CSAR Subsidiary Regulations: Draft Guidelines for Cosmetic Efficacy Claim Evaluation Unveiled

Cosmetic efficacy claims can be evaluated through four evaluation principles: human trials, consumer tests, laboratory tests, and document literature. The Guidelines also clarify the evaluation exemption, accepted evaluation methods and institutions, obligations of institutions and registrants/notifiers, necessary content in the evaluation report, etc.

On September 1, 2020, China National Institutes for Food and Drug Control (NIFDC) released the draft Guidelines for Cosmetic Efficacy Claim Evaluation for public consultation ^[1]. Any suggestions can be mailed to ChemLinked (cosmetic@chemlinked.com) prior to September 14, 2020, and we will submit to the NIFDC.

Background

Formerly, there were no requirements for other cosmetic efficacy claims except for sunscreens and the waterproof efficacy of sunscreen products which had to be evaluated in accordance with STSC (Safety and Technical Standards for Cosmetics 2015).

Article 22 of the CSAR released on June 29 stipulates:

"Efficacy claims of cosmetics should be supported by a sufficient scientific basis. Cosmetics registrants and notifiers should disclose the abstract of the document literature, research data or product efficacy evaluation document on which the efficacy claims are based on the special website prescribed by the NMPA of the State Council, and accept social supervision.”

The Guidelines are drafted to guide the cosmetic efficacy claims evaluation.

Key Points

1. Evaluation Principle

Cosmetic efficacy claims can be evaluated through four evaluation principles: human trials, consumer tests, laboratory tests, and document literature.