If the illegal act of cosmetics occurs before January 1, 2021, the "Regulations on Cosmetics Hygiene Supervision" shall apply, but if it is considered that it is not illegal or should be given a lighter punishment according to the "Regulations", the "Regulations" shall apply. If the violation occurs after January 1, 2021, the Regulations shall apply.

On January 12, 2021, the State Administration of Market Supervision and Administration issued the Measures for the Administration of Registration and Filing of Cosmetics (hereinafter referred to as the Measures), which shall come into force on May 1, 2021. The "Measures" is one of the important supporting documents of the "Regulations on the Supervision and Administration of Cosmetics" (hereinafter referred to as the "Regulations"), which explains in detail the registration and filing management system of cosmetics and new cosmetics raw materials.

1. new cosmetics raw materials to implement a two-track system of registration and filing, predicting a blowout in the filing of new cosmetics raw materials.

Article 4 of the "Measures" stipulates that the state implements registration management for special cosmetics and new cosmetic raw materials with a higher degree of risk, and implements record management for ordinary cosmetics and other new cosmetic raw materials.

Article 18 stipulates that the filing of new raw materials for cosmetics shall be completed after the filing of materials in accordance with the requirements of the State Drug Administration.

Article 26 stipulates that three years after the expiration of the safety monitoring period for new cosmetic raw materials, the technical review agency shall report to the country

The National Drug Administration put forward the opinion of whether the new raw materials of cosmetics meet the safety requirements. For new cosmetic raw materials with safety problems, the registration or filing shall be canceled by the SDA; if no safety problems occur, the SDA shall include them in the catalogue of used cosmetic raw materials.

The relevant information of new raw materials submitted by the enterprise will be completed for filing without going through at least 90 working days of examination, and no safety problems will occur within the 3-year monitoring period after filing, and can be included in the catalogue of used cosmetic raw materials after the opinions of the technical review institution are put forward. In this context, it is expected that a large number of new cosmetic raw materials (non-high risk) will be added to the market after the implementation of the new regulations on May 1.

The supervision of new raw materials for 2. cosmetics during and after the event, the annual report and adverse reaction monitoring during the three-year monitoring period, and the verification of filing data.

Articles 19 to 27 of the Measures clearly stipulate the supervision of new cosmetic raw materials during and after the event. The safety monitoring period shall be within 3 years after the filing/registration is completed. During the monitoring period, the registrant/filer shall conduct follow-up research on the safety of raw materials and provide annual reports (summarizing the use and safety of raw materials) on schedule.

At the same time, Article 58 of the measures stipulates that "if the drug supervision and administration department responsible for the filing management finds that the filing materials of the filed cosmetics and new cosmetics raw materials do not meet the requirements, it shall order it to make corrections within a time limit. If the filing materials related to the safety of cosmetics and new cosmetics raw materials do not meet the requirements, they may be ordered to suspend sales and use at the same time. For cosmetics and new raw materials for cosmetics that have been filed but the filing information has not been released to the public, if the drug supervision and administration department responsible for the filing management finds that the filing information does not meet the requirements, it may order the filing person to make corrections and publish the filing information to the public after meeting the requirements", thus avoiding the possible risks of completing the filing without reviewing the filing materials in the filing system of new raw materials for cosmetics.

The full text of the measures is attached below:

Order of the State Administration of Market Supervision and Administration

No. 35

The Measures for the Administration of Registration and Filing of Cosmetics, which were deliberated and adopted at the 14th Executive Meeting of the State Administration for Market Regulation in 2020 on December 31, 2020, are hereby promulgated and shall come into force on May 1, 2021.

Director Zhang Gong

January 7, 2021

Measures for the Administration of Registration and Filing of Cosmetics

(Promulgated by Order No. 35 of the State Administration for Market Regulation on January 7, 2021)

Chapter I General Provisions

Article 1 In order to regulate the registration and filing of cosmetics and ensure the quality and safety of cosmetics, these Measures are formulated in accordance with the Regulations on the Supervision and Administration of Cosmetics.

Article 2 These Measures shall apply to the registration, filing and supervision and administration of cosmetics and new cosmetic raw materials within the territory of the People's Republic of China.

Article 3 The registration of new raw materials of cosmetics and cosmetics refers to the activities in which the registration applicant submits an application for registration in accordance with the legal procedures and requirements, and the drug regulatory department examines the safety and quality controllability of the new raw materials of cosmetics and cosmetics applied for registration, and decides whether to approve the application.

