Decree of the State Council of the People's Republic of China
No. 727
The "Cosmetic Supervision and Administration Regulations" have been adopted by the 77th executive meeting of the State Council on January 3, 2020, and are now promulgated and will come into effect on January 1, 2021.
Prime Minister Li Keqiang
June 16, 2020
Regulations on Cosmetics Supervision and Administration
Chapter 1 General
Article 1 In order to standardize the production and operation of cosmetics, strengthen the supervision and management of cosmetics, ensure the quality and safety of cosmetics, protect the health of consumers, and promote the healthy development of the cosmetics industry, these Regulations are formulated.
Article 2 Engaging in cosmetics production and operation activities and its supervision and management within the territory of the People's Republic of China shall abide by these regulations.
Article 3 Cosmetics referred to in these Regulations refer to daily chemical industrial products applied to skin, hair, nails, lips and other human surfaces by scrubbing, spraying or other similar methods for the purpose of cleaning, protection, beautification and modification .
Article 4 The state shall implement classified management of cosmetics and cosmetic raw materials according to the degree of risk.
Cosmetics are divided into special cosmetics and ordinary cosmetics. The state 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 cosmetic raw materials with a high degree of risk, and records management for other cosmetic raw materials.
Article 5 The drug regulatory department of the State Council is responsible for the national cosmetics supervision and management. The relevant departments of the State Council are responsible for the supervision and management of cosmetics within their respective responsibilities.
The department in charge of drug supervision and management of the local people's government at or above the county level is responsible for the supervision and management of cosmetics in its administrative area. The relevant departments of the local people's governments at or above the county level are responsible for the supervision and management of cosmetics within their respective responsibilities.
Article 6 Cosmetics registrants and filers declare responsibility for the quality, safety and efficacy of cosmetics.
Cosmetics producers and business operators shall engage in production and business activities in accordance with laws, regulations, mandatory national standards, and technical specifications, strengthen management, exercise integrity and self-discipline, and ensure the quality and safety of cosmetics.
Article 7 The cosmetics industry association shall strengthen industry self-discipline, urge and guide cosmetics producers and operators to engage in production and operation activities according to law, and promote the construction of industry integrity.
Article 8 Consumer associations and other consumer organizations shall conduct social supervision in accordance with law on violations of the provisions of these regulations that damage the legitimate rights and interests of consumers.
Article 9 The state encourages and supports the research and innovation of cosmetics to meet consumer needs, promote the building of cosmetics brands, and play a leading role in the brand. The legal rights and interests of national protection 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 of cosmetics; encourage and support the use of modern science and technology, combined with my country's traditional superior projects and special plant resources to research and develop cosmetics.
Article 10 The state strengthens the information construction of cosmetics supervision and management, improves the online government service level, facilitates the handling of cosmetics administrative licenses and filings, and promotes the sharing of supervision and management information.
Chapter 2 Raw Materials and Products
Article 11 The natural or artificial raw materials used for cosmetics for the first time in China are new cosmetic raw materials. New cosmetic raw materials with functions of antisepsis, sun protection, coloring, hair coloring, freckles and whitening can only be used after being registered by the drug regulatory department of the State Council; other new cosmetic raw materials should be filed with the drug regulatory department of the State Council before use. The drug regulatory department of the State Council may adjust the scope of new cosmetic raw materials subject to registration management in accordance with the development of scientific research, which will be implemented after approval by the State Council.
Article 12 When applying for registration of new cosmetic raw materials or filing new cosmetic raw materials, the following materials shall be submitted:
(1) The name, address and contact information of the registered applicant and the filing party;
(2) Research report on new raw materials;
(3) Research materials such as 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 filing party shall be responsible for the authenticity and scientificity of the materials submitted.
Article 13 The drug regulatory department of the State Council shall transfer the application materials to the technical review agency within 3 working days from the date of acceptance of the application for registration of new cosmetic raw materials. The technical review agency shall complete the technical review within 90 working days from the date of receipt of the application materials and submit the review comments to the drug regulatory authority under the State Council. The drug regulatory department of the State Council shall make a decision within 20 working days from the date of receiving the review opinion. For those that meet the requirements, registration is granted and a new cosmetics raw material registration certificate is issued; for those that do not meet the requirements, registration is not granted and the reasons are stated in writing.
The filing person of the 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 announce the registration and filing information to the public within 5 working days from the date of approval of the registration of new cosmetic raw materials and the filing date of the filing person.
Article 14: Within 3 years after the new cosmetic raw materials registered and filed are put into use, the new raw material registrants and filers shall report the use and safety of the new raw materials to the drug regulatory department under the State Council every year. For new cosmetic raw materials with safety problems, the drug regulatory department of the State Council shall cancel the registration or cancel the record. New cosmetic raw materials that do not cause safety problems at the end of the 3-year period are included in the catalog of used cosmetic raw materials formulated by the State Council's drug regulatory authority.
