Detailed rules of the latest cosmetics supervision and administration regulations
Order of the State Council of the people's Republic of China
No. 727
The regulations on the supervision and administration of cosmetics, which were adopted at the 77th executive meeting of the State Council on January 3, 2020, are hereby promulgated and shall enter into force as of January 1, 2021.
Premier Li Keqiang
June 16, 2020
Regulations on the supervision and administration of cosmetics
Chapter I General Provisions
Article 1 These Regulations are formulated in order to standardize the production and business activities 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 These Regulations shall be observed in the production and operation of cosmetics and their supervision and administration within the territory of the people's Republic of China.
Article 3 the term "cosmetics" as mentioned in these Regulations refers to daily-use chemical industrial products applied to the skin, hair, nails, lips and other human surfaces by wiping, spraying or other similar methods for the purpose of cleaning, protecting, beautifying and decorating.
Article 4 the State implements 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 implements registration management for special cosmetics and filing management for ordinary cosmetics.
Cosmetic raw materials are divided into new raw materials and used raw materials. The State implements registration management for new cosmetics raw materials with high risk, and records management for other new cosmetics raw materials.
Article 5 the drug regulatory department under the State Council shall be responsible for the supervision and administration of cosmetics throughout the country. The relevant departments of the State Council shall be responsible for the supervision and administration of cosmetics within their respective functions and responsibilities.
The drug supervision and administration departments of the local people's governments at or above the county level shall be responsible for the supervision and administration of cosmetics in their respective administrative areas. The relevant departments of the local people's governments at or above the county level shall be responsible for the supervision and administration of cosmetics within the scope of their respective responsibilities.
Article 6 the registrants and recorders of cosmetics shall be responsible for the quality, safety and efficacy of cosmetics.
Cosmetics producers and operators shall engage in production and business activities in accordance with laws, regulations, mandatory national standards and technical specifications, strengthen management, integrity and self-discipline, and ensure the quality and safety of cosmetics.
Article 7 the cosmetics industry association shall strengthen industry self-discipline, supervise and guide cosmetics producers and operators to engage in production and business activities according to law, and promote the construction of industry integrity.
Article 8 consumer associations and other consumer organizations shall conduct social supervision according to law over acts that violate the provisions of these regulations and damage the legitimate rights and interests of consumers.
Article 9 the State encourages and supports the research and innovation of cosmetics to meet the needs of consumers, promote the construction of cosmetics brands and give play to the leading role of brands. The state protects the legitimate rights and interests of units and individuals to carry out cosmetic research and innovation.
The State encourages and supports cosmetics producers and operators to adopt advanced technology and advanced management standards to improve the quality and safety level of cosmetics; Encourage and support the use of modern science and technology to research and develop cosmetics in combination with China's traditional advantageous projects and characteristic plant resources.
Article 10 the State shall strengthen the informatization construction of cosmetics supervision and management, improve the online government service level, facilitate the handling of cosmetics administrative license and filing, and promote the sharing of supervision and management information.
Chapter II raw materials and products
Article 11 the natural or artificial raw materials used in cosmetics for the first time in China are new raw materials for cosmetics. New cosmetic raw materials with anti-corrosion, sunscreen, coloring, hair dyeing, freckle removing and whitening functions can be used only after being registered by the drug regulatory department under the State Council; Other new cosmetic raw materials shall be filed with the drug regulatory department under the State Council before use. The drug regulatory department under the State Council may adjust the scope of new cosmetic raw materials subject to registration management according to the development of scientific research, which shall be implemented after being approved by the State Council.
Article 12 when applying for the registration of new cosmetic raw materials or filing new cosmetic raw materials, the following materials shall be submitted:
(1) The name and address of the applicant;
(2) New raw material development report;
(3) Research data on the preparation process, stability and quality control standard of new raw materials;
(4) Safety assessment data of new raw materials.
Registration applicants and recorders shall be responsible for the authenticity and scientificity of the materials submitted.
Article 13 the drug regulatory department under the State Council shall, within 3 working days from the date of accepting the application for registration of new cosmetic raw materials, transfer the application materials to the technical evaluation institution. The technical evaluation institution shall complete the technical evaluation within 90 working days from the date of receiving the application materials and submit the evaluation opinions to the drug regulatory department under the State Council. The drug regulatory department under the State Council shall make a decision within 20 working days from the date of receiving the review opinions. For those who meet the requirements, registration is approved and a registration certificate of new cosmetic raw materials is issued; Those who do not meet the requirements shall not be registered and the reasons shall be explained in writing.
The registrant of new cosmetic raw materials shall complete the filing after submitting the filing materials specified in these regulations through the online government service platform of the drug regulatory department of the State Council.
The drug regulatory department under the State Council shall publish the relevant information of registration and filing to the public within 5 working days from the date when the registration of new cosmetic raw materials is approved and the date when the filing person submits the filing materials.
