How are color additives in cosmetics regulated?

Color additives are subject to a strict system of approval under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Except in the case of coal-tar hair dyes, all color additives used in cosmetics must be approved by FDA.  Color additive violations are a common reason for detaining imported cosmetic products offered for entry into the United States.

According to FDA regulations, if your product (except coal-tar hair dyes) contains a color additive, you must adhere to requirements for:

• Approval. All color additives used in cosmetics (or any other FDA-regulated product) must be approved by FDA. There must be a regulation specifically addressing a substance’s use as a color additive, its specifications, and restrictions.
• Certification. In addition to approval, for a number of color additives, every batch made must be certified by FDA if they are to be used in cosmetics (or any other FDA-regulated product) marketed in the U.S.
• Identity and specifications. All color additives must meet the requirements for identity and specifications stated in the Code of Federal Regulations (CFR).
• Use and restrictions. Color additives may be used only for the intended uses stated in the regulations that pertain to them. The regulations also specify other restrictions for certain colors, such as the maximum permissible concentration in the finished product.

According to Linda Katz, M.D., M.P.H., Director of the Office of Cosmetics and Colors in FDA’s Center for Food Safety and Applied Nutrition, “Color additives are very safe when used properly.”

The FDA conducts detailed safety reviews for colors used in cosmetics and the approval process may involve numerous studies to establish safety. FDA lists the approved colors in the Code of Federal Regulations (Title 21). These regulations describe the identity of the color, the allowed composition, the uses and restrictions and any other requirement necessary to ensure safe use.

Find out more about FDA regulation of Color Additives in Cosmetics

How are color additives regulated around the world?

Colors are also regulated in other countries. For instance, in the European Union, colors are identified on a list of allowed ingredients for coloring purposes. The colors are identified by a Colour Index number rather than a descriptive name such as Yellow 5 or Red 7. Many other countries follow the European Union model for color regulation.