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 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.
Regulatory Implications of Color Additives Permitted for Use in Cosmetics
In the U.S., color additives in cosmetics are strictly regulated by the FDA under the FD&C Act and only FDA-approved color additives may be used. Therefore, it is strongly recommended that cosmetic companies continuously monitor regulatory updates, reformulate products if needed, and ensure proper labeling and documentation to maintain market access to U.S. and consumer trust.
How to Search Color Additives Permitted for Use in Cosmetics
Click here to search Color Additives Permitted for Use in Cosmetics on GlobalCosIng.
Regulations and Standards
- The MoCRA (Modernization of Cosmetics Regulation Act of 2022)
- The Federal Food, Drug, and Cosmetic Act (FD&C Act)
- Color Additives and Cosmetics
Our Services
- The United States Agent
- The United States FDA Cosmetic Facility Registration
- The United States FDA Cosmetic Product Listing
- The United States FDA OTC Drug Registration
- The United States Color Additive Batch Certification
- The United States Cosmetic/OTC Drug Labeling Review
- International Cosmetic Ingredient Name (INCI) Application
If you have any questions, please contact us at cosmetic@cirs-group.com.
