Measures for the supervision and administration of the production and marketing of cosmetics

(Draft for comment)

Chapter I General provisions

Article 1 (Legislative purpose) These Measures are formulated in accordance with the Regulations on Supervision and Administration of Cosmetics in order to regulate the production and operation of cosmetics, strengthen the supervision and administration of cosmetics, and ensure the quality and safety of cosmetics.

Article 2 (Scope of application) In the People's Republic of China engaged in cosmetics production and marketing activities and supervision and administration, shall abide by these Measures.

Article 3 (Division of duties) The State Drug Administration shall be responsible for the supervision and administration of the production and marketing of cosmetics throughout the country, and shall supervise and guide the supervision and administration of the production and marketing of cosmetics by the drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government.

The drug regulatory department of the province, autonomous region and municipality directly under the Central Government shall be responsible for the supervision and administration of the production of cosmetics within its administrative region and the supervision and administration of the registrants, recordholders and operators of the cosmetics e-commerce platform whose registration place is within its administrative region.

The departments in charge of drug supervision and administration under the people's governments of cities and counties divided into districts shall, according to the division of duties, be responsible for the supervision and administration of cosmetics distribution within their respective administrative areas.

Article 4 (Registrant recordholder system) The State implements a registrant and recordholder system for cosmetics management. Cosmetics registrants and record holders put products on the market in their own name, and bear the main responsibility for the quality and safety of their registered products.

Cosmetics registrants and recordholders shall comply with national laws, regulations, mandatory national standards and technical specifications, organize production in accordance with the requirements of the cosmetic production quality management standards, establish a cosmetic production quality management system, and fulfill the relevant obligations of post-market product adverse reaction monitoring, product risk control and recall, and product and raw material safety reassessment.

Article 5 (domestic responsible person system) Where the registrant or record holder of cosmetics is an overseas enterprise, an enterprise legal person within China shall be designated as the domestic responsible person. The domestic responsible person shall be responsible for the registration and filing of cosmetics, assist the registrant and filing person to perform the obligation of monitoring adverse reactions of cosmetics, implement product recall, and cooperate with the supervision and inspection work of the department responsible for drug supervision and administration.

Article 6 (information disclosure) The department responsible for drug supervision and administration shall, in accordance with the law, timely publish the cosmetics production license, the results of daily supervision and inspection, and the investigation and punishment of illegal acts.

Article 7 (Social co-governance) Departments responsible for drug supervision and administration shall strengthen departmental collaboration, give full play to the role of industry associations, consumers, news media, etc., promote the construction of a credit system, and promote the social co-governance of cosmetic safety.

 

Chapter II Production license administration

Article 8 (Production licensing system) to engage in the production of cosmetics, an application shall be filed with the drug regulatory department of the province, autonomous region or municipality directly under the Central Government. Only after data review and on-site verification by the drug regulatory department of the province, autonomous region and municipality directly under the Central government meet the conditions and obtain the production license of cosmetics can they be produced.

Where the preparation, filling or filling of cosmetic contents, as well as the labeling or packaging of products are in direct contact with cosmetic contents, a cosmetic production license shall be obtained.

Article 9 (Application for license) To apply for a cosmetic production license, the following materials shall be submitted to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government:

(1) An application for cosmetic production license;

(2) a copy of the business license;

(3) A copy of the identity certificate of the legal representative and the principal person in charge;

(4) Copies of the quality and safety responsible person's identity, major, educational background or professional title;

(5) Certification materials for the lawful use of the production site;

(6) Within one year, the production workshop air cleanliness and production water sanitation test report issued by the qualified inspection and testing institution, the production of eye skin care, infant and child skin care cosmetics, should meet the requirements of the cosmetic production quality management code on the production workshop clean area environment indicators;

(7) The general plan of the production site and the plan of the production workshop (including the layout of each functional workshop);

(8) Production process description and sketch;

(9) the catalogue of production quality management system documents and the catalogue of main equipment;

(10) Letter of authorization from the agent.

Provincial, autonomous regions, municipalities directly under the central government drug regulatory departments should be in the administrative organ's website and office site to publicize the requirements for the application of cosmetics production license, procedures, deadlines, need to submit all the materials of the catalogue and application model text, improve the level of online government services, through online access and inspection of information, without the applicant to provide paper documents.

The applicant shall be responsible for the authenticity, accuracy and completeness of the materials submitted.

Article 10 (License acceptance) After receiving the application, the drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall deal with it according to the following circumstances:

(1) Where the application is within the scope of its functions and powers, and the application information is complete and complies with the statutory form, the application shall be accepted;

(2) If the application information is not complete or does not meet the statutory form, the applicant shall be informed on the spot or within 5 working days at one time of all the content and the time limit for submitting the correction information. If the applicant fails to notify the applicant within the time limit, the application shall be accepted from the date of receipt of the application information. If the applicant fails to correct the information within the time limit without justifiable reasons, the application shall be deemed abandoned;

(3) If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot;

(4) If the application does not fall within the scope of acceptance of the department, a decision shall be made immediately to reject the application, and the applicant shall be informed in writing of the reasons for the rejection.

Where the drug regulatory department of a province, autonomous region or municipality directly under the Central Government accepts or refuses to accept an application for a cosmetic production license, it shall issue a notice of acceptance or refusal.

Article 11 (License review) The drug regulatory department of the province, autonomous region and municipality directly under the Central Government shall review the application materials, carry out on-site verification in accordance with the relevant requirements of the cosmetic production quality management standards, and make a decision on whether to grant the license within 30 working days from the date of accepting the application for the cosmetic production license.

If the applicant needs to make rectification after on-site verification, the applicant shall make rectification in accordance with the required time limit, and if the rectification is not completed within the time limit without justifiable reasons, the application shall be deemed abandoned. The rectification time of the applicant is not included in the approval time limit.

If the prescribed conditions are met, a written decision on licensing shall be made according to law, and the cosmetic production license shall be issued within 10 working days; If the prescribed conditions are not met, a written decision shall be made to deny the license, and the reasons shall be explained in writing.

Article 12 (Suspension of license) Where the applicant is being investigated by the department responsible for drug supervision and administration for illegal production and sale of cosmetics but the case has not been concluded, or where the decision of administrative punishment has been received but has not been implemented, the drug supervision and administration department of the province, autonomous region and municipality directly under the Central Government shall suspend the license until the case is handled.

Article 13 (Disclosure of licensing information) The drug regulatory department of the province, autonomous region and municipality directly under the Central government shall, when reviewing the application for a cosmetic production license, disclose the approval results and provide conditions to facilitate the applicant to inquire about the approval process.

The relevant information of the cosmetic production license issued by the drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall be made public and the public shall have the right to consult it.

