CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

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: 21CFR82.6]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A - GENERAL

PART 82 -- LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS

Subpart A - General Provisions

Sec. 82.6 Certifiable mixtures.

(a) A batch of a mixture which contains no straight color listed in subpart C or D may be certified for use in food, drugs and cosmetics, if:

(1) Each coal-tar color used as an ingredient in mixing such batch is from a previously certified batch and such color has not changed in composition in any manner whatever since such previous certification, except by mixing into such batch of mixture;

(2) Each diluent in such batch of mixture is harmless and suitable for use therein; and

(3) No diluent (except resins, natural gum, pectin and, in the case of mixtures which are aqueous solutions or aqueous pastes, sodium benzoate in a quantity of not more than 1/10 of 1 percent) in such mixture is a nonnutritive substance, unless such mixture is for external application to shell eggs, or for use in coloring a food specified in the requests for certification of such batch submitted in accordance with § 80.21 of this chapter, and such diluent, in the usual process of manufacturing such food, is removed and does not become a component of such food.

(b) A batch of a mixture which contains no straight color listed in subpart D, or which contains a diluent not permitted by paragraph (a)(3) of this section, may be certified in accordance with the provisions of this part, for use only in drugs and cosmetics, if:

(1) Each coal-tar color used as an ingredient in mixing such batch is from a previously certified batch and such color has not changed in composition in any manner whatever since such previous certification, except by mixing into such batch of mixture.

(2) Each diluent in such batch of mixture is harmless and suitable for use therein.

(c) A batch of a mixture which contains a straight color listed in subpart D may be certified in accordance with the provisions of this part, for use only in externally applied drugs and cosmetics, if:

(1) Each coal-tar color used as an ingredient in mixing such batch is from a previously certified batch and such color has not changed in composition in any manner whatever since such previous certification, except by mixing into such batch of mixture; and

(2) Each diluent in such batch of mixture is harmless and suitable for use therein.