Order of the State Administration for Market Regulation
No. 35
The Provisions for Registration and Filing of Cosmetics adopted at the 14th Executive Meeting of the State Administration for Market Regulation on December 31, 2020 is hereby promulgated and shall go into effect as of May 1, 2021.
Minister Zhang Gong
January 7, 2021
The Provisions for Registration and Filing of Cosmetics
(Announced by Order No. 35 of the State Administration for Market Regulation on January 7, 2021)
Chapter I General Provisions
Article 1 These Provisions are formulated for the purpose of regulating registration and filing of cosmetics, while ensuring the quality and safety of cosmetics in accordance with the Regulations on Supervision and Administration of Cosmetics.
Article 2 The registration and filing activities of cosmetics and new cosmetic ingredients and their supervision and administration within the territory of the People's Republic of China shall comply with these Provisions.
Article 3 The registration of cosmetics and new cosmetic ingredients refers to the activity that a registrant submits a registration application in accordance with legal procedures and requirements, and the drug regulatory department reviews the safety and quality control of the cosmetics and new cosmetic ingredients applied for registration and decides whether it agrees to the application.
The filing of cosmetics and new cosmetic ingredients refers to the activity that a filing person submits the dossier indicating the safety and quality control of the cosmetics and new cosmetic ingredients in accordance with legal procedures and requirements, and the drug regulatory department files the submitted dossier for reference.
Article 4 The State implements registration administration for special cosmetics and new cosmetic ingredients with high risks, and filing administration for general cosmetics and other new cosmetic ingredients.
Article 5 The National Medical Products Administration (NMPA) is responsible for the registration and filing administration of special cosmetics, imported general cosmetics and new cosmetic ingredients, and guiding and supervising the related cosmetic filing work undertaken by the drug regulatory departments of provinces, autonomous regions, and municipalities. The NMPA may entrust the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government that have corresponding capabilities to implement the filing administration of imported general cosmetics.
The cosmetic technical assessment agency of the NMPA (hereinafter referred to as the technical assessment agency) is responsible for the technical assessment of the registration of special cosmetics and new cosmetic ingredients, the technical verification of imported general cosmetics and the new cosmetic ingredients after filing, and the evaluation of the use and safety reports of new cosmetic ingredients.
The administrative affairs service agency of the NMPA (hereinafter referred to as service agency), the inspection agency, adverse reaction monitoring agency and information management agency shall be responsible for the registration acceptance, on-site inspections, adverse reaction monitoring, informatization and management respectively.
Article 6 The drug regulatory departments of provinces, autonomous regions and municipalities are responsible for the filing administration of domestic general cosmetics within their administrative areas, implementing the filing administration of imported general cosmetics in the name of the NMPA within the scope of entrustment, and assisting in the on-site inspection for registration of special cosmetics etc.
Article 7 The registrant and filing person of cosmetics and new cosmetic ingredients shall perform product registration and filing obligations in accordance with law and shall be responsible for the quality and safety of cosmetics and new cosmetic ingredients.
Registrants and filing persons of cosmetics and new cosmetic ingredients shall comply with the requirements of relevant laws, administrative regulations, mandatory national standards and technical specifications when applying for registration or filing for filing, and shall be responsible for the authenticity and scientificalness of the submitted dossiers.
Article 8 Overseas registrants and filing persons shall designate an enterprise legal person within the territory of China as the domestic responsible person. The domestic responsible person shall fulfill the following obligations:
(1) In the name of the registrants and filing persons, handling the registration and filing of cosmetics and new cosmetic ingredients;
(2) Assisting the registrants and filing persons in carrying out cosmetic adverse reaction monitoring, safety monitoring and reporting of new cosmetic ingredients;
(3) Assisting the registrants and filing persons in implementing the recall of cosmetics and new cosmetic ingredients;
(4) In accordance with the agreement with the registrants and filing persons, assuming corresponding quality and safety responsibilities for cosmetics and new cosmetic ingredients released in the domestic market; and
(5) Cooperating with the supervision and inspection of the drug regulatory department.
