To implement Regulations on supervision and administration of cosmetics  Measures for supervision and administration of cosmetics production and operation ,The State Food and Drug Administration organized the drafting of Measures for supervision and administration of cosmetics network operation Draft for comments  ,We are now seeking public opinions.

     The time for public consultation is:2022year8month17day 9month6day.Relevant units and individuals can give feedback to:hzpjgc@nmpa.gov.cn,Please indicate in the email subject: Measures for supervision and administration of cosmetics network operation Feedback on opinions and suggestions .

enclosure

1. Measures for supervision and administration of cosmetics network operation Draft for comments

2. Comments and suggestions feedback form template
   

Comprehensive Department of State Food and Drug Administration

2022year8month16day

enclosure1   Measures for supervision and administration of cosmetics network operation Draft for comments

Chapter I  total  be

Article 1 Purpose and basis   In order to standardize the online operation of cosmetics and the service behavior of cosmetics e-commerce platform,Ensure the safety of public makeup,according to Electronic commerce law of the people's Republic of China  Regulations on supervision and administration of cosmetics  Measures for supervision and administration of cosmetics production and operation  Measures for supervision and administration of online transactions And other laws, regulations and rules,These measures are formulated.

Article 2 Scope of application   Engaged in cosmetics network business in the people's Republic of China Provide cosmetics e-commerce platform service and its supervision and management,These Measures shall apply.

Article 3 Regulatory object   Cosmetics e-commerce operators include cosmetics e-commerce platform operators Cosmetics operators within the platform and e-commerce operators operating cosmetics through self built websites or other network services.Operating cosmetics through self built websites and other network services,It shall fulfill the obligations of cosmetics operators within the platform as stipulated in these measures.

Article 4 Regulatory principles   The departments responsible for drug supervision and administration shall persist in encouraging innovation Tolerance and prudence Stick to the bottom line Principle of online and offline Integrated Supervision,Encourage the use of information technology to carry out supervision and management,Ensure the quality and safety of cosmetics.

Article 5 Regulatory responsibilities   The State Drug Administration is responsible for organizing and guiding the national cosmetics network operation Supervision and management of cosmetics e-commerce platform services.

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 cosmetics network operation within their respective administrative areas according to their duties Supervision and management of cosmetics e-commerce platform services.

Article 6 Social co governance   The departments responsible for drug supervision and administration shall strengthen cooperation with relevant departments,Guide industry organizations Consumer organizations and other organizations jointly participate in the management of cosmetics network operation market environment,Strengthen industry self-discipline and integrity construction,Promote cosmetic safety and social governance.

Chapter II  Operator management of cosmetics e-commerce platform

Article 7 (Management System) Cosmetic e-commerce platform operators shall bear the responsibility for the management of cosmetic operators on the platform according to law, establish and effectively implement cosmetics quality and safety management systems such as real-name registration, daily inspection, stopping illegal acts, reporting, and handling complaints and reports. Cosmetics e-commerce platform operators shall, in accordance with the electronic commerce of the People's Republic of China law on the need for platform service agreement and trading rules, including the entry and exit platform, goods and services, quality assurance, consumers' rights and interests protection shall include product certification, product information release, illegal disposal requirements.

Article 8 (Establishment of organization) Cosmetics e-commerce platform operators shall set up cosmetics quality and safety management institutions, or appoint full-time and part-time quality and safety management personnel, who shall be responsible for establishing and organizing the implementation of cosmetics quality and safety management system, and organizing daily inspection of the operation activities of cosmetics operators on the platform.

Article 9 (Real-name registration) Cosmetic e-commerce platform operators shall require cosmetic operators who apply to enter the platform to submit real information such as identity, address and contact information for verification and registration, and establish registration files, which shall be verified and updated at least once every six months. The cosmetic e-commerce platform operators shall keep the identity information of the cosmetic operators on the platform for no less than three years from the date of their withdrawal from the platform.

Article 10 (Daily Inspection System) Cosmetic e-commerce platform operators shall establish a daily inspection system for cosmetic operators on the platform, which includes the inspection of online product information release and the inspection of daily operation behavior, etc.

In daily inspection, an inspection plan shall be made to specify the inspection object, inspection frequency and inspection content, etc., and an inspection record shall be formed after the inspection is completed. The inspection record shall at least include the identity information of the cosmetic operators on the platform inspected, the contents of the inspection, the results of the inspection, the disposal measures and other information, and the record shall be kept for no less than two years from the date of the inspection.