Without the consent of the applicant, the drug regulatory department, professional technical institutions and their staff shall not disclose the trade secrets submitted by the applicant, except as otherwise provided by law or involving national security or major social and public interests.

Article 14 (Right to hearing) Where the application for a cosmetics production license directly involves a significant interest relationship between the applicant and others, the applicant and the interested party shall have the right to apply for a hearing in accordance with laws and regulations.

When reviewing the application for the production license of cosmetics, the drug regulatory department of the province, autonomous region and municipality directly under the Central Government considers that the public interest is involved, it shall make a public announcement and hold a hearing.

Article 15 (License management) Cosmetics production license is divided into original and copy, the original, copy and the corresponding electronic certificate have the same legal effect. Cosmetics production license is valid for 5 years.

The State Drug Administration is responsible for the formulation of the original, duplicate and electronic certificate specifications of the production license for cosmetics. The drug regulatory department of the province, autonomous region and municipality directly under the Central Government shall be responsible for the printing of the original and duplicate of the cosmetic production license, the production and issuance of electronic certificates and other administrative work within its administrative region.

Article 16 (contents specified in the license) The original and copy of the cosmetics production license shall contain the license number, enterprise name, residence, production address, unified social credit code, legal representative or the main person in charge, the person in charge of quality and safety, the license item, the period of validity, the issuing authority, the issuing date and other matters.

The production address is the address of the actual production site of cosmetics. License projects shall be marked with specific license units.

The copy of the cosmetics production license shall also indicate the changes and the address of the peripheral warehouse.

Article 17 (Classification of changes) Changes in cosmetic production licenses are divided into changes in licensed items and changes in registered items.

The change of permitted matters refers to the change of the person in charge of quality and safety, the change of the permitted project, and the substantial change of the production site such as the relocation, reconstruction and expansion of the production site.

The change of registered items refers to the change of the enterprise name, domicile, unified social credit code, legal representative or main person in charge, as well as the literal change of the production address and the change of the address of the peripheral warehouse.

The items such as enterprise name, unified social credit code, legal representative or main person in charge shall be consistent with the relevant contents contained in the business license issued by the market supervision and administration department.

Article 18 (Change of license items) Where the license items are changed, an application shall be made to the original license-issuing department for the change of the cosmetic production license before the change occurs, and the relevant information concerning the content of the change stipulated in Article 9 of these Measures shall be submitted. The original issuing department shall review and carry out on-site verification in accordance with the provisions of Article 11 of these Measures, and the change of matters such as the person in charge of quality and safety may not carry out on-site verification. The original certificate-issuing department shall, within 30 working days from the date of accepting the application for change of cosmetic production license, make a decision on whether to approve the change. For the change of the person in charge of quality and safety, the original issuing department shall make a decision on whether to approve the change within 10 working days from the date of accepting the change application.

Where the change information is incomplete or does not conform to the legal form, it shall notify all the contents that need to be corrected at one time. The time for the applicant to correct the information is not included in the approval time limit.

If the original issuing department approves the change, the newly issued cosmetic production license number remains unchanged, the issuing date is the date on which the license change decision is made, and the validity period is consistent with the original certificate. Due to the relocation of production site, reconstruction, expansion and other licensing changes for a comprehensive on-site verification, the newly issued cosmetic production license is valid from the date of issuance.

Article 19 (Change of registered items) If the registered items are changed, the cosmetics manufacturer shall, within 30 working days from the date of the change, report to the original issuing department, and submit the business license and relevant certification materials before and after the change. The original issuing department shall handle the alteration within 5 working days from the date of receiving the declaration materials. If the original issuing department approves the change, the newly issued cosmetic production license number remains unchanged, the issuing date is the date on which the license change decision is made, and the validity period is consistent with the original certificate.

Article 20 (License renewal notification commitment) If the expiration of the cosmetic production license needs to be extended, the cosmetic production enterprise shall carry out a comprehensive self-inspection in accordance with the requirements of the cosmetic production quality management standards within 3 months before the expiration of the expiration date. After the self-inspection evaluation meets the requirements, the cosmetics production enterprise shall submit the license extension application and self-inspection commitment report to the original issuing department 30 working days before the expiration of the license term. After receiving the application, the original issuing department shall make a decision to grant the extension of the cosmetic production license before the expiration of its validity. If the original license-issuing department fails to make a decision within the time limit, it shall be deemed to be approved for renewal. After the renewal, the number of the newly issued cosmetic production license will remain unchanged, and the date of issuance will be the date on which the renewal decision is made. The drug regulatory department of the province, autonomous region and municipality directly under the Central Government shall promptly organize the post-facto supervision and inspection of the cosmetics manufacturing enterprises that have been granted the continuation, and shall investigate and punish the illegal acts found in accordance with law.

Article 21 (License renewal review) The expiration of the cosmetic production license needs to be extended, there are any of the following circumstances, do not apply to inform the commitment, cosmetic production enterprises should be 30 working days before the expiration of the expiration of the original license application for renewal:

(1) continuous suspension of production for more than one year before the expiration of the cosmetic production license;

(2) In the past two years, the illegal production and marketing of cosmetics has been punished by the department in charge of drug supervision and administration.

The original issuing department shall review the extension application in accordance with the provisions of Article 11 of these Measures, and make a decision on whether to grant the extension before the expiration of the cosmetic production license. If it meets the prescribed conditions, it will be allowed to continue. Those who fail to meet the prescribed conditions shall be ordered to make rectification within a time limit; If the rectification is not made in accordance with the requirements, it shall not be continued, and the reasons shall be explained in writing. If the original license-issuing department fails to make a decision within the time limit, it shall be deemed to be approved for renewal. After the renewal, the number of the newly issued cosmetic production license will remain unchanged, and the date of issuance will be the date on which the renewal decision is made.

Article 22 (Overdue application for extension) Where a cosmetic production enterprise fails to apply for the extension of the cosmetic production license in accordance with the prescribed time limit, the cosmetic production license shall become invalid as of the expiration date. If it is necessary to continue to apply, the cosmetic production license shall be applied for in accordance with the procedures for newly established cosmetic production enterprises.

Article 23 (Reissue of license) If the original or copy of the production license of cosmetics is lost or damaged, the enterprise shall disclose it to the public in an appropriate form and apply to the original issuing department for reissue in time. The original license-issuing department shall reissue the cosmetic production license within 10 working days from the date of accepting the reissue application. The reissued cosmetic production license number remains unchanged, the date of issue is the reissue date, and the validity period is consistent with the original certificate.

