eCFR Reference Browser

---

title: "21 CFR §74.2053"

source: "https://www.ecfr.gov/current/title-21/section-74.2053"

title_number: "21"

volume_number: "1"

chapter_number: "Unknown"

subchapter_code: "A"

subchapter_subject: "GENERAL"

part_code: "74"

part_subject: "LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION"

subpart_code: "C"

subpart_subject: "Cosmetics"

section_number: "74.2053"

section_subject: "D&C Black No. 3."

cfr_reference: "21 CFR 74.2053"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 1 to 99"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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 °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.

§74.2053 - D&C Black No. 3.