed 0.45
Service Registry No. 10213–78–2, N-(2-hydroxyethyl)-N- percent by weight in polypropylene films complying with
octadecylglycine (monosodium salt), Chemical Abstracts § 177.1520 of this chapter, and used for packaging food of
Service Registry No. 66810–88–6, and N,N-Bis(2-hydroxy- Types I, II, III, IV, V, VI-B, VII, VIII, and IX described in table
ethyl)-N-(carboxymethyl) octadecanaminum hydroxide (inner 1 of § 176.170(c) of this chapter, and under conditions of use
salt), Chemical Abstracts Service Registry No. 24170–14–7, B through H described in table 2 of § 176.170(c). The aver-
as the major components of a mixture prepared by reacting age thickness of such polypropylene film shall not exceed
ethylene oxide with octadecylamine and further reacting this 0.002 inch.
product with sodium monochloroacetate and sodium hydrox-
ide, such that the final product has: A nitrogen content of
3.3–3.8 percent; a melting point of 42°–50 °C; and a pH of
10.0–11.5 in a 1 percent by weight aqueous solution.
a-n-Dodecanol-omega-hydroxypoly (oxyethylene) produced by For use only as an antistatic agent at levels not to exceed 0.2
the condensation of 1 mole of n-dodecanol with an average pct by weight in low-density polyethylene film having an av-
of 9.5 moles of ethylene oxide to form a condensate having erage thickness not exceeding 0.005 inch.
a hydroxyl content of 2.7 to 2.9 pct and having a cloud point
of 80 °C to 92 °C in 1 pct by weight aqueous solution.
Glycerol ester mixtures of ricinoleic acid, containing not more As an antifogging agent at levels not exceeding 1.5 pct by
than 50 percent monoricinoleate, 45 pct diricinoleate, 10 pct weight of permitted plasticized vinyl chloride homo-and/or
triricinoleate, and 3.3 pct free glycerine. copolymers.
N-Methacryloyloxyethyl-N,N-dimethylammonium-a-N-methyl For use only as an antistatic agent at levels not to exceed 0.2
carboxylate chloride sodium salt, octadecyl methacrylate, percent by weight of polyolefin films that contact foods under
ethyl methacrylate, cyclohexyl methacrylate, N-vinyl-2- the conditions of use B through H described in table 2 of
pyrrolidone copolymer (CAS Reg. No. 66822–60–4). § 176.170(c) of this chapter. The average thickness of such
polyolefin film shall not exceed 0.02 centimeter (0.008 inch).
410
Octadecanoic acid 2-[2-hydroxyethyl) octadecylamino]ethyl For use only as an antistatic agent at levels such that the
ester (CAS Reg. No. 52497–24–2), (octadecylimino) diethyl- product of film thickness in microns times the weight percent
ene distearate (CAS Reg. No. 94945–28–5), and octadecyl additive does not exceed 16, in polypropylene films com-
bis(hydroxyethyl)amine (CAS Reg. No. 10213–78–2), as the plying with § 177.1520(c)1.1 of this chapter, and used for
major components of a mixture prepared by reacting ethyl- packaging food (except for food containing more than 8 per-
ene oxide with octadecylamine and further reacting this prod- cent alcohol) under conditions of use B through H described
uct with octadecanoic acid, such that the final product has: a in table 2 of § 176.170(c) of this chapter.
maximum acid value of 5 mg KOH/g and total amine value
of 86±6 mg KOH/g as determined by a method entitled
‘‘Total Amine Value,’’ which is incorporated by reference.
Copies of the method are available from the Center for Food
Safety and Applied Nutrition (HFS–200), Food and Drug Ad-
ministration, 5001 Campus Dr., College Park, MD 20740, or
available for inspection at the National Archives and Records
Administration (NARA). For information on the availability of
this material at NARA, call 202–741–6030, or go to: http://
[42 FR 14609, Mar. 15, 1977, as amended at 45 FR 56797, Aug. 26, 1980; 45 FR 85727, Dec. 30, 1980;
46 FR 13688, Feb. 24, 1981; 47 FR 26824, June 22, 1982; 51 FR 28932, Aug. 13, 1986; 56 FR 41457,
Aug. 21, 1991; 58 FR 57556, Oct. 26, 1993; 60 FR 54430, Oct. 24, 1995; 60 FR 18351, Apr. 11, 1995;
62 FR 31511, June 10, 1997; 63 FR 38748, July 20, 1998; 64 FR 62585, Nov. 17, 1999; 76 FR 59249,
Sept. 26, 2011]
§ 178.3280 Castor oil, hydrogenated. (a) The quantity used shall not ex-
Hydrogenated castor oil may be safe- ceed the amount reasonably required
ly used in the manufacture of articles to accomplish the intended technical
or components of articles intended for effect.
use in contact with food subject to the (b) The additive is used as follows:
provisions of this section.
Use Limitations
1. As a lubricant for vinyl chloride polymers used in the manu- For use only at levels not to exceed 4 pct by weight of vinyl
facture of articles or components of articles authorized for chloride polymers.
food-contact use.
2. As a component of cellophane ............................................... Complying with § 177.1200 of this chapter.
3. As a component of resinous and polymeric coatings ............. Complying with § 175.300 of this chapter.
4. As a component of paper and paperboard in contact with Complying with § 176.170 of this chapter.
aqueous and fatty food.
5. As a component of closures with sealing gaskets for food Complying with § 177.1210 of this chapter.
containers.
6. As a component of cross-linked polyester resins ................... Complying with § 177.2420 of this chapter.
7. As a component of olefin polymers complying with For use only at levels not to exceed 2 percent by weight of the
§ 177.1520 of this chapter. polymer.
[42 FR 14609, Mar. 15, 1977, as amended at 55 FR 8914, Mar. 9, 1990]
§ 178.3290 Chromic chloride com- complish the intended technical effect

plexes. nor exceed 7 micrograms of chromium
Myristo chromic chloride complex per square inch of closure area.
and stearato chromic chloride complex (b) The packaging container which
may be safely used as release agents in has its closure area treated with the
the closure area of packaging con- release agent shall have a capacity of
tainers intended for use in producing, not less than 120 grams of food per
manufacturing, packing, processing, square inch of such treated closure
preparing, treating, packaging, trans- area.
porting, or holding food, subject to the
provisions of this section:

(a) The quantity used shall not ex-
ceed that reasonably required to ac-
411
§ 178.3295 21 CFR Ch. I (4–1–23 Edition)
§ 178.3295 Clarifying agents for poly- nents of articles intended for use in
mers. contact with food, subject to the provi-
Clarifying agents may be safely used sions of this section:
in polymers that are articles or compo-
Aluminum, hydroxybis[2,4,8,10-tetrakis(1,1-dimethylethyl)-6-hy- For use only as a clarifying agent at levels not to exceed 0.25
droxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxidato]- percent by weight of polypropylene and polypropylene co-
(CAS Reg. No. 151841–65–5). polymers complying with § 177.1520(c) of this chapter, items
1.1, 3.1, or 3.2. The finished polymers contact food only of
types I, II, IV-B, VI-B, VII-B, and VIII as identified in Table 1
of § 176.170(c) of this chapter, under conditions of use B
through H described in Table 2 of § 176.170(c) of this chap-
ter or foods only of types III, IV-A, V, VI-A, VI-C, VII-A, and
IX as identified in Table 1 of § 176.170(c) of this chapter,
under conditions of use C through G described in Table 2 of
Bis(p-ethylbenzylidene) sorbitol (CAS Reg. No. 79072–96–1) ... For use only as a clarifying agent at a level not to exceed 0.35
percent by weight of olefin polymers complying with
§ 177.1520(c) of this chapter, items 1.1a, 1.1b, 3.1a, 3.2a, or
3.2b, where the copolymers complying with items 3.1a, 3.2a,
or 3.2b contain not less than 85 weight percent of polymer
units derived from propylene.
Di(p-tolylidene) sorbitol (CAS Reg. No. 54686–97–4) ................ For use only as a clarifying agent at a level not to exceed 0.32
percent by weight in propylene homopolymer complying with
§ 177.1520(c) of this chapter, item 1.1, and in olefin copoly-
mers complying with § 177.1520(c) of this chapter, item 3.1
(containing at least 85 weight percent of polymer units de-
rived from propylene), in contact with all food types under
conditions of use C through G described in table 2 of
Dibenzylidene sorbitol (CAS Reg. No. 32647–67–9) formed by For use only as a clarifying agent for olefin polymers com-
the condensation of two moles of benzaldehyde with one plying with § 177.1520(c) 1.1, 3.1, and 3.2 of this chapter
mole of sorbitol, such that the final product has a minimum under conditions of use C, D, E, F, and G, described in table
content of 95 percent dibenzylidene sorbitol. 2 of § 176.170(c) of this chapter at a level not exceeding
0.25 percent by weight of the polymer.
Dimethyldibenzylidene sorbitol (CAS Reg. No. 135861–56–2) For use only as a clarifying agent at a level not to exceed 0.4
percent by weight of olefin polymers complying with
§ 177.1520(c) of this chapter, items 1.1, 3.1, and 3.2, where
the copolymers complying with items 3.1 and 3.2 contain not
less than 85 weight percent of polymer units derived from
polypropylene. The finished polymers shall be used in con-
tact with food under conditions of use A through H described
in table 2 of § 176.170(c) of this chapter.
Polyvinylcyclohexane (CAS Reg. No. 25498–06–0) ................... For use only as a clarifying agent for polypropylene complying
with § 177.1520(c) of this chapter, item 1.1., and in pro-
pylene containing copolymers complying with § 177.1520(c)
of this chapter, items 3.1 and 3.2, at a level not exceeding
0.1 percent by weight of the polyolefin.
Sodium di(p-tert-butylphenyl)phosphate (CAS Reg. No. 10491– For use only as a clarifying agent at a level not exceeding 0.35
31–3). parts per hundred of the resin in olefin polymers complying
with § 177.1520(c) of this chapter, items 1.1, 3.1, or 3.2
(where the copolymers complying with items 3.1 and 3.2
contain not less than 85 weight percent of polymer units de-
rived from propylene).
412
Sodium 2,2′-methylenebis(4,6-di-tert-butylphenyl)phosphate For use only:

(CAS Reg. No. 85209–91–2). 1. As a clarifying agent at a level not exceeding 0.30 percent
by weight of olefin polymers complying with § 177.1520(c) of
this chapter, items 1.1, 3.1, or 3.2 (where the copolymers
complying with items 3.1 and 3.2 contain not less than 85
weight percent of polymer units derived from polypropylene).
The finished polymers contact foods only of types I, II, IV-B,
VI-B, VII-B, and VIII as identified in table 1 of § 176.170(c) of
this chapter and limited to conditions of use B through H, de-
scribed in table 2 of § 176.170(c), or foods of all types, lim-
ited to conditions of use C through H described in table 2 of
§ 176.170(c).
2. As a clarifying agent at levels not exceeding 0.10 percent by
weight of polypropylene complying with § 177.1520(c) of this
chapter, items 1.1(a) or 1.1(b) and of olefin polymers com-
plying with § 177.1520(c) of this chapter, items 3.1(a), 3.1(b),
3.1(c), 3.2(a), or 3.2(b) (where the copolymers contain not
less than 85 weight percent of the polymer units derived
from polypropylene.) The finished polymers shall be used in
contact with foods only under conditions of use A through H
3. As a clarifying agent at a level not exceeding 0.30 percent
by weight of olefin polymers complying with § 177.1520(c) of
this chapter, item 2.2, where the finished polymer contacts
food only of types I, II, IV-B, VI-A, VI-B, and VII-B as identi-
fied in Table 1 of § 176.170(c) of this chapter, and limited to
conditions of use B through H described in Table 2 of
§ 176.170(c) of this chapter, or foods of types III, IV-A, V, VI-
C, and VII-A as identified in Table 1 of § 176.170(c) of this
chapter and limited to conditions of use C through G de-
scribed in Table 2 of § 176.170(c) of this chapter.
[46 FR 59236, Dec. 4, 1981, as amended at 52 FR 30920, Aug. 18, 1987; 53 FR 30049, Aug. 10, 1988;
54 FR 12432, Mar. 27, 1989; 54 FR 14734, Apr. 12, 1989; 55 FR 52990, Dec. 26, 1990; 56 FR 1085, Jan.
11, 1991; 59 FR 13650, Mar. 23, 1994; 59 FR 25323, May 16, 1994; 61 FR 33847, July 1, 1996; 61 FR
51588, Oct. 3, 1996; 61 FR 65943, Dec. 16, 1996; 63 FR 56789, Oct. 23, 1998; 63 FR 68392, Dec. 11,
1998; 64 FR 26843, May 18, 1999; 65 FR 16316, Mar. 28, 2000]
§ 178.3297 Colorants for polymers. (b) The colorant must be used in ac-
cordance with current good manufac-
The substances listed in paragraph
turing practice, including use levels
(e) of this section may be safely used as
which are not in excess of those reason-
colorants in the manufacture of arti-
ably required to accomplish the in-
cles or components of articles intended
tended coloring effect.
for use in producing, manufacturing,
packing, processing, preparing, treat- (c) Colorants in this section must
ing, packaging, transporting, or hold- conform to the description and speci-
ing food, subject to the provisions and fications indicated. If a polymer de-
definitions set forth in this section: scribed in this section is itself the sub-
ject of a regulation promulgated under
(a) The term colorant means a dye,
section 409 of the Federal Food, Drug,
pigment, or other substance that is
and Cosmetic Act, it shall also comply
used to impart color to or to alter the
with any specifications and limitations
color of a food-contact material, but
prescribed by that regulation. Extrac-
that does not migrate to food in
tion testing guidelines to conduct stud-
amounts that will contribute to that
ies for additional uses of colorants
food any color apparent to the naked
eye. For the purpose of this section, under this section are available from
the term ‘‘colorant’’ includes sub- the Food and Drug Administration free
stances such as optical brighteners and of charge from the Food and Drug Ad-
fluorescent whiteners, which may not ministration, Center for Food Safety
and Applied Nutrition, 5001 Campus
themselves be colored, but whose use is

intended to affect the color of a food- Dr., College Park, MD 20740, 240–402–
contact material. 1200
413
§ 178.3297 21 CFR Ch. I (4–1–23 Edition)
(d) Color additives and their lakes chapter, may also be used as colorants
listed for direct use in foods, under the for food-contact polymers.
provisions of the color additive regula- (e) List of substances:
tions in parts 73, 74, 81, and 82 of this
Aluminum.
Aluminum hydrate.
Aluminum and potassium silicate (mica).
Aluminum mono-, di-, and tristearate.
Aluminum silicate (China clay).
4-[[5-[[[4-(Aminocarbonyl) phenyl] amino]carbonyl]- 2- For use at levels not to exceed 1 percent by weight of poly-
methoxyphenyl]azo]-N-(5-chloro-2,4-dimethoxyphenyl)-3-hy- mers. The finished articles are to contact foods only under
droxy-2-naphthalene-carboxamide (C.I. Pigment Red 187, conditions of use B through H described in table 2 of
CAS Reg. No. 59487–23–9). § 176.170(c) of this chapter.
N-[4-(Aminocarbonyl)phenyl]-4-[[1-[[(2,3-dihydro-2-oxo-1H- For use at levels not to exceed 1 percent by weight of poly-
benzimidazol-5-yl)amino]carbonyl]-2- mers. The finished articles are to contact food only under
oxopropyl]azo]benzamide (C. I. Pigment Yellow 181, CAS conditions of use B through H described in table 2 of
Reg. No. 74441–05–7). § 176.170(c) of this chapter.
Anthra(2,1,9-def:(6,5,10-d′e′f)diisoquinoline-1,3,8,10(2H,9H)- For use at levels not to exceed 1% by weight of polymers. The
tetrone (C.I. Pigment Violet 29; CAS Reg. No. 81–33–4). finished articles are to contact food only under conditions of
use B through H as described in Table 2 of § 176.170(c) of
this chapter.
Barium sulfate.
Bentonite.
Bentonite, modified with 3-dimethyldioctadecylammonium ion.
1,4-Bis[(2,4,6-trimethylphenyl)amino]-9,10-anthracenedione For use at levels not to exceed 0.0004 percent by weight of
(CAS Reg. No. 116–75–6). polyethylene phthalate polymers complying with § 177.1630
of this chapter.
3,6-Bis(4-chlorophenyl)-2,5-dihydro-pyrrolo[3,4-c]pyrrole-1,4- For use only at levels not to exceed 1 percent by weight of
dione (C.I. Pigment Red 254, CAS Reg. No. 84632–65–5). polymers. The finished articles are to contact food only
under conditions of use B through H, described in table 2 of
4,4′-Bis(4-anilino-6-diethanolamine-a-triazin-2-ylamino)-2,2′-stil- For use only in the textile fibers specified in § 177.2800 of this
bene disulfonic acid, disodium salt. chapter.
4,4′-Bis(4-anilino-6-methylethanolamine-a-triazin-2-ylamino)- Do.
2,2′-stilbene disulfonic acid, disodium salt.
Burnt umber.
Calcium carbonate.
Calcium silicate.
Calcium sulfate.
Carbon black (channel process, prepared by the impingement
process from stripped natural gas).
4-Chloro-2-[[5-hydroxy-3-methyl-1-(3-sulfophenyl)-1H-pyrazol-4- For use at levels not to exceed 1.0 percent by weight of the
yl]azo]-5-methylbenzenesulfonic acid, calcium salt (1:1); (C.I. finished polymers. The finished articles are to contact food
Pigment Yellow 191, CAS Reg. No. 129423–54–7). only under conditions of use B through H as described in
4-Chloro-2-[[5-hydroxy-3-methyl-1-(3-sulfophenyl)-1H-pyrazol-4- For use at levels not to exceed 0.5 percent by weight of poly-
yl]azo]-5-methylbenzenesulfonic acid, diammonium salt (1:2): mers. The finished articles are to contact food under condi-
(C.I. Pigment Yellow 191:1, CAS Reg. No. 154946–66–4). tions of use A through H described in Table 2 of
Chrome antimony titanium buff rutile (C.I. Pigment Brown 24, For use at levels not to exceed 1 percent by weight of poly-
CAS Reg. No. 68186–90–3). mers. The finished articles are to contact food only under
Chromium oxide green, Cr2O3 (C.I. Pigment Green 17, C.I. No. For use only:
77288). 1. In polymers used in contact with food at a level not to ex-
ceed 5 percent by weight of the polymer, except as specified
below.
2. In olefin polymers complying with § 177.1520 of this chapter.
3. In repeat-use rubber articles complying with § 177.2600 of
this chapter; total use is not to exceed 10 percent by weight
of rubber articles.
414
Cobalt aluminate .......................................................................... For use only:

1. In resinous and polymeric coatings complying with § 175.300
of this chapter.
2. Melamine-formaldehyde resins in molded articles complying
3. Xylene-formaldehyde resins condensed with 4-
4′isopropylidenediphenol-epichlorohydrin epoxy resins com-
4. Ethylene-vinyl acetate copolymers complying with
5. Urea-formaldehyde resins in molded articles complying with
6. At levels not to exceed 5 percent by weight of all polymers
except those listed under limitations 1 through 5 of this item.
The finished articles are to contact food under conditions of
use A through H described in table 2 of § 176.170(c) of this
chapter.
Copper chromite black spinel (C.I. Pigment Black 28, CAS For use at levels not to exceed 5 percent by weight of poly-
Reg. No. 68186–91–4). mers. The finished articles are to contact food only under
conditions of use A through H as described in table 2 of
D&C Red No. 7 and its lakes.
Diatomaceous earth.
4,4′-Diamino-[1,1′-bianthracene]-9,9′,10,10′-tetrone (CAS Reg. For use at levels not to exceed 1 percent by weight of poly-
No. 4051–63–2). mers. The finished articles are to contact food only under
conditions of use B through H described in table 2 of
2,9-Dichloro-5,12-dihydroquinone[2,3-b]acridine-7,14-dione (C.I. For use at levels not to exceed 1.0 percent by weight of poly-
Pigment Red 202, CAS Reg. No. 3089–17–6). mers.
4,5-Dichloro-2-((5-hydroxy-3-methyl-1-(3-sulfophenyl)-1H- For use only:
pyrazol-4- yl)azo)benzenesulfonic acid, calcium salt(1:1), 1. At levels not to exceed 1 percent by weight of polypropylene
(C.I. Pigment Yellow 183, CAS Reg. No. 65212–77–3). polymers and copolymers complying with § 177.1520(c) of
this chapter, items 1.1a, 1.1b, 1.2, 1.3, 3.1a, 3.1b, 3.1c,
3.2a, 3.2b, 3.4, or 3.5. The finished articles are to contact
food only under conditions of use E through G, as described
in Table 2 of § 176.170(c) of this chapter.
2. At levels not to exceed 1 percent by weight of high density
polyethylene polymers and copolymers complying with
§ 177.1520(c) of this chapter, items 2.1, 2.2, 2.3, 3.1a, 3.1b,
3.1c, 3.2a, 3.2b, 3.6 (density not less than 0.94 grams per
cubic centimeter), or 5. The finished articles are to contact
food only under conditions of use E through G, as described
in Table 2 of § 176.170(c) of this chapter.
5-[(2,3-Dihydro-6-methyl-2-oxo-1H-benzimidazol-5-yl)azo]- For use at levels not to exceed 1 percent by weight of poly-
2,4,6(1H, 3H, 5H)-pyrimidinetrione (CAS Reg. No. 72102– mers. The finished articles are to contact food only under
84–2). conditions of use B through H described in table 2 of
2,9-Dimethylanthra(2,1,9-def:6,5,10-d′e′f′)diisoquinoline- For use at levels not to exceed 1 percent by weight of poly-
1,3,8,10(2H,9H)-tetrone (C.I. Pigment Red 179, CAS Reg. mers. The finished articles are to contact food only under
No. 5521–31–3). conditions of use B through H as described in Table 2 of
3,3′-[(2,5-Dimethyl-1,4-phenylene)bis[imino(1-acetyl-2-oxo-2,1- For use at levels not to exceed 1 percent by weight of poly-
ethanediyl)azo]]bis[4-chloro-N-(5-chloro-2-methylphenyl)- mers. The finished articles are to contact food only under
benzamide] (CAS Reg. No. 5280–80–8). conditions of use B through H described in table 2 of
3,3′-[(2,5-Dimethyl-1,4-phenylene)bis[imino-carbonyl(2-hydroxy- For use at levels not to exceed 1 percent by weight of poly-
3,1-naphthalenediyl) azo]] bis(4-methylbenzoic acid), bis(2- mers. The finished articles are to contact food only under
chloroethyl) ester (CAS Reg. No. 68259–05–2). conditions of use B through H described in table 2 of
2,2′-[1,2-Ethanediylbis(oxy-2,1-phenyleneazo)]bis[N-(2,3- For use at levels not to exceed 1.0 percent by weight of poly-
dihydro-2-oxo-1H-benzimidazol-5-yl)]-3-oxo-butanamide (C.I. mers. The finished articles are to contact food only under
Pigment Yellow 180, CAS Reg. No. 77804–81–0). conditions of use B through G described in table 2 of
2,2′-(1,2-Ethenediyldi-4,1-phenylene) bis(benzoxazole) (CAS For use as an optical brightener for all polymers at a level not
Reg. No. 1533–45–5). to exceed 0.025 percent by weight of polymer. The finished
polymer shall contact foods only of the types identified in
table 1 of § 176.170(c) of this chapter, under categories I, II,
IV-B, VI-A, VI-B, VII-B, and VIII at temperatures not to ex-
ceed 275 °F.
415
§ 178.3297 21 CFR Ch. I (4–1–23 Edition)
High-purity furnace black (CAS Reg. No. 1333–86–4) con- For use at levels not to exceed 2.5 percent by weight of the
taining total polynuclear aromatic hydrocarbons not to ex- polymer.
ceed 0.5 parts per million, and benzo[a]pyrene not to exceed
5.0 parts per billion, as determined by a method entitled
‘‘Determination of PAH Content of Carbon Black,’’ dated July
8, 1994, as developed by the Cabot Corp., which is incor-
porated by reference in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. Copies may be obtained from the Office of
Food Additive Safety (HFS–200), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Cam-
pus Dr., College Park, MD 20740, 240–402–1200, or may be
examined at the Food and Drug Administration’s Main Li-
brary, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Sil-
ver Spring, MD 20993, 301–796–2039, or at the National Ar-
chives and Records Administration (NARA). For information
on the availability of this material at NARA, call 202–741–
6030, or go to: http://www.archives.gov/federal_register/
Iron oxides.
Kaolin-modified, produced by treating kaolin with a reaction For use only in olefin polymers complying with § 177.1520 of
product of isopropyl titanate and oleic acid in which 1 mole this chapter at levels not to exceed 40 percent by weight of
of isopropyl titanate is reacted with 1 to 2 moles of oleic olefin polymer.
acid. The reaction product will not exceed 8 percent of the
modified kaolin. The oleic acid used shall meet the require-
ments specified in § 172.860 of this chapter.
Magnesium oxide.
Magnesium silicate (talc).
Manganese Violet (manganese ammonium pyrophosphate; For use at levels not to exceed 2 percent by weight of poly-
CAS Reg. No. 10101–66–3).. mers. The finished articles are to contact food only under
conditions of use A through H as described in table 2 of
Mixed methylated 4,4′-bis(2-benzoxazolyl)stilbenes with the For use as an optical brightener only at levels not to exceed
major portion consisting of 4-(2-benzoxazolyl)-4′-(5-methyl-2- 0.05 percent by weight of rigid and semirigid polyvinyl chlo-
benzoxazolyl)stilbene (CAS Registry No. 5242–49–9) and ride and not to exceed 0.03 percent by weight in all other
lesser portions consisting of 4,4′-bis(5-methyl-2- polymers. The finished food-contact articles shall be used
benzoxazolyl)stilbene (CAS Registry No. 2397–00–4) and only under conditions of use D, E, F, and G described in
4,4′-bis(2-benzoxazolyl)stilbene (CAS Registry No. 1533–45– table 2 of § 176.170(c) of this chapter.
5).
7-(2H-Naphtho[1,2-d]triazol-2-yl)-3-phenylcoumarin (CAS Reg. For use as an optical brightener only in:
No. 3333–62–8) having a melting point of 250 °C to 251 °C 1. Olefin polymers complying with § 177.1520 of this chapter
and a nitrogen content of 10.7 to 11.2 percent. only at levels such that the product of concentration of the
optical brightener (expressed in parts per million by weight of
the olefin polymer) multiplied by the thickness of the olefin
polymer (expressed in thousandths of an inch and limited to
no more than 0.400 inch) shall not exceed 500; provided
that the level of the brightener shall not exceed 20 parts per
million by weight of the olefin polymer, and further that the
olefin polymers shall comply with specifications for items 1.1,
2.1, 3.1, 3.3, and 4 of § 177.1520(c) of this chapter. The
polymer may be used under the conditions described in
§ 176.170(c) of this chapter, table 2, under conditions of use
E, F, and G.
2. Polyethylene terephthalate specified in § 177.2800(d)(5)(i) of
this chapter at a level not to exceed 0.035 percent by weight
of the finished fibers.
Nickel antimony titanium yellow rutile (C.I. Pigment Yellow 53, For use at levels not to exceed 1 percent by weight of poly-
CAS Reg. No. 8007–18–9). mers. The finished articles are to contact food only under
1,1′-[(6-Phenyl-1,3,5-triazine-2,4-diyl)diimino]bis-9,10- For use at levels not to exceed 0.25 percent by weight of poly-
anthracenedione (CAS Reg. No. 4118–16–5). ethylene phthalate polymers that comply with § 177.1630 of
this chapter. The finished articles are to contact food only
under conditions of use E, F, and G described in table 2,
§ 176.170(c) of this chapter, except, when such articles are
used with food types III, IV-A, and V, described in table 1,
§ 176.170(c) of this chapter, the finished articles are to con-
tact food only under conditions of use D, E, F, and G.
Phthalocyanine blue (C.I. pigment blue 15, 15:1, 15:2, 15:3,
and 15:4; C.I. No. 74160; CAS Reg. No. 147–14–8).
Phthalocyanine green (C.I. pigment green 7, C.I. No. 74260).
C.I. Pigment red 38 (C.I. No. 21120) .......................................... For use only in rubber articles for repeated use complying with
§ 177.2600 of this chapter; total use is not to exceed 10 per-
cent by weight of rubber article.
416
Quinacridone red (C.I. Pigment violet 19, C.I. No. 73900).

