Code of Federal Regulations Title 21. Food and Drugs § 21.74.2602a 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 °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.