CFR 2018 Title21 Vol1 Part73 Additives Exempt From Certification

Food and Drug Administration, HHS Pt.
74
subpart E of part 807 of this chapter, if § 73.3129 Disodium 1-amino-4-[[4-[(2-

the device is not subject to premarket bromo-1-oxoallyl)amino]-2-
approval, or submit and receive ap- sulfonatophenyl]amino]-9,10-
proval of an original or supplemental dihydro-9,10-dioxoanthracene-2-
sulfonate.
premarket approval application if the
device is subject to premarket ap- (a) Identity. The color additive is di-
proval. sodium 1-amino-4-[[4-[(2-bromo-1-
(c) Labeling. The label of the color ad- oxoallyl)amino]-2-
ditive shall conform to the require- sulfonatophenyl]amino]-9,10-dihydro-
ments of § 70.25 of this chapter. 9,10-dioxoanthracene-2-sulfonate (Reac-
tive Blue 69) (CAS Reg. No. 70209–99–3,
(d) Exemption from certification. Cer-
Colour Index No. 612037).
tification of this color additive is not
(b) Uses and restrictions. (1) The sub-
necessary for the protection of the pub-
stance listed in paragraph (a) of this
lic health, and therefore, this color ad- section may be used as a color additive
ditive is exempt from the certification in contact lenses in amounts not to ex-
requirements of section 721(c) of the ceed the minimum reasonably required
act. to accomplish the intended coloring ef-
[58 FR 3227, Jan. 8, 1993, as amended at 58 FR fect.
17510, Apr. 5, 1993] (2) Authorization and compliance
with this use shall not be construed as
§ 73.3128 Mica-based pearlescent pig- waiving any of the requirements of sec-
ments. tions 510(k), 515, and 520(g) of the Fed-
(a) Identity and specifications. The eral Food, Drug, and Cosmetic Act
color additive is formed by depositing with respect to the contact lenses in
which the additive is used.
titanium or iron salts from a basic so-
(c) Labeling. The label of the color ad-
lution onto mica, followed by calci-
ditive shall conform to the require-
nation to produce titanium dioxide or
ments in § 70.25 of this chapter.
iron oxides on mica. Mica used to man- (d) Exemption from certification. Cer-
ufacture the color additive shall con- tification of this color additive is not
form in identity and specifications to necessary for the protection of the pub-
the requirements of § 73.1496(a)(1) and lic health, and therefore batches there-
(b). of are exempt from the certification re-
(b) Uses and restrictions. (1) Mica- quirements of section 721(c) of the Fed-
based pearlescent pigments listed in eral Food, Drug, and Cosmetic Act.
paragraph (a) of this section may be
[76 FR 25235, May 4, 2011, as amended at 78
used as a color additive in contact FR 14664, Mar. 7, 2013]
lenses in amounts not to exceed the
minimum reasonably required to ac-
complish the intended coloring effect.
PART 74—LISTING OF COLOR AD-
(2) Authorization and compliance
DITIVES SUBJECT TO CERTIFI-
with this use shall not be construed as CATION
waiving any of the requirements of sec-
Subpart A—Foods
tions 510(k), 515, and 520(g) of the Fed-
eral Food, Drug, and Cosmetic Act (the Sec.
act) with respect to the contact lenses 74.101 FD&C Blue No. 1.
in which the additive is used. 74.102 FD&C Blue No. 2.
74.203 FD&C Green No. 3.
(c) Labeling. The label of the color ad- 74.250 Orange B.
ditive shall conform to the require- 74.302 Citrus Red No. 2.
ments in § 70.25 of this chapter. 74.303 FD&C Red No. 3.
(d) Exemption from certification. Cer- 74.340 FD&C Red No. 40.
tification of this color additive is not 74.705 FD&C Yellow No. 5.
74.706 FD&C Yellow No. 6.
necessary for the protection of the pub-
lic health, and therefore batches there- Subpart B—Drugs
kpayne on DSK54DXVN1OFR with $$_JOB
of are exempt from the certification re-

quirements of section 721(c) of the act. 74.1101 FD&C Blue No. 1.
74.1102 FD&C Blue No. 2.
[67 FR 65312, Oct. 24, 2002] 74.1104 D&C Blue No. 4.
479
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§ 74.101 21 CFR Ch. I (4–1–18 Edition)
74.1109 D&C Blue No. 9. 74.2707 D&C Yellow No. 7.
74.1203 FD&C Green No. 3. 74.2707a Ext. D&C Yellow No. 7.
74.1205 D&C Green No. 5. 74.2708 D&C Yellow No. 8.
74.1254 D&C Orange No. 4.
74.1255 D&C Orange No. 5. Subpart D—Medical Devices
74.1260 D&C Orange No. 10.
74.1261 D&C Orange No. 11. 74.3045 [Phthalocyaninato(2-)] copper.
74.1303 FD&C Red No. 3. 74.3102 FD&C Blue No. 2.
74.1304 FD&C Red No. 4. 74.3106 D&C Blue No. 6.
74.1306 D&C Red No. 6. 74.3206 D&C Green No. 6.
74.1307 D&C Red No. 7. 74.3230 D&C Red No. 17.
74.1317 D&C Red No. 17. 74.3602 D&C Violet No. 2.
74.1321 D&C Red No. 21. 74.3710 D&C Yellow No. 10.
74.1322 D&C Red No. 22. AUTHORITY: 21 U.S.C. 321, 341, 342, 343, 348,
74.1327 D&C Red No. 27. 351, 352, 355, 361, 362, 371, 379e.
74.1328 D&C Red No. 28.
74.1330 D&C Red No. 30. SOURCE: 42 FR 15654, Mar. 22, 1977, unless
74.1331 D&C Red No. 31. otherwise noted.
74.1333 D&C Red No. 33.
74.1334 D&C Red No. 34. Subpart A—Foods
74.1336 D&C Red No. 36.
74.1339 D&C Red No. 39. § 74.101 FD&C Blue No. 1.
74.1340 FD&C Red No. 40.
74.1602 D&C Violet No. 2. (a) Identity. (1) The color additive
74.1705 FD&C Yellow No. 5. FD&C Blue No. 1 is principally the di-
74.1706 FD&C Yellow No. 6. sodium salt of ethyl [4-[p-[ethyl (m-
74.1707 D&C Yellow No. 7. sulfobenzyl) amino]-a-(o-sulfophenyl)
74.1707a Ext. D&C Yellow No. 7. benzylidene] - 2,5 -cyclohexadien - 1 -
74.1708 D&C Yellow No. 8. ylidene] (m-sulfobenzyl) ammonium hy-
74.1710 D&C Yellow No. 10. droxide inner salt with smaller
74.1711 D&C Yellow No. 11.
amounts of the isomeric disodium salts
Subpart C—Cosmetics of ethyl [4-[p-[ethyl(p-sulfobenzyl)
amino]-a-(o-sulfophenyl) benzylidene]-
74.2052 D&C Black No. 2. 2,5-cyclohexadien-1-ylidene] (p-
74.2053 D&C Black No. 3. sulfobenzyl) ammonium hydroxide
74.2101 FD&C Blue No. 1. inner salt and ethyl [4-[p-[ethyl (o-
74.2104 D&C Blue No. 4. sulfobenzyl) amino] - a - (o
74.2151 D&C Brown No. 1.
-sulfophenyl) benzylidene]-2,5-
74.2203 FD&C Green No. 3.
74.2205 D&C Green No. 5. cyclohexadien-1-ylidene] (o-
74.2206 D&C Green No. 6. sulfobenzyl) ammonium hydroxide
74.2208 D&C Green No. 8. inner salt.
74.2254 D&C Orange No. 4. (2) Color additive mixtures for food
74.2255 D&C Orange No. 5. use (including dietary supplements)
74.2260 D&C Orange No. 10. made with FD&C Blue No. 1 may con-
74.2261 D&C Orange No. 11. tain only those diluents that are suit-
74.2304 FD&C Red No. 4. able and that are listed in part 73 of
74.2306 D&C Red No. 6.
this chapter as safe for use in color ad-
74.2307 D&C Red No. 7.
74.2317 D&C Red No. 17. ditive mixtures for coloring foods.
74.2321 D&C Red No. 21. (b) Specifications. FD&C Blue No. 1
74.2322 D&C Red No. 22. shall conform to the following speci-
74.2327 D&C Red No. 27. fications and shall be free from impuri-
74.2328 D&C Red No. 28. ties other than those named to the ex-
74.2330 D&C Red No. 30. tent that such other impurities may be
74.2331 D&C Red No. 31. avoided by current good manufacturing
74.2333 D&C Red No. 33.
practice:
74.2334 D&C Red No. 34.
74.2336 D&C Red No. 36. Sum of volatile matter (at 135 °C) and
74.2340 FD&C Red No. 40. chlorides and sulfates (calculated as so-
74.2602 D&C Violet No. 2. dium salts), not more than 15.0 percent.
74.2602a Ext. D&C Violet No. 2. Water-insoluble matter, not more than 0.2
74.2705 FD&C Yellow No. 5. percent.
74.2706 FD&C Yellow No. 6. Leuco base, not more than 5 percent.
480
Food and Drug Administration, HHS § 74.102
Sum of o-, m-, and p-sulfobenzaldehydes, not hydroxides under ammonia pressure.
more than 1.5 percent. The indigo is isolated and subjected to
N-Ethyl,N-(m-sulfobenzyl)sulfanilic acid, not
purification procedures prior to
more than 0.3 percent.
Subsidiary colors, not more than 6.0 percent. sulfonation.
Chromium (as Cr), not more than 50 parts (2) Color additive mixtures for food
per million. use (including dietary supplements)
Manganese (as Mn), not more than 100 parts made with FD&C Blue No. 2 may con-
per million.
tain only those diluents that are suit-
Arsenic (as As), not more than 3 parts per
million. able and that are listed in part 73 of
Lead (as Pb), not more than 10 parts per mil- this chapter as safe for use in color ad-
lion. ditive mixtures for coloring foods.
Total color, not less than 85.0 percent. (b) Specifications. The color additive
(c) Uses and restrictions. FD&C Blue FD&C Blue No. 2 shall conform to the
No. 1 may be safely used for coloring following specifications and shall be
foods (including dietary supplements) free from impurities other than those
generally in amounts consistent with named to the extent that such other
good manufacturing practice except impurities may be avoided by current
that it may not be used to color foods good manufacturing practice:
for which standards of identity have
Sum of volatile matter at 135 °C (275 °F) and
been promulgated under section 401 of
chlorides and sulfates (calculated as so-
the act unless added color is authorized dium salts), not more than 15 percent.
by such standards. Water insoluble matter, not more than 0.4
(d) Labeling. The label of the color ad- percent.
ditive and any mixtures prepared Isatin-5-sulfonic acid, not more than 0.4 per-
therefrom intended solely or in part for cent.
coloring purposes shall conform to the 5-Sulfoanthranilic acid, not more than 0.2
requirements of § 70.25 of this chapter. percent.
(e) Certification. All batches of FD&C Disodium salt of 2-(1,3-dihydro-3-oxo-7-sulfo-
Blue No. 1 shall be certified in accord- 2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-
ance with regulations in part 80 of this indole-5-sulfonic acid, not more than 18
chapter. percent.
Sodium salt of 2-(1,3-dihydro-3-oxo-2H-indol-
[42 FR 15654, Mar. 22, 1977, as amended at 58 2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5-
FR 17511, Apr. 5, 1993] sulfonic acid, not more than 2 percent.
Lead (as Pb), not more than 10 parts per mil-
§ 74.102 FD&C Blue No. 2.
lion.
(a) Identity. (1) The color additive Arsenic (as As), not more than 3 parts per
FD&C Blue No. 2 is principally the di- million.
sodium salt of 2-(1,3-dihydro-3-oxo-5- Mercury (as Hg), not more than 1 part per
sulfo-2H-indol-2-ylidene)-2,3-dihydro-3- million.
oxo-1H-indole-5-sulfonic acid (CAS Reg. Total color, not less than 85 percent.
No. 860–22–0) with smaller amounts of
(c) Uses and restrictions. The color ad-
the disodium salt of 2-(1,3-dihydro-3-
oxo-7-sulfo-2H-indol-2-ylidene)-2,3- ditive FD&C Blue No. 2 may be safely
dihydro-3-oxo-1H-indole-5-sulfonic acid used for coloring foods (including die-
(CAS Reg. No. 54947–75–0) and the so- tary supplements) generally in
dium salt of 2-(1,3-dihydro-3-oxo-2H- amounts consistent with current good
indol-2-ylidene)-2,3-dihydro-3-oxo-1H- manufacturing practice except that it
indole-5-sulfonic acid (CAS Reg. No. may not be used to color foods for
605–18–5). Additionally, FD&C Blue No. which standards of identity have been
2 is obtained by heating indigo (or in- promulgated under section 401 of the
digo paste) in the presence of sulfuric Federal Food, Drug, and Cosmetic Act
acid. The color additive is isolated and unless added color is authorized by
subjected to purification procedures. such standards.
The indigo (or indigo paste) used above (d) Labeling. The label of the color ad-
is manufactured by the fusion of N- ditive and any mixtures prepared
phenylglycine (prepared from aniline therefrom intended solely or in part for

and formaldehyde) in a molten mixture coloring purposes shall conform to the
of sodamide and sodium and potassium requirements of § 70.25 of this chapter.
481
§ 74.203 21 CFR Ch. I (4–1–18 Edition)
(e) Certification. All batches of FD&C desired 2-formyl-5-

Blue No. 2 shall be certified in accord- hydroxybenzenesulfonic acid.
ance with regulations in part 80 of this (2) Color additive mixtures for food
chapter. use (including dietary supplements)
[48 FR 5260, Feb. 4, 1983] made with FD&C Green No. 3 may con-
§ 74.203 FD&C Green No. 3. able and that are listed in part 73 of
(a) Identity. (1) The color additive
ditive mixtures for coloring food.
FD&C Green No. 3 is principally the
inner salt disodium salt of N-ethyl-N- (b) Specifications. The color additive
[4-[[4-[ethyl[(3- FD&C Green No. 3 shall conform to the
sulfophenyl)methyl]amino]phenyl](4- following specifications and shall be
hydroxy-2-sulfophenyl)methylene]-2,5- free from impurities other than those
cyclohexadien-1-ylidene]-3- named to the extent that such other
sulfobenzenemethanaminium hydrox- impurities may be avoided by current
ide (CAS Reg. No. 2353–45–9); with good manufacturing practice:
smaller amounts of the isomeric inner Sum of volatile matter at 135 °C (275 °F) and
salt disodium salt of N-ethyl-N-[4-[[4- chlorides and sulfates (calculated as so-
[ethyl[(3-sulfophenyl)methyl] dium salts), not more than 15 percent.
amino]phenyl](4-hydroxy-2- Water-insoluble matter, not more than 0.2
sulfophenyl)methylene]-2,5- percent.
cyclohexadien-1-ylidene]-4- Leuco base, not more than 5 percent.
sulfobenzenemethanaminium hydrox- Sum of 2-,3-,4-formylbenzenesulfonic acids,
ide; of N-ethyl-N-[4-[[4-[ethyl[(4- sodium salts, not more than 0.5 percent.
sulfophenyl)methyl]amino]phenyl](4- Sum of 3- and 4-[[ethyl(4-
hydroxy-2-sulfophenyl)methylene]-2,5- sulfophenyl)amino]methyl]
cyclohexadien-1-ylidene]-4- benzenesulfonic acid, disodium salts, not
sulfobenzenemethanaminium hydrox- more than 0.3 percent.
ide and of N-ethyl-N-[4-[[4-[ethyl[(2- 2-Formyl-5-hydroxybenzenesulfonic acid, so-
dium salt, not more than 0.5 percent.
sulfophenyl)methyl]amino]phenyl](4-
Subsidiary colors, not more than 6 percent.
hydroxy-2-sulfophenyl)methylene]-2,5-
Chromium (as Cr), not more than 50 parts
cyclohexadien-1-ylidene]-3-
per million.
sulfobenzenemethanaminium hydrox- Arsenic (as As), not more than 3 parts per
ide. Additionally, FD&C Green No. 3 is million.
manufactured by the acid catalyzed Lead (as Pb), not more than 10 parts per mil-
condensation of one molecule of 2- lion.
formyl-5-hydroxybenzenesulfonic acid Mercury (as Hg), not more than 1 part per
with two molecules from a mixture million.
consisting principally of 3- Total color, not less than 85 percent.
[(ethylphenylamino)methyl]
benzensulfonic acid, and smaller
ditive FD&C Green No. 3 may be safely
amounts of 4-
used for coloring foods (including die-
tary supplements) generally in
benzenesulfonic acid and 2- amounts consistent with current good
[(ethylphenylamino)methyl] manufacturing practice except that it
benzenesulfonic acid to form the leuco may not be used to color foods for
base. The leuco base is then oxidized which standards of identity have been
with lead dioxide and acid or with di- promulgated under section 401 of the
chromate and acid to form the dye. The act unless added color is authorized by
intermediate 2-formyl-5- such standards.
hydroxybenzenesulfonic acid is pre- (d) Labeling. The label of the color ad-
pared by the potassium permanganate ditive and any mixtures prepared
oxidation of 2,2′-(1,2-ethenediyl)-bis(5- therefrom intended solely or in part for
aminobenzenesulfonic acid) to sodium
coloring purposes shall conform to the

5-amino-2-formylbenzenesulfonate.
requirements of § 70.25 of this chapter.
This amine is diazotized and the result-
ing diazonium salt is hydrolyzed to the
482
(e) Certification. All batches of FD&C § 74.302 Citrus Red No. 2.

