State Council: cosmetic advertisements shall not explicitly imply medical effects

category:Finance
 State Council: cosmetic advertisements shall not explicitly imply medical effects


June 16, 2020

Regulations on supervision and administration of cosmetics

Article 2 These Regulations shall be abided by in the production and operation of cosmetics and their supervision and management within the territory of the peoples Republic of China.

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

Cosmetics are divided into special cosmetics and ordinary cosmetics. The State implements registration management for special cosmetics and records management for ordinary cosmetics.

Cosmetics raw materials are divided into new raw materials and used raw materials. The state carries out registration management for new cosmetics raw materials with high risk and records management for other new cosmetics raw materials.

Article 5 the drug regulatory department under the State Council shall be responsible for the supervision and administration of cosmetics throughout the country. The relevant departments of the State Council shall be responsible for the supervision and administration of cosmetics within their respective responsibilities.

Article 7 the cosmetics industry association shall strengthen the self-discipline of the industry, urge and guide the cosmetics producers and operators to engage in production and operation activities according to law, and promote the construction of industry integrity.

The State encourages and supports cosmetics producers and operators to adopt advanced technology and advanced management standards to improve the quality and safety level of cosmetics; it also encourages and supports the use of modern science and technology to research and develop cosmetics in combination with Chinas traditional advantageous projects and characteristic plant resources.

Chapter II raw materials and products

Article 11 the natural or artificial raw materials used in cosmetics for the first time in China are new cosmetics raw materials. New cosmetic raw materials with the functions of antisepsis, sunscreen, coloring, hair dyeing, freckle removing and whitening can be used only after being registered by the drug regulatory department under the State Council; other new cosmetic raw materials shall be filed with the drug regulatory department under the State Council before use. The pharmaceutical supervisory and administrative 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, which shall be implemented after being approved by the State Council.

uff081uff09 The name, address and contact information of the registration applicant and the filing person;

uff084uff09 Safety assessment data of new raw materials.

The registration applicant and the record holder shall be responsible for the authenticity and scientificity of the materials submitted.

Article 13 the drug regulatory department under the State Council shall, within 3 working days from the date of accepting the application for registration of new cosmetic raw materials, transfer the application materials to the technical evaluation institution. The technical evaluation institution shall complete the technical evaluation within 90 working days from the date of receiving the application materials, and submit the evaluation opinions to the drug regulatory department under the State Council. The drug regulatory department under the State Council shall make a decision within 20 working days from the date of receiving the evaluation opinions. For those that meet the requirements, the registration shall be approved and the registration certificate of new cosmetic raw materials shall be issued; if the requirements are not met, the registration shall not be allowed and the reasons shall be explained in writing.

The filing of new cosmetic raw materials shall be completed after the filing materials specified in the regulations are submitted through the online government affairs service platform of the drug regulatory department of the State Council.

The drug regulatory department under the State Council shall, within 5 working days from the date of approval of registration of new cosmetic raw materials and the date of filing materials submitted by the filing person, announce the relevant information of registration and filing to the society.

Article 14 within three years after the registered and filed new cosmetic raw materials are put into use, the new raw materials registrants and recorders shall report the use and safety of 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 under the State Council shall cancel the registration or cancel the filing. The new cosmetic raw materials without safety problems after the expiration of three years shall be included in the list of used cosmetic raw materials formulated by the drug regulatory department of the State Council.

Before the registered and filed new cosmetic raw materials are included in the list of used cosmetics raw materials, they are still managed according to the new cosmetic raw materials.

Article 16 cosmetics used for hair dyeing, perming, freckle removing and whitening, sunscreen and hair loss prevention, and cosmetics with new efficacy are special cosmetics. Cosmetics other than special cosmetics are ordinary cosmetics.

According to the State Council, the Department of cosmetic administration shall make a list of cosmetic products according to the classification of products and the use of cosmetics.

Article 17 special cosmetics can be produced and imported only after they have been registered by the drug regulatory department under the State Council. Domestic ordinary cosmetics shall be filed with the drug regulatory department of the peoples Government of the province, autonomous region or municipality directly under the central government where the registrant is located before it is put on the market for sale. The import of ordinary cosmetics shall be filed with the drug regulatory department under the State Council before import.

Article 18 the cosmetic registration applicant and record holder shall meet the following requirements:

uff081uff09 They are enterprises or other organizations established according to law;

uff083uff09 Have the ability to monitor and evaluate the adverse reactions of cosmetics.