Article 24 (license cancellation) In any of the following circumstances, the original license-issuing department shall cancel its cosmetics production license according to law and publish it on the government website:

(1) The enterprise voluntarily proposes to cancel;

(2) The production license expires but the enterprise fails to apply for renewal as required;

(3) The original issuing department made a decision not to renew the production license;

(4) The production license of cosmetics has been revoked according to law;

(5) do not have the production conditions, and can not get in touch, after the original issuing department on the government website for 15 working days still can not get in touch;

(6) Circumstances in which laws and regulations provide for cancellation.

Those who are being investigated and punished by the department in charge of drug supervision and administration for illegal production and marketing of cosmetics shall not apply for cancellation of the cosmetic production license on their own.

Article 25 (the principle of one place, one certificate) only one cosmetic production enterprise can be established on the same production site. The same cosmetic production enterprise in the same province, autonomous region, municipality directly under the administrative area to open a branch factory in different places, shall be in accordance with the provisions of these measures to apply for permission to change, the original cosmetic production license to add the address of the production site. If the branch factory is a separate enterprise established according to law, it shall apply for a separate cosmetic production license.

Cosmetic production enterprises that set up production sites across provinces, autonomous regions or municipalities directly under the central government shall separately apply for cosmetic production licenses.

Article 26 (Archives management) The drug regulatory department of the province, autonomous region and municipality directly under the Central government shall establish license files for the issuance, alteration, renewal, reissuance, revocation and cancellation of the cosmetic production license. The licensed archives may be managed by information technology.

Article 27 (Prohibited acts) No unit or individual may forge, alter, rent, lend or transfer the cosmetic production license, and may not mark the relevant information of the cosmetic production license on non-cosmetic products.

 

Chapter III production quality control

Article 28 The State Drug Administration shall formulate standards for the quality control of cosmetics production and supervise their implementation.

Cosmetic registrants, recordholders and entrusted manufacturers shall establish a cosmetic production quality management system, organize the production of cosmetics in accordance with the requirements of the cosmetic production quality management standards, and continue to operate effectively.

Article 29 (Quality management system) Cosmetics registrants, recordholders and entrusted production enterprises shall establish and implement supplier selection audit, raw materials and direct contact with cosmetics packaging materials purchase inspection records, production process and quality control, facilities and equipment management, product inspection and sample retention, product sales records, product storage and transportation, health management of employees, no Good reaction monitoring, recall and other management systems.

Article 30 (Organization of production according to registration and filing) the cosmetics registrant, filing person and entrusted production enterprise shall organize production in accordance with the technical requirements specified in the product registration or filing materials. Before cosmetics are placed on the market, they shall pass the factory inspection and be accompanied by a certificate of conformity or a mark of conformity.

Article 31 (Quality and safety person in charge) Cosmetics registrants, record holders, and entrusted production enterprises shall establish a quality and safety person in charge to assume the corresponding product quality and safety management and product release responsibilities.

The person in charge of quality and safety shall have professional background in chemistry, chemical engineering, biology, medicine, pharmacy, public health or food, have professional knowledge related to cosmetic quality and safety, and have more than 5 years of experience in cosmetic production or quality management.

Article 32 (Health Management of Employees) Cosmetic registrants, recordholders and commissioned production enterprises shall exercise health management on the personnel directly engaged in the production of cosmetics, undergo health examination every year, and can only engage in cosmetic production activities after obtaining health certificates.

Persons suffering from diseases that are harmful to the quality and safety of cosmetics as prescribed by the competent department of health under The State Council shall not directly engage in the production of cosmetics.

Article 33 (qualification of both parties) Where cosmetics are commissioned for production, the entrusting party shall be the registrant of special cosmetics or the recordholder of ordinary cosmetics.

The entrusted production enterprise shall be an enterprise holding a valid cosmetic production license, and accept the entrustment within the scope of its production license.

Article 34 (entrustment contract) The registrant, recordholder and the entrustment manufacturer shall sign an entrustment production contract, which shall specify the entrustment matters, entrustment term, quality agreement, rights, obligations and liability for breach of contract of both parties, specify the mandatory national standards and technical specifications for the implementation of the product, and agree on the technical requirements specified in the product registration and filing materials.

Article 35 (Liability of the entrusting party) Registrants and record holders who entrust the production of cosmetics shall be responsible for the quality and safety of the products they entrust.

The registrant and record holder who entrust the production of cosmetics shall evaluate the production conditions, technical level and quality management ability of the entrusted production enterprise, confirm that the entrusted party has the conditions and ability of entrusted production, clarify the quality management requirements of entrusted production of cosmetics, and guide and supervise the production process and quality control.

Article 36 (Responsibility of the entrusted party) The entrusted production enterprise shall be responsible for the production activities and bear corresponding responsibilities for the quality and safety of the entrusted cosmetics according to law.

The entrusted production enterprise shall organize production in accordance with the quality management standards for cosmetics production, mandatory national standards, cosmetic safety technical specifications, technical requirements specified in product registration or filing materials and entrusted production contracts, and keep all entrusted production documents and records, and retain samples according to regulations.

The commissioned production enterprise shall not entrust the commissioned production of cosmetics to another enterprise.

Article 37 (Management of Materials in entrusted production) Where the registrant or record holder who entrusts the production of cosmetics provides the raw materials of cosmetics and packaging materials in direct contact with cosmetics to the entrusted production enterprise, it shall also provide the true information of the raw materials of cosmetics and packaging materials in direct contact with cosmetics. The entrusted production enterprise shall inspect the cosmetic raw materials and packaging materials directly in contact with the cosmetics, clarify the ingredients and contents of the cosmetic raw materials, obtain relevant documents and inspection reports, and confirm that they are in compliance with the regulations before they can be put into production.

Article 38 (Change of entrustment) When the entrustment relationship or entrustment matters change, the cosmetics registrant, recordholder and the entrusted manufacturer shall re-sign the entrustment contract, and make corresponding registration and recordkeeping changes for the cosmetics involved in accordance with regulations.

Article 39 (record keeping) Where cosmetics are produced by the registrant or recordholder themselves, Supplier selection and review records, raw materials and packaging materials in direct contact with cosmetics purchase inspection records, production records, facility and equipment management records, product inspection and sample retention records, product sales records, product storage and transportation records, employee health management records, adverse reaction monitoring records, recall records and related supporting documents shall be kept in a true and complete manner. Traceability guaranteed.

Where the cosmetics registrant or recordholder entrusts the production, the product sales records, adverse reaction monitoring records, recall records and other relevant supporting documents shall be kept by themselves in accordance with the provisions of the preceding paragraph. The entrusted production enterprise shall keep the purchase inspection records of raw materials and packaging materials in direct contact with cosmetics, production records, facility and equipment management records, product inspection and sample retention records, adverse reaction report records, health management records of employees and other relevant supporting documents. The party or both of the entrusting party and the entrusted production enterprise specifically responsible for supplier selection, product storage and transportation shall keep supplier selection and audit records, product storage and transportation records.

