China cosmetics efficacy claims FAQ is available to help answer cosmetics manufacturers and ingredient suppliers’ questions.
The special issue FAQ (13th edition) was prepared by Beijing’s Cosmetic Review and Inspection Center of the Beijing Medical Products Administration (MPA).
Q1: How to determine whether a product is a general cosmetic product according to the efficacy claim in the classification code of the filing application form?
A: According to Article 16 of the Regulations on the Supervision and Administration of Cosmetics, “cosmetics used for hair coloring, perming, freckle removal and whitening, sun protection, hair loss prevention, and cosmetics claiming new effects are special cosmetics.” Cosmetics other than special cosmetics are general cosmetics.
Therefore, when filing general cosmetics, if the efficacy claim of the classification code involves 01 hair coloring, 02 perm, 03 freckle removal and whitening, 04 sun protection, 05 hair loss prevention and A new effect, it is not a general cosmetic and should be declared as special cosmetics.
Q2: How should cosmetics systems that claim mild or quantitative indicators or specific claims be reported?
A: For the following three categories of cosmetics:
1. Cosmetics that claim to be mild (such as non-irritating) or quantitative indicators (such as efficacy claim retention time, efficacy claim related statistics, etc.);
2. Cosmetics with specific claims (such as claims to be suitable for sensitive skin and tear-free formulas);
3. Cosmetics that claim the efficacy of products by claiming the efficacy of raw materials.
The filer shall check and fill in the corresponding content in the other special declarations under the product label in the general cosmetics filing management system, as shown in the figure below.
Q3: How to understand that the use of specific raw material names or words indicating the category of raw materials in the generic name of the product should be consistent with the formula ingredients of the product, and the efficacy of the raw material in the product should be consistent with the product efficacy claim?
A: The use of specific raw material names or terms indicating the category of raw materials shall be consistent with the ingredients of the product formula, and the efficacy of the raw materials in the product shall be consistent with the product efficacy claims.
If the name of an animal, plant or mineral is used to describe the fragrance, color or shape of the product, the raw material may not be included in the formula, and the name of the animal, plant or mineral may be used in the generic name in the form of fragrance, color or shape, or it may be indicated after the attribute name.”
Among them, “the use of specific raw material names or words indicating the category of raw materials shall be consistent with the formula ingredients of the product, and the efficacy of the raw materials in the product shall be consistent with the product efficacy claim” should contain three meanings:
1. Tt should be consistent with the product formula ingredients, that is, the formula should contain the corresponding raw materials;
2. The efficacy of the raw material in the product shall be consistent with the product efficacy claim, that is, the raw material shall have the efficacy corresponding to the product efficacy claim;
3. The amount of raw materials added should meet the corresponding efficacy in the product.
Q4: How to grasp the requirements of cosmetic efficacy claims? What is the timing for uploading a summary of product efficacy claims?
A: Cosmetics registrants and filers shall publish the literature, research data or abstracts of product efficacy evaluation materials on which efficacy claims are based on a special website prescribed by the drug regulatory department under the State Council.
As from January 1, 2022, cosmetics registrants and filers applying for special cosmetics registration or filing of general cosmetics shall evaluate the efficacy claims of cosmetics in accordance with the requirements of the Specification and upload a summary of the basis of product efficacy claims on a special website designated by the NMPA (National Medical Products Administration).
For cosmetics that have been registered or filed before May 1, 2021, the cosmetics registrant and filer shall, before May 1, 2023, evaluate the efficacy claims of the cosmetics in accordance with the requirements of the Code, and upload a summary of the basis for the product efficacy claims.
For cosmetics that have been registered or filed between May 1, 2021 and December 31, 2021, the cosmetics registrant and filer shall, before May 1, 2022, evaluate the efficacy claims of the cosmetics in accordance with the requirements of the Code, and upload a summary of the basis for the product efficacy claims.
Therefore, when filing general cosmetics, enterprises should pay attention to the scientificity and authenticity of efficacy claims and should not exaggerate or make false efficacy claims. In addition, it should also be noted that uploading product efficacy claims is completed within the specified time according to the time node of the summary.
Q5: Which products are exempt from publishing a summary of the basis for the product efficacy claim?
A: According to Article 7 of the “Specification for the Evaluation of Cosmetic Efficacy Claims”, “those that can be directly recognized by sight, smell and other senses (such as cleaning, makeup removal, beauty modification, aromatic, talcum, hair dyeing, perm, hair color care, hair removal, deodorization and auxiliary shaving, etc.), or through simple physical covering, attachment, friction, etc. (such as physical covering, freckle whitening, physical exfoliation and physical blackhead removal, etc.) and clearly identify on the label the efficacy claims that only have physical effects are exempted from the publication of a summary of the basis for the product’s efficacy claim.
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