Article 14 within three years after the registered and filed new cosmetic raw materials are put into use, the registrant and filer of new raw materials shall report the use and safety of new raw materials to the drug regulatory department under the State Council every year. The registration of new cosmetic raw materials with safety problems shall be revoked or the record shall be cancelled by the drug regulatory department under the State Council. New cosmetic raw materials without safety problems at the expiration of 3 years shall be included in the catalogue of used cosmetic raw materials formulated by the drug regulatory department under the State Council.
Before the registered and filed new cosmetic raw materials are included in the catalogue of used cosmetic raw materials, they shall still be managed according to the new cosmetic raw materials.
Article 15 the catalogue of raw materials prohibited from being used in the production of cosmetics shall be formulated and published by the drug regulatory department under the State Council.
Article 16 cosmetics used for hair dyeing, perm, freckle removal, whitening, sunscreen and hair loss prevention, as well as cosmetics claiming new effects are special cosmetics. Cosmetics other than special cosmetics are ordinary cosmetics.
The drug regulatory department of the State Council formulates and publishes the classification rules and catalogue of cosmetics according to the efficacy claims, action parts, product dosage forms, users and other factors of cosmetics.
Article 17 special cosmetics can be produced and imported only after being registered by the drug regulatory department under the State Council. Domestic ordinary cosmetics shall be filed with the drug regulatory department of the people's Government of the province, autonomous region or municipality directly under the central government where the filer is located before being put on the market. The import of ordinary cosmetics shall be filed with the drug regulatory department under the State Council before import.
Article 18 the applicant and filer of cosmetics registration shall meet the following conditions:
(1) It is an enterprise or other organization established according to law;
(2) Have a quality management system suitable for the products applied for registration and filing;
(3) Have the ability to monitor and evaluate adverse reactions of cosmetics.
Article 19 when applying for registration of special cosmetics or filing of ordinary cosmetics, the following materials shall be submitted:
(1) The name, address and contact information of the registration applicant and the filer;
(2) Name, address and contact information of the manufacturer;
(3) Product name;
(4) Product formula or whole product ingredients;
(5) Standards implemented by products;
(6) Sample product label;
(7) Product inspection report;
(8) Product safety assessment data.
If the registration applicant applies for the registration of special cosmetics for the first time or the filer files ordinary cosmetics for the first time, it shall submit the certification materials that it meets the conditions specified in Article 18 of these regulations. When applying for the registration of imported special cosmetics or the filing of imported ordinary cosmetics, the supporting documents that the products have been listed and sold in the producing country (region) and the supporting materials that the overseas production enterprises meet the standards for the production quality management of cosmetics shall be submitted at the same time; If it is specially produced for export to China and it is impossible to submit the supporting documents that the products have been listed and sold in the producing country (region), the relevant research and test materials for Chinese consumers shall be submitted.
Registration applicants and recorders shall be responsible for the authenticity and scientificity of the materials submitted.
Article 20 the drug regulatory department under the State Council shall examine the application for registration of special cosmetics in accordance with the procedures for registration and examination of new cosmetic raw materials specified in paragraph 1 of Article 13 of these regulations. For those who meet the requirements, registration is approved and a special cosmetics registration certificate is issued; Those who do not meet the requirements shall not be registered and the reasons shall be explained in writing. In case of substantial changes in the production process and efficacy declaration of registered special cosmetics, the registrant shall apply to the original registration department for change of registration.
The ordinary cosmetics filer shall complete the filing after submitting the filing materials specified in these regulations through the online government service platform of the drug regulatory department of the State Council.
The drug regulatory department of the people's government at or above the provincial level shall publish the relevant information of registration and filing to the society within 5 working days from the date when the registration of special cosmetics is approved and the date when the filing materials of ordinary cosmetics are submitted.
Article 21 before the registration and filing of new cosmetic raw materials and cosmetics, the registration applicant and filer shall conduct safety assessment by themselves or entrust a professional organization.
Personnel engaged in safety assessment shall have professional knowledge related to the quality and safety of cosmetics and have more than 5 years of relevant professional experience.
Article 22 the efficacy claim of cosmetics shall have sufficient scientific basis. The registrant and filer of cosmetics shall publish the literature, research data or summary of product efficacy evaluation data on the special website specified by the drug regulatory department under the State Council, and accept social supervision.
Article 23 the registrants and recorders of overseas cosmetics shall designate domestic enterprises as legal persons to handle the registration and filing of cosmetics, and assist in the monitoring of adverse reactions of cosmetics and the implementation of product recall.
Article 24 the registration certificate of special cosmetics is valid for 5 years. If the registration needs to be renewed at the expiration of the validity period, an application for renewal of registration shall be submitted 30 working days before the expiration of the validity period. Except for the circumstances specified in paragraph 2 of this article, the drug regulatory department under the State Council shall make a decision to approve the renewal before the expiration of the registration certificate of special cosmetics; If no decision is made within the time limit, it shall be deemed to have been granted.
Under any of the following circumstances, the registration shall not be renewed:
(1) The registrant fails to apply for renewal of registration within the specified time limit;
(2) Mandatory national standards and technical specifications have been revised, and cosmetics applying for renewal of registration cannot meet the requirements of the revised standards and technical specifications.
