Announcement of the State Food and Drug Administration on Issuing the Measures for the Monitoring and Administration of Adverse Reactions of Cosmetics (No. 16 of 2022)

In order to regulate the monitoring of adverse reactions of cosmetics, in accordance with the Regulations on the Supervision and Administration of Cosmetics, the Measures for the Supervision and Administration of the Production and Operation of Cosmetics and other laws and regulations, the State Food and Drug Administration has organized and formulated the Measures for the Monitoring and Administration of Adverse Reactions of Cosmetics, which are hereby promulgated and shall come into force on October 1, 2022.

It is hereby announced.

State Food and Drug Administration

February 15, 2022

Annex: Measures for the Monitoring and Management of Adverse Reactions of Cosmetics

Chapter I General Provisions

Article 1 In order to strengthen the monitoring of adverse reactions of cosmetics, control the safety risks of cosmetics in a timely and effective manner, and protect the health of consumers, these Measures are formulated in accordance with the "Regulations on the Supervision and Administration of Cosmetics", "Measures for the Supervision and Administration of Cosmetic Production and Operation" and other laws and regulations.

Article 2 These Measures shall apply to the monitoring of adverse reactions of cosmetics and the supervision and administration thereof within the territory of the People's Republic of China.

Article 3 The SDA shall be responsible for the monitoring and administration of adverse reactions of cosmetics throughout the country. The departments responsible for drug supervision and administration of the local people's governments at or above the county level shall be responsible for the monitoring and administration of adverse reactions to cosmetics in their respective administrative regions.

The department responsible for drug supervision and administration of the local people's government at or above the county level shall specify the cosmetic adverse reaction monitoring agency and be responsible for the technical work of cosmetic adverse reaction monitoring in its administrative region.

Article 4 Cosmetics registrants and registrants shall establish a monitoring and evaluation system for adverse reactions of cosmetics, actively collect the adverse reactions of cosmetics on the market, conduct analysis and evaluation in a timely manner, and report to the cosmetics adverse reaction monitoring agency in accordance with the provisions of these Measures to implement cosmetics The main responsibility for quality and safety. Entrusted production enterprises, cosmetics operators and medical institutions shall report adverse reactions that may be related to the use of cosmetics to the cosmetics adverse reaction monitoring agency in accordance with the provisions of these Measures.

Article 5 The State encourages 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 administration, so as to give full play to the role of social supervision and promote the safe and social co-governance of cosmetics.

Article 6 The SDA shall be responsible for establishing the national information system for monitoring adverse reactions of cosmetics and strengthening the information construction for monitoring adverse reactions of cosmetics.

Chapter II Duties and Obligations

Article 7 The SDA shall be responsible for the monitoring and administration of adverse reactions of cosmetics throughout the country, and shall perform the following main duties:

(I) establish and improve the national cosmetics adverse reaction monitoring and management system, organize the formulation of cosmetics adverse reaction monitoring and management system, and supervise the implementation;

(II) organize the investigation of cosmetic adverse reactions that may cause greater social impact, and take control measures in accordance with the law;

(III) organize supervision and inspection of cosmetics adverse reaction monitoring work;

(IV), formulate and publish the accreditation standards and management norms of the national cosmetic adverse reaction monitoring and evaluation base (hereinafter referred to as the national monitoring base), and organize the selection and management of the national monitoring base;

(V) organize and carry out national cosmetics adverse reaction monitoring publicity, training, research and international exchanges.

Article 8 The pharmaceutical supervisory and administrative departments of provinces, autonomous regions, and municipalities directly under the Central Government (hereinafter referred to as the provincial pharmaceutical supervisory departments) shall be responsible for the monitoring and management of adverse reactions of cosmetics in their respective administrative regions, and perform the following main duties:

(I) establish and improve the monitoring and management system of adverse reactions of cosmetics in the administrative region, allocate institutions and personnel suitable for the monitoring work, improve the working system and supervise the implementation;

(II) organize the investigation of serious adverse reactions of cosmetics that occur in the administrative area and may cause greater social impact, and take control measures in accordance with the law;

(III) the organization of supervision and inspection of the administrative region of cosmetics adverse reaction monitoring work;

(IV) organize and carry out the publicity, training and research on the monitoring of adverse reactions of cosmetics in the administrative region.

