1. What are the items included in the cosmetic filing inspection?
According to the NMPA Announcement on Implementing Work Specifications for Cosmetics Registration and Record-filing Inspection (No. 72, 2019) (hereinafter referred to as the Specifications), filing inspection includes microbiological and physicochemical tests, toxicological tests, human safety tests, human efficacy tests, etc.
The tested samples in the product inspection report should be products with the same product name and batch number.
2. Does the filing inspection have to be completed by the cosmetic registration and filing inspection institution?
No, it doesn’t. According to the NMPA Announcement on Optimizing the Management Measures for Filing Inspection of General Cosmetics (No. 13, 2023) (hereinafter referred to as the Measures), as of January 18, general cosmetics that have adopted the inspection method as the quality control measure with a production process that has been included in the daily supervision scope of the provincial drug regulatory department and the product safety risk assessment results can fully confirm the product safety, the filing person can submit the inspection report issued by itself or the entrusted manufacturing enterprise according to the relevant requirements of the cosmetics technical specification when conducting cosmetic notification.
3. Can multiple enterprises or institutions jointly complete the filing inspection items for the same product?
(1) For self-inspection items, according to the Measures and the FAQs on Cosmetics Supervision and Management (6), if the self-inspection items that can be completed by the filer or entrusted production enterprise through self-inspection have not yet covered all the filing inspection items required by regulations, only inspection items that can be completed can be conducted self-inspection with issuing corresponding self-inspection reports; other inspection items that are temporarily unable to be conducted through self-inspection can be entrusted to a qualified inspection institution to complete and issue inspection reports in accordance with the Work Specifications for Cosmetics Registration and Record-filing Inspection.
(2) For inspection items completed by entrusted inspection institutions, according to the Specifications, the registration or filing inspection items of the same product should generally be independently completed and an inspection report should be issued by the same inspection and testing institution.
If human safety tests and efficacy evaluation tests are involved, or if the asbestos is not included in the qualification certification (CMA) capability scope of the inspection and testing institution, cosmetic enterprises can choose other inspection and testing institutions that have obtained the CMA and corresponding inspection capabilities to complete it at the same time.
4. Can the inspection report that has already been issued be altered, added, or deleted?
According to the requirements of the Specifications, the inspection report shall not be altered, added, or deleted, and the inspection and testing institution shall not make changes to the inspection report that has already been issued. Cosmetic enterprises can apply to the inspection and testing institution to change the inspection report due to the changes in the product name, enterprise name, address, and other items that do not affect the inspection results, or if they find printing errors in the inspection reports. After confirmation, the inspection and testing institution can issue a supplementary inspection report or correction letter, and explain the reasons.
According to Article 33 of the Provisions for the Registration or Filing Dossier of Cosmetics, product information stated in the product inspection report should be consistent with the relevant information of the registered or filed product. If the information in the inspection report, such as product name and enterprise name, which do not affect the inspection results, is inconsistent with the registration and filing information due to reasons such as name changes, it should be explained and an application form for inspection report change, and a supplementary inspection report or correction letter issued by the inspection and testing institution should be submitted.
5. Test requirements for microbiological and physicochemical items
(1) If multiple production enterprises produce the same product, a complete product inspection report for one of the production enterprise samples should be provided, and microbiological and physicochemical inspection reports for samples from other production enterprises should be submitted.
(2) If the production site is changed or added, a microbiological and physicochemical inspection report of the products produced at the proposed change site should be submitted.
(3) If there are changes in the production process description, an explanation of the changes should be submitted, and a microbiological and physicochemical inspection report of the proposed product should be submitted.
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