The retention period of records and related supporting documents shall not be less than 1 year after the expiration of the product use period; If the service life of the product is less than 1 year, the retention period of the records and relevant supporting documents shall not be less than 2 years.

Article 40 (Storage and transportation) The registrant, recordholder and commissioned manufacturer of cosmetics shall take effective measures to store and transport cosmetics, cosmetic raw materials and packaging materials that come into direct contact with cosmetics in accordance with the requirements of product instructions or labels, regularly check and timely dispose of products that have deteriorated or exceeded the use period, and make corresponding records.

Article 41 (Personnel training) Cosmetics registrants, record holders, and entrusted manufacturers shall conduct knowledge training on cosmetics laws, regulations, mandatory national standards, and cosmetic safety technical specifications for relevant practitioners, and establish training files. The operators and inspectors of production posts shall have appropriate knowledge and practical skills.

Article 42 (self-inspection report) Cosmetic registrants, recordholders, and commissioned production enterprises shall regularly conduct a comprehensive self-inspection of the implementation of cosmetic production quality management norms every year, and the self-inspection report shall be kept for not less than 2 years.

Article 43 (stop production and rectification) If the cosmetics registrant, recordholder or entrusted manufacturer has any of the following circumstances, it shall immediately stop all or part of the production, make rectification, and report to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where it is located, and can resume production after verifying that it meets the requirements:

(1) relocation, reconstruction or expansion of the production site;

(b) change the layout of process equipment, the main production equipment and other production conditions have undergone major changes, no longer meet the requirements of the cosmetic production quality management code, and may affect the quality and safety of cosmetics.

Where a cosmetics registrant, recordholder or commissioned manufacturer has ceased production for more than one year continuously, it shall report in advance to the drug regulatory department of the province, autonomous region or municipality directly under the Central government where the production is resumed. Production may be resumed only after the drug regulatory department of the province, autonomous region or municipality directly under the Central Government has checked that the requirements are met.

Article 44 (Adverse reaction monitoring) the registrant and recordholder of cosmetics shall monitor the adverse reactions of cosmetics on the market and report the adverse reactions of cosmetics through the national Adverse Reaction Monitoring information System of cosmetics as required; Evaluate the collected adverse reactions of cosmetics in a timely manner, and self-check the causes of adverse reactions that may be caused by products; If a product is found to have safety risks that may harm human health, risk control measures such as stopping production and sales of related products and recalling products shall be taken.

The domestic responsible person shall assist the cosmetics registrant and recordholder to carry out the work of monitoring adverse reactions of cosmetics, perform the obligation of monitoring adverse reactions of cosmetics, and report adverse reactions of cosmetics through the national Adverse Reaction Monitoring information System of cosmetics as required.

The entrusted production enterprise finds adverse reactions that may be related to the use of cosmetics, and shall report adverse reactions of cosmetics through the national Adverse Reaction Monitoring information system for cosmetics, and inform the registrant and recordholder of cosmetics.

Cosmetic registrants, recordholders, and entrusted manufacturers shall cooperate with cosmetic adverse reaction monitoring institutions and departments responsible for drug supervision and administration to carry out adverse reaction investigations.

Article 45 (product recall) Where a registrant or recordholder of a cosmetic product finds that there are quality defects or other problems in a cosmetic product that may endanger human health, it shall immediately stop production, recall the cosmetic product that has been put on sale, notify the relevant cosmetic business operators and consumers to stop operation and use, and record the recall and notification; Measures such as remediation, harmless treatment and destruction of the recalled cosmetics shall be taken, and the recall of the cosmetics shall be reported to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the cosmetics are located.

The domestic responsible person shall assist the cosmetics registrant or recordholder to carry out the work of product recall notification, record, handling of recalled products, and reporting of recall situations.

If the entrusted manufacturer finds that the cosmetics produced by it have quality defects or other problems that may endanger human health, it shall immediately stop production, notify the relevant registrant or recordholder of cosmetics, and cooperate with the registrant or recordholder of cosmetics to carry out a recall.

Article 46 (Labeling and packaging filing) Where the process of labeling and packaging of a product does not directly contact the cosmetic contents, the cosmetic registrant or filing person shall promptly file with the drug regulatory department of the province, autonomous region or municipality directly under the Central Government. The contents of the record include: enterprise name, label or packaging address, legal representative or main person in charge, quality and safety person in charge.

 

Chapter IV Management of business quality

Article 47 (Business quality Management system) Cosmetics operators shall comply with the relevant requirements of laws, regulations and rules for the supervision and management of cosmetics, establish and implement the business quality management system, ensure that the business behavior continues to meet the requirements, and ensure that the source of the cosmetics they operate can be traced.

Article 48 (Quality of gift behavior) Providing cosmetics to consumers in the form of free trial, gift, etc., is a cosmetic business act.

Article 49 (Purchase inspection record system) Cosmetics business operators shall establish and implement the purchase inspection record system, and check the following documents of suppliers according to the varieties of business:

(1) The business license of the domestic supplier or the registration certificate of the market entity of the overseas supplier;

(2) Registration certificate of special cosmetics or record of ordinary cosmetics;

(3) the production license, factory inspection certificate or qualification mark of domestic cosmetics;

(4) The legal certificate of imported cosmetic goods.

Cosmetic business operators shall obtain sales vouchers and relevant certification documents from the supplier and truthfully record the inspection results. The above certification documents may be managed by information technology.

Purchase inspection records shall include cosmetics name, special cosmetics registration certificate number or ordinary cosmetics record number, production batch number or production date, expiration date, purchase quantity, supplier name, address and contact information, purchase date, etc.

Article 50 (Unified distribution) For cosmetics operators who implement unified distribution, the headquarters of the operator may establish and implement the purchase inspection record system, obtain sales vouchers and relevant certification documents from the supplier, truthfully record the inspection results and save the relevant certification documents. The headquarters of the business operator shall ensure that the above purchase inspection records and sales vouchers can be checked in its branch stores.

Article 51 (Sales records) Where a cosmetic business operator sells cosmetics to other cosmetic business operators, a sales record system shall be established.

Sales records shall include the name of the cosmetics, special cosmetics registration certificate number or ordinary cosmetics record number, production batch number or production date, sales quantity, sales date, buyer name, address and contact information.

Article 52 (record preservation) A cosmetics operator shall truthfully and completely keep the purchase inspection records, sales records, adverse reaction report records and relevant supporting documents.

The retention period of records and related supporting documents shall not be less than 1 year after the expiration of the product use period; If the service life of the product is less than 1 year, the retention period of the records and relevant supporting documents shall not be less than 2 years.

