Order of the State Council of the people's Republic of China

The first727number

       Regulations on the supervision and administration of cosmetics already2020year1month3The State Council No77Adopted at the second executive meeting,It is hereby announced,since2021year1month1Effective as of.

total reason  Li Keqiang

2020year6month16day

Regulations on the supervision and administration of cosmetics 

Chapter I total  be

Article 1 In order to standardize the production and operation of cosmetics,Strengthen the supervision and management of cosmetics,Ensure the quality and safety of cosmetics,Protect consumer health,Promote the healthy development of cosmetics industry,Formulate these Regulations.

Article 2 Engaging in the production and operation of cosmetics within the territory of the people's Republic of China and its supervision and Administration,These Regulations shall be observed.

Article 3 Cosmetics referred to in these Regulations,It means to wipe Spraying or other similar methods,Apply to skin hair nail Lips and other human surfaces,To clean protect beautify Daily chemical industrial products for the purpose of modification.

Article 4 The state regulates cosmetics according to the degree of risk Cosmetics raw materials shall be subject to classified management.

Cosmetics are divided into special cosmetics and ordinary cosmetics.The State applies registration management to special cosmetics,Record management shall be implemented for ordinary cosmetics.

Cosmetic raw materials are divided into new raw materials and used raw materials.The State implements registration management for new cosmetic raw materials with high risk,Other new cosmetic raw materials shall be subject to filing management.

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

The drug regulatory departments of the local people's governments at or above the county level shall be responsible for the supervision and administration of cosmetics in their respective administrative areas.The relevant departments of the local people's governments at or above the county level shall be responsible for the supervision and administration related to cosmetics within their respective functions and responsibilities.

Article 6 Cosmetic registrant The filer shall be responsible for the quality, safety and efficacy claims of cosmetics.

Cosmetics producers and operators shall act in accordance with the law statute Mandatory national standards Engage in production and business activities according to technical specifications,strengthen management,Integrity and self-discipline,Ensure the quality and safety of cosmetics.

Article 7 Cosmetics industry associations shall strengthen industry self-discipline,Supervise and guide cosmetics producers and operators to engage in production and business activities according to law,Promote the construction of industry integrity.

Article 8 Consumer associations and other consumer organizations are responsible for acts that violate the provisions of these regulations and harm the legitimate rights and interests of consumers,Social supervision according to law.

Article 9 The State encourages and supports cosmetics research innovate,Meet consumer needs,Promote the construction of cosmetics brands,Play the leading role of brand.National protection units and individuals carry out cosmetics research Legal rights and interests of innovation.

The State encourages and supports cosmetics producers and operators to adopt advanced technology and advanced management standards,Improve the quality and safety level of cosmetics Encourage and support the use of modern science and technology,Research and develop cosmetics in combination with China's traditional advantageous projects and characteristic plant resources.

Article 10 The state strengthens the informatization construction of cosmetics supervision and management,Improve online government service level,To apply for administrative license for cosmetics Facilitate filing,Promote the sharing of supervision and management information.

Chapter II Raw materials and products

Article 11 The natural or artificial raw materials used in cosmetics for the first time in China are new cosmetic raw materials.Anti corrosion Sunscreen to color dye one 's hair New cosmetic raw materials with freckle removing and whitening function,It can only be used after being registered by the drug regulatory department under the State Council Other new cosmetic raw materials shall be filed with the drug regulatory department under the State Council before use.The drug regulatory department under the State Council may, according to the development of scientific research,Adjust the scope of new cosmetic raw materials subject to registration management,It shall be implemented after being approved by the State Council.

Article 12 Apply for registration of new cosmetic raw materials or record new cosmetic raw materials,The following information shall be submitted

one Registered applicant Name of filer address contact information

two New raw material development report

three Preparation process of new raw materials Stability and quality control standards

four Safety assessment data of new raw materials.

Registered applicant The filer shall be responsible for the authenticity of the materials submitted Scientific responsibility.

Article 13 The drug regulatory department under the State Council shall start from the date of accepting the application for registration of new cosmetic raw materials3The application materials shall be transmitted to the technical review body within working days.The technical review institution shall start from the date of receiving the application materials90The technical review shall be completed within working days,Submit review opinions to the drug regulatory department under the State Council.The drug regulatory department under the State Council shall start from the date of receiving the review opinions20Make a decision within working days.For qualified,Approve the registration and issue the registration certificate of new cosmetic raw materials For non-conforming,Refuse to register and explain the reasons in writing.

The registrant of new cosmetic raw materials shall complete the filing after submitting the filing materials specified in these regulations through the online government service platform of the drug regulatory department of the State Council.

The drug regulatory department under the State Council shall start from the date when the registration of new cosmetic raw materials is approved From the date when the filing person submits the filing materials5Announce the registration to the public within working days Filing related information.

Article 14 Registered After the new cosmetic raw materials put on record are put into use3Within the year,New material registrant The filer shall report the use and safety of new raw materials to the drug regulatory department under the State Council every year.New cosmetic raw materials with safety problems,The drug regulatory department under the State Council shall revoke the registration or cancel the filing.3New cosmetic raw materials without safety problems at the expiration of years,Included in the catalogue of used cosmetic raw materials formulated by the drug regulatory department under the State Council.