Green No. 3 shall be certified in accord-
ance with regulations in part 80 of this
Citrus Red No. 2 is principally 1–(2,5–
chapter.
dimethoxyphenylazo)-2-naphthol.
[47 FR 52143, Nov. 19, 1982; 47 FR 56489, Dec. (2) The following diluents may be
17, 1982] used in aqueous suspension, in the per-
centages specified, to facilitate appli-
§ 74.250 Orange B. cation to oranges in accordance with
(a) Identity. (1) The color additive Or- paragraph (c)(1) of this section:
ange B is principally the disodium salt (i) Suitable diluents used in accord-
of 1-(4-sulfophenyl)-3-ethylcarboxy-4-(4- ance with § 73.1(a) of this chapter.
sulfonaphthylazo)-5-hydro-xypyrazole. (ii) Volatile solvents that leave no
(2) The diluents in color additive residue after application to the orange.
mixtures for food use containing Or- (iii) Salts of fatty acids meeting the
ange B are limited to those listed in requirements of § 172.863 of this chap-
part 73 of this chapter as safe and suit- ter.
able in color additive mixtures for (iv) Sodium tripolyphosphate, not
coloring foods. more than 0.05 percent.
(b) Specifications. Orange B shall con- (b) Specifications. Citrus Red No. 2
form to the following specifications: shall conform to the following speci-
Volatile matter (at 135 °C.), not more than fications and shall be free from impuri-
6.0 percent. ties, other than those named, to the ex-
Chlorides and sulfates (calculated as the so- tent that such other impurities may be
dium salts), not more than 7.0 percent. avoided by good manufacturing prac-
Water insoluble matter, not more than 0.2
tice:
percent.
1-(4-Sulfophenyl)-3-ethylcarboxy-5- Volatile matter (at 100 °C.), not more than
hydroxypyrazolone and 1-(4-sulfophenyl)-3- 0.5 percent.
carboxy-5-hydroxypyrazolone, not more Water-soluble matter, not more than 0.3 per-
than 0.7 percent. cent.
Naphthionic acid, not more than 0.2 percent. Matter insoluble in carbon tetrachloride, not
Phenylhydrazine-p-sulfonic acid, not more more than 0.5 percent.
than 0.2 percent. Uncombined intermediates, not more than
The trisodium salt of 1-(4-sulfophenyl)-3- 0.05 percent.
carboxy-4-(4-sulfonaphthylazo)-5- Subsidiary dyes, not more than 2.0 percent.
hydroxypyrazole, not more than 6.0 per- Lead (as Pb), not more than 10 parts per mil-
cent. lion.
Other subsidiary dyes, not more than 1.0 per- Arsenic (as As), not more than 1 part per
cent. million.
Lead (as Pb), not more than 10 parts per mil- Total color, not less than 98 percent.
lion.
Arsenic (as As), not more than 1 part per (c) Uses and restrictions. (1) Citrus Red
million. No. 2 shall be used only for coloring the
Total color, not less than 87.0 percent. skins of oranges that are not intended
(c) Uses and restrictions. Orange B or used for processing (or if so used are
may be safely used for coloring the cas- designated in the trade as Packinghouse
ings or surfaces of frankfurters and elimination) and that meet minimum
sausages subject to the restriction that maturity standards established by or
the quantity of the color additive does under the laws of the States in which
not exceed 150 parts per million by the oranges are grown.
weight of the finished food. (2) Oranges colored with Citrus Red
(d) Labeling requirements. The label of No. 2 shall bear not more than 2.0 parts
the color additive and any mixtures in- per million of such color additive, cal-
tended solely or in part for coloring culated on the basis of the weight of
purposes prepared therefrom shall con- the whole fruit.
form to the requirements of § 70.25 of (d) Labeling. The label of the color ad-
this chapter. ditive and any mixtures prepared
(e) Certification. All batches of Orange therefrom and intended solely or in
B shall be certified in accordance with part for coloring purposes shall con-
regulations promulgated under part 80 form to the requirements of § 70.25 of
of this chapter. this chapter. To meet the requirements
483
§ 74.303 21 CFR Ch. I (4–1–18 Edition)
of § 70.25 (b) and (c) of this chapter the good manufacturing practice except
label shall bear: that it may not be used to color foods
(1) The statement (or its equivalent) for which standards of identity have
‘‘To be used only for coloring skins of been promulgated under section 401 of
oranges.’’ the act unless added color is authorized
(2) Directions for use to limit the by such standards.
amount of the color additive to not (d) Labeling. The label of the color ad-
more than 2.0 parts per million, cal- ditive and any mixtures prepared
culated on the basis of the weight of therefrom intended solely or in part for
the whole fruit. coloring purposes shall conform to the
(e) Certification. All batches of Citrus requirements of § 70.25 of this chapter.
Red No. 2 shall be certified in accord- (e) Certification. All batches of FD&C
ance with regulations in part 80 of this Red No. 3 shall be certified in accord-
chapter. ance with regulations in part 80 of this
chapter.
§ 74.303 FD&C Red No. 3.
(a) Identity. (1) The color additive § 74.340 FD&C Red No. 40.
FD&C Red No. 3 is principally the (a) Identity. (1) The color additive
monohydrate of 9 (o- carboxyphenyl)-6- FD&C Red No. 40 is principally the di-
hydroxy - 2,4,5,7-tetraiodo-3H-xanthen- sodium salt of 6-hydroxy-5-[(2-
3-one, disodium salt, with smaller methoxy-5-methyl-4-sulfophenyl)azo]-2-
amounts of lower imdinated naphthalenesulfonic acid.
fluoresceins. (2) Color additive mixtures for food
(2) Color additive mixtures for food use (including dietary supplements)
use made with FD&C Red No. 3 may made with FD&C Red No. 40 may con-
contain only those diluents that are tain only those diluents that are suit-
suitable and that are listed in part 73 able and that are listed in part 73 of
of this chapter as safe for use in color this chapter as safe for use in color ad-
additive mixtures for coloring foods. ditive mixtures for coloring foods.
(b) Specifications. FD&C Red No. 3 (3) The listing of this color additive
shall conform to the following speci- includes lakes prepared as described in
fications and shall be free from impuri- § 82.51 of this chapter, except that the
ties other than those named to the ex- color additive used is FD&C Red No. 40
tent that such other impurities may be and the resultant lakes meet the speci-
avoided by good manufacturing prac- fication and labeling requirements pre-
tice: scribed by § 82.51 of this chapter.
Volatile matter (at 135 °C.) and chlorides and (b) Specifications. FD&C Red No. 40
sulfates (calculated as the sodium salts), shall conform to the following speci-
total not more than 13 percent. fications and shall be free from impuri-
Water-insoluble matter, not more than 0.2 ties other than those named to the ex-
percent. tent that such other impurities may be
Unhalogenated intermediates, total not avoided by good manufacturing prac-
more than 0.1 percent. tice:
Sodium iodide, not more than 0.4 percent.
Triiodoresorcinol, not more than 0.2 percent. Sum of volatile matter (at 135 °C.) and
2(2′,4′-Dihydroxy-3′, 5′-diiodobenzoyl) benzoic chlorides and sulfates (calculated as so-
acid, not more than 0.2 percent. dium salts), not more than 14.0 percent.
Monoiodofluoresceins not more than 1.0 per- Water-insoluble matter, not more than 0.2
cent. percent.
Other lower iodinated fluoresceins, not more Higher sulfonated subsidiary colors (as so-
than 9.0 percent. dium salts), not more than 1.0 percent.
Lead (as Pb), not more than 10 parts per mil- Lower sulfonated subsidiary colors (as so-
lion. dium salts), not more than 1.0 percent.
Arsenic (as As), not more than 3 parts per Disodium salt of 6-hydroxy-5-[(2-methoxy-5-
million. methyl-4-sulfophenyl) azo] -8-(2-methoxy-5-
Total color, not less than 87.0 percent. methyl-4-sulfophenoxy)-2-
naphthalenesulfonic acid, not more than
(c) Uses and restrictions. FD&C Red
1.0 percent.
No. 3 may be safely used for coloring Sodium salt of 6-hydroxy-2-
foods generally (including dietary sup- naphthalenesulfonic acid (Schaeffer’s salt),
plements) in amounts consistent with not more than 0.3 percent.
484
4-Amino-5-methoxy-o- toluenesulfonic acid, Sum of volatile matter at 135 °C (275 °F) and
not more than 0.2 percent. chlorides and sulfates (calculated as so-
Disodium salt of 6,6′-oxybis (2-naphthalene- dium salts), not more than 13 percent.
sulfonic acid), not more than 1.0 percent. Water-insoluble matter, not more than 0.2
Lead (as Pb), not more than 10 parts per mil- percent.
lion. 4,4′-[4,5-Dihydro-5-oxo-4-[(4-
Arsenic (as As), not more than 3 parts per sulfophenyl)hydrazono]-1H-pyrazol-1,3-
million. diyl]bis[benzenesulfonic acid], trisodium
Total color, not less than 85.0 percent. salt, not more than 1 percent.
4-[(4′,5-Disulfo[1,1′-biphenyl]-2-yl)hydrazono]-
(c) Uses and restrictions. FD&C Red 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyr-
No. 40 may be safely used for coloring azole-3-carboxylic acid, tetrasodium salt,
foods (including dietary supplements) not more than 1 percent.
generally in amounts consistent with Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-
good manufacturing practice except sulfophenyl)-4-[(4-sulfophenyl)hydrazono]-
1H-pyrazole-3-carboxylate, disodium salt,
that it may not be used to color foods
not more than 1 percent.
for which standards of identity have Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4-
been promulgated under section 401 of sulfophenyl)azo]-1H-pyrazole-3-carboxylic
the act unless added color is authorized acid, disodium salt, and 4,5-dihydro-5-oxo-
by such standards. 4-(phenylazo)-1-(4-sulfophenyl)-1H-pyr-
(d) Labeling. The label of the color ad- azole-3-carboxylic acid, disodium salt, not
ditive and any lakes or mixtures pre- more than 0.5 percent.
pared therefrom intended solely or in 4-Aminobenzenesulfonic acid, sodium salt,
not more than 0.2 percent.
part for coloring purposes shall con-
4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyr-
form to the requirements of § 70.25 of azole-3-carboxylic acid, disodium salt, not
this chapter. more than 0.2 percent.
(e) Certification. All batches of FD&C Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-
Red No. 40 and lakes thereof shall be sulfophenyl)-1H-pyrazole-3-carboxylate, so-
certified in accordance with regula- dium salt, not more than 0.1 percent.
tions in part 80 of this chapter. 4,4′-(1-Triazene-1,3-diyl)bis[benzenesulfonic
acid], disodium salt, not more than 0.05
§ 74.705 FD&C Yellow No. 5. percent.
4-Aminoazobenzene, not more than 75 parts
(a) Identity. (1) The color additive per billion.
FD&C Yellow No. 5 is principally the 4-Aminobiphenyl, not more than 5 parts per
trisodium salt of 4,5-dihydro-5-oxo-1-(4- billion.
sulfophenyl)-4-[4-sulfophenyl-azo]-1H- Aniline, not more than 100 parts per billion.
pyrazole-3-carboxylic acid (CAS Reg. Azobenzene, not more than 40 parts per bil-
No. 1934–21–0). To manufacture the ad- lion.
Benzidine, not more than 1 part per billion.
ditive, 4-amino-benzenesulfonic acid is
1,3-Diphenyltriazene, not more than 40 parts
diazotized using hydrochloric acid and per billion.
sodium nitrite. The diazo compound is Lead (as Pb), not more than 10 parts per mil-
coupled with 4,5-dihydro-5-oxo-1-(4- lion.
sulfophenyl)-1H-pyrazole-3-carboxylic Arsenic (as As), not more than 3 parts per
acid or with the methyl ester, the million.
ethyl ester, or a salt of this carboxylic Mercury (as Hg), not more than 1 part per
acid. The resulting dye is purified and million.
isolated as the sodium salt. Total color, not less than 87 percent.
(2) Color additive mixtures for food (c) Uses and restrictions. FD&C Yellow
use made with FD&C Yellow No. 5 may No. 5 may be safely used for coloring
contain only those diluents that are foods (including dietary supplements)
suitable and that are listed in part 73 generally in amounts consistent with
of this chapter as safe for use in color good manufacturing practice, except
additive mixtures for coloring foods. that it may not be used to color foods
(b) Specifications. FD&C Yellow No. 5 for which standards of identity have
shall conform to the following speci- been promulgated under section 401 of
fications and shall be free from impuri- the act unless added color is authorized
ties other than those named to the ex- by such standards.
tent that such other impurities may be (d) Labeling requirements. (1) The label
avoided by good manufacturing prac- of the color additive and any mixtures
tice: intended solely or in part for coloring
485
§ 74.706 21 CFR Ch. I (4–1–18 Edition)
purposes prepared therefrom shall con- Sum of volatile matter (at 135 °C) and
form to the requirements of § 70.25 of chlorides and sulfates (calculated as so-
this chapter. dium salts), not more than 13 percent.
Water insoluble matter, not more than 0.2
(2) Foods for human use that contain percent.
FD&C Yellow No. 5, including butter, Sodium salt of 4-aminobenzenesulfonic acid,
cheese, and ice cream, shall specifi- not more than 0.2 percent.
cally declare the presence of FD&C Sodium salt of 6-hydroxy-2-
Yellow No. 5 by listing the color addi- naphthalenesulfonic acid, not more than
tive as FD&C Yellow No. 5 among the 0.3 percent.
list of ingredients. Disodium salt of 6,6′-oxybis[2-
(e) Certification. All batches of FD&C naphthalenesulfonic acid], not more than 1
percent.
Yellow No. 5 shall be certified in ac-
Disodium salt of 4,4′-(1-triazene-1,3-
cordance with regulations in part 80 of diyl)bis[benzenesulfonic acid], not more
this chapter. than 0.1 percent.
Sum of the sodium salt of 6-hydroxy-5-
[42 FR 15654, Mar. 22, 1977; 44 FR 17658, Mar.
(phenylazo)-2-naphthalenesulfonic acid and
23, 1979, as amended at 44 FR 37220, June 26,
the sodium salt of 4-[(2-hydroxy-1-
1979; 51 FR 24519, July 7, 1986]
naphthalenyl)azo]benzenesulfonic acid, not
more than 1 percent.
§ 74.706 FD&C Yellow No. 6. Sum of the trisodium salt of 3-hydroxy-4-[(4-
(a) Identity. (1) The color additive sulfophenyl)azo]-2,7-naphthalenedisulfonic
FD&C Yellow No. 6 is principally the acid and other higher sulfonated subsidi-
disodium salt of 6-hydroxy-5-[(4- aries, not more than 5 percent.
sulfophenyl)azo]-2-naphthalenesulfonic
per billion.
acid (CAS Reg. No. 2783–94–0). The tri- 4-Aminobiphenyl, not more than 15 parts per
sodium salt of 3-hydroxy-4-[(4- billion.
sulfophenyl)azo]-2,7- Aniline, not more than 250 parts per billion.
naphthalenedisulfonic acid (CAS Reg. Azobenzene, not more than 200 parts per bil-
No. 50880–65–4) may be added in small lion.
amounts. The color additive is manu- Benzidine, not more than 1 part per billion.
factured by diazotizing 4- 1,3-Diphenyltriazene, not more than 40 parts
aminobenzenesulfonic acid using hyper billion.
drochloric acid and sodium nitrite or 1-(Phenylazo)-2-naphthalenol, not more than
10 parts per million.
sulfuric acid and sodium nitrite. The
diazo compound is coupled with 6-hy- lion.
droxy-2-naphthalene-sulfonic acid. The Arsenic (as As), not more than 3 parts per
dye is isolated as the sodium salt and million.
dried. The trisodium salt of 3-hydroxy- Mercury (as Hg), not more than 1 part per
4-[(4-sulfophenyl)azo]-2,7- million.
naphthalenedisulfonic acid which may Total color, not less than 87 percent.
be blended with the principal color is (c) Uses and restrictions. The color ad-
prepared in the same manner except ditive FD&C Yellow No. 6 may be safe-
the diazo benzenesulfonic acid is cou- ly used for coloring foods (including di-
pled with 3-hydroxy-2,7- etary supplements) generally in
naphthalenedisulfonic acid. amounts consistent with current good
(2) Color additive mixtures for food manufacturing practice, except that it
use made with FD&C Yellow No. 6 may may not be used to color foods for
contain only those diluents that are which standards of identity have been
suitable and that are listed in part 73 promulgated under section 401 of the
of this chapter as safe for use in color act unless added color is authorized by
additive mixtures for coloring foods. such standards.
(b) Specifications. The color additive (d) Labeling requirements. (1) The label
FD&C Yellow No. 6 shall conform to of the color additive and any mixtures
the following specifications and shall intended solely or in part for coloring
be free from impurities other than purposes prepared therefrom shall con-
those named to the extent that such form to the requirements of § 70.25 of
other impurities may be avoided by this chapter.
current good manufacturing practice: (2) [Reserved]
486
(e) Certification. All batches of FD&C ance with regulations in part 80 of this
Yellow No. 6 shall be certified in ac- chapter.
cordance with regulations in part 80 of
[47 FR 42565, Sept. 28, 1982, as amended at 59
this chapter. FR 7638, Feb. 16, 1994]
[51 FR 41782, Nov. 19, 1986, as amended at 52
FR 21508, June 8, 1987; 53 FR 49138, Dec. 6, § 74.1102 FD&C Blue No. 2.
1988] (a) Identity. (1) The color additive
FD&C Blue No. 2 shall conform in iden-
Subpart B—Drugs tity to the requirements of
§ 74.102(a)(1).
§ 74.1101 FD&C Blue No. 1 (2) Color additive mixtures for use in
(a) Identity. (1) For ingested drugs, ingested drugs made with FD&C Blue
the color additive FD&C Blue No. 1 No. 2 may contain only those diluents
shall conform in identity to the re- that are suitable and that are listed in
quirements of § 74.101(a)(1). part 73 of this chapter as safe for use in
color additive mixtures for coloring
(2) For externally applied drugs, the
drugs.
color additive FD&C Blue No. 1 shall
conform in identity to the require- (b) The color additive FD&C Blue No.
2 for use in coloring ingested drugs
ments of § 74.2101(a).
shall conform to the specifications in
(3) Color additive mixtures for drug § 74.102(b).
use made with FD&C Blue No. 1 may
(c) The color additive FD&C Blue No.
contain only those diluents that are 2 may be safely used for coloring in-
suitable and that are listed in part 73 gested drugs in amounts consistent
of this chapter as safe for use in color with current good manufacturing prac-
additive mixtures for coloring drugs. tice.
(b) Specifications. (1) The color addi- (d) Labeling. The label of the color ad-
tive FD&C Blue No. 1 for use in color- ditive and any mixtures prepared
ing drugs generally shall conform in therefrom intended solely or in part for
specifications to the requirements of coloring purposes shall conform to the
§ 74.101(b). requirements of § 70.25 of this chapter.
(2) FD&C Blue No. 1 Aluminum Lake (e) Certification. All batches of FD&C
shall be prepared in accordance with Blue No. 2 shall be certified in accord-
the requirements of § 82.51 of this chap- ance with regulations in part 80 of this
ter. chapter.
(c) Uses and restrictions. (1) FD&C [48 FR 5260, Feb. 4, 1983, as amended at 49 FR
Blue No. 1 may be safely used for color- 10090, Mar. 19, 1984; 64 FR 48290, Sept. 3, 1999]
ing drugs, including drugs intended for
use in the area of the eye, in amounts § 74.1104 D&C Blue No. 4.
consistent with current good manufac- (a) Identity. (1) The color additive
turing practice. D&C Blue No. 4 is principally the
(2) FD&C Blue No. 1 Aluminum Lake diammonium salt of ethyl[4-[p[ethyl(m-
may be safely used for coloring drugs sulfobenzyl)ami-no]-a-(o-
intended for use in the area of the eye, sulfophenyl)benzylidene]-2,5-cyclo-
in amounts consistent with current hexadien-1-ylidene] (m- sulfobenzyl)
good manufacturing practice, subject ammonium hydroxide inner salt with
to the restrictions on the use of color smaller amounts of the isomeric
additives in § 70.5(b) and (c) of this diammonium salts of ethyl [4-[p-
chapter. [ethyl(p- sulfobenzyl) amino]-a-(o-
(d) Labeling. The label of the color ad- sulfophenyl) benzylidene]-2,5-
ditive and any mixtures prepared cyclohexadien - 1-ylidene](p-
therefrom intended solely or in part for sulfobenzyl) ammonium hydroxide
coloring purposes shall conform to the inner salt and ethyl[4-[p-[ethyl (o-
requirements of § 70.25 of this chapter. sulfobenzyl)amino]-a-(o- sulfophenyl)
(e) Certification. All batches of FD&C benzylidene]-2,5-cyclohexadien-1-