Article 53 (Storage and transportation) A cosmetic business operator or a third party shall store and transport the products in accordance with the requirements of the cosmetic instructions or labels, regularly check and timely dispose of the products that have deteriorated or exceeded the use period, and make relevant records.

Article 54 (Adverse reaction report) If a cosmetic operator finds an adverse reaction that may be related to the use of cosmetics, it shall report the adverse reaction monitoring institution for cosmetics, and cooperate with the adverse reaction monitoring institution for cosmetics and the department responsible for drug supervision and administration to carry out adverse reaction investigation.

Cosmetics operators are encouraged to inform cosmetic registrants and recordholders of adverse reactions found that may be related to the use of cosmetics.

Article 55 (Prohibited products) The following cosmetics are prohibited:

(1) The legal source cannot be proved;

(2) Domestic cosmetics that cannot provide the certificate of conformity of factory inspection or the mark of conformity;

(3) Imported cosmetics that cannot provide legal proof of entry goods;

(4) The department in charge of drug supervision and administration issues a notice, circular or announcement requiring suspension or suspension of sales or recall;

(5) The drug regulatory department at the provincial level or above decides to revoke or cancel the registration certificate of special cosmetics after production, or cancel or cancel the record of ordinary cosmetics after production;

(6) The provincial or above drug regulatory department decides to revoke the cosmetic production license or special cosmetic registration certificate;

(7) the registrant or recordholder of cosmetics initiates the recall;

(8) Other cosmetics prohibited by laws and regulations.

Article 56 (false claims beyond the label) Cosmetic business operators shall not express or imply that the products have medical effects or falsely claim efficacy in the publicity of cosmetics business.

Article 57 (Illegal preparation is prohibited) Cosmetic dealers may not prepare cosmetics on their own.

Cosmetics operators engaged in direct contact with the contents of cosmetics packaging behavior belongs to the self-preparation of cosmetics.

Article 58 (Assisting in product recall) Where a cosmetic business operator finds that the cosmetics it operates have quality defects or other problems that may endanger human health, it shall immediately stop operating the said products and notify the relevant cosmetic registrant or recordholder.

Cosmetic business operators shall actively cooperate with cosmetic registrants and record holders to fulfill cosmetic recall obligations, timely convey and feedback cosmetic recall information, and control and recover recalled products.

Article 59 (beauty salon hotel) Beauty salon institutions, hotels and other service industry operators who use cosmetics in their business services or provide cosmetics to consumers shall establish and implement purchase inspection records and other systems to fulfill the obligations of cosmetics operators.

 

Service industry operators such as beauty salons and hotels shall show consumers the sales packaging of the cosmetics they use, properly use or guide consumers to use cosmetics in accordance with the requirements of product labels and instructions, and shall not falsely claim the efficacy of cosmetics.

Encourage beauty salons, hotels and other service industry operators in their service places to publicize the name of their use of cosmetics, cosmetics registrants or record the name and address, the name and address of domestic cosmetics production enterprises or the name and address of the domestic responsible person for imported cosmetics, special cosmetics registration certificate number, ordinary cosmetics record number, necessary safety warnings and other letters Interest, honest management in accordance with the law, accept social supervision.

Article 60 (centralized trading market) The operator of the centralized trading market of cosmetics and the organizer of the exhibition shall establish a management system for cosmetics dealers, establish a cosmetic quality management organization or designate special personnel to undertake the management of cosmetics dealers.

The operator of the cosmetics centralized trading market and the organizer of the exhibition shall review the registration certificate of the market subject of the cosmetics operator entering the market, including: business license, legal representative or responsible person identity information, residence, unified social credit code, contact information, etc., and establish the file of the operator entering the market.

The operator of a centralized cosmetic trading market shall inspect the cosmetic operators entering the market regularly every year. The organizer of the trade fair shall, during the trade fair, regularly inspect the cosmetics dealers entering the fair. Inspection records shall be formed, and the records shall be kept for at least 1 year. If a cosmetic operator is found to be suspected of illegal operation of cosmetics, it shall promptly stop and report to the department responsible for drug supervision and administration of the local county-level people's government.

Where the rental counters of shopping malls and supermarkets issue sales invoices in their own names, the management of shopping malls, supermarkets and rental counters shall refer to the operators of centralized trading markets and the operators of cosmetics entering the market.

 

Chapter V Network management

Article 61 (Definition of network operators) Cosmetics network operators refer to natural persons, legal persons and unlegal organizations engaged in cosmetics business activities through the Internet and other information networks, including cosmetics e-commerce platform operators and cosmetics online sellers.

Cosmetics e-commerce platform operators refer to legal or unincorporated organizations that provide online business sites, deal making, information release and other services for both parties or parties to carry out transactions independently in e-commerce activities.

Cosmetics online sellers refer to natural persons, legal persons and unincorporated organizations that operate cosmetics through self-established websites, e-commerce platforms or other online services.

Article 62 (Responsibility of Online sellers) Online sellers of cosmetics shall comply with the provisions of these Measures on management quality and fulfill the obligations of cosmetic operators.

Online sellers of cosmetics shall take effective measures to ensure the authenticity, integrity and timely update of materials, information and data, and ensure that the source of cosmetics can be traced.

Article 63 (Qualification Information display) Online sellers of cosmetics shall continue to publicize the market entity registration and other information stipulated in the E-commerce Law of the People's Republic of China in a prominent position on the home page of the website or the main page of their business activities, or the link logo of the above information.

Article 64 (Cosmetic Information display) The cosmetic information displayed by online sellers shall be comprehensive, true, accurate and timely. It shall include the name of the cosmetics, the name and address of the registrant or record holder of the cosmetics, the name and address of the domestic cosmetics manufacturer or the name and address of the domestic responsible person of the imported cosmetics, the number of the special cosmetics registration certificate, the whole ingredients, the net content, the method of use, the necessary safety warning words and other information.

Article 65 (Forbidden to display information) Online sellers of cosmetics shall not display the relevant information of cosmetics prohibited in Article 55 of these measures. The product network publicity page shall not express or imply that it has medical effects or false exaggerated effects.

Article 66 (platform filing) Cosmetic e-commerce platform operators shall file with the drug regulatory department of the province, autonomous region and municipality directly under the Central Government, and update it in a timely manner. The contents of the record include: enterprise name, address, contact information, website name or network client application name, network domain name and other information.

Article 67 (the platform shall establish a system) the operators of the cosmetics e-commerce platform shall comply with the relevant requirements of the national online transaction management and cosmetics supervision and management laws, regulations and rules, establish a cosmetics quality management organization or designate specialized personnel to undertake the quality management of cosmetics business, and establish and implement the following systems:

(1) Management system for operators within the Platform;

(b) cosmetics product information and transaction record keeping system;

(3) Cosmetics complaint management and dispute resolution system.