Article 9 The drug regulatory department under the State Council shall release the information on registration and filing of cosmetics and new cosmetic ingredients to the public for reference within 5 working days since the date when the registration is approved or the filing is filed.
Article 10 The NMPA shall strengthen informatization to provide convenient services for registrants and filing persons.
Registrants and filing persons of cosmetics and new cosmetic ingredients shall apply for registration and filing through the information service platform of registration and filing for cosmetics and new cosmetic ingredients (hereinafter referred to as the information service platform) in accordance with regulations.
The NMPA shall formulate the inventory of existing cosmetic ingredients, update it in a timely manner and make it public to facilitate enterprises for reference.
Article 11 The drug regulatory department may establish an expert consultation mechanism to listen to expert opinions on important issues in the process of technical evaluation, on-site inspection, supervision and inspection, and give play to the role of experts for technical support.
Chapter II The Registration and Filing Administration of New Cosmetic Ingredients
Section I Registration and Filing of New Cosmetic Ingredients
Article 12 Natural or artificial ingredients used in cosmetics for the first time in China are new cosmetic ingredients.
To adjust the purpose of use, safe dosage etc. of the existing cosmetic ingredients, registration application or filing shall be performed as required by the administration and filing of new cosmetic ingredients.
Article 13 To apply for registration of new cosmetic ingredients with functions such as preservative, sunscreen, colorant, hair dye, spot corrector and whitening, the application dossiers shall be submitted in accordance with the requirements of the NMPA. The service agency shall complete the format review of the application dossiers within 5 working days from the date of receipt, and deal with it separately according to the following circumstances:
(1) Where the application items do not require registration in accordance with law, a decision of non-acceptance shall be made and a notice of non-acceptance shall be issued;
(2) Where the application items do not fall within the scope of NMPA's terms of reference in accordance with law, a decision of non-acceptance shall be made, a notice of non-acceptance shall be issued, and the applicant shall be informed to apply to the relevant administrative organization;
(3) Where the application dossiers are incomplete or do not conform to the prescribed form, a notice of supplement shall be issued to notify the applicant of all the contents that need to be supplemented and corrected at one time. If no notice is made within the time limit, the application shall be deemed as accepted since the date of receipt; and
(4) Where the application dossiers are complete and meet the prescribed form as required, or the applicant submits all supplementary documents as required, the registration application shall be accepted and a notice of acceptance shall be issued.
The service agency shall transfer the application dossiers to the technical assessment agency within 3 working days from the date of accepting the registration application of new cosmetic ingredients.
Article 14 The technical assessment agency shall, within 90 working days from the date of receiving the application dossiers, organize the technical evaluation in accordance with the requirements of the technical evaluation, and deal with it separately according to the following circumstances:
(1) If the application dossiers are authentic, complete, and able to prove the safety and quality control of the ingredient, and meet the requirements of laws, administrative regulations, mandatory national standards and technical specifications, the technical assessment agency shall make an evaluation conclusion of approval;
(2) If the application dossiers are not authentic, and unable to prove the safety and quality control of the ingredient, and do not meet the requirements of laws, administrative regulations, mandatory national standards and technical specifications, the technical assessment agency shall make an evaluation conclusion of disapproval; and
(3) Where supplementary documents are required from the applicant, the applicant shall be notified once of all the contents to be supplemented; the applicant shall provide supplementary documents at one time as required within 90 working days, and the evaluation time limit shall be recalculated after the technical assessment agency receives the supplementary documents; if the supplementary documents are not submitted within the specified timeline, the technical assessment agency shall make an evaluation conclusion of disapproval.
Article 15 If the evaluation conclusion is disapproval, the technical assessment agency shall notify the applicant and explain the reasons. If disagreements exist, the applicant may apply for re-evaluation within 20 working days from the date of receiving the evaluation conclusion. The content of the re-evaluation is limited to the original application items and application dossiers.
