Cosmetics business involves multiple business entities such as cosmetics producers, sellers, and agents. Before the implementation of the new regulations, there was a lot of debate about who claimed responsibility for the efficacy of cosmetics. Article 6 of the Regulations on the Supervision and Administration of Cosmetics stipulates that the registrant and registrant of cosmetics are responsible for the quality, safety, and efficacy claims of cosmetics. Therefore, under the new regulations, the legal responsibility for claiming the efficacy of cosmetics is the registrant of special cosmetics or the registrant of ordinary cosmetics; Cosmetic sellers and other business entities are not legally responsible for claiming the efficacy of cosmetics.

Article 7 of the "Measures for the Administration of Cosmetic Labels" stipulates that Chinese labels for cosmetics should at least include the following content:

（1） Product Chinese name and special cosmetics registration certificate number;

（2） The name and address of the registrant or registrant, and if the registrant or registrant is an overseas enterprise, the name and address of the responsible person in China shall also be marked;

（3） The name and address of the production enterprise, as well as the production license number of the domestic cosmetics, should be marked simultaneously;

（4） The standard number of the product execution;

（5） All components;

（6） Net content;

（7） Service life;

（8） Usage method;

（9） Necessary safety warning language;

（10） Other contents that should be marked in accordance with laws, administrative regulations, and mandatory national standards.

According to the above regulations, efficacy claims are not mandatory for cosmetic labeling. However, when applying for special cosmetics registration or ordinary cosmetics registration, cosmetic registrants and registrants should fill in the product classification code, and the declared product efficacy classification is an important component of the product classification code; If the product is not labeled with efficacy claims, the complete product classification code cannot be determined, resulting in the inability to complete product registration or filing. Therefore, whether from the perspective of product promotion or product compliance, efficacy claims are mandatory for cosmetics. It should be emphasized that the labeling method for claiming the efficacy of cosmetics should be marked on the visible surface of the sales packaging of cosmetics, but small size packaged products with a net content of no more than 15g or 15mL of cosmetics can be marked on the accompanying product manual.

Article 4 of the Regulations on the Supervision and Administration of Cosmetics stipulates that the state implements classified management of cosmetics and cosmetic raw materials based on the degree of risk. In order to implement the "Regulations on the Supervision and Administration of Cosmetics", standardize and guide the classification of cosmetics, the National Drug Administration announced the "Classification Rules and Catalogue of Cosmetics" (hereinafter referred to as the "Classification Rules") on April 8, 2021, which has been implemented since May 1, 2021. The cosmetics classification catalog is an important means of strengthening the efficacy management of cosmetics under the new regulations. According to the "Classification Rules", cosmetics are classified specifically based on their efficacy claims, areas of action, product dosage forms, and user groups, while also considering their usage methods. The classification of cosmetic efficacy claims is an important component of the cosmetic classification catalog. According to the Classification Rules, the specific classification of cosmetic efficacy claims is as follows:

The evaluation of cosmetic efficacy claims refers to the process of scientifically testing and reasonably evaluating the efficacy claims of cosmetics under normal use conditions through literature research, research data analysis, or cosmetic efficacy claim evaluation experiments, and making corresponding evaluation conclusions. The evaluation of cosmetic efficacy claims is a new measure to strengthen the supervision of cosmetic efficacy claims under the new regulations. In order to standardize the evaluation of cosmetic efficacy claims, ensure the scientificity, accuracy, and reliability of efficacy claim evaluation results, safeguard the legitimate rights and interests of consumers, and promote social co governance and the healthy development of the cosmetics industry, the National Drug Administration issued the "Evaluation Standards for Cosmetic Efficacy Claims" (hereinafter referred to as the "Evaluation Standards") on April 8, 2021, which has been implemented since May 1, 2021. Article 2 of the Evaluation Standard stipulates that cosmetics produced and operated within the territory of the China shall be evaluated for efficacy claims in accordance with this Standard. Cosmetic registrants and registrants may conduct cosmetic efficacy claims and evaluations on their own or by entrusting evaluation institutions with corresponding capabilities. After the completion of the cosmetic efficacy claim evaluation test, the agency responsible for efficacy evaluation should also issue a cosmetic efficacy claim evaluation report. The efficacy claim evaluation report should have complete information, standardized format, clear conclusions, and be signed and confirmed by the evaluation agency. The efficacy evaluation report of cosmetics should generally include the following content:

（1） The name, address, and other relevant information of the cosmetic registrant, registrant, or domestic responsible person;

（2） The name, address, and other relevant information of the evaluation agency for efficacy claims;

（3） Product name, quantity and specifications, production date or batch number, color and physical state, and other relevant information;

（4） Test items and basis, start and completion dates of the test, materials and methods, test results, test conclusions, and other relevant information.

Article 5 of the "Regulations on the Evaluation of Cosmetic Efficacy Claims" stipulates that the efficacy claims of cosmetics should have sufficient scientific basis, including literature, research data, or the results of cosmetic efficacy claim evaluation experiments. The specific basis for claiming the efficacy of cosmetics is as follows:

（1） Literature: refers to publicly published scientific research, investigation, evaluation reports, and works obtained through search and other means, including current effective laws, regulations, technical literature, etc. at home and abroad. The literature should indicate the source to ensure effective traceability, and relevant conclusions should fully support the efficacy claim of the product.

