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

China released the second draft of Guidelines for Cosmetic Efficacy Claim Evaluation, which amends the evaluation requirements for partial efficacy claims, redefines the evaluation methods and reports, and further specifies the requirements for evaluation abstracts.

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 (cosmetic@chemlinked.com) 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

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




6

Repairing




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:

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