Article 68 (self-operated business) cosmetic e-commerce platform operators who carry out self-operated business on their platforms shall fulfill the obligations of online cosmetic sellers for their self-operated cosmetics in accordance with the law, and bear the main responsibility for the operation.

69th (platform review) Cosmetics e-commerce platform operators should apply for the platform operators real-name registration, including its business license, legal representative or responsible person identity information, actual place of operation, contact information, etc., to ensure that the platform operators meet the legal requirements, establish registration files and timely verification and update.

The operator of the cosmetics e-commerce platform shall sign an agreement with the operator within the platform to clarify the requirements for the quality and safety management of cosmetics and the liability for breach of contract.

Article 70 (Platform management) Operators of the cosmetics e-commerce platform shall strengthen the management of operators within the platform, take the initiative to check the cosmetic information published on the platform, supervise the trading behavior, and take necessary measures to delete, shield, disconnect, terminate transactions and services when it is found that the display of information is prohibited; Any illegal acts shall be promptly stopped and reported to the drug regulatory department of the province, autonomous region or municipality where the platform is located.

Article 71 (Stop providing platform services) If the operator of the cosmetics e-commerce platform finds evidence that the operator of the platform has serious illegal acts, it shall immediately stop providing the cosmetics e-commerce platform services to it.

Under any of the following circumstances, it is a serious illegal act:

(1) dealing in cosmetics produced without production permission;

(2) dealing in unregistered special cosmetics;

(3) dealing in cosmetics that illegally add raw materials prohibited for the production of cosmetics;

(4) Continuation of business after the drug regulatory department orders a recall or suspension or suspension of sales.

After investigation and verification by the department in charge of drug supervision and administration, the operators within the platform do not exist the above serious illegal acts, or the department in charge of drug supervision and administration has issued a warning, fine, confiscation of illegal income administrative punishment and has been executed, the operators of the cosmetics e-commerce platform shall resume to provide cosmetics e-commerce platform services.

The operator of the cosmetics e-commerce platform knows or should know that the operator of the platform is prohibited from engaging in the production and operation of cosmetics by the department responsible for drug supervision and administration, and shall not provide the service of the cosmetics e-commerce platform.

Article 72 (Handling of complaints and reports) Cosmetic e-commerce platform operators who receive complaints and reports related to cosmetic quality and safety shall record and deal with them in a timely manner.

Article 73 (Adverse reaction report processing) Cosmetic e-commerce platform operators receive adverse reaction information of cosmetics, shall record and timely transfer to the platform operators for processing.

Article 74 (platform record preservation) Cosmetic e-commerce platform operators shall keep the latest three years of cosmetic display information, transaction records, complaints and reports handling records, adverse reaction transfer records.

The operators of the cosmetics e-commerce platform shall adopt effective technical means to ensure the authenticity, integrity and safety of the materials, information and data, and provide convenience for the operators within the platform to save the above data by themselves.

Article 75 (with investigation and collection of evidence) If the drug regulatory department requires the operators of the cosmetics e-commerce platform to provide the identity information of the operators in the platform, product and service information published on the platform, and transaction information due to the needs of investigation and collection of evidence, supervision and inspection, the operators of the cosmetics e-commerce platform shall provide assistance and cooperation. No refusal, evasion, obstruction or delay.

Article 76 (cooperate to stop illegal) Where the drug supervisory and administrative department finds that there is a violation of the cosmetics supervision and administration laws, regulations and the provisions of these measures in the cosmetics e-commerce platform, and requires the cosmetics e-commerce platform operators to take necessary measures to stop, the cosmetics e-commerce platform operators shall provide assistance and cooperation. No refusal, evasion, obstruction or delay.

 

Chapter VI Supervision and administration

Article 77 (Supervision and Inspection) The State Drug Administration shall be responsible for formulating and organizing the implementation of the regulations on the administration of cosmetic inspection and the regulations on the administration of overseas inspection of cosmetics.

The department in charge of drug supervision and administration shall make clear the inspection priorities and inspection requirements before carrying out supervision and inspection; When conducting supervision and inspection, it shall truthfully record the on-the-spot inspection and inform the inspected units of the inspection results in writing.

According to the needs of supervision and inspection, the department responsible for drug supervision and administration may carry out extended inspection on the suppliers and manufacturers of cosmetic raw materials and packaging materials that come into direct contact with cosmetics.

The unit under inspection shall cooperate with the supervision and inspection and may not refuse, evade, obstruct or delay the inspection.

Article 78 (Sampling inspection) The State Drug Administration shall be responsible for formulating and organizing the implementation of the administration standards for sampling inspection of cosmetics, and organizing the national sampling inspection of cosmetics. The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall organize the sampling inspection of cosmetics in their respective administrative areas.

The drug regulatory departments at the provincial level and above shall, in accordance with regulations, promptly publish the results of cosmetic sampling inspection.

The department in charge of drug supervision and administration of the people's government of the city or county level divided into districts shall, in accordance with the work arrangements of the department in charge of drug supervision and administration at the next higher level, carry out sampling inspection at the national and provincial levels.

The department responsible for drug supervision and administration may conduct special sampling inspection for cosmetics that may have quality and safety risks found in complaints and reports, supervision and inspection, adverse reaction monitoring and risk monitoring. The results of special sampling inspection shall be published in accordance with regulations.

Article 79 (Supplementary Inspection) The State Drug Administration shall be responsible for formulating and organizing the implementation of the working procedures for the administration of supplementary inspection methods for cosmetics. The cosmetic supplementary inspection methods and inspection items issued by the State Drug Administration can be used for sampling inspection of cosmetics, investigation and treatment of cosmetic quality and safety cases, and investigation and disposal of adverse reactions, and the test results can be directly used as a basis for law enforcement.

The State encourages cosmetic inspection institutions, scientific research institutes, colleges and universities to carry out research on cosmetic supplementary inspection items and inspection methods.

Article 80 (Monitoring of adverse reactions) The State establishes a monitoring system for adverse reactions of cosmetics. The State Drug Administration is responsible for formulating and organizing the implementation of the measures for monitoring and management of adverse reactions to cosmetics, and establishing and improving the national adverse reaction monitoring system for cosmetics. Organize the establishment of a national adverse reaction monitoring information system for cosmetics, and strengthen the construction of an information network and database for adverse reaction monitoring of cosmetics.

The department responsible for drug supervision and administration shall organize the investigation and treatment of cosmetic adverse reactions according to regulations, timely control of product risks, and strengthen the analysis and utilization of cosmetic adverse reaction monitoring data.

