The registration of new raw materials for cosmetics ushered in new opportunities, and the draft for comments on the management of cosmetics registration was released.

On July 21, the State Food and Drug Administration issued two supporting management regulations of the Regulations on the Supervision and Administration of Cosmetics-the Measures for the Registration and Administration of Cosmetics (Draft for Comment) and the Measures for the Supervision and Administration of Cosmetics Production and Operation (Draft for Comment), To further refine and improve the relevant provisions in the new regulations.

Among them, the core of the "Cosmetics Registration Management Measures (Draft for Comment)" is to clarify the institutional framework, work responsibilities, basic systems, and responsibilities and obligations of all parties for the registration and filing management of cosmetics and new raw materials.

The measures for the Supervision and Administration of Cosmetics production and Operation (draft for soliciting opinions) is the first special departmental regulation set up for the supervision and management of cosmetics production and operation in China. It provides for the requirements and legal responsibilities of the supervision of cosmetics production and operation in the new regulations, which is an important legal basis for the supervision of cosmetics after listing.

Measures for the Administration of Registration of Cosmetics

(Exposure Draft)

Chapter I General Provisions

Article 1 (Basis for Formulation) In order to regulate the registration and administration 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 and the provisions of relevant laws and regulations.

Article 2 (Scope of Application) Cosmetics and new raw materials for cosmetics produced and operated within the territory of the People's Republic of China shall be applied for registration or put on record in accordance with the provisions of these Measures.

Article 3 (Definition) Registration refers to the activities in which the registration applicant submits an application for registration in accordance with the statutory conditions, procedures and requirements, and the drug regulatory department examines the safety and quality controllability of the cosmetics or new cosmetics raw materials applied for registration, and decides whether to agree to its registration application.

Filing refers to the activities in which the filing person submits the information indicating product safety and quality controllability to the drug supervision and administration department for filing for future reference in accordance with the legal conditions, procedures and requirements.

Article 4 (Classified Management) The State implements registration management of special cosmetics and new raw materials with higher safety risks with anti-corrosion, sun protection, coloring, hair dyeing, freckle removing and whitening functions, and implements record management of ordinary cosmetics and other new raw materials.

Article 5 (Powers of the State Administration) The State Drug Administration is in charge of the registration and filing administration of cosmetics and new raw materials throughout the country, and is responsible for the registration and filing administration of special cosmetics, imported ordinary cosmetics and new raw materials.

The technical review department of cosmetics of the State Drug Administration (hereinafter referred to as the technical review department) is responsible for the technical review of the registration of special cosmetics and new raw materials, and undertakes the review of imported ordinary cosmetics and new raw materials after filing.

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

Article 6 (Powers of Provincial Bureaus) The drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the filing and management of domestic general cosmetics within their administrative regions, and participate in the on-site verification work related to the registration of special cosmetics. The administrative department is entrusted by the State Drug Administration to undertake the filing and management of imported general cosmetics.

Article 7 (Information Disclosure) The drug supervision and administration department responsible for the registration and filing management shall take the initiative to disclose the relevant information on the registration and filing of cosmetics and new raw materials for the public to inquire.

Chapter II Basic Requirements

Article 8 (General Requirements) The registrants and filers of cosmetics and new raw materials shall abide by relevant laws, standards and technical specifications, and ensure that the submitted declaration or filing materials are true, accurate, complete and traceable.

Article 9 (Registrant Filing Person) A registrant or filing person refers to an enterprise or other organization that brings products to the market in its own name and can independently bear civil liability.

Registrants and filers assume the main responsibility for product quality and safety, perform product registration and filing obligations in accordance with the law, and claim responsibility for the quality, safety and efficacy of their products.

Article 10 (Requirements of the Registrant for Filing) The applicant for cosmetic registration and the Filing shall meet the following conditions:

The (I) has a quality management system suitable for the cosmetics to be registered and filed, and has established a quality and safety manager with professional knowledge related to cosmetics quality and safety and more than 5 years of cosmetics production or quality management experience;

The (II) has management systems such as supplier selection, raw material acceptance, production process and quality control, equipment management, product inspection and sample retention that are suitable for the cosmetics to be registered and filed;

The (III) has a cosmetic safety risk assessment, adverse reaction monitoring and evaluation, and a cosmetic recall system that is compatible with the cosmetics to be registered and filed.

