On January 12, 2021, the State Administration for Market Regulation (SAMR) officially published the finalized Administrative Measures on Cosmetics Registration and Filing. It is a subsidiary to the CSAR, covers 6 chapters with 63 articles and will take effect on May 1, 2021.
The new regulation clarifies the basic requirements for registration and filing management of cosmetics and new cosmetic ingredients. Some of the major changes compared to the draft version, including but not limited to:
– Cosmetic and new cosmetic ingredient enterprises must have a suitable quality management system in place and monitor and evaluate adverse reactions.
– Apart from the obvious registration and filing tasks, domestic responsible agents have to bear corresponding responsibilities for quality and safety of cosmetics and new cosmetic ingredients, assist with adverse reaction and recall activities and cooperate with NMPA departments.
– The cosmetic registrant or filer shall submit a document confirming the relationship of entrusted production. This has been the case for imported cosmetics in the past. For domestic cosmetics, manufacturers shall now confirm this relationship via the online platform.
– The formula of general cosmetics cannot be changed, except for minor differences, i.e., the source of ingredients.
– Renewal applications of special cosmetics should be submitted between 90 and 30 working days prior to certificate expiration.
– The provisions regarding soap were removed from the finalized measure.
By Jacky Li. Contact Cisema if you would like to learn more.