CSAR Subsidiary Regulations: China Finalizes Standards for Cosmetic Efficacy Claim Evaluation

China NMPA released the finalized Standards for Cosmetic Efficacy Claim Evaluation on April 9 and will implement it starting from May 1, 2021. 20 kinds of efficacy claims such as anti-hair loss and sunscreen require efficacy evaluation. Cosmetic registrants and notifiers shall complete the efficacy evaluation and disclose the abstract of efficacy evaluation basis online at the time of registration and notification.

After two rounds of public consultation on September 1, 2020 and November 5, 2020 respectively, China NMPA officially released the finalized Standards for Cosmetic Efficacy Claim Evaluation (hereinafter referred to as "the Standards") on April 9 and will implement it starting from May 1, 2021.

The standards stipulate that 20 kinds of efficacy claims require efficacy evaluation. The efficacy evaluation basis may include literature documents, research data, or test reports of efficacy evaluation test (including human trial, consumer use test and laboratory test). Cosmetic registrants and notifiers shall complete the efficacy evaluation and disclose the abstract of efficacy evaluation basis on the website specified by the NMPA for public view at the time of registration and notification.

1. Efficacy claims requiring evaluation

No.	Efficacy claim	Human trial	Consumer use test	Laboratory test	Literature documents/ research data
1	Freckle-removing and whitening	√
2	Sunscreen	√
3	Anti-hair loss	√
4	Acne-removing	√
5	Nourishing^①	√
6	Repairing^①	√
7	Anti-wrinkle	*	*	*	△
8	Tightening	*	*	*	△
9	Relieving	*	*	*	△
10	Oil-control	*	*	*	△
11	Exfoliating	*	*	*	△
12	Hair breakage prevention	*	*	*	△
13	Anti-dandruff	*	*	*	△
14	Moisturizing	*	*	*	*
15	Hair care	*	*	*	*
16	Specific claims (claiming suitable for sensitive skins, tear-free formula)	*	*
17	Specific claims (efficacy of an ingredient)^②	*	*	*	*
18	Claim gentle (no stimulation)	*	*	*	△
19	Claim quantitative index (time, statistics, etc.)	*	*	*	△
20	Claim new efficacy	The evaluation method should be selected according to the specific efficacy claim.
Notes: 1. √ means mandatory 2. * means optional, but it is a must to choose at least one of them. 3. △ means "can be combined", but it is a must to conduct human trial, consumer use test or laboratory test simultaneously.
Annotations: ① If the effect area of the efficacy claim is hair, real hair in vitro can be chosen for evaluation. ② It must be validated that the ingredient has the claimed efficacy, and the efficacy claim of the ingredient should be fully related to that of the cosmetic product.

The above 20 kinds of efficacy claims require the efficacy evaluation and the disclosure of evaluation abstracts. It should be noted that there are two special circumstances for the efficacy evaluation.