FDA reopens comments for color additive certification fee increase

06 May 2024 --- The US Food and Drug Administration (FDA) has reopened the comment period for 30 days for the proposed rule entitled “Color Additive Certification; Increase in Fees for Certification Services.” The reopening comes in tandem with rising concerns about regulatory costs from the cosmetics and personal care industry.

The FDA says it is taking this action to add supporting information to the administrative record and to adjust the record to reflect the same cost and benefit figures published in the preliminary regulatory impact analysis. 

“We are reopening the comment period specifically to invite public comments on the new information being added to the administrative record,” writes the organization. 

Rising costs
The rule initially appeared in the Federal Register on November 2, 2022, and increased the fees for certification services. The proposed rule will implement a US$0.10 per pound increase in color certification fees if finalized. This is the first increase proposed since 2005.

The FDA says an increase in fees is “necessary” to cover increased operating costs to ensure the color certification program continues operating at the high level of quality and efficiency that the industry expects.

The US FDA is open to comments on its “Color Additive Certification; Increase in Fees for Certification Services.”Under the Federal Food, Drug and Cosmetic Act, the FDA must certify certain color additives for use in food, drugs, cosmetics and medical devices. The FDA analyzes samples from each batch of color additives received from a manufacturer and verifies that it meets composition and purity specifications. 

Certification is performed before the color additives are permitted in products marketed to US consumers. Manufacturers pay fees based on the weight of each batch, and the FDA says these fees support its color certification program.

Those interested in filing comments should submit them to Regulations.gov and be identified with the docket number FDA-2022-N-1635.

FDA tests
In other developments, the FDA recently released the results of its 2023 sampling assignment, testing talc-containing cosmetic products for asbestos using Polarized Light Microscopy and Transmission Electron Microscopy. The FDA tested 50 samples but did not detect asbestos in any of them.

In accordance with the Modernization of Cosmetics Regulations Act of 2022, the FDA said it intends to develop regulations for standardized testing procedures for detecting asbestos in cosmetic products containing talc.

By Sabine Waldeck