Article 9 the departments in charge of drug supervision and administration at the municipal and county levels divided into districts (hereinafter referred to as the municipal and county-level regulatory departments) shall be responsible for the monitoring and management of adverse reactions of cosmetics in their respective administrative regions, and perform the following main duties:

(I) establish and improve the monitoring and management system of adverse reactions of cosmetics in the administrative region, allocate institutions and personnel suitable for the monitoring work, improve the working system and supervise the implementation;

(II) investigate the serious adverse reactions of cosmetics that occur in the administrative area and may cause greater social impact, investigate other adverse reactions of cosmetics in the administrative area according to the monitoring results and work needs, and take control measures according to law;

(III) supervise and inspect the monitoring of adverse reactions of cosmetics in their respective administrative regions;

(IV) organize and carry out the publicity, training and research on the monitoring of adverse reactions of cosmetics in the administrative region.

Article 10 The national cosmetic adverse reaction monitoring agency (hereinafter referred to as the national monitoring agency) shall be responsible for the technical work of national cosmetic adverse reaction monitoring, and perform the following main duties:

(I) collection, analysis and evaluation of national cosmetic adverse reactions, and risk management recommendations to the State Drug Administration;

(II) to the adverse reactions of cosmetics that may cause greater social impact, put forward suggestions to the SDA and cooperate with the investigation;

(III) responsible for the construction and maintenance of the national cosmetic adverse reaction monitoring information system;

(IV) formulate technical standards and norms for the monitoring of adverse reactions of cosmetics, and provide operational guidance to local monitoring agencies at all levels and national monitoring bases;

(V) carry out national cosmetics adverse reaction monitoring publicity, training, research and international exchanges.

Article 11 The provincial-level cosmetics adverse reaction monitoring agency (hereinafter referred to as the provincial-level monitoring agency) shall be responsible for the technical work of cosmetics adverse reaction monitoring in its administrative region, and perform the following main duties:

(I) collect, analyze and evaluate the adverse reactions of cosmetics in the administrative area, and put forward risk management suggestions to the local provincial drug administration department;

(II) the serious cosmetic adverse reactions that occur in the administrative area and may cause greater social impact, put forward handling suggestions to the local provincial drug administration department and cooperate with the investigation work;

(III) be responsible for the use and management of the national cosmetic adverse reaction monitoring information system in their respective administrative regions;

The (IV) shall provide business guidance to the municipal and county-level cosmetics adverse reaction monitoring institutions divided into districts (hereinafter referred to as the municipal and county-level monitoring institutions), and organize the cosmetics registrants, filers, domestic responsible persons, entrusted production enterprises, and cosmetics within the administrative area Provide technical guidance to operators, medical institutions, etc;

(V) carry out the administrative region of cosmetics adverse reaction monitoring publicity, training, research and other work.

Article 12 The municipal and county-level monitoring institutions shall be responsible for the technical work of monitoring adverse reactions of cosmetics in their respective administrative regions, and perform the following main duties:

(I) collect, analyze and evaluate the adverse reactions of cosmetics in the administrative area, and put forward risk management suggestions to the local department in charge of drug supervision and administration at the same level;

(II) the serious cosmetic adverse reactions that occur in the administrative area and may cause greater social impact, put forward handling suggestions to the local department responsible for drug supervision and management at the same level and cooperate with the investigation. According to the monitoring results and risk level, other adverse reactions of cosmetics in the administrative area shall be put forward to the local department responsible for drug supervision and management at the same level and cooperate with the investigation work;

(III) to assist provincial monitoring agencies to carry out technical work on the monitoring of adverse reactions of cosmetics;

(IV) provide technical guidance to cosmetics registrants, filers, domestic responsible persons, entrusted production enterprises, cosmetics operators, medical institutions, etc. within their administrative areas;

(V) carry out the administrative region of cosmetics adverse reaction monitoring publicity, training, research and other work.

