Regulation on the Supervision and Administration of Cosmetics

Regulation on the Supervision and Administration of Cosmetics Order of the State Council of the People's Republic of China (No. 727) The Regulation on the Supervision and Administration of Cosmetics, as adopted at the 77th executive meeting of the State Council on January 3, 2020, is hereby issued, and shall come into force on January 1, 2021. Premier: Li Keqiang June 16, 2020 Regulation on the Supervision and Administration of Cosmetics Chapter I General Provisions Article 1 This Regulation is developed to regulate the production and distribution of cosmetics, strengthen the supervision and administration of cosmetics, ensure the quality and safety of cosmetics, safeguard consumers' health, and promote the healthy development of the cosmetics industry. Article 2 Whoever engages in the production and distribution as well as supervision and administration of cosmetics within the territory of the People's Republic of China shall comply with this Regulation. Article 3 For the purpose of this Regulation, “cosmetics” means those daily used chemical products applied on the surface of any parts of the human body, such as skin, hair, nails and lips, by way of smearing, spraying or other similar methods for the purposes of cleaning, protection, beautification and modification. Article 4 The state implements classified administration of cosmetics and cosmetic raw materials according to the degree of risks. Cosmetics are divided into special cosmetics and general cosmetics. The state shall conduct registration administration of special cosmetics and conduct recordation administration of general cosmetics. Cosmetic raw materials shall be divided into new raw materials and used raw materials. The state conducts registration administration of new cosmetic raw materials with a high degree of risks, and conduct recordation administration of other new cosmetic raw materials. Article 5 The drug supervision and administration department of the State Council shall take charge of the supervision and administration of cosmetics nationwide. The relevant departments of the State Council shall take charge of the supervision and administration work related to cosmetics within the scope of their respective functions. The departments in charge of drug supervision and administration of the local people's government at or above the county level shall take charge of the supervision and administration of cosmetics within their respective administrative regions. The relevant departments of the local people's governments at or above the county level shall take charge of the supervision and administration work related to cosmetics within the scope of their respective functions. Article 6 Cosmetic registrants and recordation entities shall be responsible for the quality and safety of and the efficacy claims for cosmetics. Cosmetic manufacturers and distributors shall, in accordance with laws, regulations, compulsory national standards, and technical specifications, engage in production and distribution activities, strengthen administration, and be honest and self-regulatory to ensure the quality and safety of cosmetics. Article 7 Cosmetic industry associations shall strengthen industry self-regulation, supervise and guide the production and distribution activities engaged in by cosmetic manufacturers and distributors according to the law, and promote the building of integrity in the industry. Article 8 Consumer associations and other consumer organizations shall conduct social supervision against activities damaging the lawful rights and interests of consumers in violation of this Regulation. Article 9 The state encourages and supports the research and innovation of cosmetics to satisfy consumer demands, promote the building of cosmetic brands, and maximize the leading role of brands. The state protects the legitimate rights and interests of entities and individuals in the research and innovation on cosmetics. The state encourages and supports cosmetic manufacturers and distributors' adoption of advanced technologies and advanced administration standards to improve the quality and safety of cosmetics; and encourages and supports the use of modern scientific technologies to research and develop cosmetics in consideration of China's traditional advantageous projects and characteristic plant resources. Article 10 The state strengthens the information technology construction for the supervision and administration of cosmetics, enhances the level of online government affairs services, facilitates the handling of cosmetics administrative licensing and recordation, and promotes the sharing of supervision and administration information. Chapter II Raw Materials and Products Article 11 The natural or artificial raw materials used for cosmetics for the first time within the territory of China are new cosmetic raw materials. New cosmetic raw materials with functions of anti-corrosion, sun protection, coloring, hair coloring, freckle removal and skin whitening may not be used unless they have been registered with the drug supervision and administration department of the State Council; and other new cosmetic raw materials shall be filed with the drug supervision and administration department of the State Council before being used. The drug supervision and administration department of the State Council may, according to the development of scientific research, adjust the scope of new cosmetic raw materials subject to registration administration, which shall be implemented upon approval by the State Council. Article 12 Whoever applies for the registration of new cosmetic raw materials or undergoes the recordation formalities for new cosmetic raw materials shall submit the following materials: (1) The name, address and contact information of the registration applicant or recordation entity. (2) Research and development report on the new raw materials. (3) Research materials on the preparation process for, the stability of and the quality control standards for new raw materials, among others. (4) Safety assessment materials on new raw materials. The registration applicant or recordation entity shall be responsible for the authenticity