On 8 November 2024, the US Food and Drug Administration (FDA) announced the publication of a “final rule” introducing an increase in fees for certification services for color additives, particularly for cosmetic use. The new rules come into force on 9 December 2024.
According to the FDA, these increases will allow “to continue to provide, maintain, and equip an adequate color additive certification program as required by the Federal Food, Drug, and Cosmetic Act”.
This law provides that 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 new rules provide for:
• an increase in the fee for certification services from $0.35 to $0.45 per pound for straight colors including lakes, and change the minimum fee from $224 to $288;
• an increase in the fees for repacks of certified color additives and color additive mixtures from $35 for 100 pounds or less to $45;
• an increase in the fees for repacks of certified color additives and color additive mixtures over 100 pounds, but not over 1,000 pounds, from $35 plus $0.06 for each pound over 100 pounds to $45 plus $0.08 for each pound over 100 pounds;
• an increase in the fees for repacks of certified color additives and …
