On November 1, the FDA issued a proposed rule to amend the color additive regulation to increase the fee for certification services. If finalized, the fees for straight colors including lakes would be $0.45 per pound ($0.10 per pound increase) with a minimum fee of $288. There would be similar increases in fees for repacks of certified color additives and color additive mixtures.

Certification of certain color additives is required under the Federal Food, Drug, & Cosmetic Act in order for those colors to be used in food, drugs, cosmetics, and medical devices. The FDA analyzes samples from each batch of color additive received from a manufacturer and verifies that it meets composition and purity specifications. Manufacturers pay fees, based on the weight of each batch, and these fees support the FDA’s color certification program.

In the press release announcing the proposed rule, the FDA noted that an increase in fees is needed to cover the increased operating costs of the color certification program, and that this is the first fee increase proposed since 2005 when the current schedule became effective.

Stakeholders may submit comments on the proposed rule by January 3, 2023.