[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR74.2151]
[Page 413-414]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 74 LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION--Table of Contents
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.
[[Page 414]]
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 Sec. 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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