The filing of new raw materials for cosmetics and cosmetics refers to the activities in which the filing person submits information indicating the safety and quality controllability of new raw materials for cosmetics and cosmetics in accordance with legal procedures and requirements, and the drug supervision and administration department archives the submitted information for future reference.

Article 4 The State shall implement registration management for special cosmetics and new raw materials for cosmetics with a relatively high degree of risk, and implement record management for ordinary cosmetics and other new raw materials for cosmetics.

Article 5 The SDA shall be responsible for the registration and filing administration of special cosmetics, imported ordinary cosmetics, and new raw materials for cosmetics, and guide and supervise the filing-related work of cosmetics undertaken by the drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government. The SDA may entrust the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government with corresponding capabilities to implement the record-keeping management of imported ordinary cosmetics.

The technical review body of the State Drug Administration for cosmetics (hereinafter referred to as the technical review body) shall be responsible for the technical review of the registration of special cosmetics and new raw materials for cosmetics, the technical verification of the data after the filing of imported ordinary cosmetics and new raw materials for cosmetics, and the assessment of the use and safety reports of new raw materials for cosmetics.

The administrative matters acceptance service institutions of the State Drug Administration (hereinafter referred to as the acceptance institutions), audit and inspection institutions, adverse reaction monitoring institutions, information management institutions and other professional and technical institutions shall undertake the registration acceptance, on-site verification, adverse reaction monitoring, information construction and management required for the registration and filing management of cosmetics.

Article 6 The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the filing and administration of domestic ordinary cosmetics within their respective administrative regions, implement the filing and administration of imported ordinary cosmetics in the name of the State Drug Administration within the scope of entrustment, and assist in the on-site verification of special cosmetics registration.

Article 7 The registrant and the archivist of new raw materials for cosmetics and cosmetics shall perform the obligations of product registration and archival filing in accordance with the law, and shall be responsible for the quality and safety of new raw materials for cosmetics and cosmetics.

When applying for registration or filing, registrants and filers of cosmetics and new raw materials for cosmetics shall abide by the requirements of relevant laws, administrative regulations, mandatory national standards and technical specifications, and shall be responsible for the authenticity and scientificity of the submitted materials.

Article 8 Where a registrant or recordholder is outside the territory, an enterprise legal person within the territory of China shall be designated as the responsible person within the territory. The responsible person within the territory shall perform the following obligations:

The (I) shall, in the name of the registrant and the recordholder, handle the registration and recordation of cosmetics and new raw materials for cosmetics;

(II) assist registrants and filers in the monitoring of adverse reactions to cosmetics and the safety monitoring and reporting of new cosmetic raw materials;

(III) assist registrants and filers to implement the recall of cosmetics and new raw materials for cosmetics;

The (IV) shall, in accordance with the agreement with the registrant and the filer, bear the corresponding quality and safety responsibilities for the cosmetics and new cosmetics raw materials put on the domestic market;

(V) cooperate with the supervision and inspection work of the pharmaceutical supervisory and administrative departments.

Article 9 The pharmaceutical supervisory and administrative department shall, within 5 working days from the date when the registration of cosmetics and new raw materials for cosmetics is granted and the filing is completed, announce to the public the relevant information on the registration and filing management of new raw materials for cosmetics and cosmetics for the public to inquire.

Article 10 The SDA shall strengthen the construction of informatization and provide facilitation services for registrants and filers.

Cosmetics, cosmetics new raw materials registrants, filers in accordance with the provisions of the cosmetics, cosmetics new raw materials registration information service platform (hereinafter referred to as the information service platform) to apply for registration, filing.

The State Drug Administration shall formulate a catalogue of used cosmetic raw materials, update them in a timely manner and make them public to facilitate enterprises to inquire.

Article 11 The pharmaceutical supervisory and administrative department may establish an expert consultation mechanism to listen to the opinions of experts on important issues in the process of technical review, on-site verification, supervision and inspection, and give full play to the technical support role of experts.

Chapter II Administration of Registration and Filing of New Raw Materials for Cosmetics

Section 1 Registration and Filing of New Raw Materials for Cosmetics

Article 12 Natural or artificial raw materials used in cosmetics for the first time in the territory of China shall be new raw materials for cosmetics.

