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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Jul 20, 2022.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[CITE: 21CFR74.2151]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A - GENERAL

PART 74 -- LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION

Subpart C - Cosmetics

Sec. 74.2151 D&C Brown No. 1.

(a) Identity. The color additive D&C Brown No. 1 is a mixture of the sodium salts of 4<5-[(dialkylphenyl)- azo]-2,4-dihydroxyphenyl]azo]-benzene sulfonic acid. The alkyl group is principally the methyl group.

(b) Specifications. D&C Brown No. 1 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice:

Sum of volatile matter (at 135 deg.C) and chlorides and sulfates (calculated as sodium salts), not more than 16 percent.

Water-insoluble matter, not more than 0.2 percent.

Sulfanilic acid, sodium salt, not more than 0.2 percent.

Resorcinol, not more than 0.2 percent.

Xylidines, not more than 0.2 percent.

Disodium salt of 4<5-[(4-sulfophenyl)-azo]-2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not more than 3 percent.

Monosodium salt of 4<5-[(2,4-dimethyl-phenyl)azo] -2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not less than 29 percent and not more than 39 percent.

Monosodium salt of 4<5-[(2,5-dimethyl-phenyl)azo] -2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not less than 12 percent and not more than 17 percent.

Monosodium salt of 4<5-[(2,3-dimethyl-phenyl)azo] - 2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not less than 6 percent and not more than 13 percent.

Monosodium salt of 4<5-[(2-ethylphenyl)-azo]-2,4-dihydroxyphenyl]-azo] benzenesulfonic acid, not less than 5 percent and not more than 12 percent.

Monosodium salt of 4<5-[(3,4-dimethyl-phenyl)azo] -2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not less than 3 percent and not more than 9 percent.

Monosodium salt of 4<5-[(2,6-dimethyl-phenyl)azo] -2,4-dihydroxyphenyl]azo] benzenesulfonic acid, not less than 3 percent and not more than 8 percent.

Monosodium salt of 4<5-[(4-ethylphenyl) azo]-2,4-dihydroxyphenyl]-azo] benzenesulfonic acid, not less than 2 percent and not more than 8 percent.

Lead (as Pb), not more than 20 parts per million.

Arsenic (as As), not more than 3 parts per million.

Mercury (as Hg), not more than 1 part per million.

Total color, not less than 84 percent.

(c) Uses and restrictions. D&C Brown No. 1 may be safely used for coloring externally applied cosmetics in amounts consistent with good manufacturing practice.

(d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter.

(e) Certification. All batches of D&C Brown No. 1 shall be certified in accordance with regulations in part 80 of this chapter.

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