Article 13 Cosmetics registrants and filers shall have the ability to carry out the monitoring of adverse reactions of cosmetics, and perform the following obligations in accordance with the regulations on the supervision and administration of cosmetics:

(I) establish and implement a monitoring and evaluation system for adverse reactions of cosmetics, and equip institutions and personnel suitable for their products to engage in the monitoring of adverse reactions of cosmetics;

(II) take the initiative to collect and report cosmetic adverse reactions to the cosmetic adverse reaction monitoring agency in accordance with the provisions of these Measures;

The (III) shall analyze and evaluate the adverse reactions of cosmetics found or learned in time, and take measures to control the risks according to the evaluation results;

(IV) cooperate with the cosmetic adverse reaction monitoring agency and the department responsible for drug supervision and administration to carry out cosmetic adverse reaction investigation.

Overseas cosmetics registrants and filers shall establish an assistance mechanism for active collection, reporting, analysis, evaluation, investigation and handling of adverse reactions with domestic responsible persons to ensure the fulfillment of the obligations stipulated in the first paragraph of this article.

Article 14 the entrusted production enterprises and cosmetics operators shall, in accordance with the regulations on the supervision and administration of cosmetics and the provisions of these measures, report the adverse reactions of cosmetics found or learned to the adverse reaction monitoring institutions of cosmetics, and cooperate with the adverse reaction monitoring institutions of cosmetics and the departments responsible for drug supervision and administration to carry out the investigation of adverse reactions of cosmetics.

Article 15 Medical institutions shall, in accordance with the regulations on the supervision and administration of cosmetics and the provisions of these measures, report the adverse reactions of cosmetics found or learned to the adverse reactions of cosmetics to the monitoring institutions of adverse reactions of cosmetics, and cooperate with the monitoring institutions of adverse reactions of cosmetics and the departments responsible for drug supervision and administration to carry out the investigation of adverse reactions of cosmetics.

Junior College medical institutions for dermatology and second-level or above medical institutions with dermatology departments shall establish a monitoring system for adverse reactions of cosmetics suitable for their scope of diagnosis and treatment, and ensure the effective implementation of the monitoring system.

Article 16 If an operator of a cosmetics e-commerce platform learns of an adverse reaction of cosmetics, it shall record and promptly transfer it to the cosmetics operator on the platform for processing, urge the cosmetics operator on the platform to perform the adverse reaction reporting obligations of the cosmetics operator, and cooperate with the cosmetics adverse reaction monitoring agency, The department responsible for drug supervision and management conducts investigations on adverse reactions of cosmetics.

Article 17 The national monitoring base shall, in accordance with the requirements of the management norms, provide technical support for the monitoring of adverse reactions of cosmetics, participate in the analysis and evaluation of adverse reactions of cosmetics that are serious and may cause greater social impact by drug regulatory departments and monitoring institutions at or above the provincial level, and assist in the monitoring and publicity, training, research and technical guidance of adverse reactions of cosmetics.

Chapter III Adverse Reaction Reports

Article 18 The reporting of adverse reactions of cosmetics shall follow the principle of reporting when suspicious, and all human body injuries suspected to be related to the use of cosmetics shall be reported.

The contents of the report of adverse reactions of cosmetics shall be true, complete and accurate. Cosmetic adverse reaction report should include the reporter information, adverse reaction information, adverse reaction information, the use of cosmetics information and other content.

Article 19 cosmetics registrants and filers shall publish effective contact information such as telephone numbers and electronic E-mail to the public through product labels, official websites and other means that are convenient for consumers to know, and actively collect adverse reactions reported by entrusted production enterprises, cosmetics operators, medical institutions and consumers on the market.

Cosmetic registrants and filers shall report adverse reactions to cosmetics through the national cosmetic adverse reaction monitoring information system after discovering or learning thereof.

Article 20 After discovering or learning of adverse reactions of cosmetics, entrusted production enterprises, cosmetics operators, and medical institutions shall report through the National Adverse Reaction Monitoring Information System of Cosmetics and encourage them to inform the registrant and recordholder of cosmetics.

Cosmetic operators and medical institutions that do not have the conditions for online reporting for the time being shall report to the monitoring institutions at the city and county level through paper statements, and submit the report online on their behalf.