The technical assessment agency shall make a re-evaluation conclusion within 30 working days from the date of receiving the re-evaluation application.
Article 16 The NMPA shall, within 20 working days from the date of receipt of the technical evaluation conclusions, review the legality, standardization and completeness of the technical evaluation procedures and conclusions, and whether to grant approval to the registration.
The service agency shall issue to the applicant the registration license of the new cosmetic ingredient or a decision letter of disapproval of the registration within 10 working days from the date when the NMPA makes the administrative examination and approval decision.
Article 17 Before the technical assessment agency makes a technical evaluation conclusion, the applicant may withdraw the registration application. In the process of technical evaluation, if it is suspected that false documents have been provided or the new cosmetic ingredient has any safety issue, the technical assessment agency shall handle it in accordance with law, and the applicant shall not withdraw the application for registration.
Article 18 The filing of new cosmetic ingredient is completed when the filing person submits the dossiers as required.
Section II Safety Monitoring and Reporting
Article 19 New cosmetic ingredients that have been registered or filed shall follow a safety monitoring system. The period of safety monitoring is 3 years, starting from the date when cosmetics using new cosmetic ingredients for the first time are registered or filed.
Article 20 During the safety monitoring period, registrants and filing persons of new cosmetic ingredients may use the new cosmetic ingredient to produce cosmetics.
If cosmetic registrants and filing persons use new cosmetic ingredients to produce cosmetics, the relevant cosmetic registration application and filing shall be associated and confirmed by the registrant or filing person of the new cosmetic ingredient through the information service platform.
Article 21 Registrants and filing persons of new cosmetic ingredients shall establish a safety risk monitoring and evaluation system after the launch of new cosmetic ingredients, conduct follow-up research on the safety of new cosmetic ingredients, and continue to monitor and evaluate the use and safety of new cosmetic ingredients.
Registrants and filing persons of new cosmetic ingredients shall, within 30 working days before a year period of safety monitoring of new cosmetic ingredients, prepare an annual report summarizing and analyzing the use and safety conditions of new ingredients, and submit it to the NMPA.
Article 22 If the following situations are found, the registrants and filing persons of new cosmetic ingredients shall immediately conduct research and report to the technical assessment agency:
(1) Where serious cosmetic adverse reactions or group adverse reaction incidents suspected to be caused by using similar ingredients are found in other countries (regions);
(2) Where the laws, regulations and standards for cosmetics of other countries (regions) raise the ingredient standards, increase the restriction condition or prohibit the use of similar ingredients; and
(3) Other circumstances related to the safety of new cosmetic ingredients.
If there is evidence showing that the new cosmetic ingredient has any safety issues, the registrant and filing person of the new cosmetic ingredients shall immediately take measures to control the risks and report to the technical assessment agency.
Article 23 The registrant and filing person of cosmetics who use new cosmetic ingredients to produce cosmetics shall give prompt feedback on the use and safety of the new cosmetic ingredients to the registrant and filing person of new cosmetic ingredients.
If there is any cosmetic adverse reaction or safety issue that may relate to new cosmetic ingredients, the cosmetic registrant and filing person shall immediately take measures to control risks, notify the registrant and filing person of the new cosmetic ingredient, and report to the drug regulatory department of province, autonomous region, or municipality where it is located as prescribed.
Article 24 After receiving reports of adverse reactions or safety issues of cosmetics using new cosmetic ingredients, the drug regulatory departments of provinces, autonomous regions, and municipalities shall carry out research, judgment and analysis, and if the new cosmetic ingredients may have safety risks that cause body injury or health hazard, measures shall be taken to control the risks in accordance with relevant provisions, and the technical assessment agency shall be immediately informed.