Before new cosmetic raw materials that have been registered and filed are included in the catalog of used cosmetic raw materials, they are still managed according to the new cosmetic raw materials.
Article 15 The catalogue of raw materials prohibited from use in the production of cosmetics shall be formulated and published by the drug regulatory authority under the State Council.
Article 16 Cosmetics used for hair coloring, perming, freckles and whitening, sun protection, anti-hair loss, and cosmetics claiming new effects are special cosmetics. Cosmetics other than special cosmetics are ordinary cosmetics.
The drug regulatory department under the State Council shall formulate and publish cosmetic classification rules and catalogues based on factors such as the claims of cosmetics' efficacy, active sites, product dosage forms, and users.
Article 17 Special cosmetics may only be produced and imported after they are registered by the drug regulatory authority under the State Council. Domestic general cosmetics should be filed with the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government before the listing and sales. Imported general cosmetics should be filed with the drug regulatory department of the State Council before import.
Article 18 Applicants for the registration of cosmetics and the filing party shall meet the following requirements:
(1) It is an enterprise or other organization established according to law;
(2) It has a quality management system suitable for the products applying for registration and filing;
(3) Ability to monitor and evaluate the adverse effects of cosmetics.
Article 19 When applying for registration of special cosmetics or filing general cosmetics, the following materials shall be submitted:
(1) The name, address and contact information of the registered applicant and the filing party;
(2) The name, address and contact information of the production enterprise;
(3) Product name;
(4) Product formula or full product ingredients;
(5) Standards for product implementation;
(6) Sample product label drafts;
(7) Product inspection report;
(8) Product safety assessment data.
Registration applicants who apply for special cosmetics registration for the first time or who file for general cosmetics for the first time shall submit proof that they meet the conditions specified in Article 18 of these Regulations. When applying for registration of imported special cosmetics or filing for import of ordinary cosmetics, it should also submit the certification documents of the products that have been listed and sold in the country of production (region) and the certification data of the overseas production enterprise's compliance with the cosmetics production quality management regulations; specifically for export production to China, If it is not possible to submit the certification documents that the product has been put on the market in the country (region) of production, it should submit relevant research and test materials for consumers in China.
The applicant for registration and the filing party 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 application for registration of special cosmetics in accordance with the procedures for the registration of new cosmetic raw materials as prescribed in the first paragraph of Article 13 of these Regulations. For those that meet the requirements, registration is granted and a special cosmetics registration certificate is issued; for those that do not meet the requirements, registration is not allowed and the reasons are stated in writing. If the registered special cosmetics have undergone substantial changes in the production process, efficacy claims, etc., the registrant shall apply to the original registration department for registration changes.
The general cosmetics filing person shall complete the filing after submitting the filing information specified in these regulations through the online government service platform of the drug regulatory department under the State Council.
The drug supervision and administration department of the people's government at or above the provincial level shall announce the registration and filing information to the public within 5 working days from the date of registration of the special cosmetics and the filing date of the general cosmetics filing person.
Article 21 Before the registration and filing of new cosmetic raw materials and cosmetics, registration applicants and filing applicants shall conduct safety assessments by themselves or by entrusting professional institutions.
The personnel engaged in safety assessment should have professional knowledge related to cosmetics quality and safety, and have more than 5 years of relevant professional experience.
Article 22 The declaration of the efficacy of cosmetics shall have sufficient scientific basis. The cosmetics registrant and the filing party shall publish the summary of the literature, research data or product efficacy evaluation data on which the efficacy claims are based on the special website prescribed by the State Council’s drug regulatory authority, and accept social supervision.
Article 23 Overseas cosmetics registrants and registrants shall designate corporate legal persons within China to handle cosmetics registration and filing, assist in the monitoring of cosmetics adverse reactions, and implement product recalls.
Article 24 Special cosmetics registration certificate is valid for 5 years. If the registration needs to be renewed after the expiry of the validity period, an application for renewal of registration shall be submitted 30 working days before the expiry of the validity period. Except for the circumstances specified in the second paragraph of this article, the drug regulatory department of the State Council shall make a decision to approve the renewal before the expiry of the validity period of the special cosmetics registration certificate;
In one of the following circumstances, registration will 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 cosmetics applying for renewal of registration cannot meet the requirements of the revised standards and technical specifications.
Article 25 The drug regulatory department of the State Council is responsible for the project proposal, organization drafting, soliciting opinions and technical review of the mandatory national standards for cosmetics. The standardization administrative 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 freely disclosed to the public.
Cosmetics should meet mandatory national standards. Enterprises are encouraged to formulate enterprise standards that are stricter than mandatory national standards.
Chapter III Production and Operation
Article 26 Engaged in cosmetics production activities shall meet the following conditions:
(1) It is an enterprise established according to law;
(2) It has a production site, environmental conditions, production facilities and equipment suitable for the cosmetics produced;
(3) Having technical personnel suitable for the cosmetics produced;
(4) There are inspectors and inspection equipment capable of inspecting the produced cosmetics;
(5) There is a management system to ensure the quality and safety of cosmetics.