Article 21 If an operator of a cosmetics e-commerce platform learns of an adverse reaction of cosmetics, it shall record the information of the reporter, the information of the person who has the adverse reaction, the information of the adverse reaction, the information of the cosmetics used, etc., and transfer it to the cosmetics on the platform within 7 days. Operator processing. For major information related to product quality and safety, the operator of the cosmetics e-commerce platform shall, after learning the above information, report in writing to the provincial drug administration department where the operator of the e-commerce platform is located within 15 days, the information of the person who has the adverse reaction, the symptoms or signs, the severity of the adverse reaction, the date of occurrence of the adverse reaction, the name of the cosmetics used, and the operator in the platform where the cosmetics are sold.

Article 22 Other units and individuals may report adverse reactions to cosmetics registrants, filers, and domestic responsible persons, and may also report to the local city and county-level monitoring agencies or city and county-level regulatory agencies, and the above-mentioned enterprises or units may act on their behalf. Submit the report online.

The departments responsible for drug supervision and administration at all levels shall publish the telephone number, mailing address and other contact information of their own departments and monitoring institutions at the same level.

Article 23 If an adverse reaction of general cosmetics is found, the registered person, the filing person, the entrusted manufacturer, the cosmetics operator, the medical institution, etc. shall report it within 30 days from the date of discovery or knowledge of the adverse reaction of cosmetics, and if it is a serious adverse reaction of cosmetics, it shall report it within 15 days from the date of discovery or knowledge, adverse reactions of cosmetics that may cause greater social impact shall be reported within 3 days from the date of discovery or knowledge. For adverse reactions and analysis and evaluation results, such as new findings or cognition, should be timely supplementary report.

Article 24 Cosmetics registrants, filers, entrusted production enterprises, and medical institutions shall objectively and truthfully record activities related to adverse reaction monitoring and form monitoring records. The record retention period shall not be less than 3 years from the date of reporting. The responsible person within the territory shall assist in establishing and keeping the monitoring records of adverse reactions of cosmetics.

Cosmetic adverse reaction monitoring records should at least include: reporter information, adverse reaction information, symptoms or signs, severity of adverse reactions, adverse reaction date, adverse reaction discovery or known date, adverse reaction report date, the name of the cosmetics used, etc. For cosmetics adverse reactions that are serious and may cause greater social impact, cosmetics registrants and filers should also record the causes of adverse reactions that may cause adverse reactions, analyze and evaluate the situation, and follow-up risk control measures. Medical institutions should also record the diagnosis and treatment of adverse reactions related to cosmetics.

The following contents should be collected and recorded as far as possible: the registration certificate number of special cosmetics or the record number of ordinary cosmetics, production batch number, start date and stop date of use of cosmetics used for adverse reactions, and the diagnosis and treatment of medical institutions.

Article 25 If the overseas cosmetics registrant or recordholder whose products are listed and sold inside and outside China are taken to stop production or operation, implement product recall, release safety warning information and other risk control measures due to adverse reactions of cosmetics abroad, the overseas cosmetics registrant or recordholder shall, within 7 days from the date of discovery or knowledge, report the relevant adverse reaction information and the risk control measures taken in writing to the national monitoring agency, the domestic responsible person shall assist the overseas cosmetics registrant and the filing person to fulfill the reporting obligation.

Chapter Four Adverse Reaction Analysis and Evaluation

Article 26 Cosmetics registrants and filers shall analyze and evaluate the adverse reactions of cosmetics discovered or learned, and if necessary, self-examine the causes of adverse reactions that may be caused by product raw materials, formulas, production processes, production quality management, storage and transportation. The domestic responsible person shall actively assist the overseas cosmetics registrant and the filing person to analyze and evaluate the adverse reactions of cosmetics discovered or learned.

If it is a serious adverse reaction of cosmetics, the cosmetic registrant or the filing person shall, within 20 days from the date of discovery or knowledge of the adverse reaction, if it is a cosmetic adverse reaction that may cause greater social impact, it shall be analyzed and evaluated within 10 days from the date of discovery or knowledge of the adverse reaction and form a self-examination report, and submit it to the provincial monitoring institution where the cosmetic registrant, the filing person and the domestic responsible person are located, and the provincial drug administration department are located.

Article 27 Monitoring institutions at all levels shall analyze and evaluate the adverse reactions of cosmetics that occur within their respective administrative areas, and put forward suggestions for handling to the local department responsible for drug supervision and administration at the same level according to the results of the analysis and evaluation and the degree of risk.

