Under the Federal Food, Drug, and Cosmetic Act (Chapter VII, section 721), color additives, except coal tar hair dyes, are subject to FDA approval before they may be used in food, drugs, or cosmetics, or in medical devices that come in contact with the bodies of people or animals for a significant period of time. In addition, many of these color additives must be batch certified by FDA. The following are resources related to the certification of color additives.
- Color Certification FAQs
- Improvements to Color Additive Certificates of Analysis
- Color Certification Reports: Amounts of Color Additives Certified by FDA, Updated Quarterly
- Companies Requesting Color Certification Within the Last Two Years: Updated Semi-annually
- Color Certification User Fees: From the Code of Federal Regulations
November 1, 2022
The U.S. Food and Drug Administration (FDA) issued a proposed rule to amend the color additive regulations to increase the fees for certification services. If finalized, the proposed rule will implement a 10 cent per pound increase in color certification fees. This is the first increase proposed since 2005 when the current schedule became effective.