Article 25 The technical assessment agency shall, after receiving the feedback or report from the drug regulatory department of the province, autonomous region, or municipality, or the registrant and filing person of new cosmetic ingredients, assess the situation in accordance with the annual statistical analysis results of cosmetic adverse reactions from the adverse reaction monitoring agency. When believing that the safety risks can be eliminated by adjusting technical requirements of the new cosmetic ingredients, the technical assessment agency may propose opinions of adjustment and report to the NMPA; when believing that there are safety issues, the technical assessment agency shall report to the NMPA and request to revoke the registration or nullify the filing. The NMPA shall make decisions in a timely manner.
Article 26 After three-year safety monitoring period for new cosmetic ingredients, the technical assessment agency shall submit an opinion on whether the new cosmetic ingredients meet the safety requirements to the NMPA.
For new cosmetic ingredients with safety issues, the NMPA shall revoke the registration or nullify the filing; if no safety issues are found, the NMPA shall include them into the inventory of existing cosmetic ingredients.
Article 27 During the safety monitoring period, if a new cosmetic ingredient is ordered to suspend the use, the cosmetic registrant and filing person shall also suspend the production and operation of cosmetics using the new cosmetic ingredient at the same time.
Chapter III Cosmetic Registration and Filing Administration
Section I General Requirements
Article 28 The applicants for cosmetics registration and filing persons shall meet the following requirements:
(1) They shall be enterprises or organizations that are established according to law;
(2) They shall have a quality management system that corresponds with the cosmetics for which registration or filing is done; and
(3) They shall have the abilities to monitor and evaluate adverse reactions.
To apply for registration of special cosmetics for the first time or filing of general cosmetics for the first time, the applicant for registration or the filing person shall submit the document that meets the requirements as set forth before.
Article 29 The cosmetic registrant and filing person shall carry out cosmetic research and development, safety assessment, testing of registration and filing, etc. in accordance with laws, administrative regulations, mandatory national standards, technical specifications, and provisions for registration and filing administration etc., and submit registration and filing documents in accordance with the instructions for cosmetic registration and filing dossiers.
Article 30 Cosmetic registrants and filing persons shall select ingredients that meet the requirements of laws, administrative regulations, mandatory national standards and technical specifications for cosmetic production, and shall be responsible for the safety of cosmetic ingredients they use. When applying for registration and filing for filing, the cosmetic registrant and filing person shall clarify the source of ingredients and relevant information on ingredient safety through the information service platform.
Article 31 If cosmetic registrants and filing persons entrust cosmetic manufacturing, for domestic cosmetics, the entrustment shall be associated and confirmed by the cosmetic manufacturers through the information service platform when applying for registration or filing; for imported cosmetics, relevant documents demonstrating the entrustment shall be submitted by the cosmetic registrants or filing persons.
Article 32 Cosmetic registrants and filing persons shall clarify the product standards that are implemented, and submit it to the drug regulatory department when applying for registration or filing for filing.
Article 33 Cosmetic registrants and filing persons shall entrust a testing agency that has obtained qualification certifications and meets the needs for testing on cosmetic registration and filing to conduct testing according to mandatory national standards, technical specifications and testing requirements of registration and filing.
Section II Filing Administration
Article 34 Before a general cosmetic is marketed or imported, the filing person shall complete the filing by submitting the filing dossiers through the information service platform as required by the NMPA.
Article 35 If the general cosmetics that have been filed are to be imported at a port outside the administrative area of the province, autonomous region, or municipality where the domestic responsible person is located, the import port and the information on the contact person for handling customs clearance procedures shall be supplemented and filled on the information service platform.
Article 36 For general cosmetics that have been filed, the name of the product may not be changed at will without proper reasons; and the efficacy claim shall not be changed at will without sufficient scientific basis.
General cosmetics that have been filed are not allowed to change the product formula at will, except for minor changes in the product formula due to changes in the source of ingredients and other reasons.
If the address of the filing person or the domestic responsible person changes which causes the filing administration department changes, the filing person shall re-file.