Adr monitoring institutions are responsible for the collection, analysis and evaluation of ADR information, put forward risk management suggestions to the departments responsible for drug supervision and administration at the same level, and cooperate with the investigation and handling work; At the same time, he was responsible for the construction, maintenance and use management of the national adverse reaction monitoring information system for cosmetics.

Article 81 (Risk Monitoring and evaluation) The State establishes a monitoring and evaluation system for cosmetic safety risks, establishes a mechanism for exchanging information on cosmetic quality and safety risks, and provides a scientific basis for the formulation and revision of cosmetic quality and safety risk control measures and standards, compulsory national standards and technical specifications for cosmetics, and carries out cosmetic sampling inspection.

The State Drug Administration is responsible for formulating and organizing the implementation of cosmetic safety risk monitoring work norms, and in accordance with the principles of risk management, formulate, publish and organize the implementation of the annual national cosmetic safety risk monitoring plan, and clarify the key monitoring varieties, projects and regions. The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall, in accordance with their duties, organize the investigation and disposal of cosmetic safety risk information.

The State Drug Administration regularly organizes cosmetic quality and safety risk information exchange meetings, inviting cosmetic manufacturers and operators, inspection agencies, industry associations, consumer associations, news media, medical institutions, cosmetic e-commerce platform operators, relevant experts, etc., to exchange and communicate cosmetic quality and safety risk information. And form an annual cosmetic risk management analysis report based on the exchange.

Cosmetic registrants and recordholders shall take the initiative to monitor and report adverse reactions of their marketed cosmetics in accordance with regulations. Cosmetics registrants and recordholders who use new raw materials shall take the initiative to monitor and report the use of new raw materials in accordance with regulations, and evaluate the risks of new raw materials to product safety. The registrant and recordholder of new raw materials of cosmetics shall take the initiative to monitor and report the use and safety of new raw materials in accordance with regulations, and evaluate the safety risks of new raw materials.

Article 82 (Risk control measures) Where the department in charge of drug supervision and administration finds in the inspection that the cosmetic manufacturer or trader has not performed the relevant quality control obligations according to regulations, and the cosmetic products produced or sold have caused human injury or there is evidence that they may harm human health, it may take emergency control measures to order the manufacturer or trader to suspend production or business, and issue safety warning information.

Where the production or marketing of cosmetics is resumed, the manufacturer or trader of cosmetics shall file an application with the department in charge of drug supervision and administration that originally made the decision on handling the matter, and may resume only after the examination is passed.

Article 83 (Responsibility Interview) In any of the following circumstances, the department responsible for drug supervision and administration may interview its legal representative or the person in charge of the enterprise in accordance with its duties:

(1) There is a hidden danger of cosmetic quality and safety, which may cause cosmetic quality and safety incidents;

(2) failing to take effective measures in time to investigate and eliminate hidden dangers of cosmetic quality and safety, and failing to implement responsibility for cosmetic quality and safety;

(3) Other circumstances requiring an interview.

The interview will not affect the department responsible for drug supervision and administration to carry out other administrative treatment in accordance with the law, and the interview and follow-up treatment can be disclosed to the public.

The interview and rectification shall be included in the credit files of cosmetic producers and operators.

Article 84 (Credit files) Drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall organize the establishment of credit files of cosmetic registrants, recordholders and entrusted manufacturers in their respective administrative areas. The department in charge of drug supervision and administration of a districted city shall establish the credit files of the cosmetics trading enterprises in its administrative area.

The credit file shall include the basic information of the enterprise and the supervisory information. Enterprise basic information includes: enterprise name, address, unified social credit code, legal representative, enterprise responsible person, quality and safety responsible person name and ID card number and other information. Supervision information includes: administrative license, filing, supervision and inspection results, sampling inspection results, complaints and reports processing results, illegal behavior investigation results, responsibility interview information.

Article 85 (Bad credit record) Cosmetics manufacturers and dealers who are subject to administrative penalties by the department responsible for drug supervision and administration and whose products do not meet the provisions of sample inspection shall be included in the bad credit record and the frequency of supervision and inspection shall be increased.

Article 86 The State Drug Administration shall regularly publish the list of persons who are not allowed to engage in the production or marketing of cosmetics, and provide convenience for the public to inquire.

 

Chapter VII Legal liability

Article 87 (especially serious violations) in one of the following circumstances, by the department responsible for drug supervision and administration in accordance with the provisions of Article 59 of the Regulations on the Supervision and Administration of cosmetics punishment:

(1) The registrant, recordholder or commissioned production enterprise of cosmetics moves, rebuilds or expands the production site without authorization, and produces cosmetics in the unauthorized production site;

(2) Producing cosmetics beyond the permitted items;

(3) Continue to produce cosmetics after the expiration of the cosmetic production license is not renewed according to law;

(4) Producing, marketing or importing special cosmetics whose formulations are changed without authorization.

Article 88 (serious violations) in any of the following circumstances, by the department responsible for drug supervision and administration in accordance with the provisions of Article 60 of the Regulations on the Supervision and Administration of cosmetics to punish:

(1) The use of restricted components in the production of cosmetics beyond the scope of use and restrictions;

(2) The production and operation of cosmetics that do not meet the requirements according to the supplementary inspection items and inspection methods, and the detected ingredients do not belong to the raw materials prohibited for the production of cosmetics;

(3) The cosmetic production quality management system inspection results are not passed;

(4) Fabricating or tampering with certification documents, production inspection records or failing to provide production inspection records during the production of cosmetics.

Article 89 (more serious violations) in one of the following circumstances, by the department responsible for drug supervision and administration in accordance with the provisions of Article 61 of the Regulations on the Supervision and Administration of cosmetics punishment:

(1) selling, dealing in or importing ordinary cosmetics whose formulations have been changed without authorization;

(b) the quality safety responsible person does not have the conditions stipulated in these measures;

(3) the registrant or record holder who entrusts the production of cosmetics fails to sign an entrustment production contract with the entrusted production enterprise in accordance with regulations;

(4) The registrant or recordholder of cosmetics fails to evaluate the production conditions, technical level and quality management ability of the entrusted production enterprise, or fails to guide and supervise the production process and quality control;

(5) The production conditions of the cosmetics registrant, record holder, and entrusted production enterprise change and may affect the quality and safety of cosmetics, and do not immediately stop production and report;

(6) Employing persons who have not obtained health certificates or whose health certificates have exceeded the validity period to directly engage in cosmetic production activities.

Article 90 (general illegal acts) in any of the following circumstances, by the department responsible for drug supervision and administration in accordance with the provisions of Article 62 of the Regulations on the Supervision and Administration of cosmetics punishment:

(1) The cosmetics registrant, recordholder, and entrusted manufacturer do not keep the purchase inspection records of raw materials and packaging materials directly in contact with cosmetics truthfully and completely, or the record retention period does not meet the provisions;

(2) The cosmetics business operator does not keep the purchase inspection records truthfully and completely or the retention period of the records does not meet the provisions;

(C) the implementation of unified distribution mode of cosmetics business operators can not check the purchase inspection records in their branches;

(4) The cosmetic business operator or the third party entrusted by it fails to fulfill the obligations of storage and transportation of cosmetics stipulated in these Measures.