Sienna (raw and burnt).
Silica.
2,3,4,5-Tetrachloro-6-cyanobenzoic acid, methyl ester reaction For use only at levels not to exceed 1 percent by weight of
products with p-phenyllenediamine and sodium methoxide polymers. The finished articles are to contact food only
(CAS reg. No. 106276–80–6). under conditions of use B through H, described in table 2, of
4,5,6,7-Tetrachloro-2-[2-(4,5,6,7-tetrachloro-2,3-dihydro-1,3- For use only at levels not to exceed 1 percent by weight of
dioxo-1H-inden-2-yl)-8-quinolinyl]-1H-isoindole-1,3(2H)-dione polymers. The finished articles are to contact food only
(C. I. Pigment Yellow 138, CAS Reg. No.30125–47–4). under conditions of use C through H, as described in table 2
of § 176.170(c) of this chapter; provided further that the fin-
ished articles shall not be filled at temperatures exceeding
158 °F (70 °C).
2,2′-(2,5-Thiophenediyl)-bis(5-tert-butylbenzoxazole) (CAS Reg. For use as an optical brightener:
No. 7128–64–5). 1. In all polymers at levels not to exceed 0.015 percent by
weight of the polymer. The finished articles are to contact
food only under conditions of use A through H described in
2. In all polymers at levels not to exceed 0.05 percent by
weight of the polymer. The finished articles shall contact
foods only of the types identified in table 1 of § 176.170(c) of
this chapter, under Categories I, II, IV-B, VI-A, VI-B, VI-C,
VII-B, and VIII under conditions of use A through H de-
3. In adhesives complying with § 175.105 of this chapter and in
pressure-sensitive adhesives complying with § 175.125 of
this chapter.
Titanium dioxide.
Titanium dioxide-barium sulfate.
Titanium dioxide-magnesium silicate.
Ultramarines ................................................................................ As identified in § 73.2725 of this chapter.
Zinc carbonate ............................................................................. For use only:
of this chapter.
2. Melamineformaldehyde resins in molded articles complying
3. Xylene-formaldehyde resins condensed with 4-4′-
isopropylidene diphenol-epichlorohydrin epoxy resins com-
Zinc chromate .............................................................................. For use only in rubber articles for repeated use complying with
§ 177.2600 of this chapter; total use is not to exceed 10 per-
cent by weight of rubber article.
Zinc oxide .................................................................................... For use only:
of this chapter.
2. Melamine-formaldehyde resins in molded articles complying
3. Xylene-formaldehyde resins condensed with 4-4′-
isopropylidene-diphenol-epichlorohydrin epoxy resins com-
Zinc sulfide .................................................................................. For use at levels not to exceed 10 percent by weight.
[48 FR 46775, Oct. 14, 1983]

www.govinfo.gov.
417
§ 178.3300 21 CFR Ch. I (4–1–23 Edition)
§ 178.3300 Corrosion inhibitors used List of substances Limitations

for steel or tinplate.
Propylene glycol.
Corrosion inhibitors may be safely
used for steel or tinplate intended for § 178.3400 Emulsifiers and/or surface-
use in, or to be fabricated as, food con- active agents.
tainers or food-processing or handling
The substances listed in paragraph
equipment, subject to the provisions of
(c) of this section may be safely used as
this section.
emulsifiers and/or surface-active
(a) The corrosion inhibitors are pre- agents in the manufacture of articles
pared from substances identified in this or components of articles intended for
section and used subject to the limita- use in producing, manufacturing, pack-
tions prescribed. ing, processing, preparing, treating,
(b) The following corrosion inhibitors packaging, transporting, or holding
or adjuvants are used in amounts not food, subject to the provisions of this
to exceed those reasonably required to section.
accomplish the intended physical or (a) The quantity used shall not ex-
technical effect: ceed the amount reasonably required
(1) Corrosion inhibitors (active ingre- to accomplish the intended technical
dients) used in packaging materials for effect; and the quantity that may be-
the packaging of steel or tinplate or ar- come a component of food as a result of
ticles fabricated therefrom: such use shall not be intended to, nor
in fact, accomplish any physical or
technical effect in the food itself.
Dicyclohexylamine and its salts of (b) The use as an emulsifier and/or
fatty acids derived from animal surface-active agent in any substance
or vegetable oil. or article that is the subject of a regu-
Dicyclohexylamine nitrite.
lation in parts 174, 175, 176, 177, 178 and
Morpholine and its salts of fatty
acids derived from animal or § 179.45 of this chapter conforms with
vegetable oils. any specifications and limitations pre-
scribed by such regulation for the fin-
(2) Adjuvants employed in the appli- ished form of the substance or article.
cation and use of corrosion inhibitors: (c) List of substances:
a-Alkyl-, a-alkenyl-, and a-alkylaryl-omega- For use only at levels not to exceed 0.5 pct by weight of coat-
hydroxypoly(oxyethylene) mixture consisting of 30 weight pct ings complying with § 175.320 of this chapter and limited to
of a-(2,4,6-triisobutylphenyl)-omega- use as an emulsifier for polyhydric alcohol diesters used as
hydroxypoly(oxyethylene) having an average provided in § 178.3770(b). The weight of the finished coating
poly(oxyethylene) content of 7 moles and 70 weight pct of a shall not exceed 2 milligrams per square inch of food-contact
1:1 weight ratio mixture of a-(Z)-9-octadecenyl-omega- surface.
hydroxypoly(oxyethylene) having an average
poly(oxyethylene) content of 18 moles and a-alkyl(C16-C18)-
omega-hydroxypoly(oxyethylene) having an average
poly(oxyethylene) content of 18 moles.
n-Alkylbenzenesulfonic acid (alkyl group consisting of not less For use only as emulsifiers and/or surface active agents as
than 95 percent C10 to C16) and its ammonium, calcium, components of nonfood articles complying with §§ 175.300,
magnesium, potassium, and sodium salts. 175.320, 175.365, 175.380, 176.170, 176.180, 177.1010,
177.1200, 177.1210, 177.1630, 177.2600, and 177.2800 of
this chapter and § 178.3120.
418
n-alkanes in the range of C10-C18 with not less than 50 per- 1. As provided in § 176.170 of this chapter.
cent C14-C16). 2. At levels not to exceed 2 percent by weight of polyvinyl
chloride and/or vinyl chloride copolymers complying with
3. As emulsifiers in vinylidene chloride copolymer or
homopolymer coatings at levels not to exceed a total of 2.6
percent by weight of coating solids. The finished polymer
contacts food only of the Types I, II, III, IV, V, VIA, VIB, VII,
VIII, and IX as identified in table 1 of § 176.170(c) of this
chapter, and limited to conditions of use E, F, and G de-
scribed in table 2 of § 176.170 of this chapter.
4. As emulsifiers and/or surface-active agents at levels not to
exceed 3.0 percent by weight of polystyrene or rubber-modi-
fied polystyrene complying with § 177.1640(c) of this chapter
under conditions of use B through H described in table 2 of
a-Alkyl-omega-hydroxypoly(oxyethylene) produced by con-
densation of 1 mole of C11-C15 straight-chain randomly sub-
stituted secondary alcohols with an average of 7–20 moles
of ethylene oxide.
alpha Olefin sulfonate [alkyl group is in the range of C10-C18 For use only:
with not less than 50 percent C14-C16], ammonium, calcium, 1. In acrylonitrile-butadiene copolymers identified in
magnesium, potassium, and sodium salts. § 177.2600(c)(4)(i) of this chapter.
2. At levels not to exceed 1 percent by weight of acrylic coat-
ings complying with § 175.300(b)(3)(xx) of this chapter and
having a maximum thickness of 0.051 millimeter (0.002
inch). The finished polymers contact food only of the Types
V, VIII, and IX as identified in table 1 of § 176.170(c) of this
chapter.
3. At levels not to exceed 2 percent by weight of vinyl chloride
copolymer coatings having a maximum thickness of 0.051
millimeter (0.002 inch) and complying with
§ 175.300(b)(3)(xv) of this chapter. The finished polymers
contact food only of the Types V, VIII, and IX as identified in
Alpha-sulfo-omega-(dodecyloxy)poly(oxyethylene) ammonium For use only as an emulsifier at levels not to exceed 0.3 per-
salt (CAS Reg. No. 32612–48–9). cent by weight of styrene-butadiene copolymer coatings for
paper and paperboard complying with § 176.170 of this
chapter.
Ammonium salt of epoxidized oleic acid, produced from For use only:
epoxidized oleic acid (predominantly dihydroxystearic and 1. As a polymerization emulsifier at levels not to exceed 1.5
acetoxyhydroxystearic acids) meeting the following specifica- pct by weight of vinyl chloride polymers used as components
tions: Acid number 160–180, saponification number 210– of nonfood articles complying with §§ 175.105, 175.300,
235, iodine number 2–15, and epoxy groups 0–0.4 percent. 176.170, 176.180, and 177.1210 of this chapter. Such vinyl
chloride polymers are limited to polyvinyl chloride and/or
vinyl chloride copolymers complying with § 177.1980 of this
chapter.
2. As a polymerization emulsifier at levels not to exceed 1.5
pct by weight of vinyl chloride-vinyl acetate copolymers used
as components of nonfood articles complying with
§§ 175.105, 175.300, 176.170, 176.180, and 177.1210 of this
chapter.
Butanedioic acid, sulfo-1,4-di-(C9-C11 alkyl) ester, ammonium For use as a surface active agent as provided in §§ 175.105,
salt (also known as butanedioic acid, sulfo-1,4-diisodecyl 175.125, 176.170, and 176.180 of this chapter.
a-Di-sec-butylphenyl-omega-hydroxypoly(oxyethylene) pro-
duced by the condensation of 1 mole of di-sec-butylphenol
with an average of 4–14 or 30–50 moles of ethylene oxide; if
a blend of products is used, the average number of moles of
ethylene oxide reacted to produce any product that is a com-
ponent of the blend shall be in the range 4–14 or 30–50;
sec-butyl groups are predominantly (90 percent or more) o-,
p-substituents.
Disodium 4-isodecyl sulfosuccinate (CAS Reg. No. 37294–49– For use only as an emulsifier at levels not to exceed 5 percent
8). by weight of polymers intended for use in coatings.
a-Dodecyl-omega-hydroxpoly (oxyethylene) mixture of dihydro-
gen phosphate and monohydrogen phosphate esters that
have an acid number (to pH 5.2) of 103–111 and that are
produced by the esterification of the condensation product of

1 mole of n-dodecyl alcohol with 4–4.5 moles of ethylene
oxide.
419
§ 178.3400 21 CFR Ch. I (4–1–23 Edition)
a-(p-Dodecylphenyl)-omega-hydroxypoly (oxyethylene) pro-

duced by the condensation of 1 mole of dodecylphenol
(dodecyl group is a propylene tetramer isomer) with an aver-
age of 4–14 or 30–50 moles of ethylene oxide; if a blend of
products is used, the average number of moles of ethylene
oxide reacted to produce any product that is a component of
the blend shall be in the range 4–14 or 30–50.
Naphthalene sulfonic acid-formaldehyde condensate, sodium For use only:
salt (CAS Reg. No. 9084–06–4). 1. At levels not to exceed 10 micrograms/in2 (0.16 mg/dm2) in
vinylidene chloride copolymer or homopolymer coatings ap-
plied to films of propylene polymers complying with
2. At levels not to exceed 14 micrograms/in2 (0.21 mg/dm2) in
vinylidene chloride copolymer or homopolymer coatings ap-
plied to films of polyethylene phthalate polymers complying
a-(p-nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of
dihydrogen phosphate and monohydrogen phosphate esters
that have an acid number (to pH 5.2) of 49–59 and that are
produced by the esterification of a-(p-nonylphenyl)-omega-
hydroxypoly (oxyethylene) complying with the identity pre-
scribed in § 178.3400(c) and having an average
poly(oxyethylene) content of 5.5–6.5 moles.
a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of
produced by the esterification of ′-(p-nonylphenyl)omega-
poly(oxyethylene) content of 9–10 moles.
a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of
produced by the esterification of a-(p-nonylphenyl)-omega-
poly(oxyethylene) content of 45–55 moles.
a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) produced
by the condensation of 1 mole of nonylphenol (nonyl group
is a propylene trimer isomer) with an average of 4–14 or 30–
50 moles of ethylene oxide: if a blend of products is used,
the average number of moles of ethylene oxide reacted to
produce any product that is a component of the blend shall
be in the range 4–14 or 30–50.
a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) sulfate,
ammonium or sodium salt: the nonyl group is a propylene
trimer isomer and the poly (oxyethylene) content average 4
moles.
Polyethyleneglycol alkyl(C10-C12)ether sulfosuccinate, disodium For use only at levels not to exceed 5 percent by weight of
salt (CAS Reg. No. 68954–91–6). total monomers used in the emulsion polymerization of poly-
vinyl acetate, acrylic, and vinyl/acrylic polymers intended for
use as coatings for paper and paperboard.
Poly[(methylene-p-nonylphenoxy) poly(oxypropylene)(4–12 For use in coatings at levels not to exceed 1 mg per square
moles) propanol] of minimum molecular weight 3500. foot of food-contact surface.
Poly(oxypropylene) (45–48 moles) block polymer with For use only as a surface-active agent at levels not to exceed
poly(oxyethylene). The finished block polymers meet the fol- 0.5 percent by weight of polyolefin film or polyolefin coatings.
lowing specifications: Average molecular weight 11,000– Such polyolefin film and polyolefin coatings shall have an av-
18,000; hydroxyl number 6.2–10.2; ·cloud point above 100 erage thickness not to exceed 0.005 inch and shall be lim-
°C. for 10 pct solution. ited to use in contact with foods that have a pH above 5.0
and that contain no more than 8 pct of alcohol.
Polysorbate 20 (polyoxyethylene (20) sorbitan monolaurate)
meeting the following specifications: Saponification number
40–50, acid number 0–2, hydroxyl number 60–108, oxy-
ethylene content 70–74 pct.
Polysorbate 40 (polyoxyethylene (20) sorbitan monopalmitate)
meeting the following specifications: Saponification number
41–52, oxyethylene content 66–70.5 pct.
Polysorbate 60 conforming to the identity prescribed in

420
Polysorbate 85 (polyoxyethylene (20) sorbitan trioleate) meet-

ing the following specifications: Saponification number 80–
95, oxyethylene content 46–50 percent.
Sodium 1,4-dicylcohexyl sulfosuccinate.
Sodium 1,4-dihexyl sulfosuccinate.
Sodium 1,4 diisobutyl sulfosuccinate.
Sodium 1,4-dipentyl sulfosuccinate.
Sodium 1,4-ditridecyl sulfosuccinate.
Sodium monoalkylphenoxybenzenedisulfonate and sodium
dialkylphenoxybenzenedisulfonate mixtures containing not
less than 70 pct of the monoalkylated product where the
alkyl group is C8C16.
Sorbitan monolaurate meeting the following specifications. Sa-
ponification number 153–170; and hydroxyl number 330–360.
Sorbitan monooleate meeting the following specifications: Sa-
ponification number 145–160, hydroxyl number 193–210.
Sorbitan monopalmitate meeting the following specifications:
Saponification No. 140–150; and hydroxyl No. 275–305.
Sorbitan monostearate conforming to the identity prescribed in
Sorbitan trioleate meeting the following specifications: Saponi-
fication No. 170–190; and hydroxyl No. 55–70.
Sorbitan tristearate meeting the following specifications: Sa-
ponification No. 176–188; and hydroxyl No. 66–80.
Sulfosuccinic acid 4-ester with polyethylene glycol dodecyl For use only at levels not to exceed 5 percent by weight of
ether, disodium salt (CAS Reg. No. 39354–45–5). total monomers used in the emulsion polymerization of poly-
vinyl acetate, acrylic, and vinyl/acrylic polymers intended for
use as coatings for paper and paperboard.
Sulfosuccinic acid 4-ester with polyethylene glycol nonylphenyl For use only at levels not to exceed 5 percent by weight of the
ether, disodium salt (alcohol moiety produced by condensa- total coating monomers used in the emulsion polymerization
tion of 1 mole nonylphenol and an average of 9–10 moles of of polyvinyl acetate and vinyl-acrylate copolymers intended
ethylene oxide) (CAS Reg. No. 9040–38–4). for use as coatings for paper and paperboard.
a-[p-(1,1,3,3-Tetramethylbutyl)phenyl] omega-
hydroxypoly(oxyethylene) produced by the condensation of 1
mole of p-(1,1,3,3-tetramethylbutyl) phenol with an average
of 4–14 or 30–40 moles of ethylene oxide; if a blend of prod-
ucts is used, the average number of moles of ethylene oxide
reacted to produce any product that is a component of the
blend shall be in the range 4–14 or 30–50.
Tetrasodium N-(1,2-dicarboxyethyl)-N-octadecyl-sulfosuccinate For use only as a polymerization emulsifier for resins applied
to tea-bag material.
a-Tridecyl-omega-hydroxypoly (oxyethylene) mixture of di-
hydrogen phosphate and monohydrogen phosphate esters
one mole of ‘‘oxo’’ process tridecyl alcohol with 5.5–6.5
moles of ethylene oxide.
a-Tridecyl-omega-hydroxypoly (oxyethyl-ene) mixture of di-
hydrogen phosphate and monohydrogen phosphate esters
one mole of ‘‘oxo’’ process tridecyl alcohol with 9–10 moles
of ethylene oxide.
(d) The provisions of this section are Finding Aids section of the printed volume
not applicable to emulsifiers and/or and at www.govinfo.gov.
surface-active agents listed in
§ 178.3450 Esters of stearic and pal-
§ 175.105(c)(5) of this chapter and used in
mitic acids.
food-packaging adhesives complying
with § 175.105 of this chapter. The ester stearyl palmitate or
palmityl stearate or mixtures thereof
[42 FR 14609, Mar. 15, 1977] may be safely used as adjuvants in
EDITORIAL NOTE: For FEDERAL REGISTER ci- food-packaging materials when used in
tations affecting § 178.3400, see the List of accordance with the following pre-
CFR Sections Affected, which appears in the scribed conditions:
421
§ 178.3480 21 CFR Ch. I (4–1–23 Edition)
(a) They are used or intended for use www.archives.gov/federal_register/

as plasticizers or lubricants in poly- code_of_federal_regulations/
styrene intended for use in contact ibr_locations.html.
with food. (1) Synthetic fatty alcohols. (i) Hexyl,
(b) They are added to the formulated octyl, decyl, lauryl, myristyl, cetyl,
polymer prior to extrusion. and stearyl alcohols meeting the speci-
(c) The quantity used shall not ex- fications and definition prescribed in
ceed that required to accomplish the § 172.864 of this chapter, except that
intended technical effect. they may contain not more than 0.8
weight percent total diols.
§ 178.3480 Fatty alcohols, synthetic. (ii) Lauryl, myristyl, cetyl, and ste-
Synthetic fatty alcohols may be safe- aryl alcohols manufactured by the
ly used as components of articles in- process described in § 172.864(a)(2) of
tended for use in contact with food, this chapter such that lauryl and
and in synthesizing food additives and myristyl alcohols meet the specifica-
other substances permitted for use as tions in § 172.864(a)(1)(i) of this chapter,
components of articles intended for use and cetyl and stearyl alcohols meet the
in contact with food in accordance specifications in § 172.864(a)(1)(ii) of this
with the following prescribed condi- chapter.
tions: (2) Conditions of use. (i) Synthetic
(a) The food additive consists of fatty fatty alcohols as substitutes for the
alcohols meeting the specifications and corresponding naturally derived fatty
definition prescribed in § 172.864 of this alcohols permitted for use in compli-
chapter, except as provided in para- ance with § 178.3910.
graph (c) of this section. (ii) Synthetic lauryl alcohol as a sub-
(b) It is used or intended for use as stitute for the naturally derived lauryl
follows: alcohol permitted as an intermediate
(1) As substitutes for the cor- in the synthesis of sodium lauryl sul-
responding naturally derived fatty al- fate used in compliance with § 178.3400.
cohols permitted for use as components
of articles intended for use in contact [42 FR 14609, Mar. 15, 1977, as amended at 47
with food by existing regulations in FR 11847, Mar. 19, 1982; 54 FR 24898, June 12,
1989]
parts 174, 175, 176, 177, 178 and § 179.45 of
this chapter: Provided, That the use is § 178.3500 Glycerin, synthetic.
in compliance with any prescribed lim-
itations. Synthetic glycerin may be safely
(2) As substitutes for the cor- used as a component of articles in-
responding naturally derived fatty al- tended for use in packaging materials
cohols used as intermediates in the for food, subject to the provisions of
synthesis of food additives and other this section:
substances permitted for use as compo- (a) It is produced by the hydro-
nents of food-contact articles. genolysis of carbohydrates, and shall
(c) Synthetic fatty alcohols identi- contain not in excess of 0.2 percent by
fied in paragraph (c)(1) of this section weight of a mixture of butanetriols.
may contain not more than 0.8 weight (b) It is used in a quantity not to ex-
percent of total diols as determined by ceed that amount reasonably required
a method titled ‘‘Diols in Monohydroxy to produce its intended physical or
Alcohol by Miniature Thin Layer Chro- technical effect, and in accordance
matography (MTLC),’’ which is incor- with any limitations prescribed by ap-
porated by reference. Copies are avail- plicable regulations in parts 174, 175,
able from the Center for Food Safety 176, 177, 178 and 179 of this chapter. It
and Applied Nutrition (HFS–200), Food shall not be intended to, nor in fact ac-
and Drug Administration, 5001 Campus complish, any direct physical or tech-
Dr., College Park, MD 20740, or avail- nical effect in the food itself.
able for inspection at the National Ar-
chives and Records Administration § 178.3505 Glyceryl tri-(12-acetoxy-
stearate).