Article 19 when applying for registration of special cosmetics or filing of ordinary cosmetics, the following materials shall be submitted:

uff081uff09 The name, address and contact information of the registration applicant and the filing person;

uff083uff09 Product name;

uff084uff09 Product formula or full ingredients of the product;

uff085uff09 Standards for product implementation;

uff086uff09 Sample of product label;

uff087uff09 Product inspection report;

uff088uff09 Product safety assessment data.

If the registration applicant applies for the registration of special cosmetics for the first time or the filing person carries out the filing of ordinary cosmetics for the first time, he / she shall submit the certification materials that meet the requirements specified in Article 18 of these regulations. When applying for the registration of imported special cosmetics or filing for the import of ordinary cosmetics, the certification documents that the products have been marketed in the producing country (region) and the certification materials that the overseas production enterprises conform to the production quality management standards of cosmetics shall be submitted at the same time; those specially designed for export to China and unable to submit the certification documents for the products marketing in the producing country (region) shall be submitted We should submit relevant research and experimental data for Chinese consumers.

The registration applicant and the record holder shall be responsible for the authenticity and scientificity of the materials submitted.

Article 20 the pharmaceutical supervisory and administrative department under the State Council shall examine the application for registration of special cosmetics in accordance with the procedures for registration and examination of new cosmetic raw materials as stipulated in paragraph 1 of Article 13 of these regulations. For those that meet the requirements, the registration shall be approved and the registration certificate of special cosmetics shall be issued; for those that do not meet the requirements, the registration shall not be allowed and the reasons shall be explained in writing. If the registered special cosmetics have substantial changes in production technology, efficacy declaration, etc., the registrant shall apply to the original registration department for change of registration.

The filing of ordinary cosmetics shall be completed after the filing materials specified in the regulations are submitted through the online government affairs service platform of the drug supervision and Administration Department of the State Council.

Article 21 before the registration and filing of new cosmetic raw materials and cosmetics, the registration applicant and the filing person shall carry out safety assessment on their own or entrust a professional organization.

The personnel engaged in safety assessment shall have professional knowledge related to cosmetic quality and safety, and have more than 5 years of relevant professional experience.

Article 22 the efficacy claims of cosmetics shall have sufficient scientific basis. The registrant and record holder of cosmetics shall publish the literature, research data or summary of product efficacy evaluation materials based 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 the registrants and recorders of overseas cosmetics shall appoint enterprises within the territory of China to handle the registration and filing of cosmetics, and assist in the monitoring of adverse reactions of cosmetics and the implementation of product recall.

Article 24 the registration certificate of special cosmetics shall be valid for 5 years. If the registration needs to be extended after the expiration of the validity period, an application for renewal of registration shall be submitted 30 working days before the expiration of the validity period. Except for the circumstances specified in the second paragraph of this article, the drug regulatory department under the State Council shall make a decision to approve the renewal of the registration certificate of special cosmetics before the expiration of the validity period; if no decision is made within the time limit, the extension shall be deemed to be granted.

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

uff081uff09 The registrant fails to apply for renewal of registration within the prescribed time limit;

uff082uff09 The compulsory national standards and technical specifications have been revised, and the cosmetics applying for renewal registration cannot meet the requirements of the revised standards and technical specifications.

Article 25 the pharmaceutical supervisory and administrative department under the State Council shall be responsible for proposing, organizing drafting, soliciting opinions and technical examination of compulsory national standards for cosmetics. The standardization administrative department of the State Council is responsible for the establishment, numbering and external notification of compulsory national standards for cosmetics.

The national standards for cosmetics shall be made public free of charge.

Cosmetics shall meet the compulsory national standards. Enterprises are encouraged to formulate enterprise standards that are stricter than the mandatory national standards.

Article 26 to engage in cosmetics production activities, the following conditions shall be met:

uff083uff09 There are technicians suitable for cosmetics production;

uff084uff09 Have inspection personnel and equipment to inspect the cosmetics produced;

uff085uff09 There is a management system to ensure the quality and safety of cosmetics.

Article 27 in the production of cosmetics, an application shall be submitted to the drug regulatory department of the peoples Government of the province, autonomous region or municipality directly under the central government where it is located, and the certification materials meeting the requirements specified in Article 26 of these Regulations shall be submitted, and the authenticity of the data shall be responsible.

The drug regulatory departments of the peoples governments of provinces, autonomous regions and municipalities directly under the central government shall examine the application materials, conduct on-site verification of the applicants production site, and make a decision within 30 working days from the date of accepting the application for cosmetic production license. For those who meet the prescribed conditions, a license shall be granted and a cosmetic production license shall be issued; for those that do not meet the prescribed conditions, the license shall not be granted and the reasons shall be explained in writing.