Where the purpose of use and the safe amount of use of the used cosmetic raw materials are adjusted, the registration and filing shall be applied for in accordance with the registration and filing requirements of the new raw materials.

Article 13 To apply for the registration of new cosmetic raw materials with functions of anti-corrosion, sun protection, coloring, hair dyeing, freckle removal and whitening, the application materials shall be submitted in accordance with the requirements of the SDA. The accepting institution shall complete the formal examination of the application materials within 5 working days from the date of receipt of the application, and deal with it according to the following circumstances:

If the (I) application does not need to be registered according to law, it shall make a decision not to accept the application and issue a notice of rejection;

(II) the application does not fall within the scope of the SDA's functions and powers according to law, it shall make a decision not to accept the application, issue a notice of non-acceptance, and inform the applicant to apply to the relevant administrative organ;

If the (III) application materials are incomplete or do not conform to the prescribed form, a notice of correction shall be issued to inform the applicant of all the contents that need to be corrected at one time. If the application materials are not notified within the time limit, the application shall be accepted from the date of receipt;

If the (IV) application materials are complete and meet the prescribed form requirements, or if the applicant submits all the supplementary materials as required, the registration application shall be accepted and a notice of acceptance shall be issued.

The accepting institution shall, within 3 working days after accepting the registration application, transfer the application materials to the technical review institution.

Article 14 The technical review institution shall, within 90 working days from the date of receipt of the application materials, organize and carry out the technical review in accordance with the requirements of the technical review, and deal with them separately according to the following circumstances:

If the (I) application materials are true and complete, can prove the safety and quality controllability of raw materials, and meet the requirements of laws, administrative regulations, mandatory national standards and technical specifications, the technical review agency shall make a review conclusion passed by the technical review;

If the (II) application materials are not true, cannot prove the safety and quality controllability of raw materials, and do not meet the requirements of laws, administrative regulations, mandatory national standards and technical specifications, the technical review agency shall make a review conclusion that the technical review is not passed;

If the (III) needs the applicant's supplementary information, it shall inform all the contents to be supplemented at one time; the applicant shall provide the supplementary information at one time as required within 90 working days, and the time limit for review shall be recalculated after the technical review institution receives the supplementary information; if the supplementary information is not provided within the prescribed time limit, the technical review institution shall make a review conclusion that the technical review fails.

Article 15 If the conclusion of the technical review is that the review is not passed, the technical review institution shall inform the applicant and explain the reasons. If the applicant has any objection, he may apply for review within 20 working days from the date of receiving the technical review conclusion. The content of the review is limited to the original application matters and application materials.

The technical review institution shall make a review conclusion within 30 working days from the date of receipt of the review application.

Article 16 The SDA shall, within 20 working days from the date of receipt of the technical review conclusions, examine the legality, standardization and completeness of the technical review procedures and conclusions, and make a decision on whether to approve the registration.

The accepting institution shall, within 10 working days from the date of the administrative examination and approval decision made by the SDA, issue a certificate of registration of new raw materials for cosmetics or a decision not to register to the applicant.

Article 17 Before the technical review institution makes a technical review conclusion, the applicant may apply for withdrawal of registration. In the process of technical review, if it is found that it is suspected of providing false information or there are safety problems with new raw materials for cosmetics, the technical review institution shall deal with it according to law, and the applicant shall not withdraw the registration application.

Article 18 The filing of new raw materials for cosmetics shall be completed after the filing of the materials submitted in accordance with the requirements of the State Drug Administration.

Section 2 Safety Monitoring and Reporting

Article 19 The new cosmetic raw materials that have been registered and completed the record shall be subject to a safety monitoring system. The period of safety monitoring is 3 years, counting from the date of registration or filing of cosmetics for the first time using new raw materials for cosmetics.

Article 20 During the period of safety monitoring, the registrant and the recordholder of the new raw materials for cosmetics may use the new raw materials for cosmetics to produce cosmetics.

If the cosmetics registrant or the filing person uses new cosmetics raw materials to produce cosmetics, the relevant cosmetics shall apply for registration and filing through the information service platform and be confirmed by the new cosmetics raw material registrant and the filing person.

Article 21 The registrant and the filing person of new raw materials for cosmetics shall establish a safety risk monitoring and evaluation system for new raw materials for cosmetics after they are put on the market, conduct follow-up research on the safety of new raw materials for cosmetics, and conduct continuous use and safety of new raw materials for cosmetics. Monitoring and evaluation.