Blue No. 1 shall be certified in accord- ylidene] (o- sulfobenzyl) ammonium
hydroxide inner salt.
487
§ 74.1109 21 CFR Ch. I (4–1–18 Edition)
(2) Color additive mixtures for use in Volatile matter (at 135 °C.), not more than 3
externally applied drugs made with percent.
D&C Blue No. 4 may contain only those Matter extractable by alcoholic HCl (0.1 ml
of concentrated hydrochloric acid per 50 ml
diluents that are suitable and that are
of 95 percent ethyl alcohol), not more than
listed in part 73 of this chapter for use 1 percent.
in color additive mixtures for coloring 2-Amino anthraquinone, not more than 0.2
externally applied drugs. percent.
(b) Specifications. D&C Blue No. 4 Organically combined chlorine in pure dye,
shall conform to the following speci- 13.0–14.8 percent.
fications and shall be free from impuri- Lead (as Pb), not more than 20 p/m.
ties other than those named to the ex- Arsenic (as As), not more than 3 p/m.
tent that such impurities may be Total color, not less than 97 percent.
avoided by good manufacturing prac- (c) Uses and restrictions. D&C Blue No.
tice: 9 may be safely used for coloring cot-
Sum of volatile matter (at 135 °C) and ton and silk surgical sutures, including
chlorides and sulfates (calculated as so- sutures for ophthalmic use, subject to
dium salts), not more than 15 percent. the following restrictions:
Water-insoluble matter, not more than 0.2 (1) The dyed suture shall conform in
percent. all respects to the requirements of the
Leuco base, not more than 5 percent.
United States Pharmacopeia XX (1980).
Sum of o-, m, and p- sulfobenzaldehydes, am-
monium salt, not more than 1.5 percent. (2) The quantity of the color additive
N-ethyl, N-(m- sulfobenzyl) sulfanilic acid does not exceed 2.5 percent by weight
ammonium salt, not more than 0.3 percent. of the suture.
Subsidiary colors, not more than 6 percent. (3) When the sutures are used for the
Chromium (as Cr), not more than 50 parts purposes specified in their labeling, the
per million. color additive does not migrate to the
Lead (as Pb), not more than 20 parts per mil- surrounding tissue.
lion.
(4) If the suture is a new drug, a new-
million. drug application approved pursuant to
Mercury (as Hg), not more than 1 part per section 505 of the act is in effect for it.
million. (d) Labeling. The label of the color ad-
Total color, not less than 85 percent. ditive shall conform to the require-
(c) Uses and restrictions. D&C Blue No. ments of § 70.25 of this chapter.
4 may be safely used in externally ap- (e) Certification. All batches of D&C
plied drugs in amounts consistent with Blue No. 9 shall be certified in accord-
good manufacturing practice. ance with regulations in part 80 of this
(d) Labeling. The label of the color ad- chapter.
ditive and any mixtures prepared [42 FR 15654, Mar. 22, 1977, as amended at 49
therefrom intended solely or in part for FR 10090, Mar. 19, 1984; 58 FR 17098, Apr. 1,
coloring purposes shall conform to the 1993]
(e) Certification. All batches of D&C § 74.1203 FD&C Green No. 3.
Blue No. 4 shall be certified in accord- (a) Identity and specifications. (1) The
ance with regulations in part 80 of this color additive FD&C Green No. 3 shall
chapter. conform in identity and specifications
to the requirements of § 74.203(a)(1) and
§ 74.1109 D&C Blue No. 9. (b).
(a) Identity. The color additive D&C (2) Color additive mixtures for drug
Blue No. 9 is principally 7,16-dichloro- use made with FD&C Green No. 3 may
6,15 - dihydro - 5,9,14,18 - anthrazine- contain only those diluents that are
tetrone. suitable and that are listed in part 73
(b) Specifications. D&C Blue No. 9 of this chapter as safe for use in color
shall conform to the following speci- additive mixtures for coloring drugs.
fications and shall be free from impuri- (b) Uses and restrictions. The color ad-
ties other than those named to the ex- ditive FD&C Green No. 3 may be safely
tent that such impurities may be used for coloring drugs generally in
avoided by good manufacturing prac- amounts consistent with current good
tice: manufacturing practice.
488
(c) Labeling. The label of the color ad- 1,4-Dihydroxyanthraquinone, not more than
ditive and any mixtures prepared 0.2 percent.
therefrom intended solely or in part for Sulfonated toluidines, total not more than
0.2 percent.
coloring purposes shall conform to the p-Toluidine, not more than 0.0015 percent.
requirements of § 70.25 of this chapter. Sum of monosulfonated D&C Green No. 6 and
(d) Certification. All batches of FD&C Ext. D&C Violet No. 2, not more than 3 per-
Green No. 3 shall be certified in accord- cent.
ance with regulations in part 80 of this Lead (as Pb), not more than 20 parts per mil-
chapter. lion.
[47 FR 52144, Nov. 19, 1982] million.
Mercury (as Hg), not more than 1 part per
§ 74.1205 D&C Green No. 5. million.
(a) Identity. (1) The color additive Total color, not less than 80 percent.
D&C Green No. 5 is principally the di- (c) Use and restrictions. (1) D&C Green
sodium salt of 2,2′-[(9,10-dihydro-9,10- No. 5 may be safely used to color nylon
dioxo-1,4-anthracenediyl)diimino]bis- 66 (the copolymer of adipic acid and
[5-methylbenzenesulfonic acid] (CAS hexamethylenediamine) and/or nylon
Reg. No. 4403–90–1). 6[poly-(e-caprolactam)]nonabsorbable
(2) Color additive mixtures for use in surgical sutures for use in general sur-
drugs made with D&C Green No. 5 may gery, subject to the following restric-
contain only those diluents that are tions:
suitable and those that are listed in (i) The quantity of color additive
part 73 of this chapter for use in color does not exceed 0.6 percent by weight
additive mixtures for coloring drugs. of the suture.
(b) Specifications. (1) D&C Green No. 5 (ii) When the sutures are used for the
for use in coloring surgical sutures purposes specified in their labeling,
shall conform to the following speci- there is no migration of the color addi-
fications and shall be free from impuri- tive to the surrounding tissue.
ties other than those named to the ex- (iii) If the suture is a new drug, an
tent that such impurities may be approved new drug application, under
avoided by current good manufacturing section 505 of the act, is in effect for it.
practice: (2) D&C Green No. 5 may be safely
Sum of volatile matter (at 135 °C) and
used for coloring drugs generally, in-
chlorides and sulfates (calculated as so- cluding drugs intended for use in the
dium salts), not more than 20 percent. area of the eye, in amounts consistent
Water insoluble matter, not more than 0.2 with current good manufacturing prac-
percent. tice.
1,4-Dihydroxyanthraquinone, not more than (d) Labeling. The label of the color ad-
0.2 percent. ditive shall conform to the require-
2-Amino-m-toluenesulfonic acid, not more ments of § 70.25 of this chapter.
than 0.2 percent.
(e) Certification. All batches of D&C
Lead (as Pb), not more than 10 parts per mil- Green No. 5 shall be certified in accord-
lion. ance with regulations in part 80 of this
Arsenic (as As), not more than 3 parts per chapter.
million.
[47 FR 24284, June 4, 1982; 47 FR 27551, June
Total color, not less than 80 percent.
25, 1982, as amended at 59 FR 40805, Aug. 10,
(2) D&C Green No. 5 for use in color- 1994]
ing drugs shall conform to the fol-
lowing specifications and shall be free § 74.1206 D&C Green No. 6.
from impurities other than those (a) Identity. The color additive D&C
named to the extent that such other Green No. 6 is 1,4-bis[(4-
impurities may be avoided by current methylphenyl)amino]-9,10-
good manufacturing practice: anthracenedione (CAS. Reg. No. 128–80–
3).
(b) Specifications. The color additive

dium salts), not more than 20 percent. D&C Green No. 6 for use in coloring ex-
Water-insoluble matter, not more than 0.2 ternally applied drugs shall conform to
percent. the following specifications and shall
489
§ 74.1208 21 CFR Ch. I (4–1–18 Edition)
be free from impurities other than Water-insoluble matter, not more than 0.2
those named to the extent that such percent.
other impurities may be avoided by Chlorides and sulfates (calculated as sodium
current good manufacturing practice: salt), not more than 20 percent.
The trisodium salt of 1,3,6-pyrenetrisulfonic
Volatile matter (at 135 °C), not more than 2.0 acid, not more than 6 percent.
percent. The tetrasodium salt of 1,3,6,8-
Water-soluble matter, not more than 0.3 per- pyrenetetrasulfonic acid, not more than 1
cent. percent.
Matter insoluble in carbon tetrachloride, not Pyrene, not more than 0.2 percent.
more than 1.5 percent. Lead (as Pb), not more than 20 parts per mil-
p-Toluidine, not more than 0.1 percent. lion.
1,4-Dihydroxyanthraquinone, not more than Arsenic (as As), not more than 3 parts per
0.2 percent. million.
1-Hydroxy-4-[(4-methylphenyl)amino]-9, 10-
anthracenedione, not more than 5.0 per-
million.
cent.
Lead (as Pb), not more than 20 parts per mil- Total color, not less than 65 percent.
lion. (c) Uses and restrictions. D&C Green
Arsenic (as As), not more than 3 parts per No. 8 may be safely used in externally
million.
applied drugs in amounts not exceeding
million. 0.01 percent by weight of the finished
Total color, not less than 96.0 percent. product.
(d) Labeling. The label of the color ad-
ditive and any mixtures prepared
ditive D&C Green No. 6 may be safely
therefrom intended solely or in part for
used for coloring externally applied
coloring purposes shall conform to the
drugs in amounts consistent with cur-
rent good manufacturing practice.
Green No. 8 shall be certified in accord-
ments of § 70.25 of this chapter.
(e) Certification. All batches of D&C chapter.
Green No. 6 shall be certified in accord- § 74.1254 D&C Orange No. 4.
ance with regulations promulgated
under part 80 of this chapter. (a) Identity. (1) the color additive
D&C Orange No. 4 is principally the so-
[42 FR 15654, Mar. 22, 1977, as amended at 47 dium salt of 4-[(2-hydroxy-1-
FR 14146, Apr. 2, 1982; 47 FR 24278, June 4,
naphthalenyl)azo]benzenesulfonic acid.
1982; 51 FR 9784, Mar. 21, 1986]
(2) Color additive mixtures for use in
§ 74.1208 D&C Green No. 8. externally applied drugs made with
D&C Orange No. 4 may contain only
those diluents that are suitable and
D&C Green No. 8 is principally the tri-
that are listed in part 73 of this chapter
sodium salt of 8-hydroxy-1,3,6-pyrene-
for use in color additive mixtures for
trisulfonic acid.
coloring externally applied drugs.
(2) Color additive mixtures for use in
externally applied drugs made with (b) Specifications. D&C Orange No. 4
D&C Green No. 8 may contain only shall conform to the following speci-
those diluents that are suitable and fications and shall be free from impuri-
that are listed in part 73 of this chapter ties other than those named to the ex-
for use in color additive mixtures for tent that such impurities may be
coloring externally applied drugs. avoided by good manufacturing prac-
(b) Specifications. D&C Green No. 8 tice.
shall conform to the following speci- Sum of volatile matter (at 135 °C) and
fications and shall be free from impuri- chlorides and sulfates (calculated as so-
ties other than those named to the ex- dium salts), not more than 13 percent.
tent that such impurities may be Water-insoluble matter, not more than 0.2
avoided by good manufacturing prac- percent.
2-Naphthol, not more than 0.4 percent.
tices:
Sulfanilic acid, sodium salt, not more than
Volatile matter (at 135 °C), not more than 15 0.2 percent.
percent. Subsidiary colors, not more than 3 percent.
490
4,4′-(Diazoamino)-dibenzenesulfonic acid, not 2′,4′,5′-tribromofluorescein, not less than 30
more than 0.1 percent. percent and not more than 40 percent.
Lead (as Pb), not more than 20 parts per mil- 2′,4′,5′,7′-tetrabromofluorescein, not more
lion. than 10 percent.
Arsenic (as As), not more than 3 parts per Sum of 2′,4′-dibromofluorescein and 2′,5′-
million. dibromofluorescein, not more than 2 per-
Mercury (as Hg), not more than 1 part per cent.
million. 4′–Bromofluorescein, not more than 2 per-
Total color, not less than 87 percent. cent.
Fluorescein, not more than 1 percent.
(c) Uses and restrictions. D&C Orange Phthalic acid, not more than 1 percent.
No. 4 may be safely used for coloring 2-(3,5-Dibromo-2,4-dihydroxybenzoyl) benzoic
externally applied drugs in amounts acid, not more than 0.5 percent.
consistent with good manufacturing Brominated resorcinol, not more than 0.4
practice. percent.
Sum of volatile matter (at 135 °C) and halides
(d) Labeling. The label of the color ad- and sulfates (calculated as sodium salts),
ditive and any mixtures prepared not more than 10 percent.
therefrom intended solely or in part for Insoluble matter (alkaline solution), not
coloring purposes shall conform to the more than 0.3 percent.
requirements of § 70.25 of this chapter. Lead (as Pb), not more than 20 parts per mil-
(e) Certification. All batches of D&C lion.
Orange No. 4 shall be certified in ac- Arsenic (as As), not more than 3 parts per
million.
cordance with regulations in part 80 of Mercury (as Hg), not more than 1 part per
this chapter. million.
[42 FR 52396, Sept. 30, 1977, as amended at 43 Total color, not less than 90 percent.
FR 14642, Apr. 7, 1978; 46 FR 8461, Jan. 27, (c) Uses and restrictions. D&C Orange
1981] No. 5 may be safely used for coloring
mouthwashes and dentifrices that are
§ 74.1255 D&C Orange No. 5.
ingested drugs in amounts consistent
(a) Identity. (1) the color additive with current good manufacturing prac-
D&C Orange No. 5 is a mixture con- tice. D&C Orange No. 5 may be safely
sisting principally the sodium salt of used in externally applied drugs in
4′,5′-dibromofluorescein (CAS Reg. No. amounts not exceeding 5 milligrams
596–03–2) and 2′,4′,5′-tribromofluorescein per daily dose of the drug.
(CAS Reg. No. 25709–83–5) and 2′,4′,5′,7′- (d) Labeling. The label of the color ad-
tetrabromofluorescein (CAS Reg. No. ditive and any mixtures prepared
15086–94–9). D&C Orange No. 5 is manu- therefrom intended solely or in part for
factured by brominating fluorescein coloring purposes shall conform to the
with elemental bromine. The fluores- requirements of § 70.25 of this chapter.
cein is manufactured by the acid con- (e) Certification. All batches of D&C
densation of resorcinol and phthalic Orange No. 5 shall be certified in ac-
acid or its anhydride. The fluorescein cordance with regulations in part 80 of
is isolated and partially purified prior this chapter.
to bromination.
[47 FR 44635, Nov. 2, 1982, as amended at 49
(2) Color additive mixtures for drug FR 13342, Apr. 4, 1984]
use made with D&C Orange No. 5 may
contain only those diluents that are § 74.1260 D&C Orange No. 10.
suitable and that are listed in part 73
of this chapter for use in color additive
D&C Orange No. 10 is a mixture con-
mixtures for coloring drugs.
sisting principally of 4′,5′-
(b) Specifications. D&C Orange No. 5 diiodofluorescein, 2′,4′,5′-
shall conform to the following speci- triiodofluorescein, and 2′,4′,5′,7′-
fications and shall be free from impuri- tetraiodofluorescein.
ties other than those named to the ex- (2) Color additive mixtures for drug
tent that such impurities may be use made with D&C Orange No. 10 may
avoided by good manufacturing prac- contain only those diluents listed in
tice. this subpart as safe and suitable for use

4′,5′-dibromofluorescein, not less than 50 per- in color additive mixtures for coloring
cent and not more than 65 percent. externally applied drugs.
491
§ 74.1261 21 CFR Ch. I (4–1–18 Edition)
(b) Specifications. D&C Orange No. 10 in color additive mixtures for coloring
shall conform to the following speci- externally applied drugs.
fications and shall be free from impuri- (b) Specifications. The color additive
ties other than those named to the ex- D&C Orange No. 11 shall conform to
tent that such other impurities may be the following specifications and shall
avoided by good manufacturing prac- be free from impurities other than
tice: those named to the extent that such
impurities may be avoided by good
and sulfates (calculated as sodium salts), manufacturing practice:
not more than 8 percent. Sum of volatile matter (at 135 °C) and halides
Insoluble matter (alkaline solution), not and sulfates (calculated as sodium salts),
more than 0.5 percent. not more than 8 percent.
Phthalic acid, not more than 0.5 percent. Water-insoluble matter, not more than 0.5
2-[3′,5′-Diiodo-2′,4′-dihydroxybenzoyl] benzoic percent.
acid, not more than 0.5 percent. Phthalic acid, not more than 0.5 percent.
Fluorescein, not more than 1 percent. 2-[3′,5′-Diiodo-2′,4′-dihydroxybenzoyl] benzoic
4′-Iodofluorescein, not more than 3 percent. acid, sodium salt, not more than 0.5 per-
2′,4′-Diiodofluorescein and 2′,5′- cent.
diiodofluorescein, not more than 2 percent. Fluorescein, disodium salt, not more than 1
2′,4′,5′-Triiodofluorescein, not more than 35 percent.
percent. 4′-Iodofluorescein, disodium salt, not more
2′,4′,5′,7′-Tetraiodofluorescein, not more than than 3 percent.
10 percent. 2′,4′-Diiodofluorescein and 2′,5′-
4′,5′-Diiodofluorescein, not less than 60 per- diiodofluorescein, not more than 2 percent.
cent and not more than 95 percent. 2′,4′,5′-Triiodofluorescein, not more than 35
lion. 2′,4′,5′,7′-Tetraiodofluorescein, disodium salt,
Arsenic (as As), not more than 3 parts per not more than 10 percent.
million. 4′,5′-Diiodofluorescein, disodium salt, not
Mercury (as Hg), not more than 1 part per less than 60 percent and not more than 95
million. percent.
Total color, not less than 92 percent. Lead (as Pb), not more than 20 parts per mil-
lion.
(c) Uses and restrictions. D&C Orange Arsenic (as As), not more than 3 parts per
No. 10 may be safely used for coloring million.
externally applied drugs in amounts Mercury (as Hg), not more than 1 part per
consistent with good manufacturing million.
practice. Total color, not less than 92 percent.
(d) Labeling requirements. The label of (c) Uses and restrictions. D&C Orange
the color additive and any mixtures No. 11 may be safely used for coloring
prepared therefrom intended solely or externally applied drugs in amounts
in part for coloring purposes shall con- consistent with good manufacturing
form to the requirements of § 70.25 of practice.
this chapter. (d) Labeling requirements. The label of
(e) Certification. All batches of D&C the color additive and any mixtures
Orange No. 10 shall be certified in ac- prepared therefrom intended solely or
cordance with regulations in part 80 of in part for coloring purposes shall con-
this chapter. form to the requirements of § 70.25 of
[46 FR 18953, Mar. 27, 1981] this chapter.
§ 74.1261 D&C Orange No. 11. Orange No. 11 shall be certified in ac-
this chapter.
D&C Orange No. 11 is a mixture con-
sisting principally of the disodium [46 FR 18953, Mar. 27, 1981]
salts of 4′,5′-diiodofluorescein, 2′,4′,5′-
triiodofluorescein and 2′,4′,5′,7′- § 74.1303 FD&C Red No. 3.
tetraiodofluorescein. (a) Identity and specifications. (1) The
(2) Color additive mixtures for drug color additive FD&C Red No. 3 shall
use made with D&C Orange No. 11 may conform in identity and specifications
contain only those diluents listed in to the requirements of § 74.303(a)(1) and
this subpart as safe and suitable for use (b).
492
(2) Color additive mixtures for in- applied drugs in amounts consistent
gested drug used made with FD&C Red with good manufacturing practice.
No. 3 may contain only those diluents (d) Labeling. The label of the color ad-
that are suitable and that are listed in ditive and any mixtures prepared
part 73 of this chapter as safe for use in therefrom intended solely or in part for
color additive mixtures for coloring in- coloring purposes shall conform to the
gested drugs. requirements of § 70.25 of this chapter.
(b) Uses and restrictions. FD&C Red (e) Certification. All batches of FD&C
No. 3 may be safely used for coloring Red No. 4 shall be certified in accord-
ingested drugs in amounts consistent ance with regulations in part 80 of this
with good manufacturing practice. chapter.
ditive and any mixtures prepared § 74.1306 D&C Red No. 6.
therefrom intended solely or in part for (a) Identity. (1) The color additive
coloring purposes shall conform to the D&C Red No. 6 is principally the diso-
requirements of § 70.25 of this chapter. dium salt of 3-hydroxy-4-[(4-methyl-2-
(d) Certification. All batches of FD&C sulfophenyl)azo]-2-
Red No. 3 shall be certified in accord- naphthalenecarboxylic acid (CAS Reg.
ance with regulations in part 80 of this No. 5858–81–1). To manufacture the ad-
chapter. ditive, 2-amino-5-
methylbenzenesulfonic acid is
§ 74.1304 FD&C Red No. 4. diazotized with hydrochloric acid and
(a) Identity. (1) The color additive sodium nitrite. The diazo compound is
FD&C Red No. 4 is principally the diso- coupled in alkaline medium with 3-hy-
dium salt of 3-[(2,4-dimethyl-5- droxy-2-naphthalenecarboxylic acid.
sulfophenyl)azo] -4-hydroxy-1- The resulting dye precipitates as the
naphthalenesulfonic acid. disodium salt.
(2) Color additive mixtures for use in (2) Color additive mixtures for drug
externally applied drugs made with use made with D&C Red No. 6 may con-
FD&C Red No. 4 may contain only tain only those diluents that are suit-
those diluents that are suitable and able and that are listed in part 73 of
that are listed in part 73 of this chapter this chapter as safe for use in color ad-
for use in color additive mixtures for ditive mixtures for coloring drugs.
coloring externally applied drugs. (b) Specifications. The color additive
(b) Specifications. FD&C Red No. 4 D&C Red No. 6 shall conform to the fol-
shall conform to the following speci- lowing specifications and shall be free
fications and shall be free from impuri- from impurities other than those
ties other than those named to the ex- named to the extent that such impuri-
tent that such impurities may be ties may be avoided by current good
avoided by good manufacturing prac- manufacturing practice:
tice: Sum of volatile matter (at 135 °C) and
Sum of volatile matter (at 135 °C.) and chlorides and sulfates (calculated as so-
chlorides and sulfates (calculated as sodium salts), not more than 10 percent.
dium salts), not more than 13 percent. 1-[(4-methylphenyl)azo]-2-naphthalenol, not
Water-insoluble matter, not more than 0.2 more than 0.015 percent.
percent. 2-Amino-5-methylbenzenesulfonic acid, so-
5-Amino-2,4-dimethyl-1-benzenesulfonic acid, dium salt, not more than 0.2 percent.
sodium salt, not more than 0.2 percent. 3-Hydroxy-2-naphthalenecarboxylic acid, so-
4-Hydroxy-1-naphthalenesulfonic acid, sodium salt, not more than 0.4 percent.
dium salt, not more than 0.2 percent. 3-Hydroxy-4-[(4-methylphenyl)azo]-2-
Subsidiary colors, not more than 2 percent. naphthalenecarboxylic acid, sodium salt,
Lead (as Pb), not more than 10 parts per mil- not more than 0.5 percent.
lion. p- Toluidine, not more than 15 parts per mil-
Arsenic (as As), not more than 3 parts per lion.
million. Lead (as Pb), not more than 20 parts per mil-
Mercury (as Hg), not more than 1 part per lion.
million. Arsenic (as As), not more than 3 parts per
Total color, not less than 87 percent. million.

