In the United States, the FDA (Food and Drug Administration) regulates cosmetic ingredients under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Color additives must be FDA-approved for specific uses. In addition, some may be used only if they are from batches that FDA has tested and certified. 

There are 29 color additives included in the list of “Color Additives That Are Exempt from Certification and Permitted for Use in Cosmetics (21 CFR Part 73 Subpart C—Cosmetics)”. The list also specifies the Eye Area, Generally (Includes Lipsticks), External Use, Specific Limitations and Comments as well as the corresponding 21 CFR Section for each color additives.

There are 36 color additives included in the list of “Color Additives That Are Subject to Certification and Permitted for Use in Cosmetics Includes Straight Colors and Lakes (21 CFR Part 74 Subpart C—Cosmetics and 21 CFR Part 82 Subparts B, C, and D)”. The list also specifies the Eye Area, Generally (Includes Lipsticks), External Use, Specific Limitations and Comments as well as the corresponding 21 CFR Section for each color additives.

Batch certification of color additives in the United States

USA-Color Additives Permitted for Use in Cosmetics (Subject to Certification)

USA-Color additives permitted for use in cosmetics-2

Eye area (Excludes lakes except where noted Only)