Article 11 (Inspection of Online Product Release Information) Cosmetic e-commerce platform operators shall carry out online inspection when cosmetic operators on the platform publish cosmetic product information. Verify the consistency between the product name, registration certificate number of special cosmetics, product standard number and other information published by the cosmetic operator on the platform and the corresponding product information published on the official website of the National Medical Products Administration. Encourage cosmetic e-commerce platform operators to use information technology and other technical means to carry out online product release information inspection, urge cosmetic operators on the platform to release product information comprehensively, truthfully and accurately.

Article 12 (Daily Business Operation Inspection) Cosmetic e-commerce platform operators shall, according to product risks, regularly organize daily business operation inspection of cosmetic operators on the platform, focusing on the following contents:

(1) To check whether cosmetics sold by cosmetic operators on the platform are not registered or put on record, or use the registration certificate number or record number of others' cosmetics falsely;

(2) Check whether the cosmetics labels and other information displayed on the main page of the business activities of the cosmetics operators on the platform are consistent with the corresponding product information published on the official website of the National Medical Products Administration;

(3) Check whether the cosmetic labels and other information displayed on the homepage of the business activities of cosmetic operators on the platform contain contents prohibited by laws and regulations, such as explicit or implied medical effects, false or misleading, and violation of social order and good customs.

Cosmetics e-commerce platform operators are encouraged to regularly conduct quality and safety monitoring of cosmetics sold on the platform through sampling inspection and other means, and to identify major quality and safety risks of cosmetics online.

Article 13 (Self-inspection of Regulatory Disclosure Information) Cosmetic e-commerce platform operators shall take the initiative to collect the regulatory disclosure information concerning product quality and safety, such as sampling inspection, suspension or cessation of trading in cosmetics, issued by drug regulatory authorities at or above the provincial level, and conduct self-inspection on the platform in a timely manner.

Article 14 (Stopping Illegal Acts) If the cosmetics e-commerce platform operators find that the cosmetics operators on the platform are suspected of illegal operation of cosmetics while carrying out daily inspection, self-inspection of public information in supervision or other quality and safety management activities, Necessary measures such as deleting, blocking and disconnecting links shall be taken in a timely manner in accordance with the law or in accordance with the platform service agreement and trading rules, and certification materials of suspected illegal operations shall be kept.

Cosmetics e-commerce platform operators shall be found inside the platform of cosmetics operators clues transfer platform in cosmetics suspected of illegal business operator is actually the local pharmaceutical supervisory and administrative departments at the provincial level transfer content includes the main body of suspected of illegal information, illegal behavior related case, cosmetics e-commerce platform operators have made the information such as the disposal measures. If there are any of the following circumstances in the conduct suspected of illegal business operation, it belongs to the major information of product quality and safety, and the cosmetics e-commerce platform operator shall, within 10 days from the date of discovery, forward the relevant clues to the provincial drug regulatory department where the cosmetics operator actually operates:

(1) Causing systemic damage to human body, endangering life or causing death due to the use of cosmetics sold online;

(2) where there is evidence that raw materials that are prohibited from being used in the production of cosmetics may be used or substances that may harm human health may be illegally added in the cosmetics sold online;

(3) Cosmetics sold online cause widespread public concern due to quality and safety problems.

Platform in the cosmetics operators actual premises pharmaceutical supervisory and administrative department shall be responsible for investigating suspected of illegal operation clue disposal, after investigation that platform within the operator's illegal conduct relating to the quality and safety of cosmetics, it shall timely to cosmetics label cosmetics registrant, for the record people responsible for the pharmaceutical supervisory and administrative departments of information; If the investigation finds that the operators on the platform have committed illegal acts, the operators of the cosmetics e-commerce platform shall be informed of the investigation result in time.

Article 15 (Disposal Behavior Report) The cosmetics e-commerce platform operator shall report in writing every quarter the suspected illegal operations of the cosmetics operators on the platform and the disposal measures found by the platform to the drug regulatory department at the provincial level where the cosmetics e-commerce platform operator resides; Which belongs to the paragraph 2 of article 14 of this regulation material information, the product quality and safety cosmetics e-commerce platform operators shall, within 15 days from the date of discovery will this platform found suspected of illegal conduct and disposal measures of the written report cosmetics e-commerce platform operators of the pharmaceutical supervisory and administrative departments at the provincial level.

