Color Additive Petitions

Hair Coloring Regulation Issues. In the United States the classification of color additives is complex. Under the Federal Food, Dmg and Cosmetic Act, all cosmetic colors must be the subject of an approved color additive petition to the Food and Dmg Administration there is an exception for coal-tar colorants used to color hair. Based on the composition of these colorants, FDA can require a certification on each manufactured batch of colorant to assure conformance with the approved specifications. In the early 1990s FDA has required certification only for synthetically derived coal-tar type colors. Many of the approved color additives, both certified and noncertified, are restricted ia their potential use. These restrictions can be found ia the color additive regulations ia the Code of Federal Regulations at 21 CFR 73 and 74. 

Color Additives. The FDA has created a unique classification and strict limitations on color additives (see also CoLORANTS FOR FOOD, DRUGS, COSMETICS, AND MEDICAL DEVICES). Certified color additives are synthetic organic dyes that ate described in an approved color additive petition. Each manufactured lot of a certified dye must be analyzed and certified by the EDA prior to usage. Color lakes are pigments (qv) that consist of an insoluble metallic salt of a certified color additive deposited on an inert substrate. Lakes are subject to the color additive regulations of the EDA and must be certified by EDA prior to use. Noncertifted color additives requite an approved color additive petition, but individual batches need not be EDA certified prior to use. 

Part 71 Color additive petitions — These regulations describe the pre-market approval process for new color additives or new uses for listed color additives. ... 

The FDA regulations or guidelines prescribe the types of safety tests for a particular product. Sponsors may conduct the studies in their own laboratories or have them performed by a contract laboratory, a university, or some other type of laboratory. The sponsor submits the study reports to the FDA in food and color additive petitions, investigational new drug applications, new drug applications, new animal drug applications, biological product license applications, and other requests for permission to market a product. 

The FDA Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Additive Safety (OFAS) is responsible for reviewing food and color additive petitions and GRAS Notifications (13). OFAS has four divisions ... 

Color Additive Petitions are being submitted and reviewed by the FDA for a number of new colors and extended uses of existing colors. During the next several years, it is expected that many of these colorants may be approved for these uses in the U.S. pharmaceutical industry. 

Certified color additives are synthetic organic dyes that are described in an approved color additive petition. Each manufactured lot of a certified dye must be analyzed and certified by the FDA prior to usage. 

Color additives that are not classified as certified color or color lakes are identified as non-certified color additives. Each of these substances is the subject of an approved color additive petition, but individual batches do not require certification by the FDA prior to use. 

Manufacturers may use color additive regulations in 21 CFR Parts 70 to 82 as a reference to get more information, but toxicity of color additives for food may not be relevant to devices. If a color additive has not been previously listed, manufacturers may need to submit a color additive petition. (See HHS Publication FDA-97-4214—Premarket Approval Manual, January 1998.)... 

---