FDA issued a draft guidance for facility registration and product listing on August 7, offering comprehensive directions for the entities responsible for product listing, necessary dossiers, submission methods, submission deadlines, etc. Cosmetic products already on the market before December 29, 2022, must be listed with the FDA no later than December 29, 2023.
On August 7, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on cosmetic facility registrations and product listings (draft guidance). This document, available for public consultation until September 7, 2023, holds significant relevance under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
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Under the current regulatory framework, cosmetics registrants and notifiers can continue to submit a simplified version of the safety assessment report during the registration or notification process until May 1, 2025. Following this deadline, a full version of the safety assessment will be mandated. To facilitate a smooth transition, China is planning to release a set of technical guidelines.
The current cosmetic technical standard STSC 2015 specifies the cosmetics' general safety standards, prohibited/restricted/permitted ingredients and testing methods. It is revised aperiodically in response to changing trade practices in the industry. China is planning to issue a new version of STSC.