（2） Research data: Refers to unpublished research results related to product efficacy claims obtained through scientific research and other means. The research data should be accurate and reliable, and the relevant research results can fully support the efficacy claim of the product.

（3） Human efficacy evaluation test: refers to the process of making objective evaluation conclusions on product efficacy claims through subjective evaluation, objective measurement and statistical analysis of Human subject research results under laboratory conditions and in accordance with specified methods and procedures.

（4） Consumer use testing: refers to the process of effectively collecting, organizing, and analyzing consumer product usage and efficacy claims evaluation information based on objective and scientific methods.

（5） Laboratory test: refers to the test conducted according to the specified methods and procedures under specific environmental conditions, including but not limited to Animal testing, in vitro test (including in vitro organ, tissue, cell, microorganism, physical and chemical test), etc.

Article 6 of the "Regulations on the Evaluation of Cosmetic Efficacy Claims" stipulates that cosmetic registrants and registrants may conduct cosmetic efficacy claim evaluations on their own or by entrusting evaluation institutions with corresponding capabilities in accordance with the requirements of the cosmetic efficacy claim evaluation project. In terms of the aforementioned literature, research data, human efficacy evaluation experiments, consumer use tests, and laboratory experiments, the specific basis required for cosmetic efficacy claims depends on the product efficacy claim. For example, if cosmetics claim whitening effects, it is necessary to provide human efficacy evaluation experiments as a basis; If cosmetics claim moisturizing effects, any basis such as literature, research data, human efficacy evaluation experiments, consumer use tests, or laboratory experiments can be used. The specific requirements for the evaluation of cosmetic efficacy claims are as follows:

Items marked with a √ in the option bar of the above table are mandatory; Items marked with * in the options bar are optional, but at least one item must be selected from them; The items marked with △ in the option bar are compatible items, but must be used in conjunction with human efficacy evaluation tests, consumer use tests, or laboratory tests.

Article 22 (2) of the Regulations on the Supervision and Administration of Cosmetics stipulates that cosmetic registrants and registrants shall publish a summary of the literature, research data, or product efficacy evaluation materials used for efficacy claims on a specialized website designated by the drug regulatory department of the State Council, and accept social supervision. The publication of a summary of the basis for cosmetic efficacy claims is another new measure to strengthen the supervision of cosmetic efficacy claims under the new regulations. When applying for registration or filing, cosmetic registrants and registrants shall upload the abstract of the basis for product efficacy claims on the special website designated by the National Medical Products Administration as required; The registrant and registrant of cosmetics are responsible for the scientific, truthful, reliable, and traceable nature of the abstract based on which the efficacy claims are submitted. However, those that can be directly recognized through visual and olfactory senses (such as cleaning, makeup removal, beauty modification, fragrance, refreshing, hair dyeing, perm, hair color care, hair removal, deodorization, and auxiliary shaving), or through simple physical covering, attachment If the effect occurs through friction or other methods (such as physical covering, freckle removal and whitening, physical exfoliation, and physical blackhead removal) and the label clearly identifies the efficacy claims that only have physical effects, the summary of product efficacy claims can be exempted from publication. The summary of the basis for cosmetic efficacy claims should briefly list the content of the product efficacy claims, including at least the following information: basic product information, efficacy claim evaluation items and institutions, evaluation methods and results brief description, efficacy claim evaluation conclusions, etc. The summary format for the claimed efficacy of cosmetics is as follows:

The claimed compliance of cosmetic efficacy includes two levels: formal compliance and substantive compliance. In terms of formal compliance, as mentioned above, it is necessary to clearly label the efficacy claims on the sales packaging, strictly evaluate the efficacy claims in accordance with the requirements of the cosmetic efficacy claims project, form and file the efficacy evaluation report, and publish the summary of the cosmetic efficacy claims basis in accordance with regulations. In terms of substantive compliance, the claimed content of cosmetic efficacy needs to be legal, true, accurate, and traceable. The details are as follows:

（1） The efficacy of cosmetics is claimed to be legal, divided into broad legal and chivalrous legal. The term 'legal' referred to in this article refers to the narrow sense of 'legal', which means that cosmetic efficacy claims cannot be claimed in the content prohibited by the new regulations. For example, medical terminology, the names of medical celebrities, words describing medical effects and effects, or approved drug names are not allowed to be used to express or imply that the product has medical effects; Ordinary cosmetics are not allowed to claim that the product has whitening effects, etc.

（2） The authenticity of cosmetic efficacy claims refers to the fact that cosmetic efficacy claims must be evaluated through efficacy claims and have scientific validity, and cannot claim fictional product efficacy or product efficacy without scientific basis. For example, sunscreen products that do not have waterproof properties claim to have waterproof properties.

