Product Compliance
filing/registration/consulting/training
preface
According to relevant regulations, cosmetic registrants and recorders must be responsible for the quality, safety, and efficacy claims of cosmetics. The efficacy claims of cosmetics should have sufficient scientific basis. At the same time, the registrant and registrant should publish the summary on which the efficacy claim is based on on the special website of the drug regulatory department, and accept the inspection of social supervision and regulatory departments.
Relevant regulatory basis
"Regulations on the Supervision and Administration of Cosmetics", "Regulations on the Administration of Registration and Filing Materials of Cosmetics", "Cosmetics Classification Rules and Classification Catalogues", "Cosmetics Efficacy Declaration and Evaluation Criteria"
Evaluation methods for different efficacy claims
In terms of the evaluation path, the methods for evaluating the efficacy of cosmetics are generally divided into: human body method (i.e., human efficacy experiments), consumer use data), laboratory method, and documentary evidence.
According to regulatory requirements, there are corresponding evaluation methods for different efficacy claims, as follows:
1、Cosmetics that have the effects of spot removing, whitening, sunscreen and anti-alopecia should be evaluated for efficacy through human efficacy evaluation tests.A qualified experimental institution shall conduct human efficacy evaluation tests in accordance with mandatory national standards and technical specifications, and issue a report;
2、Cosmetics that only have moisturizing and hair care effects can be evaluated in any of the four ways mentioned above;
3、Cosmetics with acne removing, nourishing, and repairing effects should be evaluated through human efficacy evaluation tests for efficacy claims. Unlike spot removing, whitening, sunscreen and anti-alopecia, there is currently no regulatory uniform method and requirements for the qualification of testing institutions.
4、Cosmetics that have anti-wrinkle, firming, soothing, oil control, exfoliation, anti-breakage and anti-dandruff effects, as well as claims of mild (such as non-irritating), can choose the human method, consumer use test, laboratory method in either way to do efficacy evaluation, but also combined with literature or research data analysis results, efficacy claims evaluation.
5、For those that can be directly identified through visual and olfactory senses (such as cleaning, makeup removal, beauty modification, aroma, refreshing, hair coloring, perm, hair color care, epilation, deodorization and auxiliary shaving, etc.), or through the simple physical covering, attachment, friction and other methods make effects (such as physical covering, freckle removal, whitening, physical exfoliation, and blackhead removal) and the label clearly identifies the efficacy claims that only have physical effects, can be exempted from the summary of the basis for the product's efficacy claims.
The summary reference is as follows:
Requirements for Evaluation of Cosmetic Efficacy Claims Note: 1. Items marked with a √ in the option bar are mandatory items; "Items marked with an * in the option bar are optional items, but at least one item must be selected from them;"; "Items marked with △ in the option bar are optional items, but must be used in conjunction with human efficacy evaluation tests, consumer use tests, or laboratory tests.". Note: ① If the freckle removing and whitening effect is only achieved through physical covering, and it is explicitly indicated in the label as a physical effect, the product efficacy declaration and evaluation data may be exempted from submission; ② If the efficacy claims that the action site is only hair, it can be evaluated by selecting in vitro real hair.
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