(c) Uses and restrictions. FD&C Red million.
No. 4 may be safely used in externally Total color, not less than 90 percent.
493
§ 74.1307 21 CFR Ch. I (4–1–18 Edition)
(c) Uses and restrictions. The color ad- Lead (as Pb), not more than 20 parts per mil-
ditive D&C Red No. 6 may be safely lion.
used for coloring drugs such that the Arsenic (as As), not more than 3 parts per
million.
combined total of D&C Red No. 6 and Mercury (as Hg), not more than 1 part per
D&C Red No. 7 does not exceed 5 milli- million.
grams per daily dose of the drug. Total color, not less than 90 percent.
ditive and any mixtures prepared (c) Uses and restrictions. The color ad-
therefrom intended solely or in part for ditive D&C Red No. 7 may be safely
coloring purposes shall conform to the used for coloring drugs such that the
requirements of § 70.25 of this chapter. combined total of D&C Red No. 6 and
(e) Certification. All batches of D&C D&C Red No. 7 does not exceed 5 milli-
Red No. 6 shall be certified in accord- grams per daily dose of the drug.
ance with regulations in part 80 of this (d) Labeling. The label of the color ad-
chapter. ditive and any mixtures prepared
[47 FR 57687, Dec. 28, 1982, as amended at 77 coloring purposes shall conform to the
FR 39923, July 6, 2012] requirements of § 70.25 of this chapter.
§ 74.1307 D&C Red No. 7.
Red No. 7 shall be certified in accord-
(a) Identity. (1) The color additive ance with regulations in part 80 of this
D&C Red No. 7 is principally the cal- chapter.
cium salt of 3-hydroxy-4-[(4-methyl-2-
sulfophenyl)azo]-2- [47 FR 57687, Dec. 28, 1982, as amended at 77
FR 39923, July 6, 2012]
naphthalenecarboxylic acid (CAS Reg.
No. 5281–04–9). To manufacture the ad- § 74.1317 D&C Red No. 17.
ditive, 2-amino-5-
methylbenzenesulfonic acid is (a) Identity. (1) The color additive
D&C Red No. 17 is principally 1-[[4-
diazotized with hydrochloric acid and
(phenylazo)phenyl]azo]-2-naphthalenol.
sodium nitrite. The diazo compound is
(2) Color additive mixtures for drug
coupled in alkaline medium with 3-hy-
use made with D&C Red No. 17 may
droxy-2-naphthalenecarboxylic acid
contain only those diluents that are
and the resulting dye converted to the
calcium salt with calcium chloride.
of this chapter as safe for use in color
additive mixtures for coloring exter-
use made with D&C Red No. 7 may con-
nally applied drugs.
(b) Specifications. D&C Red No. 17
able and that are listed in part 73 of
shall conform to the following speci-
fications and shall be free from impuri-
ditive mixtures for coloring drugs.
ties, other than those named, to the ex-
tent that such other impurities may be
D&C Red No. 7 shall conform to the fol-
avoided by good manufacturing prac-
lowing specifications and shall be free
tice:
from impurities other than those
named to the extent that such impuri- Volatile matter (at 135 °C), not more than 5
ties may be avoided by current good percent.
manufacturing practice: Matter insoluble in both toluene and water
(color additive mixed in toluene and the
Sum of volatile matter (at 135 °C) and resultant residue isolated and mixed with
chlorides and sulfates (calculated as so- water to obtain the matter insoluble in
dium salts), not more than 10 percent. both toluene and water), not more than 0.5
1-[(4-methylphenyl)azo]-2-naphthalenol, not percent.
more than 0.015 percent. Chlorides and sulfates (calculated as sodium
2-Amino-5-methylbenzenesulfonic acid, cal- salts), not more than 3 percent.
cium salt, not more than 0.2 percent. Aniline, not more than 0.2 percent.
3-Hydroxy-2-naphthalenecarboxylic acid, cal- 4-Aminoazobenzene, not more than 0.1 per-
cium salt, not more than 0.4 percent. cent.
3-Hydroxy-4-[(4-methylphenyl)azo]-2- 2-Naphthol, not more than 0.2 percent.
naphthalenecarboxylic acid, calcium salt, 1-(Phenylazo)-2-naphthol, not more than 3

not more than 0.5 percent. percent.
p-Toluidine, not more than 15 parts per mil- 1-[[2-(phenylazo) phenyl]azo]-2-naphthalenol,
lion. not more than 2 percent.
494
Lead (as Pb), not more than 20 parts per mil- 2′,4′,5′,7′-Tetrabromofluorescein, ethyl ester,
lion. not more than 1 percent.
Arsenic (as As), not more than 3 parts per Brominated resorcinol, not more than 0.4
million. percent.
Mercury (as Hg), not more than 1 part per Fluorescein, not more than 0.2 percent.
million. Sum of mono- and dibromofluoresceins, not
Total color, not less than 90 percent. more than 2 percent.
(c) Uses and restrictions. D&C Red No. Tribromofluoresceins, not more than 11 per-
17 may be safely used in externally ap- cent.
plied drugs in amounts consistent with 2′,4′,5′,7′-Tetrabromofluorescein, not less
than 87 percent.
good manufacturing practice.
lion.
ditive and any mixtures prepared Arsenic (as As), not more than 3 parts per
therefrom intended solely or in part for million.
coloring purposes shall conform to the Mercury (as Hg), not more than 1 part per
requirements of § 70.25 of this chapter. million.
(e) Certification. All batches of D&C Total color, not less than 90 percent.
ance with regulations in part 80 of this (c) Uses and restrictions. The color ad-
chapter. ditive D&C Red No. 21 may be safely
used for coloring drugs generally in
[42 FR 15654, Mar. 22, 1977, as amended at 42 amounts consistent with current good
FR 27225, May 27, 1977]
manufacturing practice.
§ 74.1321 D&C Red No. 21. (d) Labeling. The label of the color ad-
(a) Identity. (1) The color additive therefrom intended solely or in part for
D&C Red No. 21 is principally 2′,4′,5′,7′- coloring purposes shall conform to the
tetrabromofluorescein (CAS Reg. No. requirements of § 70.25 of this chapter.
15086–94–9), and may contain smaller
amounts of 2′,4′,5′-tribromofluorescein
(CAS Reg. No. 25709–83–5) and 2′,4′,7′-
tribromofluorescein (CAS Reg. No.
chapter.
25709–84–6). The color additive is manu-
factured by brominating fluorescein [47 FR 53846, Nov. 30, 1982]
with elemental bromine. The fluores-
cein is manufactured by the acid con- § 74.1322 D&C Red No. 22.
densation of resorcinol and phthalic (a) Identity. (1) The color additive
acid or its anhydride. The fluorescein D&C Red No. 22 is principally the diso-
is isolated and partially purified prior dium salt of 2′,4′,5′7′-
to bromination. tetrabromofluorescein (CAS Reg. No.
(2) Color additive mixtures for drug 17372–87–1) and may contain smaller
use made with D&C Red No. 21 may amounts of the disodium salts of 2′,4′,5′-
contain only those diluents that are tribromofluorescein and 2′,4′,7′-
suitable and that are listed in part 73 tribromofluorescein. The color additive
of this chapter as safe for use in color is manufactured by alkaline hydrolysis
additive mixtures for coloring drugs. of 2′,4′,5′,7′-tetrabromofluorescein.
2′,4′,5′,7′-Tetrabromofluorescein is man-
D&C Red No. 21 shall conform to the
ufactured by brominating fluorescein
following specifications and shall be
with elemental bromine. The fluores-
free from impurities other than those
cein is manufactured by the acid con-
named to the extent that such impuri-
densation of resorcinol and phthalic
ties may be avoided by current good
acid or its anhydride. Fluorescein is
manufacturing practice:
isolated and partially purified prior to
Sum of volatile matter (at 135 °C) and halides bromination.
and sulfates (calculated as sodium salts), (2) Color additive mixtures for drug
not more than 10 percent. use made with Red No. 22 may contain
Insoluble matter (alkaline solution), not
only those diluents that are suitable

Phthalic acid, not more than 1 percent. and that are listed in part 73 of this
2-(3,5-Dibromo-2,4-dihydroxybenzoyl) benzoic chapter as safe for use in color additive
acid, not more than 0.5 percent. mixtures for coloring drugs.
495
§ 74.1327 21 CFR Ch. I (4–1–18 Edition)
(b) Specifications. The color additive bromine. The 4,5,6,7-

D&C Red No. 22 shall conform to the tetrachlorofluorescein is manufactured
following specifications and shall be by the acid condensation of resorcinol
free from impurities other than those and tetrachlorophthalic acid or its an-
named to the extent that such impuri- hydride. The 4,5,6,7-
ties may be avoided by current good tetrachlorofluorescein is isolated and
manufacturing practice: partially purified prior to bromination.
and sulfates (calculated as soduim salts), use made with D&C Red No. 27 may
not more than 10 percent. contain only those diluents that are
Water-insoluble matter not more than 0.5 suitable and that are listed in part 73
percent. of this chapter as safe for use in color
Disodium salt of phthalic acid, not more additive mixtures for coloring drugs.
than 1 percent. (b) Specifications. D&C Red No. 27
Sodium salt of 2-(3,5-Dibromo-2,4-
dihydroxybenzoyl)benzoic acid, not more
than 0.5 percent. fications and shall be free from impuri-
2′,4′,5′,7′-Tetrabromofluorescein, ethyl ester, ties other than those named to the ex-
not more than 1 percent. tent that such impurities may be
Brominated resorcinol, not more than 0.4 avoided by current good manufacturing
percent. practice:
Sum of disodium salts of mono- and
dibromofluoresceins, not more than 2 per- Sum of volatile matter (at 135 °C) and halides
cent. and sulfates (calculated as sodium salts),
Sum of disodium salts of not more than 10 percent.
tribromofluoresceins, not more than 25 Insoluble matter (alkaline solution), not
percent. more than 0.5 percent.
Disodium salt of 2′,4′,5′,7′- Tetrachlorophthalic acid, not more than 1.2
Tetrabromofluorescein, not less than 72 percent.
percent. Brominated resorcinol, not more than 0.4
lion. 2,3,4,5-Tetrachloro-6-(3,5-dibromo-2,4-
Arsenic (as As), not more than 3 parts per dihydroxybenzoyl) benzoic acid, not more
million. than 0.7 percent.
Mercury (as Hg), not more than 1 part per 2′,4′,5′,7′-Tetrabromo-4,5,6,7-
million. tetrachlorofluorescein, ethyl ester, not
Total color, not less than 90 percent. more than 2 percent.
Lower halogenated subsidiary colors, not
(c) Uses and restrictions. The color ad- more than 4 percent.
ditive D&C Red No. 22 may be safely Lead (as Pb), not more than 20 parts per mil-
used for coloring drugs generally in lion.
amounts consistent with current good Arsenic (as As), not more than 3 parts per
manufacturing practice. million.
(d) Labeling. The label of the color ad- Mercury (as Hg), not more than 1 part per
ditive and any mixtures prepared million.
therefrom intended solely or in part for Total color, not less than 90 percent.
coloring purposes shall conform to the (c) Uses and restrictions. D&C Red No.
requirements of § 70.25 of this chapter. 27 may be safely used for coloring
(e) Certification. All batches of D&C drugs generally in amounts consistent
Red No. 22 shall be certified in accord- with current good manufacturing prac-
ance with regulations in part 80 of this tice.
chapter. (d) Labeling. The label of the color ad-
[47 FR 53846, Nov. 30, 1982] ditive and any mixtures prepared
§ 74.1327 D&C Red No. 27. coloring purposes shall conform to the
(a) Identity. (1) The color additive requirements of § 70.25 of this chapter.
D&C Red No. 27 is principally 2′,4′,5′,7′- (e) Certification. All batches of D&C
tetrabromo-4,5,6,7- Red No. 27 shall be certified in accord-
tetrachlorofluorescein (CAS Reg. No. ance with regulations in part 80 of this
13473-26-2). The color additive is manu- chapter.

factured by brominating 4,5,6,7- [47 FR 42567, Sept. 28, 1982; 47 FR 51106, Nov.
tetrachlorofluorescein with elemental 12, 1982]
496
§ 74.1328 D&C Red No. 28. § 74.1330 D&C Red No. 30.
(a) Identity. (1) The color additive (a) Identity. (1) The color additive
D&C Red No. 28 is principally the diso- D&C Red No. 30 is principally 6-chloro-
dium salt of 2′,4′,5′,7′-tetrabromo-4,5,6,7- 2-(6-chloro-4-methyl-3-
tetrachlorofluorescein (CAS Reg. No. oxobenzo[b]thien-2(3H)-ylidene)-4-
18472–87–2) formed by alkaline hydrol- methyl-benzo[b]thiophen-3(2H)-one
ysis of the parent (CAS Reg. No. 2379–74–0).
tetrabromotetrachlorofluorescein. (2) Color additive mixtures for drug
(2) Color additive mixtures for drug use made with D&C Red No. 30 may
use made with D&C Red No. 28 may contain only those diluents that are
contain only those diluents that are suitable and that are listed in part 73
suitable and that are listed in part 73 of this chapter as safe for use in color
of this chapter as safe for use in color additive mixtures for coloring drugs.
additive mixtures for coloring drugs. (b) Specifications. D&C Red No. 30
(b) Specifications. D&C Red No. 28 shall conform to the following speci-
shall conform to the following specifications and shall be free from impuri-
fications and shall be free from impurities other than those named to the ex-
ties other than those named to the extent that such impurities may be
tent that such impurities may be avoided by current good manufacturing
avoided by current good manufacturing practice:
practice: Volatile matter (at 135 °C), not more than 5
Sum of volatile matter (at 135 °C) and halides percent.
and sulfates (calculated as sodium salts), Chlorides and sulfates (calculated as sodium
not more than 15 percent. salts), not more than 3 percent.
Insoluble matter (alkaline solution), not Matter soluble in acetone, not more than 5
more than 0.5 percent. percent.
Tetrachlorophthalic acid, not more than 1.2 Total color, not less than 90 percent.
percent. Lead (as Pb), not more than 20 parts per mil-
Brominated resorcinol, not more than 0.4 lion.
percent.
2,3,4,5-Tetrachloro-6-(3,5-dibromo-2,4- million.
dihydroxybenzoyl)benzoic acid, not more
million.
than 0.7 percent.
2′,4′,5′,7′-Tetrabromo-4,5,6,7- (c) Uses and restrictions. D&C Red No.
tetrachlorofluorescein, ethyl ester, not 30 may be safely used for coloring
more than 2 percent. drugs generally in amounts consistent
Lower halogenated subsidiary colors, not
more than 4 percent.
with current good manufacturing prac-
Lead (as Pb), not more than 20 parts per mil- tice.
lion. (d) Labeling. The label of the color ad-
Arsenic (as As), not more than 3 parts per ditive and any mixtures prepared
million. therefrom intended solely or in part for
Mercury (as Hg), not more than 1 part per coloring purposes shall conform to the
million. requirements of § 70.25 of this chapter.
Total color, not less than 85 percent. (e) Certification. All batches of D&C
(c) Uses and restrictions. D&C Red No. Red No. 30 shall be certified in accord-
28 may be safely used for coloring ance with regulations in part 80 of this
drugs generally in amounts consistent chapter.
with current good manufacturing prac- [47 FR 22510, May 25, 1982]
tice.
(d) Labeling. The label of the color ad- § 74.1331 D&C Red No. 31.
ditive and any mixtures prepared (a) Identity. (1) The color additive
therefrom intended solely or in part for D&C Red No. 31 is principally the cal-
coloring purposes shall conform to the cium salt of 3-hydroxy-4-(phenylazo)-2-
requirements of § 70.25 of this chapter. naphthalenecarboxylic acid.
(e) Certification. All batches of D&C (2) Color additive mixtures for drug
Red No. 28 shall be certified in accord- use made with D&C Red No. 31 may
ance with regulations in part 80 of this contain only those diluents that are
chapter. suitable and that are listed in part 73
[47 FR 42568, Sept. 28, 1982] of this chapter as safe for use in color
497
§ 74.1333 21 CFR Ch. I (4–1–18 Edition)
additive mixtures for coloring exter- tent that such impurities may be
nally applied drugs. avoided by current good manufacturing
(b) Specifications. D&C Red No. 31 practices:
Sum of volatile matter at 135 °C (275 °F) and
fications and shall be free from impuri- chlorides and sulfates (calculated as so-
ties, other than those named, to the ex- dium salts), not more than 18 percent.
tent that such other impurities may be Water-insoluble matter, not more than 0.3
avoided by good manufacturing prac- percent.
tice: 4-Amino-5-hydroxy-2,7-naphthalenedisulfonic
acid, disodium salt, not more than 0.3 per-
cent.
dium salts), not more than 10 percent. 4,5-Dihydroxy-3-(phenylazo)-2,7-
Aniline, not more than 0.2 percent. naphthalenedisulfonic acid, disodium salt,
3-Hydroxy-2-naphthoic acid, calcium salt, not more than 3.0 percent.
not more than 0.4 percent. Aniline, not more than 25 parts per million.
Subsidiary colors, not more than 1 percent. 4-Aminoazobenzene, not more than 100 parts
Lead (as Pb), not more than 20 parts per mil- per billion.
lion. 1,3-Diphenyltriazene, not more than 125 parts
Arsenic (as As), not more than 3 parts per per billion.
million. 4-Aminobiphenyl, not more than 275 parts
Mercury (as Hg), not more than 1 part per per billion.
million. Azobenzene, not more than 1 part per mil-
Total color, not less than 90 percent. lion.
Benzidine, not more than 20 parts per billion.
(c) Uses and restrictions. D&C Red No. Lead (as Pb), not more than 20 parts per mil-
31 may be safely used in externally ap- lion.
plied drugs in amounts consistent with Arsenic (as As), not more than 3 parts per
good manufacturing practice. million.
(d) Labeling. The label of the color ad- Mercury (as Hg), not more than 1 part per
ditive and any mixtures prepared million.
therefrom intended solely or in part for Total color, not less than 82 percent.
coloring purposes shall conform to the (c) Uses and restrictions. The color ad-
requirements of § 70.25 of this chapter. ditive D&C Red. No 33 may be safely
(e) Certification. All batches of D&C used for coloring ingested drugs, other
Red No. 31 shall be certified in accord- than mouthwashes and dentifrices, in
ance with regulations in part 80 of this amounts not to exceed 0.75 milligram
chapter. per daily dose of the drug. D&C Red No.
§ 74.1333 D&C Red No. 33. 33 may be safely used for coloring ex-
ternally applied drugs, mouthwashes,
(a) Identity. (1) The color additive and dentifrices in amounts consistent
D&C Red No. 33 is principally the diso- with current good manufacturing prac-
dium salt of 5-amino-4-hydroxy-3- tice.
(phenylazo)-2,7-naphthalenedisulfonic (d) Labeling requirements. The label of
acid (CAS Reg. No. 3567–66–6). To manu- the color additive and any mixtures
facture the additive, the product ob- prepared therefrom intended solely or
tained from the nitrous acid in part for coloring purposes shall con-
diazotization of aniline is coupled with form to the requirements of § 70.25 of
4-hydroxy-5-amino-2,7- this chapter.
naphthalenedisulfonic acid in an alka- (e) Certification. All batches of D&C
line aqueous medium. The color addi- Red No. 33 shall be certified in accord-
tive is isolated as the sodium salt. ance with regulations in part 80 of this
(2) Color additive mixtures for drug chapter.
use made with D&C Red No. 33 may
contain only those diluents that are [53 FR 33120, Aug. 30, 1988]
of this chapter as safe for use in color § 74.1334 D&C Red No. 34.
additive mixtures for coloring drugs. (a) Identity. (1) The color additive
(b) Specifications. D&C Red No. 33 D&C Red No. 34 is principally the cal-
shall conform to the following speci- cium salt of 3-hydroxy-4-[(1-sulfo-2-

