FDA Proposes Rule To Amend Color Additive Regulations

The US Food and Drug Administration (FDA) has issued a proposed rule to amend the color additive regulations to increase the fees for certification services. If finalized, the proposed rule will implement a 10 cent per pound increase in color certification fees. This is the first increase proposed since 2005 when the current schedule became effective.

An increase in fees is necessary to cover increased operating costs in order to ensure the color certification program continues operating at the high level of quality and efficiency that industry expects, said FDA.

Under FD&C  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 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.

The current fee schedule specified in part 80 (21 CFR part 80) became effective in 2005 and was amended in 2006. Since 2005, the costs of the certification program have significantly increased because of general operating expenses, including the purchase and maintenance of critical equipment, rent and facility charges, and escalating staff payroll, according to FDA.

Electronic or written comments on the proposed rule must be submitted by January 3, 2023. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2022-N-1635.