The validity period of cosmetic production license is 5 years. If the term of validity needs to be extended, it shall be handled in accordance with the provisions of the administrative license law of the peoples Republic of China.

In the case of entrusted production of cosmetics, the cosmetics registrant and the record holder 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), so as to ensure the production in accordance with the legal requirements. The entrusted production enterprise shall carry out production in accordance with laws, regulations, mandatory national standards, technical specifications and the contract, be responsible for the production activities, and accept the supervision of the cosmetics registrant and filing person.

Article 29 cosmetics registrants, recorders and entrusted production enterprises shall organize the production of cosmetics in accordance with the requirements of the cosmetics production quality management standards formulated by the drug regulatory department under the State Council, establish a quality management system for cosmetics production, establish and implement the management of supplier selection, raw material acceptance, production process and quality control, equipment management, product inspection and sample retention, etc Management system.

Cosmetics registrants, recorders and entrusted production enterprises shall produce cosmetics in accordance with the technical requirements specified in the cosmetics registration or filing materials.

It is not allowed to produce cosmetics by using cosmetics or cosmetics raw materials that are beyond the service life, discarded or recycled.

Article 31 cosmetics registrants, recorders and entrusted production enterprises shall establish and implement the purchase inspection record system and product sales record system for raw materials and packaging materials directly in contact with cosmetics. The purchase inspection records and product sales records shall be authentic, complete and traceable, and the retention period shall not be less than 1 year after the expiration of the product service life; if the product service life is less than 1 year, the record retention period shall not be less than 2 years.

Cosmetics can only be sold after passing the factory inspection.

Article 32 the registration person, record holder and entrusted production enterprise of cosmetics shall set up a quality and safety director to undertake the corresponding responsibilities of product quality and safety management and product release.

The person in charge of quality and safety shall have professional knowledge related to the quality and safety of cosmetics, and have more than 5 years of experience in cosmetics production or quality and safety management.

Article 33 the registrant, record holder and entrusted production enterprise of cosmetics shall establish and implement the health management system for employees. Personnel suffering from diseases that hinder the quality and safety of cosmetics as stipulated by the competent health department of the State Council shall not be directly engaged in the production of cosmetics.

Article 34 the registrant, record holder and entrusted production enterprise of cosmetics shall regularly carry out self inspection on the implementation of the quality management standards for cosmetics production; if the production conditions change and no longer meet the requirements of the quality management standards for cosmetics production, rectification measures shall be taken immediately; if the quality and safety of cosmetics may be affected, the production shall be stopped immediately and the local province and the local government shall report to the local government Report of the drug regulatory department of the peoples Government of the district 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 contents shall be authentic, complete and accurate.

Imported cosmetics may be directly labeled in Chinese or attached with Chinese labels; if Chinese labels are attached, the contents of Chinese labels shall be consistent with the contents of the original labels.

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

uff081uff09 Product name, registration certificate number of special cosmetics;

uff082uff09 The name and address of the registrant, the filing person and the entrusted production enterprise;

uff083uff09 Cosmetic production license number;

uff084uff09 The standard number of product implementation;

uff085uff09 Total components;

uff086uff09 Net content;

uff087uff09 Service life, use method and necessary safety warning;

uff088uff09 Other contents that shall be marked according to laws, administrative regulations and compulsory national standards.

Article 37 the following contents are prohibited in the label of cosmetics:

uff081uff09 Explicit or implied contents with medical effect;

uff082uff09 False or misleading content;

uff083uff09 The content of violating social order and good customs;

uff084uff09 Other contents prohibited by laws and administrative regulations.

Cosmetic operators shall not prepare cosmetics by themselves.

Article 39 cosmetics producers and operators shall store and transport cosmetics in accordance with the provisions of relevant laws and regulations and the requirements of cosmetics labels and labels, regularly inspect and timely dispose of cosmetics that have deteriorated or exceeded their service life.

Article 41 the e-commerce platform operator shall register the real name of the cosmetic operator on the platform, undertake the management responsibility of the cosmetic operator on the platform, and shall stop and report to the drug regulatory department of the peoples Government of the province, autonomous region or municipality directly under the central government where the e-commerce platform operator is located In case of serious illegal activities, it is necessary to stop providing e-commerce platform services to illegal cosmetics operators immediately.

Cosmetics operators on the platform shall disclose the information of cosmetics in a comprehensive, true, accurate and timely manner.

Article 43 the contents of cosmetic advertisements shall be authentic and legal.

Cosmetics advertisements shall not express or imply that the products have medical effects, contain false or misleading contents, and shall not deceive or mislead consumers.