fications and shall be free from impuri- naphthalenyl)azo]-2-naphthalene-car-
ties other than those named to the ex- boxylic acid.
498
(2) Color additive mixtures for drug (b) Specifications. D&C Red No. 36
use made with D&C Red No. 34 may shall conform to the following speci-
contain only those diluents that are fications and shall be free from impuri-
suitable and that are listed in part 73 ties other than those named to the ex-
of this chapter as safe for use in color tent that such impurities may be
additive mixtures for coloring exter- avoided by current good manufacturing
nally applied drugs. practice:
(b) Specifications. D&C Red No. 34 Volatile matter at 135 °C (275 °F), not more
shall conform to the following speci- than 1.5 percent.
fications and shall be free from impuri- Matter insoluble in toluene, not more than
ties, other than those named, to the ex- 1.5 percent.
tent that such other impurities may be 2-Chloro-4-nitrobenzenamine, not more than
avoided by good manufacturing prac- 0.3 percent.
tice: 2-Naphthalenol, not more than 1 percent.
2,4-Dinitrobenzenamine, not more than 0.02
Sum of volatile matter (at 135 °C) and percent.
chlorides and sulfates (calculated at so- 1-[(2,4-Dinitrophenyl)azo]-2-naphthalenol,
dium salts), not more than 15 percent. not more than 0.5 percent.
2-Amino-1-naphthalenesulfonic acid, calcium 4-[(2-Chloro-4-nitrophenyl)azo]-1-
salt, not more than 0.2 percent. naphthalenol, not more than 0.5 percent.
3-Hydroxy-2-naphthoic acid, not more than 1-[(4-Nitrophenyl)azo]-2-naphthalenol, not
0.4 percent. more than 0.3 percent.
Subsidiary colors, not more than 4 percent. 1-[(4-Chloro-2-nitrophenyl)azo]-2-
Lead (as Pb), not more than 20 parts per mil- naphthalenol, not more than 0.3 percent.
lion. Lead (as Pb), not more than 20 parts per mil-
Arsenic (as As), not more than 3 parts per lion.
million. Arsenic (as As), not more than 3 parts per
Mercury (as Hg), not more than 1 part per million.
million. Mercury (as Hg), not more than 1 part per
Total color not less than 85 percent. million.
ditive D&C Red No. 34 may be safely (c) Uses and restrictions. The color ad-
used for coloring externally applied ditive D&C Red No. 36 may be safely
drugs in amounts consistent with good used for coloring ingested drugs, other
manufacturing practice. than mouthwashes and dentifrices, in
(d) Labeling. The label of the color ad- amounts not to exceed 1.7 milligrams
ditive and any mixtures prepared per daily dose of the drug for drugs
therefrom intended solely or in part for that are taken continuously only for
coloring purposes shall conform to the less than 1 year. For drugs taken con-
requirements of § 70.25 of this chapter. tinuously for longer than 1 year, the
(e) Certification. All batches of D&C color additive shall not be used in
Red No. 34 shall be certified in accord- amounts to exceed 1.0 milligram per
ance with regulations in part 80 of this daily dose of the drug. D&C Red No. 36
chapter. may be safely used for coloring exter-
nally applied drugs in amounts con-
§ 74.1336 D&C Red No. 36. sistent with current good manufac-
(a) Identity. (1) The color additive turing practice.
D&C Red No. 36 is 1-[(2-chloro-4- (d) Labeling requirements. The label of
nitrophenyl)azo]-2-naphthalenol (CAS the color additive and any mixtures
Reg. No. 2814–77–9). The color additive prepared therefrom intended solely or
is manufactured by diazotization of 2- in part for coloring purposes shall con-
chloro-4-nitrobenzenamine in acid me- form to the requirements of § 70.25 of
dium and coupling with 2-naphthalenol this chapter.
in acid medium. (e) Certification. All batches of D&C
(2) Color additive mixtures for drug Red No. 36 shall be certified in accord-
use made with D&C Red No. 36 may ance with regulations in part 80 of this
contain only those diluents that are chapter.
suitable and that are listed in part 73 [53 FR 29031, Aug. 2, 1988; 53 FR 35255, Sept.
of this chapter as safe for use in color 12, 1988, as amended at 53 FR 52130, Dec. 27,
additive mixtures for coloring drugs. 1988]
499
§ 74.1339 21 CFR Ch. I (4–1–18 Edition)
§ 74.1339 D&C Red No. 39. suitable and that are listed in part 73
of this chapter as safe for use in color
additive mixtures for coloring drugs.
D&C Red No. 39 is o-[p(b,b′-dihydroxy-
(3) The listing of this color additive
diethylamino)-phenylazo]-benzoic acid.
includes lakes prepared as described in
(2) Color additive mixtures made
§§ 82.51 and 82.1051 of this chapter, ex-
with D&C Red No. 39 may contain the
cept that the color additive used is
following diluents: Water, acetone, iso-
FD&C Red No. 40 and the resultant
propyl alcohol, and specially denatured
lakes meet the specification and label-
alcohols used in accordance with 26
ing requirements prescribed by §§ 82.51
CFR part 212.
or 82.1051 of this chapter.)
(b) Specifications. D&C Red No. 39 (b) Uses and restrictions. (1) FD&C Red
shall conform to the following speci- No. 40 and FD&C Red No. 40 Aluminum
fications and shall be free from impuri- Lake may be safely used in coloring
ties other than those named to the ex- drugs, including those intended for use
tent that such other impurities may be in the area of the eye, subject to the
avoided by good manufacturing prac- restrictions on the use of color addi-
tice: tives in § 70.5(b) and (c) of this chapter,
Volatile matter (at 100 °C.), not more than in amounts consistent with current
2.0 percent. good manufacturing practice.
Matter insoluble in acetone, not more than (2) Other lakes of FD&C Red No. 40
1.0 percent. may be safely used in coloring drugs,
Anthranilic acid, not more than 0.2 percent. subject to the restrictions on the use of
N,N-(b,b′-Dihydroxy-diethyl) aniline, not
color additives in § 70.5 of this chapter,
Subsidiary colors, not more than 3.0 percent. in amounts consistent with current
Lead (as Pb), not more than 20 parts per mil- good manufacturing practice.
lion. (c) Labeling. The label of the color ad-
Arsenic (as As), not more than 3 parts per ditive and any lakes or mixtures pre-
million. pared therefrom intended solely or in
Total color, not less than 95.0 percent. part for coloring purposes shall con-
(c) Uses and restrictions. The color ad- form to the requirements of § 70.25 of
ditive D&C Red No. 39 may be safely this chapter.
used for the coloring of quaternary am- (d) Certification. All batches of FD&C
monium type germicidal solutions in- Red No. 40 and lakes thereof shall be
tended for external application only, certified in accordance with regula-
and subject to the further restriction tions, in part 80 of this chapter.
that the quantity of the color additive [42 FR 15654, Mar. 22, 1977, as amended at 59
does not exceed 0.1 percent by weight FR 7636, Feb. 16, 1994]
of the finished drug product.
(d) Labeling. The label of the color ad- § 74.1602 D&C Violet No. 2.
ditive and any mixtures prepared (a) Identity. (1) The color additive
therefrom and intended solely or in D&C Violet No. 2 is principally 1-hy-
part for coloring purposes shall con- droxy -4-[(4-methylphenyl)amino]-9,10-
form to the requirements of § 70.25 of anthracenedione.
this chapter. (2) Color additive mixtures for use in
(e) Certification. All batches of D&C externally applied drugs made with
Red No. 39 shall be certified in accord- D&C Violet No. 2 may contain only
ance with regulations promulgated those diluents that are suitable and
under part 80 of this chapter. that are listed in part 73 of this chapter
as safe for use in color additive mix-
§ 74.1340 FD&C Red No. 40. tures for coloring externally applied
(a) Identity and specifications. (1) The drugs.
color additive FD&C Red No. 40 shall (b) Specifications. D&C Violet No. 2
conform in identity and specifications shall conform to the following speci-
to the requirements of § 74.340(a)(1) and fications and shall be free from impuri-
(b). ties, other than those named, to the ex-
(2) Color additive mixtures for drug tent that such other impurities can be
use made with FD&C Red No. 40 may avoided by good manufacturing prac-
contain only those diluents that are tice:
500
Volatile matter (at 135 °C.), not more than the eye, when prepared in accordance
2.0 percent. with § 82.51 of this chapter.
Matter insoluble in both carbon tetra- (c) Labeling requirements. (1) The label
chloride and water, not more than 0.5 per-
cent.
of the color additive and any mixtures
p- Toluidine, not more than 0.2 percent. intended solely or in part for coloring
1-Hydroxy-9,10-anthracenedione, not more purposes prepared therefrom shall con-
than 0.5 percent. form to the requirements of § 70.25 of
1,4-Dihydroxy-9,10-anthracenedione, not this chapter.
more than 0.5 percent. (2) The label of OTC and prescription
Subsidiary colors, not more than 1.0 percent. drug products intended for human use
Lead (as Pb), not more than 20 parts per mil- administered orally, nasally, rectally,
lion. or vaginally, or for use in the area of
million.
the eye, containing FD&C Yellow No. 5
Total color, not less than 96.0 percent. shall specifically declare the presence
of FD&C Yellow No. 5 by listing the
(c) Uses and restrictions. The color ad- color additive using the names FD&C
ditive D&C Violet No. 2 may be safely Yellow No. 5 and tartrazine. The label
used for coloring externally applied shall bear a statement such as ‘‘Con-
drugs in amounts consistent with good tains FD&C Yellow No. 5 (tartrazine)
manufacturing practice. as a color additive’’ or ‘‘Contains color
(d) Labeling. The label of the color ad- additives including FD&C Yellow No. 5
ditive and any mixtures prepared (tartrazine).’’ The labels of certain
therefrom intended solely or in part for drug products subject to this labeling
coloring purposes shall conform to the requirement that are also cosmetics,
requirements of § 70.25 of this chapter. such as: antibacterial mouthwashes
(e) Certification. All batches of D&C and fluoride toothpastes, need not com-
Violet No. 2 shall be certified in ac- ply with this requirement provided
cordance with regulations in part 80 of they comply with the requirements of
this chapter. § 701.3 of this chapter.
[42 FR 15654, Mar. 22, 1977, as amended at 45 (3) For prescription drugs for human
FR 62978, Sept. 23, 1980; 55 FR 18868, May 7, use containing FD&C Yellow No. 5 that
1990] are administered orally, nasally,
vaginally, or rectally, or for use in the
§ 74.1705 FD&C Yellow No. 5. area of the eye, the labeling required
(a) Identity and specifications. (1) The by § 201.100(d) of this chapter shall, in
color additive FD&C Yellow No. 5 shall addition to the label statement re-
conform in identity and specifications quired under paragraph (c)(2) of this
to the requirements of § 74.705 (a)(1) and section, bear the warning statement
(b). ‘‘This product contains FD&C Yellow
(2) FD&C Yellow No. 5 Aluminum No. 5 (tartrazine) which may cause al-
Lake shall be prepared in accordance lergic-type reactions (including bron-
with the requirements of § 82.51 of this chial asthma) in certain susceptible
chapter. persons. Although the overall incidence
(3) Color additive mixtures for drug of FD&C Yellow No. 5 (tartrazine) sen-
use made with FD&C Yellow No. 5 may sitivity in the general population is
contain only those diluents that are low, it is frequently seen in patients
suitable and are listed in part 73 of this who also have aspirin hyper-
chapter as safe for use in color additive sensitivity.’’ This warning statement
mixtures for coloring drugs. shall appear in the ‘‘Precautions’’ sec-
(b) Uses and restrictions. (1) FD&C Yel- tion of the labeling.
low No. 5 may be safely used for color- (d) Certification. All batches of FD&C
ing drugs generally, including drugs in- Yellow No. 5 shall be certified in ac-
tended for use in the area of the eye, in cordance with regulations in part 80 of
amounts consistent with current good this chapter.
[42 FR 15654, Mar. 22, 1977, as amended at 44

(2) FD&C Yellow No. 5 Aluminum FR 37220, June 26, 1979; 50 FR 35782, Sept. 4,
Lake may be safely used for coloring 1985; 51 FR 24519, July 7, 1986; 59 FR 60897,
drugs intended for use in the area of Nov. 29, 1994]
501
§ 74.1706 21 CFR Ch. I (4–1–18 Edition)
§ 74.1706 FD&C Yellow No. 6. Lead (as Pb), not more than 20 parts per mil-
lion.
(a) Identity and specifications. (1) The Arsenic (as As), not more than 3 parts per
color additive FD&C Yellow No. 6 shall million.
conform in identity and specifications Mercury (as Hg), not more than 1 part per
to the requirements of § 74.706(a)(1) and million.
(b). Total color, not less than 94 percent.
(2) Color additive mixtures for drug (c) Uses and restrictions. D&C Yellow
use made with FD&C Yellow No. 6 may No. 7 may be safely used in externally
contain only those diluents that are applied drugs in amounts consistent
suitable and that are listed in part 73 with good manufacturing practice.
of this chapter as safe for use in color (d) Labeling. The label of the color ad-
additive mixtures for coloring drugs. ditive and any mixtures prepared
(b) Uses and restrictions. FD&C Yellow therefrom intended solely or in part for
No. 6 may be safely used for coloring coloring purposes shall conform to the
drugs generally in amounts consistent requirements of § 70.25 of this chapter.
with current good manufacturing prac- (e) Certification. All batches of D&C
tice. Yellow No. 7 shall be certified in ac-
(c) Labeling requirements. (1) The label cordance with regulations in part 80 of
of the color additive and any mixtures this chapter.
intended solely or in part for coloring
purposes prepared therefrom shall con- § 74.1707a Ext. D&C Yellow No. 7.
form to the requirements of § 70.25 of (a) Identity. (1) The color additive
this chapter. Ext. D&C Yellow No. 7 is principally
(2) [Reserved] the disodium salt of 8-hydroxy-5,7-di-
(d) Certification. All batches of FD&C nitro-2-naphthalenesulfonic acid.
Yellow No. 6 shall be certified in ac- (2) Color additive mixtures for drug
cordance with regulations in part 80 of use made with Ext. D&C Yellow No. 7
this chapter. may contain only those diluents that
[51 FR 41782, Nov. 19, 1986, as amended at 52 are suitable and that are listed in part
FR 21508, June 8, 1987; 53 FR 49138, Dec. 6, 73 of this chapter as safe for use in
1988] color additive mixtures for coloring ex-
ternally applied drugs.
§ 74.1707 D&C Yellow No. 7. (b) Specifications. Ext. D&C Yellow
(a) Identity. (1) The color additive No. 7 shall conform to the following
D&C Yellow No. 7 is principally fluo- specifications and shall be free from
rescein. impurities, other than those named, to
(2) Color additive mixtures for use in the extent that such other impurities
externally applied drugs made with may be avoided by good manufacturing
D&C Yellow No. 7 may contain only practice:
those diluents that are suitable and
that are listed in part 73 of this chapter
for use in color additive mixtures for dium salts), not more than 15 percent.
coloring externally applied drugs. Water-insoluble matter, not more than 0.2
(b) Specifications. D&C Yellow No. 7 percent.
shall conform to the following speci- 1-Naphthol, not more than 0.2 percent.
fications and shall be free from impuri- 2,4-Dinitro-1-naphthol, not more than 0.03
ties other than those named to the ex- percent.
tent that such impurities may be Lead (as Pb), not more than 20 parts per mil-
lion.
tice: million.
Sum of water and chlorides and sulfates (cal- Mercury (as Hg), not more than 1 part per
culated as sodium salts), not more than 6 million.
percent. Total color, not less than 85 percent.
Matter insoluble in alkaline water, not more
(c) Uses and restrictions. Ext. D&C
than 0.5 percent.
Yellow No. 7 may be safely used in ex-
Resorcinol, not more than 0.5 percent.