Registered Before the new cosmetic raw materials filed are included in the catalogue of used cosmetic raw materials,It is still managed according to new cosmetics raw materials.

Article 15 The catalogue of raw materials prohibited for the production of cosmetics shall be formulated by the drug regulatory department under the State Council publish.

Article 16 For hair dyeing Perm Freckle removing and whitening Sunscreen Anti hair loss cosmetics and cosmetics claiming new effects are special cosmetics.Cosmetics other than special cosmetics are ordinary cosmetics.

The drug regulatory department of the State Council declares according to the efficacy of cosmetics Action site Product dosage form Users and other factors,formulate Publish the classification rules and catalogue of cosmetics.

Article 17 Special cosmetics can be produced only after being registered by the drug regulatory department under the State Council Import.Domestic ordinary cosmetics shall be reported to the province where the filer is located before being put on the market Autonomous Region For the record by the drug regulatory department of the people's Government of the municipality directly under the central government.The import of ordinary cosmetics shall be filed with the drug regulatory department under the State Council before import.

Article 18 Cosmetic registration applicant The filer shall meet the following conditions

one It is an enterprise or other organization established according to law

two Yes and apply for registration The quality management system corresponding to the recorded products

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

Article 19 Application for registration of special cosmetics or filing of ordinary cosmetics,The following information shall be submitted

one Registered applicant Name of filer address contact information

two Name of manufacturer address contact information

three Product name

four Product formula or whole product ingredients

five Product implementation standards

six Sample product label

seven Product inspection report

eight Product safety assessment data.

The registration applicant applies for the registration of special cosmetics for the first time or the filing person makes the filing of ordinary cosmetics for the first time,It shall submit supporting materials that meet the conditions specified in Article 18 of these regulations.Applying for the registration of imported special cosmetics or filing the import of ordinary cosmetics,At the same time, the product in the country of production shall be submitted region The documents proving that the products have been sold on the market and the documents proving that the overseas production enterprises comply with the cosmetics production quality management standards Designed for export to China The product cannot be submitted in the country of manufacture region Of the supporting documents that have been listed for sale,Relevant research and test materials for Chinese consumers shall be submitted.

Registered applicant The filer shall be responsible for the authenticity of the materials submitted Scientific responsibility.

Article 20 The drug regulatory department under the State Council shall examine the application for registration of special cosmetics in accordance with the procedures for registration and examination of new cosmetic raw materials specified in paragraph 1 of Article 13 of these regulations.For qualified,Approval of registration and issuance of registration certificate for special cosmetics For non-conforming,Refuse to register and explain the reasons in writing.Registered special cosmetics in the production process Substantial changes in efficacy claims, etc,The registrant shall apply to the original registration department for change of registration.

The ordinary cosmetics filer shall complete the filing after submitting the filing materials specified in these regulations through the online government service platform of the drug regulatory department of the State Council.

The drug regulatory department of the people's government at or above the provincial level shall start from the date when the registration of special cosmetics is approved From the date when the ordinary cosmetics filer submits the filing materials5Announce the registration to the public within working days Filing related information.

Article 21 Registration of new cosmetics raw materials and cosmetics Before filing,Registered applicant The filer shall conduct safety assessment by itself or entrust a professional institution.

Personnel engaged in safety assessment shall have professional knowledge related to the quality and safety of cosmetics,And have5More than years of relevant professional experience.

Article 22 The efficacy claim of cosmetics should have sufficient scientific basis.Cosmetic registrant The filing person shall publish the documents and materials on which the efficacy claim is based on on the special website specified by the drug regulatory department under the State Council Summary of research data or product efficacy evaluation data,Accept social supervision.

Article 23 Overseas cosmetics registrant The filer shall designate an enterprise legal person within the territory of China to handle the registration of cosmetics keep on record,Assist in monitoring adverse reactions of cosmetics Implement product recall.

Article 24 The registration certificate of special cosmetics is valid for5year.Renewal of registration is required at the expiration of the term of validity,It shall expire within the period of validity30An application for renewal of registration shall be submitted three working days ago.Except as provided in paragraph 2 of this article,The drug regulatory department under the State Council shall make a decision to approve the renewal before the expiration of the registration certificate of special cosmetics Failing to make a decision within the time limit,Deemed to be granted continuation.

Under any of the following circumstances,No renewal of registration

one The registrant failed to apply for renewal of registration within the specified time limit

two Mandatory national standards The technical specifications have been revised,Cosmetics applying for renewal of registration cannot meet the revised standards Requirements of technical specifications.

Article 25 The drug regulatory department of the State Council is responsible for proposing the items of mandatory national standards for cosmetics Organize drafting Consultation and technical review.The Standardization Administration Department of the State Council is responsible for the establishment of compulsory national standards for cosmetics Numbering and external notification.

The text of the national standard for cosmetics shall be made public to the public free of charge.