Cosmetics registration applicants and filers shall be equipped with institutions and personnel suitable for the implementation of the above-mentioned systems, and have the ability to ensure the implementation of various systems and systems.

Article 11 (Obligations of Domestic Responsible Persons) If the applicant for registration or the record holder is an overseas enterprise, an enterprise legal person within the territory of China shall be designated as the domestic responsible person. The responsible person within the territory shall perform the following obligations:

(I) the registration and filing of cosmetics and new raw materials in the name of the registration applicant and the filing person, and put the products on the domestic market;

(II) assist registrants and filers in monitoring adverse reactions of cosmetics, product recalls and safety monitoring and reporting of new raw materials;

(III) cooperate with the supervision and inspection work of the regulatory authorities.

Article 12 (Requirements for First Registration and Filing) Before the first registration or filing, the registration applicant, the filing person, and the domestic responsible person shall submit relevant materials that meet the requirements of these Measures.

Article 13 (Expert Consultation Mechanism) Technical institutions such as drug supervision and administration departments and technical review departments responsible for registration and filing management shall establish a registration or filing expert consultation mechanism to listen to expert opinions on important issues in the process of technical review, supervision and inspection, and give full play to the technical support role of experts.

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

Section 1 Administration of Registration and Filing

Article 14 (Filing) The new raw material filer shall submit the materials for filing in accordance with the requirements of the new raw material registration filing materials specification, and complete the filing after submitting the materials.

Article 15 (Information Disclosure) The information management department shall, within 5 days from the date when the filing person submits the filing materials, disclose to the public the relevant information of the filing person, the domestic responsible person and the basic information of raw materials.

Article 16 (Registration Acceptance) The applicant for new raw material registration shall submit the application materials in accordance with the requirements of the new raw material registration filing materials specification. The acceptance department shall, within 5 days from the date of receiving the registration application submitted by the applicant, complete the formal examination of the application materials and make a decision on whether to accept or not:

If the (I) information is complete and meets the prescribed form requirements, it shall be accepted, a notice of acceptance shall be issued, and the application information shall be sent to the technical review department within 3 days;

If the (II) information is incomplete or does 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 applicant is not informed of the correction within the time limit, the application shall be accepted from the date of receipt of the application materials;

If the (III) does not fall within the scope of acceptance, a notice of inadmissibility shall be issued to inform the applicant of the specific reasons.

Article 17 (Technical Review) The technical review department shall, within 90 days from the date of receipt of the application materials, organize the technical review of the application materials in accordance with the main points of the technical review, and make a technical review conclusion:

If the (I) declaration information is true and complete, the quality and safety of raw materials meet the requirements, the production process is reasonable and feasible, and it meets the requirements of current laws, standards and technical specifications, it shall be reviewed and approved;

If the (II) application materials are not true, the raw materials have safety or quality controllability problems, or do not meet the requirements of current laws, standards and technical specifications, the review shall not be passed;

If there is a problem with the (III) declaration information, or if the declaration information is insufficient to prove the safety of the raw materials, the applicant is required to supplement the information.

Article 18 (Supplementary Information) If the applicant needs supplementary information, the technical review department shall inform all the contents that need to be supplemented at one time.

The applicant shall provide one-time supplementary information within 90 days as required, and the technical review department shall conduct a technical review and make a review conclusion within 60 days from the date of receipt of the supplementary information. If the information is not supplemented within the prescribed time limit, the technical review department shall terminate the review and make a technical review conclusion that the review is not passed.

Article 19 (Review Application) If the review fails to pass the technical review conclusion, the technical review department shall inform the applicant. If the applicant has any objection, it shall submit an application for review within 20 days from the date of receipt of the technical review conclusion. If the application for review is not submitted within the time limit, the technical review department shall maintain the original technical review conclusion.

The technical review department shall, within 30 days from the date of receipt of the review application, organize a study of the review application submitted by the applicant. If it is necessary to change the original technical review conclusion, it shall make a new technical review conclusion.

Article 20 (Administrative Examination and Approval) The SDA shall make a decision on administrative examination and approval within 20 days from the date of receiving the conclusion of the technical review.

Article 21 (Notice of Approval Results) The accepting department shall, within 10 days from the date of receipt of the approval decision, issue a new raw material registration certificate to the approved registration.