The registrant and the filing person of the new raw materials of cosmetics shall summarize and analyze the use and safety of the new raw materials of cosmetics within 30 working days before the safety monitoring of the new raw materials of cosmetics, and form an annual report and submit it to the State Drug Administration.

Article 22 If the following circumstances are found, the registrant and the recordholder of new raw materials for cosmetics shall immediately carry out research and report to the technical review agency:

(I) other countries (regions) found suspected serious cosmetic adverse reaction or group adverse reaction caused by the use of similar raw materials;

(II) the laws, regulations and standards of other countries (regions) to raise the use standards, increase the use restrictions or prohibit the use of similar raw materials;

(III) other situations related to the safety of new cosmetic ingredients.

If there is evidence that there is a safety problem with the new raw materials of cosmetics, the registrant and the filing person of the new raw materials of cosmetics shall immediately take measures to control the risk and report to the technical review agency.

Article 23 The registrant and recordholder of cosmetics that use new raw materials for cosmetics to produce cosmetics shall promptly feedback the use and safety of new raw materials for cosmetics to the registrant and recordholder of new raw materials for cosmetics.

In the event of adverse cosmetic reactions or safety issues that may be related to new cosmetic raw materials, the cosmetic registrant and the filing person shall immediately take measures to control the risk, notify the new cosmetic raw material registrant and the filing person, and report to the drug of the province, autonomous region, or municipality directly under the Central Government in accordance with regulations. Report to the supervisory and administrative department.

Article 24 after receiving a report of adverse reactions or safety problems of cosmetics using new cosmetic raw materials, the drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government shall organize research, judgment and analysis. If it is believed that the new cosmetic raw materials may cause human harm or endanger human health and other safety risks, measures shall be taken to control the risks in accordance with the relevant provisions, And immediately feedback to the technical review agency.

Article 25 After receiving the feedback or report from the drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government or the registrant or filing person of the new raw material of cosmetics, the technical review institution shall make an assessment in combination with the annual statistical analysis results of adverse reaction of cosmetics by the adverse reaction monitoring institution. If it believes that the safety risk can be eliminated by adjusting the technical requirements of the new raw material of cosmetics, it may put forward adjustment opinions and report to the SDA, should be reported to the State Drug Administration to cancel the registration or cancel the record. The SDA shall make a decision in a timely manner.

Article 26 Three years after the expiration of the safety monitoring period of new cosmetic raw materials, the technical review agency shall submit to the SDA an opinion on whether the new cosmetic raw materials meet the safety requirements.

For new cosmetic raw materials with safety problems, the registration or filing shall be canceled by the SDA; if no safety problems occur, the SDA shall include them in the catalogue of used cosmetic raw materials.

Article 27 If the use of new cosmetic raw materials is ordered to be suspended during the safety monitoring period, the cosmetic registrant and the filing person shall suspend the production and operation of cosmetics using the new cosmetic raw materials at the same time.

Chapter III Administration of Registration and Filing of Cosmetics

Section 1 General Requirements

28th cosmetics registration applicant, filing person shall meet the following conditions:

(I) are enterprises or other organizations established in accordance with the law;

The (II) has a quality management system that is compatible with the application for registration and filing of cosmetics;

(III) have the ability to monitor and evaluate adverse reactions.

Where the registration applicant applies for the registration of special cosmetics for the first time or the filing person conducts the filing of ordinary cosmetics for the first time, it shall submit the certification materials that meet the requirements of the preceding paragraph.

Article 29 Cosmetics registrants and filers shall, in accordance with laws, administrative regulations, mandatory national standards, technical specifications and registration and filing management, carry out cosmetics development, safety assessment, registration and filing inspection, etc., and submit registration and filing materials in accordance with the requirements of cosmetics registration and filing data specifications.

Article 30 The registrant and recordal person of cosmetics shall select raw materials that meet the requirements of laws, administrative regulations, mandatory national standards and technical specifications for the production of cosmetics, and shall be responsible for the safety of the cosmetic raw materials used. When applying for registration and filing, the registrant and the filing person of cosmetics shall clarify the source of raw materials and information related to the safety of raw materials through the information service platform.