ability of this material at NARA, call Glyceryl tri-(12-acetoxystearate)
202–741–6030, or go to: http:// (CAS Reg. No. 139–43–5) may be safely
422
used as a component of articles in- § 178.3520 Industrial starch-modified.

tended for use in producing, manufac- Industrial starch-modified may be
turing, packing, processing, preparing, safely used as a component of articles
treating, packaging, transporting, or intended for use in producing, manu-
holding food, subject to the provisions facturing, packing, processing, pre-
of this section. paring, treating, packaging, trans-
(a) The additive is applied to the sur- porting, or holding food, subject to the
face of calcium carbonate at a level not provisions of this section.
to exceed 1 weight-percent of the total (a) Industrial starch-modified is iden-
mixture. tified as follows:
(b) The calcium carbonate/glyceryl (1) A food starch-modified or starch
tri-(12-acetoxystearate) mixture is used or any combination thereof that has
as an adjuvant in polymers in contact been modified by treatment with one of
with nonfatty foods at a level not to the reactants hereinafter specified, in
exceed 20 weight-percent of the poly- an amount reasonably required to
mer. achieve the desired functional effect
but in no event in excess of any limita-
[50 FR 1503, Jan. 11, 1985] tion prescribed, with or without subse-
quent treatment as authorized in
List of reactants Limitations
Ammonium persulfate, not to exceed 0.3 pct. or in alkaline

starch not to exceed 0.6 pct..
(4-Chlorobutene-2) trimethylammonium chloride, not to exceed Industrial starch modified by this treatment shall be used only
5 pct. as internal sizing for paper and paperboard intended for food
packaging.
b-Diethylaminoethyl chloride hydrochloride, not to exceed 4 pct.
Dimethylaminoethyl methacrylate, not to exceed 3 pct.
Dimethylol ethylene urea, not to exceed 0.375 pct .................... Industrial starch modified by this treatment shall be used only
as internal sizing for paper and paperboard intended for food
packaging.
2,3-Epoxypropyltrimethylammonium chloride, not to exceed 5
pct.
Ethylene oxide, not to exceed 3 pct of reacted ethylene oxide
in finished product.
Phosphoric acid, not to exceed 6 pct and urea, not to exceed Industrial starch modified by this treatment shall be used only
20 pct. as internal sizing for paper and paperboard intended for food
packaging and as surface sizing and coating for paper and
paperboard that contact food only of Types IV-A, V, VII, VIII,
and IX described in table 1 of § 176.170(c) of this chapter.
(2) A starch irradiated under one of (ii) An electron beam source at a

the following conditions to produce maximum energy of 7 million electron
free radicals for subsequent graft po- volts of ionizing radiation, maximum
lymerization with the reactants listed absorbed dose not to exceed 5.0
in this paragraph (a)(2): megarads.
(i) Radiation from a sealed cobalt 60
source, maximum absorbed dose not to
exceed 5.0 megarads.
Acrylamide and [2-(methacryloyloxy) ethyl]trimethylammonium For use only as a retention aid and dry strength agent em-
methyl sulfate, such that the finished industrial starch-modi- ployed before the sheet-forming operation in the manufac-
fied shall contain: ture of paper and paperboard intended to contact food, and
used at a level not to exceed 0.25 pct by weight of the fin-
ished dry paper and paperboard fibers.
1. Not more than 60 weight percent vinyl copolymer (of
which not more than 32 weight percent is [2-
(methacryloyloxy)ethyl] trimethylammonium methyl sul-
fate).
423
§ 178.3530 21 CFR Ch. I (4–1–23 Edition)
2. Not more than 0.20 pct residual acrylamide.

3. A minimum nitrogen content of 9.0 pct.
(b) The following adjuvants may be Nonvolatile residue 0.002 gram per 100 milli-
used as surface-active agents in the liters maximum.
processing of industrial starch-modi- Synthetic isoparaffinic petroleum hydro-
fied: carbons containing antioxidants shall meet
the specified ultraviolet absorbance limits
Polyethylene glycol (400) dilaurate. after correction for any absorbance due to
Polyethylene glycol (400) monolaurate. the antioxidants. The ultraviolet absorb-
Polyoxyethylene (4) lauryl ether. ance shall be determined by the procedure
(c) To insure safe use of the indus- described for application to mineral oil
trial starch-modified, the label of the under ‘‘Specifications’’ on page 66 of the
‘‘Journal of the Association of Official Ag-
food additive container shall bear the
ricultural Chemists,’’ Vol. 45 (February
name of the additive ‘‘industrial 1962), which is incorporated by reference,
starch-modified,’’ and in the instance disregarding the last sentence of that pro-
of an industrial starch-modified which cedure. For hydrocarbons boiling below 121
is limited with respect to conditions of °C, the nonvolatile residue shall be deter-
use, the label of the food additive con- mined by ASTM method D1353–78, ‘‘Stand-
tainer shall contain a statement of ard Test Method for Nonvolatile Matter in
such limited use. Volatile Solvents for Use in Paint, Var-
nish, Lacquer, and Related Products;’’ for
[42 FR 14609, Mar. 15, 1977, as amended at 42 those boiling above 121 °C, ASTM proce-
FR 49453, Sept. 27, 1977]
dure D381–80, ‘‘Standard Test Method for
Existent Gum in Fuels by Jet Evapo-
§ 178.3530 Isoparaffinic petroleum hy-
ration,’’ which are incorporated by ref-
drocarbons, synthetic.
erence. Copies may be obtained from the
Isoparaffinic petroleum hydro- American Society for Testing Materials,
carbons, synthetic, may be safely used 100 Barr Harbor Dr., West Conshohocken,
in the production of nonfood articles Philadelphia, PA 19428-2959, or may be ex-
intended for use in producing, manu- amined at the National Archives and
facturing, packing, processing, pre- Records Administration (NARA). For in-
paring, treating, packaging, trans- formation on the availability of this mate-
porting, or holding food, subject to the rial at NARA, call 202–741–6030, or go to:
provisions of this section.
(a) The isoparaffinic petroleum hy- ibr_locations.html.
drocarbons, produced by synthesis from
petroleum gases consist of a mixture of (b) Isoparaffinic petroleum hydro-
liquid hydrocarbons meeting the fol- carbons may contain antioxidants au-
lowing specifications: thorized for use in food in an amount
not to exceed that reasonably required
Boiling point 63°–260 °C, as determined by
ASTM method D86–82, ‘‘Standard Method to accomplish the intended technical
for Distillation of Petroleum Products,’’ effect.
which is incorporated by reference. Copies (c) Isoparaffinic petroleum hydro-
may be obtained from the American Soci- carbons are used in the production of
ety for Testing Materials, 100 Barr Harbor nonfood articles. The quantity used
Dr., West Conshohocken, Philadelphia, PA
19428-2959, or may be examined at the Na- shall not exceed the amount reason-
tional Archives and Records Administra- ably required to accomplish the in-
tion (NARA). For information on the avail- tended technical effect, and the resid-
ability of this material at NARA, call 202– ual remaining in the finished article
741–6030, or go to: http://www.archives.gov/ shall be the minimum amount reason-
federal_register/code_of_federal_regulations/
ably attainable.
ibr_locations.html.
Ultraviolet absorbance: [42 FR 14609, Mar. 15, 1977, as amended at 47
260–319 millimicrons—1.5 maximum. FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19,
320–329 millimicrons—0.08 maximum. 1984]
330–350 millimicrons—0.05 maximum.
424
§ 178.3570 Lubricants with incidental (a) The lubricants are prepared from
food contact. one or more of the following sub-
stances:
Lubricants with incidental food con-
tact may be safely used on machinery
as safe for use in food.
used for producing, manufacturing, (2) Substances used in accordance
packing, processing, preparing, treat- with the provisions of a prior sanction
ing, packaging, transporting, or hold- or approval.
ing food, subject to the provisions of (3) Substances identified in this para-
this section: graph (a)(3).
Aluminum stearoyl benzoyl hydroxide ......................................... For use only as a thickening agent in mineral oil lubricants at a
level not to exceed 10 pct by weight of the mineral oil.
N,N-Bis(2-ethylhexyl)-ar-methyl-1H-benzotriazole-1- For use as a copper deactivator at a level not to exceed 0.1
methanamine (CAS Reg. No. 94270–86–7). percent by weight of the lubricant.
BHA.
BHT.
a-Butyl-omega-hydroxypoly(oxyethylene) poly(oxypropylene) Addition to food not to exceed 10 parts per million.
produced by random condensation of a 1:1 mixture by
weight of ethylene oxide and propylene oxide with butanol;
minimum molecular weight 1,500; Chemical Abstracts Serv-
ice Registry No. 9038–95–3.
a-Butyl-omega-hydroxypoly(oxypropylene); minimum molecular Do.
weight 1,500; Chemical Abstracts Service Registry No.
9003–13–8.
Castor oil ..................................................................................... Do.
Castor oil, dehydrated ................................................................. Do.
Castor oil, partially dehydrated .................................................... Do.
Dialkyldimethylammonium aluminum silicate (CAS Reg. No. For use only as a gelling agent in mineral oil lubricants at a
68953–58–2), which may contain up to 7 percent by weight level not to exceed 15 percent by weight of the mineral oil.
1,6-hexanediol (CAS Reg. No. 629–11–8), where the alkyl
groups are derived from hydrogenated tallow fatty acids
(C14-C18) and where the aluminum silicate is derived from
bentonite.
Dimethylpolysiloxane (viscosity greater than 300 centistokes) ... Addition to food not to exceed 1 part per million.
Di (n-octyl) phosphite (CAS Reg. No. 1809–14–9) ..................... For use only as an extreme pressure-antiwear adjuvant at a
level not to exceed 0.5 percent by weight of the lubricant.
Disodium decanedioate (CAS Reg. No. 17265–14–4) ............... For use only:
1. As a corrosion inhibitor or rust preventative in mineral oil-
bentonite lubricants at a level not to exceed 2 percent by
weight of the grease.
2. As a corrosion inhibitor or rust preventative only in greases
at a level not to exceed 2 percent by weight of the grease.
Disodium EDTA (CAS Reg. No. 139–33–3) ............................... For use only as a chelating agent and sequestrant at a level
not to exceed 0.06 percent by weight of lubricant at final use
dilution.
Ethoxylated resin phosphate ester mixture consisting of the fol- For use only as a surfactant to improve lubricity in lubricating
lowing compounds: fluids complying with this section at a level not to exceed 5
percent by weight of the lubricating fluid.
1. Poly(methylene-p-tert-butyl- phenoxy)poly-(oxyethylene)
mixture of dihydrogen phosphate and monohydrogen
phosphate esters (0 to 40 percent of the mixture). The
resin is formed by condensation of 1 mole of p-tert-
butylphenol with 2 to 4 moles of formaldehyde and sub-
sequent ethoxylation with 4 to 12 moles of ethylene
oxide;.
2. Poly(methylene-p-nonylphenoxy) poly(oxyethylene) mix-
ture of dihydrogen phosphate and monohydrogen phos-
phate esters (0 to 40 percent of the mixture). The resin
is formed by condensation of 1 mole of p-nonylphenol
with 2 to 4 moles of formaldehyde and subsequent
ethoxylation with 4 to 12 moles of ethylene oxide; and.
3. n-Tridecyl alcohol mixture of dihydrogen phosphate and
monohydrogen phosphate esters (40 to 80 percent of
the mixture; CAS Reg. No. 56831–62–0).
Fatty acids derived from animal or vegetable sources, and the
hydrogenated forms of such fatty acids.
2-(8-Heptadecenyl)-4,5-dihydro-1H-imidazole-1-ethanol (CAS For use at levels not to exceed 0.5 percent by weight of the lu-
Reg. No. 95–38–5). bricant.

Hexamethylenebis(3,5-di-tert-butyl-4-hydroxyhydrocinnamate) For use as an antioxidant at levels not to exceed 0.5 percent
(CAS Reg. No. 35074–77–2). by weight of the lubricant.
425
§ 178.3570 21 CFR Ch. I (4–1–23 Edition)
a-Hydro-omega-hydroxypoly (oxyethylene) poly(oxypropylene) Addition to food not to exceed 10 parts per million.
produced by random condensation of mixtures of ethylene
oxide and propylene oxide containing 25 to 75 percent by
weight of ethylene oxide; minimum molecular weight 1,500;
Chemical Abstracts Service Registry No. 9003–11–6.
12-Hydroxystearic acid.
Isopropyl oleate ........................................................................... For use only as an adjuvant (to improve lubricity) in mineral oil
lubricants.
Magnesium ricinoleate ................................................................. For use only as an adjuvant in mineral oil lubricants at a level
not to exceed 10 percent by weight of the mineral oil.
Mineral oil .................................................................................... Addition to food not to exceed 10 parts per million.
N-Methyl-N-(1-oxo-9- octadecenyl)glycine (CAS Reg. No. 110– For use as a corrosion inhibitor at levels not to exceed 0.5 per-
25–8). cent by weight of the lubricant.
N-phenylbenzenamine, reaction products with 2,4,4- For use only as an antioxidant at levels not to exceed 0.5 per-
trimethylpentene (CAS Reg. No. 68411–46–1). cent by weight of the lubricant.
Petrolatum ................................................................................... Complying with § 178.3700. Addition to food not to exceed 10
parts per million.
Phenyl-a-and/or phenyl-b-naphthylamine ................................... For use only, singly or in combination, as antioxidant in mineral
oil lubricants at a level not to exceed a total of 1 percent by
weight of the mineral oil.
Phosphoric acid, mono- and dihexyl esters, compounds with For use only as an adjuvant at levels not to exceed 0.5 per-
tetramethylnonylamines and C11-14 alkylamines. cent by weight of the lubricant.
Phosphoric acid, mono- and diisooctyl esters, reacted with tert- For use only as a corrosion inhibitor or rust preventative
alkyl and (C12-C14) primary amines (CAS Reg. No. 68187– inlubricants at a level not to exceed 0.5 percent by weight of
67–7). the lubricant.
Phosphorothioic acid, O, O, O-triphenyl ester, tert-butyl deriva- For use only as an extreme pressure-antiwear adjuvant at a
tives (CAS Reg. No. 192268–65–8). level not to exceed 0.5 percent by weight of the lubricant.
Polyurea, having a nitrogen content of 9–14 percent based on For use only as an adjuvant in mineral oil lubricants at a level
the dry polyurea weight, produced by reacting tolylene not to exceed 10 percent by weight of the mineral oil.
diisocyanate with tall oil fatty acid (C16 and C18) amine and
ethylene diamine in a 2:2:1 molar ratio.
Polybutene (minimum average molecular weight 80,000) .......... Addition to food not to exceed 10 parts per million.
Polybutene, hydrogenated; complying with the identity pre- Do.
scribed under § 178.3740.
Polyethylene ................................................................................ Do.
Polyisobutylene (average molecular weight 35,000–140,000 For use only as a thickening agent in mineral oil lubricants.
(Flory)).
Sodium nitrite ............................................................................... For use only as a rust preventive in mineral oil lubricants at a
level not to exceed 3 percent by weight of the mineral oil.
Tetrakis[methylene(3,5-di-tert-butyl-4-hydroxyhydro- For use only as an antioxidant in lubricants at a level not to ex-
cinnamate)]methane (CAS Reg. No. 6683–19–8). ceed 0.5 percent by weight of the lubricant.
Thiodiethylenebis (3,5-di-tert-butyl-4-hydroxyhydrocinnamate) For use as an antioxidant at levels not to exceed 0.5 percent
(CAS Reg. No. 41484-35-9). by weight of the lubricant.
Tri[2(or 4)-C9-10-branched alkylphenyl]phosphorothioate (CAS For use only as an extreme pressure-antiwear adjuvant at lev-
Reg. No. 126019–82–7). els not to exceed 0.5 percent by weight of the lubricant.
Triphenyl phosphorothionate (CAS Reg. No. 597–82–0) ........... For use as an adjuvant in lubricants herein listed at a level not
to exceed 0.5 percent by weight of the lubricant.
Tris(2,4-di-tert-butylphenyl)phosphite (CAS Reg. NO. 31570– For use only as a stabilizer at levels not to exceed 0.5 percent
04–4). by weight of the lubricant.
Thiodiethylenebis(3,5-di-tert-butyl-4-hydroxy-hydro- cinnamate) For use as an antioxidant at levels not to exceed 0.5 percent
(CAS Reg. No. 41484–35–9). by weight of the lubricant.
Zinc sulfide .................................................................................. For use at levels not to exceed 10 percent by weight of the lu-
bricant.
(b) The lubricants are used on food- (c) Any substance employed in the
processing equipment as a protective production of the lubricants described
antirust film, as a release agent on gas- in this section that is the subject of a
kets or seals of tank closures, and as a regulation in parts 174, 175, 176, 177, 178
lubricant for machine parts and equip- and § 179.45 of this chapter conforms
ment in locations in which there is ex- with any specification in such regula-
posure of the lubricated part to food. tion.
The amount used is the minimum re- [42 FR 14609, Mar. 15, 1977]
quired to accomplish the desired tech-
nical effect on the equipment, and the EDITORIAL NOTE: For FEDERAL REGISTER ci-
tations affecting § 178.3570, see the List of
addition to food of any constituent
CFR Sections Affected, which appears in the

identified in this section does not ex- Finding Aids section of the printed volume
ceed the limitations prescribed. and at www.govinfo.gov.
426
§ 178.3600 Methyl glucoside-coconut oil this chapter may be used as a compo-

ester. nent of nonfood articles provided such
Methyl glucoside-coconut oil ester use complies with any applicable limi-
identified in § 172.816(a) of this chapter tations in parts 170 through 189 of this
may be safely used as a processing aid chapter. The use of white mineral oil in
(filter aid) in the manufacture of or on food itself, including the use of
starch, including industrial starch- white mineral oil as a protective coat-
modified complying with § 178.3520, in- ing or release agent for food, is subject
tended for use as a component of arti- to the provisions of § 172.878 of this
cles that contact food. chapter.
(b) Technical white mineral oil iden-
§ 178.3610 α-Methylstyrene- tified in paragraph (b)(1) of this section
vinyltoluene resins, hydrogenated. may be used as provided in paragraph
Hydrogenated a-methylstyrene- (b)(2) of this section.
vinyltoluene copolymer resins having a (1) Technical white mineral oil con-
molar ratio of 1 a-methylstyrene to 3 sists of specially refined distillates of
vinyltoluene may be safely used as virgin petroleum or of specially refined
components of polyolefin film intended distillates that are produced syn-
for use in contact with food, subject to thetically from petroleum gases. Tech-
the following provisions: nical white mineral oil meets the fol-
(a) Hydrogenated a-methylstyrene- lowing specifications:
vinyltoluene copolymer resins have a (i) Saybolt color 20 minimum as de-
drop-softening point of 125° to 165 °C termined by ASTM method D156–82,
and a maximum absorptivity of 0.17 ‘‘Standard Test Method for Saybolt
liter per gram centimeter at 266 nano- Color of Petroleum Products (Saybolt
meters, as determined by methods ti- Chromometer Method),’’ which is in-
tled ‘‘Determination of Softening Point corporated by reference. Copies may be
(Drop Method)’’ and ‘‘Determination of obtained from the American Society
Unsaturation of Resin 1977,’’ which are for Testing Materials, 100 Barr Harbor
incorporated by reference. Copies are Dr., West Conshohocken, Philadelphia,
available from the Center for Food PA 19428-2959, or may be examined at
Safety and Applied Nutrition (HFS– the National Archives and Records Ad-
200), Food and Drug Administration, ministration (NARA). For information
5001 Campus Dr., College Park, MD on the availability of this material at
20740, or available for inspection at the NARA, call 202–741–6030, or go to: http://
National Archives and Records Admin- www.archives.gov/federal_register/
istration (NARA). For information on code_of_federal_regulations/
the availability of this material at ibr_locations.html.
NARA, call 202–741–6030, or go to: http:// (ii) Ultraviolet absorbance limits as
www.archives.gov/federal_register/ follows:
ibr_locations.html. Maximum
absorb-
(b) The polyolefin film is produced ance per
Wavelength (mμ)
from olefin polymers complying with centimeter
optical
§ 177.1520 of this chapter, and the aver- pathlength
age thickness of the film in the form in
280 to 289 ........................................................... 4.0
which it contacts food does not exceed
290 to 299 ........................................................... 3.3
0.002 inch. 300 to 329 ........................................................... 2.3
330 to 350 ........................................................... 0.8
FR 11847, Mar. 19, 1982; 54 FR 24898, June 12,
1989] Technical white mineral oil containing
antioxidants shall meet the specified
§ 178.3620 Mineral oil. ultraviolet absorbance limits after cor-
Mineral oil may be safely used as a rection for any absorbance due to the
component of nonfood articles intended antioxidants. The ultraviolet absorb-
for use in contact with food, subject to ance shall be determined by the proce-
the provisions of this section: dure described for application to min-