Cosmetics shall comply with mandatory national standards.Enterprises are encouraged to formulate enterprise standards that are stricter than mandatory national standards.

Chapter III Production and operation

Article 26 Engaged in cosmetics production activities,The following conditions shall be met

one It is an enterprise established according to law

two There is a production site suitable for the cosmetics produced environment condition Production facilities and equipment

three There are technicians suitable for the production of cosmetics

four There are inspectors and inspection equipment capable of inspecting the cosmetics produced

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

Article 27 Engaged in cosmeticsProduction activities,It should be reported to the local province Autonomous Region The drug regulatory department of the people's Government of the municipality directly under the central government shall submit an application,Submit supporting materials that meet the conditions specified in Article 26 of these regulations,And be responsible for the authenticity of the data.

province Autonomous Region The drug regulatory department of the people's Government of the municipality directly under the central government shall examine the application materials,Conduct on-site inspection on the applicant's production site,And from the date of accepting the application for cosmetics production license30Make a decision within working days.For those meeting the specified conditions,License granted and cosmetics production license issued For those who do not meet the specified conditions,Disapproval and reasons in writing.

The cosmetics production license is valid for5year.It needs to be renewed at the expiration of the term of validity,according to Administrative License Law of the people's Republic of China In accordance with relevant regulations.

Article 28 Cosmetic registrant The registrant may produce cosmetics by himself,It can also entrust other enterprises to produce cosmetics.

Commissioned production of cosmetics,Cosmetic registrant The filer shall entrust the enterprise that has obtained the corresponding cosmetics production license,And to the entrusted enterprise Hereinafter referred to as entrusted production enterprise Supervise the production activities,Ensure that it is produced in accordance with legal requirements.The entrusted production enterprise shall comply with the law statute Mandatory national standards Production shall be carried out in accordance with the technical specifications and the contract,Responsible for production activities,And accept cosmetics registrants Supervision of the filer.

Article 29 Cosmetic registrant Filed by The entrusted production enterprise shall organize the production of cosmetics in accordance with the requirements of the cosmetics production quality management standards formulated by the drug regulatory department under the State Council,Establish cosmetics production quality management system,Establish and implement supplier selection Raw material acceptance Production process and quality control device management Product inspection and sample retention management system.

Cosmetic registrant Filed by The entrusted production enterprise shall produce cosmetics in accordance with the technical requirements specified in the cosmetics registration or filing materials.

Article 30 Cosmetic raw materials Packaging materials in direct contact with cosmetics shall comply with mandatory national standards technical specifications.

It shall not be used beyond the service life Abandoned Production of cosmetics from recycled cosmetics or cosmetics raw materials.

Article 31 Cosmetic registrant Filed by The entrusted production enterprise shall establish and implement the incoming inspection record system for raw materials and packaging materials in direct contact with cosmetics Product sales record system.Incoming inspection records and product sales records shall be true complete,Guarantee traceability,The storage period shall not be less than after the expiration of the service life of the product1year Insufficient service life of the product1Year,The retention period of records shall not be less than2year.

Cosmetics can be sold only after passing the factory inspection.

Article 32 Cosmetic registrant Filed by The entrusted production enterprise shall have a person in charge of quality and safety,Undertake corresponding product quality and safety management and product release responsibilities.

The person in charge of quality and safety shall have professional knowledge related to the quality and safety of cosmetics,And have5At least years experience in cosmetics production or quality and safety management.

Article 33 Cosmetic registrant Filed by The entrusted production enterprise shall establish and implement the employee health management system.Persons suffering from diseases that hinder the quality and safety of cosmetics as stipulated by the competent department of health under the State Council shall not directly engage in cosmetics production activities.

Article 34 Cosmetic registrant Filed by The entrusted production enterprise shall regularly conduct self inspection on the implementation of the cosmetics production quality management standards Changes in production conditions,No longer meet the requirements of cosmetics production quality management specifications,Rectification measures shall be taken immediately Factors that may affect the quality and safety of cosmetics,Production shall be stopped immediately and reported to the local province Autonomous Region Report of the drug regulatory department of the people's Government of the municipality directly under the central government.

Article 35 The minimum sales unit of cosmetics shall be labeled.The label shall comply with relevant laws Administrative regulations Mandatory national standards,True content complete accuracy.

Imported cosmetics can use Chinese labels directly,Chinese labels can also be added Labeled in Chinese,The content of the Chinese label shall be consistent with that of the original label.

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

one Product name Registration Certificate No. of special cosmetics

two Registrant Filed by Name of entrusted manufacturer address

three Cosmetics production license No

four Standard number of product execution

five Total composition

six Net content

seven Service life Method of use and necessary safety warnings

eight law Other contents that shall be marked according to administrative regulations and mandatory national standards.

Article 37 It is forbidden to label cosmetics with the following contents

one Contents that express or imply medical effects

two False or misleading content

three Contents violating social public order and good customs

four law Other contents prohibited by administrative regulations.

