The evaluation of cosmetics efficacy claims refers to the scientific testing, evaluation, and conclusion of cosmetics efficacy claims, under normal using conditions, through scientific methods, such as literature review, data analysis, testing, etc.
As an important basis for the administration of cosmetics, the Classification Rules and Catalog of Cosmetics has carried out a detailed classification of cosmetics efficacy, including 26+x efficacy claim categories. It also attaches explanations and guidance for each category.
I. Types of Substantiation
(1) Literature Review
(2) Data Analysis
(3) Human Trial
(4) Consumer Use Test
(5) Laboratory Test
II. Substantiation Required for Different Efficacy Claims
With regard to the Standard for the Evaluation of Efficacy Claims of Cosmetics, the following efficacy claims, with clear clarification for the use of physical methods to achieve the efficacy on the label, can be exempted from submitting substantiation:
A. Efficacy claims can be directly recognized by senses, such as vision and smell, e.g. cleansing, make-up removing, beautifying, aromatics, body refreshing, hair perm, hair-dye, hair-care, deodorant, assisted shaving.
B. Efficacy claims are achieved through the simple and physical covering, attachment, friction, etc., for example, physical covering of freckles, physical exfoliation, physical removal of blackheads, etc.
Cosmetics other than these are required to conduct the evaluation of efficacy claims and submit the substantiation to the specific website designated by National Medical Products Administration (NMPA). Table 1 is the substantiation required for different efficacy claims.
Table 1 Substantiation Required for Different Efficacy Claims
Cosmetics Category | Efficacy Claims | Required Substantiation |
Special Cosmetics | Hair-dye, hair-perm | Exemption |
Whitening and freckle removal, anti-hair loss, sun protection | Human trial | |
Other new efficacy | It depends on efficacy claims. | |
General Cosmetics | Anti-acne, nourishing, repairing | Human trial |
Exfoliating, oil-control, soothing, tightening, anti-wrinkle, anti-dandruff, hair-breakage prevention, claims of gentleness (no stimulation), claims of quantitative indication | Human trial/consumer use test/laboratory test (at least choose one of the three); Literature review or data analysis can be provided to substantiate the claims. | |
Hair care, moisturizing, specific claims (the efficacy of ingredients) | Human trial/consumer use test/laboratory test/literature review or test (at least choose one of the four) | |
Specific claims (suitable for sensitive skin, tear-free formula) | Human trial/consumer use test (at least choose one of the two) |
Human trial for products with efficacy claims of whitening and freckle removal, anti-hair loss, and sun protection has to be carried out in accordance with mandatory national standard and technical specification.
No unified methods have been issued for the evaluation of the other efficacy claims, therefore, they are allowed to use other relevant regulations, national standards, industry standards, guidance issued by authoritative institutions at home and abroad, methods from literature review, or other self-built/innovated methods.
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