Regulations on supervision and Administration of cosmetics
Release date: July 06, 2020: the system administrator sources:

Decree of The State Council of the People's Republic of China

727号

  The Regulations on the Supervision and Administration of Cosmetics have beenAdopted at the 77th Executive Meeting of The State Council on January 3, 2020, it is hereby promulgated and shall come into force as of January 1, 2021。

总 理  李克强

June 16, 2020

Regulations on supervision and Administration of cosmetics


Chapter I General provisions


Article 1 These Regulations are formulated for the purpose of regulating the production and marketing activities of cosmetics, strengthening the supervision and administration of cosmetics, ensuring the quality and safety of cosmetics, safeguarding the health of consumers and promoting the healthy development of the cosmetics industry。

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

Article 3 The term "cosmetics" as mentioned in these Regulations refers to the daily chemical industry products applied to skin, hair, nails, lips and other human surfaces by rubbing, spraying or other similar methods for the purpose of cleaning, protecting, beautifying and modifying。

Article 4 The State shall exercise classified control over cosmetics and cosmetic raw materials according to the degree of risk。

Cosmetics are divided into special cosmetics and ordinary cosmetics。The state shall exercise registration administration for special cosmetics and archival administration for ordinary cosmetics。

Cosmetic raw materials are divided into new raw materials and used raw materials。The state implements registration management for new raw materials of cosmetics with a higher degree of risk, and archival management for other new raw materials of cosmetics。

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 under The State Council shall be responsible for the supervision and administration of cosmetics within the scope of their respective functions and duties。

The department in charge of drug supervision and administration under the local people's government at or above the county level shall be responsible for the supervision and administration of cosmetics in its administrative area。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 functions and duties。

Article 6 The registrant or recordholder of cosmetics shall be responsible for the claim of quality safety and efficacy of cosmetics。

Cosmetic manufacturers and dealers shall engage in production and business activities in accordance with laws, regulations, mandatory national standards and technical norms, strengthen management, integrity and self-discipline, and ensure the quality and safety of cosmetics。

Article 7 The cosmetics industry association shall strengthen the self-discipline of the industry, urge and guide the cosmetics manufacturers 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, in accordance with law, exercise social supervision over acts that violate the provisions of these Regulations and harm the lawful rights and interests of consumers。

Article 9 The State encourages and supports the research and innovation of cosmetics, meets the needs of consumers, promotes the construction of cosmetics brands, and gives play to the leading role of brands。The State protects the lawful rights and interests of units and individuals to carry out cosmetic research and innovation。

The State encourages and supports cosmetics manufacturers and dealers to adopt advanced technologies and management practices to improve the quality and safety of cosmetics;Encourage and support the use of modern science and technology, combined with China's traditional advantages of projects and characteristic plant resources research and development of cosmetics。

Article 10 The State shall strengthen the informatization construction of cosmetics supervision and management, improve the level of online government services, facilitate the handling of cosmetics administrative licensing and filing, and promote the sharing of supervision and management information。


Chapter II Raw materials and products


Article 11 Natural or artificial raw materials used in cosmetics for the first time in China shall be new raw materials for cosmetics。New cosmetic raw materials with anti-corrosion, sunscreen, coloring, hair coloring, freckle whitening functions may not be used until they have been 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, in accordance with the development of scientific research, adjust the scope of new cosmetic raw materials subject to registration administration, and implement them after approval by The State Council。

Article 12 To apply for the registration of new raw materials of cosmetics or for the record of new raw materials of cosmetics, the following information shall be submitted:

(1) the name, address and contact information of the applicant for registration and the person for filing the record;

(2) New raw material development report;

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

(4) Safety assessment data of new raw materials。

The applicant for registration and the person filing the record shall be responsible for the authenticity and scientificity of the materials submitted。

Article 13 The drug regulatory department under The State Council shall accept the application for registration of new cosmetic raw materials from the date of acceptanceThe application materials will be forwarded to the technical review agency within 3 working days。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 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, the registration shall be granted and the registration certificate of new cosmetic raw materials shall be issued;Those who do not meet the requirements shall not be registered and give reasons in writing。

The recordholder of new cosmetic raw materials shall complete the recordkeeping after submitting the recordkeeping information provided for in these Regulations through the online government service platform of the drug regulatory Department under The State Council。

The drug regulatory department under The State Council shall, from the date of approval for registration of new cosmetic raw materials and the date of submission of archival materials by the recordholderWithin 5 working days to publish the registration, record the relevant information。

Article 14 After the registered and filed new cosmetic raw materials are put into useWithin three years, the registrant and recordholder of new raw materials shall report the use and safety of new raw materials annually to the drug regulatory department under The State Council。For new cosmetic raw materials with safety problems, the drug regulatory department under The State Council shall cancel the registration or cancel the record。New cosmetic raw materials that have not caused safety problems within three 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 used catalogue of cosmetic raw materials, they are still managed in accordance with the new cosmetic raw materials。

Article 15 The list of raw materials prohibited for use 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 coloring, perm, freckle whitening, sun protection, hair loss prevention and cosmetics claiming new effects shall be special cosmetics。Cosmetics other than special cosmetics are general cosmetics。