Phthalic acid, not more than 0.5 percent. ternally applied drugs in amounts con-
2-2,4-(Dihydroxybenzoyl) benzoic acid, not sistent with good manufacturing prac-
more than 0.5 percent. tice.
502
(d) Labeling. The label of the color ad- disulfonic acids of 2-(2-quinolinyl)-1H-
ditive and any mixtures prepared indene-1,3 (2H)-dione consisting prin-
therefrom intended solely or in part for cipally of the sodium salts of 2-(2,3-
coloring purposes shall conform to the dihydro-1,3-dioxo-1H-indene-2-yl)-6-
requirements of § 70.25 of this chapter. quinolinesulfonic acid and 2-(2,3-
(e) Certification. All batches of Ext. dihydro-1,3-dioxo-1H-indene-2-yl)-8-
D&C Yellow No. 7 shall be certified in quinolinesulfonic acid with lesser
accordance with regulations in part 80 amounts of the disodium salts of the
of this chapter. disulfonic acids of 2-(2-quinolinyl)-1H-
indene-1,3(2H)-dione (CAS Reg. No.
§ 74.1708 D&C Yellow No. 8. 8004–92–0). D&C Yellow No. 10 is manu-
(a) Identity. (1) The color additive factured by condensing quinaldine with
D&C Yellow No. 8 is principally the di- phthalic anhydride to give the
sodium salt of fluorescein. unsulfonated dye, which is then sulfo-
(2) Color additive mixtures for use in nated with oleum.
externally applied drugs made with (2) Color additive mixtures made
D&C Yellow No. 8 may contain only with D&C Yellow No. 10 for drug use
those diluents that are suitable and may contain only those diluents that
that are listed in part 73 of this chapter are suitable and that are listed in part
for use in color additive mixtures for 73 of this chapter as safe for use in
coloring externally applied drugs. color additive mixtures for coloring
(b) Specifications. D&C Yellow No. 8 drugs.
shall be free from impurities other (b) Specifications. The color additive
than those named to the extent that D&C Yellow No. 10 shall conform to the
such impurities may be avoided by following specifications and shall be
good manufacturing practice: free from impurities other than those
named to the extent that such other
Sum of water and chlorides and sulfates (cal- impurities may be avoided by current
culated as sodium salts), not more than 15
percent.
good manufacturing practice:
Matter insoluble in alkaline water, not more Sum of volatile matter at 135 °C (275 °F) and
than 0.3 percent. chlorides and sulfates (calculated as so-
Resorcinol, not more than 0.5 percent. dium salts), not more than 15 percent.
Phthalic acid, not more than 1 percent. Matter insoluble in both water and chloro-
2-(2,4-Dihydroxybenzoyl) benzoic acid, not form, not more than 0.2 percent.
more than 0.5 percent. Total sulfonated quinaldines, sodium salts,
Lead (as Pb), not more than 20 parts per mil- not more than 0.2 percent.
lion. Total sulfonated phthalic acids, sodium
Arsenic (as As), not more than 3 parts per salts, not more than 0.2 percent.
million. 2-(2-Quinolinyl)-1H-indene-1,3 (2H)-dione, not
Mercury (as Hg), not more than 1 part per more than 4 parts per million.
million. Sum of sodium salts of the monosulfonates
Total color, not less than 85 percent. of 2-(2-quinolinyl)-1H-indene-1,3 (2H)-dione,
(c) Uses and restrictions. D&C Yellow not less than 75 percent.
Sum of sodium salts of the disulfonates of 2-
No. 8 may be safely used in externally (2-quinolinyl)-1H-indene-1,3 (2H)-dione, not
applied drugs in amounts consistent more than 15 percent.
with good manufacturing practice. 2-(2,3-Dihydro-1,3-dioxo-1H-indene-2-yl)-6, 8-
(d) Labeling. The label of the color ad- quinolinedisulfonic acid, disodium salt, not
ditive and any mixtures prepared more than 3 percent.
therefrom intended solely or in part for Diethyl ether soluble matter other than that
coloring purposes shall conform to the specified, not more than 2 parts per mil-
lion, using added 2-(2-quinolinyl)-1H-in-
dene-1,3 (2H)-dione for calibration.
(e) Certification. All batches of D&C Lead (as Pb), not more than 20 parts per mil-
Yellow No. 8 shall be certified in ac- lion.
cordance with regulations in part 80 of Arsenic (as As), not more than 3 parts per
this chapter. million.
§ 74.1710 D&C Yellow No. 10. million.

D&C Yellow No. 10 is a mixture of the (c) Uses and restrictions. The color ad-
sodium salts of the mono- and ditive D&C Yellow No. 10 may be safely
503
§ 74.1711 21 CFR Ch. I (4–1–18 Edition)
used for coloring drugs generally in cordance with regulations in part 80 of

amounts consistent with current good this chapter.
(d) Labeling. The label of the color ad- Subpart C—Cosmetics
therefrom and intended solely or in § 74.2052 D&C Black No. 2.
part for coloring purposes shall con-
(a) Identity. The color additive D&C
form to the requirements of § 70.25 of
Black No. 2 is a high-purity carbon
this chapter.
black prepared by the oil furnace proc-
(e) Certification. All batches of D&C ess. It is manufactured by the combus-
Yellow No. 10 shall be certified in ac- tion of aromatic petroleum oil feed-
cordance with regulations in part 80 of stock and consists essentially of pure
this chapter. carbon, formed as aggregated fine par-
[48 FR 39219, Aug. 30, 1983, as amended at 49 ticles with a surface area range of 200
FR 8432, Mar. 7, 1984] to 260 meters (m)2/gram.
(b) Specifications. D&C Black No. 2
§ 74.1711 D&C Yellow No. 11. shall conform to the following speci-
(a) Identity. (1) The color additive fications and shall be free from impuri-
D&C Yellow No. 11 is principally 2-(2- ties other than those named to the ex-
quinolyl)-1,3-indandione. tent that such other impurities may be
(2) Color additive mixtures, for drug avoided by good manufacturing prac-
use made with D&C Yellow No. 11 may tice:
contain only those diluents that are (1) Surface area by nitrogen BET
suitable and that are listed in part 73 (Brunauer, Emmett, Teller) method,
of this chapter as safe for use in color 200 to 260 m2/gram.
additive mixtures for coloring exter- (2) Weight loss on heating at 950 °C
nally applied drugs. for 7 minutes (predried for 1 hour at 125
(b) Specifications. D&C Yellow No. 11 °C), not more than 2 percent.
shall conform to the following speci- (3) Ash content, not more than 0.15
fications and shall be free from impuri- percent.
ties, other than those named, to the ex- (4) Arsenic (total), not more than 3
tent that such other impurities may be milligrams per kilogram (mg/kg) (3
avoided by good manufacturing prac- parts per million).
tice: (5) Lead (total), not more than 10 mg/
Volatile matter (at 135 °C), not more than 1 kg (10 parts per million).
percent. (6) Mercury (total), not more than 1
Ethyl alcohol-insoluble matter, not more mg/kg (1 part per million).
than 0.4 percent. (7) Total sulfur, not more than 0.65
Phthalic acid, not more than 0.3 percent. percent.
Quinaldine, not more than 0.2 percent. (8) Total PAHs, not more than 0.5 mg/
kg (500 parts per billion).
lion. (9) Benzo[a]pyrene, not more than
Arsenic (as As), not more than 3 parts per 0.005 mg/kg (5 parts per billion).
million. (10) Dibenz[a,h]anthracene, not more
Mercury (as Hg), not more than 1 part per than 0.005 mg/kg (5 parts per billion).
million. (11) Total color (as carbon), not less
Total color, not less than 96 percent. than 95 percent.
(c) Uses and restrictions. D&C Yellow (c) Uses and restrictions. D&C Black
No. 11 may be safely used in externally No. 2 may be safely used for coloring
applied drugs in amounts consistent the following cosmetics in amounts
with good manufacturing practice. consistent with current good manufac-
(d) Labeling. The label of the color ad- turing practice: Eyeliner, brush-on-
ditive and any mixtures prepared brow, eye shadow, mascara, lipstick,
therefrom intended solely or in part for blushers and rouge, makeup and foun-
coloring purposes shall conform to the dation, and nail enamel.
requirements of § 70.25 of this chapter. (d) Labeling. The label of the color ad-
(e) Certification. All batches of D&C ditive shall conform to the require-
Yellow No. 11 shall be certified in ac- ments of § 70.25 of this chapter.
504
(e) Certification. All batches of D&C § 74.2101 FD&C Blue No. 1.

Black No. 2 shall be certified in accord- (a) Identity. The color additive FD&C
ance with regulations in part 80 of this Blue No. 1 is principally the disodium
chapter. salt of ethyl[4-[p-[ethyl(m-
[69 FR 44930, July 28, 2004, as amended at 72 sulfobenzyl)amino]-a-(o-
FR 10357] sulfophenyl)benzylidene]-2,5-
cyclohexadien-1-ylidene](m-
§ 74.2053 D&C Black No. 3. sulfobenzyl)ammonium hydroxide
inner salt with smaller amounts of the
(a) Identity. The color additive D&C isomeric disodium salts of ethyl[4-[p-
Black No. 3 is a washed bone char pre- [ethyl(p-sulfobenzyl)amino]-a-(o-
pared from calcined cattle bones. The sulfophenyl)benzylidene]-2,5-
bones are twice heated in excess of 700 cyclohexadien-1-ylidene](p-
°C for at least 6 hours. sulfobenzyl)ammonium hydroxide
(b) Specifications. D&C Black No. 3 inner salt and ethyl[4-[p-[ethyl(o-
shall conform to the following speci- sulfobenzyl)amino]-a-(o-
fications and shall be free from impuri- sulfophenyl)benzylidene]-2,5-
ties other than those named, to the ex- cyclohexadien-1-ylidene](o-
tent that such other impurities may be sulfobenzyl)ammonium hydroxide
avoided by current good manufacturing inner salt. Additionally, FD&C Blue
practices: No. 1 is manufactured by the acid cata-
(1) Calcium hydroxyapatite (CaO and lyzed condensation of one mole of so-
P2O5), not less than 75 percent and not dium 2-formylbenzenesulfonate with
more than 84 percent; two moles from a mixture consisting
principally of 3-
(2) Elemental carbon, not less than 7
percent; benzenesulfonic acid, and smaller
(3) Moisture, not more than 7 per- amounts of 4-
cent; [(ethylphenylamino)methyl]
(4) Silica (SiO2), not more than 5 per- benzenesulfonic acid and 2-
cent; [(ethylphenylamino)methyl]
(5) Arsenic, not more than 3 milli- benzenesulfonic acid to form the leuco
grams (mg)/kilogram (kg) (3 parts per base. The leuco base is then oxidized
million (ppm)); with lead dioxide and acid, or with di-
(6) Lead, not more than 10 mg/kg (10 chromate and acid, or with manganese
ppm); and dioxide and acid to form the dye. The
(7) Total polycyclic aromatic hydro- intermediate sodium 2-
carbons (PAHs), not more than 5 mg/kg formylbenzenesulfonate is prepared
(5 ppm). from 2-chlorobenzaldehyde and sodium
sulfite.
(c) Uses and restrictions. Cosmetics
(b) Specifications. (1) The color addi-
containing D&C Black No. 3 must com-
tive FD&C Blue No. 1 shall conform in
ply with § 700.27 of this chapter with re- specifications to the requirements of
spect to prohibited cattle materials in § 74.101(b).
cosmetic products. D&C Black No. 3 (2) FD&C Blue No. 1 Aluminum Lake
may be safely used for coloring the fol- shall be prepared in accordance with
lowing cosmetics in amounts con- the requirements of § 82.51 of this chap-
sistent with current good manufac- ter.
turing practice: Eyeliner, eye shadow, (c) Uses and restrictions. (1) FD&C
mascara, and face powder. Blue No. 1 may be safely used for color-
(d) Labeling. The label of the color ad- ing cosmetics generally, including cos-
ditive shall conform to the require- metics intended for use in the area of
ments of § 70.25 of this chapter. the eye, in amounts consistent with
(e) Certification. All batches of D&C current good manufacturing practice.
Black No. 3 shall be certified in accord- (2) FD&C Blue No. 1 Aluminum Lake
ance with regulations in part 80 of this may be safely used for coloring cos-
chapter. metics intended for use in the area of

the eye, in amounts consistent with
[72 FR 33666, June 19, 2007] current good manufacturing practice.
505
§ 74.2104 21 CFR Ch. I (4–1–18 Edition)
(d) Labeling. The label of the color ad- Monosodium salt of 4[[5-[(2,5-dimethyl-
ditive shall conform to the require- phenyl)azo] -2,4-dihydroxyphenyl]azo]
ments of § 70.25 of this chapter. benzenesulfonic acid, not less than 12 per-
(e) Certification. All batches of FD&C cent and not more than 17 percent.
Blue No. 1 shall be certified in accord- Monosodium salt of 4[[5-[(2,3-dimethyl-
ance with regulations in part 80 of this phenyl)azo] - 2,4-dihydroxyphenyl]azo]
benzenesulfonic acid, not less than 6 per-
chapter.
cent and not more than 13 percent.
[47 FR 42565, Sept. 28, 1982, as amended at 58 Monosodium salt of 4[[5-[(2-ethylphenyl)-
FR 17511, Apr. 5, 1993; 59 FR 7638, Feb. 16, azo]-2,4-dihydroxyphenyl]-azo]
1994] benzenesulfonic acid, not less than 5 per-
§ 74.2104 D&C Blue No. 4. Monosodium salt of 4[[5-[(3,4-dimethyl-
(a) Identity and specifications. The phenyl)azo] -2,4-dihydroxyphenyl]azo]
color additive D&C Blue No. 4 shall benzenesulfonic acid, not less than 3 per-
conform in identity and specifications cent and not more than 9 percent.
to the requirements of § 74.1104(a)(1) Monosodium salt of 4[[5-[(2,6-dimethyl-
and (b). phenyl)azo] -2,4-dihydroxyphenyl]azo]
(b) Uses and restrictions. D&C Blue No. benzenesulfonic acid, not less than 3 per-
4 may be safely used for coloring exter-
Monosodium salt of 4[[5-[(4-ethylphenyl)
nally applied cosmetics in amounts
azo]-2,4-dihydroxyphenyl]-azo]
consistent with good manufacturing benzenesulfonic acid, not less than 2 per-
practice. cent and not more than 8 percent.
(c) Labeling. The label of the color ad- Lead (as Pb), not more than 20 parts per mil-
ditive shall conform to the require- lion.
ments of § 70.25 of this chapter. Arsenic (as As), not more than 3 parts per
(d) Certification. All batches of D&C million.
Blue No. 4 shall be certified in accord- Mercury (as Hg), not more than 1 part per
ance with regulations in part 80 of this million.
chapter. Total color, not less than 84 percent.
§ 74.2151 D&C Brown No. 1. (c) Uses and restrictions. D&C Brown
No. 1 may be safely used for coloring
Brown No. 1 is a mixture of the sodium externally applied cosmetics in
salts of 4[[5-[(dialkylphenyl)- azo]-2,4- amounts consistent with good manu-
dihydroxyphenyl]azo]-benzene sulfonic facturing practice.
acid. The alkyl group is principally the (d) Labeling. The label of the color ad-
methyl group. ditive shall conform to the require-
(b) Specifications. D&C Brown No. 1 ments of § 70.25 of this chapter.
shall conform to the following speci- (e) Certification. All batches of D&C
fications and shall be free from impuri- Brown No. 1 shall be certified in ac-
ties other than those named to the ex- cordance with regulations in part 80 of
tent that such other impurities may be this chapter.
tice: § 74.2203 FD&C Green No. 3.
Sum of volatile matter (at 135 °C) and (a) Identity and specifications. The
chlorides and sulfates (calculated as so- color additive FD&C Green No. 3 shall
dium salts), not more than 16 percent. conform in identity and specifications
Water-insoluble matter, not more than 0.2
to the requirements of § 74.203(a)(1) and
percent.
Sulfanilic acid, sodium salt, not more than (b).
0.2 percent. (b) Uses and restrictions. The color ad-
Resorcinol, not more than 0.2 percent. ditive FD&C Green No. 3 may be safely
Xylidines, not more than 0.2 percent. used for coloring cosmetics generally
Disodium salt of 4[[5-[(4-sulfophenyl)-azo]-
in amounts consistent with current
2,4-dihydroxyphenyl]azo] benzenesulfonic
acid, not more than 3 percent. good manufacturing practice.
Monosodium salt of 4[[5-[(2,4-dimethyl-

phenyl)azo] -2,4-dihydroxyphenyl]azo] ditive shall conform to the require-
benzenesulfonic acid, not less than 29 per- ments of § 70.25 of this chapter.
506
(d) Certification. All batches of FD&C amounts not exceeding 0.01 percent by
Green No. 3 shall be certified in accord- weight of the finished cosmetic prod-
ance with regulations in part 80 of this uct.
chapter. (c) Labeling. The label of the color ad-
[47 FR 52144, Nov. 19, 1982] ditive shall conform to the require-
§ 74.2205 D&C Green No. 5. (d) Certification. All batches of D&C
(a) Identity and specifications. The Green No. 8 shall be certified in accord-
color additive D&C Green No. 5 shall ance with regulations in part 80 of this
conform in identity and specifications chapter.
to the requirements of § 74.1205 (a)(1)
and (b)(2). § 74.2254 D&C Orange No. 4.
(b) Uses and restrictions. D&C Green (a) Identity and specifications. The
No. 5 may be safely used for coloring color additive D&C Orange No. 4 shall
cosmetics generally, including cos-
conform in identity and specifications
metics intended for use in the area of
to the requirements of § 74.1254 (a)(1)
current good manufacturing practice. and (b).
(c) Labeling requirements. The label of (b) Uses and restrictions. D&C Orange
the color additive shall conform to the No. 4 may be safely used for coloring
requirements of § 70.25 of this chapter. externally applied cosmetics in
(d) Certification. All batches of D&C amounts consistent with good manu-
Green No. 5 shall be certified in accord- facturing practice.
ance with regulations in part 80 of this (c) Labeling. The label of the color ad-
chapter. ditive shall conform to the require-
[47 FR 24285, June 4, 1982, as amended at 59 ments of § 70.25 of this chapter.
FR 40805, Aug. 10, 1994] (d) Certification. All batches of D&C
Orange No. 4 shall be certified in ac-
§ 74.2206 D&C Green No. 6. cordance with regulations in part 80 of
(a) Identity and specifications. The this chapter.
color additive D&C Green No. 6 shall
[42 FR 52396, Sept. 30, 1977]
to the requirements of § 74.1206 (a) and § 74.2255 D&C Orange No. 5.
(b).
(b) Uses and restrictions. D&C Green (a) Identity and specifications. The
No. 6 may be safely used for coloring color additive D&C Orange No. 5 shall
externally applied cosmetics in conform in identity and specifications
amounts consistent with good manu- to the requirements of § 74.1255 (a)(1)
facturing practice. and (b).
(c) Labeling requirements. The label of (b) Uses and restrictions. D&C Orange
the color additive shall conform to the No. 5 may be safely used for coloring
requirements of § 70.25 of this chapter. mouthwashes and dentifrices that are
(d) Certification. All batches of D&C ingested cosmetics in amounts con-
Green No. 6 shall be certified in accord- sistent with current good manufac-
ance with regulations in part 80 of this turing practice. D&C Orange No. 5 may
chapter. be safely used for coloring lipsticks
[47 FR 14146, Apr. 4, 1982, as amended at 51 and other cosmetics intended to be ap-
FR 9784, Mar. 21, 1986] plied to the lips in amounts not exceed-
ing 5.0 percent by weight of the fin-
§ 74.2208 D&C Green No. 8.
ished cosmetic products. D&C Orange
(a) Identity and specifications. The No. 5 may be safely used for coloring
color additive D&C Green No. 8 shall externally applied cosmetics in
conform in identity and specifications amounts consistent with current good
to the requirements of § 74.1208(a)(1) manufacturing practice.
and (b).

