FDA Issues Final Rule on Amended Color Additive Certification Fees

Certain color additives must be certified by the FDA for use in cosmetics. Here are the new fees and a link to impacted materials.

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By: Christine Esposito

Editor-in-Chief

The US Food and Drug Administration (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), according to the Administration.

Certain color additives must be certified by the FDA for use in food, drugs, cosmetics, and certain medical devices. Certification is performed before the color additives are permitted to be used in these products. Manufacturers pay fees for certification services and the fees support the FDA’s color certification program.

The final rule will be effective 30 days after its November 8, 2024, date of publication in the Federal Register.

Color Additives in Color Cosmetics

Which additives in color cosmetics are impacted by the final rule? Here is your link to the FDA page with pertinent information.

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