China’s cosmetic ingredient safety information requirements have recently been updated by the National Medical Product Administration (NMPA) and include a revised transition period.
The recent announcement (No. 34 of 2023) clarifies the safety information content to be provided by raw material and cosmetics manufacturers and how such information should be submitted. Finally it lays out a new timetable for submitting the cosmetic ingredient safety information for products already registered or filed in China as well as those seeking to register or notify a product.
1. Contents of safety information on cosmetic raw materials
Cosmetics registrants and filers have the main responsibility for product quality and safety and should therefore collect and obtain detailed raw material safety-related information by asking their raw material suppliers, consulting literature, conducting research and testing, etc.
Raw material manufacturers should register raw material safety information in accordance with relevant regulations and technical specifications and be responsible for the authenticity and completeness of the raw material safety information.
2. Submission of safety information on cosmetic raw materials
Registrants and filers have 3 ways to submit cosmetic ingredient safety information:
(1) If the raw material manufacturer has registered on the raw material platform and obtained the cosmetic ingredient submission code, the cosmetics registrant and filer should directly fill in the raw material submission code.
(2) If the raw material manufacturer has not obtained a cosmetic ingredient submission code, the cosmetics registrant/filer can complete the raw material’s safety-related information through the cosmetics registration and filing information service platform, and upload a scanned copy of the paper materials affixed with the seal of the registrant/filer. Such evidence may include raw material quality specification certification documents literature consulted, relevant research and test data, etc.
(3) If only some of the raw materials used in the product formula have safety information submission codes, the cosmetics registrant/filer may follow the above requirements simultaneously by providing the submission codes for those ingredients that have them and filling in safety information for the remaining raw materials which do not have codes.
Cosmetic registrants and filers should review and evaluate the authenticity and completeness of the submission code provided by the raw material manufacturer and the corresponding raw material safety information. If there is a problem with the authenticity of the safety information provided, the raw material shall not be used. If there is a problem with the information’s integrity, the cosmetics registrant/filer may supplement and collect corresponding raw material safety information, and submit ingredient safety information by filling in the report by themselves. Any issues with cosmetic ingredient submission codes should be explained.
3. Adjustments to the transitional period of policy implementation
(1) From January 1, 2024, when applying for new registrations of special cosmetics or filings of general cosmetics, cosmetics registrants and filers shall fill in the information of all raw materials used in product formulas in accordance with relevant regulations, technical specifications and the requirements of this announcement.
(2) For cosmetics registered or filed between May 1, 2021 and December 31, 2023, if the product formula uses raw materials with antiseptic, sunscreen, coloring, hair dyeing, freckle and whitening functions, the registrant/filer shall supplement and submit the quality specification certification documents or raw material safety information of the relevant raw materials before January 1, 2024. The raw material safety information of other raw materials in the product formula shall be archived by the registrant/filer for future reference.
(3) For cosmetics that have been registered or filed before May 1, 2021, if the product formula uses raw materials that are subject to the quality specifications of the “Safety and Technical Standards for Cosmetics”, the registrant/filer shall submit the registration before January 1, 2024.
Please note that the registrant/filer shall archive raw material safety information of all raw materials in the product formula for future reference.
Please note that cosmetics registrants and filers should also ask cosmetic ingredient manufacturers for the corresponding raw material’s safety information for archiving for future reference. And that registrants and filers shall cooperate with the national or local Medical Products Administrations (MPAs) when they request to review the raw material safety information that has been archived by the cosmetics registrant or filer future reference such as during:
• the technical review of cosmetics registration
• technical verification of data after filing
• or on-site inspection.
The updated requirements for the management of safety information is summarized below for reference:
√ After January 1, 2024
The safety information for all raw materials must be submitted.
√ After May 1, 2021
√ After January 1, 2022
√ After January 1, 2023
√ Before December 31, 2023
Supplementary submission for registered/filed products
√ For products registered/filed before May 1, 2021
The quality specification materials or safety information documents of raw materials with specific requirements in the Safety and Technical Standards for Cosmetics (STSC) must be submitted before January 1, 2024.
√ For products registered/filed during May 1, 2021 to December 31, 2023
√ For products registered/filed before January 1, 2023
The safety information for all raw materials must be submitted before May 1, 2023.
Read our article on the previous transitions for China’s cosmetic ingredient safety information.
Read our article on China Cosmetics Label Requirements for Ingredients added to Cosmetic Raw Materials.
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