Article 37 The filing person of general cosmetics shall report the production and import status, as well as the compliance with laws and regulations, compulsory national standards, and technical specifications to the drug regulatory department responsible for filing administration on a yearly basis.
If the products that have been filed are no longer produced or imported, the filing person shall promptly report to the drug regulatory department responsible for the filing administration for cancelling the filing.
Section III Registration Administration
Article 38 Before a special cosmetic is produced or imported, the registrant shall submit the application dossiers as required by the NMPA.
If the procedures and time limit for the registration of special cosmetics are not stipulated, the regulations on registration of new cosmetic ingredients in these Provisions shall be applied.
Article 39 The technical assessment agency shall, within 90 working days from the date of receiving the application dossiers, organize the technical evaluation in accordance with the requirements of technical evaluation, and deal with it respectively according to the following circumstances:
(1) If the application dossiers are true, complete, and able to prove that the product safety and quality control, product formula and product executive standards are reasonable, and meet the requirements of current laws, administrative regulations, mandatory national standards and technical specifications, a technical assessment conclusion of pass shall be made;
(2) If the application dossiers are untrue and unable to prove the product safety and quality control, product formula and product executive standards are reasonable, or do not meet the requirements of current laws, administrative regulations, mandatory national standards and technical specifications, a technical assessment conclusion of not pass shall be made; and
(3) If supplementary documents are required, the registrant shall be notified of all the content to be supplemented once; the registrant shall provide supplementary documents at one time as required within 90 working days, and the evaluation time limit shall be recalculated after the technical assessment agency receives the supplementary documents; if the supplementary documents are not submitted within the specified timeline, the technical assessment agency shall make a technical assessment conclusion of not pass.
Article 40 The NMPA shall, within 20 working days from the date of receiving the technical evaluation conclusions, review the legality, standardization and completeness of the technical evaluation procedures and conclusions, and decide whether to approve registration.
The service agency shall issue the cosmetic registration license or the decision letter of non-registration to the registrant within 10 working days from the date when the NMPA makes the administrative decision. The registration license for cosmetics is valid for 5 years.
Article 41 If the registration items of the registered special cosmetics are changed, the NMPA shall implement classified management according to the degree of influence of the changed items on product safety and efficacy:
(1) If there are changes in matters that do not involve safety or efficacy claims, the registrant shall promptly report to the NMPA for filing;
(2) If there are changes in safety-related matters, as well as substantial changes in the production process, efficacy claims, etc., the registrant shall submit an application for change for the registered product to the NMPA; and
(3) If the product name, formula, etc. changes, which constitutes a new product in essence, the registrant shall re-apply for registration.
Article 42 If the registered product is no longer produced or imported, the registrant shall take the initiative to apply for cancellation of the registration license.
Section IV Renewal of Registration License
Article 43 If the registration license of a special cosmetic expires and requires a renewal, the registrant shall apply for the renewal of the registration within 30 to 90 working days before the expiration of the product registration license, and promise to comply with the requirements of mandatory national standards and technical specifications. The registrant shall be responsible for the authenticity and legality of the submitted documents and promises made.
If the application for renewal of registration is not submitted within the time limit, its application for renewal of registration will no longer be accepted.
Article 44 The service agency shall conduct a formal review of the application dossiers within 5 working days after receiving the application for renewal, accept the application if it meets the requirements, and issue a new registration license to the applicant within 10 working days from the date of acceptance. The validity period of the registration license shall be recalculated from the day after the expiration date of the original registration license.
Article 45 The drug regulatory department shall supervise the activities related to the application dossiers and promises of the special cosmetics that have been renewed for registration. If the supervision and inspection or technical evaluation reveals that there is a circumstance that does not meet the mandatory national standards or technical specifications, the cosmetic registration license of special cosmetics shall be revoked according to law.