Article 22 (Registration Information Disclosure) The information management department shall, within 5 days from the date of issuance of the registration certificate, take the initiative to disclose the relevant information of the registrant, the domestic responsible person and the basic information of raw materials.

Article 23 (Registration Withdrawal) Before the technical review department makes a technical review conclusion, the applicant may apply for withdrawal of registration. If it is found in the process of technical review that false information is provided or there are safety problems in raw materials, it shall not be withdrawn.

Section 2 Safety Monitoring and Reporting

Article 24 (Monitoring System) The State implements a safety monitoring system for new raw materials that have been registered and put on record. The period of safety monitoring shall be 3 years from the date of registration or filing of cosmetics using new raw materials for the first time.

Article 25 (Use of New Raw Materials) The registrant and recordholder of new raw materials may use new raw materials to produce cosmetics.

With the consent of the new raw material registrant and the filing person, the cosmetic registrant and the filing person may use the new raw material to produce cosmetics. If other cosmetic registrants and filers intend to use new raw materials to produce cosmetics, they shall submit an application for registration of new raw materials or apply for filing of new raw materials in accordance with the requirements of these Measures.

Article 26 (Monitoring Responsibility) Registrants and filers of new raw materials shall establish a new post-marketing safety risk monitoring and evaluation system for new raw materials, and conduct continuous tracking, research, monitoring and evaluation of the safety of the use of new raw materials.

Cosmetics registrants and filers who use new raw materials to produce cosmetics shall monitor the safety of the use of new raw materials in real time, and timely feedback the use of new raw materials, adverse reactions and safety of related cosmetics to the registrants and filers of new raw materials.

Article 27 (Product Situation Report) In case of adverse reactions of cosmetics using new raw materials, the cosmetic registrant and the filing person shall timely report the adverse reactions in accordance with the relevant provisions of adverse reaction reporting; if there is evidence that cosmetics using new raw materials may have safety problems, the cosmetic registrant and the filing person shall immediately take measures to control the risks, and report to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the registered person, the filing person or the responsible person in the territory is located.

Article 28 (Disposal of Product Reports) After receiving reports of adverse reactions or safety risks, the drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the Central Government shall organize investigations in accordance with relevant regulations, and find that cosmetics using new raw materials have safety risks., Should take risk control measures and order cosmetics registrants and filers to suspend the use of new raw materials, cosmetics production or import.

Article 29 (Report on the situation of raw materials) If the following situations occur in new raw materials, the registrant and the filing person of the new raw materials shall carry out safety assessment. If the new raw materials are assessed to have safety risks, measures shall be taken immediately to control the risks and report to the technical review department:

Serious cosmetic adverse reactions, cosmetic adverse reactions that may cause greater social impact, or other safety problems occur in (I) cosmetics that use new raw materials;

(II) there is evidence that the new raw material may have safety problems;

(III) found in other countries (regions) suspected of serious cosmetic adverse reactions or group adverse reactions caused by the raw materials;

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

(V) other cases involving new raw materials and the safety of cosmetics using new raw materials.

Article 30 (Disposal of Safety Reports) After receiving the reports on the safety of new raw materials from registrants and filers of new raw materials, the technical review department shall organize an assessment of the safety of new raw materials and deal with them in the following situations:

If the (I) finds that it is necessary to carry out supplementary assessment, it shall order the new raw material registrant and the filing person to carry out supplementary assessment within a time limit;

If the (II) finds that there is a safety risk in the new raw material and needs further research, it shall require the registrant and the recordholder of the new raw material to carry out the research within a time limit, and report to the State Drug Administration to suspend the use of the new raw material;;

(III) there is evidence that there are safety problems with new raw materials, overdue supplementary information, failure to suspend the use of new raw materials as required, or failure to prove the safety of new raw materials after further research, it shall be reported to the State Drug Administration to cancel the record or cancel the registration.

Article 31 (Annual Report) New Raw Material Safety Monitoring Each full year, the new raw material registrant and the filing person shall, within 30 days, summarize and analyze the use and safety of new raw materials, form an annual report and submit it to the adverse reaction monitoring department and the technical review department.

Article 32 (Report Disposal) The adverse reaction monitoring department shall, in combination with the annual report, conduct statistical analysis on the adverse reaction reports of cosmetics using new raw materials.