Article 31 Where a cosmetics registrant or recordholder entrusts the production of cosmetics, domestic cosmetics shall be confirmed by the cosmetics manufacturer through the information service platform when applying for registration or filing; imported cosmetics shall be submitted by the cosmetics registrant or recordholder Relevant materials with entrustment relationship.

Article 32 The registrant and recordation person of cosmetics shall specify the standards for product implementation and submit them to the drug regulatory department when applying for registration or filing.

Article 33 Cosmetics registration applicants and filers shall entrust inspection institutions that have obtained qualification certification and meet the needs of cosmetics registration and filing inspection work to conduct inspections in accordance with the requirements of mandatory national standards, technical specifications and registration and filing inspection regulations.

Section 2 Filing Management

Article 34 Before ordinary cosmetics are put on the market or imported, the filing person shall complete the filing after submitting the filing materials through the information service platform in accordance with the requirements of the State Drug Administration.

Article 35 If the imported ordinary cosmetics that have been filed are intended to be imported at a port outside the administrative region of the province, autonomous region, or municipality directly under the Central Government where the responsible person is located, the information service platform shall be supplemented to fill in the port of import and the contact information for customs clearance procedures.

Article 36 For ordinary cosmetics that have been put on record, the product name shall not be changed at will without justifiable reasons; without sufficient scientific basis, the efficacy claim shall not be changed at will.

Ordinary cosmetics that have been filed shall not change the product formula at will, except for minor changes in the product formula due to changes in the source of raw materials.

If the change of the address of the filing person or the domestic responsible person leads to the change of the filing management department, the filing person shall make a new filing.

Article 37 The filing holder of ordinary cosmetics shall report the production and import situation, as well as the compliance with laws and regulations, mandatory national standards and technical specifications, to the drug regulatory department responsible for the filing management every year.

If the products that have been put on record are no longer produced or imported, the person who has put on record shall promptly report to the drug regulatory department responsible for the management of the record to cancel the record.

Section III Registration Management

Article 38 Before the production or import of special cosmetics, the registration applicant shall submit the application materials according to the requirements of the SDA.

Where the procedures and time limits for the registration of special cosmetics are not specified, the provisions of these Measures on the registration of new raw materials for cosmetics shall apply.

Article 39 The technical review institution shall, within 90 working days from the date of receipt of the application materials, organize and carry out the technical review in accordance with the requirements of the technical review, and deal with them separately according to the following circumstances:

If the (I) application materials are true and complete, can prove the product safety and quality controllability, the product formula and the standards implemented by the product are reasonable, and meet the requirements of current laws, administrative regulations, mandatory national standards and technical specifications, the technical review shall be made. Review conclusions;

If the (II) application materials are not true, cannot prove the product safety and quality controllability, the product formula and the standards implemented by the product are unreasonable, or do not meet the requirements of current laws, administrative regulations, mandatory national standards and technical specifications, the technical review shall be made. Review conclusions that fail;

If the (III) needs the applicant's supplementary information, it shall inform all the contents to be supplemented at one time; the applicant shall provide the supplementary information at one time as required within 90 working days, and the time limit for review shall be recalculated after the technical review institution receives the supplementary information; if the supplementary information is not provided within the prescribed time limit, the technical review institution shall make a review conclusion that the technical review fails.

Article 40 The SDA shall, within 20 working days from the date of receipt of the technical review conclusions, examine the legality, standardization and completeness of the technical review procedures and conclusions, and make a decision on whether to approve the registration.

The accepting institution shall, within 10 working days from the date of the administrative examination and approval decision made by the SDA, issue a cosmetic registration certificate or a decision not to register to the applicant. The cosmetic registration certificate is valid for 5 years.

Article 41 Where the registration matters of registered special cosmetics change, the SDA shall implement classified management according to the degree of influence of the changed matters on product safety and efficacy:

Where the (I) does not involve the safety or efficacy claims, the registrant shall promptly file with the SDA for the record;

(II) the safety-related matters change, and the production process, efficacy claims and other aspects of substantial changes, the registrant shall apply to the SDA for product registration change;

If the name, formula, etc. of the (III) product changes and essentially constitutes a new product, the registrant shall apply for registration again.

Article 42 Where a registered product is no longer produced or imported, the registrant shall voluntarily apply for the cancellation of the registration certificate.

