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  1. Color Additives

Color Certification

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.  

FDA Issues Final Rule to Increase Color Additive Certification Fees

November 8, 2024

The FDA issued a final rule to amend the color additive regulations to increase the fees for certification services. The new fees include a $0.10 per pound increase for straight colors including lakes. There are also similar increases in fees for repacks of certified color additives and color additive mixtures. This increase will allow FDA to continue to provide, maintain, and equip an adequate color additive certification program as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act). For additional information, see FDA Issues Final Rule to Increase Color Additive Certification Fees. 



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