On September 1, in order to implement the Regulations on the Supervision and Administration of Cosmetics, the Cosmetics Supervision Department of the State Drug Administration commissioned the China Food and Drug Control Institute to organize the drafting of the Guiding Principles for the Evaluation of Cosmetic Efficacy Claims (draft for comments), and formally solicited comments from the public. The draft for comments is as follows:

Guidelines for evaluation of cosmetic efficacy claims

(Draft for comment)

Article 1 (Purpose) These guiding Principles are formulated in order to guide the cosmetic industry to carry out the efficacy claim evaluation in a scientific and standardized way and promote the healthy development of the industry.

Article 2 (Scope of Application) These Guidelines apply to the evaluation of the efficacy claims of cosmetic products.

Article 3 (responsible subjects) Cosmetics registrants and record holders are responsible for the evaluation of cosmetic efficacy claims, and are responsible for the authenticity and integrity of the test samples and relevant information provided by them and the scientific nature of the evaluation conclusions.

Article 4 (General Principle) The evaluation of cosmetic efficacy claims is to conduct scientific testing and reasonable analysis of cosmetic efficacy claims under normal, reasonable and foreseeable conditions of use, and make corresponding evaluation conclusions.

Article 5 (Scope of efficacy evaluation) The efficacy claims of cosmetics should have sufficient scientific basis, and the efficacy claims of products can be evaluated through human trials, consumer use tests, laboratory tests and other research results, combined with literature, and the evaluation principles are shown in Schedule 1.

Article 6 (Exemption for efficacy evaluation) can be directly identified by visual, olfactory and other senses, such as cleaning, makeup removal, beauty modification, fragrance, refreshing body, hair coloring, hair perm, hair styling, hair color care, hair removal, deodorization, assisted shaving; If the effect occurs through simple physical covering, adhesion, friction, etc., and is clearly physical on the label, such as physical covering whitening, physical exfoliation, and physical removal of blackheads, it can be exempted from submitting efficacy claim evaluation data.

Article 7 (New efficacy evaluation requirements) For cosmetics claiming new efficacy, select appropriate methods to carry out evaluation according to the efficacy claims, and submit efficacy claim evaluation data in accordance with the registration management requirements. If the new work efficiency is directly recognized by the senses such as vision and smell, or the effect occurs through physical action and is expressed in the label, it can be exempted from submitting the efficacy evaluation data.

Article 8 (Selection of evaluation methods) The evaluation of cosmetic efficacy claims should be combined with product classification and scientific and reasonable selection of evaluation methods. Methods prescribed by relevant domestic and foreign laws, standards and norms, authoritative organizations or technical institutions and industry association guidelines, professional academic journal published methods, etc., can also be used certified laboratory self-designed methods, but the complete text of self-designed methods must be provided in the evaluation report. When the same efficacy claims that there are many alternative evaluation methods, priority should be given to the methods in our current laws and regulations, national standards or technical specifications. Sunscreen, freckle whitening, anti-hair loss claims evaluation of the selection of methods other than the "Cosmetic Safety Technical Code", method validation is required.

Article 9 (selection of evaluation institutions) The evaluation of cosmetic efficacy claims can be carried out by the cosmetic registrant or the record holder themselves or entrusted with the corresponding ability of evaluation institutions to undertake. Evaluation and method verification of sunscreen, freckle whitening, hair loss prevention and new work effect were commissioned by cosmetic registration and filing inspection institutions.

Article 10 (requirements of evaluation institutions) Cosmetic efficacy claim evaluation institutions shall follow the principles of science, objectivity and good faith, conduct efficacy claim evaluation work in a standardized manner, and issue efficacy claim evaluation reports. The report results should be accurate and reliable, and the original records should be true, standardized, complete, traceable, and kept in accordance with relevant regulations.

Article 11 (Evaluation requirements) Evaluation methods should be scientific, reasonable, clear, detailed, operable, and meet the purpose of evaluation of cosmetic efficacy claims.

