A few days ago, NIFDC(National Institutes for Food and Drug Control) introduce the draft version of cosmetics registration and filing management standards under the #csar (new cosmetics supervision & management regulations). The following are key points worth to pay attention to:
1. Responsible Person (RP) Account:
As you may know, you need a responsible person to handle the cosmetics filing and registration in China, in the past, the qualification of an RP is limited, but after 2021, more materials will be needed to apply the RP account:
a. Overview of the Quality Management System
b. Resume of the person in charge of quality and safety (More than 5 years of experience in cosmetics production or quality and safety management)
c. RP Authorization does not need to add “sales and import” at business scope anymore, but will add new responsibility such as quality and assistance in adverse reaction monitoring;
d. Production qualification certification for oversea manufacturers.
2. Registration Dossiers Requirements
1. Determine the product classification code according to the “Rules for Classification of Cosmetics” and determine the application category (general, special cosmetics). Multiple functions can be declared, if involves special claims, products should do special cosmetics registration.
2. The Chinese name of the product cannot be named arbitrarily, and the corresponding relationship with the foreign name should be explained.
3. Nano ingredients will be allowed to be used;
4. All raw materials should provide the raw material manufacturer and quality specification certificate;
5. New requirements for packaging materials that directly contact the contents are added, and packaging materials that are prohibited in domestic and foreign laws and regulations should not be used;
6. Animal tests can be exempted if the conditions are met;
7. Efficacy test report: special cosmetics with sunscreen, freckle whitening, hair loss prevention, and new functions need to provide an efficacy test report;
8. For cosmetics used with equipment or tools: safety assessment should be provided, and product permeability should not be changed, such as those introduced into the skin are not within this range.
Although this is a public consulting version, the above statements may not be fully implemented. However, we still can see the big trends here, the main changes are focusing on responsible person’s responsibility, safety, and efficacy testing. Few months left to prepare or change your plans for entering China. Stay tuned with me for more information in the future to adjust your plans.