Cosmetics e-commerce platform operator local pharmaceutical supervisory and administrative departments at the provincial level shall be written report of the audit cosmetics e-commerce platform operator, found that the make-up e-commerce platform operator fails to take necessary measures in a timely manner to prevent illegal behavior or cooperate with regulatory obligations in accordance with the law and reported to the pharmaceutical supervisory and administrative departments at the provincial level according to the requirement of alleged illegal operation of clues, The drug regulatory department at the provincial level where the cosmetic e-commerce platform operator has his home shall investigate and handle the matter according to law.

Article 16 (stop platform service) cosmetics e-commerce platform operators found in any of the following serious illegal ACTS, shall immediately stop the cosmetics business operators to provide e-commerce platform service platform, and the disposal results in 15 days report cosmetics pharmaceutical supervisory and administrative departments at the provincial level of e-commerce platform operators:

(1) Those who have been sentenced by the people's court for crimes related to the quality and safety of cosmetics;

(2) being detained by a public security organ or given other administrative penalties for public security because of illegal acts concerning the quality and safety of cosmetics;

(3) where a drug supervisory and administrative department has, according to law, imposed a punishment such as revoking its license, ordering it to stop production or business;

(4) other serious illegal acts.

If the cosmetics e-commerce platform operator is investigated or prosecuted for suspected cosmetics quality and safety crimes, and the evidence proves that it may endanger human health, the cosmetics e-commerce platform operator may suspend providing e-commerce platform services to the cosmetics operator in the platform according to law or according to the platform service agreement and trading rules.

Where the cosmetics e-commerce platform operator knows or should know that the cosmetics operator on the platform is prohibited from engaging in cosmetics production and operation according to law, it shall not provide e-commerce platform services to such operator.

Article 17 (Technical Support) Cosmetic e-commerce platform operators shall provide necessary technical support and services for cosmetic operators on the platform to fulfill obligations such as cosmetic information disclosure according to law.

Encourage cosmetic e-commerce platform operators to establish an automatic information reporting mechanism in the form of open data interface with the departments responsible for drug supervision and administration.

Article 18 (regulations training) cosmetics e-commerce platform operators should strengthen the conduct propaganda of knowledge of relevant laws and regulations within the platform on the cosmetics operator training, publicity and training content should include cosmetics within the relevant laws and regulations, the platform operator legal obligations and legal liability, the platform service agreement and trading rules, cosmetic information release requirements, etc.

ChapterⅢManagement of cosmetics operators on the platform

Article 19 (Incoming Goods Inspection) Cosmetics dealers on the platform shall establish and implement the incoming goods inspection record system, check the registration certificates of market entities, registration certificates of special cosmetics or record information of ordinary cosmetics, and quality inspection certificates of cosmetics products of direct suppliers, and keep relevant certificates. Record the name of cosmetics, registration certificate number of special cosmetics or record number of ordinary cosmetics, service life, net content, purchased quantity, supplier's name, address, contact information, purchase date and other contents truthfully. Those selling children's cosmetics shall also examine the marks of children's cosmetics, and check the label information of the children's cosmetics they sell with the corresponding product information published on the official website of the National Medical Products Administration.

Article 20 (Information display) Cosmetic operators on the platform shall fulfill the obligation of cosmetic information disclosure, and disclose cosmetics labels and other information consistent with the registered or recorded information in a comprehensive, true, accurate, clear and timely manner on the homepage of their business activities. The cosmetic label information to be disclosed shall include all the contents of the cosmetics label in which the product name and the standard serial number of the product shall be displayed in words in a prominent position on the main page of the business activities. Other information about product safety and efficacy claims disclosed shall be consistent with the contents related to the cosmetics labels of the products it sells.

Cosmetics operators on the platform are encouraged to display the special cosmetics registration certificate or the record information of ordinary cosmetics on the homepage of their business activities.

Where the product combinations, gifts and so on belong to or cover cosmetics, the cosmetics operator on the platform shall disclose relevant cosmetics labels and other information in accordance with the provisions of Paragraph 1 of this Article.