Article 12 (Basic Principles of human testing) Human testing shall comply with ethical principles, and product safety evaluation shall be completed before the test to ensure the safety of the product. Before the test, the subjects should sign informed consent and take necessary medical protective measures to protect the rights and interests of the subjects to the greatest extent. Test methods should provide subject selection principles and meet statistical requirements. Cosmetics that have been evaluated in human trials can claim that the efficacy is "evaluated and verified" on the product label. The guiding principles are in annex 1.

Article 13 (Basic Principles of Consumer Use testing) Consumers shall abide by ethical principles when using tests, and shall complete product safety evaluation before testing to ensure product safety. The selection of consumers should be representative, the number of consumers, the test questionnaire and the test method should meet the test purpose and statistical requirements, and the guiding principles are shown in Annex 2.

Article 14 (Basic Principles of Laboratory testing) Laboratory testing includes animal testing and in vitro testing, and the guiding principles are shown in Annex 3.

Article 15 (Requirements for documentary materials) The documentary materials cited include the laws, regulations and standards currently in effect at home and abroad; A published, non-review scientific study, survey, assessment report, or book. The cited literature should be relevant to the product efficacy claim, that is, the concentration, range and all other restrictions are consistent with the cited literature requirements, and ensure effective traceability of the information.

Article 16 (Freckle whitening effect cross-reference) When meeting the requirements of the guiding principles of freckle whitening effect cross-reference, freckle whitening cosmetics of the same enterprise can choose representative products to carry out human tests (the number of products carrying out human tests is not less than 20% of the total number of products), and the claims of freckle whitening effect of other products can be evaluated by cross-reference. The guiding principles are in annex 4. Products that have not been tested on humans may not be declared "proven for efficacy."

Article 17 (Efficacy claim evaluation Report) The efficacy claim evaluation report shall have complete information, standardized format, clear conclusions, and be signed by the evaluation institution. The report shall include the following information: registrant or recordholder information, evaluation organization information, product information (including formula information), evaluation items, evaluation basis, materials and methods, results and conclusions, evaluation date, etc. Human trials and consumer use tests should also include subject (or consumer) information description (screening criteria and number of completed and lost visits, etc.), informed consent, adverse reactions and other relevant information.

Article 18 (Summary of efficacy claim evaluation) The summary of cosmetic efficacy claim evaluation should at least include the purpose, method, result, conclusion and evaluation agency information of efficacy evaluation, and the correlation between each efficacy claim and its evaluation method should be briefly described, the summary is shown in Annex 5, and published on the website designated by the drug regulatory department under The State Council.

Article 19 (Filing and reference) Cosmetics registrants and recordholders shall timely file the evaluation summary, evaluation report, related literature and materials (paper or electronic version, foreign literature and materials related to the efficacy claim should be translated, and keep the translated copy and the complete original), the contract or agreement entrusted by the evaluation agency, and keep it for reference at any time. Efficacy claims as part of the cosmetic registration records, should be kept until the end of the shelf life of the last batch of products on the market ten years.

The efficacy evaluation institution shall file the evaluation report, original record, entrustment agreement, literature, electronic data, instruction manual and other related materials issued by the cosmetic efficacy claim and properly keep them for reference, and the retention period shall not be less than six years. The retention period of the sample is two years from the date of issuance of the inspection report or until the end of the shelf life or the limited use date of the sample.

Article 20 (Terminology and Interpretation) The meanings of the following terms in these Guiding Principles:

(1) Human test: refers to the observation and evaluation of human body under laboratory conditions, non-invasive instrument testing, image acquisition and analysis evaluation, subject self-assessment, etc.

(2) Consumer use test: refers to the effective collection and analysis of consumer use and evaluation information through on-site research and online research on the basis of objective and scientific methods.

(3) Laboratory tests: refers to tests conducted under specific environmental conditions and in accordance with prescribed procedures, including animal tests, in vitro tests (including in vitro organs, tissues, cells, microorganisms, physical and chemical tests), etc.