CSAR Subsidiary Regulations: China Amends Requirements for Cosmetic Efficacy Claim Evaluation

On November 5, 2020, China released the second draft of Guidelines for Cosmetic Efficacy Claim Evaluation for public consultation. Any suggestions can be mailed to ChemLinked ([email protected]) prior to November 29, 2020, and we will submit to the NMPA.

In comparison with the first draft (click here to read the interpretations of the first draft), the major changes in the new draft are related to the evaluation requirements for efficacy claims, evaluation methods, evaluation reports and evaluation abstracts.

Note: Text in red indicates a change from the first draft, a strikethrough indicates a removal from the first draft.

1. Amend the Evaluation Requirements for Partial Efficacy Claims

1.1 General amendments

The new draft updates the list of the evaluation items for cosmetic efficacy claims. Partial efficacy claims are subject to changes, as shown below:

No.	Efficacy Claims	Human trials	Consumer tests	Laboratory tests	Document literature
1	Anti-hair loss	√
2	Freckle removing and whitening^① Products that only evaluate whitening efficacy should not claim "freckle-removing."	√
3	Sunscreen	√
4	Acne removing (including blackheads removing) Products that only evaluate the efficacy of blackheads removing should not claim "acne removing."	√
5	Nourishing^②	√
6	Repairing^②	√
7	Anti-wrinkle	*	*	*	△
8	Tightening	*	*	*	△
9	Relieving	*	*	*	△
10	Oil-control	*	*	*	△
11	Exfoliating (non-physical effect)	*	*	*	△
12	Hair breakage prevention	*	*	*	△
13	Anti-dandruff	*	*	*	△
14	Moisturizing	*	*	*	*
	Moistening	*	*	*	*
15	Hair care	*	*	*	*
16	Claim tear-free formula	√
17	Claim suitable for sensitive skin	*	*
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 either the consumer tests or laboratory tests simultaneously.
Annotations: ① Products with the efficacy of freckle removing/whitening only through the physical application and the clear indication of physical effects on their labels can be exempted from submission of efficacy evaluation documents. ② If the application area of the efficacy claim is hair, real hair in vitro can be chosen for evaluation.

1.2 Evaluation requirements for freckle-removing and whitening

The new draft deletes the requirements for the cross-reference of the efficacy evaluation of freckle-removing and whitening products stipulated in the first draft:

"Under the premise of meeting the cross-reference principles' requirements, the freckle-removing and whitening products of the same enterprise can choose representative products for human trials, and other products can be evaluated by cross-reference. Products that have not been tested on humans should not claim "the efficacy has been validated."

Therefore, it's possible that the cross-reference of the efficacy evaluation would not be acceptable in the future. Cosmetic products that have undergone human trials can't also claim "the efficacy has been validated" on the label.

1.3 Evaluation requirements for new efficacy

The new draft adds the following requirements for new efficacy evaluation:

For the evaluation of new efficacy, cosmetics registration and notification testing institutions shall conduct human trials in accordance with the testing methods specified in the mandatory national standards or norms.
If the testing method not specified in mandatory national standards or norms is used, two or more cosmetics registration and notification testing institutions 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.

2. Redefine the Evaluation Methods and Reports

2.1 Evaluation methods

The new draft refines the accepted evaluation methods and sets the selection rules.

First draft

New draft

1). Methods prescribed by relevant domestic and foreign laws, standards, and norms;

2). Methods publicly published by authoritative organizations or technical institutions, and on industry association guidance and professional academic journals, etc.;

3). The validated laboratory self-developed methods, but the complete texts of the self-developed methods should be provided in the evaluation report.

Except for special provisions, the efficacy evaluation method shall be selected according to the following priority order:

1). Methods prescribed by mandatory national standards and norms in China;

2). Methods specified in other relevant laws, regulations, national and industry standards in China;

3). Methods prescribed by relevant international regulations or technical standards;

4). Methods publicly published by domestic or international authoritative organizations or technical institutions, and on industry association guidance;

5). Methods publicly published by professional academic magazines or periodicals;

6). The self-developed methods, but they shall be scientific and reliable and validated by two or more testing institutions.

2.2 Evaluation reports

The contents of evaluation reports are also subject to changes:

First draft

New draft

Registrant/notifier information;
Evaluation institution information;
Product information (including formula);
Evaluation items;
Evaluation basis;
Documents and methods;
Results and conclusions;
Evaluation date, etc.

The evaluation involved human trials and consumer tests should also include subject (or consumer) information description (screening conditions and the number of completed and lost to follow-up, etc.), informed consent, adverse reactions, and other related information.

Information such as the name and address of registrants/notifiers or domestic responsible persons;
Information such as the name and address of evaluation institutions;
The Chinese name, quantity and specifications, production date or batch number, color and physical state and other relevant information of the sample
The start and completion date of the evaluation, documents and methods, results and other relevant information.

If an evaluation method except for the method 1 and 2 mentioned in the part 2.1 is used, the complete text of the evaluation method shall be attached to the report. If the text is in a foreign language, it shall also be translated into Chinese.

For the keeping of evaluation reports and other related information, the new draft only regulates that those documents shall be kept by registrants/notifiers and evaluation institutions, deleting the requirements for the duration stipulated in the first draft:

“The efficacy evaluation report and abstract shall be well kept for ten years after the last batch of marketed products are expired, and the evaluation institution shall keep related documents for not less than 6 years and the samples for 2 years as of the issuance of evaluation report or until the expiration date.”

3. Further Specify the Requirements for Evaluation Abstracts

The new draft makes it clear that cosmetic registrants and notifiers shall compile an abstract of efficacy claim evaluation report (hereinafter "evaluation abstract") based on the evaluation conclusion, and publish it on the publicly-accessible website to be established by the NMPA. It also puts a particular emphasis on the mandatory disclosure of evaluation abstracts with repeated sentences of "shall publish evaluation abstracts".

In addition, it redefines the contents of evaluation abstracts and sets the exemption rules for the disclosure of evaluation abstracts:

3.1 Contents of evaluation abstracts

First draft	New draft
Evaluation purpose Methods Results Conclusion Evaluation institution information Brief description of the correlation between each efficacy claim and its evaluation method	Product basic information Efficacy claim evaluation items and evaluation institution Evaluation method and result Evaluation conclusion (shall describe the correlation among the efficacy claim, its evaluation method and evaluation result)

3.2 Exemption rules for the disclosure of evaluation abstracts

The product belongings to the following categories can be exempted from the efficacy evaluation disclosure of evaluation abstracts:

1) Product with 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 styling
hair color maintaining
depilating
deodorizing
shaving and barbering

2) Product with efficacy that is achieved through the simple physical application, adhesion, friction, etc., and is clearly indicated "physical effects only" on the label:

whitening through the physical application
physical exfoliation
physical removal of blackheads

It should be noted that only the disclosure of evaluation abstracts can be exempted for the above-mentioned products instead of efficacy evaluation mentioned in the first draft. But those products are still not subject to mandatory efficacy evaluation as per the new draft. ChemLinked estimates that NMPA might hope to encourage companies to conduct the efficacy evaluation voluntarily through such a change of wordings.

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