Article 44 If a cosmetic registrant or filing person discovers that a cosmetic has quality defects or other problems that may endanger human health, it shall immediately stop production, recall the cosmetics already on the market, notify the relevant cosmetic operators and consumers to stop operation and use, and record the recall and notification. The cosmetic registrant and record holder shall take remedial, harmless treatment and destruction measures for the recalled cosmetics, and report the recall and disposal of the cosmetics to the drug regulatory department of the peoples Government of the province, autonomous region or municipality directly under the central government.

If the entrusted production enterprise or cosmetic business operator discovers that the cosmetics produced or operated by the entrusted manufacturer or cosmetic operator have the circumstances specified in the preceding paragraph, they shall immediately stop the production and marketing and notify the relevant cosmetics registrants and recorders. The registrant and recorder of cosmetics shall immediately recall the cosmetics.

The entrusted production enterprises and cosmetic operators shall cooperate in the recall of cosmetics registered or filed.

If the registrant, record holder, entrusted production enterprise or business operator of cosmetics fails to recall or stop production or marketing in accordance with the provisions of this article, the Department in charge of drug supervision and administration shall order it to carry out the recall or stop its production and marketing.

Article 45 the entry-exit inspection and quarantine authorities shall inspect the imported cosmetics in accordance with the provisions of the law of the peoples Republic of China on import and export commodity inspection; those that fail to pass the inspection shall not be imported.

The importers shall examine whether the cosmetics to be imported have been registered or put on record and whether they conform to the regulations and the 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 storage period of the records shall comply with the provisions of the first paragraph of Article 31 of these regulations.

The cosmetics to be exported shall conform to the standards or contract requirements of the importing country (region).

Chapter IV Supervision and Administration

Article 46 when supervising and inspecting the production and operation of cosmetics, the Department in charge of drug supervision and administration has the right to take the following measures:

uff081uff09 Enter the production and operation site to carry out on-site inspection;

uff082uff09 Carry out sampling inspection on cosmetics produced and operated;

uff083uff09 Consulting and copying relevant contracts, bills, account books and other relevant materials;

uff084uff09 To seal up or detain cosmetics and their raw materials that do not conform to the compulsory national standards and technical specifications, or have evidence to prove that they may endanger human health, packaging materials that directly contact cosmetics, and tools and equipment used for illegal production and business operations that are proved by evidence;

Article 47 when the Department in charge of drug supervision and administration supervises and inspects the production and operation of cosmetics, the number of supervisors and inspectors shall not be less than two, and they shall show their law enforcement certificates. The supervision and inspection personnel shall keep the business secrets of the inspected unit known during supervision and inspection in accordance with the law. The inspected unit shall cooperate with the supervision and inspection and shall not conceal the relevant information.

The Department in charge of drug supervision and administration shall record the supervision and inspection and the handling results, which shall be signed by the supervision and inspection personnel and the person in charge of the inspected unit; if the person in charge of the inspected unit refuses to sign, it shall be indicated.

The Department in charge of drug supervision and administration shall timely publish the results of cosmetic sampling inspection in accordance with the provisions.

Article 49 cosmetic inspection institutions shall not engage in cosmetic inspection until they have obtained the qualification certification in accordance with the relevant provisions of the state. The qualifications of cosmetic inspection institutions shall be determined by the drug regulatory department of the State Council and the market supervision and Administration Department of the State Council.

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

Article 50 for cosmetics that may be adulterated or produced with raw materials that are prohibited from being used in the production of cosmetics, and cannot be inspected according to the inspection items and methods specified in the national standards for cosmetics, the drug regulatory department under the State Council may formulate supplementary inspection items and methods for sampling inspection of cosmetics, investigation and handling of cosmetic quality and safety cases, and defective products Reaction investigation and disposal.

Article 51 in case of any objection to the inspection conclusion implemented in accordance with the provisions of these regulations, the cosmetics manufacturer or operator may, within 7 working days from the date of receiving the inspection conclusion, file an application for re inspection to the Department implementing the sampling inspection or the Department in charge of drug administration at the next higher level. The department accepting the application for re inspection shall randomly determine the re inspection institution in the list of re inspection institutions for re inspection. The re inspection conclusion issued by the re inspection organization is the final inspection conclusion. The re inspection institution and the preliminary inspection institution shall not be the same organization. The list of re inspection institutions shall be published by the drug regulatory department under the State Council.