Article 38 Cosmetics business operators shall establish and implement a purchase inspection record system,Check the supplier's market entity registration certificate Registration or filing of cosmetics Product delivery inspection certificate,Truthfully record and keep relevant vouchers.The retention period of records and vouchers shall comply with the provisions of paragraph 1 of Article 31 of these regulations.

Cosmetic operators shall not prepare cosmetics by themselves.

Article 39 Cosmetics producers and operators shall comply with relevant laws Regulations and labeling requirements for cosmetics Transportation of cosmetics,Regularly check and timely deal with cosmetics that have deteriorated or have expired.

Article 40 Founder of cosmetics centralized trading market The organizer of a trade fair shall examine the registration certificate of the market subject of the admitted cosmetics operators,Undertake the management responsibility of cosmetics operators entering the site,Regularly inspect the operators of cosmetics entering the site It is found that the operators of cosmetics entering the site have committed acts in violation of the provisions of these regulations,It shall stop in time and report to the drug regulatory department of the local people's government at the county level.

Article 41 The operator of the e-commerce platform shall register the real name of the cosmetics operator in the platform,Assume the management responsibility of cosmetics operators in the platform,It is found that the cosmetics operators in the platform have violated the provisions of these regulations,It shall timely stop and report to the province where the operator of the e-commerce platform is located Autonomous Region Drug regulatory departments of the people's governments of municipalities directly under the central government Serious violations are found,The provision of e-commerce platform services to illegal cosmetics operators shall be stopped immediately.

Cosmetics operators on the platform shall fully real accuracy Disclose the information of cosmetics in time.

Article 42 Beauty salon Hotels use cosmetics or provide cosmetics to consumers in their business,It shall fulfill the obligations of cosmetic operators as stipulated in these regulations.

Article 43 The contents of cosmetic advertisements should be true legitimate.

Cosmetics advertisements shall not express or imply that the products have medical effects,It shall not contain false or misleading contents,No cheating Mislead consumers.

Article 44 Cosmetic registrant The filer finds that the cosmetics have quality defects or other problems,May endanger human health,Production should be stopped immediately,Recall cosmetics already on the market,Inform relevant cosmetics operators and consumers to stop operation use,Recall and notification shall be recorded.Cosmetic registrant The filer shall remedy the recalled cosmetics Harmless treatment Destruction and other measures,And report the recall and disposal of cosmetics to the local province Autonomous Region Report of the drug regulatory department of the people's Government of the municipality directly under the central government.

Entrusted production enterprise Cosmetics operators find their production The cosmetics sold are under the circumstances specified in the preceding paragraph,Production should be stopped immediately management,Notify the relevant cosmetic registrant Filed by.Cosmetic registrant The recorder shall immediately implement the recall.

The Department in charge of drug supervision and administration finds that cosmetics fall under the circumstances specified in paragraph 1 of this article during supervision and inspection,The cosmetic registrant shall be notified Recall by the recorder,Notify the entrusted manufacturer Cosmetics operators stop production management.

Cosmetic registrant Recall by the recorder,Entrusted production enterprise Cosmetics operators shall cooperate. Cosmetic registrant Filed by Entrusted production enterprise The business operator fails to recall or stop production in accordance with the provisions of this article Operating,The Department in charge of drug supervision and administration shall order it to recall or stop production management.

Article 45 Entry exit inspection and quarantine authorities in accordance with Law of the People's Republic of China on the Inspection of Import and Export Commodities The imported cosmetics shall be inspected in accordance with the provisions of the State Council Unqualified in inspection,No import.

The importer shall check whether the cosmetics to be imported have been registered or filed, and whether they comply with these regulations and mandatory national standards Review of technical specifications Audit unqualified,No import.The importer shall truthfully record the information of imported cosmetics,The retention period of records shall comply with the provisions of paragraph 1 of Article 31 of these regulations.

The exported cosmetics shall meet the requirements of the importing country region Standards or contractual requirements.

Chapter IV supervision

Article 46 When the Department in charge of drug supervision and administration supervises and inspects the production and operation of cosmetics,Have the right to take the following measures

one Enter the production and business premises for on-site inspection

two Conduct sampling inspection on cosmetics produced and operated

three consult Copy relevant contracts bill Account books and other relevant materials

four Seal up Seizure does not meet mandatory national standards Technical specifications or cosmetics and their raw materials with evidence that may endanger human health Packaging materials in direct contact with cosmetics,And there is evidence to prove the tools used for illegal production and operation equipment

five Seal up places that illegally engage in production and business activities.

Article 47 When the Department in charge of drug supervision and administration supervises and inspects the production and operation of cosmetics,The number of supervision and inspection personnel shall not be less than2people,And shall produce law enforcement certificates.The supervision and inspection personnel shall be responsible for the business secrets of the inspected unit known in the supervision and inspection,It shall be kept confidential according to law.The inspected unit shall cooperate with the supervision and inspection,Relevant information shall not be concealed.

The Department in charge of drug supervision and administration shall record the supervision and inspection and handling results,It shall be signed by the supervisor and inspector and the person in charge of the inspected unit The person in charge of the inspected unit refuses to sign,It should be noted.