The technical review department shall review the annual report in combination with the statistical analysis of the adverse reaction monitoring department:

If the (I) finds that the contents of the report are incomplete or irregular, and further additional explanations are required by the registrant or filer of the new raw material, it shall require the registrant or filer of the new raw material to supplement the relevant information or information within a time limit;

If the (II) discovers that there is a safety risk in the new raw material and needs further research, it shall require the registrant and the recordholder of the new raw material to carry out the research within a time limit, and report to the State Drug Administration to suspend the use of the new raw material;

(III) there is evidence that there are safety problems with new raw materials, overdue supplementary information, failure to suspend the use of new raw materials as required, or failure to prove the safety of new raw materials after further research, it shall be reported to the State Drug Administration to cancel the record or cancel the registration.

Article 33 (expiration of safety monitoring period) The State Drug Administration shall organize the evaluation of new raw materials that have been monitored for three years. New raw materials that have not found safety problems shall be included in the catalogue of used cosmetic raw materials, and other same new raw materials that are still under safety monitoring shall be terminated together; new raw materials with safety problems shall be canceled for filing or deregistration.

Article 34 (Related Products) Where the use of new raw materials in safety monitoring is ordered to be suspended, the production or import of cosmetics using new raw materials shall be suspended at the same time; where the filing or registration of new raw materials in safety monitoring is canceled, the filing and registration of cosmetics using new raw materials shall be canceled at the same time.

Article 35 (use of new raw materials beyond the scope) If the raw materials to be used in the production of cosmetics exceed the use purpose and safe use of the raw materials already used, the registration of new raw materials or the filing of new raw materials shall be applied for in accordance with the requirements of these Measures; If the safety difference is not involved, the safety monitoring period for new raw materials will no longer be set.

Chapter IV Administration of Registration and Filing of Cosmetics

Section 1 General Requirements

Article 36 (Requirements for the Use of Raw Materials) Cosmetic registrants and filers shall be responsible for the safety of the cosmetic raw materials used, and shall specify the source of the raw materials and their quality specifications when applying for registration or filing.

Article 37 (Segmented Production) Where the production of cosmetics is completed in segments at multiple addresses, the registrant and recordholder of cosmetics shall carry out quality management of the whole process and provide a complete production process when applying for registration or filing.

Article 38 (Requirements for Imported Cosmetics) Imported cosmetics that apply for registration or filing shall be sold on the market in the country (region) where the applicant is registered, the place where the filing person is registered, or the country (region) where the production place is located; imported cosmetics produced exclusively for my country, Information on relevant research and experiments conducted for Chinese consumers shall be submitted.

Article 39 (suit Products) Two or more doses of products that must be used together and non-separable combined packaging products shall be registered or filed as one product.

Article 40 (Confirmation of Entrustment) Where the production of cosmetics is entrusted, the cosmetic registration applicant and the filing person shall submit the documents of the entrustment relationship when applying for registration or filing.

Article 41 (Standards for Product Implementation) The registrant and recordation of cosmetics shall formulate standards for the product implementation of cosmetics to be registered and filed. The standards for the implementation of ordinary cosmetics shall be submitted to the drug supervision and administration department by the filing person when handling the filing, and the standards for the implementation of special cosmetics shall be reviewed by the drug supervision and administration department at the time of registration.

Article 42 (Registration and Filing Inspection) Cosmetic registration applicants and filers shall register and record inspection in accordance with the requirements of standards, technical specifications and registration and filing inspection regulations before applying for registration or filing.

The inspection institution undertaking the registration or filing inspection of cosmetics shall have the qualification ability for the registration and filing inspection of cosmetics, and disclose the relevant qualification information of the inspection institution to the public through the website of the State Drug Administration.

Article 43 (Efficacy Data) The efficacy claims of cosmetics shall have sufficient scientific basis. The scientific basis for cosmetic efficacy claims includes research data and evaluation conclusions obtained through human efficacy evaluation tests, laboratory tests, consumer use tests, and relevant scientific literature.

Cosmetic registrants and filers may apply for registration or filing only after obtaining the scientific basis for product efficacy claims. The guiding principles on which cosmetic efficacy claims are based shall be separately formulated and promulgated by the State Drug Administration.