(a) White mineral oil meeting the eral oil under ‘‘Specification’’ on page
specifications prescribed in § 172.878 of 66 of the ‘‘Journal of the Association of
427
§ 178.3620 21 CFR Ch. I (4–1–23 Edition)
Official Agricultural Chemists,’’ Vol- reference is given in paragraph (b)(1)(i)

ume 45 (February 1962) (which is incor- of this section.
porated by reference; copies are avail- (iii) Ultraviolet absorbance limits as
able from the Center for Food Safety follows as determined by the analytical
and Applied Nutrition (HFS–200), Food method described in paragraph (c)(3) of
and Drug Administration, 5001 Campus this section:
Dr., College Park, MD 20740, or avail-
able for inspection at the National Ar- Maximum
absorb-
chives and Records Administration Wavelength (mμ) ance per
(NARA). For information on the avail- centimeter
optical
ability of this material at NARA, call pathlength
202–741–6030, or go to: http://
280 to 289 ........................................................... 0.7
www.archives.gov/federal_register/ 290 to 299 ........................................................... 0.6
code_of_federal_regulations/ 300 to 359 ........................................................... 0.4
ibr_locations.html.), disregarding the 360 to 400 ........................................................... .09
last two sentences of that procedure
and substituting therefor the fol- (2) The mineral oil may be used wher-
lowing: Determine the absorbance of ever mineral oil is permitted for use as
the mineral oil extract in a 10-milli- a component of nonfood articles com-
meter cell in the range from 260–350 plying with §§ 175.105 and 176.210 of this
mμ, inclusive, compared to the solvent chapter and § 178.3910 (for use only in
control. If the absorbance so measured rolling of metallic foil and sheet
exceeds 2.0 at any point in range 280–350 stock), §§ 176.200, 177.2260, 177.2600, and
mμ, inclusive, dilute the extract and 177.2800 of this chapter.
the solvent control, respectively, to (3) The analytical method for deter-
twice their volume with dimethyl sulf- mining ultraviolet absorbance limit is
oxide and remeasure the absorbance. as follows:
Multiply the remeasured absorbance
values by 2 to determine the absorb- GENERAL INSTRUCTIONS
ance of the mineral oil extract per cen- Because of the sensitivity of the test, the
timeter optical pathlength. possibility of errors arising from contamina-
(2) Technical white mineral oil may tion is great. It is of the greatest importance
be used wherever mineral oil is per- that all glassware be scrupulously cleaned to
mitted for use as a component of remove all organic matter such as oil,
grease, detergent residues, etc. Examine all
nonfood articles complying with
glassware, including stoppers and stopcocks,
§§ 175.105, 176.200, 176.210, 177.2260, under ultraviolet light to detect any residual
177.2600, and 177.2800 of this chapter and fluorescent contamination. As a pre-
§§ 178.3570 and 178.3910. cautionary measure it is recommended prac-
(3) Technical white mineral oil may tice to rinse all glassware with purified iso-
contain any antioxidant permitted in octane immediately before use. No grease is
food by regulations issued in accord- to be used on stopcocks or joints. Great care
ance with section 409 of the Act, in an to avoid contamination of oil samples in
handling and to assure absence of any extra-
amount not greater than that required
neous material arising from inadequate
to produce its intended effect. packaging is essential. Because some of the
(c) Mineral oil identified in para- polynuclear hydrocarbons sought in this test
graph (c)(1) of this section may be used are very susceptible to photo-oxidation, the
as provided in paragraph (c)(2) of this entire procedure is to be carried out under
section. subdued light.
(1) The mineral oil consists of virgin
APPARATUS
petroleum distillates refined to meet
the following specifications: Separatory funnels. 250-milliliter, 500-milli-
(i) Initial boiling point of 450 °F min- liter, 1,000-milliliter, and preferably 2,000-
imum. milliliter capacity, equipped with tetra-
fluoroethylene polymer stopcocks.
(ii) Color 5.5 maximum as determined
Reservoir. 500-milliliter capacity, equipped
by ASTM method D1500–82, ‘‘Standard with a 24/40 standard taper male fitting at
Test Method for ASTM Color of Petro- the bottom and a suitable ball-joint at the
leum Products (ASTM Color Scale),’’ top for connecting to the nitrogen supply.
which is incorporated by reference. The The male fitting should be equipped with
availability of this incorporation by glass hooks.
428
Chromatographic tube. 180 millimeters in REAGENTS AND MATERIALS
length, inside diameter to be 15.7 millimeters
±0.1 millimeter, equipped with a coarse, frit- Organic solvents. All solvents used through-
ted-glass disc, a tetrafluoroethylene polymer out the procedure shall meet the specifica-
stopcock, and a female 24/40 standard tapered tions and tests described in this specifica-
fitting at the opposite end. (Overall length of tion. The isooctane, benzene, acetone, and
the column with the female joint is 235 milli- methyl alcohol designated in the list fol-
meters.) The female fitting should be lowing this paragraph shall pass the fol-
equipped with glass hooks. lowing test:
Disc. Tetrafluoroethylene polymer 2-inch To the specified quantity of solvent in a
diameter disk approximately 3⁄16-inch thick 250-milliliter Erlenmeyer flask, add 1 milli-
with a hole bored in the center to closely fit liter of purified n-hexadecane and evaporate
the stem of the chromatographic tube. on the steam bath under a stream of nitro-
gen (a loose aluminum foil jacket around the
Suction flask. 250-milliliter or 500-milliliter
flask will speed evaporation). Discontinue
filter flask.
evaporation when not over 1 milliliter of res-
Condenser. 24/40 joints, fitted with a drying
idue remains. (To the residue from benzene
tube, length optional.
add a 10-milliliter portion of purified iso-
Evaporation flask (optional). 250-milliliter or octane, reevaporate, and repeat once to in-
500-milliliter capacity all-glass flask sure complete removal of benzene.)
equipped with standard taper stopper having
Alternatively, the evaporation time can be
inlet and outlet tubes to permit passage of
reduced by using the optional evaporation
nitrogen across the surface of contained liq-
flask. In this case the solvent and n-hexa-
uid to be evaporated.
decane are placed in the flask on the steam
Spectrophotometric cells. Fused quartz cells, bath, the tube assembly is inserted, and a
optical path length in the range of 5,000 cen- stream of nitrogen is fed through the inlet
timeter ±0.005 centimeter; also for checking tube while the outlet tube is connected to a
spectrophotometer performance only, optical solvent trap and vacuum line in such a way
path length in the range 1,000 centimeter as to prevent any flow-back of condensate
±0.005 centimeter. With distilled water in the into the flask.
cells, determine any absorbance differences.
Dissolve the 1 milliliter of hexadecane res-
Spectrophotometer. Spectral range 250 milli- idue in isooctane and make to 25 milliliters
microns—400 millimicrons with spectral slit volume. Determine the absorbance in the 5-
width of 2 millimicrons or less; under instru- centimeter path length cells compared to
ment operating conditions for these absorb- isooctane as reference. The absorbance of the
ance measurements, the spectrophotometer solution of the solvent residue (except for
shall also meet the following performance methyl alcohol) shall not exceed 0.01 per cen-
requirements: timeter path length between 280 and 400 mμ.
Absorbance repeatability, ±0.01 at 0.4 ab- For methyl alcohol this absorbance value
sorbance. shall be 0.00.
Absorbance accuracy 1 ±0.05 at 0.4 absorb- Isooctane (2,2,4-trimethylpentane). Use 180
ance. milliliters for the test described in the pre-
Wavelength accuracy, ±1.0 millimicron. ceding paragraph. Purify, if necessary, by
Nitrogen cylinder. Water-pumped or equiva- passage through a column of activated silica
lent purity nitrogen in cylinder equipped gel (Grade 12, Davison Chemical Company,
with regulator and valve to control flow at 5 Baltimore, Maryland, or equivalent) about 90
p.s.i.g. centimeters in length and 5 centimeters to 8
centimeters in diameter.
1 As determined by procedure using potas- Benzene, A.C.S. reagent grade. Use 150 milli-
sium chromate for reference standard and liters for the test. Purify, if necessary, by
described in National Bureau of Standards distillation or otherwise.
Circular 484, Spectrophotometry, U.S. De- Acetone, A.C.S. reagent grade. Use 200 milli-
partment of Commerce (1949). The accuracy liters for the test. Purify, if necessary, by
is to be determined by comparison with the distillation.
standard values at 290, 345, and 400 milli- Eluting mixtures:
microns. Circular 484 is incorporated by ref- 1. 10 percent benzene in isooctane. Pipet 50
erence. Copies are available from the Center milliliters of benzene into a 250-milliliter
for Food Safety and Applied Nutrition (HFS– glass-stoppered volumetric flask and adjust
200), Food and Drug Administration, 5001 to volume with isooctane, with mixing.
Campus Dr., College Park, MD 20740, or 2. 20 percent benzene in isooctane. Pipet 50
available for inspection at the National Ar- milliliters of benzene into a 250-milliliter
chives and Records Administration (NARA). glass-stoppered volumetric flask and adjust
For information on the availability of this to volume with isooctane, with mixing.
material at NARA, call 202–741–6030, or go to: 3. Acetone-benzene-water mixture. Add 20

http://www.archives.gov/federal_register/ milliliters of water to 380 milliliters of ace-
code_of_federal_regulations/ibr_locations.html. tone and 200 milliliters of benzene, and mix.
429
§ 178.3620 21 CFR Ch. I (4–1–23 Edition)
n-Hexadecane, 99-percent olefin-free. Dilute meter to 2 centimeters thick. Reheat the
1.0 milliliter of n-hexadecane to 25 milliliters mixture at 160 °C ±1 °C for 2 hours, and store
with isooctane and determine the absorbance in a tightly closed flask.
in a 5-centimeter cell compared to isooctane Sodium sulfate, anhydrous, A.C.S. reagent
as reference point between 280 mμ–400 mμ. grade, preferably in granular form. For each
The absorbance per centimeter path length bottle of sodium sulfate reagent used, estab-
shall not exceed 0.00 in this range. Purify, if lish as follows the necessary sodium sulfate
necessary, by percolation through activated prewash to provide such filters required in
silica gel or by distillation. the method: Place approximately 35 grams of
Methyl alcohol, A.C.S. reagent grade. Use anhydrous sodium sulfate in a 30-milliliter
10.0 milliliters of methyl alcohol. Purify, if course, fritted-glass funnel or in a 65-milli-
necessary, by distillation. meter filter funnel with glass wool plug;
Dimethyl sulfoxide. Spectrophotometric wash with successive 15-milliliter portions of
grade (Crown Zellerbach Corporation, the indicated solvent until a 15-milliliter
Camas, Washington, or equivalent). Absorb- portion of the wash shows 0.00 absorbance
ance (1-centimeter cell, distilled water ref- per centimeter path length between 280 mμ
erence, sample completely saturated with ni- and 400 mμ when tested as prescribed under
trogen). ‘‘Organic solvents.’’ Usually three portions
of wash solvent are sufficient.
Absorb- Before proceeding with analysis of a sam-
Wavelength ance (max- ple, determine the absorbance in a 5-centi-
imum)
meter path cell between 250 millimicrons and
261.5 .................................................................... 1.00 400 millimicrons for the reagent blank by
270 ....................................................................... .20 carrying out the procedure, without an oil
275 ....................................................................... .09 sample, recording the spectra after the ex-
280 ....................................................................... .06 traction stage and after the complete proce-
300 ....................................................................... .015 dure as prescribed. The absorbance per centi-
meter pathlength following the extraction
There shall be no irregularities in the ab- stage should not exceed 0.02 in the wave-
sorbance curve within these wavelengths. length range from 280 mμ to 400 mμ; the ab-
Phosphoric acid. 85 percent A.C.S. reagent sorbance per centimeter pathlength fol-
grade. lowing the complete procedure should not
Sodium borohydride. 98 percent. exceed 0.02 in the wavelength range from 280
Magnesium oxide (Sea Sorb 43, Food Machin- mμ to 400 mμ. If in either spectrum the char-
ery Company, Westvaco Division, distributed by acteristic benzene peaks in the 250 mμ–260
chemical supply firms, or equivalent). Place 100 mμ region are present, remove the benzene
grams of the magnesium oxide in a large by the procedure under ‘‘Organic solvents’’
beaker, add 700 milliliters of distilled water and record absorbance again.
to make a thin slurry, and heat on a steam Place 300 milliliters of dimethyl sulfoxide
bath for 30 minutes with intermittent stir- in a 1-liter separatory funnel and add 75 mil-
ring. Stir well initially to insure that all the liliters of phosphoric acid. Mix the contents
adsorbent is completely wetted. Using a of the funnel and allow to stand for 10 min-
Buchner funnel and a filter paper (Schleicher utes. (The reaction between the sulfoxide
& Schuell No. 597, or equivalent) of suitable and the acid is exothermic. Release pressure
diameter, filter with suction. Continue suc- after mixing, then keep funnel stoppered.)
tion until water no longer drips from the Add 150 milliliters of isooctane and shake to
funnel. Transfer the adsorbent to a glass pre-equilibrate the solvents. Draw off the in-
trough lined with aluminum foil (free from dividual layers and store in glass-stoppered
rolling oil). Break up the magnesia with a flasks.
clean spatula and spread out the adsorbent Weigh a 20-gram sample of the oil and
on the aluminum foil in a layer about 1 cen- transfer to a 500-milliliter separatory funnel
timeter to 2 centimeters thick. Dry for 24 containing 100 milliliters of pre-equilibrated
hours at 160 °C ±1 °C. Pulverize the magnesia sulfoxide-phosphoric acid mixture. Complete
with mortar and pestle. Sieve the pulverized the transfer of the sample with small por-
adsorbent between 60–180 mesh. Use the mag- tions of preequilibrated isooctane to give a
nesia retained on the 180-mesh sieve. total volume of the oil and solvent of 75 mil-
Celite 545. Johns Mansville Company, diato- liliters. Shake the funnel vigorously for 2
maceous earth, or equivalent. minutes. Set up three 250-milliliter sepa-
Magnesium oxide-Celite 545 mixture (2 + 1) by ratory funnels with each containing 30 milli-
weight. Place the magnesium oxide (60–180 liters of pre-equilibrated isooctane. After
mesh) and the Celite 545 in 2 to 1 propor- separation of liquid phases, carefully draw
tions, respectively, by weight in a glass- off lower layer into the first 250-milliliter
stoppered flask large enough for adequate separatory funnel and wash in tandem with
mixing. Shake vigorously for 10 minutes. the 30-milliliter portions of isooctane con-
Transfer the mixture to a glass trough lined tained in the 250-milliliter separatory fun-
with aluminum foil (free from rolling oil) nels. Shaking time for each wash is 1
and spread it out on a layer about 1 centi- minute. Repeat the extraction operation
430
with two additional portions of the sulf- denser equipped with a 24/40 joint and with a
oxide-acid mixture and wash each extractive drying tube into the flask, mix until the
in tandem through the same three portions borohydride is dissolved, and allow to stand
of isooctane. for 30 minutes at room temperature, with
Collect the successive extractives (300 mil- intermittent swirling. At the end of this pe-
liliters total) in a separatory funnel (pref- riod, disconnect the flask and evaporate the
erably 2-liter) containing 480 milliliters of methyl alcohol on the steam bath under ni-
distilled water; mix, and allow to cool for a trogen until the sodium borohydride begins
few minutes after the last extractive has to come out of the solution. Then add 10 mil-
been added. Add 80 milliliters of isooctane to
liliters of isooctane and evaporate to a vol-
the solution and extract by shaking the fun-
ume of about 2–3 milliliters. Again, add 10
nel vigorously for 2 minutes. Draw off the
lower aqueous layer into a second separatory milliliters of isooctane and concentrate to a
funnel (preferably 2-liter) and repeat the ex- volume of approximately 5 milliliters. Swirl
traction with 80 milliliters of isooctane. the flask repeatedly to assure adequate
Draw off and discard the aqueous layer. washing of the sodium borohydride residues.
Wash each of the 80-milliliter extractives Fit the tetrafluoroethylene polymer disc
three times with 100-milliliter portions of on the upper part of the stem of the
distilled water. Shaking time for each wash chromatographic tube, then place the tube
is 1 minute. Discard the aqueous layers. Fil- with the disc on the suction flask and apply
ter the first extractive through anhydrous the vacuum (approximately 135 millimeters
sodium sulfate prewashed with isooctane (see Hg pressure). Weigh out 14 grams of the 2:1
Sodium sulfate under ‘‘Reagents and Mate- magnesium oxide-Celite 545 mixture and
rials’’ for preparation of filter) into a 250- pour the adsorbent mixture into the
milliliter Erlenmeyer flask (or optionally chromatographic tube in approximately 3-
into the evaporation flask). Wash the first centimeter layers. After the addition of each
separatory funnel with the second 80-milli- layer, level off the top of the adsorbent with
liter isooctane extractive and pass through a flat glass rod or metal plunger by pressing
the sodium sulfate. Then wash the second
down firmly until the adsorbent is well
and first separatory funnels successively
packed. Loosen the topmost few millimeters
with a 20-milliliter portion of isooctane and
of each adsorbent layer with the end of a
pass the solvent through the sodium sulfate
into the flask. Add 1 milliliter of n-hexa- metal rod before the addition of the next
decane and evaporate the isooctane on the layer. Continue packing in this manner until
steam bath under nitrogen. Discontinue all the 14 grams of the adsorbent is added to
evaporation when not over 1 milliliter of res- the tube. Level off the top of the adsorbent
idue remains. To the residue, add a 10-milli- by pressing down firmly with a flat glass rod
liter portion of isooctane, reevaporate to 1 or metal plunger to make the depth of the
milliliter of hexadecane, and repeat this op- adsorbent bed approximately 12.5 centi-
eration once. meters in depth. Turn off the vacuum and re-
Quantitatively transfer the residue with move the suction flask. Fit the 500–milliliter
isooctane to a 200-milliliter volumetric reservoir onto the top of the
flask, make to volume, and mix. Determine chromatographic column and prewet the col-
the absorbance of the solution in the 1-centi- umn by passing 100 milliliters of isooctane
meter pathlength cells compared to iso- through the column. Adjust the nitrogen
octane as reference between 280 mμ–400 mμ pressure so that the rate of descent of the
(take care to lose none of the solution in fill- isooctane coming off the column is between
ing the sample cell). Correct the absorbance 2–3 milliliters per minute. Discontinue pres-
values for any absorbance derived from re- sure just before the last of the isooctane
agents as determined by carrying out the
reaches the level of the adsorbent. (Caution:
procedure without an oil sample. If the cor-
Do not allow the liquid level to recede below
rected absorbance does not exceed the limits
the adsorbent level at any time.) Remove the
prescribed in this paragraph, the oil meets
reservoir and decant the 5–milliliter iso-
the ultraviolet absorbance specifications. If
the corrected absorbance per centimeter octane concentrate solution onto the column
pathlength exceeds the limits prescribed in and with slight pressure again allow the liq-
this paragraph, proceed as follows: Quan- uid level to recede to barely above the ad-
titatively transfer the isooctane solution to sorbent level. Rapidly complete the transfer
a 125-milliliter flask equipped with 24/40 similarly with two 5–milliliter portions of
joint, and evaporate the isooctane on the isooctane, swirling the flask repeatedly each
steam bath under a stream of nitrogen to a time to assure adequate washing of the res-
volume of 1 milliliter of hexadecane. Add 10 idue. Just before the final 5–milliliter wash
milliliters of methyl alcohol and approxi- reaches the top of the adsorbent, add 100 mil-
mately 0.3 gram of sodium borohydride. liliters of isooctane to the reservoir and con-
(Minimize exposure of the borohydride to the tinue the percolation at the 2–3 milliliters
atmosphere. A measuring dipper may be per minute rate. Just before the last of the
used.) Immediately fit a water-cooled con- isooctane reaches the adsorbent level, add
431
§ 178.3620 21 CFR Ch. I (4–1–23 Edition)
100 milliliters of 10 percent benzene in iso- 2 percent, as determined by ASTM
octane to the reservoir and continue the per- method D86–82, ‘‘Standard Method for
colation at the aforementioned rate. Just be-
fore the solvent mixture reaches adsorbent
Distillation of Petroleum Products,’’
level, add 25 milliliters of 20 percent benzene which is incorporated by reference. The
in isooctane to the reservoir and continue availability of this incorporation by
the percolation at 2–3 milliliters per minute reference is given in paragraph (b)(1)(i)
until all this solvent mixture has been re- of this section.
moved from the column. Discard all the
elution solvents collected up to this point.
(ii) Ultraviolet absorbance limits as
Add 300 milliliters of the acetone-benzene- follows as determined by the method
water mixture to the reservoir and percolate described in paragraph (d)(3) of this
through the column to eluate the section.
polynuclear compounds. Collect the eluate in
a clean 1-liter separatory funnel. Allow the Maximum
column to drain until most of the solvent absorb-
ance per
mixture is removed. Wash the eluate three Wavelength (mμ) centimeter
times with 300-milliliter portions of distilled optical
water, shaking well for each wash. (The addi- pathlength
tion of small amounts of sodium chloride fa-
280 to 299 ........................................................... 2.3
cilitates separation.) Discard the aqueous
300 to 319 ........................................................... 1.2
layer after each wash. After the final separa-
320 to 359 ........................................................... .8
tion, filter the residual benzene through an-
360 to 400 ........................................................... .3
hydrous sodium sulfate pre-washed with ben-
zene (see Sodium sulfate under ‘‘Reagents
and Materials’’ for preparation of filter) into (iii) Pyrene content not to exceed a
a 250-milliliter Erlenmeyer flask (or option- maximum of 25 parts per million as de-
ally into the evaporation flask). Wash the termined by the method described in
separatory funnel with two additional 20- paragraph (d)(3) of this section.
milliliter portions of benzene which are also
filtered through the sodium sulfate. Add 1
(2) The mineral oil may be used only
milliliter of n-hexadecane and completely re- in the processing of jute fiber employed
move the benzene by evaporation under ni- in the production of textile bags in-
trogen, using the special procedure to elimi- tended for use in contact with the fol-
nate benzene as previously described under lowing types of food: Dry grains and
‘‘Organic solvents.’’ Quantitatively transfer dry seeds (for example, beans, peas,
the residue with isooctane to a 200-milliliter
volumetric flask and adjust to volume. De- rice, and lentils); whole root crop vege-
termine the absorbance of the solution in the tables of the types identified in 40 CFR
1-centimeter pathlength cells compared to 180.34(f); unshelled and shelled nuts (in-
isooctane as reference between 250 mμ–400 cluding peanuts); and dry animal feed.
mμ. Correct for any absorbance derived from The finished processed jute fiber shall
the reagents as determined by carrying out contain no more than 6 percent by
the procedure without an oil sample. If ei-
ther spectrum shows the characteristic ben- weight of residual mineral oil.
zene peaks in the 250 mμ–260 mμ region, evap- (3) The analytical method for deter-
orate the solution to remove benzene by the mining ultraviolet absorbance limits
procedure under ‘‘Organic solvents.’’ Dis- and pyrene content is as follows:
solve the residue, transfer quantitatively,
and adjust to volume in isooctane in a 200- I. Apparatus. A. Assorted beakers, sepa-
milliliter volumetric flask. Record the ab- ratory funnels fitted with tetrafluoro-
sorbance again. If the corrected absorbance ethylene polymer stopcocks, and graduated
does not exceed the limits proposed in this cylinders.
paragraph, the oil meets the proposed ultra- B. Volumetric flasks, 200-milliliter.
violet absorbance specifications. C. A chromatographic column made from
(d) Mineral oil identified in para- nominal 1.3 centimeters outside diameter ×
75 centimeters glass tubing tapered at one
graph (d)(1) of this section may be used
end and joined to a 2-millimeter-bore tetra-
as provided in paragraph (d)(2) of this fluoroethylene polymer stopcock. The oppo-
section. site end is flanged and joined to a female 24/
(1) The mineral oil consists of virgin 40 standard taper fitting. This provides for
petroleum distillates refined to meet accommodating the 500-milliliter reservoir
the following specifications: described in item I.E below.
(i) Distillation endpoint at 760 milli- D. A chromatographic column made from