Chapter IV Supervision and Administration
Article 46 The drug regulatory department shall supervise and inspect the activities of registration and filing conducted by the registrant and the filing person in accordance with the provisions of laws and regulations, and may conduct extended inspections of the entities involved when necessary. The relevant entities and individuals shall cooperate, and shall not refuse the inspection or conceal relevant information.
Article 47 During the process of registration technical evaluation, the technical assessment agency may notify the inspection agency to carry out on-site inspection as needed. Domestic on-site inspections should be completed within 45 working days, and overseas on-site inspections should be implemented in accordance with relevant provisions on overseas inspections. The time for on-site inspection is not included in the time limit of technical evaluation.
Registrants shall cooperate with the on-site inspection, and provide samples as required when sampling and testing is required.
Article 48 After obtaining the registration license of special cosmetics, the registrant shall upload the picture of the marketed product label to the information service platform for public inquiry before the products are put on the market.
Article 49 The transfer of cosmetic registration license is prohibited. The change application of registration shall be followed in accordance with these Provisions, if the registrant is changed to a new company or another organization due to company merger or split causing the cancellation of the original registrant as an entity.
The altered registrant shall comply with requirements of a registrant in these Provisions and shall be responsible for the quality and safety of the products already on the market.
Article 50 Where progress in scientific research changes the understanding of the safety of cosmetics and cosmetic ingredients, or there is evidence to show that certain cosmetics and cosmetic ingredients may be defective, the drug regulatory departments undertaking registration and filing may order the registrants and filing persons of cosmetics and new cosmetic ingredients to carry out safety re-evaluation or may directly organize relevant ingredients and cosmetics enterprises to conduct a safety re-evaluation.
Where the re-evaluation results show that the safety of cosmetics and cosmetic ingredients cannot be ensured, the original registration department shall withdraw the registration, the filing department shall cancel the filing, and the drug regulatory department under the State Council shall include such cosmetic ingredients in the list of ingredients banned for use in the production of cosmetics, and make it known to the public.
Article 51 Where progress in scientific research, risks monitoring on cosmetics safety and evaluation shows that there are safety risks in certain cosmetic ingredients, and such risks could be eliminated by setting the use scope and conditions of ingredients, such use restrictions and conditions of ingredients should be clarified in the inventory of existing cosmetic ingredients.
Article 52 If the drug regulatory department responsible for registration and filing administration is unable to contact the registrant, the filing person, or the domestic responsible person through the registration and filing information, it may list the registrant, filing person, and domestic responsible person on the information service platform as key targets for supervision and make an announcement on the platform.
Article 53 The drug regulatory department shall implement risk classification management based on the operation of quality control system, post-filing supervision, and post-marketing supervision and inspection status of the filing persons, the domestic responsible person and the cosmetic manufacturer.
Article 54 The drug regulatory departments, technical evaluation, on-site inspection and testing agencies and their staff shall strictly abide by the laws, regulations, rules and the relevant provisions of the NMPA to ensure that relevant work is scientific, objective and impartial.
Article 55 Without the consent of the registrant and the filing person, the drug regulatory departments, professional technical institutions and their staff, and those who involved in the evaluation shall not disclose the business secrets, undisclosed information or confidential business information submitted by the registrant or filing person, except as otherwise provided by law or involving national security or major public interests.
Chapter V Legal Liability
Article 56 If the registrant of cosmetics and new cosmetic ingredients fails to apply for the change of registration for special cosmetics and new cosmetic ingredients in accordance with the requirements of these Provisions, the drug regulatory department that originally issued the license shall give an order for rectification, give a disciplinary warning, and impose a fine of not less than 10,000 yuan but no more than 30,000 yuan.
If the filing person of cosmetics and new cosmetics ingredients fails to update the filing information of general cosmetics and new cosmetics ingredients in accordance with the requirements of these Provisions, the drug regulatory department responsible for the filing administration shall order corrections, give warnings, and impose a fine of no less than 5,000 yuan but no more than 30,000 yuan.
