On January 12, 2021, the State Administration for Market Regulation issued the Management Measures for Cosmetics Registration and Filing (hereinafter referred to as the "Measures"), which will come into force on May 1, 2021. This is the first formal supporting regulations after the release of Cosmetics Supervision and Administration Regulations. It is the first departmental regulation specifically for the registration and filing management of cosmetics in China.
The Measures consist of six chapters and 63 articles, covering registration and filing management of cosmetics and new cosmetic ingredients, supervision and administration, legal liability, etc. There are great changes compared with the old regulations.
1. Cosmetics product management changes
1.1 Requirements for Registrants and Filers
Measures: cosmetics registration applicants and filers shall meet the following requirements:
(1) It is an enterprise or organization established according to Chinese regulations
(2) It shall have a quality management system suitable for the registration and filing application of cosmetics
(3) It shall have an ability to monitor and evaluate adverse reactions.
Old regulations: there is no concept of registrant and filer.
1.2 Obligations of responsible person
Measures: for overseas registrant or filer, a Chinese enterprise legal person shall be designated as the domestic responsible person. The responsible person shall perform the following obligations:
(1) Handling the registration and filing of cosmetics and new cosmetics raw materials in the name of the registrant and filer
(2) Assisting registrants and filers in the monitoring of adverse reactions to cosmetics and the safety monitoring and reporting of new cosmetics raw materials
(3) Assisting the registrants and the filers in the recall of cosmetics and new cosmetics raw materials
(4) In accordance with the agreement with the registrants and filers, taking corresponding responsibility for the quality and safety of the cosmetics and new cosmetic ingredients
(5) Cooperating with the official supervision and inspection work.
Old regulations: When foreign enterprises registered imported special use cosmetics and new cosmetic ingredients, they were required to designate a responsible person in China as an entity responsible for registration. The responsible person was only in charge of the matters related to administrative license. For the filing of the imported non-special use cosmetics, the foreign applicant shall designate a legal person in China as the responsible person. Who shall be responsible for the product filing, operation and the product quality and safety according to law.
1.3 Filing management
Measures: Before marketing or import of ordinary cosmetics, the filer shall submit the filing materials through the information service platform to fulfil the filing work. The filer 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 NMPA.
Old regulations: Before the import of non-special use cosmetics, it is required to file with the provincial MPA where the responsible person is located in China. The local MPA will conduct formal review of the application materials within 5 working days, and organize technical review within 3 months after the product filing. For domestic non-special use cosmetics, pre-market filing is required with the local MPA where the manufacturer or the entrusted manufacturer is located. The local MPA will complete the format review of online materials within 5 working days, and the provincial competent authorities shall organize and carry out the examination of the filed products within 3 months after the filing.
1.4 Management of registration change
Measures: If the registration info change for the registered special use cosmetics, NMPA shall implement classified management according to the impact of the changed info on the product safety and efficacy:
(1) When there is no change related to the product safety and efficacy claims, the registrant shall promptly file the info with NMPA
(2) In case of any change related to the safety, the production process or efficacy claim, the registrant shall apply to the NMPA for a change of product registration;
(3) When there is a change in the product name or formula, the registrant shall apply for a new registration.
Old regulations: all changes in the registered info shall be handled according to the procedure of registration change.
1.5 Raw material use requirements
Measures: Cosmetic registrants and filers shall choose the raw materials that meet the requirements of laws, administrative regulations, mandatory national standards and technical specifications for the cosmetics production and shall be responsible for the safety of the cosmetics raw materials used in cosmetics. When applying for the registration and filing, cosmetic registrants and filers shall clarify the source of raw materials and safety related information of raw materials through the information service platform.
Old regulations: if there are requirements for the quality specification of raw materials required by the Safety and Technical Standards for Cosmetics, the certificate of analysis issued by the raw material manufacturer is generally required. When the extracts of animal organ tissues and blood are used as raw materials in the product formula, the source, quality specifications and the approval certificate of the country of origin of the raw materials shall be reported. The safety information of raw material should also be provided if containing safety risk substances.
1.6 Implementation standards
Measures: The cosmetics registrant and filers shall clarify the product implementation standards, and submit to the competent authorities when applying for the registration or filing.
Old regulations: no such requirement. However, the documents such as product quality and safety control requirements, brief description and diagrams of production process, and technical requirements shall be provided.
1.7 Upload packaging of special cosmetics
Measures:After obtaining the registration certificate for special cosmetics, the registrant shall upload the pictures of product label to the information service platform for public search before the products are put on the market.