The drug regulatory department under The State Council shall formulate and publish rules and catalogues for the classification of cosmetics based on such factors as claims of efficacy, sites of action, dosage forms and users of cosmetics。

Article 17 Special cosmetics may not be manufactured or imported until they have been registered by the drug regulatory department under The State Council。Domestic ordinary cosmetics shall be put on record with the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government where the recordholder is located before being put on sale。The import of ordinary cosmetics shall be filed with the drug regulatory department under The State Council for record before import。

Article 18 Cosmetics registration applicants and record holders shall meet the following conditions:

(1) Enterprises or other organizations established according to law;

(2) there is a quality management system suitable for the products applied for registration and filed;

(3) Have the ability to monitor and evaluate adverse reactions of cosmetics。

Article 19 To apply for the registration of special cosmetics or for the record of ordinary cosmetics, the following materials shall be submitted:

(1) the name, address and contact information of the applicant for registration and the person for filing the record;

(2) the name, address and contact information of the production enterprise;

(3) Product name;

(4) the product formula or the whole composition of the product;

(5) Standards for product implementation;

(6) Product label sample;

(7) Product inspection report;

(8) Product safety assessment data。

Where the registration applicant applies for the registration of special cosmetics for the first time or the filing person for the record of ordinary cosmetics for the first time, it shall submit the certification materials that it meets the conditions stipulated in Article 18 of these Regulations。Applying for the registration of imported special cosmetics or filing for the import of ordinary cosmetics,At the same time, the certification documents that the products have been listed in the producing country (region) and the certification materials that the overseas production enterprises meet the quality management standards of cosmetics production should be submitted;For the purpose of export production to our country, unable to submit the product in the producing country (region) has been on the market for sale documents,Data on relevant studies and tests conducted for Chinese consumers should be submitted。

The applicant for registration and the person filing the record 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 the registration of new cosmetic raw materials prescribed in paragraph 1 of Article 13 of these Regulations。Those who meet the requirements shall be granted registration and issued a special cosmetic registration certificate;Those who do not meet the requirements shall not be registered and give reasons in writing。Where a registered special cosmetic has undergone substantial changes in the production process, efficacy claims, etc., the registrant shall apply to the original registration department for change of registration。

The recordholder of ordinary cosmetics shall complete the recordkeeping after submitting the recordkeeping materials provided for in these Regulations through the online government service platform of the drug regulatory department under The State Council。

The drug regulatory department of the people's government at or above the provincial level shall, from the date of approval for registration of special cosmetics and the date of submission of filing materials by the recordholder of ordinary cosmeticsWithin 5 working days to publish the registration, record the relevant information。

Article 21 Before the registration and filing of new raw materials and cosmetics, the registration applicant and the filing person shall carry out safety assessment by themselves or entrust professional institutions。

Personnel engaged in safety assessment shall have professional knowledge related to cosmetic quality and safety, and haveAt least 5 years related professional experience。

Article 22 The claims of the efficacy of cosmetics shall have sufficient scientific basis。The registrant or recordholder of cosmetics shall publish the summary of the literature, research data or product efficacy evaluation data on which the efficacy claim is based on on the special website prescribed by the drug regulatory department under The State Council, and accept social supervision。

Article 23 Overseas registrants and recordholders of cosmetics shall designate domestic enterprise legal persons to handle cosmetics registration and recordkeeping, assist in monitoring adverse reactions of cosmetics, and implement product recalls。

Article 24 The validity period of the registration certificate of special cosmetics is5年。If the registration needs to be renewed after the expiration of the validity period, an application for renewal of registration shall be filed 30 working days before the expiration of the validity period。Except for the circumstances provided for in paragraph 2 of this article, the drug regulatory department under The State Council shall make a decision to grant the renewal of the special cosmetic registration certificate before its expiration.If no decision is made within the time limit, the extension shall be deemed to be granted。

Under any of the following circumstances, registration shall not be renewed:

(1) the registrant fails to apply for renewal of registration within the prescribed time limit;

(2) The mandatory national standards and technical specifications have been revised, and the cosmetics applied 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 the project of compulsory national standards for cosmetics, organizing the drafting, soliciting opinions and technical review。The administrative department of standardization under The State Council shall be responsible for the formulation, numbering and notification of compulsory national standards for cosmetics。

The text of the national standard for cosmetics shall be open to the public free of charge。

Cosmetics shall comply with mandatory national standards。Enterprises are encouraged to develop 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) having technical personnel suitable for the cosmetics produced;

(4) having inspectors and testing equipment capable of inspecting the cosmetics produced;

(5) There is a management system to ensure the quality and safety of cosmetics。

Article 27 Any person engaged in the production of cosmetics shall submit an application to the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government where he is located, submit the certification materials that meet the conditions specified in Article 26 of these Regulations, and be responsible for the authenticity of the materials。

The drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall review the application materials, conduct on-site verification of the production site of the applicant, and from the date of accepting the application for cosmetic production license30 working days to make a decision。To those who meet the prescribed conditions, a license shall be granted and a cosmetic production license shall be issued;Those who do not meet the prescribed conditions shall not be granted permission and shall state the reasons in writing。

