On April 9, 2021, the National Medical Products Administration (NMPA) promulgated the “Cosmetic Efficacy Claims Evaluation Standards”, which will be implemented on May 1, 2021. Following hereby “The Standards”. This Standards serves as an important regulatory basis for the evaluation of cosmetic efficacy claims in China after the implementation of the “Cosmetics Supervision and Administration Regulations (CSAR).”
The CosmeticsBridge expert sorted out the six key points of the “Cosmetics Efficacy Claim Evaluation Specification” to help you quickly understand the new regulations.
1. Submit Basis Summary of Efficacy Claims
Except for the efficacy claims that only have physical effects, the Standards requires cosmetic registrants or filing persons to upload a basis summary of product efficacy claims on a special website designated by the NMPA. This provision applies to all cosmetics that are marketed in the Chinese market. Therefore, cosmetics that have been registered or filed/notified before May 1, 2021, need to supplement the basis summary before May 1, 2023.
2. Specified Evaluation Methods
The Standards specified 19 efficacy claims as the following table shows are necessary to do the efficacy claim evaluation. The evaluation methods should according to National Standards and Cosmetics Safety Technical Standards.
| No. | Efficacy claim | evaluation principle |
| 1 | Anti-hair loss | human body test |
| 2 | Freckle (whitening) | human body test; products that only evaluate whitening efficacy cannot claim “freckle” |
| 3 | Sunscreen | human body test |
| 4 | Removal Acne (including blackhead removal) | human body test; evaluation only Products with blackhead removal effects must not be claimed as “acne removal” |
| 5 | Repair | human body test; if the application scope is only hair, you can choose real hair in vitro for evaluation. |
| 6 | Nourish | human body test, if the application scope is only hair, you can choose real hair in vitro for evaluation. |
| 7 | Anti-wrinkle | choose any of the following methods, which can be combined with literature data:1 Human test2. Consumer test3. Laboratory test |
| 8 | Firming | |
| 9 | Soothing | |
| 10 | Oil control | |
| 11 | EHaircareg (non-physical) | |
| 12 | Prevent hair breaking | |
| 13 | Anti-dandruff | |
| 14 | Moisturizing | You can choose any of the following methods:1. Literature information2. Human body test3. Consumer test4. Laboratory test |
| 15 | Moistening (滋润) | |
| 16 | Hair care | |
| 17 | Claim to be suitable for sensitive skin (skin) | Choose any of the following methods:1. Human body test2. Consumer test |
| 18 | Claim mild ( No irritation) | You can choose any of the following methods:1. Human test2. Consumer test3. Laboratory test |
| 19 | Declared tear-free formula | 1. Human test2. Consumer test |
| 20 | Declared quantitative index (time, statistical data, etc.) | Choose any of the following methods Either:1. Human test2. Consumer test3. Laboratory test |
| 21 | Claiming new efficacy | According to the specific efficacy claim, the evaluation method should be selected; the registration agency should be selected to carry out the evaluation and verification work |
The Equivalence Evaluation
“Guidelines for Equivalence Evaluation (First Edition)” are included in the Standards. For makeup products such as lipsticks with the same basic formula, if they do not claim to have acne removal, nourishment, and repair effects, the efficacy claim evaluation testing data can be shared under certain conditions.
The cosmetics registrant and filing person can perform efficacy evaluation tests in random inspections samples for multi-color makeup products. The number of random inspection samples should not be less than 20% of the total number of the series products. If the total number is less than 5, it will be counted as 5.
The Testing Agency
Special cosmetics such as anti-freckle, whitening, sunscreen, and anti-hair loss effects, must conduct the human efficacy evaluation test in NMPA certified agency. However, General cosmetics efficacy evaluation can be carried out by the registrant, the filing person, or by an evaluation agency with certain capabilities.
New efficacy claims
For new efficacy claims, the Standards requires to provide an appropriate evaluation basis according to the specific functions. If this new effect uses test methods that are not listed in the “Cosmetics Safety Technical Standards”, it is necessary to entrust two or more cosmetic efficacy evaluation agencies to conduct method verification.
Product efficacy can be claimed through raw material efficacy
After confirming the raw material has specific efficacy claims, the product that is fully related to the raw material can also adopt its efficacy claims.