and scientificity of the materials submitted. Article 13 The drug supervision and administration department of the State Council shall transfer the application materials to the technical review institution within three working days from the date when it accepts the application for the registration of new cosmetic raw materials. The technical review institution shall complete the technical review within 90 working days from the date when it receives application materials, and submit the review opinions to the drug supervision and administration department of the State Council. The drug supervision and administration department of the State Council shall make a decision within 20 working days from the date when it receives the review opinions. If the application meets the requirements, registration shall be granted and a registration certificate for new cosmetic raw materials shall be issued; and if the application fails to meet the requirements, no registration shall be granted, and the reasons therefor shall be given in writing. Recordation formalities are completed once an entity undergoing the recordation formalities for new cosmetic raw materials submits the recordation materials as prescribed in this Regulation through the online government affairs service platform of the drug supervision and administration department of the State Council. The drug supervision and administration department of the State Council shall, within five working days from the date when the registration of new cosmetic raw materials is granted and the recordation entity submits the recordation materials, issue to the public the relevant information on registration and recordation. Article 14 Within three years after the new cosmetic raw materials registered and filed are put into use, the new raw material registrants and recordation entities shall report to the drug supervision and administration department of the State Council the information on the use and safety of new raw materials each year. For the new cosmetic raw materials with safety problems, the drug supervision and administration department of the State Council shall cancel the registration or recordation. The new cosmetic raw materials that do not have any safety problem during three-year period shall be included in the catalogue of cosmetic raw materials that have been put into use developed by the drug supervision and administration department of the State Council. Before being included in the catalogue of cosmetic raw materials that have been put into use, the new cosmetic raw materials registered and filed shall remain administered as new cosmetic raw materials. Article 15 The catalogue of materials prohibited from being used for cosmetics production shall be developed and issued by the drug supervision and administration department of the State Council. Article 16 Cosmetics used for hair coloring, perming, freckle removal and skin whitening, sunscreening, and hair loss prevention, and cosmetics with new efficacy claims are special cosmetics. Cosmetics other than special cosmetics are general cosmetics. The drug supervision and administration department of the State Council shall develop and issue the cosmetic classification rules and catalogues according to the efficacy claims for cosmetics, parts to which cosmetics apply, product dosage forms, and users and other factors. Article 17 Special cosmetics may not be produced and imported unless they have been registered with the drug supervision and administration department of the State Council. Domestically produced general cosmetics shall be filed with the drug supervision and administration departments of the people's governments of the provinces, autonomous regions, and municipalities directly under the Central Government at the places where the recordation entities are located before they are marketed. Imported general cosmetics shall be filed with the drug supervision and administration department of the State Council before import. Article 18 A cosmetics registration applicant or recordation entity shall meet the following conditions: (1) It is an enterprise or other organization formed according to the law. (2) It has the quality management system appropriate for the products to be registered upon request or filed. (3) It has the capabilities for monitoring and evaluating the adverse reactions of cosmetics. Article 19 An applicant for the registration of special cosmetics or an entity undergoing the recordation formalities for general cosmetics shall submit the following materials: (1) The name, address and contact information of the registration applicant or the recordation entity. (2) The name, address and contact information of the manufacturer. (3) Product name. (4) Product formula or all ingredients of the product. (5) Standards to which the product conforms. (6) Sample product label. (7) Product inspection report. (8) Product safety assessment materials. Where the registration applicant applies for the registration of special cosmetics for the first time or the recordation entity undergoes the recordation formalities for general cosmetics for the first time, it shall submit the certification materials proving that it meets the conditions as prescribed in Article 18 of this Regulation. Whoever applies for the registration of imported special cosmetics or undergoes the formalities for imported general cosmetics shall submit the certification documents proving that products have been marketed in the country (region) where they are produced and the certification materials proving that the overseas manufacturer complies with the Good Manufacturing Practices for Cosmetics; where products are produced exclusively for export to China, and the certification materials proving that products have been marketed in the country (region) where they are produced cannot be submitted, the materials on the relevant research and experimentation conducted for consumers in China shall be submitted. The registration applicant or recordation entity shall be responsible for the authenticity and scientificity of the materials submitted. Article 20 The drug supervision and administration department of the State Council shall examine the applications for the registration