meters pressure not to exceed 371 °C, nominal 1.7 centimeters outside diameter ×
with a maximum residue not to exceed 115 centimeters glass tubing tapered at one
432
end and joined to a 2-millimeter-bore tetra- n-hexadecane residue in isooctane and make
fluoroethylene polymer stopcock. The oppo- to 10-milliliter volume. Determine the ab-
site end is flanged and joined to a 2.5 centi- sorbance in 1.0-centimeter pathlength cells
meters outside diameter × 9.0 centimeters compared to water as reference. The absorb-
glass tube having a female 24/40 standard ance of the solution of solvent residue shall
taper fitting. This provides for accommo- not exceed 0.05 between 280 and 400 mμ.
dating the 500-milliliter reservoir described 1. Isooctane (2,2,4-trimethylpentane). Use 240
in item I. E below. milliliters for the above test. Purify, if nec-
E. A 500-milliliter reservoir having a 24/40 essary, by passage through a column of acti-
standard taper male fitting at bottom and a vated silica gel.
suitable ball joint at the top for connecting 2. Benzene. Use 200 milliliters for the above
to the nitrogen supply. The female fitting of test. Purify, if necessary, by distillation or
the chromatographic columns described in otherwise.
items I. C and D above and the male fitting 3. Cyclohexane. Use 70 milliliters for the
of the reservoir described in this item E above test. Purify, if necessary, by distilla-
should both be equipped with glass hooks. tion, silica gel percolation, or otherwise.
(NOTE: Rubber stoppers are not to be used. 4. Nitromethane. Use 125 milliliters for the
Stopcock grease is not to be used on ground- above test. Purify, if necessary, by distilla-
glass joints in this method.) tion or otherwise.
5. n-Hexadecane. Determine the absorbance
F. A spectrophotometer equipped to auto-
on this solvent directly. Purify, if necessary,
matically record absorbance of liquid sam-
by silica gel percolation or otherwise.
ples in 1-centimeter pathlength cells in the
B. Other materials—1. Pyrene standard ref-
spectral region of 280–400 mμ with a spectral
erence. Pyrene, reagent grade, melting point
slit width of 2 mμ or less. At an absorbance
level of about 0.4, absorbance measurements range 150–152 °C. (Organic Chemical 3627,
shall be repeatable within ±0.01 and accurate Eastman Kodak Co., Rochester, N.Y., or
within ±0.05. Wavelength measurements shall equivalent). The standard reference absorb-
be repeatable with ±0.2 mμ and accurate ance is the absorbance at 334 millimicrons of
within ±1.0 mμ. Instrument operating condi- a standard reference solution of pyrene con-
tions are selected to realize this performance taining a concentration of 1.0 milligram per
under dynamic (automatic) recording oper- liter in purified isooctane measured against
ations. Accuracy of absorbance measure- isooctane of the same spectral purity in 1.0-
ments are determined at 290, 345, and 400 mμ, centimeter cells. (This absorbance will be ap-
using potassium chromate as the reference proximately 0.28.)
standard. (National Bureau of Standards Cir- 2. Chrysene solution. Prepare a solution at a
cular 484, Spectrophotometry, U.S. Depart- concentration of 5.0 milligrams per liter by
ment of Commerce, 1949.) dissolving 5.0 milligrams of chrysene in puri-
G. Two fused quartz cells having fied isooctane in a 1-liter volumetric flask.
pathlengths of 1.00±0.005 centimeter or bet- Adjust to volume with isooctane.
ter. 3. Nitrogen gas. Water pumped or equivalent
II. Purity of reagents and materials. Reagent- purity, cylinder with regulator, and valve
grade chemicals shall be used in all tests. It control flow at 5 p.s.i.
is further specified that each chemical shall 4. Silica gel. 100–200 mesh (Davison Chem-
be tested for purity in accordance with the ical, Baltimore, Md., Grade 923, or equiva-
instruction given under ‘‘Reagents and Mate- lent), purified and activated by the following
rials’’ in III below. In addition, a blank run procedure: Place about 1 kilogram of silica
by the procedure shall be made on each puri- gel in a large column and wash with con-
fied lot of reagents and materials. Unless taminant-free benzene until a 200-milliliter
otherwise indicated, references to water sample of the benzene coming off the column
shall be understood to mean distilled water. will pass the ultraviolet absorption test for
III. Reagents and materials— A. Organic sol- benzene. This test is performed as stipulated
vents. All solvents used throughout the pro- under ‘‘Organic solvents’’ in A under III
cedure shall meet the specifications and above. When the silica gel has been suffi-
tests described in this section III. The iso- ciently cleaned, activate the gel before use
octane, benzene, cyclohexane, nitromethane, by placing the 1-kilogram batch in a shallow
and n-hexadecane designated shall pass the container in a layer no greater than 1 inch in
following test: To the specified quantity of depth and heating in an oven (Caution! Ex-
solvent in a 150-milliliter beaker, add 1 milli- plosion Hazard) at 130 °C. for 16 hours, and
liter of purified n-hexadecane and evaporate store in a vacuum desiccator. Reheating
on the steam bath under a stream of nitro- about once a week is necessary if the silica
gen. Discontinue evaporation when not over gel is repeatedly removed from the desic-
1 milliliter of residue remains (to the residue cator.
from benzene and nitromethane add a 10-mil- 5. Aluminum oxide (Aluminum Co. of America,
liliter portion of purified isooctane, re-evap- Grade F-20, or equivalent grade). 80–200 mesh,
orate, and repeat once to insure complete re- purified and activated by the following pro-
moval of solvent). Dissolve the 1 milliliter of cedure: Place about 1 kilogram of aluminum
433
§ 178.3620 21 CFR Ch. I (4–1–23 Edition)
oxide in a large column and wash with con- tion until a 100-milliliter eluate has been ob-
taminant-free benzene until a 200-milliliter tained.
sample of the benzene coming off the column h. Measure the amount of chrysene in this
will pass the ultraviolet absorption test for 100-milliliter fraction by ultraviolet anal-
benzene. This test is performed as stipulated ysis. If the aluminum oxide is satisfactory,
under ‘‘Organic solvents’’ in A under III more than 80 percent of the original amount
above. (Caution! Remove Benzene From Ad- of chrysene should be found in this fraction.
sorbent Under Vacuum To Minimize Explo- (NOTE: If the amount of chrysene recovered
sion Hazard in Subsequent Heating!) When is less than 80 percent, the original batch of
the aluminum oxide has been sufficiently aluminum oxide should be sieved between
cleaned and freed of solvent, activate it be- 100–160 mesh. Activation and testing of this
fore use by placing the 1-kilogram batch in a sieved batch should indicate a satisfactory
shallow container in a layer no greater than aluminum oxide for use.)
1 inch in depth. Heat in an oven at 130 °C for IV. Sampling. Precautions must be taken to
16 hours. Upon removal from heat, store at insure that an uncontaminated sample of the
atmospheric pressure over 80 percent (by mineral oil is obtained since ultraviolet ab-
weight) sulfuric acid in a desiccator for at sorption is very sensitive to small amounts
least 36 hours before use. This gives alu- of extraneous material contaminating the
minum oxide with between 6 to 9.5 percent sample through careless handling.
volatiles. This is determined by heating a V. Procedure. A. Blank. Before proceeding
weighed sample of the prepared aluminum with the analysis of a sample, determine the
oxide at 2,000 °F for 2 hours and then quickly absorbance of the solvent residues by car-
reweighing. To insure the proper adsorptive rying out the procedure without a sample.
properties of the aluminum oxide, perform B. Sample. 1. Weigh out 20.0 grams ±0.1
the following test: gram of the mineral oil into a beaker and
a. Weigh 50 grams ±1 gram of the activated transfer to a 250-milliliter separatory funnel
aluminum oxide and pack into the fitted with a tetrafluoroethylene polymer
chromatographic column (1.3 centimeters × stopcock, using enough cyclohexane (25 mil-
75 centimeters) described under ‘‘Apparatus’’ liliters) to give a final total volume of 50
in C under I above. Use glass wool at the col- milliliters (mineral oil plus cyclohexane).
umn exit to prevent the aluminum oxide 2. Add 25 milliliters of nitromethane satu-
from passing through the column. rated with cyclohexane and shake by hand
b. Place a 250-milliliter graduated cylinder vigorously for 3 minutes. Recover the lower
under the column to measure the amount of nitromethane layer in a 150-milliliter beaker
eluate coming from the column. containing 1 milliliter of n-hexadecane and
c. Prewet the aluminum oxide by passing evaporate on the steam bath under nitrogen.
40 milliliters of isooctane through the col- Repeat the extraction four more times, re-
umn. Adjust the nitrogen pressure so that covering each extract in the 150-milliliter
the rate of descent of the isooctane coming beaker. Exercise care not to fill the beaker
off the column is between 1.5 to 2.5 milli- to such a capacity that solvent losses may
liters per minute. occur. Evaporate the combined
d. Just prior to the last of the isooctane nitromethane extracts to 1 milliliter of n-
reaching the top of the aluminum oxide bed, hexadecane residue containing the
add 10 milliliters of the isooctane solution nitromethane-soluble mineral oil extrac-
containing 5.0 milligrams of chrysene per tives. (NOTE: Complete removal of the
liter. nitromethane is essential. This can be as-
e. Continue percolation until the isooctane sured by two successive additions of 5 milli-
is just above the aluminum oxide. Then add liters of isooctane and reevaporation.)
200 milliliters of a mixture of benzene and 3. Remove the beaker from the steam bath
isooctane (331⁄3 percent benzene and 662⁄3 per- and allow to cool.
cent isooctane by volume) to the reservoir 4. Weigh 50 grams ±1 gram of activated alu-
and continue percolation. minum oxide and pack into the
f. Continue percolation, collecting the chromatographic column (1.3 centimeters ×
eluates (40 milliliters of the prewet solution, 75 centimeters) described under ‘‘Apparatus’’
10 milliliters of the sample solution, and 200 in C under I above. (NOTE: A small plug of
milliliters of the gradient solution) in the glass wool is placed at the column exit to
250-milliliter graduated cylinder until the prevent the aluminum oxide from passing
level of the gradient solution is just above through the column. After adding aluminum
the aluminum oxide. Add 200 milliliters of oxide, tap the column lightly to remove air
the eluting solution of benzene and isooctane voids. All percolations using aluminum oxide
(90 percent benzene and 10 percent isooctane are performed under nitrogen pressure. The
by volume) to the column and continue col- 500-milliliter reservoir described under ‘‘Ap-
lecting until a total of 250 milliliters of solu- paratus’’ in E under I above is to be used to
tion has been obtained. This may be dis- hold the elution solvents.)
carded. Now begin to collect the final eluate. 5. Prewet the column by adding 40 milli-
g. Place a 100-milliliter graduated cylinder liters of isooctane to the column. Adjust ni-
under the column and continue the percola- trogen pressure so that rate of descent of the
434
isooctane coming off the column is 2.0 to 3.0 glass-stoppered Erlenmeyer flask. Add to the
milliliters per minute. Be careful to main- silica gel 46.2 grams (41 milliliters) of
tain the level of solvent in the reservoir to nitromethane. Stopper and shake the flask
prevent air from entering the aluminum vigorously until no lumps of silica gel are
oxide bed. New or additional solvent is added observed and then shake occasionally during
just before the last portion of the previous a period of 1 hour. The resultant
solvent enters the bed. To minimize possible nitromethane-treated silica gel is 29 weight-
photo-oxidation effects, the following proce- percent nitro-methane and 71 weight-percent
dures (steps 6 through 18) shall be carried out silica gel.
in subdued light. 15. Place a small plug of glass wool in the
6. Before the last of the isooctane reaches tapered end of the 1.7 centimeters outside di-
the top of the aluminum oxide bed, release ameter × 115 centimeters column, described
the nitrogen pressure and turn off the stop- under ‘‘Apparatus’’ in D of I above, adjacent
cock on the column. Transfer the n-hexa- to the stopcock to prevent silica gel from
decane residue from the 150-milliliter beaker passing through the stopcock. Pack the
from procedure step 3 above onto the col- nitromethane-treated silica gel into the col-
umn, using several washes of isooctane (total umn, tapping lightly. The resultant silica gel
volume of washes should be no greater than bed should be about 95 centimeters in depth.
10–15 milliliters). Place into a flask 170 milliliters of isooctane
7. Open the stopcock and continue percola- saturated with nitromethane.
tion until the isooctane is about 1 centi- 16. Place a 100-milliliter graduated cyl-
meter above the top of the aluminum oxide inder under the column and transfer the res-
bed. Add 200 milliliters of isooctane to the idue from the beaker in procedure step 13
reservoir, and continue the percolation at above with several washes of the 170 milli-
the specified rate. liters of isooctane, saturated with
8. Just before the isooctane surface reaches nitromethane, onto the top of the column.
the top of the aluminum oxide bed, add 200 (Total volume of washes should be no greater
milliliters of a mixture of benzene and iso- than 10 to 15 milliliters.) Permit isooctane
octane (331⁄3 percent benzene and 662⁄3 percent solution to enter the silica gel bed until the
isooctane by volume) to the reservoir, and liquid level is at the top bed level. Place the
continue the percolation. remaining amount of the 170 milliliters of
9. Just before the surface of this mixture isooctane, saturated with nitromethane, in
reaches the top of the aluminum oxide bed, the reservoir above the bed for percolation
release the nitrogen pressure, turn off the through the silica gel. Apply nitrogen pres-
stopcock, and discard all the elution solvents sure to the top of the column, adjusting the
collected up to this point. pressure so that the isooctane is collected at
10. Add to the reservoir 300 milliliters of a the rate of 2.5 to 3.5 milliliters per minute,
mixture of benzene and isooctane (90 percent and percolate isooctane through the bed
benzene and 10 percent isooctane by volume), until a quantity of 75.0 milliliters of eluate is
place a 25-milliliter graduated cylinder collected. Discard the 75 milliliters of eluate.
under the column, continue the percolation Turn off the stopcock and add 250 milliliters
until 20 milliliters of eluate has been col- of benzene to the reservoir above the bed.
lected, and then discard the eluate. Use a 400-milliliter beaker to collect the re-
11. At this point, place a clean 250-milli- maining eluate.
liter Erlenmeyer flask under the column. 17. Open the stopcock, renew the pressure,
Continue the percolation and collect all the and percolate the remaining isooctane and
remaining eluate. benzene through the column eluting the re-
(NOTE: Allow the column to drain com- maining aromatics. Transfer the eluate in
pletely. An increase in the nitrogen pressure small portions from the 400 milliliter beaker
may be necessary as the last of the solvent to a 150-milliliter beaker containing 1 milli-
comes off the column.) liter of n-hexadecane and evaporate on the
12. Place 1 milliliter of n-hexadecane into a steam bath under nitrogen. Rinse the 400-
150-milliliter beaker. Place this onto a steam milliliter beaker well with small portions of
bath under a nitrogen stream and transfer in isooctane to obtain a complete transfer.
small portions the eluate from step 11 above. (NOTE: Complete removal of the
Wash out the Erlenmeyer flask with small nitromethane and benzene is essential. This
amounts of benzene and transfer to the evap- can be assured by successive additions of 5
oration beaker. Evaporate until only 1 milli- milliliters of isooctane and reevaporation.)
liter of hexadecane residue remains. (NOTE: 18. Transfer the residue with several wash-
Complete removal of the benzene is essen- es of isooctane into a 200-milliliter volu-
tial. This can be assured by two successive metric flask. Add isooctane to mark.
additions of 5 milliliters of isooctane and re- 19. Record the spectrum of the sample solu-
evaporation.) tion in a 1-centimeter cell compared to iso-
13. Remove the beaker from the steam bath octane from 270 to 400 mμ. After making nec-
and cool. essary corrections in the spectrum for cell

14. Place a sample of 113.5 grams activated differences and for the blank absorbance,
100- 200-mesh silica gel in a 500-milliliter record the maximum absorbance in each of
435
§ 178.3650 21 CFR Ch. I (4–1–23 Edition)
the wavelength intervals (mμ), 280–299, 300– fied wavelength intervals shall not exceed
319, 320–359, 360–400. the limits prescribed in paragraph (d)(1)(ii)
a. If the spectrum then shows no discern- of this section.
ible peak corresponding to the absorbance d. If the spectrum as a whole of the sample
maximum of the pyrene reference standard solution is in any respect clearly incompat-
solution at 334 mμ, the maximum ible with the presence of pyrene as the
absorbances in the respective wavelength in- source of the peak at 334 mμ, then the max-
tervals recorded shall not exceed those pre- imum absorbances in the respective wave-
scribed in paragraph (d)(1)(ii) of this section. length intervals without correction for any
b. If such a peak is evident in the spectrum assumed pyrene content shall not exceed the
of the sample solution, and the spectrum as limits prescribed in paragraph (d)(1)(ii) of
a whole is not incompatible with that of a this section.
pyrene contaminant yielding such a peak of
the observed absorbance, calculate the con- [42 FR 14609, Mar. 15, 1977, as amended at 47
centration of pyrene that would yield this FR 11847, Mar. 19, 1982; 49 FR 10112, Mar. 19,
peak (334 m) by the base-line technique de- 1984; 54 FR 24898, June 12, 1989]
scribed in ASTM method E169–63 (Re-
approved 1981), ‘‘Standard Recommended § 178.3650 Odorless light petroleum hy-
Practices for General Techniques of Ultra- drocarbons.
violet Quantitative Analysis,’’ which is in-
corporated by reference. The availability of
Odorless light petroleum hydro-
this incorporation by reference is given in carbons may be safely used, as a com-
paragraph (b)(1)(i) of this section. Correct ponent of nonfood articles intended for
each of the maximum absorbances in the reuse in contact with food, in accordance
spective specified wavelength intervals by with the following prescribed condi-
subtracting the absorbance due to pyrene, tions:
determined as follows: (a) The additive is a mixture of liquid
Cp × Sa hydrocarbons derived from petroleum
Absorbance due to pyrene = or synthesized from petroleum gases.
Sp The additive is chiefly paraffinic,
isoparaffinic, or naphthenic in nature.
where:
(b) The additive meets the following
Cp = Calculated concentration of pyrene in
sample solution;
specifications:
Sp = Concentration of pyrene reference (1) Odor is faint and not kerosenic.
standard solution in same units of con- (2) Initial boiling point is 300 °F min-
centration; imum.
Sa = Absorbance of pyrene reference stand- (3) Final boiling point is 650 °F max-
ard solution at wavelength of maximum imum.
absorbance of sample solution in the re-
spective specified wavelength intervals. (4) Ultraviolet absorbance limits de-
termined by method specified in
Also calculate the pyrene content of the
oil sample in parts per million as follows: § 178.3620(b)(1)(ii), as follows:
Pyrene content ( 200/1000 ) × C

Maximum
= = 10 C
absorb-
ance per
(p. p. m.) 20/1000
Wavelength (Mμ) centimeter
optical
where: pathlength
C = Calculated concentration of pyrene in 280 to 289 ........................................................... 4.0

milligrams per liter of sample solution. 290 to 299 ........................................................... 3.3
c. The pyrene content so determined shall 300 to 329 ........................................................... 2.3
not exceed 25 p.p.m. The maximum 330 to 360 ........................................................... .8
absorbances corrected for pyrene content as
described in this step 19 for each of the speci- (c) The additive is used as follows:
Use Limitations
As a plasticizer and absorber oil in the manufacture of In an amount not to exceed that required to produce intended
polyolefin articles authorized for food contact use. effect, consistent with good manufacturing practice.
As a lubricant of fibers of textiles authorized for food contact At a use level not to exceed 0.15 percent by weight of finished
use. fibers.
As a component of adhesives ..................................................... Complying with § 175.105 of this chapter.
As a defoamer in the manufacture of paper and paperboard .... Complying with § 176.210 of this chapter.
As a defoamer in coatings .......................................................... Complying with § 176.200 of this chapter.

ER01JA93.408</GPH>
436
ER01JA93.407</GPH>
§ 178.3690 Pentaerythritol adipate-ste- NARA, call 202–741–6030, or go to: http://

arate. www.archives.gov/federal_register/
Pentaerythritol adipate-stearate code_of_federal_regulations/
identified in paragraph (a) of this sec- ibr_locations.html.
tion may be safely used as a lubricant (3) Saponification number of 270–280
in the fabrication of rigid and semi- as determined by ASTM method D1387–
rigid polyvinyl chloride and/or vinyl 78, ‘‘Standard Test Method for Acid
chloride-propylene copolymers com- Number (Empirical) of Synthetic and
plying with § 177.1980 of this chapter Natural Waxes’’ (Revised 1978), which is
used as articles or components of arti- incorporated by reference. Copies are
cles that contact food, excluding food available from American Society for
with alcohol content greater than 8 Testing and Materials (ASTM), 100
percent under conditions of use of E, F, Barr Harbor Dr., West Conshohocken,
and G described in table 2 in § 175.300(d) Philadelphia, PA 19428-2959, or avail-
of this chapter, subject to the provi- able for inspection at the National Ar-
sions of this section. chives and Records Administration
(a) Identity. For the purpose of this (NARA). For information on the avail-
section, pentaerythritol adipate-stea- ability of this material at NARA, call
rate is an ester of pentaerythritol with 202–741–6030, or go to: http://
adipic acid and stearic acid and its as- www.archives.gov/federal_register/
sociated fatty acids (chiefly palmitic), code_of_federal_regulations/
with adipic acid comprising 14 percent ibr_locations.html.
and stearic acid and its associated (4) Iodine number not to exceed 2 as
acids (chiefly palmitic) comprising 71 determined by Iodine Absorption Num-
percent of the organic moieties. ber, Hanus Method, of the ‘‘Official
(b) Specifications. Pentaerythritol adi- Methods of Analysis of the Association
pate-stearate has the following speci- of Official Analytical Chemists,’’ sec-
fications: tions 28.018–28.019, 13th Ed. (1980), which
(1) Melting point (dropping) of 55–58 is incorporated by reference. Copies
°C as determined by ASTM method may be obtained from the AOAC
D566–76 (Reapproved 1982), ‘‘Standard INTERNATIONAL, 481 North Frederick
Test Method for Dropping Point of Lu- Ave., suite 500, Gaithersburg, MD 20877,
bricating Grease,’’ which is incor- or may be examined at the National
porated by reference. Copies may be Archives and Records Administration
obtained from the American Society (NARA). For information on the avail-
for Testing Materials, 100 Barr Harbor ability of this material at NARA, call
Dr., West Conshohocken, Philadelphia, 202–741–6030, or go to: http://
PA 19428-2959, or may be examined at www.archives.gov/federal_register/
the National Archives and Records Ad- code_of_federal_regulations/
ministration (NARA). For information ibr_locations.html.
on the availability of this material at (c) The total amount of ester (cal-
NARA, call 202–741–6030, or go to: http:// culated as free pentaerythritol) shall
www.archives.gov/federal_register/ not exceed 0.4 percent by weight of the
code_of_federal_regulations/ polyvinyl chloride and/or the vinyl
ibr_locations.html. chloride-propylene copolymers com-
(2) Acid value not to exceed 15 as de- plying with § 177.1980.
termined by ASTM method D1386–78, [45 FR 1018, Jan. 4, 1980, as amended at 47 FR
‘‘Standard Test Method for Saponifica- 11848, Mar. 19, 1982; 49 FR 10112, Mar. 19, 1984;
tion Number (Empirical) of Synthetic 54 FR 24898, June 12, 1989; 57 FR 18082, Apr.
and Natural Waxes’’ (Revised 1978), 29, 1992; 70 FR 40880, July 15, 2005; 70 FR 67651,
which is incorporated by reference. Nov. 8, 2005]
Copies are available from American So-
ciety for Testing and Materials § 178.3700 Petrolatum.
(ASTM), 100 Barr Harbor Dr., West Petrolatum may be safety used as a
Conshohocken, Philadelphia, PA 19428- component of nonfood articles in con-
2959, or available for inspection at the tact with food, in accordance with the
National Archives and Records Admin- following conditions:

istration (NARA). For information on (a) Petrolatum complies with the
the availability of this material at specifications set forth in the United
437
§ 178.3710 21 CFR Ch. I (4–1–23 Edition)
States Pharmacopeia XX (1980) for Ultraviolet absorbance per centi-

white petrolatum or in the National meter pathlength:
Formulary XV (1980) for yellow petro-
latum. Millimicrons Maximum
(b) Petrolatum meets the following 280 to 289 ........................................................... 0.15

