By Percefoni Doufou-Shafiq, Ph.D., Regulatory Affairs Lead, Supply Chain Team, UL Solutions
The U.S. Food and Drug Administration (FDA) announced on Nov. 8, 2023, that it will delay, by 6 months, enforcement of the requirements for product facility registration and cosmetic product listing as mandated by the Modernization of Cosmetics Regulation Act (MoCRA). The delay of enforcement applies to both existing and new facilities and products.
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The FDA mentions in its Nov. 2023 document, Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing, that it anticipates electronic (strongly recommended) and paper form submissions to be available in early December 2023, and encourages companies to do their registration/product listing if they have all the necessary information ready. It acknowledges, however, industry concerns regarding readiness to follow ongoing developments and meeting requirements in a timely manner. The industry has stated, among others, needing additional time to gather required information, obtain Facility Establishment Numbers (FEI) before registering/product listing, and gain access to the electronic submissions database. In light of these concerns, the FDA has decided to delay enforcement of the requirements under section 607 of the FD&C Act (facility registration/product listing) for an additional 6 months for both existing and new facilities:
- July 1, 2024, instead of Dec. 29, 2023, for registration of existing facilities/product listing.
- July 1, 2024, for facilities that first engaged in manufacturing/processing a cosmetic product after Dec. 29, 2022, or product listing for cosmetic products marketed after Dec. 29, 2022.
Read the full article here.
For a quick summary of the specific requirements under MoCRA please refer to the article ‘’Newly Passed Law Tightens U.S. Cosmetics Regulations’’ which was previously published by UL Solutions.
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