CFR - Code of Federal Regulations Title 21

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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: 21CFR74.2053]

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. 74.2053 D&C Black No. 3.

(a) Identity. The color additive D&C Black No. 3 is a washed bone char prepared from calcined cattle bones. The bones are twice heated in excess of 700 deg.C for at least 6 hours.

(b) Specifications. D&C Black No. 3 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 current good manufacturing practices:

(1) Calcium hydroxyapatite (CaO and P2O5), not less than 75 percent and not more than 84 percent;

(2) Elemental carbon, not less than 7 percent;

(3) Moisture, not more than 7 percent;

(4) Silica (SiO2), not more than 5 percent;

(5) Arsenic, not more than 3 milligrams (mg)/kilogram (kg) (3 parts per million (ppm));

(6) Lead, not more than 10 mg/kg (10 ppm); and

(7) Total polycyclic aromatic hydrocarbons (PAHs), not more than 5 mg/kg (5 ppm).

(c) Uses and restrictions. Cosmetics containing D&C Black No. 3 must comply with § 700.27 of this chapter with respect to prohibited cattle materials in cosmetic products. D&C Black No. 3 may be safely used for coloring the following cosmetics in amounts consistent with current good manufacturing practice: Eyeliner, eye shadow, mascara, and face powder.

(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. 3 shall be certified in accordance with regulations in part 80 of this chapter.

[72 FR 33666, June 19, 2007]