Article 52 The State shall establish a monitoring system for adverse reactions of cosmetics. The registrant and recorder of cosmetics shall monitor the adverse reactions of cosmetics sold on the market, conduct evaluation in a timely manner, and report to the cosmetics adverse reaction monitoring agency in accordance with the provisions of the drug regulatory department under the State Council. If the entrusted production enterprise, cosmetic operator and medical institution find any adverse reactions that may be related to the use of cosmetics, they shall report to the cosmetics adverse reaction monitoring institution. Other units and individuals are encouraged to report the adverse reactions that may be related to the use of cosmetics to the cosmetics adverse reaction monitoring institution or the Department in charge of drug supervision and administration.

The cosmetics adverse reaction monitoring institution is responsible for the collection, analysis and evaluation of cosmetic adverse reaction information, and puts forward handling suggestions to the Department in charge of drug supervision and management.

The cosmetics manufacturers and operators shall cooperate with the cosmetics adverse reaction monitoring institutions and the departments responsible for drug supervision and management to carry out the investigation of adverse reactions of cosmetics.

Article 53 The State shall establish a monitoring and evaluation system for cosmetic safety risks to monitor and evaluate the risk factors affecting the quality and safety of cosmetics, so as to provide a scientific basis for formulating the control measures and standards for the quality and safety risks of cosmetics and for carrying out the 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 shall specify the varieties, items and regions to be monitored.

Article 54 for cosmetics that cause human body injury or have evidence to prove that they may endanger human health, the Department in charge of drug supervision and administration may take emergency control measures to order the suspension of production and marketing, and issue safety warning information; for imported cosmetics, the state entry-exit inspection and quarantine department may suspend the import.

Article 55 in the light of the development of scientific research, if there is a change in the understanding of the safety of cosmetics and cosmetics raw materials, or there is evidence indicating that there may be defects in the cosmetics and cosmetics raw materials, the drug regulatory department of the peoples government at or above the provincial level may order the registrants and recorders of cosmetics and new cosmetic raw materials to carry out safety re assessment or directly organize the development of safety Total reassessment. If the re evaluation results show that the safety of cosmetics and cosmetic raw materials cannot be guaranteed, the original registration department shall cancel the registration, and the filing department shall cancel the filing. The drug regulatory department under the State Council shall include the cosmetic raw materials in the list of raw materials prohibited for cosmetics production and make them available to the public.

Article 56 the Department in charge of drug supervision and administration shall timely publish the supervision and management information of cosmetics such as administrative license, record, daily supervision and inspection results, investigation and punishment of illegal acts, etc. When publishing the supervision and management information, the commercial secrets of the parties concerned shall be kept confidential.

The Department in charge of drug supervision and administration 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 implemented for producers and operators with serious bad credit records according to regulations.

Article 57 If there are potential safety hazards in the production and operation 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 cosmetics manufacturer or operator. Cosmetics producers and operators 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 its website address, e-mail address or telephone number, accept consultation, complaint and report, and reply or deal with it in a timely manner. Rewards shall be given to the informants in accordance with the relevant provisions of the state.

Article 59 in any of the following circumstances, the Department in charge of drug supervision and administration shall confiscate the illegal income, the cosmetics illegally produced and sold, and the raw materials, packaging materials, tools, equipment and other articles specially used for the illegal production and operation; if the value of the cosmetics illegally produced and traded is less than 10000 yuan, a fine of not less than 50000 yuan but not more than 150000 yuan shall be imposed; if the value of the cosmetics is more than 10000 yuan, the Department in charge of drug supervision and administration shall confiscate the illegal income, cosmetics produced and sold illegally, and the raw If the case is serious, it shall be ordered to stop production or business, the record keeping department shall cancel the record, or the original license issuing department shall revoke the cosmetic license, and shall not handle the cosmetics filing or accept the cosmetics administrative license application submitted by the original license issuing department within 10 years, and the legal representative or principal responsible person of the illegal unit and the person directly responsible shall be liable The person in charge and other persons directly responsible shall be fined not less than three times but not more than five 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:

uff081uff09 Engaging in cosmetics production activities without permission, or entrusted by the cosmetics registrant or filing person to produce cosmetics without corresponding cosmetics production license;

uff082uff09 Producing, marketing or importing unregistered special cosmetics;

uff083uff09 To produce cosmetics by using raw materials prohibited for cosmetics production, new raw materials that should be registered but not registered, illegally adding substances that may endanger human health in cosmetics, or using cosmetics or raw materials that are beyond the service life, discarded or recycled to produce cosmetics.

