On April 9th, the National Medical Products Administration issued three important announcements: "Rules and Classifications of Cosmetics Classification", "Specifications for Evaluation of Cosmetic Efficacy Claims", and "Technical Guidelines for Cosmetic Safety Evaluation (2021 Edition)".
As a supporting bill of the new "Regulations on Cosmetics Supervision and Administration", these three notices set detailed and specific specifications on the classification rules, efficacy claims evaluation and safety assessment technical standards of cosmetics, and stipulated that they will be officially implemented on May 1.
Involving 26 functional classifications, 11 product formulations
In accordance with the cosmetics' efficacy claims, role parts, users, product formulations, and usage methods, the "Cosmetics Classification Rules and Classification Directory" subdivide cosmetics from five levels, and number the different divisions.
For cosmetics that need to be registered/filed according to the above five levels of different functions and parts of action, select the corresponding serial numbers in turn, and use "-" to connect each group of catalog codes to form a complete product classification code.
In terms of the catalogue of efficacy claims, the "Classification Rules and Catalogue of Cosmetics" divides the efficacy of cosmetics into hair dye, perm, freckle whitening, sunscreen, anti-hair loss, acne, nourishment, repair, cleansing, makeup remover, moisturizing, beauty modification, and fragrance , Deodorant, anti-wrinkle, firming, soothing, oil control, exfoliating, body conditioning, hair care, anti-breaking, anti-dandruff, hair color care, hair removal, auxiliary shaving, shaving, a total of 26 categories.
Compared with the previous effect types in the "Cosmetics Classification Rules and Classification Catalogue", the "hair styling" category has been removed, and the "freckle whitening" and "freckle whitening (physical cover only)" categories have been combined into "freckle removal". "Whitening" category, the effect refers to help reduce or slow down skin pigmentation, achieve skin whitening and whitening effect; achieve skin whitening and whitening effect through physical covering (including products that improve acne marks caused by pigment deposition).
In terms of product dosage forms, freeze-dried powders, freeze-dried tablets, and other freeze-dried dosage forms also appear in the 11 prescribed dosage forms. The main product formulations of cosmetics include creams, liquids, gels, powders, blocks, mud, wax-based, sprays, aerosols, stickers, films, and substrates.
In addition, in the classification of the user population, the "Cosmetics Classification Rules and Classification Directory" divides the population into infants (0 to 3 years old, including 3 years old), children (3 to 12 years old, including 12 years old) and the general population. For the first two categories, cosmetics also have different regulations on their efficacy claims. Among them, cosmetic products for infants and young children are limited to cleansing, moisturizing, hair care, sun protection, soothing, and body care; cosmetic products for children are limited to cleaning, makeup removal, moisturizing, beauty modification, fragrance, hair care, sun protection, and repair. , Soothing and refreshing. In addition, cosmetics claimed to be suitable for pregnant women and breastfeeding women shall be managed in accordance with the registration of special cosmetics.
It is worth noting that if the same product has multiple efficacy claims, action sites, users or product formulations, multiple corresponding serial numbers can be selected. The serial numbers should be arranged in order, and the serial numbers are connected by "/".
In addition, the "Cosmetics Classification Rules and Classification Catalogue" shows that for cosmetics that have been registered or completed the filing before May 1, 2021, the cosmetics registrant and filing person should pass the cosmetics registration filing information service platform before May 1, 2022 Supplement to provide product classification codes.
Efficacy claims need to be "graded" to provide scientific basis
The "Specifications for the Evaluation of Cosmetic Efficacy Claims" pointed out that the efficacy claims of cosmetics should have sufficient scientific basis, which mainly include literature, research data or cosmetic efficacy claims evaluation tests (mainly refer to: human efficacy evaluation tests, consumer use tests and laboratory Test) results, etc.
Registrants and record holders can, by themselves or by entrusting evaluation agencies with corresponding capabilities, to carry out cosmetic efficacy claims evaluation according to the requirements of cosmetic efficacy claims evaluation items; and upload the product efficacy claims on the special website designated by the State Drug Administration according to the specified requirements. Summary.
According to the degree of cosmetic efficacy, the "Evaluation Norm for Cosmetic Efficacy Claims" divides the basis of cosmetic efficacy claims into four levels. The simple understanding is: the stronger the efficacy, the more sufficient evidence is required.
The first level can be directly recognized by the senses such as vision and smell (such as cleaning, makeup removal, beauty modification, fragrance, body conditioning, hair coloring, perming, hair color care, hair removal, deodorization, and auxiliary shaving, etc.), or The effect occurs through simple physical covering, adhesion, friction, etc. (such as physical covering, freckle whitening, physical exfoliation, and physical blackhead removal, etc.) and clearly marking the efficacy claims that only have physical effects on the label, which can be exempted from publishing product efficacy The abstract on which the claim is based.
