China's fundamental pre-market approval regulation-Administrative Measures on Cosmetic Registration and notification (hereinafter referred to as the Measures) was officially released on January 12, 2021, and will be implemented starting from May 1, 2021.
Compared with the draft version released on July 21, 2020, the finalized Measures are simplified to add clarity and increase the logicality. The main changes are as follows:
1. Delete several articles in the previous draft
The following articles are deleted in the finalized Measures:
Article 10 (Requirements for Registrants and Notifiers) (1) Having a quality management system compatible with the cosmetics to be registered or notified, and equipped with a quality and safety responsible person with professional knowledge of cosmetics quality and safety and more than 5 years of experience in cosmetics production or quality management.
Article 38 (Requirements for Imported Cosmetics) Imported cosmetics to be registered or notified shall have been marketed in the country/region where the registration place of the applicant or notifier or the production place is located. For imported cosmetics specially produced for China, the documents of relevant research and testing carried out for Chinese consumers shall be submitted.
Article 39 (Product Kits) Products that must be used in conjunction with two or more dosages and are non-separable product kits shall be subject to an application for registration or notification as one product.
Article 43 (Efficacy Information) The efficacy claims of cosmetics shall be supported by a sufficient scientific basis, which includes research data and evaluation conclusions obtained through human efficacy evaluation tests, laboratory tests, consumer use tests, and relevant scientific literature documents, etc.…
Article 87 (Soaps) These measures shall apply to soaps that claim to have special cosmetics efficacy.
However, it should be noted that the deletion of the articles is not equal to the cancellation of the requirements. Some of them may be deleted just because of the overlap with the CSAR. The future management on these matters depends on the NMPA's further explanations or the upcoming subsidiary regulations.
2. Clarify the qualification of cosmetic registrants and notifiers
The Measures specify that cosmetic registrants and notifiers shall meet the following requirements:
Be a legally established enterprise or other organization;
Have a quality management system compatible with the cosmetics subject to an application for registration or handling of notification;
Able to perform adverse reaction monitoring and evaluation
The qualifications are defined as preconditions for obtaining the username and password to submit applications of notification or registration. Based on this requirement, ChemLinked advises cosmetic registrants and notifiers to establish related systems as soon as possible in case of the delay or failure of applications.
3. Add one responsibility of domestic responsible persons
One responsibility of domestic responsible persons is added in the Measures, shown as follows:
Bearing corresponding quality and safety responsibilities of cosmetics and new cosmetic ingredients placed on the domestic market in accordance with the agreement with the registrants and notifiers.