(b) Uses and restrictions. D&C Green
No. 8 may be safely used for coloring
externally applied cosmetics in
507
§ 74.2260 21 CFR Ch. I (4–1–18 Edition)
(d) Certification. All batches of D&C (c) Labeling. The label of the color ad-
Orange No. 5 shall be certified in ac- ditive shall conform to the require-
cordance with regulations in part 80 of ments of § 70.25 of this chapter.
this chapter. (d) Certification. All batches of FD&C
[47 FR 49635, Nov. 2, 1982, as amended at 49 Red No. 4 shall be certified in accord-
FR 13342, Apr. 4, 1984] ance with regulations in part 80 of this
chapter.
§ 74.2260 D&C Orange No. 10.
§ 74.2306 D&C Red No. 6.
(a) Identity and specifications. The
color additive D&C Orange No. 10 shall (a) Identity and specifications. The
conform in identity and specifications color additive D&C Red No. 6 shall con-
to the requirements of § 74.1260(a)(1) form in identity and specifications to
and (b). the requirements of § 74.1306 (a)(1) and
(b) Uses and restrictions. D&C Orange (b).
No. 10 may be safely used for coloring (b) Uses and restrictions. The color ad-
externally applied cosmetics in ditive D&C Red No. 6 may be safely
amounts consistent with good manu- used for coloring cosmetics generally
facturing practice. in amounts consistent with current
(c) Labeling requirements. The label of good manufacturing practice.
the color additive shall conform to the (c) Labeling requirements. The label of
requirements of § 70.25 of this chapter. the color additive shall conform to the
(d) Certification. All batches of D&C requirements of § 70.25 of this chapter.
Orange No. 11 shall be certified in ac- (d) Certification. All batches of D&C
cordance with regulations in part 80 of Red No. 6 shall be certified in accord-
this chapter. ance with regulations in part 80 of this
[46 FR 18954, Mar. 27, 1981] chapter.
§ 74.2261 D&C Orange No. 11. [47 FR 57688, Dec. 28, 1982]
(a) Identity and specifications. The § 74.2307 D&C Red No. 7

color additive D&C Orange No. 11 shall
color additive D&C Red No. 7 shall con-
to the requirements of § 74.1261(a)(1)
form in identity and specifications to
and (b).
(b) Uses and restrictions. D&C Orange the requirements of § 74.1307 (a)(1) and
No. 11 may be safely used for coloring (b).
externally applied cosmetics in (b) Uses and restrictions. The color ad-
amounts consistent with good manu- ditive D&C Red No. 7 may be safely
facturing practice. used for coloring cosmetics generally
(c) Labeling requirements. The label of in amounts consistent with current
the color additive shall conform to the good manufacturing practice.
requirements of § 70.25 of this chapter. (c) Labeling requirements. The label of
(d) Certification. All batches of D&C the color additive shall conform to the
Orange No. 11 shall be certified in ac- requirements of § 70.25 of this chapter.
cordance with regulations in part 80 of (d) Certification. All batches of D&C
this chapter. Red No. 7 shall be certified in accord-
[46 FR 18954, Mar. 27, 1981] chapter.
§ 74.2304 FD&C Red No. 4. [47 FR 57688, Dec. 28, 1982]
§ 74.2317 D&C Red No. 17.
color additive FD&C Red No. 4 shall
conform in identity and specifications (a) Identity and specifications. The
to the requirements of § 74.1304(a)(1) color additive D&C Red No. 17 shall
and (b). conform in identity and specifications
(b) Uses and restrictions. FD&C Red to the requirements of § 74.1317(a)(1)
No. 4 may be safely used for coloring and (b).
externally applied cosmetics in (b) Uses and restrictions. D&C Red No.
amounts consistent with good manu- 17 may be safely used for coloring ex-
facturing practice. ternally applied cosmetics in amounts
508
consistent with good manufacturing metics generally in amounts consistent

practice. with current good manufacturing prac-
(c) Labeling. The label of the color ad- tice.
ditive shall conform to the require- (c) Labeling requirements. The label of
ments of § 70.25 of this chapter. the color additive shall conform to the
(d) Certification. All batches of D&C requirements of § 70.25 of this chapter.
Red No. 17 shall be certified in accord- (d) Certification. All batches of D&C
ance with regulations in part 80 of this Red No. 27 shall be certified in accord-
chapter.
§ 74.2321 D&C Red No. 21.
[47 FR 42568, Sept. 28, 1982]
color additive D&C Red No. 21 shall § 74.2328 D&C Red No. 28.
(b) Uses and restrictions. The color ad- to the requirements of § 74.1328 (a)(1)
ditive D&C Red No. 21 may be safely and (b).
used for coloring cosmetics generally (b) Uses and restrictions. D&C Red No.
in amounts consistent with current 28 may be safely used for coloring cos-
good manufacturing practice. metics generally in amounts consistent
(c) Labeling requirements. The label of with current good manufacturing prac-
the color additive shall conform to the tice.
Red No. 21 shall be certified in accord- requirements of § 70.25 of this chapter.
ance with regulations in part 80 of this (d) Certification. All batches of D&C
chapter. Red No. 28 shall be certified in accord-
[47 FR 53846, Nov. 30, 1982] ance with regulations in part 80 of this
chapter.
§ 74.2322 D&C Red No. 22. [47 FR 42568, Sept. 28, 1982]
(b) Uses and restrictions. The color ad- to the requirements of § 74.1330 (a)(1)
ditive D&C Red No. 22 may be safely and (b).
used for coloring cosmetics generally (b) Uses and restrictions. D&C Red No.
in amounts consistent with current 30 may be safely used for coloring cos-
good manufacturing practice. metics generally in amounts consistent
(c) Labeling requirements. The label of with current good manufacturing prac-
the color additive shall conform to the tice.
Red No. 22 shall be certified in accord- requirements of § 70.25 of this chapter.
ance with regulations in part 80 of this (d) Certification. All batches of D&C
chapter. Red No. 30 shall be certified in accord-
[47 FR 53846, Nov. 30, 1982]
chapter.
§ 74.2327 D&C Red No. 27. [47 FR 22511, May 25, 1982]
to the requirements of § 74.1327 (a)(1) color additive D&C Red No. 31 shall

(b) Uses and restrictions. D&C Red No. to the requirements of § 74.1331(a)(1)
27 may be safely used for coloring cos- and (b).
509
§ 74.2333 21 CFR Ch. I (4–1–18 Edition)
(b) Uses and restrictions. D&C Red No. ance with regulations in part 80 of this
31 may be safely used for coloring ex- chapter.
ternally applied cosmetics in amounts
consistent with good manufacturing § 74.2336 D&C Red No. 36.
practice. (a) Identity and specifications. The
(c) Labeling. The label of the color ad- color additive D&C Red No. 36 shall
ditive shall conform to the require- conform in identity and specifications
ments of § 70.25 of this chapter. to the requirements of § 74.1336 (a)(1)
(d) Certification. All batches of D&C and (b).
Red No. 31 shall be certified in accord- (b) Uses and restrictions. The color ad-
ance with regulations in part 80 of this ditive D&C Red No. 36 may be safely
chapter. used for coloring cosmetic lip products
§ 74.2333 D&C Red No. 33. in amounts not to exceed 3 percent
total color by weight of the finished
(a) Identity and specifications. The cosmetic products. D&C Red No. 36
color additive D&C Red No. 33 shall may be safely used for coloring exter-
conform in identity and specifications nally applied cosmetics in amounts
to the requirements of § 74.1333(a) (1) consistent with current good manufac-
and (b). turing practice.
(b) Uses and restrictions. The color ad- (c) Labeling requirements. The label of
ditive D&C Red No. 33 may be safely the color additive shall conform to the
used for coloring cosmetic lip products requirements of § 70.25 of this chapter.
in amounts not to exceed 3 percent
(d) Certification. All batches of D&C
total color by weight of the finished
cosmetic products. D&C Red No. 33
may be safely used for coloring
chapter.
mouthwashes (including breath fresh-
eners), dentifrices, and externally ap- [53 FR 29031, Aug. 2, 1988]
plied cosmetics in amounts consistent
with current good manufacturing prac- § 74.2340 FD&C Red No. 40.
tice. (a) Identity and specifications. (1) The
(c) Labeling requirements. The label of color additive FD&C Red No. 40 shall
the color additive and any mixtures conform in identity and specifications
prepared therefrom intended solely or to the requirements of § 74.340(a)(1) and
in part for coloring purposes shall con- (b) of this chapter.
form to the requirements of § 70.25 of (2) The listing of this color additive
this chapter. includes lakes prepared as described in
(d) Certification. All batches of D&C §§ 82.51 and 82.1051 of this chapter, ex-
Red No. 33 shall be certified in accord- cept that the color additive used is
ance with regulations in part 80 of this FD&C Red No. 40 and the resultant
chapter. lakes meet the specification and label-
[53 FR 33120, Aug. 30, 1988] ing requirements prescribed by § 82.51
or § 82.1051 of this chapter.
§ 74.2334 D&C Red No. 34. (b) Uses and restrictions. FD&C Red
(a) Identity and specifications. The No. 40 may be safely used in coloring
color additive D&C Red No. 34 shall cosmetics generally, except that only
conform in identity and specifications FD&C Red No. 40 and FD&C Red No. 40
to the requirements of § 74.1334(a)(1) Aluminum Lake may be safely used in
and (b). coloring cosmetics intended for use in
(b) Uses and restrictions. D&C Red No. the area of the eye. These uses are sub-
34 may be safely used for coloring ex- ject to the following restrictions:
ternally applied cosmetics in amounts (1) The color additive may be used in
consistent with good manufacturing amounts consistent with current good
practice. manufacturing practice.
(c) Labeling. The label of the color ad- (2) The color additive shall not be ex-
ditive shall conform to the require- posed to oxidizing or reducing agents
ments of § 70.25 of this chapter. that may affect the integrity of the
(d) Certification. All batches of D&C color additives or any other condition
Red No. 34 shall be certified in accord- that may affect their integrity.
510
(c) Labeling. The label of the color ad- Mercury (as Hg), not more than 1 part per
ditive shall conform to the require- million.
ments of § 70.25 of this chapter. Total color, not less than 80 percent.
(d) Certification. All batches of FD&C (c) Uses and restrictions. The color ad-
Red No. 40 shall be certified in accord- ditive Ext. D&C Violet No. 2 may be
ance with regulations in part 80 of this safely used for coloring externally ap-
chapter. plied cosmetics in amounts consistent
[42 FR 15654, Mar. 22, 1977, as amended at 59 with good manufacturing practice.
FR 7636, Feb. 16, 1994] (d) Labeling. The label of the color ad-
§ 74.2602 D&C Violet No. 2. ments of § 70.25 of this chapter.
(a) Identity and specifications. The (e) Certification. All batches of Ext.
color additive D&C Violet No. 2 shall D&C Violet No. 2 shall be certified in
conform in identity and specifications accordance with regulations in part 80
to the requirements of § 74.1602(a)(1) of this chapter.
and (b).
(b) Uses and restrictions. The color ad- § 74.2705 FD&C Yellow No. 5.
ditive D&C Violet No. 2 may be safely (a) Identity. The color additive FD&C
used for coloring externally applied Yellow No. 5 is principally the tri-
cosmetics in amounts consistent with sodium salt of 4,5-dihydro-5-oxo-(1-4-
good manufacturing practice. sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-
(c) Labeling. The label of the color ad- pyrazole-3-carboxylic acid (CAS Reg.
ditive shall conform to the require- No. 1934–21–0). To manufacture the ad-
ments of § 70.25 of this chapter. ditive, 4-aminobenzenesulfonic acid is
(d) Certification. All batches of D&C diazotized using hydrochloric acid and
Violet No. 2 shall be certified in ac- sodium nitrite. The diazo compound is
cordance with regulations in part 80 of coupled with 4,5-dihydro-5-oxo-1-(4-
this chapter. sulfophenyl)-1H-pyrazole-3-carboxylic
acid or with the methyl ester, the
§ 74.2602a Ext. D&C Violet No. 2. ethyl ester, or a salt of this carboxylic
(a) Identity. The color additive Ext. acid. The resulting dye is purified and
D&C Violet No. 2 is principally the isolated as the sodium salt.
monosodium salt of 2-[(9,10-dihydro-4- (b) Specifications. (1) FD&C Yellow
hydroxy -9,10-dioxo-1-anthracenyl) No. 5 shall conform to the following
amino]-5-methyl-benzenesulfonic acid. specifications and shall be free from
(b) Specifications. Ext. D&C Violet No. impurities other than those named to
2 shall conform to the following speci- the extent that such other impurities
fications and shall be free from impuri- may be avoided by good manufacturing
ties, other than those named, to the ex- practice:
tent that such other impurities may be
avoided by good manufacturing prac- Sum of volatile matter at 135 °C (275 °F) and
tice:
dium salts), not more than 13 percent.
Sum of volatile matter (at 135 °C) and Water-insoluble matter, not more than 0.2
chlorides and sulfates (calculated as so- percent.
dium salts), not more than 18 percent. 4,4′-[4,5-Dihydro-5-oxo-4-[(4-
Water-insoluble matter, not more than 0.4 sulfophenyl)hydrazono]-1H-pyrazol-1,3-
percent. diyl]bis[benzenesulfonic acid], trisodium
1-Hydroxy-9,10-anthracenedione, not more salt, not more than 1 percent.
than 0.2 percent. 4-[(4′,5-Disulfo[1,1′-biphenyl]-2-yl)hydrazono]-
1,4-Dihydroxy-9,10-anthracenedione, not 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyr-
more than 0.2 percent. azole-3-carboxylic acid, tetrasodium salt,
p- Toluidine, not more than 0.1 percent. not more than 1 percent.
p- Toluidine sulfonic acids, sodium salts, not Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-
more than 0.2 percent. sulfophenyl)-4-[(4-sulfophenyl)hydrazono]-
Subsidiary colors, not more than 1 percent. 1H-pyrazole-3-carboxylate, disodium salt,
Lead (as Pb), not more than 20 parts per mil- not more than 1 percent.
lion. Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4-

Arsenic (as As), not more than 3 parts per sulfophenyl)azo]-1H-pyrazole-3-carboxylic
million. acid, disodium salt, and 4,5-dihydro-5-oxo-
511
§ 74.2706 21 CFR Ch. I (4–1–18 Edition)
4-(phenylazo)-1-(4-sulfophenyl)-1H-pyr- § 74.2706 FD&C Yellow No. 6.
azole-3-carboxylic acid, disodium salt, not
more than 0.5 percent. (a) Identity and specifications. The
4-Aminobenzenesulfonic acid, sodium salt, color additive FD&C Yellow No. 6 shall
not more than 0.2 percent. conform in identity and specifications
4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyr- to the requirements of § 74.706 (a)(1) and
azole-3-carboxylic acid, disodium salt, not (b).
more than 0.2 percent. (b) Uses and restrictions. FD&C Yellow
Ethyl or methyl 4,5-dihydro-5-oxo-1-(4- No. 6 may be safely used for coloring
sulfophenyl)-1H-pyrazole-3-carboxylate, so- cosmetics generally in amounts con-
dium salt, not more than 0.1 percent. sistent with current good manufac-
4,4′-(1-Triazene-1,3-diyl)bis[benzenesulfonic turing practice.
acid], disodium salt, not more than 0.05
percent.
per billion. ments of § 70.25 of this chapter.
4-Aminobiphenyl, not more than 5 parts per (d) Certification. All batches of FD&C
billion. Yellow No. 6 shall be certified in ac-
Aniline, not more than 100 parts per billion. cordance with regulations in part 80 of
Azobenzene, not more than 40 parts per bil- this chapter.
lion.
[51 FR 41782, Nov. 19, 1986]
Benzidine, not more than 1 part per billion.
1,3-Diphenyltriazene, not more than 40 parts § 74.2707 D&C Yellow No. 7.
per billion.
Lead (as Pb), not more than 10 parts per mil- (a) Identity and specifications. The
lion. color additive D&C Yellow No. 7 shall
Arsenic (as As), not more than 3 parts per conform in identity and specifications
million. to the requirements of § 74.1707(a)(1)
Mercury (as Hg), not more than 1 part per and (b).
million. (b) Uses and restrictions. D&C Yellow
Total color, not less than 87 percent. No. 7 may be safely used for coloring
(2) FD&C Yellow No. 5 Aluminum externally applied cosmetics in
Lake shall be prepared in accordance amounts consistent with good manu-
with the requirements of § 82.51 of this facturing practice.
chapter. (c) Labeling. The label of the color ad-
(c) Uses and restrictions. (1) FD&C Yel- ditive shall conform to the require-
low No. 5 may be safely used for color-
ing cosmetics generally, including cos- (d) Certification. All batches of D&C
Yellow No. 7 shall be certified in ac-
metics intended for use in the area of
this chapter.
current good manufacturing practice.
(2) FD&C Yellow No. 5 Aluminum § 74.2707a Ext. D&C Yellow No. 7.
Lake may be safely used for coloring
cosmetics intended for use in the area (a) Identity and specifications. The
of the eye, subject to the restrictions color additive Ext. D&C Yellow No. 7
shall conform in identity and specifica-
on use of color additives in § 70.5(b) and
tions to the requirements of § 74.1707a
(c) of this chapter, in amounts con-
(a)(1) and (b).
sistent with current good manufac-
(b) Uses and restrictions. Ext. D&C
turing practice.
Yellow No. 7 may be safely used for
coloring externally applied cosmetics
ditive shall conform to the require- in amounts consistent with good manu-
ments of § 70.25 of this chapter. facturing practice.
(e) Certification. All batches of FD&C (c) Labeling. The label of the color ad-
Yellow No. 5 shall be certified in ac- ditive shall conform to the require-
cordance with regulations in part 80 of ments of § 70.25 of this chapter.
this chapter. (d) Certification. All batches of Ext.
[50 FR 35782, Sept. 4, 1985, as amended at 51 D&C Yellow No. 7 shall be certified in
FR 24524, July 7, 1986; 59 FR 60898, Nov. 29, accordance with regulations in part 80
1994] of this chapter.
512
§ 74.2708 D&C Yellow No. 8. Subpart D—Medical Devices

