FAQs on Cosmetics Registration and Filing in China – Cosmetics Efficacy

We’ve translated a selection of some of the latest FAQs on cosmetics registration and filing in China with a focus on cosmetics efficacy to help you understand the current requirements.

Q: What information is required in the abstract of basis for cosmetics efficacy claims?

A: According to Article 19 of the “Criteria for the Evaluation of Cosmetic Efficacy Claims”, the abstract of the basis for the cosmetics efficacy claims should cover the contents of the basis for the efficacy claims, including:

(1) Basic information about the products;

(2) Efficacy claim evaluation project and evaluation organization;

(3) A brief description of evaluation methods and results; and

(4) Results of efficacy claim evaluation (the relevance between the product efficacy claim and the evaluation methods/ results should be clarified).

Q: How do you apply for exemption of basis of product efficacy claims on the filing system for cosmetics that can be directly identified by senses or that only have physical effects?

A: According to Article 4 of the Criteria for the Evaluation of the Efficacy of Cosmetics, when applying for registration or filing of cosmetic products, cosmetic registrants and filers must upload the abstract of the basis for the product efficacy claims on the website designated by the National Medical Products Administration. If the products are exempted from announcing the abstract of the basis for the product efficacy claim, registrants and filers are required to fill in the product efficacy claim in the “efficacy claim” module under the general cosmetics filing system, and choose the exemption option, so that the Remarks column will automatically display with “According to the Evaluation Specification for Cosmetic Efficacy Claims, cosmetics that can be directly identified by vision, smell and other senses can be exempted from announcing the abstract of the basis for product efficacy claims”. Then, registrants and filers can submit the efficacy claims.

Q: Is it possible to withdraw a submission, if there are some mistakes in the abstract of efficacy claims?

A: Abstract of efficacy claims cannot be withdrawn after submission. However, the filers may prepare a new abstract and submit the new one again. The system will publicize the latest submitted abstract. All materials regarding the abstract of efficacy claims submitted by filers will be retained in the system for future reference.

Q: As anti-acne products are not classified as special cosmetics, do we still need to perform efficacy tests for these kinds of products?

A: According to the Specification for Evaluation of Efficacy Claims of Cosmetics, cosmetics with anti-acne efficacies should do human efficacy evaluation tests. However, if the product removes the blackheads in a physical way, then it shall claim that the product only has physical effects, so as to be exempted from submitting an abstract of basis for product efficacy claim.

Q: Can the oil control efficacy report of raw materials be used as the evaluation evidence of the oil control efficacy of products?

A: The evaluation of oil control efficacy of products must be a cosmetics efficacy evaluation test, that is, the human efficacy evaluation tests, consumer use tests and laboratory tests. Besides, the evaluation shall be done in combination with literature or research data. The relevance between the oil control efficacy report of raw materials and products is not clear.

Q: If the products use the name of ingredients as their generic name, is it necessary to do the efficacy test for the ingredients?

A: According to the Measures for Administration of Cosmetics Labelling, the use of specific ingredient names or words indicating the category of ingredients should be consistent with that of the product formula, and the efficacy of the raw material in the product should be consistent with the product efficacy claim. In general, the efficacy of ingredients in products is proved by the efficacy data of the ingredients.

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