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

1

Anti-hair loss

Human trials

2

Freckle removing and whitening

• Human trials;

• Products that only evaluate whitening efficacy should not claim "freckle-removing."

3

Sunscreen

Human trials

4

Acne removing (including blackheads   removing)

• Human trials;

• Products that only evaluate the efficacy of blackheads removing should not claim "acne removing."

5

Repairing

• Human trials

• If the application site is only hair, in-vitro real hair can be used for efficacy evaluation

6

Anti-wrinkle

Any of the following methods can be used, and document literature can be combined:

• Human trials

• Consumer tests

• Laboratory tests

7

Tightening

8

Relieving

9

Oil-control

10

Exfoliating (non-physical effect)

11

Hair breakage prevention

12

Anti-dandruff

13

Moisturizing

Any of the following methods can be used:

• Document literature

• Human trials

• Consumer tests

• Laboratory tests

14

Moistening

15

Hair care

16

Claim suitable for sensitive skin

Any of the following methods can be used:

• Human trials

• Consumer tests

17

Claim gentle (No stimulation)

Any of the following methods can be used:

• Human trials

• Consumer tests

• Laboratory tests

18

Claim tear-free formula

Human trials

19

Claim quantitative index (time, statistics,   etc.)

Any of the following methods can be used:

• Human trials

• Consumer tests

• Laboratory tests

20

Claim new efficacy

• The evaluation method should be selected according to the specific efficacy claim;

• Should entrust the registration and notification testing institution to conduct the efficacy evaluation and validation

Notes:

• Laboratory tests include animal tests and in vitro tests (isolated organs, tissues, cells, microorganisms, physical and chemical tests)

• The cited document literature includes 1) current laws, regulations, and standards at home and abroad; 2) publicly published, non-summative scientific research, survey, evaluation reports, and related works. The cited literature should be relevant to the product efficacy claim. The ingredient concentration, scope, and other restrictions should be consistent with the cited literature's requirements, and the information traceability should be ensured.

• Cosmetic products that have undergone human trials can claim "the efficacy has been validated" on the label.

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, assisting with shaving and barbering

Product with efficacy that is achieved through the simple physical application, adhesion, friction, etc., and is indicated physical effects on the label

Whitening through the physical application, physical exfoliation, physical removal of blackheads

Product with 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 indicated physical effects on the label

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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.

Evaluation   Institutions

The report is signed and sealed by the evaluation institution. The evaluation institution should ensure the accuracy and reliability of the evaluation report results. The original record should be true, standardized, complete, and traceable, and should be kept in accordance with relevant regulations.

The evaluation report, original record, entrusted agreements, document literature, electronic documents, instructions for use, and other relevant documents issued should be kept on file for reference, with a retention period of no less than six years.

The sample's retention period is two years from the date of issuance of the testing report or until the sample’s expiry date/shelf life.

Registrant/Notifier

Cosmetic registrant and notifier are the responsible bodies of efficacy claim evaluation. They are responsible for the samples provided, the authenticity and completeness of the relevant documents, and the evaluation conclusions' scientificity.

The abstract of the efficacy evaluation, evaluation report, relevant document literature (Paper or electronic version. Content related to efficacy claims in foreign literature should be translated into Chinese. The translation and complete original should be kept), entrusting contract/agreement, etc. should be kept on file for reference.

The relevant documents of efficacy claims should be kept until ten years after the end of the shelf life of the last batch of products on the market.

Evaluation report

• 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.

The abstract of the evaluation report

• Purpose;

• Methods;

• Results;

• Conclusion;

• Evaluation institution information;

• Brief description of the correlation between each efficacy claim and its evaluation method.