At the second level, cosmetics that only have moisturizing and hair care effects can be evaluated for efficacy claims through literature research, data research and analysis, or cosmetic efficacy claims evaluation tests.
The third level, cosmetics with anti-wrinkle, firming, soothing, oil control, exfoliating, anti-breaking and anti-dandruff effects, and claims to be mild and non-irritating or quantitative indicators, such as the retention time of efficacy claims, should be evaluated through cosmetic efficacy claims. , Can be combined with literature data or research data analysis results for efficacy claims evaluation.
The fourth level, cosmetics with anti-freckle whitening, sunscreen, anti-hair loss, anti-acne, nourishing and repairing effects, as well as cosmetics with specific claims (such as those claiming to be suitable for sensitive skin, claiming no tears formula), should pass the human efficacy evaluation test method Carry out efficacy claims evaluation, the latter can also pass consumer use tests.
In addition, new functional cosmetics should also be tested by the cosmetics registration and filing inspection agency in accordance with mandatory national standards and technical specifications, and a report should be issued.
If new efficacy products are tested using test methods other than compulsory national standards and technical specifications, the registrant and recorder shall entrust two or more cosmetic registration and record inspection agencies to conduct method verification. Only if it meets the requirements after verification Evaluation of new efficacy can be carried out, and parameters such as the validity and reliability of the method can be clarified in the product efficacy claim evaluation report.
It is worth noting that the "Code for Evaluation of Cosmetic Efficacy Claims" set a transitional period.
Starting from January 1, 2022, cosmetics registrants and recorders who apply for special cosmetics registration or general cosmetics recordation shall evaluate the efficacy claims of cosmetics in accordance with the The website uploads the summary on the basis of the product efficacy claim.
For cosmetics that have been registered or filed before May 1, 2021, the cosmetics registrant and filer shall evaluate the efficacy claims of the cosmetics and upload the product efficacy claims in accordance with the requirements of the "Specifications" before May 1, 2023 The summary of the basis.
For cosmetics that have been registered or completed registration between May 1, 2021 and December 31, 2021, the cosmetic registrant and recorder shall evaluate the efficacy claims of the cosmetics in accordance with the requirements of the "Specifications" before May 1, 2022 , And upload a summary of the basis for product efficacy claims.
Multicolor Series Makeup
Shared efficacy claim evaluation test data
In addition, the "Cosmetics Efficacy Claim Evaluation Standards" formally provides a solution to the problem of efficacy evaluation of multi-color cosmetics that the industry is concerned about.
The "Specifications" indicate that the same cosmetics registrant and filing person's multicolor series of color cosmetics products (except products that claim to have acne, nourishment, and repair effects) can share the efficacy claims evaluation when they meet the conditions and requirements of the equivalent evaluation The test data serves as the basis for the evaluation of efficacy claims.
Equivalence evaluation refers to the same cosmetics registrant and recorder's multi-color series make-up products. Except for the different types or contents of colorants (including color adjustment parts), the basic formula ingredients are the same in type and content, and their series names are the same. .
For such series of color cosmetics products, the efficacy claim evaluation test can be carried out in the form of random inspection. The number of random inspection products should not be less than 20% of the total number of series products. If the total number is less than 5, it is counted as 5. The product with the lowest colorant content should be selected first to carry out the efficacy claim evaluation test and issue a test report. For products undergoing equivalence evaluation, the equivalence evaluation report and the product test report for the efficacy claim evaluation test shall be retained for future reference.
"To a certain extent, it not only saves the cost of evaluating the efficacy of cosmetics companies, but also scientifically guarantees the safety of the products." An industry insider said. "For some companies that originally paid attention to efficacy evaluation, this move undoubtedly increased their competitive advantage. For those companies that previously ignored efficacy evaluation, there must be a difficult situation in the increasingly strict regulatory market. The process of adaptation."
Jiang Ligang, Chief Technology Officer of Proya Cosmetics Co., Ltd., once predicted that in the future, efficacy publicity will emphasize science and basis, and product claims will be consistent with actual functions. "Has been evaluated and verified" will become the mainstream propaganda to attract consumption. Cosmetics will be closer to medicines, and their functions will become simpler and clearer; the cost of new product development will increase significantly, new and updated products will slow down, "self-healing" innovation will decrease, and more attention will be paid to the actual needs of consumers.
A safer, more segmented and more down-to-earth cosmetics market is undergoing a new birth.
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