Article 27 Engaging in cosmetics production activities shall submit an application to the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government, submit proof of compliance with the conditions specified in Article 26 of these regulations, and be responsible for the authenticity of the data .
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 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, the license is granted and a cosmetics production license is issued; for those who do not meet the specified conditions, the license is not granted and the reasons are stated in writing.
The cosmetics production license is valid for 5 years. If the validity period needs to be renewed, it shall be handled in accordance with the provisions of the Administrative License Law of the People's Republic of China.
Article 28 Cosmetics registrants and registrants may produce cosmetics by themselves, or they may entrust other enterprises to produce cosmetics.
In the case of entrusting the production of cosmetics, the cosmetics registrant and the registrant 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 according to the legal requirements. The entrusted production enterprise shall carry out production in accordance with laws, regulations, mandatory national standards, technical specifications and contractual agreements, be responsible for production activities, and accept the supervision of cosmetics registrants and record holders.
Article 29 Cosmetics registrants, record holders and entrusted manufacturing enterprises shall organize the production of cosmetics in accordance with the requirements of the cosmetics production quality management regulations formulated by the drug regulatory department of the State Council, establish a cosmetics production quality management system, and establish and implement supplier selection, raw materials Management systems for acceptance, production process and quality control, equipment management, product inspection and sample retention.
Cosmetics registrants, filing parties, and entrusted manufacturing enterprises shall produce cosmetics in accordance with the technical requirements stated in the cosmetics registration or filing information.
Article 30 Cosmetics raw materials and packaging materials directly contacting cosmetics shall comply with mandatory national standards and technical specifications.
It is not allowed to use cosmetics or cosmetic raw materials that exceed the use period, discarded or recycled to produce cosmetics.
Article 31 Cosmetics registrants, registrants, and entrusted manufacturing enterprises shall establish and implement a purchase inspection record system and product sales record system for raw materials and packaging materials in direct contact with cosmetics. The purchase inspection records and product sales records shall be true and complete, with traceability guaranteed, and the retention period shall not be less than 1 year after the expiration of the product use period; if the product use period is less than 1 year, the record retention period shall not be less than 2 years.
Cosmetics can only be put on the market after passing the factory inspection.
Article 32 Cosmetics registrants, record holders, and entrusted manufacturing enterprises shall set up quality and safety persons responsible for corresponding product quality and safety management and product release responsibilities.
The person in charge of quality and safety shall have professional knowledge related to the quality and safety of cosmetics, and have more than 5 years of experience in cosmetics production or quality and safety management.
Article 33 Cosmetics registrants, record holders, and entrusted manufacturing enterprises shall establish and implement a health management system for employees. Persons suffering from diseases that impede the quality and safety of cosmetics as prescribed by the health department of the State Council may not directly engage in cosmetic production activities.
Article 34: Cosmetics registrants, record holders, and entrusted manufacturing enterprises shall regularly conduct self-examination on the implementation of cosmetics production quality management regulations; if production conditions change and no longer meet the requirements of cosmetics production quality management regulations, rectification shall be taken immediately Measures; if it may affect the quality and safety of cosmetics, production should be stopped immediately and reported to the drug regulatory department of the people’s government of the province, autonomous region, or municipality directly under the Central Government.
Article 35 The smallest sales unit of cosmetics shall have a label. 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 they can be affixed with Chinese labels; if Chinese labels are affixed, the content of the Chinese label should be consistent with the original label content.
Article 36 Cosmetics labels shall be marked with the following contents:
(1) Product name and serial number of special cosmetics registration certificate;
(2) The name and address of the registrant, the filing party, and the entrusted production enterprise;
(3) Serial number of cosmetics production license;
(4) Standard number for product implementation;
(5) Full ingredients;
(6) Net content;
(7) Use period, use method and necessary safety warnings;
(8) Other contents that should be marked in accordance with laws, administrative regulations and mandatory national standards.
Article 37 Cosmetics labels are prohibited from marking the following:
(1) Express or imply content with medical effects;
(2) False or misleading content;
(3) Contents that violate social order and good customs;
(4) Other contents prohibited by laws and administrative regulations.
Article 38 Cosmetics operators shall establish and implement a purchase inspection record system, check the supplier’s market subject registration certificate, cosmetics registration or filing status, and the product’s factory inspection qualification certificate, and truthfully record and save the relevant vouchers. The retention period of records and vouchers shall comply with the provisions of the first paragraph of Article 31 of these regulations.
Cosmetics operators are not allowed to prepare cosmetics by themselves.
Article 39 Cosmetics production and business operators shall store and transport cosmetics in accordance with the provisions of relevant laws and regulations and the requirements of the labeling of cosmetics, regularly inspect and promptly dispose of cosmetics that have deteriorated or exceeded their use period.