Article 91 (minor violations) under any of the following circumstances, the department in charge of drug supervision and administration shall give a warning, order correction within a time limit, and impose a fine of not more than 20,000 yuan:

(1) Failure to change the cosmetic production license in accordance with the provisions of these Measures;

(b) failure to establish and implement supplier selection and review, production process and quality control, facilities and equipment management, product inspection and sample retention, product storage and transportation, adverse reaction monitoring, recall management and other systems in accordance with the provisions of these Measures;

(3) Cosmetics on the market are not accompanied by inspection certificates or conformity marks as required;

(4) The entrusted production enterprise accepts the entrustment by lending the production site;

(5) the registrant or recordholder of the entrusted production of cosmetics fails to provide the entrusted production enterprise with the true information of the raw materials of cosmetics and the packaging materials directly in contact with cosmetics;

(6) The entrusted production enterprise fails to inspect the raw materials provided by the registrant or record holder of cosmetics and the packaging materials that come into direct contact with cosmetics;

(7) After the validity of the entrusted production contract is terminated, the entrusted production enterprise shall continue to produce the entrusted products;

(8) failing to keep supplier selection and review records, production records, facility and equipment management records, product inspection and sample retention records, product storage and transportation records, adverse reaction monitoring records, recall records, etc., in accordance with the provisions of these Measures;

(9) failure to carry out training and establish training files in accordance with the provisions of these Measures;

(10) Failure to report in advance to the drug regulatory department of the province, autonomous region or municipality directly under the Central government where the registrant, recordholder or entrusted manufacturer of cosmetics has ceased production for more than one consecutive year;

(11) Failure to take measures to carry out adverse reaction evaluation or suspend production of cosmetics in a timely manner in accordance with the provisions of these Measures;

(12) changing the batch number or production date of cosmetics without authorization;

(13) The cosmetics registrant or recordholder fails to record the labeling and packaging behavior in accordance with the provisions of these Measures;

(14) dealing in products recalled by the registrant or recordholder of cosmetics;

(15) The operators of service industries such as beauty salons and hotels fail to show the sales packaging of the cosmetics they use to consumers in accordance with the provisions of these Measures;

(16) Marking the relevant information of the cosmetic production license on non-cosmetic products;

(17) refusing, evading, obstructing or delaying supervision and inspection or sampling inspection.

If the circumstances listed in the preceding paragraph are serious or cause harmful consequences, they are in violation of the relevant provisions of the Regulations on Supervision and Administration of Cosmetics, and they shall be punished in accordance with the provisions of the Regulations on Supervision and Administration of Cosmetics.

Article 92 (Illegal liability of centralized trading market) If the operator of the centralized trading market of cosmetics and the organizer of the exhibition fail to establish the management system of entering cosmetics operators in accordance with the provisions of these Measures and implement effective management, the department responsible for drug supervision and administration shall be punished in accordance with the provisions of Article 66 of the Regulations on Supervision and Administration of Cosmetics.

Article 93 (Illegal liability of the domestic responsible person) Where the domestic responsible person fails to assist the cosmetic registrant or filing person to carry out cosmetic adverse reaction monitoring, perform the cosmetic adverse reaction monitoring obligations or implement product recall in accordance with the provisions of these Measures, the drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall be punished in accordance with the provisions of Article 70 of the Regulations on the Supervision and Administration of Cosmetics.

Article 94 (online sellers illegally display information) under any of the following circumstances, the department responsible for drug supervision and administration shall give a warning to the online sellers of cosmetics, order them to make corrections within a time limit, and impose a fine of not more than 20,000 yuan:

(1) The online seller of cosmetics fails to display cosmetic information in accordance with the provisions of these Measures;

(2) The online sellers of cosmetics display the information of cosmetics prohibited by these measures.

Article 95 (platform general illegal acts) under any of the following circumstances, by the provincial, autonomous region, municipality drug regulatory authorities on the cosmetics e-commerce platform operators in accordance with the "People's Republic of China E-commerce Law" Article 80, "Regulations on the Supervision and Administration of cosmetics" Article 67 of the provisions of punishment:

(A) not in accordance with the provisions of these measures to apply for the platform operators real-name registration;

(b) failure to implement management of operators within the platform in accordance with the provisions of these Measures;

(3) Failure to stop providing e-commerce platform services to operators within the platform in accordance with the provisions of these Measures.

Article 96 (platform minor violations) under any of the following circumstances, the department responsible for drug supervision and administration shall give a warning to the operator of the cosmetics e-commerce platform, order correction within a time limit, and impose a fine of less than 20,000 yuan:

(1) failing to file with the drug regulatory department of the province, autonomous region or municipality directly under the Central Government in accordance with the provisions of these Measures;

(2) Failure to establish cosmetic quality management institutions or systems in accordance with the provisions of these Measures;

(3) failing to record and handle complaints and reports related to cosmetic quality and safety in accordance with the provisions of these Measures;

(4) failure to record and transfer cosmetic adverse reaction information in accordance with the provisions of these Measures;

(5) failure to keep cosmetic display information, transaction records, evaluation and complaint information in accordance with the provisions of these Measures;

(6) failing to cooperate with the drug regulatory department to carry out investigations and evidence collection in accordance with the provisions of these Measures;

(7) Failure to cooperate with the drug regulatory department to take necessary measures to stop illegal acts in accordance with the provisions of these Measures.

 
Chapter VIII Supplementary Provisions

Article 97 (Classification of production license) Cosmetics production license items are mainly divided into general liquid unit, cream emulsion unit, powder unit, aerosol and organic solvent unit, wax-based unit, toothpaste unit and other units according to the production process, finished product status and use of cosmetics.

The production of infant and child skin care and eye skin care cosmetics shall be specially marked in the licensed items.

Article 98 (License format) The format of the original and copy of the cosmetic production license and the corresponding electronic certificate shall be formulated by the State Drug Administration.

The arrangement of the production license number of cosmetics is: X makeup XXXXXXXX. Among them:

The first X stands for the abbreviation of the province, autonomous region or municipality directly under the Central Government where the licensing department is located;

The second to five X's represent the four-digit license year;

The sixth through ninth X's represent the four-digit license number.

Article 99 (Implementation Rules) Drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government may formulate implementation rules in accordance with these Measures and in light of the actual conditions.

Article 100 (Implementation Date) These Measures shall come into force as of January 2021.