color additive D&C Yellow No. 8 shall § 74.3045 [Phthalocyaninato(2-)] cop-
per.
to the requirements of § 74.1708(a)(1) (a) Identity. The color additive is
and (b). [phthalocyaninato(2-)] copper (CAS
(b) Uses and restrictions. D&C Yellow Reg. No. 147–14–8) having the structure
No. 8 may be safely used for coloring shown in Colour Index No. 74160.
externally applied cosmetics in (b) Specifications. The color additive
amounts consistent with good manu- [phthalocyaninato(2-)] copper shall
facturing practice. conform to the following specifications
(c) Labeling. The label of the color ad- and shall be free from impurities other
ditive shall conform to the require- than those named to the extent that
ments of § 70.25 of this chapter. such impurities may be avoided by cur-
(d) Certification. All batches of D&C rent good manufacturing practice:
Yellow No. 8 shall be certified in ac- Volatile matter 135 °C (275 °F), not more than
cordance with regulations in part 80 of 0.3 percent.
this chapter. Salt content (as NaC1), not more than 0.3
percent.
§ 74.2710 D&C Yellow No. 10. Alcohol soluble matter, not more than 0.5
(a) Identity and specifications. The percent.
color additive D&C Yellow No. 10 shall Organic chlorine, not more than 0.5 percent.
conform in identity and specifications Aromatic amines, not more than 0.05 per-
cent.
and (b). lion.
(b) Uses and restrictions. The color ad- Arsenic (as As), not more than 3 parts per
ditive D&C Yellow No. 10 may be safely million.
used for coloring cosmetics generally Mercury (as Hg), not more than 1 part per
in amounts consistent with current million.
good manufacturing practice. Total color, not less than 98.5 percent.
(c) Labeling. The label of the color ad- (c) Uses and restrictions. (1) The color
ditive shall conform to the require- additive [phthalocyaninato(2-)] copper
ments of § 70.25 of this chapter. may be safely used to color poly-
(d) Certification. All batches of D&C propylene sutures, polybutester (the
Yellow No. 10 shall be certified in ac- generic designation for the suture fab-
cordance with regulations in part 80 of ricated from 1,4-benzenedicarboxylic
this chapter. acid, polymer with 1,4-butanediol and
[48 FR 39220, Aug. 30, 1983, as amended at 49 alpha-hydro-omega-hydroxypoly(oxy-
FR 8432, Mar. 7, 1984] 1,4-butanediyl), CAS Reg. No. 37282–12–
5) nonabsorbable sutures for use in gen-
§ 74.2711 D&C Yellow No. 11. eral and ophthalmic surgery,
(a) Identity and specifications. The polybutylene terephthalate nonabsorb-
color additive D&C Yellow No. 11 shall able monofilament sutures for general
conform in identity and specifications and ophthalmic surgery, nonabsorbable
to the requirements of § 74.1711(a)(1) sutures made from poly(vinylidene flu-
and (b). oride) and poly(vinylidene fluoride-co-
(b) Uses and restrictions. D&C Yellow hexafluoropropylene) for general and
No. 11 may be safely used for coloring ophthalmic surgery,
externally applied cosmetics in polymethylmethacrylate
amounts consistent with good manu- monofilament used as supporting
facturing practice. haptics for intraocular lenses, and
(c) Labeling. The label of the color ad- polymers used in orientation marks for
ditive shall conform to the require- intraocular lenses, subject to the fol-
ments of § 70.25 of this chapter. lowing restrictions:
(d) Certification. All batches of D&C (i) The quantity of the color additive
Yellow No. 11 shall be certified in ac- does not exceed 0.5 percent by weight
cordance with regulations in part 80 of of the suture, haptic material, or ori-
this chapter. entation mark.
513
§ 74.3102 21 CFR Ch. I (4–1–18 Edition)
(ii) The dyed suture shall conform in cordance with the requirements of
all respects to the requirements of the § 82.51 of this chapter.
U.S. Pharmacopeia. (c) Uses and restrictions. (1) The color
(2) The color additive additive FD&C Blue No. 2 may be safe-
[phthalocyaninato(2-)] copper may be ly used for coloring nylon (the copoly-
safely used for coloring contact lenses mer of adipic acid and hexamethylene
in amounts not to exceed the minimum diamine) surgical sutures for use in
reasonably required to accomplish the general surgery subject to the fol-
intended coloring effect. lowing restrictions:
(3) Authorization for these uses shall (i) The quantity of color additive
not be construed as waiving any of the does not exceed 1 percent by weight of
requirements of section 510(k), 515, or the suture;
520(g) the Federal Food, Drug, and Cos- (ii) The dyed suture shall conform in
metic Act with respect to the medical all respects to the requirements of the
device in which [phthalocyaninato(2-)] United States Pharmacopeia XX (1980);
copper is used. and
(d) Labeling. The label of the color ad- (iii) When the sutures are used for
ditive shall conform to the require- the purposes specified in their labeling,
ments of § 70.25 of this chapter. the color additive does not migrate to
(e) Certification. All batches of the surrounding tissues.
[phthalocyaninato (2-)] copper shall be (2) The color additive FD&C Blue No.
certified in accordance with regula- 2–Aluminum Lake on alumina may be
tions in part 80 of this chapter. safely used for coloring bone cement at
[48 FR 34947, Aug. 2, 1983, as amended at 50 a level not to exceed 0.1 percent by
FR 16228, Apr. 25, 1985; 51 FR 22929, June 24, weight of the bone cement.
1986; 51 FR 28930, Aug. 13, 1986; 51 FR 39371, (3) Authorization and compliance
Oct. 28, 1986; 52 FR 15945, May 1, 1987; 55 FR with these uses shall not be construed
19620, May 10, 1990; 64 FR 23186, Apr. 30, 1999; as waiving any of the requirements of
81 FR 75692, Nov. 1, 2016]
sections 510(k), 515, and 520(g) of the
§ 74.3102 FD&C Blue No. 2. Federal Food, Drug, and Cosmetic Act
with respect to the medical device in
(a) Identity. The color additive FD&C which the color additive FD&C Blue
Blue No. 2 shall conform in identity to No. 2 and the color additive FD&C Blue
the requirements of § 74.102(a)(1). No. 2–Aluminum Lake on alumina are
(b) Specifications. (1) The color addi- used.
tive FD&C Blue No. 2 for use in color-
(d) Labeling. The labels of the color
ing surgical sutures shall conform to
additive FD&C Blue No. 2 and the color
the following specifications and shall
additive FD&C Blue No. 2–Aluminum
be free from impurities other than
Lake on alumina shall conform to the
those named to the extent that such
impurities may be avoided by current
(e) Certification. All batches of FD&C
good manufacturing practice:
Blue No. 2 and its lake shall be cer-
Sum of volatile matter at 135 °C (275 °F) and tified in accordance with regulations in
chlorides and sulfates (calculated as so- part 80 of this chapter.
dium salts), not more than 15 percent.
Water insoluble matter, not more than 0.4 [64 FR 48290, Sept. 3, 1999]
percent.
Isatin-5-sulfonic acid, not more than 0.4 per- § 74.3106 D&C Blue No. 6.
cent.
Isomeric colors, not more than 18 percent.
Lower sulfonated subsidiary colors, not more Blue No. 6 is principally [D2,2′-
than 5 percent. biindoline]-3,3′ dione (CAS Reg. No.
Lead (as Pb), not more than 10 parts per mil- 482–89–3).
lion. (b) Specifications. D&C Blue No. 6
Arsenic (as As), not more than 3 parts per shall conform to the following speci-
million. fications and shall be free from impuri-
ties other than those named to the ex-
(2) The color additive FD&C Blue No. tent that such impurities may be
2–Aluminum Lake on alumina for use avoided by good manufacturing prac-
in bone cement shall be prepared in ac- tice:
514
Volatile matter at 135 °C (275 °F), not more § 74.3206 D&C Green No. 6.
than 3 percent.
Matter insoluble in N,N- (a) Identity. The color additive D&C
dimethylformamide, not more than 1 per- Green No. 6 shall conform in identity
cent. to the requirements of § 74.1206(a).
Isatin, not more than 0.3 percent. (b) Specifications. The color additive
Anthranilic acid, not more than 0.3 percent. D&C Green No. 6 for use in medical de-
Indirubin, not more than 1 percent. vices shall conform to the specifica-
Lead (as Pb), not more than 10 parts per mil- tions of § 74.1206(b).
lion. (c) Uses and restrictions. (1) The color
Arsenic (as As), not more than 3 parts per additive D&C Green No. 6 may be safe-
million. ly used at a level
Mercury (as Hg), not more than 1 part per (i) Not to exceed 0.03 percent by
million. weight of the lens material for coloring
Total color, not less than 95 percent. contact lenses;
(ii) Not to exceed 0.75 percent by
(c) Uses and restrictions. (1) D&C Blue weight of the suture material for color-
No. 6 may be safely used at a level— ing polyethylene terephthalate sur-
(i) Not to exceed 0.2 percent by gical sutures, including sutures for
weight of the suture material for color- ophthalmic use;
ing polyethylene terephthalate sur- (iii) Not to exceed 0.1 percent by
gical sutures for general surgical use; weight of the suture material for color-
(ii) Not to exceed 0.25 percent by ing polyglycolic acid surgical sutures
weight of the suture material for color- with diameter greater than U.S.P. size
ing plain or chromic collagen absorb- 8–0, including sutures for ophthalmic
able sutures for general surgical use; use;
(iii) Not to exceed 0.5 percent by (iv) Not to exceed 0.5 percent by
weight of the suture material for color- weight of the suture material for color-
ing plain or chromic collagen absorb- ing polyglycolic acid surgical sutures
with diameter not greater than U.S.P.
able sutures for ophthalmic surgical
size 8–0, including sutures for oph-
use; thalmic use;
(iv) Not to exceed 0.5 percent by (v) Not to exceed 0.21 percent by
weight of the suture material for color- weight of the suture material for color-
ing polypropylene surgical sutures for ing poly(glycolic acid-co-trimethylene
general surgical use; and carbonate) sutures (also referred to as
(v) Not to exceed 0.5 percent by 1,4-dioxan-2,5-dione polymer with 1,3-
weight of the suture material for color- dioxan-2-one) for general surgical use;
ing polydioxanone synthetic absorbable and
sutures for ophthalmic and general sur- (vi) Not to exceed 0.10 percent by
gical use. weight of the haptic material for color-
(2) Authorization for these uses shall ing polymethylmethacrylate support
not be construed as waiving any of the haptics of intraocular lenses.
requirements of sections 510(k), 515, (2) Authorization for these uses shall
not be construed as waiving any of the
and 520(g) of the Federal Food, Drug,
requirements of sections 510(k), 515,
and Cosmetic Act with respect to the
medical device in which the color addi- and Cosmetic Act with respect to the
tive is used. medical device in which D&C Green No.
(d) Labeling. The label of the color ad- 6 is used.
ditive shall conform to the require- (d) Labeling. The label of the color ad-
ments of § 70.25 of this chapter. ditive shall conform to the require-
(e) Certification. All batches of D&C ments of § 70.25 of this chapter.
Blue No. 6 shall be certified in accord- (e) Certification. All batches of D&C
ance with regulations in part 80 of this Green No. 6 shall be certified in accord-
chapter.
[49 FR 29956, July 25, 1984; 49 FR 34447, Aug.

31, 1984, as amended at 50 FR 30698, July 29, [48 FR 13022, Mar. 29, 1983, as amended at 51
1985] FR 9784, Mar. 21, 1986; 51 FR 37909, Oct. 27,
1986; 58 FR 21542, Apr. 22, 1993]
515
§ 74.3230 21 CFR Ch. I (4–1–18 Edition)
§ 74.3230 D&C Red No. 17. for coloring poliglecaprone 25 (e-

caprolactone/glycolide copolymer) syn-
thetic absorbable sutures for use in
color additive D&C Red No. 17 shall
general surgery.
to the requirements of § 74.1317(a)(1) (iv) At a level not to exceed 0.1 per-
and (b). cent by weight of the suture material
(b) Uses and restrictions. (1) The sub- for coloring poly(e-caprolactone) ab-
stance listed in paragraph (a) of this sorbable sutures for use in general sur-
section may be used as a color additive gery.
in contact lens in amounts not to ex- (v) At a level not to exceed 0.2 per-
ceed the minimum reasonably required cent by weight of the suture material
to accomplish the intended coloring ef- for coloring glycolide/dioxanone/
fect. trimethylene carbonate tripolymer ab-
(2) Authorization for this use shall sorbable sutures for use in general sur-
not be construed as waiving any of the gery.
requirements of section 510(k), 515, and (vi) At a level not to exceed 0.2 per-
520(g) of the Federal Food, Drug, and cent by weight of the suture material
Cosmetic Act with respect to the con- for coloring absorbable sutures pre-
tact lens in which the color additive is pared from homopolymers of glycolide
used. for use in general surgery.
(c) Labeling. The label of the color ad- (3) The color additive, D&C Violet
ditive shall conform to the require- No. 2, may be safely used for coloring
ments of § 70.25 of this chapter. polymethylmethacrylate intraocular
(d) Certification. All batches of D&C lens haptics at a level not to exceed 0.2
Red No. 17 shall be certified in accord- percent by weight of the haptic mate-
ance with regulations in part 80 of this rial.
chapter. (4) The color additive, D&C Violet
No. 2, may be safely used for coloring
[55 FR 22898, June 5, 1990]
absorbable meniscal tacks made from
§ 74.3602 D&C Violet No. 2. poly (L-lactic acid) at a level not to ex-
ceed 0.15 percent by weight of the tack
(a) Identity and specifications. The material.
color additive D&C Violet No. 2 shall
(5) Authorization for these uses shall
and (b).
(b) Uses and restrictions. (1) The color
and Cosmetic Act with respect to the
additive, D&C Violet No. 2, may be
medical devices in which the color ad-
safely used for coloring contact lenses
ditive is used.
in amounts not to exceed the minimum
reasonably required to accomplish the
intended coloring effect.
(2) D&C Violet No. 2 may be safely
used for coloring sutures for use in sur- (d) Certification. All batches of D&C
gery subject to the following condi- Violet No. 2 shall be certified in ac-
tions: cordance with regulations in part 80 of
(i) At a level not to exceed 0.2 percent this chapter.
by weight of the suture material for [52 FR 19722, May 27, 1987, as amended at 55
coloring copolymers of 90 percent FR 18868, May 7, 1990; 58 FR 60109, Nov. 15,
glycolide and 10 percent L-lactide syn- 1993; 59 FR 11720, Mar. 14, 1994; 63 FR 20098,
thetic absorbable sutures for use in Apr. 23, 1998; 64 FR 32805, June 18, 1999; 65 FR
general and ophthalmic surgery; and 46344, July 28, 2000]
(ii) At a level not to exceed 0.3 per-
§ 74.3710 D&C Yellow No. 10.
cent by weight of the suture material
for coloring polydioxanone synthetic (a) Identity. The color additive D&C
absorbable sutures for use in general Yellow No. 10 shall conform to the
and ophthalmic surgery. identity requirements of § 74.1710(a).

(iii) At a level not to exceed 0.25 per- (b) Specifications. The color additive
cent by weight of the suture material D&C Yellow No. 10 for use in contact
516
lenses shall conform to the specifica- pound of the batch covered by such re-
tions of § 74.1710(b). quests, but no such fee shall be less
(c) Uses and restrictions. (1) The color than $224.
additive D&C Yellow No. 10 may be (b) Fees for repacks of certified color
used for coloring contact lenses in additives and color additive mixtures. The
amounts not to exceed the minimum fees for the services provided under the
reasonably required to accomplish the regulations in this part in the case of
intended coloring effect. each request for certification sub-
(2) Authorization for this use shall mitted in accordance with § 80.21(j)(3)
and (j)(4) shall be:
(1) 100 pounds or less—$35.
and Cosmetic Act with respect to the (2) Over 100 pounds but not over 1,000
contact lens in which the color addi- pounds—$35 plus $0.06 for each pound
tive is used. over 100 pounds.
(d) Labeling. The label of the color ad- (3) Over 1,000 pounds—$89 plus $0.02
ditive shall conform to the require- for each pound over 1,000 pounds.
ments of § 70.25 of this chapter. (c) Advance deposits. Any person regu-
(e) Certification. All batches of D&C larly requesting certification services
Yellow No. 10 shall be certified in ac- may deposit funds in advance of re-
cordance with regulations in part 80 of quests as prepayment of fees required
this chapter. by this section.
[52 FR 28690, Aug. 3, 1987] (d) Method of payment. All deposits
and fees required by this section shall
PART 80—COLOR ADDITIVE be paid by money order, bank draft, or
CERTIFICATION certified check, drawn to the order of
the Food and Drug Administration,
Subpart A—General Provisions collectible at par at Washington, DC.
All such deposits and fees shall be for-
Sec. warded to the Center for Food Safety
80.10 Fees for certification services.
and Applied Nutrition (HFS–100), Food
Subpart B—Certification Procedures and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, whereupon
80.21 Request for certification. after making appropriate records
80.22 Samples to accompany requests for
thereof, they will be transmitted to the
certification.
80.31 Certification. Treasurer of the United States for de-
80.32 Limitations of certificates. posit to the special account ‘‘Salaries
80.34 Authority to refuse certification serv- and Expenses, Certification, Inspec-
ice. tion, and Other Services, Food and
80.35 Color additive mixtures; certification Drug Administration.’’
and exemption from certification.
80.37 Treatment of batch pending certifi-
(e) Refunds from advance deposits.
cation. Whenever in the judgment of the Com-
80.38 Treatment of batch after certification. missioner the ratio between fees col-
80.39 Records of distribution. lected (which are based upon experi-
AUTHORITY: 21 U.S.C. 371, 379e. ence and the best estimate of costs and
the best estimate of earnings) and the
SOURCE: 42 FR 15662, Mar. 22, 1977, unless
otherwise noted. costs of providing the service during an
elapsed period of time, in the light of
all circumstances and contingencies,
Subpart A—General Provisions
warrants a refund from the fund col-
§ 80.10 Fees for certification services. lected during such period, he shall
make ratable refunds to those persons
(a) Fees for straight colors including
lakes. The fee for the services provided to whom the services were rendered
by the regulations in this part in the and charged, except that no refund
case of each request for certification

submitted in accordance with
§ 80.21(j)(1) and (j)(2) shall be $0.35 per
517

CFR 2018 Title21 Vol1 Part73 Additives Exempt From Certification

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CFR 2018 Title21 Vol1 Part73 Additives Exempt From Certification

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Food and Drug Administration, HHS Pt.

subpart E of part 807 of this chapter, if § 73.3129 Disodium 1-amino-4-[[4-[(2-

of are exempt from the certification re-

phenylglycine (prepared from aniline therefrom intended solely or in part for

(e) Certification. All batches of FD&C desired 2-formyl-5-

coloring purposes shall conform to the

(e) Certification. All batches of FD&C § 74.302 Citrus Red No. 2.

(e) Certification. All batches of FD&C benzylidene]-2,5-cyclohexadien-1-

chlorides and sulfates (calculated as so-

tice. this subpart as safe and suitable for use

Total color, not less than 87 percent. million.

naphthalenecarboxylic acid, calcium salt, 1-(Phenylazo)-2-naphthol, not more than 3

more than 0.5 percent.

(b) Specifications. The color additive bromine. The 4,5,6,7-

13473-26-2). The color additive is manu- chapter.

shall conform to the following speci- cium salt of 3-hydroxy-4-[(1-sulfo-2-

[42 FR 15654, Mar. 22, 1977, as amended at 44

Resorcinol, not more than 0.5 percent.

Total color, not less than 85 percent.

used for coloring drugs generally in cordance with regulations in part 80 of

(e) Certification. All batches of D&C § 74.2101 FD&C Blue No. 1.

chapter. metics intended for use in the area of

Monosodium salt of 4[[5-[(2,4-dimethyl-

(c) Labeling. The label of the color ad-

(a) Identity and specifications. The § 74.2307 D&C Red No. 7

consistent with good manufacturing metics generally in amounts consistent

and (b). conform in identity and specifications

lion. Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4-

§ 74.2708 D&C Yellow No. 8. Subpart D—Medical Devices

[49 FR 29956, July 25, 1984; 49 FR 34447, Aug.

§ 74.3230 D&C Red No. 17. for coloring poliglecaprone 25 (e-

and ophthalmic surgery. identity requirements of § 74.1710(a).

case of each request for certification

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