Through authorities granted by Congress, the FDA has regulatory oversight for color additives used in foods, drugs, cosmetics, and certain medical devices, or on the human body. To market a new color additive (or before using a color additive already approved for one use in another manner not yet approved), a manufacturer or other sponsor must first request approval from the FDA. This request is referred to as a Color Additive Petition. The petition must provide evidence that the substance is safe for the ways in which it will be used.

Besides approving new color additives or new uses, the FDA lists new color additives or new uses for listed color additives that have been shown to be safe for their intended uses in the Code of Federal Regulations (CFR), conducts a certification program for batches of color additives that are required to be certified before they can be used in products, and monitors the use of color additives in products in the U.S., including product labeling. In addition, domestic and foreign manufacturers of color additives used as ingredients in foods are required to register with the FDA.

Color additives must comply with individual listing regulations issued by the FDA. The use of an unlisted color additive, the improper use of a listed color additive, or the use of a color additive that does not conform to the purity and identity specifications of the listing regulation may cause a product to be adulterated under the FD&C Act. The FDA may take enforcement action against such products.

The FDA has established regulations for color additives in Title 21 of the CFR, parts 70-82. The regulations in 21 CFR parts 73, 74, and 82 identify each listed color additive, provide chemical specifications for the color additives, and identify uses and restrictions, labeling requirements for the marketed color additive, and the requirement for certification. The regulations in 21 CFR parts 70 and 71 provide definitions and describe the premarket approval process for new color additives or new uses for listed color additives. 21 CFR part 80 pertains to color additive certification.

Additional regulations that provide specific requirements for color additives in foods, drugs, cosmetics, and certain medical devices are found in other parts of the CFR. For example, the labeling of color additives in food products is found at 21 CFR 101.22(k) and in cosmetic products at 21 CFR 701.3. In the labeling of foods, most certification-exempt color additives may be declared as "artificial color" or "artificial coloring" (21 CFR 101.22(k)(2)), while certified color additives must be declared by their listed names or appropriate abbreviations (for example, FD&C Red No. 40 or Red 40) (21 CFR 101.22(k)(1)). Cochineal extract and carmine, although exempt from certification, also must be declared by their listed names. From the regulatory standpoint, the term "colorant" refers to a dye or pigment used in a food contact material such as a polymer and does not migrate to food. These materials are regulated not as color additives but as food additives (21 CFR 178.3297(a)).

For More Information:

• Color Additives in Foods
• Inventory of Color Additives
• Questions and Answers on Color Additives
• Consumer Update: How Safe are Color Additives
• Color Additives and Cosmetics Fact Sheet
• Color Additives Permitted Use in Cosmetics
• Summary of Color Additives for Use in the U.S. in Foods, Drugs, Cosmetics, and Medical Devices