Article 40 The organizer of the centralized cosmetics trading market and the organizer of the trade fair shall review the registration certificate of the market subject of the admission cosmetics operator, assume the management responsibilities of the admission cosmetics operator, and regularly inspect the admission cosmetics operator; Cosmetics operators who violate the provisions of these regulations shall promptly stop and report to the department in charge of drug supervision and administration of the local county-level people's government.
Article 41 The operator of the e-commerce platform shall register the real-name of the cosmetics operator on the platform, bear the management responsibility of the cosmetics operator on the platform, and find that the cosmetics operator on the platform violates the provisions of these regulations, shall promptly stop and report the electronic The drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the business platform operator is located; if serious violations are found, they shall immediately stop providing e-commerce platform services to the illegal cosmetics operators.
The cosmetics operators on the platform shall fully, truthfully, accurately and timely disclose the information of the cosmetics they operate.
Article 42 Where cosmetics and hairdressing institutions, hotels, etc., use cosmetics or provide cosmetics to consumers, they shall perform the obligations of cosmetics operators as prescribed in these Regulations.
Article 43 The content of cosmetics advertisements shall be true and legal.
Cosmetic ads must not express or imply that the product has a medical effect, must not contain false or misleading content, and must not deceive or mislead consumers.
Article 44 If the cosmetics registrant and the filing party discover that cosmetics have quality defects or other problems that may endanger human health, they shall immediately stop production, recall the cosmetics that have been put on the market, and notify the relevant cosmetics operators and consumers to stop the operation and use , And record the recall and notification. Cosmetics registrants and filers should take measures such as remediation, harmless treatment, and destruction of the recalled cosmetics, and report the cosmetics recall and disposal to the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government.
If the entrusted manufacturing enterprise or cosmetics operator finds that the cosmetics it produces or sells are in the circumstances specified in the preceding paragraph, it shall immediately stop the production and operation, and notify the relevant cosmetics registrant and filing party. The cosmetics registrant and the filing party shall immediately implement the recall.
When the department in charge of drug supervision and management finds that cosmetics have the circumstances specified in the first paragraph of this article during the supervision and inspection, it shall notify the cosmetics registrant and the filing party to implement the recall, and notify the entrusted manufacturing enterprise and cosmetics operator to stop production and operation.
If the cosmetics registrant and the filing party implement the recall, the entrusted manufacturing enterprise and cosmetics operator shall cooperate.
If the cosmetics registrant, the filing party, the entrusted manufacturing enterprise, or the operator fail to implement the recall or stop production or operation in accordance with the provisions of this article, the department in charge of drug supervision and order shall order it to implement the recall or stop production or operation.
Article 45 The entry-exit inspection and quarantine agency shall conduct inspections on imported cosmetics in accordance with the provisions of the "Law of the People's Republic of China on Import and Export Commodity Inspection"; if the inspection fails, it shall not be imported.
The importer shall examine whether the cosmetics to be imported have been registered or put on record 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 faithfully 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 exported cosmetics should meet the standards or contract requirements of the importing country (region).
Chapter IV Supervision and Administration
Article 46 When conducting supervision and inspection of cosmetics production and operation, the department in charge of drug supervision and administration shall have the right to take the following measures:
(1) Entering the production and operation place to carry out on-site inspection;
(2) Sampling inspection of production and business cosmetics;
(3) Checking and copying relevant contracts, bills, account books and other relevant materials;
(4) Sealing up and detaining cosmetics and their raw materials that do not comply with compulsory national standards, technical specifications, or evidence that may endanger human health, packaging materials that directly contact cosmetics, and tools and equipment that have evidence to prove illegal production and operation;
(5) Sealing down places that engage in illegal production and business activities.
Article 47 When the department in charge of drug supervision and administration conducts supervision and inspection on the production and operation of cosmetics, the number of supervisors and inspectors shall not be less than two, and they shall present law enforcement certificates. Supervisors and inspectors shall keep the business secrets of the inspected units known during the supervision and inspection confidential according to law. 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 management shall record the status of the supervision and inspection and the results of the treatment, which shall be signed by the supervisor and inspector 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 indicate it.
Article 48 The drug supervision and administration department of the people's government at or above the provincial level shall organize sampling inspections of cosmetics; for cosmetics that have reported problems or are found to have more problems in daily supervision and inspection, the department in charge of drug supervision and administration may conduct special sampling inspections.
For sampling inspection, the cost of sampling samples shall be paid, and the required cost shall be included in the budget of the government at the corresponding level.
The department in charge of drug supervision and management shall promptly publish the results of sampling inspection of cosmetics in accordance with regulations.
Article 49 Cosmetic inspection agencies may only engage in cosmetics inspection activities after obtaining qualification accreditations in accordance with relevant national certification and accreditation regulations. The qualification requirements for cosmetics inspection agencies shall be formulated by the drug regulatory authority of the State Council and the market regulatory authority of the State Council.
The cosmetics inspection specifications and the regulations on the management of cosmetics-related standard products shall be formulated by the drug regulatory department of the State Council.