The validity period of the cosmetic production license is5年。If the validity period needs to be extended, it shall be handled in accordance with the provisions of the Administrative Licensing Law of the People's Republic of China。

Article 28 A registrant or record holder of cosmetics may produce cosmetics by himself or entrust other enterprises to produce cosmetics。

Where the production of cosmetics is entrusted, the registrant or recordholder of cosmetics shall entrust the enterprise that has obtained the corresponding production license for cosmetics, 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 statutory requirements。The entrusted production enterprise shall produce in accordance with laws, regulations, compulsory national standards, technical specifications and contract agreements, be responsible for production activities, and accept the supervision of the cosmetics registrant and record holder。

Article 29 The registrant, recordholder and entrusted manufacturer of cosmetics shall organize the production of cosmetics in accordance with the requirements of the standards for the quality control of cosmetics production formulated by the drug regulatory department under The State Council,Establish cosmetics production quality management system,Establish and implement supplier selection, raw material acceptance, production process and quality control, equipment management, product inspection and sample retention management system。

Cosmetics registrants, recordholders and commissioned manufacturers shall produce cosmetics in accordance with the technical requirements specified in the registration or recordkeeping materials of cosmetics。

Article 30 Raw materials of cosmetics and packaging materials in direct contact with cosmetics shall comply with mandatory national standards and technical specifications。

It is not allowed to use cosmetics or cosmetics raw materials that have expired, been discarded or recycled to produce cosmetics。

Article 31 Cosmetics registrants, recordholders, and commissioned manufacturers shall establish and implement a record system for the purchase inspection of raw materials and packaging materials in direct contact with cosmetics, and a record system for product sales。Purchase inspection records and product sales records shall be true, complete and traceable, and the retention period shall not be less than after the expiration of the product use period1 year;If the service life of the product is less than 1 year, the record keeping period shall not be less than 2 years。

Cosmetics shall not be marketed until they pass the ex-factory inspection。

32nd cosmetics registrants, record holders, entrusted production enterprises shall be responsible for quality and safety, assume the corresponding product quality and safety management and product release responsibilities。

The person in charge of quality and safety shall have professional knowledge related to cosmetic quality and safety, and shall haveAt least 5 years experience in cosmetics production or quality and safety management。

Article 33 The registrant, recordholder and entrusted manufacturer of cosmetics shall establish and implement a health management system for employees。Persons suffering from diseases that are harmful to the quality and safety of cosmetics as prescribed by the competent department of health under The State Council shall not directly engage in the production of cosmetics。

Article 34 Cosmetic registrants, recordholders and commissioned manufacturers shall regularly conduct self-checks on the implementation of cosmetic production quality management standards;Production conditions change,No longer meet the requirements of cosmetic production quality management code,Corrective measures shall be taken immediately;May affect the quality and safety of cosmetics,It shall immediately stop production and report to the drug regulatory department of the local province, autonomous region or municipality directly under the Central Government。

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 use Chinese labels directly, or can be affixed with Chinese labels;If a Chinese label is affixed, the content of the Chinese label shall be consistent with that of the original label。

Article 36 The following contents shall be marked on the label of cosmetics:

(1) Product name, special cosmetics registration certificate number;

(2) the name and address of the registrant, recordholder and entrusted production enterprise;

(3) Cosmetics production license number;

(4) the standard number of the product execution;

(5) all components;

(6) net content;

(7) term of use, method of use and necessary safety warnings;

(8) Other contents that should be marked according to laws, administrative regulations and mandatory national standards。

Article 37 The following contents shall be prohibited on cosmetic labels:

(1) Content that is expressly or implied to have medical effects;

(2) false or misleading content;

(3) Content that violates social public order and good customs;

(4) Other contents prohibited by laws and administrative regulations。

38th cosmetics business operators shall establish and implement the purchase inspection record system, check the supplier's market subject registration certificate, cosmetics registration or record, product delivery inspection certificate, truthfully record and save the relevant documents。The retention period of records and certificates shall comply with the provisions of the first paragraph of Article 31 of these Regulations。

Cosmetic dealers may not prepare cosmetics by themselves。

Article 39 Manufacturers and dealers of cosmetics shall store and transport cosmetics in accordance with the provisions of relevant laws and regulations and the requirements on the label of cosmetics, and regularly inspect and timely dispose of cosmetics that have deteriorated or have expired。

Article 40 The operator of the cosmetics centralized trading market and the organizer of the exhibition shall examine the registration certificate of the market subject of the cosmetics operator entering the market,Be responsible for the management of cosmetics operators,Regular inspection of cosmetics operators;Cosmetics operators found to have violated the provisions of these Regulations,Shall promptly stop and report to the local people's government at the county level responsible for drug supervision and administration。

Article 41 E-commerce platform operators shall carry out real-name registration of cosmetics operators within the platform,Be responsible for the management of cosmetics operators within the platform,Cosmetics operators on the platform are found to have violated the provisions of this Regulation,It shall promptly stop 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 the e-commerce platform operator is located;Where serious violations are found,The provision of e-commerce platform services to illegal cosmetics operators should be immediately stopped。