Article 48 The drug regulatory department of the people's government at or above the provincial level shall organize sampling inspection of cosmetics Cosmetics with more problems reported or found in daily supervision and inspection,The Department in charge of drug supervision and administration may conduct special sampling inspection.

Conduct sampling inspection,The cost of taking samples shall be paid,The necessary expenses shall be included in the budget of the government at the corresponding level.

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

Article 49 After the cosmetics inspection institution obtains the qualification in accordance with the relevant national certification and accreditation regulations,Before engaging in cosmetic inspection activities.The qualification of cosmetic inspection institutions shall be determined by the drug regulatory department under the State Council Formulated by the market supervision and Administration Department of the State Council.

Cosmetics inspection specifications and management regulations on cosmetics inspection related standards,It shall be formulated by the drug regulatory department under the State Council.

Article 50 Cosmetics that may be adulterated or produced with raw materials prohibited from the production of cosmetics,It cannot be inspected according to the inspection items and methods specified in the national standards for cosmetics,The drug regulatory department under the State Council may formulate supplementary inspection items and inspection methods,For sampling inspection of cosmetics Investigation and handling of cosmetic quality and safety cases and adverse reactions.

Article 51 Disagreeing with the inspection conclusion implemented in accordance with the provisions of these regulations,Cosmetics producers and operators may start from the date of receiving the inspection conclusion7Submit an application for re inspection to the Department implementing sampling inspection or the Department in charge of drug supervision and administration at the next higher level within working days,The department accepting the re inspection application shall randomly determine the re inspection institution in the list of re inspection institutions for re inspection.The re inspection conclusion issued by the re inspection authority is the final inspection conclusion.The re inspection organization and the initial inspection organization shall not be the same organization.The list of re inspection institutions shall be published by the drug regulatory department under the State Council.

Article 52 The state establishes a monitoring system for adverse reactions of cosmetics.Cosmetic registrant The filer shall monitor the adverse reactions of cosmetics on the market,Timely evaluation,Report to the adverse reaction monitoring agency of cosmetics in accordance with the provisions of the drug regulatory department of the State Council.Entrusted production enterprise Cosmetics operators and medical institutions find that there may be adverse reactions related to the use of cosmetics,It shall be reported to the cosmetics adverse reaction monitoring agency.Encourage other units and individuals to report possible adverse reactions related to the use of cosmetics to the cosmetics adverse reaction monitoring organization or the Department in charge of drug supervision and administration.

The adverse reaction monitoring organization of cosmetics is responsible for the collection of adverse reaction information of cosmetics Analysis and evaluation,And put forward handling suggestions to the Department responsible for drug supervision and administration.

Cosmetics producers and operators shall cooperate with the cosmetics adverse reaction monitoring organization The Department in charge of drug supervision and administration shall carry out investigation on adverse reactions of cosmetics.

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

Article 53 The state establishes a cosmetics safety risk monitoring and evaluation system,Monitor and evaluate the risk factors affecting the quality and safety of cosmetics,To formulate quality and safety risk control measures and standards for cosmetics Provide scientific basis for sampling inspection of cosmetics.

The national cosmetics safety risk monitoring plan shall be formulated by the drug regulatory department under the State Council Issue and organize implementation.The national cosmetics safety risk monitoring plan shall specify the key monitoring varieties Project and region, etc.

The drug regulatory department under the State Council shall establish an information exchange mechanism for the quality and safety risks of cosmetics,Organize cosmetics manufacturers and operators Inspection organization Trade Association Consumer associations and news media exchange information on cosmetics quality and safety risks.

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

Article 55 According to the development of scientific research,On cosmetics The safety of cosmetic raw materials has changed,Or there is evidence that cosmetics Possible defects in cosmetic raw materials,The drug regulatory department of the people's government at or above the provincial level may order cosmetics Registrant of new cosmetic raw materials The recorder shall carry out safety reassessment or directly organize safety reassessment.Reassessment results show that cosmetics Cosmetic raw materials cannot guarantee safety,The registration shall be revoked by the original registration department The filing Department cancels the filing,The drug regulatory department under the State Council shall include the cosmetic raw materials in the catalogue of raw materials prohibited for cosmetic production,And make it known to the public. The first

Article 56 The Department in charge of drug supervision and administration shall timely announce the administrative license for cosmetics according to law keep on record Daily supervision and inspection results Supervision and management information such as investigation and punishment of illegal acts.When publishing supervision and management information,The trade secrets of the parties shall be kept confidential.

The Department in charge of drug supervision and administration shall establish credit files for cosmetics manufacturers and operators.Cosmetics producers and operators with bad credit records,Increase the frequency of supervision and inspection For producers and operators with serious bad credit records,Implement joint punishment according to regulations.

Article 57 There are potential safety hazards in the production and operation of cosmetics,Failure to take timely measures to eliminate,The Department in charge of drug supervision and administration may conduct responsibility interviews with the legal representative or main person in charge of cosmetics manufacturers and operators.Cosmetics producers and operators shall take immediate measures,Rectification,remove a hidden danger.The responsibility interview and rectification shall be included in the credit files of cosmetics manufacturers and operators.