Article 50 For cosmetics that may be adulterated or use prohibited raw materials for cosmetics production, and cannot be inspected according to the inspection items and inspection methods stipulated by the national standards for cosmetics, the drug regulatory department of the State Council may formulate supplementary inspection items and inspections. Methods for sampling inspection of cosmetics, investigation and treatment of cosmetics quality and safety cases, and investigation and disposal of adverse reactions.
Article 51 If there is any objection to the inspection conclusions implemented in accordance with the provisions of these Regulations, the cosmetics producer or operator may be responsible for drug supervision and administration to the department performing the sampling inspection or its higher level within 7 working days from the date of receipt of the inspection conclusions. The department that applies for re-inspection, the department that accepts the application for re-inspection randomly determines the re-inspection institution in the list of re-inspection institutions for re-inspection. The re-inspection conclusion issued by the re-inspection agency is the final inspection conclusion. The re-inspection institution and the initial inspection institution shall not be the same institution. The list of re-inspection agencies shall be announced by the drug regulatory authority under the State Council.
Article 52 The state shall establish a monitoring system for adverse reactions of cosmetics. The cosmetics registrant and the filing party shall monitor the adverse reactions of their cosmetics on the market, carry out timely evaluations, and report to the cosmetics adverse reaction monitoring agency in accordance with the regulations of the drug regulatory authority under the State Council. If the entrusted manufacturing enterprise, cosmetics operator and medical institution finds possible adverse reactions related to the use of cosmetics, it shall report to the agency for monitoring the adverse reactions of cosmetics. Encourage other units and individuals to report adverse reactions that may be related to the use of cosmetics to the cosmetics adverse reaction monitoring agency or the department in charge of drug supervision and management.
The cosmetic adverse reaction monitoring agency is responsible for the collection, analysis and evaluation of cosmetic adverse reaction information, and puts forward treatment suggestions to the department in charge of drug supervision and management.
Cosmetics producers and business operators should cooperate with cosmetics adverse reaction monitoring agencies and departments responsible for drug supervision and management to carry out investigations on cosmetics adverse reactions.
Adverse effects of cosmetics refer to lesions of the skin and its accessory organs caused by 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 that affect the quality and safety of cosmetics, and provides a scientific basis for formulating cosmetics quality and safety risk control measures and standards and conducting cosmetic sampling inspections.
The national cosmetics safety risk monitoring plan is formulated, promulgated and organized by the drug regulatory department of the State Council. The national cosmetics safety risk monitoring plan shall specify the varieties, projects and regions to be monitored.
The Drug Supervision and Administration Department of the State Council establishes a communication mechanism for cosmetics quality and safety risk information, and organizes communication and communication of cosmetics quality and safety risk information with cosmetics producers and operators, inspection agencies, industry associations, consumer associations, and news media.
Article 54 For cosmetics that cause human injury or have evidence that may endanger human health, the department in charge of drug supervision and administration may take emergency control measures to order suspension of production and operation, and issue safety warning information; for imported cosmetics, the State The entry-exit inspection and quarantine department may suspend imports.
Article 55 If there is a change in the understanding of the safety of cosmetics and cosmetic raw materials according to the development of scientific research, or there is evidence that cosmetics and cosmetic raw materials may have defects, the drug supervision and administration department of the people's government at or above the provincial level may order The registrants and registrants of cosmetics and new cosmetic raw materials conduct safety reassessment or directly organize safety reassessment. If the results of the reassessment indicate that the cosmetics and cosmetic raw materials cannot be guaranteed to be safe, the original registration department will cancel the registration and the filing department will cancel the filing. The State Council’s drug regulatory authority will include the cosmetic raw materials in the list of prohibited raw materials for cosmetic production and make them public.
Article 56 The department in charge of drug supervision and management shall promptly publish supervision and management information on cosmetics administrative licensing, filing, daily supervision and inspection results, and investigation and handling of violations in accordance with law. When publishing supervision and management information, the parties' commercial secrets shall be kept.
The department in charge of drug supervision and management shall establish credit files for cosmetics producers and operators. The frequency of supervision and inspection shall be increased for cosmetics producers and operators with bad credit records; joint punishment shall be imposed on those producers and operators with serious bad credit records in accordance with regulations.
Article 57 If there are hidden safety hazards in the production and operation of cosmetics, and measures are not taken in time to eliminate them, the department in charge of drug supervision and management may conduct a duty interview with the legal representative or main person in charge of the cosmetics manufacturer. Cosmetics producers and operators should immediately take measures to make rectifications and eliminate hidden dangers. The situation of responsibility interview and rectification shall be included in the credit files of cosmetics producers and operators.
Article 58 The department in charge of drug supervision and management shall publish the website address, e-mail address or telephone number of the department, accept consultations, complaints and reports, and reply or deal with it in a timely manner. Whistleblowers are rewarded for reports that are verified and verified in accordance with relevant state regulations.