The cosmetics operators within the platform shall disclose the information of the cosmetics they operate in a comprehensive, true, accurate and timely manner。

Article 42 Beauty salons, hotels, etc. that use cosmetics in their business or provide cosmetics to consumers shall fulfill the obligations of cosmetic operators as provided for in these Regulations。

Article 43 The contents of cosmetic advertisements shall be true and legal。

Cosmetic advertisements shall not express or imply that products have medical effects, shall not contain false or misleading content, and shall not deceive or mislead consumers。

Article 44 Where a registrant or recordholder of cosmetics finds that there are quality defects or other problems in cosmetics that may endanger human health, it shall immediately stop production, recall the cosmetics that have been put on sale, notify the relevant cosmetic dealers and consumers to stop operation and use, and record the recall and notification。The registrant or recordholder of cosmetics shall take remedial, harmless treatment, destruction and other measures for the recalled cosmetics, and report the recall and disposal of cosmetics to the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government。

Where an entrusted production enterprise or a cosmetics dealer finds that the cosmetics produced or operated by it fall under the circumstances specified in the preceding paragraph, it shall immediately stop the production or operation and notify the relevant registrant or recordholder of the cosmetics。The registrant and recordholder of cosmetics shall immediately implement the recall。

Where the department in charge of drug supervision and administration finds cosmetics under the circumstances specified in the first paragraph of this article during supervision and inspection, it shall notify the registrant or record holder of cosmetics to carry out the recall, and notify the entrusted manufacturer or cosmetic dealer to stop production and operation。

Where a cosmetics registrant or recordholder carries out a recall, the entrusted production enterprise or cosmetic business operator shall cooperate。

Where the registrant, recordholder, entrusted manufacturer or distributor of cosmetics fails to recall or stop production or distribution in accordance with the provisions of this article, the department responsible for drug supervision and administration shall order it to recall or stop production or distribution。

Article 45 The entry-exit inspection and quarantine authorities shall conduct inspection of imported cosmetics in accordance with the provisions of the Law of the People's Republic of China on Import and Export Commodity Inspection;Those that fail to pass the inspection shall not be imported。

The importer shall examine whether the cosmetics to be imported have been registered or filed and whether they comply with these Regulations and mandatory national standards and technical specifications;Those that fail to pass the examination shall not be imported。The importer shall truthfully record the information of imported cosmetics, and the record retention period shall comply with the provisions of the first paragraph of Article 31 of these Regulations。

The cosmetics exported shall conform to the standards or contractual requirements of the importing country (region)。


Chapter IV Supervision and administration


Article 46 The department in charge of drug supervision and administration shall have the right to take the following measures when conducting supervision and inspection of the production and marketing of cosmetics:

(1) entering the site of production and business operation for on-site inspection;

(2) conducting sampling inspection of cosmetics produced or marketed;

(3) to consult and copy relevant contracts, bills, account books and other relevant materials;

(4) To seal up or detain cosmetics and their raw materials that do not meet mandatory national standards or technical norms or that there is evidence to prove that they may harm human health, packaging materials that come into direct contact with cosmetics, and tools and equipment that there is evidence to prove that they are used in illegal production and business operations;

(5) Closing up places that are illegally engaged in production and business activities。

Article 47 When the department in charge of drug supervision and administration conducts supervision and inspection of the production and marketing of cosmetics, the number of personnel for supervision and inspection shall not be less than that2 persons, and should present law enforcement documents。The supervisory and inspection personnel shall keep confidential the business secrets of the inspected units that they come to know in the course of supervision and inspection。The unit under inspection shall cooperate with the supervision and inspection and shall not conceal the relevant information。

The department in charge of drug supervision and administration shall keep a record of the supervision and inspection and the results of treatment, which shall be signed by the supervisory and inspection personnel and the person in charge of the unit under inspection.If the person in charge of the unit under inspection refuses to sign, it shall be indicated。

Article 48 The drug regulatory department of the people's government at or above the provincial level shall organize sampling inspection of cosmetics;The department responsible for drug supervision and administration may conduct special sampling inspection on cosmetics that have been reported or found to have many problems in daily supervision and inspection。

For sampling inspection, the cost of sampling shall be paid, and the cost shall be included in the budget of the government at the corresponding level。

The department responsible for drug supervision and administration shall, in accordance with relevant provisions, promptly publish the results of the sample inspection of cosmetics。

Article 49 A cosmetic inspection institution may engage in cosmetic inspection activities only after it has obtained qualification certification in accordance with the relevant provisions of the State for certification and accreditation。The qualification conditions for cosmetic inspection institutions shall be formulated by the drug regulatory department under The State Council and the market regulatory department under The State Council。

The standards for the inspection of cosmetics and the provisions for the administration of standards related to the inspection of cosmetics shall be formulated by the drug regulatory department under The State Council。

Article 50 Cosmetics that may be adulterated or manufactured using raw materials prohibited for the production of cosmetics,The inspection items and methods prescribed in accordance with the national standards for cosmetics cannot be inspected,The drug regulatory department under The State Council may formulate additional testing items and testing methods,It is used for sampling inspection of cosmetics, investigation and handling of cosmetic quality and safety cases, and investigation and disposal of adverse reactions。

