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

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.

Circumstance 1: Exemption from the disclosure of evaluation abstracts

Products with any of the following 3 kinds of efficacy claims can be exempted from the disclosure of evaluation abstracts:

No.	Exemption Efficacy Claims	Examples
1	Efficacy that can be directly recognized by the senses such as sight and smell	cleansing makeup removing beautifying and embellishing fragrant body refreshing hair dyeing hair perming hair color maintaining depilating deodorizing auxiliary shaving and barbering
2	Efficacy that is achieved through the simple physical application, adhesion, friction, etc., and is clearly indicated "physical effects only" on the label	freckle-removing and whitening through the physical application physical exfoliation physical removal of blackheads
3	New efficacy that can be directly recognized by the senses such as sight and smell, or new efficacy that is achieved in the physical process, and is clearly indicated "physical effects only" on the label

Circumstance 2: Sharing of efficacy evaluation test data

For make-up variants (except those claiming anti-acne, nourishing and repairing) of the same cosmetic registrant or notifier, the efficacy evaluation test data can be shared as the efficacy evaluation basis if the products meet the following conditions and requirements of equivalent evaluation:

Conditions

Except for the different types or contents of colorants (including the color adjustment part), the basic ingredients in the formula shall be the same types and have the same contents, and the series names shall be the same.

Requirements

Make-up variants may be subject to efficacy evaluation test in the form of sampling. The sampling size shall not be less than 20% of the total quantity of the make-up variants, and if the sampling size is less than 5, the total quantity should be considered as 5. The product with the lowest colorant content shall be selected first for efficacy evaluation test and a test report shall be issued.

For the products subject to equivalent evaluation, the equivalent evaluation report and the efficacy evaluation test report shall be retained for future inspection. At the time of preparing the abstract of efficacy evaluation basis, the situation of sharing the efficacy evaluation test data shall be explained.

2. Evaluation institution

Cosmetic registrants and notifiers can conduct efficacy evaluation on their own or entrust evaluation institutions with corresponding capabilities.

However, for the evaluation of the following 4 types of products, Cosmetics registration and notification testing institutions in China shall be entrusted to conduct human trials in accordance with the test methods specified in the mandatory national standards or technical norms:

sunscreen
freckle-removing and whitening products
anti-hair loss products
products with new efficacy which are not subject to the exemption from the disclosure of evaluation abstracts

For the above-mentioned products with new efficacy, if the test method not specified in mandatory national standards or technical norms is used, two or more cosmetics registration and notification testing institutions in China should be entrusted to conduct the method validation. The efficacy evaluation can only be carried out under the condition that the validation result is compliant. Furthermore, the efficacy evaluation report shall clarify the effectiveness and reliability of the method.

3. Efficacy evaluation test methods and reports

The efficacy evaluation test includes human trial, consumer use test and laboratory test. Except for special provisions, priority shall be given to the test methods in (I) and (II) for efficacy evaluation test. If no methods are prescribed in (I) and (II), the test methods in (III) and (IV) can be discretionarily selected:

Methods prescribed in mandatory national standards and technical norms for cosmetics in China;
Methods specified in other relevant regulations, national standards and industry standards in China;
Methods prescribed in relevant foreign regulations or technical standards;
Methods released by domestic or international authoritative organizations, technical institutions and industry associations, methods published in professional academic journals and magazines, or self-drafted and developed methods. Evaluation institutions shall complete the necessary test method transfer, confirmation or validation before carrying out the evaluation to ensure the scientificity and reliability.

After the completion of efficacy evaluation test, the evaluation institution will issue the evaluation test reports, which include the following contents:

Name and address of the cosmetic registrant, notifier or domestic responsible person and other related information;
Name and address of the efficacy evaluation institution and other related information;
Product name, quantity and specification, production date or batch number, color and physical state and other related information;
Test items and basis, test start and end dates, materials and methods, test results, test conclusion and other related information.

If a test method in (III) and (IV) is used, the full text of the test method shall be attached to the evaluation test report. Where the test method text or test report is in a foreign language, they shall be translated into standard Chinese.

4. Evaluation abstracts

Evaluation abstracts shall be compiled based on the efficacy evaluation basis, including at least the following information:

Product basic information
Efficacy claim evaluation items and evaluation institution
An overview of evaluation method and result
Evaluation conclusion (shall describe the correlation among the efficacy claim, its evaluation method and evaluation result)

Apart from the disclosure on the website, evaluation abstracts shall be well kept for future inspection together with the efficacy evaluation basis. If the efficacy evaluation basis is in a foreign language, it shall be translated into standard Chinese for archiving. The product formula for the efficacy evaluation test shall be consistent with that for cosmetic registration and notification, the documents proving the consistency shall be filed together with the efficacy evaluation basis.

5. Transitional measures

To ensure a smooth transition, the NMPA introduced the following transitional measures:

Starting from January 1, 2022, cosmetics registrants and notifiers shall evaluate the cosmetic efficacy claims in accordance with the Standards and upload the evaluation abstracts on the website specified by the NMPA.
For cosmetics registered or notified successfully before May 1, 2021, the cosmetics registrants or notifiers shall evaluate the cosmetic efficacy claims in accordance with the Standards and upload the evaluation abstracts before May 1, 2023.
For cosmetics registered or notified successfully between May 1, 2021 and December 31, 2021, the cosmetic registrants or notifiers shall evaluate the cosmetic efficacy claims in accordance with the Standards and upload the evaluation abstracts before May 1, 2022.

ChemLinked Comments
Compared with the second draft for comments, the Standards are more scientific and follow the market. Efficacy evaluation test data can be shared for make-up variants, saving the cost of efficacy evaluation for make-up companies and scientifically ensuring the efficacy. The Standards add that products claiming the efficacy of a certain ingredient, which are very popular in the Chinese market, require efficacy evaluation.
The Standards specify that except for the 4 types of products requiring entrusting of cosmetics registration and notification test institutions in China, other products can be evaluated by international institutions. International efficacy evaluation test methods and reports are also accepted, but the test method text or test report should be translated into standard Chinese.
The introduction of efficacy evaluation may pose great burdens to companies in the short term. The most direct impact is to increase the cost of efficacy evaluation test, especially for the 6 types of products requiring human trials. The cost of human trails is estimated to be at least 50,000 RMB per product. Furthermore, the cost of new products R&D will be increased significantly as well, which may result in a slower speed of launch and upgrade of new products.
From the perspective of industry development, the introduction of efficacy evaluation is conducive to the healthy development of the industry. For companies that previously underestimated efficacy but focused on marketing more, there must be a difficult adaptation process and some of them may face a reshuffle. But for companies that originally valued efficacy, their competitive advantage will be enhanced, and these companies may occupy more market shares.

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

2. Evaluation institution

3. Efficacy evaluation test methods and reports

4. Evaluation abstracts

5. Transitional measures

ChemLinked Comments

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