Color Additives
The law treats color additives differently from other cosmetic ingredients. Except for coloring materials used in coal-tar hair dyes, color additives need FDA approval for their intended use before they may be used in cosmetics, food, drugs, or many medical devices.
Each color additive that FDA approves is listed in a regulation, called a “listing regulation.” That regulation tells what the color additive is made of, how it is permitted to be used, and any limits on contaminants. Typically, these regulations set limits on lead at no more than 20 parts per million. When setting these limits, FDA considers factors such as how a color additive will be used and the likely exposure levels for consumers.
If a cosmetic contains a color additive that does not meet the requirements in its listing regulation, the cosmetic is adulterated under the law.
To learn more about how FDA regulates color additives for use in cosmetics, see “Color Additives and Cosmetics.” For a quick-reference list of the color additives that FDA has approved for use in cosmetics, as well as a link to the listing regulation for each one, see “Color Additives Permitted for Use in Cosmetics.”