China Implements New Testing Regulations for Cosmetic Registration and Filing

On Sept. 10, China National Medical Products Administration issued a notice ^[1] to implement a new testing regulation - Working Rules for Cosmetic Registration and Filing Testing (hereinafter referred to as “Working Rules”), which is the final version of the draft Administration Measures for Cosmetic Registration and Filing Testing opened in January ^[2] and was devised to replace the previous Measures for Cosmetic Administrative Licensing Testing and Measures for Qualification of Cosmetic Administrative Licensing Testing Institutions.

The Working Rules specify the qualification criteria, responsibilities and supervision requirements of cosmetic testing institutions as well as standard testing procedures and consists of 24 articles and 2 annexes (please contact us at [email protected] if translations are required).

As per the notice, the Working Rules greatly improve the efficiency of cosmetic registration and filing testing. All eligible cosmetic testing institutions can undertake testing work provided they are independent legal entities with a China Metrology Accreditation (CMA) and have submitted required information via the online testing information system ^[3] which was newly established by NMPA.

Notably, the relevant qualifications of cosmetic testing institutions for administrative license or testing institutions for filing of domestic non-special use cosmetics previously sanctioned by the former CFDA shall be automatically terminated starting on November 1, 2019.

From the date of issuance of this notice, cosmetics which have already applied for registration or filing but have not yet been tested, should carry out testing and generate testing reports in accordance with the "Working Rules”; for tested products or products have completed sunscreen testing items and obtained the testing report from overseas laboratories, these reports can continue to be used in the registration or filing.

For products that have been registered or filed and are in a situation where the original test items are inconsistent with the “Working Rules”, they shall complete the additional test items within one year after the issuance of this notice, in line with the test items requirements (excluding human safety test items) specified in the “Working Rules”. The supplementary report shall be submitted when applying for extending the validity period of product administrative license or provided for future reference when confirming the filed products will continue production of through the online filing system.