04.25.24
The Food and Drug Administration (FDA) is reopening the comment period on April 25, 2024 for 30 days for the proposed rule entitled Color Additive Certification; Increase in Fees for Certification Services that first appeared in the Federal Register in November 2022.
The agency said it is taking this action to “add supporting information to the administrative record and to adjust the record to reflect the same cost and benefits figures that were 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.
Comments should be submitted to Regulations.gov and identified with the docket number FDA-2022-N-1635.
FDA reopened the comment period on January 24, 2023 for 45 days for the proposed rule in response to a request from stakeholders to allow additional time for interested persons to develop and submit comments.
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.
The agency said it is taking this action to “add supporting information to the administrative record and to adjust the record to reflect the same cost and benefits figures that were 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.
Comments should be submitted to Regulations.gov and identified with the docket number FDA-2022-N-1635.
FDA reopened the comment period on January 24, 2023 for 45 days for the proposed rule in response to a request from stakeholders to allow additional time for interested persons to develop and submit comments.
Original Constituent Update
As reported by Happi, on November 1, 2022, FDA 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.