of special cosmetics under the registration examination procedures for new cosmetic raw materials as prescribed in paragraph 1 of Article 13 of this Regulation. If the application meets the requirements, registration shall be granted and a registration certificate for special cosmetics shall be issued; and if the application fails to meet the requirements, no registration shall be granted, and the reasons therefor shall be given in writing. If the registered special cosmetics have undergone substantial changes in the production technology, efficacy claims, among others, the registrant shall apply to the original registration department for registration changes. Recordation formalities are completed once an entity undergoing recordation formalities for general cosmetics submits the recordation materials as prescribed in this Regulation through the online government affairs service platform of the drug supervision and administration department of the State Council. The drug supervision and administration department of the people's government at or above the provincial level shall, within five working days from the date when the registration of special cosmetics is granted or the recordation entity submits the recordation materials, issue to the public the relevant information on registration and recordation. Article 21 Before the registration and recordation of new cosmetic raw materials and cosmetics, a registration applicant or recordation entity shall conduct safety assessment by itself or by entrusting a professional institution. The personnel engaging in safety assessment shall have professional knowledge related to cosmetics quality and safety, and have more than five years of work experience in relevant professions. Article 22 Efficacy claims for cosmetics shall have sufficient scientific basis. A cosmetic registrant or recordation entity shall publish on the special website specified by the drug supervision and administration department of the State Council the documentation based on which efficacy claims are made, research data or the summaries of product efficacy evaluation materials, and be subject to social supervision. Article 23 Overseas cosmetic registrants and recordation entities shall designate enterprise legal persons within the territory of China to undergo cosmetic registration and recordation formalities, assist in conducting the monitoring of adverse reactions of cosmetics, and implement product recalls. Article 24 A special cosmetic registration certificate shall be valid for five years. If the registration needs to be renewed upon the expiration of its validity period, an application for renewal of registration shall be filed 30 working days before the expiration of the validity period. Unless under the circumstances specified in paragraph 2 of this article, the drug supervision and administration department of the State Council shall make a decision on whether to approve the renewal before the expiration of the validity period of the special cosmetic registration certificate; and if it fails to make a decision during the specified period, it shall be deemed that the renewal has been approved. Under any of the following circumstances, registration shall not be renewed: (1) The registrant fails to submit an application for renewal of registration during the specified period. (2) The compulsory national standards or technical specifications have been revised, and the cosmetics under the application for renewal of registration fail to meet the requirements of the revised standards or technical specifications. Article 25 The drug supervision and administration department of the State Council shall take charge of the introduction of proposals, drafting organization, request for comments, and technical review of projects of compulsory national standards. The administrative department of standardization of the State Council shall take charge of the project initiation, numbering, and public notification of compulsory national standards for cosmetics. The texts of compulsory standards for cosmetics shall be disclosed to the public free of charge. Cosmetics shall conform to compulsory national standards. Enterprises are encouraged to develop the enterprise standards that are stricter than compulsory national standards. Chapter III Production and Distribution Article 26 Whoever engages in the production of cosmetics shall meet the following conditions: (1) It is an enterprise formed according to the law. (2) It has the production sites, environmental conditions, production facilities and equipment suitable for the cosmetics produced. (3) It has the technicians appropriate for the production of cosmetics. (4) It has the inspectors and inspection equipment capable of inspecting the cosmetics produced. (5) It has the management system that can ensure the quality and safety of cosmetics. Article 27 Whoever engages in the production of cosmetics shall file an application with the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government at the place where it is located, and submit the certification materials proving that it complies with the provisions of Article 26 of this Regulation, and be responsible for the authenticity of the materials. The drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall examine the application materials, conduct on-site verification of the applicant's production sites, and make a decision within 30 working days from the date when the application for cosmetics production license is accepted. Where the application meets the specified conditions, approval shall be granted and a cosmetics production license shall be issued; and if the application fails to meet the specified conditions, no approval shall be granted and the reasons therefor shall be given in writing. A cosmetics production license shall be valid for five years. If the license needs to be renewed upon the expiration of its validity period, it shall be handled in accordance with the provisions of the Administrative License Law of the People's Republic of China. Article 28 Cosmetic registrants and recordation entities may produce cosmetics by themselves or by entrusting other enterprises. In the case of entrusted production of cos......