Title 21: Food and Drugs
PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION
Subpart C—Cosmetics
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§ 74.2052 D&C Black No. 2.
(a) Identity . The color additive D&C Black No. 2 is a high-purity carbon black prepared by the oil furnace process. It is manufactured by the combustion of aromatic petroleum oil feedstock and consists essentially of pure carbon, formed as aggregated fine particles with a surface area range of 200 to 260 meters (m)2 /gram.
(b) Specifications . D&C Black 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:
(1) Surface area by nitrogen BET (Brunauer, Emmett, Teller) method, 200 to 260 m2 /gram.
(2) Weight loss on heating at 950 °C for 7 minutes (predried for 1 hour at 125 °C), not more than 2 percent.
(3) Ash content, not more than 0.15 percent.
(4) Arsenic (total), not more than 3 milligrams per kilogram (mg/kg) (3 parts per million).
(5) Lead (total), not more than 10 mg/kg (10 parts per million).
(6) Mercury (total), not more than 1 mg/kg (1 part per million).
(7) Total sulfur, not more than 0.65 percent.
(8) Total PAHs, not more than 0.5 mg/kg (500 parts per billion).
(9) Benzo[ a ]pyrene, not more than 0.005 mg/kg (5 parts per billion).
(10) Dibenz[ a,h ]anthracene, not more than 0.005 mg/kg (5 parts per billion).
(11) Total color (as carbon), not less than 95 percent.
(c) Uses and restrictions . D&C Black No. 2 may be safely used for coloring the following cosmetics in amounts consistent with current good manufacturing practice: Eyeliner, brush-on-brow, eye shadow, mascara, lipstick, blushers and rouge, makeup and foundation, and nail enamel.
(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 Black No. 2 shall be certified in accordance with regulations in part 80 of this chapter.
[69 FR 44930, July 28, 2004, as amended at 72 FR 10357]