Article 51 If there is any objection to the conclusion of the inspection carried out in accordance with the provisions of these Regulations, the cosmetic manufacturer or trader may, from the date of receipt of the inspection conclusionWithin 7 working days, an application for reinspection shall be submitted to the department conducting sampling inspection or the department in charge of drug supervision and administration at the next level, and the department accepting the application for reinspection shall randomly determine reinspection institutions in the list of reinspection institutions。The reinspection conclusion issued by the reinspection authority shall be the final inspection conclusion。The re-inspection institution and the initial inspection institution shall not be the same institution。The list of re-inspection institutions shall be published by the drug regulatory department under The State Council。

Article 52 The State establishes a monitoring system for adverse reactions of cosmetics。The registrant and recordholder of cosmetics shall monitor the adverse reactions of their marketed cosmetics, carry out evaluation in a timely manner, and report to the adverse reaction monitoring institution of cosmetics in accordance with the provisions of the drug regulatory department under The State Council。Entrusted manufacturers, cosmetics operators and medical institutions that find adverse reactions that may be related to the use of cosmetics shall report to the adverse reaction monitoring institution for cosmetics。Other units and individuals are encouraged to report adverse reactions that may be related to the use of cosmetics to adverse reaction monitoring institutions or departments responsible for drug supervision and administration。

The ADR monitoring institution is responsible for the collection, analysis and evaluation of ADR information of cosmetics, and puts forward treatment suggestions to the department in charge of drug supervision and administration。

Cosmetic manufacturers and dealers shall cooperate with cosmetic adverse reaction monitoring institutions and departments responsible for drug supervision and administration to carry out cosmetic adverse reaction investigations。

Cosmetic adverse reaction refers to the lesions of the skin and its accessory organs caused by the normal use of cosmetics, as well as local or systemic damage to the human body。

Article 53 The State establishes a cosmetics safety risk monitoring and evaluation system to monitor and evaluate the risk factors affecting the quality and safety of cosmetics, so as to provide a scientific basis for formulating risk control measures and standards for the quality and safety of cosmetics and carrying out sampling inspection of cosmetics。

The national cosmetic safety risk monitoring plan shall be formulated, issued and implemented by the drug regulatory department under The State Council。The national cosmetic safety risk monitoring plan should clarify the varieties, projects and regions of key monitoring。

The drug regulatory department under The State Council has established an information exchange mechanism on cosmetic quality and safety risks, and organized cosmetic manufacturers and operators, inspection institutions, industry associations, consumer associations and news media to exchange and communicate information on cosmetic quality and safety risks。

Article 54 Cosmetics that cause injury to human body or that can be proved to be harmful to human health,The department in charge of drug supervision and administration may take emergency control measures to order suspension of production or business,And publish safety warning information;Belonging to imported cosmetics,The state entry-exit inspection and quarantine department may suspend the import。

Article 55 According to the development of scientific research,There is a change in understanding of the safety of cosmetics and cosmetics raw materials,Or there is evidence that cosmetics or cosmetic raw materials may be defective,The drug regulatory department of the people's government at or above the provincial level may order the registrant or record holder of cosmetics and new raw materials to carry out a safety reassessment or directly organize a safety reassessment。Reassessment results show that cosmetics, cosmetics raw materials can not guarantee safety, by the original registration department to cancel the registration, the record department to cancel the record, by the drug regulatory department under The State Council will be prohibited for the production of cosmetics raw materials into the catalogue of raw materials, and announced to the public。

Article 56 The department responsible for drug supervision and administration shall, in accordance with the law, timely publish the supervision and administration information such as administrative licensing, filing, daily supervision and inspection results, and investigation and punishment of illegal acts of cosmetics。When releasing supervisory and administrative information, the business secrets of the parties concerned shall be kept confidential。

The department responsible for drug supervision and administration shall establish credit files for cosmetic producers and dealers。To increase the frequency of supervision and inspection of cosmetics producers and dealers with bad credit records;Producers and business operators with seriously bad credit records shall be subject to joint punishment in accordance with regulations。

Article 57 Where there are hidden safety risks in the production and marketing of cosmetics and no timely measures are taken to eliminate them, the department in charge of drug supervision and administration may interview the legal representative or the main person in charge of the cosmetic manufacturer or marketing。Cosmetic producers and dealers shall take immediate measures to rectify and eliminate hidden dangers。The situation of responsibility interview and rectification shall be included in the credit files of cosmetic producers and operators。

Article 58 The department in charge of drug supervision and administration shall publish the website address, E-mail address or telephone number of its own department, accept inquiries, complaints and reports, and reply or handle them in a timely manner。The informants shall be rewarded in accordance with the relevant provisions of the State for the reports that are verified and verified。