ultraviolet absorbance limits when 290 to 299 ........................................................... .12
subjected to the analytical procedure 300 to 359 ........................................................... .08
described in § 172.886(b) of this chapter: 360 to 400 ........................................................... .02
Ultraviolet absorbance per centi-
meter pathlength: (c) Petroleum wax may contain any
antioxidant permitted in food by regu-
Millimicrons Maximum lations issued in accordance with sec-
280 to 289 ........................................................... 0.25 tion 409 of the act, in an amount not
290 to 299 ........................................................... .20 greater than that required to produce
300 to 359 ........................................................... .14 its intended effect.
360 to 400 ........................................................... .04
(d) Petroleum wax may contain a
(c) It is used or intended for use as a total of not more than 1 weight percent
protective coating of the surfaces of of residues of the following polymers
metal or wood tanks used in fermenta- when such residues result from use of
tion process, in an amount not in ex- the polymers as processing aids (filter
cess of that required to produce its in- aids) in the production of the petro-
tended effect. leum wax: Homopolymers and/or co-
(d) Petrolatum as defined by this sec- polymers derived from one or more of
tion may be used for the functions de- the mixed n-alkyl (C12, C14, C16, and C18)
scribed and within the limitations pre- methacrylate esters where the C12 and
scribed by specific regulations in parts C14 alkyl groups are derived from coco-
175, 176, 177, and 178 of this chapter nut oil and the C16 and C18 groups are
which prescribe uses of petrolatum. derived from tallow.
For the purpose of cross-reference, (e) Petroleum wax may contain 2-hy-
such specific regulations include: droxy-4-n-octoxybenzophenone as a sta-
§§ 175.105, 175.125, 175.300, 176.170, 176.200, bilizer at a level not to exceed 0.01
176.210, 177.2600, 177.2800, and 178.3570 of weight percent of the petroleum wax.
this chapter. (f) Petroleum wax may contain
(e) Petrolatum may contain any anti- poly(alkylacrylate) (CAS Reg. No.
oxidant permitted in food by regula- 27029–57–8), as described in § 172.886(c)(2)
tions issued pursuant to section 409 of of this chapter, as a processing aid in
the act, in an amount not greater than the manufacture of petroleum wax.
that required to produce its intended
effect. [42 FR 14609, Mar. 15, 1977, as amended at 51
FR 19545, May 30, 1986]
FR 10113, Mar. 19, 1984; 55 FR 12172, Apr. 2, § 178.3720 Petroleum wax, synthetic.
1990]
Synthetic petroleum wax may be
§ 178.3710 Petroleum wax. safely used in applications and under
the same conditions where naturally
Petroleum wax may be safely used as
derived petroleum wax is permitted in
a component of nonfood articles in con-
tact with food, in accordance with the subchapter B of this chapter as a com-
following conditions: ponent of articles intended to contact
(a) Petroleum wax is a mixture of food, provided that the synthetic petro-
solid hydrocarbons, paraffinic in na- leum wax meets the definition and
ture, derived from petroleum, and re- specifications prescribed in § 172.888 of
fined to meet the specifications pre- this chapter.
scribed in this section.
§ 178.3725 Pigment dispersants.
(b) The petroleum wax meets the fol-
lowing ultraviolet absorbance limits Subject to the provisions of this reg-
when subjected to the analytical proce- ulation, the substances listed in this
dure described in § 172.886(b) of this section may be safely used as pigment
chapter. dispersants in food-contact materials.
438
Dimethylolpropionic acid (CAS Reg. No. 4767–03–7) ................ For use only at levels not to exceed 0.45 percent by weight of
the pigment. The pigmented articles may contact all foods
under conditions of use A through H as described in Table 2
Phosphorylated tall oil fatty acids (CAS Reg. No. 68604–99–9), For use only at levels not to exceed 1.0 percent by weight of
prepared by the reaction of dimethyl hydrogen phosphite the pigment. The pigmented polymeric films may contact all
with tall oil fatty acids. food under conditions of use D, E, F, and G described in
Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, compd. For use only at levels not to exceed 0.45 percent by weight of
with 1,1′,1″-nitrilotris [2-propanol] (1:1) (CAS Reg. No. the pigment. The pigmented articles may contact all food
221281–21–6). under conditions of use A through H as described in Table 2
Siloxanes and silicones; cetylmethyl, dimethyl, methyl 11- For use only at levels not to exceed 0.5 percent by weight of
methoxy-11-oxoundecyl (CAS Reg. No. 155419–59–3). the pigment. The pigmented polymers may contact all foods
under conditions of use C, D, E, F, and G described in Table
Trimethylolethane (CAS Reg. No. 77–85–0) .............................. For use only at levels not to exceed 0.45 percent by weight of
inorganic pigment. The pigmented articles may contact all
food under conditions of use A through H described in Table
[61 FR 43157, Aug. 21, 1996, as amended at 63 FR 35799, July 1, 1998; 64 FR 48292, Sept. 3, 1999;
64 FR 72273, Dec. 27, 1999; 65 FR 52909, Aug. 31, 2000]
§ 178.3730 Piperonyl butoxide and graph (b) of this section may be safely
pyrethrins as components of bags. used as plasticizers in polymeric sub-
Piperonyl butoxide in combination stances used in the manufacture of ar-
with pyrethrins may be safely used for ticles or components of articles in-
insect control on bags that are intended for use in producing, manufac-
tended for use in contact with dried turing, packing, processing, preparing,
feed or dried food in compliance with 40 treating, packaging, transporting, or
CFR 180.127 and 40 CFR 180.128. holding food.
[85 FR 72907, Nov. 16, 2020] (a) The quantity used shall not ex-
§ 178.3740 Plasticizers in polymeric to accomplish the intended technical
substances. effect.
Subject to the provisions of this reg- (b) List of substances:
ulation, the substances listed in para-
1,3-Butylene glycoladipic acid polyester (1,700– For use at levels not exceeding 33 percent by weight of polyvinyl chloride
2,200 molecular weight) terminated with a 16 homopolymers used in contact with food (except foods that contain more
percent by weight mixture of myristic, palmitic, than 8 percent of alcohol) at temperatures not to exceed room tempera-
and stearic acids. ture. The average thickness of such homopolymers in the form in which
439
§ 178.3740 21 CFR Ch. I (4–1–23 Edition)
Di(C7, C9-alkyl) adipate, in which the C7, C9-alkyl For use only under the conditions listed below, and excluding use as a
groups are derived from linear alpha olefins by component of resinous and polymeric coatings described in § 175.300 of
the oxo process. this chapter.
1. At levels not to exceed 24 percent by weight of permitted vinyl chloride
homo- and/or copolymers used in contact with nonfatty foods. The aver-
age thickness of such polymers in the form in which they contact food
shall not exceed 0.005 inch.
2. At levels not to exceed 24 pct by weight of permitted vinyl chloride
homo- and/or copolymers used in contact, under conditions of use F and
G described in table 2 of § 176.170(c) of this chapter, with fatty foods
having a fat and oil content not exceeding a total of 40 pct by weight.
The average thickness of such polymers in the form in which they con-
tact food shall not exceed 0.005 inch.
3. At levels not exceeding 35 pct by weight of permitted vinyl chloride
age thickness of such polymer in the form in which they contact food
G described in table 2 of § 176.170(c) of this chapter with fatty foods hav-
ing a fat and oil content not exceeding a total of 40 pct by weight. The
average thickness of such polymers in the form in which they contact
food shall not exceed 0.002 inch.
Di-n-alkyl adipate made from C6 C8-C10 (predomi- For use only:
nately C8 and C10) or C8-C10 synthetic fatty alco- 1. At levels not exceeding 24 pct by weight of permitted vinyl chloride
hols complying with § 172.864 of this chapter. homo- and/or copolymers used in contact with nonfatty foods. The aver-
The average thickness of such polymers in the form in which they con-
tact food shall not exceed 0.005 inch.
The average thickness of such polymers in which they contact food shall
Dicyclohexyl phthalate ............................................ For use only:
1. As provided in §§ 175.105, 176.170, 176.180, and 177.1200 of this chap-
ter.
2. Alone or in combination with other phthalates, in plastic film or sheet pre-
pared from polyvinyl acetate, polyvinyl chloride, and/or vinyl chloride co-
polymers complying with § 177.1980 of this chapter. Such plastic film or
sheet shall be used in contact with food at temperatures not to exceed
room temperature and shall contain no more than 10 pct by weight of
total phthalates, calculated as phthalic acid.
Di(2-ethylhexyl) adipate ..........................................
440
Diisononyl adipate ................................................... For use only:

homo- and/or copolymers used in contact with nonfatty, nonalcoholic
foods. The average thickness of such polymers in the form in which they
contact food shall not exceed 0.005 inch.
homo- and/or copolymers used in contact under conditions of use F and
G described in table 2 of § 176.170(c) of this chapter with fatty, non-
alcoholic foods having a fat and oil content not exceeding a total of 30
pct by weight. The average thickness of such polymers in the form in
foods. The average thickness of such polymers in the form in which they
G described in table 2 of § 176.170(c) of this chapter with fatty, non-
alcoholic foods having a fat and oil content not exceeding a total of 40
pct by weight. The average thickness of such polymers in the form in
Diisononyl phthalate ................................................ For use only at levels not exceeding 43 pct by weight of permitted vinyl
chloride homo- and/or copolymers used in contact with food only of the
types identified in § 176.170(c) of this chapter, table 1, under Categories
I, II, IV-B, and VIII, at temperatures not exceeding room temperature. The
average thickness of such polymers in the form in which they contact
food shall not exceed 0.005 inch.
Di(2-ethylhexyl) azelate ........................................... For use only:
food. The average thickness of such polymers in the form in which they
G described in table 2 of § 176.170(c) of this chapter, with fatty, non-
alcoholic food having a fat and oil content not exceeding a total of 30
percent by weight. The average thickness of such polymers in the form in
Di-n-hexylazelate ..................................................... For use only:
1. In polymeric substances used in contact with nonfatty food.
2. In polymeric substances used in contact with fatty food and limited to
use at levels not exceeding 15 pct by weight of such polymeric sub-
stance except as provided under limitation 3.
3. At levels greater than 15 but not exceeding 24 pct by weight of permitted
vinyl chloride homo- and/or copolymers used in contact, under conditions
of use F or G described in table 2 of § 176.170(c) of this chapter, with
fatty food having a fat and oil content not exceeding a total of 30 pct by
weight. The average thickness of such polymers in the form in which they
Epoxidized butyl esters of linseed oil fatty acids .... Iodine number, maximum 5; oxirane oxygen, minimum 7.8 pct.
Epoxidized linseed oil ............................................. Iodine number, maximum 5; oxirane oxygen, minimum 9-pct.
Mineral oil, white.
441
§ 178.3750 21 CFR Ch. I (4–1–23 Edition)
Polybutene, hydrogenated (minimum viscosity at For use only:

99 °F, 39 Saybolt Universal seconds, as deter- 1. In polymeric substances used in contact with non-fatty food.
mined by ASTM methods D445–82 (‘‘Standard 2. In polyethylene complying with § 177.1520 of this chapter and used in
Test Method for Kinematic Viscosity of Trans- contact with fatty food, provided that the hydrogenated polybutene is
parent and Opaque Liquids (and the Calculation added in an amount not to exceed 0.5 pct by weight of the polyethylene,
of Dynamic Viscosity)’’) and D2161–82 (‘‘Stand- and further provided that such plasticized polyethylene shall not be used
ard Method for Conversion of Kinematic Vis- as a component of articles intended for packing or holding food during
cosity to Saybolt Universal Viscosity or to cooking.
Saybolt Furol Viscosity’’), and bromine number 3. In polystyrene complying with § 177.1640 of this chapter and used in
of 3 or less, as determined by ASTM method contact with fatty food, provided that the hydrogenated polybutene is
D1492–78 (‘‘Standard Test Method for Bromine added in an amount not to exceed 5 pct by weight of the polystyrene,
Index of Aromatic Hydrocarbons by Coulometric and further provided that such plasticized polystyrene shall not be used
Titration’’), which are incorporated by reference. as a component of articles intended for packing or holding food during
Copies may be obtained from the American So- cooking.
ciety for Testing Materials, 100 Barr Harbor Dr.,
West Conshohocken, Philadelphia, PA 19428-
2959, or may be examined at the National Ar-
chives and Records Administration (NARA). For
information on the availability of this material at
Polyisobutylene (mol weight 300–5,000) ................ For use in polyethylene complying with § 177.1520 of this chapter, provided
that the polyisobutylene is added in an amount not exceeding 0.5 pct by
weight of the polyethylene, and further provided that such plasticized pol-
yethylene shall not be used as a component of articles intended for pack-
ing or holding food during cooking.
Polyisobutylene complying with § 177.1420 of this
chapter.
Polypropylene glycol (CAS registry No. 25322–69– For use only in polystyrene plastics, identified in § 177.1640(a)(1), in an
4) (minimum mean molecular weight 1,200). amount not to exceed 6 pct by weight of the finished food-contact article.
Propylene glycol azelate (average mol. weight For use only at levels not exceeding 41 pct by weight of permitted polyvinyl
3,000). chloride coatings. Such coatings shall be used only as bulk food contact
surfaces of articles intended for repeated use, complying with § 177.2600
of this chapter.
Triethylene glycol .................................................... Diethylene glycol content not to exceed 0.1 pct.
2,2,4-Trimethyl-1,3-pentanediol diisobutyrate ......... For use only in cellulosic plastics in an amount not to exceed 15 pct by
weight of the finished food-contact article, provided that the finished plas-
tic article contacts food only of the types identified in § 176.170(c) of this
chapter, table 1, under Categories I, II, VI-B, VII-B, and VIII.
(c) The use of the plasticizers in any (b) It contains no more than 0.2 per-
polymeric substance or article subject cent total by weight of ethylene and
to any regulation in parts 174, 175, 176, diethylene glycols if its mean molec-
177, 178 and 179 of this chapter must ular weight is 350 or higher and no
comply with any specifications and more than 0.5 percent total by weight
limitations prescribed by such regula- of ethylene and diethylene glycols if its
tion for the finished form of the sub- mean molecular weight is below 350,
stance or article. when tested by the analytical methods
prescribed in § 172.820(b) of this chapter.
FR 44223, Sept. 2, 1977; 45 FR 56052, Aug. 22, (c) The provisions of paragraph (b) of
1980; 48 FR 5748, Feb. 15, 1984; 49 FR 10113, this section are not applicable to poly-
Mar. 19, 1984; 51 FR 47011, Dec. 30, 1986; 87 FR ethylene glycols used in food-pack-
31089, May 20, 2022] aging adhesives complying with
§ 178.3750 Polyethylene glycol (mean
molecular weight 200-9,500). § 178.3760 Polyethylene glycol (400)
Polyethylene glycol identified in this monolaurate.
section may be safely used as a compo- Polyethylene glycol (400)
nent of articles intended for use in con- monolaurate containing not more than
tact with food, in accordance with the 0.1 percent by weight of ethylene and/
following prescribed conditions: or diethylene glycol may be used at a
(a) The additive is an addition poly- level not to exceed 0.3 percent by
mer of ethylene oxide and water with a weight of twine as a finish on twine to
mean molecular weight of 200 to 9,500. be used for tying meat provided the
442
twine fibers are produced from nylon NARA, call 202–741–6030, or go to: http://
resins complying with § 177.1500 of this www.archives.gov/federal_register/
chapter. code_of_federal_regulations/
ibr_locations.html.) using as solvent xy-
§ 178.3770 Polyhydric alcohol esters of lene-ethyl alcohol in a 2:1 ratio instead
oxidatively refined (Gersthofen of toluene-ethyl alcohol in a 2:1 ratio.
process) montan wax acids. (3) Saponification value 100–160, as
Polyhydric alcohol esters of determined by ASTM method D1387–78
oxidatively refined (Gersthofen proc- (‘‘Standard Test Method for Saponi-
ess) montan wax acids identified in this fication Number (Empirical) of Syn-
section may be safely used as compo- thetic and Natural Waxes’’ (Revised
nents of articles intended for use in 1978), which is incorporated by ref-
contact with food in accordance with erence; copies are available from Amer-
the following prescribed conditions: ican Society for Testing and Materials
(a) The polyhydric alcohol esters (ASTM), 100 Barr Harbor Dr., West
identified in this paragraph may be Conshohocken, Philadelphia, PA 19428-
used as lubricants in the fabrication of 2959, or available for inspection at the
vinyl chloride plastic food-contact ar- National Archives and Records Admin-
ticles prepared from polyvinyl chloride istration (NARA). For information on
and/or from vinyl chloride copolymers the availability of this material at
complying with § 177.1980 of this chap- NARA, call 202–741–6030, or go to: http://
ter. Such esters meet the following www.archives.gov/federal_register/
specifications and are produced by par- code_of_federal_regulations/
tial esterification of oxidatively re- ibr_locations.html.) using xylene-ethyl
fined (Gersthofen process) montan wax alcohol in a 2:1 ratio instead of ethyl
acids by either ethylene glycol or 1,3- alcohol in preparation of potassium hy-
butanediol with or without neutraliza- droxide solution.
tion of unreacted carboxylic groups (4) Ultraviolet absorbance limits as
with calcium hydroxide: follows, as determined by the analyt-
(1) Dropping point 76°–105 °C, as de- ical method described in this subpara-
termined by ASTM method D566–76 graph:
(Reapproved 1982), ‘‘Standard Test Ultraviolet absorbance per centi-
Method for Dropping Point of Lubri- meter pathlength.
cating Grease,’’ which is incorporated Millimicrons Maximum
by reference. Copies may be obtained
from the American Society for Testing 280 to 289 ........................................................... 0.07
290 to 299 ........................................................... .06
Materials, 100 Barr Harbor Dr., West 300 to 359 ........................................................... .04
Conshohocken, Philadelphia, PA 19428- 360 to 400 ........................................................... .01
tional Archives and Records Adminis- ANALYTICAL METHOD
NARA, call 202–741–6030, or go to: http:// Because of the sensitivity of the test, the
www.archives.gov/federal_register/ possibility of errors arising from contamina-
code_of_federal_regulations/ tion is great. It is of the greatest importance
ibr_locations.html. that all glassware be scrupulously cleaned to
remove all organic matter such as oil,
(2) Acid value 10–20, as determined by grease, detergent residues, etc. Examine all
ASTM method D1386–78 (‘‘Standard glassware, including stoppers and stopcocks,
Test Method for Acid Number (Empir- under ultraviolet light to detect any residual
ical) of Synthetic and Natural Waxes’’ fluorescent contamination. As a pre-
(Revised 1978), which is incorporated by cautionary measure it is recommended prac-
reference; copies are available from tice to rinse all glassware with purified iso-
American Society for Testing and Ma- octane immediately before use. No grease is
terials (ASTM), 100 Barr Harbor Dr., to be used on stopcocks or joints. Great care
to avoid contamination of wax samples in
West Conshohocken, Philadelphia, PA handling and to assure absence of any extra-
19428-2959, or available for inspection at neous material arising from inadequate
the National Archives and Records Ad- packaging is essential. Because some of the
ministration (NARA). For information polynuclear hydrocarbons sought in this test
on the availability of this material at are very susceptible to photo-oxidation, the
443
§ 178.3770 21 CFR Ch. I (4–1–23 Edition)
entire procedure is to be carried out under Absorbance accuracy, 1 ±0.05 at 0.4 absorb-
subdued light. ance.
Wavelength repeatability, ±0.2 milli-
APPARATUS micron.
Wavelength accuracy, ±1.0 millimicron.
Separatory funnels. 250-milliliter, 500-milli-
Recording time, 50 seconds.
liter, 1,000-milliliter, and preferably 2,000- Time constant, 0.6 second.
milliliter capacity, equipped with tetra- Sensitivity, 30.
fluoroethylene polymer stopcocks. Ordinate scale, 90–100 percent transmission
Reservoir. 1,000-milliliter capacity, through scale.
equipped with a 24/40 standard taper male fit- Abscissa scale, 8X.
ting at the bottom and a suitable balljoint at Nitrogen cylinder. Water-pumped or equiva-
the top. lent purity nitrogen in cylinder equipped
Chromatographic tube. 1,200 millimeters in with regulator and valve to control flow at 5
length, inside diameter to be 16.5 millimeters p.s.i.g.
±0.5 millimeter, equipped with a coarse, frit-
ted-glass disc, a tetrafluoroethylene polymer REAGENTS AND MATERIALS
stopcock, and a female 24/40 standard tapered Organic solvents. All solvents used through-
fitting at the opposite end. (Overall length of out the procedure shall meet the specifica-
the column with the female joint is 1,255 mil- tions and tests described in this specifica-
limeters.) The female fitting should be tion. The isooctane and benzene designated
equipped with glass hooks. in the list following this paragraph shall
Disc. Tetrafluoroethylene polymer 2-inch pass the following test:
diameter disc approximately 3⁄16-inch thick To be specified quantity of solvent in a 250-
with a hole bored in the center to closely fit milliliter Erlenmeyer flask, add 1 milliliter
the stem of the chromatographic tube. of purified n-hexadecane and evaporate on
Heating jackets. Conical, for 500-milliliter the steam bath under a stream of nitrogen (a
and 1,000-milliliter separatory funnels. (Used loose aluminum foil jacket around the flask
with variable transformer heat control.) will speed evaporation). Discontinue evapo-
Suction flask. 250-milliliter or 500-milliliter ration when not over 1 milliliter of residue
filter flask. remains. (To the residue from benzene add a
Condenser. 24⁄40 joints, fitted with a drying 10-milliliter portion of purified isooctane, re-
tube, length optional. evaporate, and repeat once to insure com-
plete removal of benzene.)
Evaporation flasks (optional). A 250-milli-
Alternatively, the evaporation time can be
liter or 500-milliliter capacity and a 1-liter
reduced by using the optional evaporation
capacity all-glass flask equipped with stand-
flask. In this case the solvent and n-hexa-
ard taper stopper having inlet and outlet
decane are placed in the flask on the steam
tubes to permit passage of nitrogen across
bath, the tube assembly is inserted, and a
the surface of contained liquid to be evapo-
stream of nitrogen is fed through the inlet
rated.
tube while the outlet tube is connected to a
Vacuum distillation assembly. All glass (for solvent trap and vacuum line in such a way
purification of dimethyl sulfoxide) 2-liter as to prevent any flow-back of condensate
distillation flask with heating mantle; into the flask.
Vigreaux vacuum-jacketed condenser (or Dissolve the 1 milliliter of hexadecane res-
equivalent) about 45 centimeters in length idue in isooctane and make up to 25 milli-
and distilling head with separable cold finger liters volume. Determine the absorbance in
condenser. Use of tetrafluoroethylene poly-
mer sleeves on the glass joints will prevent
1 As determined by procedure using potas-
freezing. Do not use grease on stopcocks or
joints. sium chromate for reference standard and
described in National Bureau of Standards
Oil bath. Capable of heating to 90 °C.
Circular 484, Spectrometry, U.S. Department
Spectrophotometric cells. Fused quartz cells,
of Commerce (1949). The accuracy is to be de-
optical pathlength in the range 1.000 centi-
termined by comparison with the standard
meter ±0.005 centimeter. With distilled water
values at 290, 345, and 400 millimicrons. Cir-
in the cells, determine any absorbance dif-
cular 484 is incorporated by reference. Copies
ferences.
are available from the Center for Food Safe-
Spectrophotometer. Spectral range 250 milli- ty and Applied Nutrition (HFS–200), Food
microns-400 millimicrons with spectral slit and Drug Administration, 5001 Campus Dr.,
width of 0.2 millimicron or less; under in- College Park, MD 20740, or available for in-
strument operating conditions for these ab- spection at the National Archives and
sorbance measurements. The spectrophotom- Records Administration (NARA). For infor-
eter shall also meet the following perform- mation on the availability of this material
ance requirements: at NARA, call 202–741–6030, or go to: http://

