The U.S. Food and Drug Administration (FDA) has announced that as of Dec. 9, 2024, it will increase fees for color additive certification services. This comes two years after the initial proposal, to provide time for public comments.
Per the FDA, this increase will allow it to continue to provide, maintain and equip an adequate color additive certification program as required by the U.S. Federal Food, Drug and Cosmetic Act (FD&C Act).
Certifying the Purity and Safety of Color Additives
"The color certification process for synthetic organic colorants is an important aspect of color additive regulations that is unique to the United States," notes industry expert Kelly Dobos. "It provides added confidence in the purity and safety of these ingredients. This is especially important in makeup and other color cosmetic products, where the concentration of these materials often far exceeds that used in other applications like foods and beverages."
20 Years in the Making and Public Comment
"This fee had remarkably not been raised in nearly 20 years," Dobos continued, "and it is not hard for any business owner to realize that the costs of maintaining a laboratory, from consumable supplies to equipment maintenance to salaries, have increased substantially over the past twenty years."
According the FDA Final Rule, during the comment period, a few comments expressed general support for FDA's color additive certification program. The rule reports: "The comments stated that the regulations, 'particularly for food and cosmetics products are necessary to ensure the safety and well-being of Americans.' With respect to the proposed fee increase in the proposed rule, one comment stated that the proposed rule 'would aid funding of a federal agency, but it would take into account recent inflation.'
"Another comment noted that 'recovering the operational costs will provide the FDA with more resources to test and evaluate color additives in consumer products, which could help protect public health,'" the rule notes.
Increased Certification Fee Structure
Per the final rule, changes to certification fees include the following.
- Straight colors including lakes will increase from US $0.35 per pound to $0.45 per pound, with the minimum fee increasing from $224 to $288.
- The fees for repacks of certified color additives and color additive mixtures will increase from $35 for 100 pounds or less to $45.
- The fee for repacks of certified color additives and color additive mixtures over 100 pounds, but not over 1,000 pounds, will increase from $35 (plus $0.06 for each pound over 100 pounds) to $45 (plus $0.08 for each pound over 100 pounds).
- The fee for repacks of certified color additives and color additive mixtures over 1,000 pounds will increase from $89 (plus $0.02 for each pound over 1,000 pounds) to $114 plus ($0.03 for each pound over 1,000 pounds).