When applying for registration or filing, the registrant and the filing person of cosmetics shall submit the summary of the basis of the efficacy claim in advance at the same time. After the cosmetics are registered or filed, the content of the summary shall be simultaneously disclosed to the public on the website designated by the State Drug Administration.

Article 44 (Merger and Separation) Cosmetics Registration Certificate and Filing Information Certificate shall not be transferred. If the main qualification of the original registered person or the filing person is destroyed due to the merger or division of the enterprise, and the registrant or the filing person is to be changed to a newly established enterprise or other organization, the registration change or filing change shall be applied for in accordance with the provisions of these Measures.

The registered person and the filing person after the change shall comply with the requirements of these Measures on the registered person and the filing person, and shall bear the responsibility for the quality and safety of the listed products.

Section 2 Filing Management

Article 45 (Filing) Before ordinary cosmetics are put on the market or imported, the filing person shall submit the materials for filing in accordance with the requirements of the cosmetic registration filing materials specification, and the filing shall be completed after the materials are submitted.

Article 46 (Information Disclosure) The drug supervision and administration department responsible for filing management shall, within 5 days from the date when the filing person submits the filing materials, disclose to the public the relevant information of the filing person, the domestic responsible person, the basic information of the product and the pictures of the product sales packaging (including labels and instructions).

Article 47 (Increase of consignees for imported products) If ordinary cosmetics imported for the record are 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 of the import port and the consignee shall be supplemented through the online filing platform.

The drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government where the consignee is located shall be responsible for organizing the post-filing supervision and administration of the cosmetics imported by the consignee.

Article 48 (Filing Change) Where the product name, formula, etc. of the filed product are to be changed, or the filing management department is changed due to the change of the address of the filing person or the domestic responsible person, the filing person shall take the initiative to cancel the original filing information and then re-file the filing.

If other matters of the filed products are to be changed, the filing changes shall be made. If the change involves the content of the product filing information disclosed to the public, the drug supervision and administration department responsible for the filing management shall disclose the relevant filing information after the product change to the public within 5 days from the date of receipt of the change information.

Article 49 (Annual Report) After the filing of ordinary cosmetics, the filing person shall report the production, import and adverse reaction monitoring of the products to the drug regulatory department that undertakes the filing management every year.

Article 50 (Product Filing and Cancellation) If a product that has been filed is no longer produced or imported, the filing person shall take the initiative to cancel the filing.

Section III Registration Management

Article 51 (Registration Acceptance) Before the production or import of special cosmetics, the registration applicant shall submit the declaration materials in accordance with the requirements of the cosmetics registration filing materials specification. The acceptance department shall complete the declaration materials within 5 days from the date of receipt of the declaration materials. The formal review of the data, and make a decision on whether to accept it:

If the (I) information is complete and meets the prescribed form requirements, it shall be accepted, a notice of acceptance shall be issued, and the application information shall be sent to the technical review department within 3 days;

If the (II) information is incomplete or does 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 applicant is not informed of the correction within the time limit, the application shall be accepted from the date of receipt of the application materials;

If the (III) does not fall within the scope of acceptance, a notice of inadmissibility shall be issued to inform the applicant of the specific reasons.

Article 52 (Technical Review) The technical review department shall, within 90 days from the date of receipt of the application materials, organize the technical review of the application materials in accordance with the main points of the technical review, and make a technical review conclusion:

If the (I) application materials are true and complete, the product quality and safety meet the requirements, the product formula and the standards implemented by the product are reasonable, and meet the requirements of current regulations, standards and technical specifications, the review shall be passed;

If the (II) declaration information is not true, the product has safety or quality problems, the product formula and the standards implemented by the product are unreasonable, or it does not meet the requirements of current regulations, standards and technical specifications, the review shall not be passed;

If there is a problem with the (III) declaration information, or the declaration information is insufficient to prove the safety of the product, the applicant is required to supplement the information.

Article 53 (Supplementary Information) If the applicant needs supplementary information, the technical review department shall inform all the contents that need to be supplemented at one time.

The applicant shall provide one-time supplementary information within 90 days as required, and the technical review department shall conduct a technical review and make a review conclusion within 60 days from the date of receipt of the supplementary information. If the information is not supplemented within the prescribed time limit, the technical review department shall terminate the review and make a technical review conclusion that the review is not passed.