Absorbance repeatability, ±0.01 at 0.4 ab- www.archives.gov/federal_register/
sorbance. code_of_federal_regulations/ibr_locations.html.
444
the 1-centimeter pathlength cells compared octane and reevaporate to 1 milliliter of
to isooctane as reference. The absorbance of hexadecane. Again, add 10 milliliters of iso-
the solution of the solvent residue (except octane to the residue and evaporate to 1 mil-
for methyl alcohol) shall not exceed 0.01 per liliter of hexadecane to insure complete re-
centimeter pathlength between 280 mμ and moval of all volatile materials. Dissolve the
400 mμ. 1 milliliter of hexadecane in isooctane and
Isooctane (2,2,4-trimethylpentane). Use 180 make to 25-milliliter volume. Determine the
milliliters for the test described in the pre- absorbance in 1-centimeter pathlength cells
ceding paragraph. Purify, if necessary, by compared to isooctane as reference. The ab-
passage through a column of activated silica sorbance of the solution should not exceed
gel (Grade 12, Davison Chemical Co., Balti- 0.02 per centimeter pathlength in the 280 mμ-
more, Md., or equivalent) about 90 centi- 400 mμ range. (NOTE: Difficulty in meeting
meters in length and 5 centimeters to 8 cen- this absorbance specification may be due to
timeters in diameter. organic impurities in the distilled water.
Benzene, A.C.S. reagent grade. Use 150 milli- Repetition of the test omitting the dimethyl
liters for the test. Purify, if necessary, by sulfoxide will disclose their presence. If nec-
distillation or otherwise. essary to meet the specification, purify the
n-Hexadecane, 99 percent olefin-free. Dilute water by redistillation, passage through an
1.0 milliliter of n-hexadecane to 25 milliliters ion-exchange resin, or otherwise.)
with isooctane and determine the absorbance Purify, if necessary, by the following pro-
in a 1-centimeter cell compared to isooctane cedure: To 1,500 milliliters of dimethyl sulf-
as reference point between 280 mμ-400 mμ. oxide in a 2-liter glass-stoppered flask, add
The absorbance per centimeter pathlength 6.0 milliliters of phosphoric acid and 50
shall not exceed 0.00 in this range. If nec- grams of Norit A (decolorizing carbon, alka-
essary, purify by filtering through a column line) or equivalent. Stopper the flask, and
containing 100 grams of aluminum oxide (use with the use of a magnetic stirrer (tetra-
same grade as described below) in the lower fluoroethylene polymer coated bar) stir the
half and 100 grams of activated silica gel in solvent for 15 minutes. Filter the dimethyl
the upper half keeping the column at 150 °C., sulfoxide through four thicknesses of fluted
for a period of 15 hours or overnight. The paper (18.5 centimeters, Schleicher &
first 100 milliliters of eluate are used. Purifi- Schuell, No. 597, or equivalent). If the initial
cation can also be accomplished by distilla- filtrate contains carbon fines, refilter
tion. through the same filter until a clear filtrate
Dimethyl sulfoxide. Pure grade, clear, is obtained. Protect the sulfoxide from air
water-white, m.p. 18° minimum. Dilute 120 and moisture during this operation by cov-
milliliters of dimethyl sulfoxide with 240 ering the solvent in the funnel and collection
milliliters of distilled water in a 500-milli- flask with a layer of isooctane. Transfer the
liter separatory funnel, mix and allow to filtrate to a 2-liter separatory funnel and
cool for 5–10 minutes. Add 40 milliliters of draw off the dimethyl sulfoxide into the 2-
isooctane to the solution and extract by liter distillation flask of the vacuum dis-
shaking the funnel vigorously for 2 minutes. tillation assembly and distill at approxi-
Draw off the lower aqueous layer into a sec- mately 3-millimeter Hg pressure or less. Dis-
ond 500-milliliter separatory funnel and re- card the first 200-milliliter fraction of the
peat the extraction with 40 milliliters of iso- distillate and replace the distillate collec-
octane. Draw off and discard the aqueous tion flask with a clean one. Continue the dis-
layer. Wash each of the 40-milliliter extrac- tillation until approximately 1 liter of the
tives three times with 50-milliliter portions sulfoxide has been collected.
of distilled water. Shaking time for each At completion of the distillation, the rea-
wash is 1 minute. Discard the aqueous lay- gent should be stored in glass-stoppered bot-
ers. Filter the first extractive through anhy- tles since it is very hygroscopic and will
drous sodium sulfate prewashed with iso- react with some metal containers in the
octane (see Sodium sulfate under ‘‘Reagents presence of air.
and materials’’ for preparation of filter), into Phosphoric acid. 85 percent A.C.S. reagent
a 250-milliliter Erlenmeyer flask, or option- grade.
ally into the evaporating flask. Wash the Aluminum oxide (80–200 mesh Woelm neutral
first separatory funnel with the second 40- activity grade 1 [Brockmann], Alupharm Chemi-
milliliter isooctane extractive, and pass cals, New Orleans, La., or equivalent). Pipette
through the sodium sulfate into the flask. 1 milliliter of distilled water into a dry 250-
Then wash the second and first separatory milliliter Erlenmeyer flask equipped with a
funnels successively with a 10-milliliter por- ground-glass stopper. Stopper the flask and
tion of isooctane, and pass the solvent rotate it in such a manner as to completely
through the sodium sulfate into the flask. wet out the inside surfaces. When this has
Add 1 milliliter of n-hexadecane and evapo- been done add 180 grams of the aluminum
rate the isooctane on the steam bath under oxide and shake until no lumps or wet spots
nitrogen. Discontinue evaporation when not remain. Allow to stand at room temperature
over 1 milliliter of residue remains. To the for a period of 2 hours. At the end of this
residue, add a 10-milliliter portion of iso- time the water should be evenly distributed
445
§ 178.3770 21 CFR Ch. I (4–1–23 Edition)
throughout the aluminum oxide powder, and nel from the jacket and shake it vigorously
it should have the same free flowing prop- for 2 minutes. Set up three 250-milliliter
erties as the original material (flow velocity separatory funnels with each containing 30
with water 0.2 milliliter per minute). At this milliliters of preequilibrated isooctane.
point the aluminum oxide has an activity of After separation of the liquid phases, allow
1 as expressed in Brockmann degrees, and to cool until the main portion of the wax-iso-
the amount of added water is 0.5 percent by octane solution begins to show a precipitate.
volume. This product is used in toto and as Gently swirl the funnel when precipitation
is, without further screening. first occurs on the inside surface of the fun-
Sodium sulfate, anhydrous, A.C.S. reagent nel to accelerate this process. Carefully draw
grade, preferably in granular form. For each off the lower layer, filter it slowly through a
bottle of sodium sulfate reagent used, estab- thin layer of glass wool fitted loosely in a fil-
lish as follows the necessary sodium sulfate ter funnel into the first 250-milliliter sepa-
prewash to provide such filters required in ratory funnel, and wash in tandem with the
the method: Place approximately 35 grams of 30-milliliter portions of isooctane contained
anhydrous sodium sulfate in a 30-milliliter in the 250-milliliter separatory funnels.
coarse, fritted-glass funnel or in a 65-milli- Shaking time for each wash is 1 minute. Re-
meter filter funnel with glass wool plug; peat the extraction operation with two addi-
wash with successive 15-milliliter portions of tional portions of the sulfoxide-acid mixture,
the indicated solvent until a 15-milliliter replacing the funnel in the jacket after each
portion of the wash shows 0.00 absorbance extraction to keep the wax in solution and
per centimeter pathlength between 280 mμ washing each extractive in tandem through
and 400 mμ when tested as prescribed under the same three portions of isooctane.
‘‘Organic solvents.’’ Usually three portions Collect the successive extractives (300 mil-
of wash solvent are sufficient. liliters total) in a separatory funnel (pref-
erably 2-liter), containing 480 milliliters of
PROCEDURE distilled water, mix, and allow to cool for a
few minutes after the last extractive has
Before proceeding with analysis of a sam- been added. Add 80 milliliters of isooctane to
ple, determine the absorbance in a 1-centi- the solution and extract by shaking the fun-
meter path cell between 250 mμ and 400 mμ nel vigorously for 2 minutes. Draw off the
for the reagent blank by carrying out the lower aqueous layer into a second separatory
procedure, without a wax sample, at room funnel (preferably 2-liter) and repeat the ex-
temperature, recording the spectrum after traction with 80 milliliters of isooctane.
the complete procedure as prescribed. The Draw off and discard the aqueous layer.
absorbance per centimeter pathlength fol- Wash each of the 80-milliliter extractives
lowing the complete procedure should not three times with 100-milliliter portions of
exceed 0.04 in the wavelength range from 280 distilled water. Shaking time for each wash
mμ to 299 mμ, inclusive, nor 0.02 in the wave- is 1 minute. Discard the aqueous layers. Fil-
length range from 300 mμ to 400 mμ. If in ei- ter the first extractive through anhydrous
ther spectrum the characteristic benzene sodium sulfate prewashed with isooctane (see
peaks in the 250 mμ-260 mμ region are Sodium sulfate under ‘‘Reagents and Mate-
present, remove the benzene by the proce- rials’’ for preparation of filter) into a 250-
dure under ‘‘Organic solvents’’ and record milliliter Erlenmeyer flask (or optionally
absorbance again. Place 300 milliliters of di- into the evaporation flask). Wash the first
methyl sulfoxide in a 1-liter separatory fun- separatory funnel with the second 80-milli-
nel and add 75 milliliters of phosphoric acid. liter isooctane extractive and pass through
Mix the contents of the funnel and allow to the sodium sulfate. Then wash the second
stand for 10 minutes. (The reaction between and first separatory funnels successively
the sulfoxide and the acid is exothermic. Re- with a 20-milliliter portion of isooctane and
lease pressure after mixing, then keep funnel pass the solvent through the sodium sulfate
stoppered.) Add 150 milliliters of isooctane into the flask. Add 1 milliliter of n-hexa-
and shake to preequilibrate the solvents. decane and evaporate the isooctane using an
Draw off the individual layers and store in aspirator vacuum under nitrogen and in an
glass-stoppered flasks. oil bath temperature of approximately 90 °C.
In a 1-liter separatory funnel place a rep- Discontinue evaporation when not over 1
resentative 25-gram sample of wax, add 50 milliliter of residue remains. To the residue,
milliliters of isooctane, heat gently, stir add a 10-milliliter portion of isooctane, re-
until the wax is in solution; add 100 milli- evaporate to 1 milliliter of hexadecane, and
liters of preequilibrated sulfoxide-phosphoric repeat this operation once.
acid mixture and shake, making sure it re- Reserve the residue for column chroma-
mains in solution. If the wax comes out of tography on the aluminum oxide. Fit the
solution during these operations, let the tetrafluoroethylene polymer disc on the
stoppered funnel remain in the jacket until upper part of the stem of the
the wax redissolves. (Remove stopper from chromatographic tube, then place the tube
the funnel at intervals to release pressure.) with the disc on the suction flask and apply
When the wax is in solution, remove the fun- the vacuum (approximately 135 millimeters
446
Hg pressure). Weigh out 180 grams of the alu- complying with § 175.320 of this chapter.
minum oxide and pour the adsorbent mixture Such esters meet the following speci-
into the chromatographic tube in approxi- fications and are produced by partial
mately 30-centimeter layers. After the addi-
tion of each layer, level off the top of the ad-
esterification of oxidatively refined
sorbent with a flat glass rod or metal plung- (Gersthofen process) montan wax acids
er by pressing down firmly until the adsorb- with equimolar proportions of ethylene
ent is well packed. Loosen the topmost few glycol and 1,3-butanediol:
millimeters of each adsorbent layer with the (1) Dropping point 77°–82 °C, as deter-
end of a metal rod before the addition of the mined by ASTM method D566–76 (Re-
next layer. Continue packing in this manner approved 1982), ‘‘Standard Test Method
until all the 180 grams of the adsorbent is
added to the tube. Level off the top of the ad-
for Dropping Point of Lubricating
sorbent by pressing down firmly with a flat Grease,’’ which is incorporated by ref-
glass rod or metal plunger to make the depth erence. The availability of this incor-
of the adsorbent bed approximately 80 centi- poration by reference is given in para-
meters in depth. Turn off the vacuum and re- graph (a)(1) of this section.
move the suction flask. Dissolve the hexa- (2) Acid value 25–35, as determined by
decane residue in 10 milliliters of warm ben- ASTM method D1386–78 (‘‘Standard
zene and decant the solution onto the col-
Test Method for Acid Number (Empir-
umn and allow the liquid level to recede to
barely above the adsorbent level. Rapidly ical) of Synthetic and Natural Waxes’’
complete the transfer similarly with two 10- (Revised 1978), which is incorporated by
milliliter portions of benzene swirling the reference; copies are available from
flask repeatedly each time to assure ade- American Society for Testing and Ma-
quate washing of the residue. Fix the 1,000- terials (ASTM), 100 Barr Harbor Dr.,
milliliter reservoir onto the top of the West Conshohocken, Philadelphia, PA
chromatographic column. Just before the
19428-2959, or available for inspection at
final 10-milliliter wash reaches the top of the
adsorbent, add 670 milliliters of benzene to the National Archives and Records Ad-
the reservoir and continue the percolation at ministration (NARA). For information
the 2–3 milliliter per minute rate until a on the availability of this material at
total of 670 milliliters of benzene has been NARA, call 202–741–6030, or go to: http://
utilized. Collect the eluate in a clean 1-liter www.archives.gov/federal_register/
Erlenmeyer flask (or optionally into a 1-liter code_of_federal_regulations/
evaporation flask). Allow the column to ibr_locations.html.) using as solvent xy-
drain until most of the solvent mixture is re-
moved. Add 1 milliliter of n-hexadecane and lene-ethyl alcohol in a 2:1 ratio instead
completely remove the benzene by evapo- of toluene-ethyl alcohol in a 1:2 ratio.
ration under nitrogen, using the special pro- (3) Saponification value 135–150, as
cedure to eliminate benzene as previously determined by ASTM method D1387–78
described under ‘‘Organic Solvents.’’ Quan- (‘‘Standard Test Method for Saponi-
titatively transfer the residue with isooctane fication Number (Empirical) of Syn-
to a 25-milliliter volumetric flask and adjust thetic and Natural Waxes’’ (Revised
to volume. Determine the absorbance of the
solution in the 1-centimeter pathlength cells
1978), which is incorporated by ref-
compared to isooctane as reference between erence; copies are available from Amer-
250 mμ-400 mμ. Correct for any absorbance ican Society for Testing and Materials
derived from the reagents as determined by (ASTM), 100 Barr Harbor Dr., West
carrying out the procedure without a wax Conshohocken, Philadelphia, PA 19428-
sample. If either spectrum shows the char- 2959, or available for inspection at the
acteristic benzene peaks in the 250 mμ-260 mμ National Archives and Records Admin-
region, evaporate the solution to remove
benzene by the procedure under ‘‘Organic
Solvents.’’ Dissolve the residue, transfer the availability of this material at
quantitatively, and adjust to volume in iso- NARA, call 202–741–6030, or go to: http://
octane in a 25-milliliter volumetric flask. www.archives.gov/federal_register/
Record the absorbance again. If the cor- code_of_federal_regulations/
rected absorbance does not exceed the limits ibr_locations.html.) using xylene-ethyl
prescribed in paragraph (a) of this section, alcohol in a 2:1 ratio instead of ethyl
the wax meets the ultraviolet absorbance alcohol in preparation of potassium hy-
specifications.
droxide solution.
(b) The polyhydric alcohol esters (4) Ultraviolet absorbance limits
identified in this paragraph may be specified in paragraph (a)(4) of this sec-

used as release agents in resinous and tion, as determined by the analytical
polymeric coatings for polyolefin films method described therein.
447
§ 178.3780 21 CFR Ch. I (4–1–23 Edition)
(c) The polyhydric alcohol esters of solvent xylene-ethyl alcohol in a 2:1

oxidatively refined (Gersthofen proc- ratio instead of toluene-ethyl alcohol
ess) montan wax acids, identified in in a 2:1 ratio.
paragraph (a) or (b) of this section, (3) Saponification value 130–160, as
may also be used as a component of an determined by ASTM Method D–1387–78
aqueous dispersion of vinylidene chlo- ‘‘Standard Test Method for Saponifica-
ride copolymers, subject to the condition Number (Empirical) of Synthetic
tions described in paragraphs (c)(1) and and Natural Waxes’’ (Revised 1978),
(2) of this section. (which is incorporated by reference in
(1) The aqueous dispersion of the ad- accordance with 5 U.S.C. 552(a); the
ditive contains not more that 18 per- availability of this incorporation by
cent polyhydric alcohol esters of reference is given in paragraph (a)(3) of
oxidatively refined (Gersthofen proc- this section), using xylene-ethyl alco-
ess) montan wax acids, not more than 2 hol in a 2:1 ratio instead of ethyl alco-
percent poly(oxyethylene) (minimum hol in the preparation of potassium hy-
20 moles of ethylene oxide) oleyl ether droxide solution.
(CAS Reg. No. 9004–98–2), and not more (4) Ultraviolet absorbance limits
than 1 percent poly(oxyethylene) (min- specified in paragraph (a)(4) of this sec-
imum 3 moles ethylene oxide) cetyl al- tion, as determined by the analytical
cohols (CAS Reg. No. 9004–95–9). method described therein.
(2) The aqueous dispersion described
in paragraph (c)(1) of this section is [42 FR 14609, Mar. 15, 1977, as amended at 47
used as an additive to aqueous disper- FR 11848, Mar. 19, 1982; 49 FR 10113, Mar. 19,
sions of vinylidene chloride copoly- 1984; 51 FR 33895, Sept. 24, 1986; 54 FR 24898,
June 12, 1989; 55 FR 28020, July 9, 1990; 58 FR
mers, regulated in §§ 175.300, 175.320,
17512, Apr. 5, 1993; 69 FR 24512, May 4, 2004]
175.360, 176.170, 176,180, and 177.1630 of
this chapter, at levels not to exceed 1.5 § 178.3780 Polyhydric alcohol esters of
percent (solids basis) in the finished long chain monobasic acids.
coating.
(d) The polyhydric alcohol esters Polyhydric alcohol esters of long
identified in this paragraph may be chain monobasic acids identified in
used as lubricants in the fabrication of this section may be safely used as lu-
vinyl chloride plastic food contact arti- bricants in the fabrication of polyvinyl
cles prepared from vinyl chloride poly- chloride and/or polyvinyl chloride co-
mers. Such esters meet the following polymer articles complying with
specifications and are produced by par- § 177.1980 of this chapter that contact
tial esterification of oxidatively re- food of Types I, II, IV-B, VI-B, VII-B,
fined (Gersthofen process) montan wax and VIII identified in table 1 in
acids with glycerol followed by neu- § 176.170(c) of this chapter under condi-
tralization: tions of use E, F, and G described in
(1) Dropping point 79 to 85 °C, as de- table 2 in § 176.170(c) of this chapter,
termined by the American Society for subject to the provisions of this sec-
Testing and Materials (ASTM), Method tion.
D–566–76 (Reapproved 1982), ‘‘Standard (a) Identity. For the purpose of this
Test Method for Dropping Point of Lu- section, polyhydric alcohol esters of
bricating Grease,’’ which is incor- long chain monobasic acids consist of
porated by reference in accordance polyhydric alcohol esters having num-
with 5 U.S.C. 552(a). The availability of ber average molecular weights in the
this incorporation by reference is given range of 1,050 to 1,700. The esters are
in paragraph (a)(1) of this section. produced by the reaction of either
(2) Acid value 20–30, as determined by ethylene glycol or glycerol with long
ASTM Method D–1386–78 ‘‘Standard chain monobasic acids containing from
Test Method for Acid Number (Empir- 9 to 49 carbon atoms obtained by the
ical) of Synthetic and Natural Waxes’’ ozonization of long chain alpha-olefins,
(Revised 1978) (which is incorporated by the unreacted carboxylic acids in the
reference in accordance with 5 U.S.C. formation of the glycerol esters being
552(a); the availability of this incorpo- neutralized with calcium hydroxide to

ration by reference is given in para- produce a composition having up to 2
graph (a)(2) of this section), using as a percent by weight calcium. The alpha-
448
olefins, obtained from the polymeriza- istration (NARA). For information on

tion of ethylene, have 20 to 50 carbon the availability of this material at
atoms and contain a minimum of 75 NARA, call 202–741–6030, or go to: http://
percent by weight straight chain alpha- www.archives.gov/federal_register/
olefins and not more than 25 percent code_of_federal_regulations/
vinylidene compounds. ibr_locations.html.
(b) Specifications. The polyhydric al- (4) Ultraviolet absorbance as speci-
cohol esters have the following specified in § 178.3770(a)(4) of this chapter
fications: when tested by the analytical method
(1) Melting point of 60–80 °C for the described therein.
ethylene glycol ester and 90–105 °C for [42 FR 14609, Mar. 15, 1977, as amended at 47
the glycerol ester as determined by the FR 11849, Mar. 19, 1982; 54 FR 24899, June 12,
Fisher Johns method as described in 1989; 61 FR 14481, Apr. 2, 1996]
‘‘Semimicro Qualitative Organic Anal-
ysis—The Systematic Identification of § 178.3790 Polymer modifiers in
Organic Compounds,’’ by Cheronis and semirigid and rigid vinyl chloride
Entrikin, 2d Ed., Interscience Pub- plastics.
lishers, NY, which is incorporated by The polymers identified in paragraph
reference. Copies are available from (a) of this section may be safely
the Center for Food Safety and Applied admixed, alone or in mixture with
Nutrition (HFS–200), Food and Drug other permitted polymers, as modifiers
Administration, 5001 Campus Dr., Col- in semirigid and rigid vinyl chloride
lege Park, MD 20740, or available for in- plastic food-contact articles prepared
spection at the National Archives and from vinyl chloride homopolymers and/
Records Administration (NARA). For or from vinyl chloride copolymers com-
information on the availability of this plying with § 177.1950, § 177.1970, and/or
material at NARA, call 202–741–6030, or § 177.1980 of this chapter, in accordance
go to: http://www.archives.gov/fed- with the following prescribed condi-
eral_register/code_of_federal_regulations/ tions:
ibr_locations.html. (a) For the purpose of this section,
(2) Acid value 15–25 for each ester as the polymer modifiers are identified as
determined by the A.O.C.S. method follows:
Trla-64T ‘‘Titer Test,’’ which is incor- (1) Acrylic polymers identified in this
porated by reference. Copies are avail- subparagraph provided that such poly-
able from American Association of Oil mers contain at least 50 weight-percent
Chemists, 36 East Wacker Drive, Chi- of polymer units derived from one or
cago, IL 60601, or available for inspec- more of the monomers listed in para-
tion at the National Archives and graph (a)(1)(i) of this section.
Records Administration (NARA). For (i) Homopolymers and copolymers of
information on the availability of this the following monomers:
n-Butyl acrylate.
go to: http://www.archives.gov/fed- n-Butyl methacrylate.
eral_register/code_of_federal_regulations/ Ethyl acrylate.
ibr_locations.html. The method is modi- Methyl methacrylate.
fied to use as the acid solvent a 1:1 vol-
(ii) Copolymers produced by co-
ume mixture of anhydrous isopropyl al-
polymerizing one or more of the mono-
cohol and toluene. The solution is
mers listed in paragraph (a)(1)(i) of this
titrated with 0.1N methanolic sodium
section with one or more of the fol-
hydroxide.
lowing monomers:
(3) Saponification value 120–160 for
the ethylene glycol ester and 90–130 for Acrylonitrile.
the glycerol ester as determined the Butadiene.
A.O.C.S. method Trla-64T ‘‘Saponifica- a-Methylstyrene.
tion Value,’’ which is incorporated by Styrene.
reference. Copies are available from
American Association of Oil Chemists, (iii) Polymers identified in para-
36 East Wacker Drive, Chicago, IL graphs (a)(1)(i) and (ii) of this section
60601, or available for inspection at the containing no more than 5 weight-per-
National Archives and Records Admin- cent of total polymer units derived by
449
§ 178.3800 21 CFR Ch. I (4–1–23 Edition)
copolymerization with one or more of yl methacrylate, a-methylstyrene and

the following monomers: acrylonitrile and may optionally con-
Acrylic acid.
tain up to 15 weight-percent of polymer
1,3-Butylene glycol dimethacrylate. units derived from butadiene-styrene
Divinylbenzene. copolymers.
Methacrylic acid. (c) No chemical reactions, other than
(iv) Mixtures of polymers identified addition reactions, occur among the
in paragraph (a)(1)(i), (ii), and (iii) of vinyl chloride polymers and the modi-
this section; provided that no chemical fying polymers present in the polymer
reactions, other than addition reac- mixture used in the manufacture of the
tions, occur when they are mixed. finished plastic food-contact article.
(2) Polymers identified in paragraph (d) The finished plastic food-contact
(a)(1) of this section combined during article, when extracted with the sol-
their polymerization with butadiene- vent or solvents characterizing the
styrene copolymers; provided that no type of food and under the conditions
chemical reactions, other than addi- of time and temperature characterizing
tion reactions, occur when they are the conditions of its intended use as de-
combined. Such combined polymers termined from tables 1 and 2 of
may contain 50 weight-percent or more § 176.170(c) of this chapter, yields ex-
of total polymer units derived from the tractives not to exceed the limits pre-
butadiene-styrene copolymers. scribed in § 177.1010 (b)(1), (2), (3), and
(b) The polymer content of the fin- (4) of this chapter when tested by the
ished plastic food-contact article con- methods prescribed in § 177.1010 (c) of
sists of: this chapter.
(1) Not less than 80 weight-percent of (e) Acrylonitrile copolymers identi-
polymer units derived from the vinyl fied in this section shall comply with
chloride polymers identified in the in- the provisions of § 180.22 of this chap-
troduction to this section and not more ter.
than 5 weight-percent of polymer units
derived from polymers identified in § 178.3800 Preservatives for wood.
paragraph (a)(1) of this section and Preservatives may be safely used on
may optionally contain up to 15 wooden articles that are used or in-
weight-percent of polymer units de- tended for use in packaging, trans-
rived from butadiene-styrene copoly- porting, or holding raw agricultural
mers; or products subject to the provisions of
(2) Not less than 50 weight-percent of this section:
polymer units derived from the vinyl (a) The preservatives are prepared
chloride polymers identified in the in- from substances identified in para-
troduction to this section, not more graph (b) of this section and applied in
than 50 weight-percent of polymer amounts not to exceed those necessary
units derived from homopolymers and/ to accomplish the technical effect of
or copolymers of ethyl acrylate and protecting the wood from decay, mil-
methyl methacrylate, and not more dew, and water absorption.
than 30 weight-percent of polymer (b) The substances permitted are as
units derived from copolymers of meth- follows:
Copper-8-quinolinolate.
Mineral spirits.
Paraffin wax ................................................................................. Used singly or in combination so as to constitute not less than
50% of the solids.
Petroleum hydrocarbon resin, produced by the homo- and co- Do.
polymerization of dienes and olefins of the aliphatic, alicyclic,
and monobenzenoid arylalkene type from distillates of
cracked petroleum stocks.
Pentachlorophenol and its sodium salt ....................................... Not to exceed 50 p.p.m. in the treated wood, calculated as
pentachlorophenol.
Rosins and rosin derivatives ....................................................... As provided in § 178.3870.
Zinc salt of sulfonated petroleum.
450
§ 178.3850 Reinforced wax. List of substances Limitations
Reinforced wax may be safely used as Copolymer of isobutylene modi-