Chapter V Legal Responsibilities
Article 59 Under any of the following circumstances, the department responsible for drug supervision and administration shall confiscate illegal income, illegal production and operation of cosmetics, and raw materials, packaging materials, tools, equipment and other items specifically used for illegal production and operation; illegal production and operation; If the value of cosmetics is less than 10,000 yuan, a fine of more than 50,000 yuan and less than 150,000 yuan will be imposed; if the value of cosmetics is more than 10,000 yuan, a fine of 15 times or more and 30 times or less will be imposed; if the circumstances are serious, it will be ordered Suspension of production and business, cancellation of the filing by the filing department, or revoking of the cosmetics license by the original issuing department, will not process the filing of the cosmetics filed or accept the application for cosmetics administrative license filed by it within 10 years. 3. The directly responsible person in charge and other directly responsible persons shall be imposed a fine of more than 3 times and less than 5 times the income obtained from the unit in the previous year, and shall be prohibited from engaging in cosmetics production and business activities for life; if a crime is constituted, criminal responsibility shall be investigated according to law:
(1) Engaged in cosmetics production activities without permission, or cosmetics registrants and record holders entrust enterprises that have not obtained corresponding cosmetics production licenses to produce cosmetics;
(2) Production and operation or import of unregistered special cosmetics;
(3) Production of cosmetics using raw materials prohibited for cosmetics production, new raw materials that should be registered but not registered, illegal addition of substances that may harm human health to cosmetics, or production of cosmetics or raw materials that exceed the use period, discarded, and recycled cosmetic.
Article 60 In any of the following situations, the department in charge of drug supervision and administration shall confiscate illegal income, illegal production and operation of cosmetics, and raw materials, packaging materials, tools, equipment and other items specifically used for illegal production and operation; If the value of cosmetics is less than 10,000 yuan, a fine of more than 10,000 yuan and less than 50,000 yuan shall be imposed; if the value of cosmetics is more than 10,000 yuan, a fine of more than 5 times and less than 20 times of the value shall be imposed; if the circumstances are serious, the production shall be ordered to be suspended Suspension of business, cancellation of the filing by the filing department, or revoking of the cosmetics license by the original issuing department, the legal representative or main person in charge of the illegal unit, the directly responsible person in charge and other directly responsible personnel shall be subject to the previous year to obtain income from the unit A fine of more than 1 times but less than 3 times, prohibiting them from engaging in cosmetics production and operation within 10 years; if it constitutes a crime, criminal responsibility shall be investigated according to law:
(1) Use raw materials that do not comply with mandatory national standards and technical specifications, packaging materials that directly contact cosmetics, and new raw materials that should be filed but not filed to produce cosmetics, or do not use raw materials in accordance with mandatory national standards or technical specifications;
(2) Production and operation of cosmetics that do not meet the mandatory national standards and technical specifications or the technical requirements stated in the cosmetics registration and filing information;
(3) Failure to organize production in accordance with the requirements of cosmetics production quality management regulations;
(4) Change the use period of cosmetics;
(5) Cosmetics operators formulate cosmetics without authorization, or operate cosmetics that have deteriorated or exceeded the use period;
(6) Refusing to recall after the department in charge of drug supervision and administration has ordered the implementation of the recall, or refusing to suspend or suspend production and operation after the department in charge of drug supervision and management has ordered the suspension or suspension of production and operation.
Article 61 Under any of the following circumstances, the department in charge of drug supervision and administration shall confiscate illegal income, illegal production and operation of cosmetics, and may confiscate raw materials, packaging materials, tools, equipment and other items specifically used for illegal production and operation; If the value of the cosmetics in illegal production and operation is less than 10,000 yuan, a fine of more than 10,000 yuan and less than 30,000 yuan shall be imposed; if the value of the cosmetic product is more than 10,000 yuan, a fine of more than 3 times and less than 10 times the value of the goods shall be imposed; the circumstances are serious , Order the suspension of production and business, cancel the filing by the filing department, or revoke the cosmetics license by the original issuing department, and punish the legal representative or main person in charge of the illegal unit, the directly responsible person in charge and other directly responsible personnel from the previous year’s The unit has a fine of more than 1 time and less than 2 times the income. It is prohibited to engage in cosmetics production and operation within 5 years:
(1) General cosmetics that have not been put on record for sale, operation or import;
(2) Failure to establish a person in charge of quality and safety in accordance with these regulations;
(3) The cosmetics registrant and the filing party did not supervise the production activities of the entrusted production enterprises;
(4) Failure to establish and implement a health management system for employees in accordance with these regulations;
(5) Cosmetics whose production and operation labels do not comply with the regulations.
If the labels of cosmetics produced and operated have defects but do not affect the quality and safety and will not cause misleading to consumers, the department in charge of drug supervision and order shall order corrections; those who refuse to make corrections shall be fined not more than 2,000 yuan.
