Color Additives

The term ''color additive'' is defined in the FD&C Act at Section 201 (t) and by regulation at 21 CFR 70.3 (f). Except for ''coal tar hair dyes'' used to color the hair (of the scalp), the 1960 Color Additive Amendments to the FD&C Act require that color additives used in food, drugs, medical devices, and cosmetics be approved by the FDA for their intended use, a process that requires both chemistry and safety reviews of the color additive by color chemistry and toxicology staff experts at the FDA. A cosmetic containing an ''unlisted'' color additive (i.e., a color additive that has not been approved by the FDA for its intended use) is considered adulterated and subject to regulatory action. Color additives listed at 21 CFR 73 (predominantly of inorganic (mineral) or botanical origin) are exempt from the FDA's ''batch certification'' requirements (see 21 CFR 80). Color additives listed at 21 CFR 74 are largely synthetic organic dyes and pigments (i.e., so-called ''coal tar'' colors) and are subject to the FDA's ''batch certification'' requirements at 21 CFR 80; provisionally listed color additives, including color additive lakes, are listed at 21 CFR 82. FDA recently published in the Federal Register a proposal to permanently list color additive lakes [20]; proposed simplifications in nomenclature for declaring straight colors and their lakes were also included as part of this proposal. It is important to note that all batches of certifiable color additives must actually be tested, certified in the FDA's laboratories for compliance with the identity and specifications established by regulation for that color additive, and issued a certification number before they may be represented and sold as an FDA-certified color additive.

FDA listing regulations for color additives specify permitted end-use applications, which may be general or specific in nature, sometimes with restrictions in permitted uses

Figure 2 Cosmetic ingredient growth. (From J. A. Wenninger and R. C. Canterbery, personal communications.)

Figure 2 Cosmetic ingredient growth. (From J. A. Wenninger and R. C. Canterbery, personal communications.)

or allowed concentrations. Cosmetic color additives, for example, may be listed for general use in imparting color to product formulations, for use in decorative cosmetics intended for external application to the hair and other appendages of the human body (other than the area of the eye), or may be specifically listed, solely or together with other cosmetic product applications, for eye area use [21]. Only color additives specifically authorized by regulation for use in the area of the eye may be legally used for such applications. Only one color additive, dihydroxyacetone (DHA), is specifically listed for an intended use in externally applied cosmetics ''to impart a color to the human body''; this finds widespread application in today's ''sunless'' or ''self-tanning'' cosmetic products [22]. No color additives are currently approved for use in injectable cosmetic tattoos [23]. Further details about the color additives currently listed (approved) by regulation for use in cosmetics in the United States may be found on the Internet at FDA's website (e.g., http:// www.cfsan.fda.gov/cosmetics.html).

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