Article 28 The city and county monitoring agencies shall review the authenticity, completeness, and accuracy of the reports of adverse reactions of cosmetics received, and conduct preliminary analysis and evaluation of the relevance of adverse reactions to products and the severity of adverse reactions.

In the case of adverse reactions to general cosmetics, the municipal and county-level monitoring agencies shall complete the analysis and evaluation within 15 working days from the date of receipt of the adverse reaction report. If it is a serious adverse reaction of cosmetics, the analysis and evaluation shall be completed within 7 working days from the date of receipt of the adverse reaction report. If it is a cosmetic adverse reaction that may cause greater social impact, the analysis and evaluation shall be completed within 3 working days from the date of receiving the adverse reaction report. Adverse reactions to cosmetics that are serious and may cause greater social impact shall be reported to the local department responsible for drug supervision and administration at the same level at the same time, and suggestions for handling shall be put forward.

The monitoring institutions at the city and county level shall follow up and investigate the adverse reactions of cosmetics that are serious and may cause great social impact, and have a detailed understanding of the basic information of the adverse reactions and the cosmetics used, the occurrence and progress of adverse reactions, and the handling of adverse reactions by the reporting unit, etc., and form a follow-up report within 7 working days from the date of receiving the adverse reaction report and submit it to the monitoring institution at the next higher level, at the same time, it shall be submitted to the local department in charge of drug supervision and administration at the same level.

Article 29 For cosmetic adverse reaction reports with clear cosmetic names and product sales packaging pictures, after checking the product registration and filing information, the cosmetics used may belong to unregistered special cosmetics or unfiled ordinary cosmetics. The county-level monitoring agency shall report to the local department responsible for drug supervision and administration at the same level. The department in charge of drug supervision and administration shall organize investigation and take control measures according to law.

Article 30 The provincial-level monitoring agency shall review the evaluation opinions of the adverse reaction report of cosmetics submitted by the next-level monitoring agency, and analyze and evaluate the correlation between the adverse reaction and the product and the severity of the adverse reaction. If the provincial-level monitoring agency is inconsistent with the evaluation opinions of the next-level monitoring agency after review, and believes that it needs to be adjusted to be serious or may cause greater social impact for treatment of adverse reactions of cosmetics, it shall give feedback to the next-level monitoring agency. The next level monitoring institution shall, within 7 working days from the date of receiving the feedback from the provincial monitoring institution, conduct a follow-up investigation on the adverse reactions and form a follow-up report, and submit it to the relevant departments in accordance with the provisions of paragraph 3 of Article 28 of these measures.

In the case of adverse reactions to general cosmetics, the provincial monitoring agency shall complete the analysis and evaluation within 15 working days from the date of receiving the evaluation opinions of the next-level monitoring agency. If it is a serious adverse reaction of cosmetics, the analysis and evaluation shall be completed within 7 working days from the date of receiving the evaluation opinions of the next-level monitoring agency. If it is a cosmetic adverse reaction that may cause greater social impact, the analysis and evaluation shall be completed within 3 working days from the date of receiving the evaluation opinions of the next-level monitoring agency. Serious adverse reactions to cosmetics that may cause greater social impact shall be reported to the local provincial drug administration department at the same time, and suggestions for handling shall be put forward.

The provincial monitoring agency shall investigate and study the adverse reactions of cosmetics that are serious and may cause greater social impact in combination with the follow-up reports submitted by the next-level monitoring agency, and carry out monitoring data analysis, literature research, and expert consultation according to actual needs. Comprehensive analysis of the occurrence of adverse reactions and the reasons that may cause adverse reactions is a serious adverse reaction of cosmetics, an analysis and evaluation report shall be formed within 15 working days from the date of receipt of the follow-up report. If it is an adverse reaction of cosmetics that may cause greater social impact, the analysis and evaluation report shall be formed within 7 working days from the date of receipt of the follow-up report., And submitted to the national monitoring agency, and at the same time submitted to the local provincial drug administration department.

Article 31 The national monitoring agency shall analyze and evaluate the collected adverse reactions of cosmetics nationwide, and put forward suggestions for handling to the SDA according to the monitoring results and risk level.

