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  1. CFSAN Constituent Updates

FDA Proposes Increase in Color Certification Fees

What's New 

January 23, 2023

The U.S. Food and Drug Administration (FDA) is reopening the comment period on January 24, 2023 for 45 days for the proposed rule entitled Color Additive Certification; Increase in Fees for Certification Services that appeared in the Federal Register on November 2, 2022. The FDA is reopening the comment period in response to a recent request from stakeholders to allow additional time for interested persons to develop and submit comments. Comments should be submitted to Regulations.gov and identified with the docket number FDA-2022-N-1635.

Original Constituent Update

November 1, 2022

The U.S. Food and Drug Administration (FDA) today 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.

Under the Federal Food, Drug, and Cosmetic (FD&C) Act, certain color additives must be certified by the FDA for use 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. Certification is performed before the color additives are permitted to be used in products marketed to U.S. consumers. Manufacturers pay fees, based on the weight of each batch, and these fees support the FDA’s color certification program.

Comments on the proposed rule should be submitted within 60 days after publication in the Federal Register. 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.

Any final rule resulting from this rulemaking will be effective 30 days after the final rule’s date of publication in the Federal Register, to provide industry sufficient time to prepare for and adjust to the change in fees.

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