No. 727

The "Regulations on the Supervision and Administration of Cosmetics" were adopted at the 77th Executive Meeting of the State Council on January 3, 2020, and are hereby promulgated and shall come into force on January 1, 2021.

Premier Li Keqiang

June 16, 2020

Regulations on the Supervision and Administration of Cosmetics

Chapter 1 General Provisions

Article 1 These Regulations are formulated to standardize the production and operation of cosmetics, strengthen the supervision and administration of cosmetics, ensure the quality and safety of cosmetics, protect the health of consumers, and promote the healthy development of the cosmetics industry.

Article 2 Those engaged in the production and operation of cosmetics and their supervision and administration within the People's Republic of China shall abide by these Regulations.

Article 3 The term "cosmetics" as used in these Regulations refers to daily chemical industrial products applied to the surface of the human body, such as skin, hair, nails, and lips, by smearing, spraying, or other similar methods, for the purpose of cleaning, protecting, beautifying, or decorating.

Article 4 The State shall implement classified management of cosmetics and cosmetic raw materials according to the degree of risk.

Cosmetics are divided into special cosmetics and ordinary cosmetics. The State shall implement registration management for special cosmetics and filing management for ordinary cosmetics.

Cosmetic raw materials are divided into new raw materials and already used raw materials. The State shall implement registration management for new cosmetic raw materials with a higher degree of risk and filing management for other new cosmetic raw materials.

Article 5 The State Council's drug supervision and administration department is responsible for the national supervision and administration of cosmetics. Relevant departments under the State Council shall be responsible for the supervision and administration related to cosmetics within their respective responsibilities.

The departments of the local people's governments at or above the county level responsible for drug supervision and administration shall be responsible for the supervision and administration of cosmetics within their respective administrative regions. Relevant departments of the local people's governments at or above the county level shall be responsible for the supervision and administration related to cosmetics within their respective responsibilities.

Article 6 The registrant and filer of cosmetics shall be responsible for the quality, safety, and efficacy claims of the cosmetics.

Cosmetic producers and operators shall engage in production and operation activities in accordance with laws, regulations, mandatory national standards, and technical specifications, strengthen management, maintain integrity and self-discipline, and ensure the quality and safety of cosmetics.

Article 7 Cosmetics industry associations shall strengthen industry self-discipline, urge and guide cosmetic producers and operators to engage in production and operation activities in accordance with the law, and promote the building of industry integrity.

Article 8 Consumer associations and other consumer organizations shall conduct social supervision in accordance with the law on acts that violate the provisions of these Regulations and harm the legitimate rights and interests of consumers.

Article 9 The State encourages and supports the conduct of cosmetic research and innovation to meet consumer needs, promote the construction of cosmetic brands, and leverage the leading role of brands. The State shall protect the legitimate rights and interests of units and individuals engaged in cosmetic research and innovation.

The State encourages and supports cosmetic producers and operators to adopt advanced technologies and advanced management norms to improve the quality and safety of cosmetics; encourages and supports the application of modern science and technology, combined with China's traditional advantages and characteristic plant resources, to research and develop cosmetics.

Article 10 The State shall strengthen the informatization construction of cosmetic supervision and administration, improve the level of online government services, provide convenience for handling cosmetic administrative licenses and filings, and promote the sharing of supervision and administration information.

Chapter 2 Raw Materials and Products

Article 11 Natural or artificial raw materials used in cosmetics for the first time within China are new cosmetic raw materials. New cosmetic raw materials with functions such as antiseptic, sunscreen, coloring, hair dyeing, and freckle removal and whitening shall be used only after registration by the State Council's drug supervision and administration department; other new cosmetic raw materials shall be filed with the State Council's drug supervision and administration department before use. The State Council's drug supervision and administration department may adjust the scope of new cosmetic raw materials subject to registration management in accordance with the development of scientific research, and implement it after approval by the State Council.

Article 12 The following materials shall be submitted when applying for the registration of new cosmetic raw materials or filing new cosmetic raw materials:

(1) Name, address, and contact information of the applicant or filer;

(2) New raw material research report;

(3) Research data on the preparation process, stability, and quality control standards of new raw materials;

(4) Safety assessment data for new raw materials.

The applicant and filer shall be responsible for the authenticity and scientific nature of the submitted materials.

Article 13 The State Council's drug supervision and administration department shall transfer the application materials to the technical review institution within 3 working days from the date of receipt of the application for registration of new cosmetic raw materials. The technical review institution shall complete the technical review within 90 working days from the date of receipt of the application materials and submit the review opinions to the State Council's drug supervision and administration department. The State Council's drug supervision and administration department shall make a decision within 20 working days from the date of receipt of the review opinions. For those that meet the requirements, registration shall be granted and a registration certificate for new cosmetic raw materials shall be issued; for those that do not meet the requirements, registration shall not be granted and the reasons shall be stated in writing.

The filer of new cosmetic raw materials shall complete the filing after submitting the filing materials stipulated in these Regulations through the online government service platform of the State Council's drug supervision and administration department.

The State Council's drug supervision and administration department shall publicly announce the registration and filing information to the public within 5 working days from the date of approval of the registration of new cosmetic raw materials and from the date of submission of the filing materials by the filer.

Article 14 Within 3 years after the registered and filed new cosmetic raw materials are put into use, the registrant and filer of the new raw materials shall report the use and safety of the new raw materials to the State Council's drug supervision and administration department annually. For cosmetic raw materials with safety problems, the State Council's drug supervision and administration department shall revoke the registration or cancel the filing. Cosmetic raw materials that have not had safety problems after 3 years shall be included in the catalog of already used cosmetic raw materials formulated by the State Council's drug supervision and administration department.

Before registered and filed new cosmetic raw materials are included in the catalog of already used cosmetic raw materials, they shall still be managed as new cosmetic raw materials.

Article 15 The catalog of raw materials prohibited from being used in the production of cosmetics shall be formulated and published by the State Council's drug supervision and administration department.

Article 16 Cosmetics used for hair dyeing, perming, freckle removal and whitening, sun protection, and hair loss prevention, as well as cosmetics claiming new efficacy, are special cosmetics. Cosmetics other than special cosmetics are ordinary cosmetics.

The State Council's drug supervision and administration department shall formulate and publish cosmetic classification rules and catalogs based on factors such as the efficacy claims, application sites, product dosage forms, and target populations of cosmetics.

Article 17 Special cosmetics may be produced and imported only after registration with the State Drug Administration. Domestic general cosmetics should be filed with the drug supervision and administration department of the provincial, autonomous regional, or municipal people's government where the filer is located before being put on the market. Imported general cosmetics should be filed with