21 CFR 74.2151 - D&C Brown No. 1.

§ 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 °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.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 74 after this date.

  • 2017-01-23; vol. 82 # 13 - Monday, January 23, 2017
    1. 82 FR 7648 - Listing of Color Additives Exempt From Certification; Titanium Dioxide and Listing of Color Additives Subject to Certification; [Phthalocyaninato (2-)] Copper; Confirmation of Effective Date
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; confirmation of effective date.
      Effective date of final rule published in the Federal Register of November 1, 2016 (81 FR 75689), confirmed: December 2, 2016.
      21 CFR Parts 73 and 74