Article 21 (Risk control) Cosmetic operators on the platform shall actively cooperate with cosmetic e-commerce platform operators in carrying out quality and safety management activities such as daily inspection, self-inspection of regulatory public information, and timely and accurately provide relevant product information to cosmetic e-commerce platform operators. And cooperate with cosmetic e-commerce platform operators to take necessary measures to control risks in a timely manner.

Cosmetic operators on the platform shall pay attention to the supervision and public information about the quality and safety of the products related to the cosmetics they sell, and shall immediately stop the operation of the specific batch of cosmetics that has been identified by the department responsible for drug supervision and administration as not conforming to the provisions through sampling inspection. If the other batches of the product for the same variety, is responsible for the pharmaceutical supervisory and administrative department does not operate to stop or other risk control measures, platform operators continue to operate, in its operating activities shall be prominently display the home page of cosmetics this year's sampling inspection is not in conformity with the provisions of the regulation, public information for reference when consumer choose and buy.

Article 22 (Recall Requirements) If a cosmetic operator on the Platform finds that the cosmetics sold have quality defects or other problems that may endanger human health, it shall immediately stop the business operation and notify the relevant cosmetic registrants and record holders. The cosmetic registrant and the filing party shall recall the cosmetics according to law. Where the cosmetic registrant, the recordholder or the cosmetic operator on the platform fails to recall or suspend its business operations according to law, the department in charge of drug supervision and administration shall order it to recall or suspend its business operations.

Article 23 (Distribution Requirements) Cosmetics operators on the platform shall store and transport cosmetics in accordance with the provisions of relevant laws and regulations and the requirements on cosmetics labels, regularly inspect and timely dispose of the deteriorated or expired cosmetics.

Chapter IV Supervision and Administration

Article 24 (General Requirements) The department responsible for drug supervision and administration shall supervise and inspect cosmetics e-commerce operators according to law. Encourage the departments in charge of drug supervision and administration to use technical means to strengthen the network monitoring of cosmetics online business and cosmetics e-commerce platform services.

The department in charge of drug supervision and administration shall investigate and dispose of illegal acts found by supervision and inspection or network monitoring according to law.

Article 25 (Power of supervision and inspection) The department responsible for drug supervision and administration shall have the right to take the following measures according to law when supervising and inspecting the cosmetics e-commerce operators:

(1) Carry out on-site inspection of the places carrying out cosmetics online business and cosmetics e-commerce platform services;

(2) to conduct sampling inspection of cosmetics sold online;

(3) To consult and copy the contracts, bills, account books and other relevant materials related to the suspected illegal online operation of cosmetics;

(4) Collecting, retrieving and copying electronic data related to the suspected illegal online operation of cosmetics;

(5) to inquire the parties suspected of engaging in illegal cosmetics online business activities, and to investigate and understand the relevant information from natural persons, legal persons and non-legal organizations related to the illegal cosmetics online business activities;

(6) To seal up or detain according to law cosmetics and their raw materials, packaging materials that come into direct contact with cosmetics and tools and equipment that have been proved to be used in illegal production or business operations, which do not conform to compulsory national standards or technical norms, or which are proved to be potentially harmful to human health;

(7) To seal up according to law places engaged in illegal online cosmetics business;

(8) other measures that may be taken as prescribed by laws and regulations.

Article 26 (Jurisdiction) The illegal acts of cosmetic e-commerce platform operators and cosmetic e-commerce operators who sell cosmetics through self-established websites or other online services shall be under the jurisdiction of the department responsible for drug supervision and administration at or above the county level where they reside. Where a cosmetic e-commerce platform operator fails to fulfill the administrative obligations of real-name registration, stopping, reporting and stopping the provision of e-commerce platform services in accordance with the Regulations on cosmetics supervision and administration, the illegal acts shall be under the jurisdiction of the provincial drug regulatory department of the place where the operator has his residence.

Any illegal acts of cosmetic operators on the platform shall be under the jurisdiction of the department responsible for drug supervision and administration at or above the county level where they actually operate. Where the cosmetics e-commerce platform operator has his residence, the department in charge of drug supervision and administration at or above the county level may also exercise jurisdiction if it first discovers any illegal clues or receives complaints or reports.

If the department in charge of drug supervision and administration that does not have jurisdiction first discovers clues that the cosmetic operators on the platform are suspected of illegal business operations, it shall initially collect and fix evidence. The actual business address, product page pictures and website links of the cosmetics operators on the platform suspected of violating the law shall be handed over to the department responsible for drug supervision and administration at or above the county level where the cosmetics operators on the platform actually operate.

