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 cosmetics production 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 compliance with the provisions,s%s s%s,s%s.

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