（3） The accurate declaration of cosmetic efficacy refers to the fact that the claimed content of cosmetic efficacy must be accurate, clear, and clear, without misleading consumers. For example, when declaring the conclusion of cosmetic efficacy experiments, not only should the conclusion be true, but also clear information such as experimental conditions and individual differences should be provided to consumers to avoid misleading them.

There is considerable debate over whether the claimed content of cosmetic efficacy should be consistent with the information on product registration or filing. In order to further strengthen the supervision of cosmetics online operation, standardize the behavior of cosmetics online operation, and ensure the quality and safety of cosmetics, in accordance with the "Regulations on the Supervision and Administration of Cosmetics" and the "Measures for the Supervision and Administration of Cosmetics Production and Operation", the National Drug Administration announced the "Measures for the Supervision and Administration of Cosmetics Online Operation" (hereinafter referred to as the "Measures for the Administration of Online Operation") on March 31, 2023, which will come into effect on September 1, 2023. Article Twenty-One Demands of the Measures for the Administration of Online Business stipulates that cosmetics operators on the platform shall fulfill their obligations to disclose cosmetics information, and disclose cosmetics labels and other information that are consistent with the registration or filing materials in a comprehensive, true, accurate, clear and timely manner. The disclosed cosmetic label information should include all the contents of the cosmetic label it operates, including the product name and standard number implemented by the product, which should be prominently displayed in text on its product display page; The other information disclosed regarding product safety and efficacy claims should be consistent with the label information and summary of efficacy claims in the registration or filing materials of the cosmetics they operate. Therefore, according to the upcoming new regulations, the claimed efficacy of cosmetics should be consistent with the label information and summary of efficacy claims in the registration or filing materials, and should not exceed the scope of claims.

In the process of cosmetics operation, prominent violations of cosmetic efficacy claims are mainly manifested in labeling prohibited content, false claims, and non disclosure of the abstract of the basis for cosmetic efficacy claims. The adverse legal consequences of the above three illegal behaviors are as follows:

（1） The illegal behavior of declaring prohibited contents on the efficacy of cosmetics, such as anti-inflammatory, bactericidal and other medical effects, belongs to the illegal situation of cosmetics that do not comply with the provisions of this regulation in the production and operation labeling. Article 61 of the Regulations on the Supervision and Administration of Cosmetics stipulates that for cosmetics whose production and operation labels do not comply with the provisions of this regulation, the department responsible for drug supervision and management shall confiscate the illegal income, illegal production and operation of cosmetics, and may also confiscate the raw materials, packaging materials, tools, equipment and other items specifically used for illegal production and operation; If the value of cosmetics produced and operated illegally is less than 10000 yuan, a fine of not less than 10000 yuan but not more than 30000 yuan shall be imposed; If the value of the goods exceeds 10000 yuan, a fine of not less than 3 times but not more than 10 times the value of the goods shall be imposed; If the circumstances are serious, it shall be ordered to suspend production and business, the filing department shall cancel the filing, or the original issuing department shall revoke the cosmetics license. The legal representative or main person in charge, directly responsible supervisors, and other directly responsible personnel of the illegal unit shall be fined not less than one time but not more than two times the income they obtained from the unit in the previous year. They shall be prohibited from engaging in cosmetics production and business activities for five years.

（2） The act of claiming false or inaccurate information about the efficacy of cosmetics to mislead consumers. If the false content is displayed on the product label, it is usually handled in accordance with Article 61 of the aforementioned Regulations on the Supervision and Administration of Cosmetics; If false content appears in promotional materials such as product sales pages, it is usually considered false advertising and handled in accordance with the provisions of the Advertising Law. Article 55 of the Advertising Law stipulates that for those who violate the provisions of this Law by publishing false advertisements, the market supervision and management department shall order them to stop publishing advertisements, order advertisers to eliminate the impact within the corresponding scope, and impose a fine of not less than three times but not more than five times the advertising expenses. If the advertising expenses cannot be calculated or are significantly low, a fine of not less than 200000 yuan but not more than one million yuan shall be imposed; If there are three or more illegal acts or other serious circumstances within two years, a fine of not less than five times but not more than ten times the advertising expenses shall be imposed. If the advertising expenses cannot be calculated or are significantly low, a fine of not less than one million yuan but not more than two million yuan shall be imposed. The business license may be revoked, and the advertising examination and approval documents shall be revoked by the advertising examination authority, and the application for advertising examination shall not be accepted within one year.

（3） Article 62 of the "Regulations on the Supervision and Administration of Cosmetics" stipulates that the department responsible for drug supervision and management shall order correction, issue a warning, and impose a fine of not less than 10000 yuan but not more than 30000 yuan on cosmetic operators who do not disclose the summary of the basis for promoting the efficacy of cosmetics in accordance with regulations; If the circumstances are serious, it shall be ordered to suspend production and business, and a fine of not less than 30000 yuan but not more than 50000 yuan shall be imposed. The legal representative or main responsible person, directly responsible supervisor, and other directly responsible personnel of the illegal unit shall be fined not less than 10000 yuan but not more than 30000 yuan.