Article 25 the drug regulatory department under the State Council shall be responsible for proposing, organizing the drafting, soliciting opinions and technical examination of the mandatory national standards for cosmetics. The Standardization Administration Department of the State Council is responsible for the establishment, numbering and external notification of mandatory national standards for cosmetics.
The text of the national standard for cosmetics shall be made public to the public free of charge.
Cosmetics shall comply with mandatory national standards. Enterprises are encouraged to formulate enterprise standards that are stricter than mandatory national standards.
Chapter III production and operation
Article 26 to engage in the production of cosmetics, the following conditions shall be met:
(1) It is an enterprise established according to law;
(2) Having production sites, environmental conditions, production facilities and equipment suitable for the cosmetics produced;
(3) Have technicians suitable for the cosmetics produced;
(4) Have inspectors and inspection equipment capable of inspecting the cosmetics produced;
(5) There is a management system to ensure the quality and safety of cosmetics.
Article 27 those engaged in the production of cosmetics shall apply to the drug regulatory department of the people's Government of the province, autonomous region or municipality directly under the central government where they are located, submit the supporting materials that meet the conditions specified in Article 26 of these regulations, and be responsible for the authenticity of the materials.
The drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the central government shall examine the application materials, conduct on-site inspection of the applicant's production site, and make a decision within 30 working days from the date of accepting the application for cosmetics production license. For those who meet the specified conditions, a license shall be granted and a cosmetics production license shall be issued; Those who do not meet the specified conditions shall not be allowed and the reasons shall be explained in writing.
The validity period of the cosmetics production license is 5 years. If it needs to be renewed at the expiration of the term of validity, it shall be handled in accordance with the provisions of the administrative license law of the people's Republic of China.
Article 28 the registrants and recorders of cosmetics may produce cosmetics by themselves or entrust other enterprises to produce cosmetics.
Where the production of cosmetics is entrusted, the cosmetic registrant and filer shall entrust the enterprise that has obtained the corresponding cosmetics production license, and supervise the production activities of the entrusted enterprise (hereinafter referred to as the entrusted production enterprise) to ensure that it produces in accordance with the legal requirements. The entrusted production enterprise shall carry out production in accordance with laws, regulations, mandatory national standards, technical specifications and contract agreements, be responsible for production activities, and accept the supervision of cosmetic registrants and recorders.
Article 29 the registrants, recorders and entrusted manufacturers of cosmetics shall organize the production of cosmetics in accordance with the requirements of the cosmetics production quality management standards formulated by the drug regulatory department under the State Council, establish a cosmetics production quality management system, and establish and implement management systems such as supplier selection, raw material acceptance, production process and quality control, equipment management, product inspection and sample retention.
The production technology of cosmetics or registered cosmetics enterprises shall be recorded in accordance with the requirements of the trustee.
Article 30 cosmetic raw materials and packaging materials in direct contact with cosmetics shall comply with mandatory national standards and technical specifications.
No cosmetics or cosmetic raw materials that exceed the service life, are discarded or recycled shall be used to produce cosmetics.
Article 31 the registrants, recorders and entrusted production enterprises of cosmetics shall establish and implement the incoming inspection record system and product sales record system for raw materials and packaging materials in direct contact with cosmetics. The incoming inspection records and product sales records shall be true and complete, traceable, and the retention period shall not be less than 1 year after the expiration of the service life of the product; If the service life of the product is less than 1 year, the record retention period shall not be less than 2 years.
Cosmetics can only be sold after passing the factory inspection.
Article 32 the registrant, filer and entrusted production enterprise of cosmetics shall set up a person in charge of quality and safety to undertake the corresponding responsibilities of product quality and safety management and product release.
The person in charge of quality and safety shall have professional knowledge related to the quality and safety of cosmetics and more than 5 years of experience in cosmetics production or quality and safety management.
Article 33 the registrants, recorders and entrusted production enterprises of cosmetics shall establish and implement the health management system for employees. Persons suffering from diseases that hinder the quality and safety of cosmetics as stipulated by the competent department of health under the State Council shall not directly engage in cosmetics production activities.
Article 34 the registrants, recorders and entrusted production enterprises of cosmetics shall regularly conduct self-examination on the implementation of the standards for the quality management of cosmetics production; If the production conditions change and no longer meet the requirements of cosmetics production quality management standards, corrective measures shall be taken immediately; If it may affect the quality and safety of cosmetics, it shall immediately stop production and report to the drug regulatory department of the people's Government of the province, autonomous region or municipality directly under the central government where it is located.
Article 35 the minimum sales unit of cosmetics shall be labeled. The label shall comply with relevant laws, administrative regulations and mandatory national standards, and the content shall be true, complete and accurate.
Imported cosmetics can be directly labeled in Chinese or labeled in Chinese; If a Chinese label is added, the contents of the Chinese label shall be consistent with the contents of the original label.
Article 36 the label of cosmetics shall indicate the following contents:
(1) Product name, registration certificate number of special cosmetics;
(2) Register
2022 05/13