For cosmetic adverse reactions that may cause greater social impact, the national monitoring agency shall organize the national monitoring base to carry out analysis and evaluation, and form an analysis and evaluation report within 7 working days from the date of receipt of the analysis and evaluation report submitted by the next-level monitoring agency The evaluation report shall be submitted to the State Drug Administration.

Article 32 The provincial-level monitoring agency shall conduct a summary analysis of the collected adverse reactions of cosmetics on a quarterly and annual basis, put forward risk management recommendations, and submit them in writing to the provincial-level drug supervision department and the national monitoring agency in a timely manner.

The national monitoring institution shall summarize and analyze the collected adverse reactions of cosmetics on a quarterly and annual basis, put forward risk management suggestions, and submit them to the SDA in writing in time.

Chapter V Investigation of Adverse Reactions

Article 33 After the department in charge of drug supervision and administration receives the suggestions on the treatment of adverse reactions of cosmetics submitted by the monitoring institution, according to the monitoring results and work needs, it may order the registered person, the filing person and the entrusted manufacturer involved in the adverse reactions to analyze and evaluate the adverse reactions and self-examine the possible causes of the adverse reactions, and take effective measures to control the risks, or carry out supervision and inspection of cosmetics registrants, filers, domestic responsible persons, entrusted production enterprises, and cosmetics operators involved in adverse reactions in accordance with their duties. According to the investigation results, if illegal acts are found, the department in charge of drug supervision and administration shall investigate and deal with them according to law.

Article 34 For serious adverse reactions of cosmetics, the supervision department at the city and county level where the adverse reactions occur shall conduct investigations in accordance with their duties within 15 working days from the date of receiving the adverse reaction evaluation opinions of the monitoring agency at the same level, and form an adverse reaction investigation The handling report shall be submitted to the department responsible for drug supervision and administration at the next higher level, and submitted to the provincial drug administration department level by level.

The provincial drug regulatory department in the place where the adverse reaction occurs shall organize the investigation according to its duties within 7 working days from the date of receiving the adverse reaction evaluation opinions of the monitoring institution at the same level, and promptly report the relevant information to the registered person, the filing person and the provincial drug regulatory department where the domestic responsible person is located. The provincial drug administration department of the place where the adverse reaction occurred shall form an investigation and handling report and notify the provincial drug administration department of the place where the registered person, the filing person and the responsible person in the territory are located.

Article 35 For cosmetic adverse reactions that may cause greater social impact, the city and county-level regulatory authorities where the adverse reactions occur shall conduct investigations in accordance with their duties within 7 working days from the date of receiving the adverse reaction evaluation opinions of the monitoring agency at the same level, And form an adverse reaction investigation and handling report and submit it to the department responsible for drug supervision and administration at the next higher level, and submit it to the provincial drug administration department level by level.

The provincial drug regulatory department in the place where the adverse reaction occurs shall organize the investigation according to its duties within 5 working days from the date of receiving the adverse reaction evaluation opinions of the monitoring institution at the same level, and promptly report the relevant information to the registered person, the filing person and the provincial drug regulatory department where the domestic responsible person is located. The provincial drug administration department of the place where the adverse reaction occurred shall form an investigation and handling report and notify the provincial drug administration department of the place where the registered person, the filing person and the responsible person in the territory are located.

For cosmetic adverse reactions that may cause greater social impact, the SDA shall organize investigations within 5 working days from the date of receipt of the analysis and evaluation report submitted by the national monitoring agency.

Article 36 according to the results of the investigation, if it is found that the product has quality defects or other problems that may endanger human health, the department in charge of drug supervision and administration shall, in accordance with the provisions of Article 44 of the regulations on the supervision and administration of cosmetics, notify the registered person of cosmetics and the person on record to carry out the recall, and notify the entrusted production enterprises and cosmetics operators to stop production and operation.

According to the results of the investigation, if it is found that the product causes harm to human body or there is evidence to prove that it may endanger human health, the department in charge of drug supervision and administration may, in accordance with the provisions of Article 54 of the regulations on the supervision and administration of cosmetics, take emergency control measures to order the suspension of production and operation.