Chapter V Legal liability


Article 59 Under any of the following circumstances, the department in charge of drug supervision and administration shall confiscate the illegal gains, cosmetics produced or traded illegally, raw materials, packaging materials, tools, equipment and other articles specially used for the illegal production or marketing;The value of cosmetics illegally produced and operated is insufficient10,000 yuan,A fine of not less than 50,000 yuan but not more than 150,000 yuan shall be imposed;The value of the goods is more than 10,000 yuan,A fine of not less than 15 times but not more than 30 times the value of the goods;serious,An order to stop production or business shall be cancelled by the recordkeeping department or the original license-issuing department shall revoke the cosmetic license,Within 10 years, it is not allowed to handle the record of cosmetics or accept the application for administrative license of cosmetics,The legal representative or the principal person in charge, the person directly in charge and other persons directly responsible for the violation of the law shall be fined not less than three times but not more than five times the income obtained from the unit in the previous year,It shall be banned from engaging in cosmetics production and business activities for life;criminal,To investigate criminal responsibility according to law:

(1) engaging in the production of cosmetics without permission, or the registrant or record holder of cosmetics entrusts an enterprise that has not obtained the corresponding production license for cosmetics to produce cosmetics;

(2) producing, trading in or importing unregistered special cosmetics;

(3) Producing cosmetics using raw materials prohibited for the production of cosmetics, new raw materials that should be registered but are not registered, illegally adding substances that may endanger human health to cosmetics, or producing cosmetics using cosmetics or raw materials that have expired, been discarded or recycled。

Article 60 Under any of the following circumstances, the department in charge of drug supervision and administration shall confiscate the illegal gains, cosmetics produced or traded illegally, raw materials, packaging materials, tools, equipment and other articles specially used for the illegal production or marketing;The value of cosmetics illegally produced and operated is insufficient10,000 yuan,A fine of not less than 10,000 yuan but not more than 50,000 yuan shall be imposed;The value of the goods is more than 10,000 yuan,A fine of not less than 5 times but not more than 20 times the value of the goods;serious,An order to stop production or business shall be cancelled by the recordkeeping department or the original license-issuing department shall revoke the cosmetic license,The legal representative or the principal person in charge, the person directly in charge and other persons directly responsible for the violation of the law shall be fined not less than one time but not more than three times the income obtained from the unit in the previous year,It shall be prohibited from engaging in cosmetics production and business activities within 10 years;criminal,To investigate criminal responsibility according to law:

(1) The use of raw materials that do not meet mandatory national standards or technical specifications, packaging materials that come into direct contact with cosmetics, the production of cosmetics with new raw materials that should be filed but have not been filed, or the use of raw materials that do not comply with mandatory national standards or technical specifications;

(2) The production and marketing of cosmetics that do not meet the mandatory national standards and technical specifications or do not meet the technical requirements specified in the registration and filing materials of cosmetics;

(3) failure to organize production in accordance with the requirements of cosmetic production quality management standards;

(4) Change the term of use of cosmetics;

(5) A cosmetic business operator prepares cosmetics without authorization, or deals in cosmetics that have deteriorated or have expired;

(6) refusing to recall a drug after being ordered to do so by the department responsible for drug supervision and administration, or refusing to stop or suspend production or business after being ordered to do so by the department responsible for drug supervision and administration。

Article 61 Under any of the following circumstances, the department in charge of drug supervision and administration shall confiscate the illegal gains and cosmetics produced or traded in violation of the law, and may confiscate raw materials, packaging materials, tools, equipment and other articles specially used for the illegal production or marketing;The value of cosmetics illegally produced and operated is insufficient10,000 yuan,A fine of not less than 10,000 yuan but not more than 30,000 yuan shall be imposed;The value of the goods is more than 10,000 yuan,A fine of not less than 3 times but not more than 10 times the value of the goods;serious,An order to stop production or business shall be cancelled by the recordkeeping department or the original license-issuing department shall revoke the cosmetic license,The legal representative or the main person in charge, the person directly in charge and other persons directly responsible for the violation of the law shall be fined not less than 1 but not more than 2 times the income obtained from the unit in the previous year,Within 5 years, it is prohibited to engage in cosmetics production and business activities:

(1) the sale, operation or import of ordinary cosmetics that have not been filed;

(2) Failure to set up a quality safety person in accordance with the provisions of these Regulations;

(3) the registrant or record holder of cosmetics fails to supervise the production activities of the entrusted production enterprise;

(4) failing to establish and implement the health management system for employees in accordance with the provisions of these Regulations;

(5) The production and marketing of cosmetics whose labels do not comply with the provisions of these Regulations。

Where there are defects in the labels of cosmetics produced or marketed, but they do not affect quality and safety and do not mislead consumers, the department in charge of drug supervision and administration shall order correction;Those who refuse to make corrections shall be punishedA fine of less than 2,000 yuan。

Article 62 Under any of the following circumstances, the department responsible for drug supervision and administration shall order it to make corrections, give it a warning and concurrentlyA fine of between 10,000 yuan and 30,000 yuan;If the circumstances are serious, it shall be ordered to suspend production and business operation, and shall be imposed a fine of not less than 30,000 yuan but not more than 50,000 yuan. The legal representative or the main person in charge, the person directly in charge and other persons directly responsible for the violation shall be imposed a fine of not less than 10,000 yuan but not more than 30,000 yuan:

(1) Failure to publish a summary of the basis for the cosmetic efficacy claim in accordance with the provisions of these Regulations;