an article or component of articles in- fied with isoprene.
Petroleum wax, Type I and Type
tended for use in producing, manufac- II.
turing, packing, processing, trans- Polyethylene.
porting, or holding food subject to the Rosins and rosin derivatives as
provided in § 178.3870.
provisions of this section. Synthetic wax polymer as de- Not to exceed 5 percent
(a) Reinforced wax consists of petro- scribed in § 176.170(a)(5) of by weight of the petro-
leum wax to which have been added this chapter. leum wax.
certain optional substances required in
its production, or added to impart de- (e) Reinforced wax conforming with
sired physical or technical properties. the specifications in this paragraph is
(b) The quantity of any optional ad- used as provided in paragraph (e)(2) of
juvant substance employed in the pro- this section.
duction of or added to reinforced wax (1) The chloroform-soluble portion of
does not exceed the amount reasonably the water extract obtained by exposing
required to accomplish the intended reinforced wax to demineralized water
physical or technical effect or any lim- at 70 °F for 48 hours shall not exceed 0.5
itation provided in this section. milligram per square inch of food-con-
(c) Any substance employed in the tact surface.
production of reinforced wax, including (2) It is used as a packaging material
any optional substance, that is the sub- or component of packaging materials
ject of a regulation in parts 174, 175, for cheese and cheese products.
176, 177, 178 and § 179.45 of this chapter, [42 FR 14609, Mar. 15, 1977, as amended at 47
conforms with any specification in FR 1288, Jan. 12, 1982]
such regulation.
(d) The substances and optional adju- § 178.3860 Release agents.
vant substances employed in the pro- Substances listed in paragraph (b) of
duction of or added to reinforced wax this section may be safely used as re-
include: lease agents in petroleum wax com-
(1) Substances generally recognized plying with § 178.3710 and in polymeric
as safe in food. resins that contact food, subject to the
(2) Substances subject to prior sanc- provisions of this section.
tion for use in reinforced wax and used (a) The quantity used shall not ex-
in accordance with such sanction or ap- ceed the amount reasonably required
proval. to accomplish the intended technical
(3) Substances identified in this sub- effect or any limitations prescribed in
paragraph and subject to any limita- this section.
tions provided therein: (b) Release agents:
Erucamide (erucylamide).
Formaldehyde, polymer with 1-naphthalenol (CAS For use only as an antiscaling or release agent, applied on the internal
Reg. No. 25359–91–5). parts of reactors employed in the production of polyvinyl chloride and
acrylic copolymers, provided that the residual levels of the additive in the
ploymer do not exceed 4 parts per million.
N,N′-Dioleoylethylenediamine ................................. For use only in polyvinyl chloride films in amounts such that the concentra-
tion of the substance in these films in the form in which the films contact
food shall not exceed 0.055 milligram of the substance per square inch of
film.
Oleyl palmitamide.
Polybutene, hydrogenated; complying with the For use only subject to the limitations prescribed for hydrogenated
identity prescribed under § 178.3740(b). polybutene under § 178.3740(b).
Poly(vinyl acetate/vinyl N-octadecylcarbamate) For use only in application to the backing of pressuresensitive adhesive
(CAS Reg. No. 70892–21–6) produced by the tapes at levels not to exceed 0.2 milligram per square centimeter (1.29
reaction between stoichiometrically equivalent milligrams per square inch) of backing.
amounts of octadecyl isocyanate and vinyl alco-
hol/vinyl acetate copolymer; minimum average
molecular weight is 500,000.
Rice bran wax ......................................................... For use only in plastics intended for contact with dry foods identified as
Type VIII in table 1 of § 176.170(c) of this chapter, at levels not in excess
of 1.0 percent by weight of the polymer.
451
§ 178.3870 21 CFR Ch. I (4–1–23 Edition)
Saturated fatty acid amides manufactured from

fatty acids derived from animal, marine, or vege-
table fats and oils.
Stearyl erucamide.
[42 FR 14609, Mar. 15, 1977, as amended at 44 FR 69649, Dec. 4, 1979; 46 FR 51902, Oct. 23, 1981;
61 FR 25396, May 21, 1996; 61 FR 42381, Aug. 15, 1996]
§ 178.3870 Rosins and rosin deriva- (iv) Fully dimerized rosin, dimerized
tives. by sulfuric acid catalyst, and from
The rosins and rosin derivatives iden- which sufficient nondimerized rosin
tified in paragraph (a) of this section has been removed by distillation to
may safely be used in the manufacture achieve a minimum drop-softening
of articles or components of articles in- point of 143 °C, and a color of H or
tended for use in producing, manufac- paler.
turing, packing, processing, preparing, (v) Disproportionated rosin, catalyt-
treating, packaging, transporting, or ically disproportionated to a minimum
holding food, subject to the provisions dehydroabietic acid content of 35 per-
of this section. cent, a maximum abietic acid content
of 1 percent, a maximum content of
(a) The rosins and rosin derivatives
substituted phenanthrenes (as retene)
are identified as follows:
of 0.25 percent, and a color of WG or
(1) Rosins:
paler.
(i) Gum rosin, refined to color grade (3) Rosin esters manufactured from
of K or paler. rosins and modified rosins identified in
(ii) Wood rosin, refined to color grade paragraphs (a)(1) and (2) of this section:
of K or paler. (i) Glycerol ester of wood rosin puri-
(iii) Tall oil rosin, refined to color fied by steam stripping to have an acid
grade of K or paler. number of 3 to 9, a drop-softening point
(iv) Dark tall oil rosin, a fraction re- of 88°–96 °C, and a color of N or paler.
sulting from the refining of tall oil (ii) Glycerol ester of partially hydro-
rosin produced by multicolumnar dis- genated wood rosin, having an acid
tillation of crude tall oil to effect re- number of 3 to 10, a drop-softening
moval of fatty acids and pitch compo- point of 79°–88 °C, and a color of N or
nents and having a saponification num- paler.
ber of from 110–135 and 32 percent–44 (iii) Glycerol ester of partially
percent rosin acids. dimerized rosin, having an acid number
(v) Dark wood rosin, all or part of the of 3 to 8, a drop-softening point of 109°–
residue after the volatile terpene oils 119 °C, and a color of M or paler.
are distilled from the oleoresin ex- (iv) Glycerol ester of fully dimerized
tracted from pine wood. rosin, having an acid number of 5 to 16,
(2) Modified rosins manufactured a drop-softening point of 165°–175 °C,
from rosins identified in paragraph and a color of H or paler.
(a)(1) of this section: (v) Glycerol ester of maleic anhy-
(i) Partially hydrogenated rosin, cat- dride-modified wood rosin, having an
alytically hydrogenated to a maximum acid number of 30 to 40, a drop-soft-
refractive index of 1.5012 at 100 °C, and ening point of 138°–146 °C, a color of M
a color of WG or paler. or paler, and a saponification number
(ii) Fully hydrogenated rosin, cata- less than 280.
lytically hydrogenated to a maximum (vi) Methyl ester of rosin, partially
dehydroabietic acid content of 2 per- hydrogenated, purified by steam strip-
cent, a minimum drop-softening point ping to have an acid number of 4 to 8,
of 79 °C, and a color of X or paler. a refractive index of 1.5170 to 1.5205 at
(iii) Partially dimerized rosin, 20 °C, and a viscosity of 23 to 66 poises
at 25 °C.
dimerized by sulfuric acid catalyst to a

drop-softening point of 95°–105 °C and a (vii) Pentaerythritol ester of wood
color of WG or paler. rosin, having an acid number of 6 to 16,
452
a drop-softening point of 109°–116 °C, ening point of 136°–140 °C, a color of M

and a color of M or paler. or paler, and a saponification number
(viii) Pentaerythritol ester of par- less than 280. For use only in cello-
tially hydrogenated wood rosin, having phane complying with § 177.1200 of this
an acid number of 7 to 18, a drop-soft- chapter.
ening point of 102°–110 °C, and a color of (xvii) Citric acid-modified glycerol
K or paler. ester of rosin, having an acid number
(ix) Pentaerythritol ester of maleic less than 20, a drop-softening point of
anhydride-modified wood rosin, having 105°–115 °C, and a color of K or paler.
an acid number of 8 to 16, a drop-soft- For use only as a blending agent in
ening point of 154°–162 °C, a color of M coatings for cellophane complying with
or paler, and having a saponification § 177.1200 of this chapter.
number less than 280. (xviii) Glycerol ester of tall oil rosin,
(x) Pentaerythritol ester of maleic purified by steam stripping to have an
anhydride-modified wood rosin, having acid number of 5–12, a softening point
an acid number of 9 to 16, a drop-soft- of 80°–88 °C, and a color of N or paler.
ening point of 130°–140 °C, a color of N (xix) Glycerol ester of maleic anhy-
or paler, and having a saponification dride-modified tall oil rosin, having an
number less than 280. acid number of 30 to 40, a drop-soft-
(xi) Pentaerythritol ester of maleic ening point of 141°–146 °C, a color of N
anhydride-modified wood rosin, having or paler, and a saponification number
an acid number of 134 to 145, a drop- less than 280.
softening point of 127°–137 °C, a color of (xx) Glycerol ester of
M or paler, and having a saponification disproportionated tall oil rosin, having
number less than 280. an acid number of 5 to 10, a drop-soft-
(xii) Pentaerythritol ester of maleic ening point of 84°–93 °C, a color of WG
anhydride-modified wood rosin, having or paler, and a saponification number
an acid number of 30 to 40, a drop-soft- less than 180.
ening point of 131°–137 °C, a color of N (4) Rosin salts and sizes—Ammo-
or paler, and having a saponification nium, calcium, potassium, sodium, or
number less than 280. zinc salts of rosin manufactured by the
(xiii) Pentaerythritol ester of maleic partial or complete saponification of
anhydride-modified wood rosin, further any one of the rosins or modified rosins
modified by reaction with 4,4′-iso- identified in paragraph (a)(1) and (2) of
propyl-idenediphenol-formaldehyde this section, or blends thereof, and
condensate, having an acid number of with or without modification by reac-
10 to 22, a drop-softening point of 162°– tion with one or more of the following:
172 °C, a color of K or paler, a saponi-
(i) Formaldehyde.
fication number less than 280, and a
maximum ultraviolet absorbance of (ii) Fumaric acid.
0.14 at 296 mμ (using a 1-centimeter cell (iii) Maleic anhydride.
and 200 milligrams of the rosin ester (iv) Saligenin.
per liter of solvent consisting of ethyl (b) The quantity used shall not ex-
alcohol made alkaline by addition of ceed the amount reasonably required
0.1 percent of potassium hydroxide). to accomplish the intended technical
(xiv) Mixed methyl and pentaeryth- effect.
ritol ester of maleic anhydride-modi- (c) The use in any substance or arti-
fied wood rosin, having an acid number cle that is the subject of a regulation
of 73 to 83, a drop-softening point of in parts 174, 175, 176, 177, 178 and § 179.45
113°–123 °C, a color of M or paler, and a of this chapter shall conform with any
saponification number less than 280. specifications and limitations pre-
(xv) Triethylene glycol ester of par- scribed by such regulation for the fin-
tially hydrogenated wood rosin, having ished form of the substance or article.
an acid number of 2 to 10, a color of K (d) The provisions of this section are
or paler, and a viscosity of 350 to 425 not applicable to rosins and rosin de-
seconds Saybolt at 100 °C. rivatives identified in § 175.300(b)(3)(v)
(xvi) Glycerol ester of maleic anhy- of this chapter and used in resinous
dride-modified wood rosin, having an and polymeric coatings complying with
acid number of 17 to 23, a drop-soft- § 175.300 of this chapter.
453
§ 178.3900 21 CFR Ch. I (4–1–23 Edition)
(e) The provisions of this section are (5) Softening point: Softening point
not applicable to rosins and rosin de- shall be as determined by ASTM meth-
rivatives identified in § 175.105(c)(5) of od E28–67, ‘‘Standard Test Method for
this chapter and used in defoaming Softening Point by Ring and Ball Ap-
agents complying with § 176.210 of this paratus’’ (Reapproved 1977), which is
chapter, food-packaging adhesives incorporated by reference. Copies are
complying with § 175.105 of this chapter, available from American Society for
and rubber articles complying with Testing and Materials (ASTM), 100
§ 177.2600 of this chapter. Barr Harbor Dr., West Conshohocken,
(f) The analytical methods for deter- Philadelphia, PA 19428-2959, or avail-
mining whether rosins and rosin de- able for inspection at the National Ar-
rivatives conform to the specifications chives and Records Administration
prescribed in paragraph (a) of this sec- (NARA). For information on the avail-
tion are as follows: ability of this material at NARA, call
(1) Color: Color shall be as deter- 202–741–6030, or go to: http://
mined by ASTM method D509–70 (Re- www.archives.gov/federal_register/
approved 1981), ‘‘Standard Methods of code_of_federal_regulations/
Sampling and Grading Rosin,’’ which is ibr_locations.html.
incorporated by reference. Copies may (6) Analytical methods for deter-
be obtained from the American Society mining drop-softening point, saponi-
for Testing Materials, 100 Barr Harbor fication number, and any other speci-
Dr., West Conshohocken, Philadelphia, fications not listed under paragraphs
PA 19428-2959, or may be examined at (f)(1) through (5) of this section, titled:
the National Archives and Records Ad- (i) ‘‘Determination of Abeitic Acid and
ministration (NARA). For information Dehydroabietic Acid in Rosins’’; (ii)
on the availability of this material at ‘‘Determination of Softening Point of
NARA, call 202–741–6030, or go to: http:// Solid Resins’’; (iii) ‘‘Determination of
www.archives.gov/federal_register/ Saponification Number of Rosin
code_of_federal_regulations/ Esters,’’ and (iv) ‘‘Determination of
ibr_locations.html. Phenolic Modification of Rosin Deriva-
(2) Refractive index: Refractive index tives,’’ which are incorporated by ref-
shall be as determined by ASTM meth- erence. Copies are available from the
od D1747–62 (Reapproved 1978), ‘‘Stand- Center for Food Safety and Applied Nu-
ard Test Method for Refractive Index of trition (HFS–200), Food and Drug Ad-
Viscous Materials,’’ which is incor- ministration, 5001 Campus Dr., College
porated by reference. The availability Park, MD 20740, or available for inspec-
of this incorporation by reference is tion at the National Archives and
given in paragraph (f)(1) of this section. Records Administration (NARA). For
(3) Acid number: Acid number shall information on the availability of this
be as determined by ASTM method material at NARA, call 202–741–6030, or
D465–82, ‘‘Standard Test Methods for go to: http://www.archives.gov/fed-
Acid Number of Rosin,’’ which is incor- eral_register/code_of_federal_regulations/
porated by reference. The availability ibr_locations.html.
of this incorporation by reference is [42 FR 14609, Mar. 15, 1977, as amended at 47
given in paragraph (f)(1) of this section. FR 11849, Mar. 19, 1982; 49 FR 10113, Mar. 19,
(4) Viscosity: Viscosity in poises 1984; 54 FR 24899, June 12, 1989]
shall be as determined by ASTM meth-
od D1824–66 (Reapproved 1980), ‘‘Stand- § 178.3900 Sodium
ard Test Method for Apparent Vis- pentachlorophenate.
cosity of Plastisols and Organosols at Sodium pentachlorophenate may be
Low Shear Rates by Brookfield Vis- safely used as a preservative for ammo-
cometer,’’ and in Saybolt seconds by nium alginate employed as a proc-
ASTM method D88–81, ‘‘Standard Test essing aid in the manufacture of poly-
Method for Saybolt Viscosity,’’ which vinyl chloride emulsion polymers in-
are incorporated by reference. The tended for use as articles or compo-
availability of this incorporation by nents of articles that contact food at

reference is given in paragraph (f)(1) of temperatures not to exceed room tem-
this section. perature. The quantity of sodium
454
pentachlorophenate used shall not ex- (a) The following substances may be
ceed 0.5 percent by weight of ammo- used in surface lubricants used in the
nium alginate solids. rolling of metallic foil or sheet stock
provided that total residual lubricant
§ 178.3910 Surface lubricants used in remaining on the metallic article in
the manufacture of metallic arti-
cles. the form in which it contacts food does
not exceed 0.015 milligram per square
The substances listed in this section
inch of metallic food-contact surface:
may be safely used in surface lubri-
cants employed in the manufacture of (1) Substances identified in para-
metallic articles that contact food, graphs (b)(1) and (2) of this section.
subject to the provisions of this sec- (2) Substances identified in this para-
tion. graph.
a-Butyl-W-–hydroxypoly (oxyethylene)-poly (oxypropylene)

(CAS Reg. No. 9038–95–3) produced by random condensa-
tion of a 1:1 mixture by weight of ethylene oxide and pro-
pylene oxide with butanol and having a minimum molecular
weight of 1,000.
a–Butyl–W–hydroxypoly(oxypropylene) (CAS Reg. No. 9003-
13–8) having a minimum molecular weight of 1000.
a–Lauroyl–W–hydroxpoly(oxyethylene) (CAS Reg. No. 9004–
81–3) having a minimum molecular weight of 200.
Acetate esters derived from synthetic straight chain alcohols
(complying with § 172.864 of this chapter) that have even
numbers of carbon atoms in the range C8-C18.
alpha-Alkyl–omega-hydroxypoly(oxyethylene) produced by the
condensation of 1 mole of C12-C15 straight chain primary al-
cohols with an average of 3 moles of ethylene oxide (CAS
Reg. No. 68002–97–1).
Benzotriazole (CAS Reg. No. 95–14–7).
Bis(hydrogenated tallow alkyl)amine (CAS Reg. No. 61789– Not to be used in combination with sodium nitrite.
79–5).
Bis(hydrogenated tallow alkyl)aminoethanol (CAS Reg. No.
116438–56–3).
N,N-Bis(2-hydroxyethyl)butylamine (CAS Reg. No. 102–79–4).
Tert-Butyl alcohol.
Di(2-ethylhexyl)phthalate.
Diethylene glycol monobutylether (CAS Reg. No. 112–34–5).
Dimers, trimers, and/or their partial methyl esters; such dimers For use only at a level not to exceed 10 percent by weight of
and trimers are of unsaturated C18 fatty acids derived from finished lubricant formulation.
animal and vegetable fats and oils and/or tall oil, and such
partial methyl esters meet the following specifications: Sa-
ponification value 180–200, acid value 70–130, and max-
imum iodine value 120.
Di-n-octyl sebacate.
Ethylenediaminetetraacetic acid, sodium salts.
Isopropyl alcohol.
Isopropyl laurate (CAS Reg. No. 10233–13–3) .......................... For use at a level not to exceed 10 percent by weight of the
finished lubricant formulation.
Isopropyl oleate.
Isotridecyl alcohol, ethoxylated (CAS Reg. No. 9043–30–5).
Methyl esters of coconut oil fatty acids.
Methyl esters of fatty acids (C16-C18) derived from animal and
vegetable fats and oils.
Polybutene, hydrogenated: complying with the identity pre-
scribed under § 178.3740(b).
Polyisobutylene (minimum molecular weight 300).
Polyoxyethylated (5 moles) tallow amine (CAS Reg. No.
61791–26–2).
Polyvinyl alcohol.
Sodium nitrite ............................................................................... For use only as a rust inhibitor in lubricant formulations pro-
vided the total residual sodium nitrite on the metallic article
in the form in which it contacts food does not exceed 0.007

milligram per square inch of metallic food-contact surface.
455
§ 178.3910 21 CFR Ch. I (4–1–23 Edition)
Sodium petroleum sulfonate, MW 440–450 (CAS Reg. No.

68608–26–4) derived from naphthenic oil having a Saybolt
viscosity range of 500–600 Saybolt Universal Seconds (SUS
at 37–8 °C (100 °F) as determined by ASTM method D88–
81, ‘‘Standard Test Method for Saybolt Viscosity,’’ which is
incorporated by reference. Copies are available from the
American Society for Testing Materials, 1961 Race St.,
Philadelphia, PA 19103, or available for inspection at the Na-
Synthetic alcohol mixture of straight-and branched-chain alco-
hols that have even numbers of carbon atoms in the range
C4C18 and that are prepared from ethylene, aluminum, and
hydrogen such that the finished synthetic alcohol mixture
contains not less than 75 pct of straight-chain primary alco-
hols and contains not less than 85 pct total C10 and C12 al-
cohols.
Synthetic primary alcohol mixture of straight- and branched- For use at a level not to exceed 8 pct by weight of the finished
chain alcohols that contain at least 99 pct primary alcohols lubricant formulation.
consisting of the following: not less than 70 pct normal alco-
hols; not less than 96.5 pct C12-C15 alcohols; and not more
than 2.5 pct alpha, omega C13-C16 diols. The alcohols are
prepared from linear olefins from a purified kerosene frac-
tion, carbon monoxide and hydrogen using a modified oxo
process, such that the finished primary alcohol mixture
meets the following specifications: Molecular weight, 207±4;
hydroxyl number, 266–276.
Synthetic primary alcohol mixture of straight- and branched- For use only at a level not to exceed 8 pct by weight of the fin-
chain alcohols that contain at least 99 pct primary alcohols ished lubricant formulation.
consisting of the following: not less than 70 percent normal
alcohols; not less than 93 pct C12-C13 alcohols; not more
than 5 pct C14-C15 alcohols; and not more than 2.5 pct
alpha, omega, C13-C16 diols. The alcohols are prepared from
linear olefins from a purified kerosene fraction, carbon mon-
oxide and hydrogen using a modified oxo process, such that
the finished primary alcohol mixture meets the following
specifications:
Molecular weight 194±5; hydroxyl number, 283–296.
Tallow, sulfonated.
Triethanolamine.
(3) Mineral oil conforming to the method D86–82, ‘‘Standard Method for
identity prescribed in § 178.3620(c). Distilla

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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 ....................................................... 613

Alphabetical List of Agencies Appearing in the CFR ......................... 633

List of CFR Sections Affected ............................................................. 643

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 (CONTINUED)

189 Substances prohibited from use in human food ...... 600

PART 170—FOOD ADDITIVES 170.106 Notification for a food contact sub-

(FDA’s) determination that a premarket the following definitions apply:

fect in such food. (l) Prior sanction means an explicit

including all commercially processed ation.

growth of microorganisms and subse- carriers, binders, fillers, plasticizers,

(14) Formulation aids: Substances used food in packaging.

poisonous or deleterious substance additive status opinion letters per-

to be food additives nor to articles in- additive regulation will be conditioned

of this chapter. When the contemplated prominently, in addition to the other

Subpart B—Food Additive Safety tation data to man of 100 to 1, will be

evidence is submitted which justifies erally available data and information.

achieve general recognition of safety GRAS without specific inclusion in

practiced prior to January 1, 1958, and the availability of this material at

code_of_federal_regulations/ chapter shall be accomplished pursuant

status of a food ingredient. Any change

dence that the substance is GRAS, he

food-processing equipment) that mi- to grant an exemption in those cases in

(b) Notwithstanding paragraph (a) of (ii) Information on the amount of the

and Drug Administration’s Office of (f) If the request for an exemption

the FCN, in the form of either: disclosure, unless extraordinary cir-

of terms in § 170.3 apply to such terms

or financial information that is privi- (d) When necessary to demonstrate

manufactured; stance above a particular level would

§ 170.265 What FDA will do with a product or products subject to regula-

issue under § 170.265(b)(1) or (c); and

your request that we cease to evaluate Subpart A—General Provisions

Attached hereto, in triplicate (quadru-

results or may reasonably be expected to re- basis of the original petition.

(l) [Reserved] each nonclinical study, either a state-

volved, additional information and at negligible levels may be reviewed

substances whose uses it determines § 171.102 Effective date of regulation.

Subpart E—Anticaking Agents 172.803 Advantame.

172.894 Modified cottonseed products in- ethyl)phenol, 4- methoxyphenol, 4,4′-(1-

prepared by condensation polymeriza- code_of_federal_regulations/

ability of this material at NARA, call Dry breakfast cereals .......................................... 50

www.archives.gov/federal_register/ Emulsion stabilizers for shortenings .................... 200

that beverages and desserts prepared Limita-

not to exceed the levels prescribed, cal- culated as anhydrous C10H12O8N2CaNa2:

Limita- accordance with the following pre-

able from the Office of Food Additive

Drug Administration, 5001 Campus Dr., § 172.135 Disodium EDTA.

(2) The intended use of the additive.

Limita- Zero in milk.

Rind-Determination of Natamycin Con- (b) The additive meets the following