CFR - Code of Federal Regulations Title 21

The information on this page is current as of Mar 22, 2024.

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

[Code of Federal Regulations]

[Title 21, Volume 1]

[CITE: 21CFR74.2602a]

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. 74.2602a Ext. D&C Violet No. 2.

(a) Identity. The color additive Ext. D&C Violet No. 2 is principally the monosodium salt of 2-[(9,10-dihydro-4-hydroxy -9,10-dioxo-1-anthracenyl) amino]-5-methyl-benzenesulfonic acid.

(b) Specifications. Ext. D&C Violet No. 2 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 18 percent.

Water-insoluble matter, not more than 0.4 percent.

1-Hydroxy-9,10-anthracenedione, not more than 0.2 percent.

1,4-Dihydroxy-9,10-anthracenedione, not more than 0.2 percent.

p- Toluidine, not more than 0.1 percent.

p- Toluidine sulfonic acids, sodium salts, not more than 0.2 percent.

Subsidiary colors, not more than 1 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 80 percent.

(c) Uses and restrictions. The color additive Ext. D&C Violet No. 2 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 Ext. D&C Violet No. 2 shall be certified in accordance with regulations in part 80 of this chapter.