Article 27 (below right) platform in actual cosmetics operators were responsible for the pharmaceutical supervisory and administrative department investigation think platform within the operator's illegal conduct relating to the quality and safety of cosmetics, and shall timely to cosmetics label cosmetics registrant, for the record people responsible for the pharmaceutical supervisory and administrative departments of the relevant information. The department in charge of drug supervision and administration in the place of domicile of the cosmetic registrant or record holder shall, upon receipt of the circular information, promptly organize the supervision and inspection of the cosmetic registrant or record holder, and investigate and punish the illegal acts according to law.

Article 28 (risk control) is responsible for the pharmaceutical supervisory and administrative department finds that platform in cosmetics operators by the human body damage or there is evidence that may endanger human body health, in accordance with the requirements of cosmetics e-commerce platform operators take necessary disposal measures to control risk, cosmetics e-commerce platform operator shall cooperate.

Where emergency control measures are involved for specific products, the drug regulatory department at the provincial level shall inform the cosmetic e-commerce platform operators of the relevant product information; Where emergency control measures are involved for a large range of products, the SDA or the drug regulatory department at the provincial level where the cosmetic e-commerce platform operator has his home shall notify the cosmetic e-commerce platform operator of the relevant product information.

Where the drug supervisory and administrative department at the city or county level with districts discovers the existence of the circumstances mentioned in the first paragraph of this Article, it shall report to the drug supervisory and administrative department at the provincial level where it is located. If the drug supervisory and administrative department at the provincial level considers it necessary to take emergency control measures after study and judgment, it shall notify the operator of the cosmetics e-commerce platform.

Article 29 (assist in the investigation) at the provincial level, responsible for the level of district-constituted municipalities pharmaceutical supervisory and administrative departments for supervision and inspection, investigation, etc., need to obtain information, product information platform in cosmetics operators, trade, logistics, express delivery and other related information of the record, shall be submitted to the e-commerce platform operators to assist in the investigation letter issued by cosmetics, State the materials, information, and time requirements to be retrieved. The operators of the cosmetics e-commerce platform shall provide them and cooperate with the departments responsible for drug supervision and administration in technical aspects to carry out the monitoring of illegal acts in the online operation of cosmetics. Where the department in charge of drug supervision and administration at the county level needs to obtain relevant information for its supervision, inspection, case investigation and other work, it shall report to the department in charge of drug supervision and administration at the city level divided into districts where it is located, and the department in charge of drug supervision and administration at the city level divided into districts shall assist in obtaining the relevant information.

If the operator of the cosmetics e-commerce platform fails to fulfill the obligation of cooperating with the supervision according to law and fails to provide relevant materials and information as required, the provincial drug regulatory department responsible for conducting the investigation shall report the relevant situation to the provincial drug regulatory department in the place where the operator of the cosmetics e-commerce platform has his residence. The drug regulatory department at the provincial level where the cosmetic e-commerce platform operator has his home shall investigate and handle the matter according to law.

Article 30 (Supervision coordination) The department responsible for drug supervision and administration shall strengthen coordination in the daily supervision and administration of cosmetics online business and case investigation.

The provincial drug regulatory department of the place where the cosmetic e-commerce platform operator has his domicile shall timely inform other provincial drug regulatory departments of the information of the person in charge of the cosmetics quality and safety administration institution or the quality and safety management personnel set up by the cosmetic e-commerce platform operator within its administrative area.

Article 31 (Online SAMPLING INSPECTION) The sampling inspection of cosmetics sold online shall be carried out in accordance with the relevant provisions on the sampling inspection of cosmetics.

Article 32 (Evidence adoption) The technical monitoring records of online cosmetics business conducted by the department in charge of drug supervision and administration may be used as electronic data evidence for imposing administrative penalties or taking administrative measures.

Chapter V Supplementary Provisions

Article 33 (Cross-border E-commerce) Cosmetic e-commerce operators engaged in cross-border e-commerce retail import cosmetics shall not apply to these Measures and shall abide by the relevant provisions of the State on the supervision of cross-border e-commerce retail import commodities.

Article 34 (Implementation Date) These Measures shall come into force as of the day of.

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