Section 4 Continuation of Registration Certificate

Article 43 If the validity period of the special cosmetics registration certificate needs to be renewed, the registrant shall submit an application for renewal of registration within 90 working days to 30 working days before the expiration of the product registration certificate, and promise to meet the requirements of mandatory national standards and technical specifications. The registrant shall be responsible for the authenticity and legality of the information submitted and the commitments made.

If the application for renewal of registration is not filed within the time limit, the application for renewal of registration shall no longer be accepted.

Article 44 the accepting institution shall, within 5 working days after receiving the application for renewal of registration, examine the application materials in form, accept those that meet the requirements, and issue a new registration certificate to the applicant within 10 working days from the date of acceptance. The validity period of the registration certificate shall be recalculated from the day following the date of expiration of the original registration certificate.

Article 45 The drug supervision and administration department shall supervise the application materials and commitments of special cosmetics that have been renewed. If it is found through supervision and inspection or technical review that there is a situation that does not meet the mandatory national standards and technical specifications, it shall revoke the special cosmetics according to law. Registration certificate.

Chapter IV Supervision and Administration

Article 46 The pharmaceutical supervisory and administrative department shall, in accordance with the provisions of laws and regulations, supervise and inspect the registration and filing-related activities of registrants and filers, and may, if necessary, carry out extended inspections on the units involved in the registration and filing activities, and the relevant units and individuals shall cooperate and shall not refuse to inspect or conceal the relevant information.

Article 47 In the process of registration technical review, the technical review institution may notify the audit and inspection institution to carry out on-site verification as needed. Domestic on-site verification shall be completed within 45 working days, and overseas on-site verification shall be carried out in accordance with the relevant provisions of overseas verification. The time taken for on-site verification is not included in the review time limit.

The registration applicant shall cooperate with the on-site verification work. If sampling inspection is required, samples shall be provided as required.

Article 48 After obtaining a registration certificate for special cosmetics, the registrant shall upload the product label picture for sale on the market to the information service platform for the public to inquire before the product is put on the market.

Article 49 The cosmetic registration certificate shall not be transferred. If the subject qualification of the original registrant is canceled due to legal reasons such as merger and division of enterprises, and the registrant is changed to a newly established enterprise or other organization, it shall apply for change of registration in accordance with the provisions of these Measures.

The registered person after the change shall comply with the provisions of these Measures on the registered person, and shall bear the responsibility for the quality and safety of the products that have been listed.

Article 50 according to the development of scientific research, if there is a change in the understanding of the safety of cosmetics and cosmetic raw materials, or if there is evidence that cosmetics and cosmetic raw materials may have defects, the drug supervision and administration department responsible for registration and filing management may order the registrants and filers of new raw materials for cosmetics and cosmetics to carry out safety reassessment, or directly organize relevant raw material enterprises and cosmetics enterprises to carry out safety reassessment.

If the re-evaluation results show that cosmetics and cosmetic raw materials cannot be guaranteed to be safe, the original registration department shall cancel the registration and the filing department shall cancel the filing, and the drug supervision and administration department of the State Council shall include the cosmetic raw materials in the list of raw materials prohibited for cosmetic production and announce them to the public.

Article 51 According to the development of scientific research, the monitoring and evaluation of cosmetic safety risks, etc., if it is found that there are safety risks in cosmetic raw materials, and the safety risks can be eliminated by setting the scope and conditions for the use of raw materials, it shall be in the catalog of used cosmetic raw materials. Clarify the scope and conditions of restricted use of raw materials.

Article 52 if the drug regulatory department responsible for the management of registration and filing cannot contact the registrant, the filing person or the domestic responsible person through the registration and filing information, it may list the registrant, the filing person and the domestic responsible person as the key supervision object on the information service platform and make an announcement through the information service platform.

Article 53 The drug supervision and administration department shall implement risk classification and grading management according to the operation of the quality management system of the filing person, the domestic responsible person and the cosmetics production enterprise, the supervision after the filing, the supervision and inspection after the product is put on the market, etc.

Article 54 Drug supervisory and administrative departments, technical review, on-site verification, inspection institutions and their staff shall strictly abide by laws, regulations, rules and the relevant provisions of the State Drug Administration, and ensure that the relevant work is scientific, objective and fair.

Article 55 Without the consent of the registrant and the filing person, the drug regulatory department, professional technical institution and its staff, and personnel participating in the review shall not disclose the business secrets, undisclosed information or confidential business submitted by the registrant and the filing person Information, unless otherwise provided by law or involving national security or major social public interests.