Old regulations: product packaging and label should be uploaded for the filing of imported non-special use cosmetics, and will be published on the filing service platform after obtaining the filing certificate. There is no such requirement for special use cosmetics.
1.8 Registration and filing number of Taiwan, Hong Kong and Macao products
Measures: independent registration and filing number shall be adopted for Taiwan, Hong Kong and Macao products. For ordinary cosmetics, the filing number starts with国妆网备制 (abbreviation of the province, autonomous region, municipality directly under the Central Government where the domestic responsible person is located) plus four digital of years and the annual sequence number of national record product. For special cosmetics, the registration number starts with 国妆特进字plus four digital of years and the annual sequence number of national registration product.
Old regulations: same format as other imported cosmetics for Taiwan, Hong Kong and Macao products.
2. Changes in management of new cosmetic raw materials
2.1 Obligations of domestic responsible persons
Refer to Section 1.2.
2.2 Filing management
Measures: The filing work is finished once the filers of new cosmetic ingredients submit the materials to the NMPA.
Old regulations: all new cosmetic raw materials are managed under the registration system.
2.3 Safety monitoring period system
Measures: the period of safety monitoring is 3 years since the date of obtaining registration or filing certificate of cosmetics using the new cosmetic ingredient for the first time. The registrants and filers of new cosmetic ingredients shall, within 30 working days prior to the end of each year during the safety monitoring period, collect and analyze the use and safety of new cosmetic ingredients, and submit an annual report to the NMPA. If the cosmetics registrant or filers use new cosmetic ingredients to produce cosmetics, this info shall be confirmed by the new cosmetic ingredient registrant and filer through the information service platform when applying for the cosmetics registration or filing. NMPA shall revoke the registration or record info of the new cosmetic ingredients with safety problems. If no safety issues occur after the monitoring period, NMPA will add them into IECIC list. If adjusting the use purpose and safe usage of cosmetic ingredients included in IECIC, new registration or filing work is required in terms of the requirements for the registration and filing of new cosmetic ingredients.
Old regulations: NMPA will release an announcement for the approval of new cosmetic ingredients. There is no safety monitoring period, all enterprises can use the new approval cosmetic ingredient for cosmetics production, but the purpose and amount of use should meet the declared technical requirements of the raw material.
2.4 Registration number
Measures: The registered or filed new cosmetic ingredients shall be numbered in accordance with the following rules.
(1) Filing number rules: 国妆原备字 + four digital of years + the annual sequence number of filed new cosmetic ingredients.
(2) Registration number rules: 国妆原注字 + four digital of years + the annual sequence number of registered new cosmetic ingredients.
Old regulations: NMPA issued the announcement for the approval of new cosmetic ingredients without setting approval number.
3. Other concerns
The Measures strengthen the post-market supervision and management, and increase the punishment of the violation of laws and regulations on the filed products. The supplementary provisions of Chapter VI clearly define the judgment basis of imported cosmetics and domestic cosmetics. The principle is to determine whether the last process of contacting with the content of cosmetics is completed in mainland China. Moreover, there are some new highlights in the Measures for attention:
1. Compared with the Management Measures for the Cosmetics Registration (Draft for Comments) issued on July 21, 2020, this Measures delete relevant contents such as efficacy evaluation, responsible person for quality and safety. Which are clearly stipulated in the Cosmetics Supervision and Administration Regulations. After the relevant supporting regulations and documents are in place, these work should be required as well.
2. The filing of ordinary cosmetics shall be completed after the filing materials are submitted through the information service platform according to the NMPA requirements. This means to cancel the format review of imported non-special use cosmetics under the old regulations. Despite official review process is simplified, the enterprises may face punishment or even cancel the filing once there is a problem after submitting the filing information of cosmetics products.
3. The competent authority shall implement risk classification and grading management according to the operation situation of quality management system of the registrant, the domestic responsible person and the cosmetics manufacturer, and the post-market supervision and inspection. To the enterprise grading in high risk, it is classified as a key supervision object.
4. According to the development of scientific research, in case the knowledge on the safety of cosmetics and cosmetic ingredients changes, or there is an evidence that the cosmetics or cosmetic raw materials have some drawbacks, the competent authority will request the registrants/filers or organize the cosmetics or raw material enterprises to re-carry out the safety assessment. If the reassessment results show that the safety of cosmetics and raw materials cannot be guaranteed, the original registration and filing info shall be canceled. The raw materials will be added to the list of banned substances for cosmetic production.
5. For the renewal of registration certificate of special cosmetics, the registrant should submit the application between 30 and 90 working days before the expiry date of the registration certificate.
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