Article 58 The Department in charge of drug supervision and administration shall publish the website address of its own department Email address or phone number,Receive consultation complaint report,And reply or deal with it in time.For verified reports,Reward informants in accordance with the relevant provisions of the state.

Chapter V legal responsibility

Article 59 Under any of the following circumstances,The illegal gains shall be confiscated by the Department in charge of drug supervision and administration Cosmetics illegally produced and operated and raw materials specially used for illegal production and operation packaging tool Equipment and other items The value of cosmetics illegally produced and operated is insufficient1Ten thousand yuan,Impose5More than 10000 yuan15Fine below 10000 yuan Value amount1More than 10000 yuan,Value of goods15More than times30Fine less than times Serious,Order to suspend production or business The filing department shall cancel the filing or the original license issuing department shall revoke the cosmetics license,10During the year, it shall not handle the filing of cosmetics or accept the application for administrative license of cosmetics,The legal representative or main person in charge of the illegal unit The persons directly in charge and other persons directly responsible shall be punished for the income they obtained from their own units in the previous year3More than times5Fine less than times,It is forbidden to engage in cosmetics production and business activities for life Constituting a crime,Investigate criminal responsibility according to law

one Engaging in cosmetics production without permission,Or cosmetic registrant The filer entrusts an enterprise that has not obtained the corresponding cosmetics production license to produce cosmetics

two Production, operation or import of unregistered special cosmetics

three Use of raw materials prohibited for cosmetic production New raw materials that should be registered but not registered to produce cosmetics,Illegal addition of substances that may endanger human health in cosmetics,Or use beyond the service life Abandoned Production of cosmetics from recycled cosmetics or raw materials.

Article 60 Under any of the following circumstances,The illegal gains shall be confiscated by the Department in charge of drug supervision and administration Cosmetics illegally produced and operated and raw materials specially used for illegal production and operation packaging tool Equipment and other items The value of cosmetics illegally produced and operated is insufficient1Ten thousand yuan,Impose1More than 10000 yuan5Fine below 10000 yuan Value amount1More than 10000 yuan,Value of goods5More than times20Fine less than times Serious,Order to suspend production or business The filing department shall cancel the filing or the original license issuing department shall revoke the cosmetics license,The legal representative or main person in charge of the illegal unit The persons directly in charge and other persons directly responsible shall be punished for the income they obtained from their own units in the previous year1More than times3Fine less than times,10It is prohibited to engage in cosmetics production and business activities during the year Constituting a crime,Investigate criminal responsibility according to law

one The use does not comply with mandatory national standards Raw materials of technical specifications Packaging materials in direct contact with cosmetics,Production of cosmetics with new raw materials that should be filed but not filed,Or do not use raw materials in accordance with mandatory national standards or technical specifications

two The production and operation do not meet the mandatory national standards Technical specifications or non-compliance with cosmetic registration Cosmetics with technical requirements specified in the filing data

three Failure to organize production in accordance with the requirements of cosmetic production quality management specifications

four Change the service life of cosmetics

five Cosmetics operators prepare cosmetics without authorization,Or business deterioration Cosmetics beyond the service life

six Refuse to recall after the Department in charge of drug supervision and Administration ordered it to implement the recall,Or order to stop or suspend production at the Department in charge of drug supervision and administration Refuse to stop or suspend production after operation management.

Article 61 Under any of the following circumstances,The illegal gains shall be confiscated by the Department in charge of drug supervision and administration Illegally produced and operated cosmetics,And may confiscate the raw materials specially used for illegal production and operation packaging tool Equipment and other items The value of cosmetics illegally produced and operated is insufficient1Ten thousand yuan,Impose1More than 10000 yuan3Fine below 10000 yuan Value amount1More than 10000 yuan,Value of goods3More than times10Fine less than times Serious,Order to suspend production or business The filing department shall cancel the filing or the original license issuing department shall revoke the cosmetics license,The legal representative or main person in charge of the illegal unit The persons directly in charge and other persons directly responsible shall be punished for the income they obtained from their own units in the previous year1More than times2Fine less than times,5It is prohibited to engage in cosmetics production and business activities during the year

one Listing sales Operate or import ordinary cosmetics that have not been filed

two Failing to set up a person in charge of quality and safety in accordance with the provisions of these regulations

three Cosmetic registrant The recorder failed to supervise the production activities of the entrusted production enterprise

four Failing to establish and implement the employee health management system in accordance with the provisions of these regulations

five The production and operation of cosmetics whose labels do not comply with the provisions of these regulations. The label of cosmetics produced and operated has defects, but does not affect quality and safety and will not mislead consumers,The Department in charge of drug supervision and administration shall order it to make corrections Refusing to correct,place2000Fine below yuan.

