Explanation of transitional period of cosmetics registration and filing
Recently, in order to implement the Measures for the Administration of Cosmetic Registration and Filing, and standardize and guide the work of cosmetic registration and filing, the State Food and Drug Administration has formulated the Regulations on the Administration of Cosmetic Registration and Filing Data, which is now published and will be implemented as of May 1, 2021. As the first supporting regulation of the New Regulations, the implementation of the Regulations on the Management of Cosmetic Registration and Filing Data will further provide detailed guidance for practical operation.
01 about the products registered and filed by the original registration and filing platform
In order to facilitate enterprises to make preparations for cosmetics registration and filing in advance, since April 1, 2021, domestic cosmetics registrants, filers, domestic responsible persons and cosmetics production enterprises can pass the national integrated online government service platform, the State Food and Drug Administration. Online service hall (https://zwfw.nmpa.gov.cn), according to the data requirements, submit relevant information on the cosmetics registration and filing information service platform (referred to as the new registration and filing platform), and handle the registration and filing of user accounts; From May 1, 2021, cosmetics registrants, filers and domestic responsible persons should apply for special cosmetics registration or ordinary cosmetics filing through the new registration and filing platform. The original cosmetics administrative license and filing information management system (hereinafter referred to as the original registration platform) will no longer receive special cosmetics registration applications or ordinary cosmetics filing. Applications for registration of special cosmetics that have been submitted and accepted on the original registration platform but have not yet made an approval decision will continue to be reviewed and approved on the original registration platform.
Since May 1, 2021, when applying for registration or filing, the registrant shall fill in the source and trade name information of the raw materials of the product formula, which involves the raw materials with quality specification requirements in the Technical Specifications for Cosmetics Safety, and shall also submit the quality specification certificate or safety-related information of the raw materials.
Since January 1, 2022, when applying for registration or filing, the registrant shall provide safety-related information of raw materials with anti-corrosion, sun protection, coloring, hair dyeing, freckle and whitening functions in accordance with the requirements of the Regulations.
In order to ensure the safety of cosmetics use and the legitimate rights and interests of consumers, the registrant and the filer should submit the product implementation standards and product label samples, fill in the product formula of domestic ordinary cosmetics and upload the label pictures of special cosmetics sales packages through the new registration platform before May 1, 2022.
Since January 1, 2023, when applying for registration or filing, the registrant shall provide safety-related information of all raw materials in accordance with the requirements of the Regulations. For cosmetics that have been registered or filed before, the registrant and the filer shall supplement the safety-related information of all raw materials in the product formula before May 1, 2023.
02 Pay attention to these when applying for special cosmetics registration for the first time or filing ordinary cosmetics
The Regulations on the Management of Cosmetic Registration and Filing Materials is divided into six chapters and sixty articles, namely, "General Provisions", "Requirements for Information Related to User Information", "Requirements for Registration and Filing Materials", "Requirements for Changes", "Requirements for Extension and Cancellation" and "Supplementary Provisions".
The management regulations propose that when applying for special cosmetics registration or filing ordinary cosmetics for the first time, domestic registration applicants, filers and domestic responsible persons should submit the following user information related materials:
(1) registrant filer information form and quality and safety person resume;
(2) an overview of the quality management system of the registrant;
(3) An overview of the monitoring and evaluation system for adverse reactions of registrants and filers;
(4) Overseas registrants and filers shall submit information forms of domestic responsible persons
(five) the original power of attorney of the responsible person in China and the original notarial certificate;
(6) If the registrant or filer produces by himself or entrusts an overseas production enterprise to produce, it shall submit the information form of the production enterprise and the information of the person in charge of quality and safety, and fill in the existing production enterprise and its information at one time. If the production enterprise is overseas, it shall submit the original certification materials of overseas production standards.
At the same time, the product inspection report of registered or filed products shall be issued by the cosmetics registration and filing inspection agency, which shall comply with the provisions of relevant laws and regulations such as Technical Specifications for Cosmetic Safety, Specifications for Cosmetic Registration and Filing Inspection and so on.
It is worth noting that cosmetics claiming new efficacy are tested in accordance with the Code for Inspection of Cosmetic Registration and Filing and related technical regulations.
If the manufacturer of ordinary cosmetics has obtained the relevant qualification certification of production quality management system issued by the competent government department of the country (region) where it is located, and the product safety risk assessment results can fully confirm the product safety, it may be exempted from submitting the toxicological test report of the product, except under the following circumstances:
1. The product claims to be used by infants and children;
2. The product uses new cosmetics raw materials that are still under safety monitoring;
3. According to the results of quantitative grading, the filing person, domestic responsible person and production enterprise are listed as key supervision objects.
03 special cosmetics efficacy test report submitted
Since January 1, 2022, when applying for the registration of freckle-removing, whitening and anti-hair loss cosmetics, the applicant for registration shall submit the human efficacy test report that meets the requirements according to the regulations.
For cosmetics that have applied for and obtained registration before May 1, 2021, the registrant shall supplement and submit the human efficacy test report before May 1, 2023.
For cosmetics with freckle removing, whitening and hair loss prevention that have applied for registration from May 1 to December 31, 2021, the registrant shall supplement and submit the human efficacy test report that meets the requirements before May 1, 2022.
04 Annual Report Management of General Cosmetics
Since January 1, 2022, the annual reporting system has been implemented uniformly for ordinary cosmetics filed through the original registration and filing platform and the new registration and filing platform. The filing person shall submit the annual report of ordinary cosmetics for one year through the newly registered filing platform from January 1 to March 31 every year.
As the first supporting regulation of the New Regulations, the Administrative Measures for Cosmetics Registration and Filing further refines the management rules of cosmetics and their raw materials, which is a new pioneering work in cosmetics supervision. With the implementation of "Regulations on the Registration and Filing of New Cosmetic Raw Materials" and "Regulations on the Registration and Filing of Cosmetics", it will further provide guidance for the practical operation process and further standardize the cosmetics market. This will promote the positive guidance of industry competition, improve industrial development, and promote a win-win situation for enterprises and consumers.