If the registrant of cosmetics and new cosmetic ingredients fails to re-register in accordance with requirements of these Provisions, it shall be punished in accordance with Article 59 of the Regulations on Supervision and Administration of Cosmetics; if the filing person of cosmetics or new cosmetic ingredients fails to re-file the filing in accordance with requirements of these Provisions, fines shall be imposed as in the first paragraph of Article 61 of the Regulations on Supervision and Administration of Cosmetics.
Article 57 If the registrant or filing person of new cosmetic ingredients violates the requirements of Article 21 of these Provisions, the drug regulatory department of the province, autonomous region, or municipality directly under the central government shall give an order for rectification; the person that refuses to do so shall be fined not less than 5,000 yuan but no more than 30,000 yuan.
Article 58 If the filing drug regulatory department finds that the dossiers of filed cosmetics or new cosmetic ingredients do not meet the requirements, the filing management department shall order that correction be made within a specified timeline; where the data filed that relate to the safety of cosmetics and new cosmetic ingredients do not meet the requirements, the filing management department may at the same time order suspension of their sales and use.
For cosmetics and new cosmetic ingredients that have been filed but the filing dossiers has not yet been released to the public, if the filing drug regulatory department finds that the filing dossiers do not meet the requirements, they may order the filing person to make corrections and release the information to the public when the requirements are met.
Article 59 If the filing person is involved in the following circumstances, the filing drug regulatory department shall cancel the filing of cosmetics and new cosmetic ingredients:
(1) Providing fake filing documents;
(2) The filing dossiers submitted do not meet the requirements, fail to make corrections within the specified timeline or suspend the sale and use of cosmetics or new cosmetic ingredients as required; and
(3) Those that do not fall into the filing scope of new cosmetic ingredients or cosmetics.
Chapter VI Supplementary Provisions
Article 60 The time limit involved in the filing of registration acceptance, filing of technical evaluation opinions, issuance of registration license and release of filing information, registration re-review, and submission of new cosmetic ingredients usage reports shall be subject to the time of submission or issuance on the information service platform.
Article 61 Cosmetics of which the last process touching the contents completes in China are domestic products, and those that completes overseas are imported products. Those that completes in Taiwan, Hong Kong SAR and Macau SAR shall be regulated by the reference of imported products.
For products used in conjunction or combination products that apply for registration or file for filing under one product name, if any of the last process touching the contents are produced overseas, the set shall be regulated as imported products.
Article 62 The numbering format of cosmetics and new cosmetic ingredients after registration or filing shall comply with the following rules:
(1) The numbering rule for the filing of new cosmetics ingredients: 国妆原备字 + year (four digits) + serial number of new cosmetic ingredients filed this year.
(2) The numbering rules for the registration of new cosmetic ingredients: 国妆原注字 + year (four digits) + serial number of new cosmetic ingredients registered this year.
(3) The numbering rules for the filing of general cosmetics:
Domestic products: the abbreviation of provinces, autonomous regions, and municipalities + G妆网备字 + year (four digits) + serial number of products filed in the administrative area this year;
Imported products: 国妆网备进字 (the abbreviation of the province, autonomous region or municipality directly under the Central Government where the domestic responsible person is located) + year (four digits) + serial number of products filed nationwide this year;
Products from Taiwan, Hong Kong SAR and Macau SAR: 国妆网备制字 (the abbreviation of province, autonomous region or municipality directly under the central government where the domestic responsible person is located) + year (four digits) + serial number of products filed nationwide this year.
The numbering rules for the registration licenses of special cosmetics;
Domestic products: 国妆特字 + year (four digits) + serial number of products registered this year;
Imported products: 国妆特进字 + year (four digits) + serial number of products registered this year;
Products from Taiwan of, Hong Kong SAR and Macau SAR: 国妆特制字 + year (four digits) + serial number of products registered this year.
Article 63 These Provisions shall go into effect as of May 1, 2021.
Note: In case of any difference in interpretation between the English version and the Chinese version, the Chinese version shall prevail.