Article 62 In any of the following situations, the department in charge of drug supervision and administration shall order correction, give a warning, and impose a fine of more than 10,000 yuan but less than 30,000 yuan; if the circumstances are serious, it shall be ordered to suspend production and business, and shall be imposed 30,000 yuan. A fine of more than 50,000 yuan or less shall be imposed on the legal representative or principal person in charge of the illegal unit, the directly responsible person in charge and other directly responsible personnel, and 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 declaration of cosmetic efficacy in accordance with these regulations;
(2) Failure to establish and implement a purchase inspection record system and product sales record system in accordance with these regulations;
(3) Failure to conduct self-examination of the implementation of cosmetics production quality management regulations in accordance with the provisions of these regulations;
(4) Failure to store or transport cosmetics in accordance with these regulations;
(5) Failure to monitor and report adverse reactions of cosmetics in accordance with the provisions of these Regulations, or not cooperate in the investigation of adverse reactions of cosmetics conducted by the monitoring agency for cosmetics adverse reactions and the department in charge of drug supervision and management.
If the importer fails to record and preserve the imported cosmetics information in accordance with these regulations, the entry-exit inspection and quarantine agency shall impose a punishment in accordance with the provisions of the preceding paragraph.
Article 63 If the registrants and filers of new cosmetic raw materials fail to report the use and safety of new cosmetic raw materials in accordance with the provisions of these Regulations, the drug regulatory department of the State Council shall order corrections and impose a fine of more than 50,000 yuan but less than 200,000 yuan; the circumstances are serious If the registration certificate of new raw materials for cosmetics is revoked or the record of new raw materials for cosmetics is cancelled, a fine of not less than 200,000 yuan but not more than 500,000 yuan shall be imposed.
Article 64 Anyone who provides false information or applies other deceptive means when applying for an administrative license for cosmetics shall not be granted an administrative license. If an administrative license has already been obtained, the administrative licensing decision shall be revoked by the department that made the administrative license. For cosmetics-related license applications, confiscated illegal income and cosmetics that have been produced or imported; if the value of cosmetics that have been produced or imported is less than 10,000 yuan, a fine of more than 50,000 yuan and less than 150,000 yuan will be imposed; And impose a fine of 15 times or more and 30 times or less the value of the goods; the legal representative or main person in charge of the illegal unit, the directly responsible person in charge and other directly responsible personnel shall be sentenced to 3 times the income from the unit in the previous year A fine of more than 5 times or more is forbidden to engage in cosmetics production and business activities for life.
Those who forge, alter, rent, lend or transfer cosmetics licenses shall be confiscated or revoked by the department in charge of drug supervision and administration or the original license-issuing department, and the illegal gains shall be confiscated; if the illegal gains are less than 10,000 yuan, they shall be imposed at least 50,000 yuan. A fine of less than 100,000 yuan; if the illegal income is more than 10,000 yuan, a fine of more than 10 times and less than 20 times the illegal income; if it constitutes a violation of public security management, the public security organ shall impose a punishment on public security management according to law; if it constitutes a crime, criminal responsibility shall be investigated according to law .
Article 65 If false information is provided at the time of filing, the filing department shall cancel the filing and will not process the filing within three years, confiscating the illegal income and the cosmetics that have been produced or imported; the value of the cosmetics that have been produced or imported If it is less than 10,000 yuan, a fine of more than 10,000 yuan and less than 30,000 yuan shall be imposed; if the value of the goods is more than 10,000 yuan, a fine of more than 3 times and less than 10 times the value of the goods shall be imposed; if the circumstances are serious, it shall be ordered to suspend production and business until the original The license-issuing department revokes the cosmetics production license, and imposes a fine of more than 1 time and less than 2 times the income received from the unit in the previous year on the legal representative or main person in charge of the illegal unit, the person in charge directly and other persons directly responsible. It is prohibited to engage in cosmetics production and operation within 5 years.
If the recorded information does not meet the requirements, the filing department shall order correction within a time limit. Among them, if the filing information related to the safety of cosmetics and new cosmetic raw materials does not meet the requirements, the filing department may order the suspension of sales and use at the same time; The filing department cancels the filing.
After the filing department cancels the filing, if it still uses the new cosmetic raw materials to produce cosmetics or is still on the market for sale or import of the ordinary cosmetics, it shall be punished in accordance with the provisions of Article 60 and Article 61 of these Regulations.
Article 66 If the organizer of the centralized cosmetics trading market or the organizer of the trade fair fails to perform the inspection, inspection, suppression, and reporting management obligations in accordance with the provisions of these regulations, the department in charge of drug supervision and administration shall impose over 20,000 to 100,000 yuan Fines; if the circumstances are serious, order to suspend business and impose a fine of more than 100,000 yuan but less than 500,000 yuan
Article 67 If the operator of the e-commerce platform fails to perform the management obligations of real-name registration, suppression, reporting, and provision of e-commerce platform services in accordance with these Regulations, the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall comply with the The Republic of Electronic Commerce Law stipulates penalties.