Article 60 in case of any of the following circumstances, the Department in charge of drug supervision and administration shall confiscate the illegal income, cosmetics produced and sold illegally, raw materials, packaging materials, tools, equipment and other articles specially used for illegal production and operation; if the value of cosmetics illegally produced and sold is less than 10000 yuan, a fine of not less than 10000 yuan but not more than 50000 yuan shall be imposed; if the value of the cosmetics is more than 10000 yuan, and If the case is serious, it shall be ordered to stop production or business, the record keeping department shall cancel the record, or the original license issuing department shall revoke the cosmetics license. The legal representative or principal person in charge, the person in charge directly responsible and other persons directly responsible of the illegal unit shall be fined not less than one time but not more than three times the income obtained from the unit in the previous year If a crime is constituted, criminal responsibility shall be investigated according to law

uff081uff09 Using raw materials that do not meet the mandatory national standards and technical specifications, or packaging materials that directly contact cosmetics, new raw materials that should be put on record but have not been put on record are used to produce cosmetics, or the raw materials are not used in accordance with the mandatory national standards or technical specifications;

uff083uff09 Failure to organize the production according to the requirements of the quality management standard for cosmetics production;

uff084uff09 Change the use life of cosmetics;

uff086uff09 The Department in charge of drug supervision and administration refuses to recall after ordering it to carry out the recall, or refuses to stop or suspend production or business operation after the Department in charge of drug supervision and administration orders it to stop or suspend production or business operation.

Article 61 in case of any of the following circumstances, the Department in charge of drug supervision and administration shall confiscate the illegal income, cosmetics illegally produced and sold, and may confiscate the raw materials, packaging materials, tools, equipment and other articles specially used for illegal production and business operation; if the value of cosmetics illegally produced or sold is less than 10000 yuan, a fine of not less than 10000 yuan but not more than 30000 yuan shall be imposed; and the value of the goods shall be 10000 yuan If the case is more than RMB yuan, a fine of more than 3 times and less than 10 times of the value of the goods shall be imposed; if the circumstances are serious, it shall be ordered to stop production or business, the record keeping department shall cancel the record, or the original license issuing department shall revoke the cosmetics license. The legal representative or principal person in charge, the person in charge directly responsible and other persons directly responsible of the illegal unit shall be imposed with a fine of more than one time of the income obtained from the unit in the previous year A fine of less than 2 times shall be imposed, and it shall be prohibited from engaging in the production and operation of cosmetics within 5 years:

uff081uff09 Marketing, marketing or importing ordinary cosmetics that have not been put on record;

uff083uff09 The registrant and the registrant of cosmetics failed to supervise the production activities of the entrusted production enterprise;

uff085uff09 Cosmetics whose labels do not conform to the regulations.

If there are defects in the labels of cosmetics that are produced or sold but do not affect the quality and safety and do not mislead consumers, the Department in charge of drug supervision and administration shall order it to make corrections; if it refuses to make corrections, it shall be fined not more than 2000 yuan.

Article 62 in case of any of the following circumstances, the Department in charge of drug supervision and administration shall order it to make corrections, give a warning and impose a fine of not less than 10000 yuan but not more than 30000 yuan; if the circumstances are serious, it shall be ordered to stop production and business, and a fine of not less than 30000 yuan but not more than 50000 yuan shall be imposed on the legal representative or principal person in charge, directly responsible person in charge and other directly responsible persons of the illegal unit Fine between RMB yuan and RMB 30000 yuan:

uff081uff09 Failing to publish the summary of the basis for claiming the efficacy of cosmetics in accordance with the provisions of these regulations;

uff082uff09 Failing to establish and implement the purchase inspection record system and product sales record system in accordance with the provisions of these regulations;

uff083uff09 Failure to carry out self-examination on the implementation of quality management standards for cosmetics production in accordance with the provisions of these regulations;

uff084uff09 Failing to store or transport cosmetics in accordance with the provisions of these regulations;

uff085uff09 Failing to monitor and report the adverse reactions of cosmetics in accordance with the provisions of these regulations, or failing to cooperate in the investigation of adverse reactions of cosmetics carried out by the cosmetics adverse reaction monitoring institution and the Department in charge of drug supervision and administration.

If the importer fails to record and keep the information of the imported cosmetics in accordance with the provisions of these regulations, the entry-exit inspection and quarantine organ shall impose a penalty in accordance with the provisions of the preceding paragraph.