Article 62 Under any of the following circumstances,The Department in charge of drug supervision and administration shall order it to make corrections,Give warning,Impose1More than 10000 yuan3Fine below 10000 yuan Serious,Order to suspend production or business,Impose3More than 10000 yuan5Fine below 10000 yuan,The legal representative or main person in charge of the illegal unit Directly responsible supervisors and other directly responsible personnel1More than 10000 yuan3Fine below 10000 yuan

one Failure to publish the summary of the basis for the efficacy claim of cosmetics in accordance with the provisions of these regulations

two Failing to establish and implement the incoming inspection record system in accordance with the provisions of these regulations Product sales record system

three Failure to conduct self inspection on the implementation of the standards for the quality management of cosmetics production in accordance with the provisions of these regulations

four Failure to store in accordance with these Regulations Transportation of cosmetics

five Failure to monitor in accordance with the provisions of these Regulations Report cosmetic adverse reactions,Or monitoring agency for adverse reactions to cosmetics The Department in charge of drug supervision and administration did not cooperate in the investigation of adverse reactions of cosmetics. The importer fails to record in accordance with the provisions of these regulations Keep information on imported cosmetics,The entry-exit inspection and quarantine organ shall impose punishment in accordance with the provisions of the preceding paragraph.

Article 63 Registrant of new cosmetic raw materials The filer fails to report the use and safety of new cosmetic raw materials in accordance with the provisions of these regulations,The drug regulatory department under the State Council shall order it to make corrections,place5More than 10000 yuan20Fine below 10000 yuan Serious,Revoke the registration certificate of new cosmetics raw materials or cancel the filing of new cosmetics raw materials,Impose20More than 10000 yuan50Fine below 10000 yuan.

Article 64 Providing false information or taking other deceptive means when applying for cosmetic administrative license,No administrative license,Having obtained administrative license,The administrative license shall be revoked by the Department that makes the administrative license decision,5The cosmetics related license applications submitted by them will not be accepted during the year,Confiscation of illegal income and production Imported cosmetics Already produced The value of imported cosmetics is insufficient1Ten thousand yuan,Impose5More than 10000 yuan15Fine below 10000 yuan Value amount1More than 10000 yuan,Value of goods15More than times30Fine less than times The legal representative or main person in charge of the illegal unit The persons directly in charge and other persons directly responsible shall be punished for the income they obtained from their own units in the previous year3More than times5Fine less than times,It is forbidden to engage in cosmetics production and business activities for life.

forge Alteration lease Lending or transferring cosmetics license,The Department in charge of drug supervision and administration or the original license issuing department shall confiscate or revoke it,Confiscation of illegal income Insufficient illegal income1Ten thousand yuan,Impose5More than 10000 yuan10Fine below 10000 yuan Illegal income1More than 10000 yuan,And impose illegal gains10More than times20Fine less than times Constituting an act against the administration of public security,The public security organ shall impose administrative penalties for public security according to law Constituting a crime,Investigate criminal responsibility according to law.

Article 65 Providing false information at the time of filing,The filing department shall cancel the filing,3Such filing shall not be handled within the year,Confiscation of illegal income and production Imported cosmetics Already produced The value of imported cosmetics is insufficient1Ten thousand yuan,Impose1More than 10000 yuan3Fine below 10000 yuan Value amount1More than 10000 yuan,Value of goods3More than times10Fine less than times Serious,It shall be ordered to suspend production or business until the original license issuing department revokes the cosmetics production license,The legal representative or main person in charge of the illegal unit The persons directly in charge and other persons directly responsible shall be punished for the income they obtained from their own units in the previous year1More than times2Fine less than times,5It is prohibited to engage in cosmetics production and business activities during the year.

The filed materials do not meet the requirements,The filing department shall order it to make corrections within a time limit,among,And cosmetics The filing materials related to the safety of new cosmetics raw materials do not meet the requirements,The filing department may order the suspension of sales at the same time use Failing to correct within the time limit,The filing department shall cancel the filing.

After the filing Department cancels the filing,The new raw material of cosmetics is still used to produce cosmetics or is still on the market Import the ordinary cosmetics,In accordance with Article 60 of these regulations Penalties shall be imposed in accordance with the provisions of Article 61.

Article 66 Founder of cosmetics centralized trading market The organizer of the trade fair fails to perform the examination in accordance with the provisions of these regulations inspect check Reporting and other management obligations,By the Department responsible for drug supervision and Administration2More than 10000 yuan10Fine below 10000 yuan Serious,Order to suspend business,Impose10More than 10000 yuan50Fine below 10000 yuan.

Article 67 E-commerce platform operators fail to perform real name registration in accordance with the provisions of these regulations check report Stop providing e-commerce platform services and other management obligations,By province Autonomous Region The drug regulatory department of the people's Government of the municipality directly under the central government shall, in accordance with Law of the people's Republic of China on Electronic Commerce Penalties shall be imposed in accordance with the provisions of the law.

Article 68 Cosmetics operators have fulfilled their obligations such as purchase inspection records stipulated in these regulations,There is evidence to prove that they do not know that the cosmetics purchased do not meet the mandatory national standards Technical specifications or non-compliance with cosmetic registration The technical requirements specified in the filing materials,Confiscating its business does not meet the mandatory national standards Technical specifications or non-compliance with cosmetic registration Cosmetics with technical requirements specified in the filing data,Administrative penalties may be exempted.

