[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR74.2053]

[Page 413]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 74_LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION--Table of Contents
 
                           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 Sec.  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 Sec.  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]