(2) failing to establish and implement the purchase inspection record system and product sales record system in accordance with the provisions of these Regulations;

(3) failing to self-inspect the implementation of cosmetic production quality management practices in accordance with the provisions of these Regulations;

(4) Failure to store and transport cosmetics in accordance with the provisions of these Regulations;

(5) failing to monitor and report adverse reactions of cosmetics in accordance with the provisions of these Regulations, or failing to cooperate with the investigation of adverse reactions of cosmetics carried out by the monitoring agency for adverse reactions of cosmetics and the department responsible for drug supervision and administration。

Importers who fail to record and keep the information of imported cosmetics in accordance with the provisions of these Regulations shall be punished by the entry-exit inspection and quarantine authorities in accordance with the provisions of the preceding paragraph。

Article 63 Any registrant or recordholder of new cosmetic raw materials who fails to report the use and safety of new cosmetic raw materials in accordance with the provisions of these Regulations shall be ordered by the drug regulatory department under The State Council to make corrections and punishA fine of between 50,000 yuan and 200,000 yuan;If the circumstances are serious, the registration certificate of new raw materials of cosmetics shall be revoked or the record of new raw materials of cosmetics shall be cancelled, and a fine of not less than 200,000 yuan but not more than 500,000 yuan shall be imposed。

Article 64 No administrative license shall be granted to anyone who provides false information or adopts other deceptive means when applying for an administrative license for cosmetics. If an administrative license has been obtained, the administrative license shall be revoked by the department that made the decision on administrative license.Within 5 years, the application for cosmetics related license will not be accepted,Confiscation of illegal gains and cosmetics already produced or imported;The value of cosmetics that have been produced or imported is less than 10,000 yuan,A fine of not less than 50,000 yuan but not more than 150,000 yuan shall be imposed;The value of the goods is more than 10,000 yuan,A fine of not less than 15 times but not more than 30 times the value of the goods;The legal representative or the principal person in charge, the person directly in charge and other persons directly responsible for the violation of the law shall be fined not less than three times but not more than five times the income obtained from the unit in the previous year,It is prohibited from engaging in cosmetics production and business activities for life。

Where a cosmetic license is forged, altered, leased, lent or transferred, the department in charge of drug supervision and administration or the original license-issuing department shall collect or revoke it and confiscate the illegal gains;Insufficient illegal gainsIf it is 10,000 yuan, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall also be imposed;If the illegal income is more than 10,000 yuan, a fine of not less than 10 times but not more than 20 times the illegal income shall be concurrently imposed;If the act constitutes a violation of the administration of public security, the public security organ shall impose a punishment for the administration of public security according to law;If the case constitutes a crime, criminal responsibility shall be investigated according to law。

Article 65 Where false information is provided during the filing, the filing department shall cancel the filing.The filing submitted by the applicant shall not be handled within three years,Confiscation of illegal gains and cosmetics already produced or imported;The value of cosmetics that have been produced or imported is less than 10,000 yuan,A fine of not less than 10,000 yuan but not more than 30,000 yuan shall be imposed;The value of the goods is more than 10,000 yuan,A fine of not less than 3 times but not more than 10 times the value of the goods;serious,Shall be ordered to suspend production or business until the original issuing department revokes the cosmetics production license,The legal representative or the main person in charge, the person directly in charge and other persons directly responsible for the violation of the law shall be fined not less than 1 but not more than 2 times the income obtained from the unit in the previous year,It is prohibited to engage in cosmetics production and business activities within 5 years。

Where the filed data do not meet the requirements, the filing department shall order correction within a time limit, and where the filed data related to the safety of cosmetics and cosmetics new raw materials do not meet the requirements, the filing department may order suspension of sales and use at the same time;If the correction is not made within the time limit, the filing department shall cancel the filing。

After the filing department cancels the filing, those who still use the new raw materials of cosmetics to produce cosmetics or still market and sell or import the ordinary cosmetics shall be punished in accordance with the provisions of Articles 60 and 61 of these Regulations respectively。

Article 66 Where the operator of a centralized cosmetic trading market or the organizer of an exhibition fails to perform the administrative obligations of examination, inspection, suppression, reporting, etc., in accordance with the provisions of these Regulations, the department responsible for drug supervision and administration shall handle the caseA fine of between 20,000 yuan and 100,000 yuan;If the circumstances are serious, he shall be ordered to suspend business and fined not less than 100,000 yuan but not more than 500,000 yuan。

Article 67 Where an operator of an e-commerce platform fails to fulfill the management obligations of real-name registration, stopping, reporting, and stopping the provision of e-commerce platform services in accordance with the provisions of these Regulations, the drug regulatory department of the People's Government of a province, autonomous region, or municipality directly under the Central Government shall be punished in accordance with the provisions of the E-commerce Law of the People's Republic of China。

Article 68 A cosmetic business operator shall fulfill the obligations stipulated in these Regulations such as purchase inspection records,There is evidence to prove that it does not know that the purchased cosmetics do not meet the mandatory national standards, technical specifications or do not meet the technical requirements specified in the registration and filing materials of cosmetics,Confiscate the cosmetics that do not meet the mandatory national standards and technical specifications or do not meet the technical requirements specified in the registration and filing materials of cosmetics,Administrative punishment may be exempted。

