FDA issued a draft guidance for facility registration and product listing on August 7, offering comprehensive directions for the entities responsible for facility registration, necessary dossiers, submission methods, submission deadlines, etc. Prior to initiating facility registration, facility owners or operators shall obtain an FDA Establishment Identifier number in advance. For facilities already in operation before December 29, 2022, the registration must be completed before December 29, 2023.
In a significant move on August 7, 2023, the U.S. Food and Drug Administration (FDA) unveiled a draft guidance on cosmetic facility registrations and product listings (draft guidance). As a crucial supporting document of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), this draft guidance is open for public consultation until September 7, 2023.
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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.
