ZMUni Compliance Centre

ZMUni Compliance Centre

菜单

News

>

Industry Insights

A Guide to Regulatory Requirements for Repair Efficacy Claims in China
Publication date:2023-06-16

In recent years, there has been a growing demand for cosmetic products that claim to have "repair" efficacy in China. This is due in part to the increasing awareness among Chinese consumers about the importance of skincare and the desire for products that can address specific skin concerns.

According to a report by Euromonitor International, the market share of skincare products that claim to have "repair" efficacy in China was around 20% in 2019. This includes products that claim to repair skin damage caused by aging, pollution, and other environmental factors.

Overall, the market share of efficacy claims of repair for cosmetics in China is significant and is expected to continue to grow in the future. However, companies must ensure that their claims are supported by scientific evidence and comply with regulatory requirements to avoid misleading consumers and facing penalties.

table 1

Therefore, in this article, we will give insights and address common confusions for businesses intending to make claims of ‘repair’ in China:

I.What is the definition of ‘repair’ in China? 

II.What claims can be made around ‘repair’? 

III.What tests are required to substantiate the efficacy of repair? 

IV.What should be contained in the report of efficacy claim of repair? 

V. Is it mandatory to have these tests conducted in China? 

 

I.What is the definition of ‘repair’ in China?

The Classification Rules and Catalogue of Cosmetics lists 26+X efficacy claims that are allowed to be made for products to be placed in the Chinese market. X stands for new efficacy claims, which normally requires longer registration time and a more extensive set of tests than the listed 26 claims. ‘Repair’ is among these 26 listed efficacy claims, and is defined as the function of helping to maintain the normal state of application site.

However, Products used for damaged areas such as scars, burns, and wounds are not considered as cosmetics, therefore ‘repair’ shall not indicate any functions of repairing damaged skin areas.

 

II.What claims can be made around ‘repair’?

With regard to the Cosmetics Supervision and Administration Regulation, cosmetics refer to chemical industrial products for daily use that are applied on our human body surfaces such as skin, hair, nails, lips, and so on. Application methods include rubbing, spraying, or other similar techniques for the purpose of cleansing, protecting, beautifying, or grooming.

According to this definition, the core of cosmetics are daily chemical products that are applied to the surface of the skin. When it comes to repair efficacy, the application site generally refers to the "skin." Therefore, the term "repairing the skin barrier" is often used when claiming repair efficacy.

Similarly, claims related to the "skin barrier" in packaging tends to be identified as claiming repair efficacy, such as "maintaining skin barrier stability".

 

table 1

III.What tests are required to substantiate the efficacy of repair?

Regarding to the Evaluation Norm for Efficacy Claims of Cosmetics (No. 50, 2021), human efficacy evaluation tests are required to be conducted to substantiate the efficacy of repair.

As it is required, Testing organizations generally evaluates the repair efficacy of products on the surface skin of different parts of the human body from the following dimensions:

1.Moisture content of the stratum corneum of the skin;

2. The water loss value through epidermis;

3. Skin hemoglobin and skin redness a* value.

By selecting the testing data from 14 and 28 days and comparing it with the data before using the sample, the conclusion can be drawn as to whether the product has repair efficacy.

It is worth noting that the design of human efficacy evaluation tests should comply with statistical principles. Therefore, it is recommended that the final valid number of participants in the test should be at least 30 people in order to obtain accurate results.

 

a

IV.What should be contained in the report of efficacy claim of repair?

Under the Evaluation Norm the Efficacy Claims of Cosmetics, the following contents shall be contained in the efficacy claim report:

1. Relevant information such as the name and address of the registration/notification persons, or domestic responsible person of the cosmetic;

2. Relevant information such as the name and address of the efficacy claim evaluation organization;

3. Relevant information such as the product name, quantity and specifications, production date or batch number, color and physical state;

4. Relevant information such as the test names and scientific basis, start and completion dates of the test, materials and methods, test results, and test conclusions.

Currently, when registering or filing for cosmetics, only a summary of the efficacy claim basis needs to be uploaded, and the original efficacy report can be kept on file by the registration/notification persons, or domestic responsible persons for future reference.

 

V. Is it mandatory to have these tests conducted in China?

Under current regulations, efficacy test reports for repair conducted outside China can be accepted for registration/notification of products. Therefore, it is not mandatory to have tests conducted in China to substantiate the efficacy claim of repair.

However, the report needs to be presented in compliance with the form required in China.

 

table 1

In summary, compliance with regulations is essential when making repair efficacy claims for cosmetics in China, and ZMUni can provide valuable assistance in this regard. Our team of experts can help businesses navigate the complex regulatory landscape and ensure that their claims are truthful and accurate.

In addition, we have a wealth of articles and resources on efficacy claims compliance in China, which can help businesses stay up-to-date with the latest regulations and best practices. By working with ZMUni and utilizing our resources, businesses can confidently bring their products to market and build a strong reputation in the Chinese cosmetics industry.

 

Contact us if you have any confusion on cosmetic efficacy claims: info@zmuni.com