Article 54 (Review Application) If the technical review conclusion is made that the review fails, the technical review department shall notify the applicant. If the applicant has any objection, he shall file an application for review within 20 days from the date of receipt of the notification. If the application for review is not submitted within the time limit, the technical review department shall maintain the original technical review conclusion.

The technical review department shall, within 30 days from the date of receipt of the review application, organize a study of the review application submitted by the applicant. If it is necessary to change the original technical review conclusion, it shall make a new technical review conclusion.

Article 55 (Administrative Examination and Approval) The SDA shall make a decision on administrative examination and approval within 20 days from the date of receiving the conclusion of technical examination and approval.

Article 56 (Notice of Examination and Approval Results) The accepting department shall, within 10 days from the date of receipt of the examination and approval decision, issue a registration certificate for cosmetics approved for registration, which shall be valid for 5 years.

Article 57 (Registration Information Disclosure) The information management department shall, within 5 days from the date of issuing the registration certificate, voluntarily disclose the relevant information of the registrant, the domestic responsible person and the basic information of the product.

Article 58 (Registration Withdrawal) Before the technical review department makes a technical review conclusion, the applicant may apply for withdrawal of registration. If it is found in the process of technical review to provide false information or product safety problems, it shall not be withdrawn.

Article 59 (Change of Registration Matters) Where the registration matters of registered special cosmetics are to be changed, the SDA shall implement classified management according to the degree of influence of the changed matters on product safety and efficacy:

(I) there is a change in matters not involving claims of safety or efficacy, the registrant shall promptly file with the SDA for the record.

(II) the matters involving safety and efficacy claims are to be changed, the registrant shall apply to the SDA for product registration change. The acceptance, technical review, administrative examination and approval, and information disclosure of registration change applications shall be implemented in accordance with the procedures and time limits stipulated in these Measures for the first registration of special cosmetics.

If the name and formula of the (III) product are to be changed, the registrant shall voluntarily cancel the original registration certificate and reapply for registration.

Article 60 (Uploading Sales Packaging) After the registration of special cosmetics or the sales packaging is to be changed, the registrant shall upload the product sales packaging (including labels, Instructions) pictures consistent with the label design sample through the online registration platform before the product is put on the market, and make it public to the public after confirmation by the drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government.

Article 61 (Cancellation of Registration Certificate) If a registered product is no longer produced or imported, the registrant shall voluntarily apply for cancellation of the registration certificate.

Section 4 Continuation of Registration Certificate

Article 62 (Continuation of self-examination and application) If the validity period of the registration certificate of special cosmetics needs to be renewed, the registrant shall carry out a comprehensive self-examination of the product six months before the expiration of the validity period of the registration certificate.

If it is confirmed by self-examination that it meets the requirements of mandatory national standards and technical specifications, the registrant shall submit an application for renewal of registration 30 days before the expiration of the product registration certificate. If an application for renewal of registration is not filed within the time limit, it shall no longer be accepted.

Article 63 (Acceptance and Certification) Where a registrant applies for renewal of registration within the prescribed time limit, the accepting department shall conduct a formal review of the application materials for renewal of registration within 5 days, accept the application materials that meet the requirements after review, and issue a new registration certificate within 10 days. The validity period of the registration certificate shall start from the expiration date of the original registration certificate.

Article 64 (Technical Review) The technical review department shall organize the post-event technical review of the application materials of the products that have been renewed. If it is found that it does not meet the mandatory national standards and technical specifications, the product registration certificate shall be revoked according to law.

Chapter V Supervision and Administration

Article 65 (Cooperation and Inspection) The drug regulatory department shall, in accordance with the provisions of laws and regulations, supervise and inspect the activities related to the registration and filing of cosmetics and new raw materials, and may, if necessary, conduct extended inspections of the units involved in the registration and filing materials. The relevant units and individuals shall cooperate and shall not refuse or conceal.

Article 66 (Due to Verification) If the technical review department finds that it is involved in submitting false information or concealing the actual situation during the registration technical review process, it may initiate on-site verification due to the reasons. Where domestic on-site verification is carried out, the department responsible for on-site verification shall complete the on-site verification within 45 days and feed back the results of the inspection; where overseas inspection is carried out, the verification department shall carry out the inspection according to the actual situation.