Article 69 Cosmetics advertisements violate the provisions of these regulations,according to Advertisement Law of the People's Republic of China Penalties shall be imposed in accordance with the provisions of the law Making false or misleading publicity on cosmetics by other means,Punishment shall be given in accordance with the provisions of relevant laws Constituting a crime,Investigate criminal responsibility according to law.

Article 70 Overseas cosmetics registrant The enterprise legal person designated by the filer in China did not assist in the monitoring of adverse reactions of cosmetics Implementation of product recall,By province Autonomous Region The drug regulatory department of the people's Government of the municipality directly under the central government shall order it to make corrections,Give warning,Impose2More than 10000 yuan10Fine below 10000 yuan Serious,place10More than 10000 yuan50Fine below 10000 yuan,5Its legal representative or main person in charge is prohibited during the year The persons directly in charge and other persons directly responsible are engaged in the production and operation of cosmetics.

Overseas cosmetics registrant The recorder refuses to implement the decision on administrative punishment made in accordance with these regulations,10The import of cosmetics was prohibited during the year.

Article 71 A cosmetics inspection institution issues a false inspection report,The certification and accreditation supervision and administration department shall revoke the qualification certificate of the inspection institution,10The application for qualification recognition will not be accepted within the year,Confiscate the inspection fees collected,Impose5More than 10000 yuan10Fine below 10000 yuan To its legal representative or main person in charge The persons directly in charge and other persons directly responsible shall be punished for the income they obtained from their own units in the previous year1More than times3Fine less than times,The post grade shall be given or ordered to be reduced according to law Punishment of dismissal or dismissal,Being dismissed,10It is prohibited to engage in cosmetics inspection during the year Constituting a crime,Investigate criminal responsibility according to law.

Article 72 Cosmetic technical evaluation organization The cosmetics adverse reaction monitoring organization and the organization responsible for cosmetics safety risk monitoring failed to perform their duties in accordance with the provisions of these regulations,Technical review Adverse reaction monitoring Major mistakes in safety risk monitoring,The Department in charge of drug supervision and administration shall order it to make corrections,Give warning,Circulate criticism Causing serious consequences,To its legal representative or main person in charge Directly responsible supervisors and other directly responsible personnel,The post grade shall be given or ordered to be reduced according to law Punishment of dismissal or dismissal.

Article 73 Cosmetics producers and operators Recruitment by inspection institutions Employing personnel who are not allowed to engage in the production and operation of cosmetics or personnel who are not allowed to engage in the inspection of cosmetics to engage in the production, operation or inspection of cosmetics,The Department in charge of drug supervision and administration or other relevant departments shall order it to make corrections,Give warning Refusing to correct,Order to suspend production or business, or even revoke the cosmetics license Qualification certificate of inspection organization.

Article 74 Under any of the following circumstances,Constituting an act against the administration of public security,The public security organ shall impose administrative penalties for public security according to law Constituting a crime,Investigate criminal responsibility according to law

one Hinder the staff of the Department responsible for drug supervision and administration from performing their duties according to law

two forge Destroy Conceal evidence or hide transfer sell off Damage and seizure according to law Seized items.

Article 75 The staff of the Department in charge of drug supervision and administration violate the provisions of these regulations,abuse one 's power be forgetful of one's duties Favoritism,Give warning according to law Punishment of demerit recording or major demerit recording Causing serious consequences,Demotion according to law Punishment of dismissal or dismissal Constituting a crime,Investigate criminal responsibility according to law.

Article 76 Violation of these Regulations,Cause personal injury Property or other damage,Assume liability for compensation according to law.

Chapter VI attach  be

Article 77 Toothpaste shall be managed with reference to the provisions of these Regulations on ordinary cosmetics.The filing person of toothpaste shall comply with the national standards After efficacy evaluation according to industry standards,It can be claimed that toothpaste has anti caries effect Plaque suppression Anti dentin hypersensitivity Reduce gum problems.The specific measures for the administration of toothpaste shall be formulated by the drug regulatory department under the State Council,Report to the market supervision and Administration Department of the State Council for examination and approval release.

This Ordinance shall not apply to soap,However, this regulation applies to those who claim to have special cosmetic effects.

Article 78 Those registered before the implementation of these Regulations shall be used for education and development Depilation beautiful breast Bodybuilding Deodorizing cosmetics shall be set up as of the date of implementation of these regulations5Transition period in,Production can continue during the transition period Import sale,No production is allowed after the transition period Import Sell the cosmetics.

Article 79 Technical specifications referred to in these Regulations,Mandatory national standards have not yet been formulated Supplementary technical requirements for the quality and safety of cosmetics formulated by the drug regulatory department under the State Council in combination with the needs of supervision and administration.

Article 80 These Regulations shall come into force from2021year1month1Effective as of. Regulations on the Supervision of Cosmetics Hygiene Repeal at the same time.