Article 69 Any cosmetic advertisement that violates the provisions of these Regulations shall be punished in accordance with the provisions of the Advertising Law of the People's Republic of China;Whoever makes false or misleading publicity of cosmetics by other means shall be punished in accordance with the provisions of relevant laws;If the case constitutes a crime, criminal responsibility shall be investigated according to law。

Article 70 Where an enterprise legal person in China designated by an overseas registrant or recordholder of cosmetics fails to assist in the monitoring of adverse reactions of cosmetics and the implementation of product recall, the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall order it to make corrections, give it a warning and concurrentlyA fine of between 20,000 yuan and 100,000 yuan;If the circumstances are serious, a fine of not less than 100,000 yuan but not more than 500,000 yuan shall be imposed, and its legal representative or the main person in charge, the person directly in charge and other persons directly responsible shall be prohibited from engaging in the production and operation of cosmetics within five years。

Where an overseas cosmetics registrant or recordholder refuses to perform the administrative penalty decision made in accordance with these Regulations,A 10-year ban on cosmetics imports。

Article 71 Where a cosmetic inspection institution issues a false inspection report, the certification and accreditation supervision and administration department shall revoke the qualification certificate of the inspection institution.The application for qualification recognition will not be accepted within 10 years,Confiscation of inspection fees collected,And impose a fine of not less than 50,000 yuan but not more than 100,000 yuan;The legal representative or the principal person in charge, the person directly in charge and other persons directly responsible shall be fined not less than one time but not more than three times the income obtained from the unit in the previous year,To be given or ordered to be given the sanction of lowering the rank of a post, removal or dismissal according to law,Being expelled,It is prohibited to engage in cosmetic inspection within 10 years;criminal,Criminal responsibility shall be investigated according to law。

Article 72 Cosmetic technical evaluation institutions, cosmetic adverse reaction monitoring institutions and institutions responsible for cosmetic safety risk monitoring fail to perform their duties in accordance with the provisions of these Regulations,Causing major errors in technical review, adverse reaction monitoring and safety risk monitoring,The department responsible for drug supervision and administration shall order it to make corrections,Give a warning,Circulate criticism;Causing serious consequences,Its legal representative or principal responsible person, the person directly in charge and other persons directly responsible,To be given or ordered to be given the sanction of lowering the rank of a post, removal or dismissal according to law。

Article 73 Where cosmetics manufacturers, dealers and inspection institutions recruit or employ persons who are not allowed to engage in the production or marketing of cosmetics or persons who are not allowed to engage in the inspection of cosmetics to engage in the production, marketing or inspection of cosmetics,The department in charge of drug supervision and administration or any other relevant department shall order it to make corrections,Give a warning;recalcitrant,Shall be ordered to stop production or suspend business until the license certificate of cosmetics and the qualification certificate of inspection institution are revoked。

Article 74 Where any of the following circumstances constitutes an act violating the administration of public security, the public security organ shall impose a penalty for the administration of public security according to law;If the case constitutes a crime, criminal responsibility shall be investigated according to law:

(1) obstructing the personnel of the department responsible for drug supervision and administration from performing their duties according to law;

(2) Forging, destroying or concealing evidence or concealing, transferring, selling or damaging articles sealed or seized according to law。

Article 75 Personnel of the department responsible for drug supervision and administration violate the provisions of these Regulations,Abuse of power, neglect of duty, favoritism and malpractice,To give a warning, demerit record or a major demerit according to law;Causing serious consequences,To be demoted, removed from office or expelled according to law;criminal,Criminal responsibility shall be investigated according to law。

Article 76 Anyone who violates the provisions of these Regulations and causes personal, property or other damage shall be liable for compensation according to law。


Chapter VI Supplementary Provisions


Article 77 Toothpaste shall be administered in accordance with the provisions of these Regulations on ordinary cosmetics。After the toothpaste filing person evaluates the efficacy according to national standards and industry standards, he can claim that the toothpaste has the effect of preventing caries, suppressing dental plaque, anti-dentin sensitivity, and reducing gum problems。Specific measures for the administration of toothpaste shall be formulated by the drug regulatory department under The State Council and submitted to the market regulatory department under The State Council for examination and issuance。

These Regulations do not apply to soap, but apply to those claiming to have special cosmetic effects。

Article 78 Cosmetics for hair growth, hair removal, breast beauty, bodybuilding and deodorization that have been registered before the implementation of these Regulations shall be installed as of the date of implementation of these RegulationsDuring the transitional period of 5 years, the production, import and sale of the cosmetics can continue, and the production, import and sale of the cosmetics shall not be allowed after the transitional period。

Article 79 The term "technical specifications" as mentioned in these Regulations refers to the supplementary technical requirements for cosmetic quality and safety that have not yet been formulated as mandatory national standards and that the drug regulatory department under The State Council needs to formulate in conjunction with supervision and administration。

Article 80. These Regulations beginEffective January 1, 2021。The Regulations on Hygiene Supervision of Cosmetics shall be repealed at the same time。