The registration applicant shall actively cooperate with the verification work, and if it is necessary to inspect and sample, it shall provide samples as required.

Article 67 (re evaluation) according to the level of scientific cognition, if the understanding of the safety of registered cosmetics and used cosmetic raw materials changes, or there is evidence that cosmetics and cosmetic raw materials may have defects, the drug supervision and administration department responsible for the registration and filing management may order the relevant raw material enterprises and cosmetics enterprises to carry out re evaluation, and the relevant enterprises may further submit safety information.

After re-assessment of the safety risk of cosmetics, cancel the record or cancel the registration; after re-assessment of the safety risk of raw materials, prohibit its use in cosmetics production or set restrictions on the use of conditions.

Article 68 (Supervision after filing) The drug supervision and administration department responsible for filing management shall organize and carry out post-filing supervision of new raw materials and ordinary cosmetics that have been filed. If it finds that the filing materials are incomplete and irregular but do not involve safety, it shall order the filing person to make corrections within a time limit; if it finds that the filing materials are insufficient to prove the safety of new raw materials or products, it shall order the filing person to make corrections within a time limit, at the same time, it shall be ordered to suspend the use of new raw materials, the production or import of cosmetics; if violations of laws and regulations are found, they shall be investigated and dealt with in accordance with the law; if the following circumstances are found, the filing shall be canceled:

The (I) fails to make corrections within the prescribed time limit as required, or fails to suspend the use of new raw materials or suspend the production or import of cosmetics as required;

(II) submitting false filing materials;

(III) new raw materials or cosmetics do not fall within the scope of filing;

The (IV) fails to carry out safety evaluation as required, or the safety evaluation does not meet the requirements of mandatory national standards and technical specifications;

(V) there is evidence that new raw materials or cosmetics have safety problems or illegal situations.

If the above circumstances exist in the filed products and the filing information has not been disclosed to the public, it shall be disclosed to the public after the filing person corrects and meets the requirements.

Article 69 (Handling of Abnormal Status of Registration and Filing) If the information filled in by the drug supervision and administration department responsible for registration and filing management through the registration and filing information platform cannot contact the registered person, the filing person, the domestic responsible person or the consignee of imported ordinary cosmetics, the online registration or filing system users of the registered person, the filing person or the domestic responsible person may be listed as abnormal status to restrict the use, and through the registration and filing information platform to notify the registrant, the filing person, and the domestic responsible person to actively contact the drug supervision and administration department at the specified time.

If the registrant, recordholder, or domestic responsible person of cosmetics fails to take the initiative to contact the drug supervision and administration department within the time limit, the drug supervision and administration department responsible for the registration and filing management shall cancel its registered and filed products.

Article 70 (Subject does not meet the requirements) If the registrant, recordholder or domestic responsible person of cosmetics no longer meets the requirements of Article 10 or Article 11 of these Measures, it shall take the initiative to cancel its registered and filed products.

If the domestic production enterprise no longer meets the relevant requirements of the cosmetics production enterprise, it shall take the initiative to cancel the relevant production information of its registered and filed products.

Article 71 (hierarchical management) the drug supervision and administration department shall carry out dynamic quantitative scoring on the basis of the quality management system of the filing person, the domestic responsible person, the cosmetics production enterprise, the filing product situation, the supervision after the filing, the supervision and inspection after the product is put on the market, etc., and implement targeted supervision measures according to the scoring situation.

Article 72 (Requirements for Institutional Personnel) Technical review, on-site verification, registration and filing inspection institutions and personnel shall strictly abide by the provisions of relevant laws, regulations and rules to carry out their work, abide by professional ethics, and ensure that the relevant work is scientific, objective and fair.

Article 73 (Confidentiality Requirements) The pharmaceutical supervisory and administrative departments, relevant technical institutions and their staff shall have the obligation to keep confidential the relevant information submitted by the registration applicant and the filing person.

Chapter VI Legal Liability

Article 74 (Unregistered Situation) Violation of the provisions of these Measures and failure to register or change the registration of cosmetics or new raw materials in accordance with the law shall be in accordance with Article 59 of the Regulations on the Supervision and Administration of Cosmetics. The situation shall be punished.

Article 75 (without filing) in violation of the provisions of these measures, failing to handle the filing or filing changes of cosmetics and new raw materials in accordance with the law, shall be punished in accordance with articles 60 and 61 of the regulations on the Supervision and Administration of Cosmetics.