Chapter V Legal Liability

Article 56 If a registrant of cosmetics or new raw materials for cosmetics fails to apply for registration of changes to new raw materials for special cosmetics or cosmetics in accordance with the provisions of these Measures, the drug regulatory department that originally issued the license shall order corrections, give a warning, and impose a penalty of 10000 yuan to 30000 yuan. Fines.

If the filing person of new raw materials for cosmetics and cosmetics fails to update the filing information of new raw materials for ordinary cosmetics and cosmetics in accordance with the provisions of these measures, the drug regulatory department responsible for the filing management shall order it to make corrections, give a warning, and impose a fine of not less than 5000 yuan but not more than 30000 yuan.

If the registrant of new raw materials for cosmetics and cosmetics fails to re-register in accordance with the provisions of these Measures, it shall be punished in accordance with the provisions of Article 59 of the Regulations on the Supervision and Administration of Cosmetics; if the registrant of new raw materials for cosmetics and cosmetics fails to re-register in accordance with the provisions of these Measures, it shall be punished in accordance with the provisions of the first paragraph of Article 61 of the Regulations on the Supervision and Administration of Cosmetics.

Article 57 Where a registrant or recordholder of a new cosmetic raw material violates the provisions of Article 21 of these Measures, the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall order it to make corrections; if it refuses to make corrections, a fine of 5000 yuan to 30000 yuan shall be imposed.

Article 58 If the drug regulatory department responsible for filing management finds that the filing materials of cosmetics and new raw materials for cosmetics do not meet the requirements, it shall order it to make corrections within a time limit. Among them, if the filing materials related to the safety of cosmetics and new raw materials for cosmetics do not meet the requirements, it may be ordered to suspend sales and use at the same time.

For cosmetics and new raw materials for cosmetics that have been filed but the filing information has not been released to the public, if the drug supervision and administration department responsible for the filing management finds that the filing information does not meet the requirements, it may order the filing person to make corrections and publish the filing information to the public after meeting the requirements.

Article 59 If the filing person has the following circumstances, the drug regulatory department that undertakes the filing management work shall cancel the filing of cosmetics and new raw materials for cosmetics:

Submitting false information when (I) filing;

(II) the materials that have been put on record do not meet the requirements, fail to make corrections within the prescribed time limit as required, or fail to suspend the sale and use of cosmetics and new raw materials for cosmetics as required;

(III) does not fall within the scope of new raw materials for cosmetics or cosmetics for the record.

Chapter VI Supplementary Provisions

Article 60 The time limit involved in the notification of registration acceptance, notification of technical review opinions, issuance of registration certificates and filing information, registration review, submission of reports on the use of new cosmetic raw materials, etc. shall be subject to the time of submission or issuance through the information service platform.

Article 61 The last process of contacting the contents of cosmetics is domestic products completed in China, imported products completed abroad, and managed with reference to imported products completed in Taiwan, Hong Kong and Macao.

For a co-use product or a combination packaging product that applies for registration or records under a product name, if the last process of contacting the contents of any one dose is completed outside the country, it shall be managed according to imported products.

Article 62 After cosmetics and new raw materials for cosmetics have been registered or put on record, they shall be numbered in accordance with the following rules.

Rules for the filing and numbering of new raw materials for (I) cosmetics: the number of new raw materials for cosmetics filed this year.

Rules for the registration and numbering of new raw materials for (II) cosmetics: the number of new raw materials for cosmetics registered in this year is four-digit year number.

(III) ordinary cosmetics filing numbering rules:

Domestic products: provinces, autonomous regions, and municipalities directly under the Central Government are referred to as the four-digit number of years for the number of products filed in the administrative area of this year;

Imported products: Guozhuangwang Bei Jin Zi (referred to as the province, autonomous region and municipality directly under the Central Government where the responsible person is located) four-digit year number of the national record product sequence number of this year;

Products from Taiwan, Hong Kong and Macao of China: the four-digit number of years in which the responsible person is located in the province, autonomous region and municipality directly under the Central Government is short for Guozhuangwang.

(IV) special cosmetics registration number rules:

Domestic products: national makeup special word four-digit year number of registered products this year sequence number;

Imported products: the number of registered products in this year;

Products from Taiwan, Hong Kong and Macao of China: The number of registered products in this year is four-digit year number.

Article 63 These Measures shall come into force as of May 1, 2021.