Article 68 Cosmetics operators have fulfilled their obligations of purchase inspection records as stipulated in these regulations, and there is evidence to prove that they do not know whether the purchased cosmetics do not comply with mandatory national standards, technical specifications or cosmetic registration and filing information. If the technical requirements are met, the collection of cosmetics that it does not meet the mandatory national standards, technical specifications or the technical requirements stated in the cosmetics registration and filing materials may be exempted from administrative penalties.
Article 69 Anyone who violates the provisions of these Regulations shall be punished in accordance with the "Advertising Law of the People's Republic of China"; those who make false or misleading publicity of cosmetics in other ways shall be punished in accordance with the relevant laws; Whoever commits a crime shall be investigated for criminal responsibility according to law.
Article 70 If an enterprise legal person designated by an overseas cosmetics registrant or filing person who does not assist in the monitoring of adverse cosmetic reactions and the implementation of product recalls, the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall order correction and give a warning. A fine of not less than 20,000 yuan but not more than 100,000 yuan shall be imposed concurrently; 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 main person in charge, directly responsible person in charge and other persons directly responsible shall be prohibited from engaging in the work within 5 years. Cosmetics production and operation activities.
Overseas cosmetics registrants and filers who refuse to perform the administrative penalty decisions made in accordance with these regulations shall prohibit the import of cosmetics within 10 years.
Article 71 If a cosmetic inspection agency issues a false inspection report, the certification and accreditation supervision department shall revoke the qualification certificate of the inspection agency, and will not accept the application for qualification certification within 10 years, confiscate the inspection fees collected, and impose a penalty of more than 50,000 yuan to 100,000 yuan. A fine of less than one yuan; the legal representative or main person in charge, directly responsible person in charge and other directly responsible personnel shall be fined more than one time and less than three times the income they received from the unit in the previous year, and shall be given or ordered to be reduced in accordance with the law. The punishment of rank, removal or dismissal shall be banned from performing cosmetics inspection within 10 years; if it constitutes a crime, criminal responsibility shall be investigated according to law.
Article 72: Cosmetics technical review agencies, cosmetics adverse reaction monitoring agencies, and agencies responsible for cosmetics safety risk monitoring fail to perform their duties in accordance with the provisions of these regulations, resulting in major errors in technical review, adverse reaction monitoring, and safety risk monitoring. The department in charge of drug supervision and management shall order corrections, give warnings, and report criticisms; if serious consequences are caused, its legal representative or main person in charge, directly responsible person in charge, and other persons directly responsible shall be given or ordered to be lowered in accordance with the law. , Removal or dismissal.
Article 73 If cosmetics production operators, inspection institutions recruit or employ personnel who are not allowed to engage in cosmetics production and operation activities or who are not allowed to engage in cosmetics inspection work to engage in cosmetics production operations or inspections, the department in charge of drug supervision and management or other relevant Departments order corrections and give warnings; if they refuse to make corrections, they are ordered to stop production and business operations until their cosmetics licenses and inspection agency qualification certificates are revoked.
Article 74 One of the following circumstances constitutes a violation of public security management, the public security organ shall give a public security management punishment according to law; if it constitutes a crime, criminal responsibility shall be investigated according to law:
(1) Obstructing the staff of the department in charge of drug supervision and management from performing their duties according to law;
(2) Forging, destroying, concealing evidence, or concealing, transferring, selling, or damaging articles that have been sealed up or seized according to law.
Article 75 If the staff of the department in charge of drug supervision and management violates the provisions of these Regulations and abuses their powers, neglects their duties, or engages in malpractices for personal gain or misconduct, they shall be given warnings, penalties, or penalties; Or the dismissal; if it constitutes a crime, it shall be investigated for criminal responsibility according to law.
Article 76 Violation of the provisions of these regulations, resulting in personal, property or other damages, shall be liable for compensation according to law.
Chapter VI Supplementary Provisions
Article 77: Toothpaste shall be managed in accordance with the provisions of this Regulation on general cosmetics. After evaluating the efficacy of toothpaste filers in accordance with national standards and industry standards, they can claim that toothpaste has the effects of preventing caries, inhibiting plaque, resisting dentin sensitivity, and reducing gum problems. The specific management measures for toothpaste are formulated by the drug regulatory department of the State Council and reported to the market regulatory department of the State Council for review and release.
This regulation does not apply to soap, but it is declared to have special cosmetic effects.
Article 78 For cosmetics registered for hair growth, depilation, beauty milk, bodybuilding, and deodorization that have been registered before the implementation of these regulations, a transition period of 5 years shall be established from the date of implementation of these regulations, and production and import may continue during the transition period , Sales, after the transition period expires, the cosmetics shall not be produced, imported or sold.
Article 79: The technical specifications referred to in these Regulations refer to the cosmetic quality and safety supplementary technical requirements that have not yet been formulated to compulsory national standards and the State Council’s drug supervision and administration department needs to formulate in conjunction with supervision and management.
Article 80. These regulations shall come into force on January 1, 2021. The “Cosmetics Hygiene Supervision Regulations” are also repealed.