Article 37 according to the results of the investigation, if the department in charge of drug supervision and administration considers that it is necessary for the cosmetic registrant or the filing person to carry out further analysis and evaluation, the provincial drug regulatory department where the cosmetic registrant, the filing person and the domestic responsible person are located may inform the cosmetic registrant, the filing person and the domestic responsible person of the relevant cosmetic adverse reaction information. Cosmetics registrants and filers shall, in accordance with the provisions of the first paragraph of Article 26 of these measures, form a self-examination report after timely analysis and evaluation, and submit it to the provincial drug regulatory department where the cosmetics registrant, filer and domestic responsible person are located.

Article 38 according to the results of the investigation, if there is evidence that cosmetics and cosmetic raw materials may be defective, the drug regulatory department at or above the provincial level may, in accordance with the provisions of Article 55 of the regulations on the supervision and administration of cosmetics, order the registrant and the filing person of cosmetics to carry out safety reassessment or directly organize safety reassessment.

According to the results of the investigation, for those who may need to formulate or revise mandatory national standards, technical specifications or develop supplementary inspection methods, the provincial drug regulatory department in charge of the investigation may request the State Drug Administration or the State Drug Administration may directly organize the development of relevant standard research and supplementary inspection methods.

Article 39 If a cosmetic registrant or recordholder finds that there is a safety risk in the product through analysis and evaluation of adverse reactions in cosmetics, it shall immediately take measures to control the risk. If it is found that the product has quality defects or other problems that may endanger human health, it shall, in accordance with the provisions of Article 44 of the regulations on the supervision and administration of cosmetics, immediately stop production, recall the cosmetics that have been put on the market, and notify the relevant cosmetics operators and consumers to stop operation and use. Domestic responsible persons shall actively assist overseas cosmetic registrants and filers in taking measures to control risks.

If the entrusted production enterprise or cosmetics operator discovers or learns that the cosmetics it produces or operates have safety risks and may endanger human health, it shall immediately stop production and operation, and at the same time inform the cosmetics registrant, the filing person, and the domestic responsible person, and cooperate with them to take Measures to control risks.

Chapter VI Supervision and Administration

Article 40 The department responsible for the supervision and administration of drugs shall supervise and inspect the monitoring of adverse reactions of cosmetics carried out by registrants, filers, domestic responsible persons, entrusted production enterprises, cosmetics operators, medical institutions, etc.

Article 41 if a registered person, a filing person, an entrusted production enterprise, a cosmetics operator or a medical institution fails to carry out the monitoring of adverse reactions of cosmetics in accordance with the provisions of these measures, it shall be punished in accordance with the regulations on the supervision and administration of cosmetics.

Article 42 The SDA shall report the annual monitoring of adverse reactions of cosmetics to the competent health department of the State Council. Encourage cosmetics registrants, filers, domestic responsible persons, entrusted manufacturers, and cosmetics operators to inform each other of adverse cosmetic reaction information.

Article 43 Trade secrets, personal privacy and other information learned in the monitoring of adverse reactions of cosmetics shall be kept confidential.

Chapter VII Supplementary Provisions

Article 44 The terms referred to in these Measures shall have the following meanings:

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

Serious cosmetic adverse reactions, refers to the normal use of cosmetics caused by one of the following damage:

(I) lead to temporary or permanent loss of sexual function, affecting normal human and social functions, such as skin lesions lasting non-healing, scar formation, permanent hair loss, obvious loss of capacity changes;

(II) lead to systemic damage, such as liver and kidney dysfunction, anaphylactic shock;

(III) leads to hospitalization or medical institutions deem it necessary to be hospitalized;

(IV) cause other serious damage to the human body, endanger life or cause death.

The adverse reactions of cosmetics that may cause greater social impact refer to the adverse reactions of cosmetics that cause greater social impact or cause serious damage to many people due to the normal use of the same cosmetics in a certain area.

The monitoring of adverse reactions of cosmetics refers to the whole process of collection, reporting, analysis and evaluation, investigation and treatment of adverse reactions of cosmetics.

Article 45 The provincial drug regulatory department shall organize an investigation into the adverse reactions of cosmetics using new raw materials, and if it is found that there are safety risks, control measures shall be taken in accordance with the law. Specific provisions shall be formulated separately.

Article 46 The provincial drug regulatory department may, in accordance with these Measures and in light of the actual situation, formulate detailed rules for implementation.

Article 47 These Measures shall come into force as of October 1, 2022.

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