Article 63 If the registrant or recorder of new cosmetic raw materials fails to report the use and safety of new cosmetic raw materials in accordance with the provisions of these regulations, the drug regulatory department under the State Council shall order it to make corrections and impose a fine of not less than 50000 yuan but not more than 200000 yuan; if the circumstances are serious, the registration certificate of new cosmetic raw materials shall be revoked or the filing of new cosmetic raw materials shall be cancelled, and a fine of not less than 200000 yuan but not more than 500000 yuan shall be imposed u3002

Article 64 those who provide false information or take other deceptive means when applying for the administrative license of cosmetics shall not be granted with the administrative license. If the administrative license has been obtained, the administrative license shall be revoked by the Department that made the administrative license decision, and the cosmetics related to cosmetics that have been produced or imported shall be confiscated within five years If the value of cosmetics is less than 10000 yuan, a fine of more than 50000 yuan and less than 150000 yuan shall be imposed; if the value of cosmetics is more than 10000 yuan, a fine of 15 times to 30 times of the value of cosmetics shall be imposed; the legal representative or principal person in charge, directly responsible person in charge and other directly responsible personnel of the illegal unit 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 forbidden to engage in cosmetics production and business activities for life.

Article 65 for those who provide false information during the filing, the filing department shall cancel the filing, refuse to handle the filing within three years, and confiscate the illegal income and the cosmetics that have been produced and imported; if the value of the cosmetics that has been produced or imported is less than 10000 yuan, a fine of more than 10000 yuan but less than 30000 yuan shall be imposed; if the value of the cosmetics is more than 10000 yuan, it shall also be more than 3 times of the value of the goods If the circumstances are serious, it shall be ordered to stop production or business or even the original license issuing department shall revoke the cosmetics production license. The legal representative or principal person in charge, the person in charge directly responsible and other persons directly responsible of the illegal unit shall be fined not less than one time but not more than two times of the income obtained from the unit in the previous year, and shall be prohibited from engaging in cosmetics production and business activities within five years u3002

If the materials that have been put on record do not meet the requirements, the filing department shall order them to make corrections within a time limit. Among them, if the filing materials related to the safety of cosmetics and new cosmetics materials do not meet the requirements, the filing department may simultaneously order the suspension of sales and use; if it fails to make corrections within the time limit, the filing department shall cancel the filing.

If the filing department still uses the new cosmetic raw materials to produce cosmetics, or still sells or imports the ordinary cosmetics after canceling the filing, it shall be punished in accordance with the provisions of articles 60 and 61 of these regulations respectively.

Article 66 If the promoters of the centralized cosmetics trading market or the organizers of trade fairs fail to perform the management obligations of examination, inspection, stopping and reporting in accordance with the provisions of these regulations, the Department in charge of drug supervision and administration shall impose a fine of not less than 20000 yuan but not more than 100000 yuan; if the circumstances are serious, it shall be ordered to suspend business and be fined not less than 100000 yuan but not more than 500000 yuan.

Article 67 If an e-commerce platform operator fails to perform the management obligations of real name registration, stop, report or stop providing e-commerce platform services in accordance with the provisions of these regulations, the drug regulatory department of the peoples Government of the province, autonomous region or municipality directly under the central government shall impose a punishment in accordance with the provisions of the e-commerce law of the peoples Republic of China.

Article 68 If a cosmetic operator has fulfilled the obligations of purchasing inspection records as stipulated in these regulations, and has evidence to prove that he does not know that the purchased cosmetics do not conform to the mandatory national standards and technical specifications or the technical requirements specified in the registration and filing materials of cosmetics, the cosmetics operators shall confiscate the cosmetics that do not conform to the mandatory national standards and technical specifications or the cosmetic labels Cosmetics with technical requirements specified in the volume and filing materials may be exempted from administrative penalty.

Article 69 Where cosmetics advertisements violate the provisions of these regulations, they shall be punished in accordance with the provisions of the advertising law of the peoples Republic of China; those who make false or misleading publicity of cosmetics by other means shall be punished in accordance with the provisions of relevant laws; if a crime is constituted, criminal responsibility shall be investigated according to law.

Article 70 If an enterprise legal person designated by an overseas cosmetics registrant or filing person fails to assist in the monitoring of adverse reactions of cosmetics and product recall, the drug regulatory department of the peoples Government of the province, autonomous region or municipality directly under the central government shall order it to correct, give a warning and impose a fine of not less than 20000 yuan but not more than 100000 yuan; if the circumstances are serious, it shall be fined not less than 100000 yuan but not more than 500000 yuan The legal representative or the principal person in charge, the person in charge directly in charge and other persons directly responsible shall be prohibited from engaging in the production and operation of cosmetics within five years.

If the foreign cosmetic registrant or record holder refuses to perform the administrative punishment decision made in accordance with these regulations, the cosmetics import shall be prohibited for 10 years.