Article 76 (Submission of False Information) Whoever provides false information or adopts other deceptive means when applying for registration of cosmetics or new raw materials shall be punished in accordance with the provisions of the first paragraph of Article 64 of the Regulations on the Supervision and Administration of Cosmetics.
Any person who provides false information or takes other deceptive means when handling the filing of cosmetics and new raw materials shall be punished in accordance with the provisions of paragraph 1 of Article 65 of the regulations on the Supervision and Administration of Cosmetics.

Article 77 (Inconsistent with the registration and filing materials) After the registration or filing is completed, the production and operation of cosmetics that are inconsistent with the product formula, product implementation standards and other technical related materials submitted at the time of registration and filing shall be handled in accordance with Article 60 of the "Regulations on the Supervision and Administration of Cosmetics" regarding the production and operation of cosmetics that do not meet the technical requirements specified in the registration and filing materials of cosmetics.

Article 78 (Forging or Alterating Registration Certificate) Anyone who forges, alters, leases, lends or transfers the registration certificate of cosmetics or new raw materials for cosmetics shall be punished in accordance with the provisions of the second paragraph of Article 64 of the Regulations on the Supervision and Administration of Cosmetics.

Article 79 (Forging or altering filing information) Those who forge or alter the filing information of cosmetics and new raw materials for cosmetics shall be punished in accordance with Articles 60 and 61 of the Regulations on the Supervision and Administration of Cosmetics.

Article 80 (New Raw Materials Failure to Fulfill Obligations) If the registrant or recordholder of the new raw materials fails to report the use and safety of the new raw materials in accordance with the requirements of these Measures or fails to provide relevant information truthfully, it shall be in accordance with the 63rd Regulations on the Supervision and Administration of Cosmetics Penalties are imposed.

Article 81 (failure to fulfill obligations when using new raw materials) if the registrant or recordholder of cosmetics fails to report the use and safety of cosmetics using new raw materials in accordance with the requirements 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, give a warning and impose a fine of not more than 30000 yuan.

Article 82 (subject qualification does not meet the requirements) if the registrant or filing person of cosmetics does not meet the requirements 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 and give a warning; if the circumstances are serious or refuse to make corrections, the registration and filing shall be canceled according to law.

Chapter VII Supplementary Provisions

Article 83 (Systematic Notification) The registration acceptance notice, notification of technical review opinions, issuance of registration certificates and filing information, registration review, submission of reports on the use of new raw materials, etc. involved in these Measures shall be carried out through the registration or filing information platform, and the time limit involved shall be subject to the operation time of the information platform.

Article 84 (Time Limit) The term "time limit" as mentioned in these Measures refers to the maximum time for each link of registration and filing, which is calculated in working days. The time used for on-site verification and supplementary information is not included in the review time limit.

Article 85 (Domestic and Imported) The last process of cosmetics contacting the contents is completed in China for domestic products, completed abroad for imported products, and completed in Taiwan, Hong Kong and Macao of China with reference to imported products management.

For a co-used product or a combined packaged product registered 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 as an imported product.

Article 86 (Registration and Filing Number) After cosmetics and new raw materials are registered or filed, they shall be numbered according to the following rules:

Rules for the filing and numbering of new (I) raw materials: the number of new raw materials filed in this year is the number of four-digit years for the original preparation of national makeup;

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

(III) ordinary cosmetics filing numbering rules:

Domestic products: provinces, autonomous regions and municipalities directly under the Central Government are referred to as G-makeup net preparation + four-digit number of years + number of products filed in the administrative region this year;

Imported products: Guozhuangwang's prepared words (abbreviated as the province, autonomous region and municipality directly under the central government where the responsible person is located) + four-digit number of years + the number of products filed nationwide this year;

Products from Taiwan, Hong Kong and Macao: prepared words of Guozhuang Network (abbreviated as the province, autonomous region and municipality directly under the Central Government where the responsible person is located) + four-digit number of years + number of products filed nationwide this year.

(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: The number of registered products in this year is four-digit year.

Article 87 (Soaps) These Measures shall apply to soaps that claim to have special cosmetic effects.

Article 88 (Time of Implementation) These Measures shall come into force as of January.