1. How to judge whether the product belongs to general cosmetics according to the efficacy claims in the classification code of the filing application form?
According to Article 16 of the Cosmetics Supervision and Administration Regulations, cosmetics used for hair dye, hair perm, anti-spot and whitening, sunscreen, anti-hair loss, and cosmetics claiming new efficacy are special cosmetics. Cosmetics other than special cosmetics are general cosmetics. In addition, according to Article 35 of the Rules for Registration and Notification Dossiers of Cosmetics, for cosmetics that contain two or more independent formulas that must be used together or whose packaging containers cannot be separated, the formulas shall be filled in separately, and the registration or filing shall be applied for according to one product. If one or more products are special cosmetics, the registration shall be applied according to the special cosmetics.
Therefore, when conducting general cosmetic notification, if the efficacy claims of classification codes involve 01 hair dye (01), hair perm (02), anti-spot and whitening (03), sunscreen (04), anti-hair loss (05), and new efficacy (A), they are not general cosmetics and shall be registered as special cosmetics.
2. For cosmetics that claim gentle, quantitative indicators or make specific claims, how to fill out and submit in the Information Service Platform for Registration and Filing of Cosmetics?
For the following three types of cosmetics:
Cosmetics that claim gentle (such as non-irritant) or quantitative indicators (such as efficacy claim retention time, efficacy claim related statistical data, etc.);
Cosmetics with specific claims (such as claims suitable for sensitive skin, tear-free formula);
Cosmetics that claim the efficacy of products by claiming the ingredient efficacy.
The filing person shall check and fill in the corresponding contents in other special claims under the product label in the general cosmetics notification management system.
3. How to understand that the specific names of ingredients or words indicating the category of ingredients used in the generic name of the product shall be consistent with the composition of the product formula, and the efficacy of the ingredient in the product shall be consistent with the product efficacy claim?
According to Article 8 (2) of the Measures for the Administration of Cosmetics Labels, generic names shall be accurate and objective. It can be the words that indicate product ingredients or describe the purpose and used body parts. The specific names of ingredients or words indicating the category of ingredients used in the generic name of the product shall be consistent with the composition of the product formula, and the ingredient efficacy in the product shall be consistent with the product efficacy claim. The name of the animal, plant, or mineral is used to describe the flavor, color, or shape of the product, the formula may not contain this raw material. Generic names may use the name of the animal, plant, or mineral along with the fragrance, color, or shape. Or the information may be noted after the attribute name.
Among them, "the specific names of ingredients or words indicating the category of ingredients used in the generic name of the product shall be consistent with the composition of the product formula, and the ingredient efficacy in the product shall be consistent with the product efficacy claim." should include three meanings. (1) It shall be consistent with the ingredients of the product formula, that is, the formula should contain corresponding ingredients; (2) The ingredient efficacy in the product shall be consistent with the product efficacy claim, that is, the ingredient should have the efficacy corresponding to the product efficacy claim; (3) The added amount of the ingredient shall meet the requirements of producing corresponding efficacy in the product.
4. How to grasp the requirements of cosmetic efficacy claims? What is the time limit for uploading the summary of efficacy claims basis?
According to Article 22 of the Cosmetics Supervision and Administration Regulations (CSAR), "the efficacy claims of cosmetics shall have a sufficient scientific basis. The registrant and filer of cosmetics shall publish the summary of efficacy claims based on the literature, research data, or product efficacy evaluation data on the website designated by China NMPA and accept social supervision."
In addition, according to the Standard for the Evaluation of Efficacy Claims of Cosmetics, "since January 1, 2022, the cosmetics registrants and filers who apply for the registration of special cosmetics or the filing of general cosmetics shall comply with the Standard to evaluate the efficacy claims of cosmetics, and upload a summary of efficacy claims basis on the website designated by China NMPA. For cosmetics that have completed registration or filing before May 1, 2021, the cosmetics registrant and filer shall, before May 1, 2023, evaluate the efficacy claims of cosmetics according to the Standard, and upload the summary of efficacy claims basis. For the cosmetics that have completed registration or filing between May 1, 2021, and December 31, 2021, the cosmetics registrant and the filer shall, before May 1, 2022, evaluate the efficacy claim of the cosmetics according to the Standard, and upload the summary of efficacy claims basis."
Therefore, enterprises should pay attention to the scientificity and authenticity of efficacy claims when conducting the filing of general cosmetics, and should not exaggerate or make false efficacy claims. In addition, it is also necessary to pay attention to the time node of uploading the summary of efficacy claims basis and complete it within the specified time.
5. Which products are exempt from publishing the summary of efficacy claims basis?
According to Article 7 of the Standard for the Evaluation of Efficacy Claims of Cosmetics, "those that can be directly identified by sight, smell and other senses (such as cleaning, makeup removal, beauty modification, fragrance, refreshing, hair coloring, hair perm, hair color care, hair removal, deodorization, assisted shaving, etc.); Or use simple ways of physical covering, adhesion, friction, etc. to achieve effects (such as anti-spot and whitening through the physical covering, exfoliation and blackhead removal with physical methods, etc. ) and physical effects only are clearly marked on the label are exempt from publishing the summary of efficacy claims basis."
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