Article 71 If 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, refuse to accept the application for qualification confirmation within 10 years, confiscate the inspection fees collected, and impose a fine of not less than 50000 yuan but not more than 100000 yuan; the legal representative or the main responsible person, the directly responsible person in charge and other directly responsible persons shall be punished He shall be fined not less than one time but not more than three times of the income he has obtained from the unit in the previous year, and shall be given or ordered to be given the punishment of lowering the post grade, removing from office or expelling him. If he is dismissed, he shall be prohibited from engaging in cosmetics inspection within 10 years; if a crime is constituted, he shall be investigated for criminal responsibility according to law.

Article 72 If a cosmetic technical evaluation institution, a cosmetic adverse reaction monitoring institution or an organization in charge of cosmetic safety risk monitoring fails to perform its duties in accordance with the provisions of these regulations, thus causing serious mistakes in the technical review, adverse reaction monitoring and safety risk monitoring, the Department in charge of drug supervision and administration shall order it to make corrections, give a warning and circulate a notice of criticism If so, the legal representative or the principal person in charge, the person in charge directly responsible and other persons directly responsible shall be given or ordered to be given the punishment of lowering the post rank, removing from office or expelling him.

Article 73 Where a cosmetic manufacturer, operator or inspection institution recruits or employs persons who are not allowed to engage in the production and marketing of cosmetics or those who are not allowed to be engaged in the inspection and production of cosmetics, the Department in charge of drug supervision and administration or other relevant departments shall order them to make corrections and give them a warning; if they refuse to make corrections, they shall be ordered to stop production or business or even be revoked Cosmetic license and qualification certificate of inspection organization.

Article 74 If any of the following circumstances constitutes an act against the administration of public security, the public security organ shall impose a penalty on the administration of public security according to law; if a crime is constituted, criminal responsibility shall be investigated according to law:

uff081uff09 Hindering the staff of the Department in charge of drug administration from performing their duties according to law;

uff082uff09 Forging, destroying or concealing evidence or concealing, transferring, selling off or damaging articles sealed up or detained according to law.

Article 75 any staff member of the Department in charge of drug supervision and administration who, in violation of the provisions of these regulations, abuses his power, neglects his duty or engages in malpractice for personal gains shall be given disciplinary sanctions of warning, demerit recording or major demerit recording according to law; if serious consequences are caused, he shall be demoted, removed from office or dismissed according to law; if a crime is constituted, criminal responsibility shall be investigated according to law.

Article 76 anyone who violates the provisions of these regulations and causes 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 these Regulations on ordinary cosmetics. After evaluating the efficacy according to the national and industrial standards, the filing person of the toothpaste can claim that the toothpaste has the effects of preventing caries, inhibiting dental plaque, resisting dentin sensitivity, and reducing gingival problems. The specific measures for the administration of toothpaste shall be formulated by the drug regulatory department under the State Council and submitted to the market supervision and Administration Department of the State Council for examination and approval and promulgation.

This regulation is not applicable to soap, but it is applicable to those who claim to have special cosmetic effects.

Article 78 a transitional period of five years shall be set up for cosmetics registered before the implementation of these Regulations for hair development, hair removal, breast beautification, bodybuilding and deodorization. During the transitional period, the cosmetics may continue to be produced, imported and sold. After the transitional period, such cosmetics shall not be produced, imported or sold.

Article 79 the technical specifications referred to in these Regulations refer to the supplementary technical requirements for the quality and safety of cosmetics formulated by the drug regulatory department under the State Council in combination with the needs of supervision and administration before the compulsory national standards have been formulated.

Article 80 these Regulations shall come into force as of January 1, 2021. The regulations on hygienic supervision of cosmetics shall be repealed at the same time.

The General Administration of market supervision and so on answered reporters questions on the regulations on the supervision and administration of cosmetics

Cosmetics are consumer goods to meet peoples demand for beauty. They directly affect the human body, and their quality is related to peoples health. In recent years, Chinas cosmetics industry has developed rapidly, but there are still some problems, such as low quality and efficiency of industry development, lack of innovation ability, low brand recognition and illegal addition. The regulations on health supervision of cosmetics have played an active role in promoting the healthy development of the cosmetics industry and ensuring the quality and safety of cosmetics since its implementation for 30 years. However, it has been unable to meet the needs of industrial development and regulatory practice. Firstly, the legislative concept focuses on prior approval and government supervision, but fails to highlight the dominant position of enterprises and give full play to the role of market mechanism; secondly, the supervision mode is relatively rough Third, the legal liability is too light. Therefore, it is necessary to make a comprehensive revision of the regulations on cosmetic hygiene supervision and formulate a new regulation on the supervision and administration of cosmetics.