Description of the transition period for the registration and filing of cosmetics

Release time:

2021-03-12 17:52

Recently, in order to implement the Measures for the Administration of Cosmetics Registration and Filing, and to standardize and guide the registration and filing of cosmetics, the State Food and Drug Administration has formulated the Provisions on the Administration of Cosmetics Registration and Filing Materials, which are hereby promulgated, and the regulations will be implemented from May 1, 2021. As the first supporting regulation of the "New Regulations", the implementation of the "Regulations on the Management of Cosmetics Registration and Filing Materials" will further provide detailed guidance for practical operations.

01 About the products registered and filed by the original registration and filing platform

In order to facilitate enterprises to prepare for the registration and filing of cosmetics in advance, starting from April 1, 2021, domestic cosmetics registrants, registrants, domestic responsible persons and cosmetics production enterprises can submit relevant information on the cosmetics registration and filing information service platform (hereinafter referred to as the new registration and filing platform) according to the information requirements through the online service hall (https://zwfw.nmpa.gov.cn) of the national integrated online government service platform of the State Food and Drug Administration, and handle the registration and filing user account number; from May 1, 2021, cosmetics registrants, filers, and domestic responsible persons shall apply for special cosmetics registration or general cosmetics filing through the new registration filing platform. The original cosmetics administrative licensing and filing information management system (hereinafter referred to as the original registration and filing platform) no longer receives special cosmetics registration applications or general cosmetics filing. Special cosmetics registration applications that have been submitted and accepted on the original registration and filing platform before, but have not yet made approval decisions, continue to be reviewed and approved on the original registration and filing platform.

Starting from 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 specifications required in the Cosmetic Safety Technical Specification, and shall also submit the quality specification certificate or safety-related information of the raw materials.
Starting from January 1, 2022, when applying for registration or filing, the registrant shall, in accordance with the requirements of the regulations, provide safety-related information on raw materials with anti-corrosion, sun protection, coloring, hair dyeing, freckle removal and whitening functions.

In order to ensure the safety of cosmetics use and the legitimate rights and interests of consumers, for cosmetics that have been registered or filed on the original registration and filing platform, the registrant and filing person shall submit the standard and sample product label of the product implementation, fill in the product formula of domestic common cosmetics, and upload the label picture of special cosmetics sales packaging before May 1, 2022 through the new registration and filing platform.
From January 1, 2023, when applying for registration or filing, the registrant shall provide safety-related information on all raw materials in accordance with the requirements of the Provisions. For cosmetics that have been registered or filed before, the registrant and the filing person shall provide additional safety-related information on all raw materials in the product formula before May 1, 2023.

02 for the first time to apply for special cosmetics registration or ordinary cosmetics for the record need to pay attention to these

The "Regulations on the Administration of Cosmetics Registration and Filing Materials" are divided into "General Provisions", "Requirements for User Information Related Materials", "Requirements for Registration and Filing Materials", "Requirements for Changes", "Requirements for Continuation, Cancellation and Other Matters" and "Supplementary Provisions" with six chapters and 60 articles.

The administrative regulation proposes that when applying for the registration of special cosmetics or filing for ordinary cosmetics for the first time, the domestic registration applicant, filing person and domestic responsible person shall submit the following user information related materials: (1) the information form of the registrant filing person and the resume of the person in charge of quality and safety;

Overview of the quality management system of the (II) registrant;

(III) registrant filer adverse reaction monitoring and evaluation system overview;

(IV) overseas registrants and filers shall submit the information form of the domestic responsible person.

The original power of attorney and the original notarial certificate of the responsible person within the territory of the (V);

If the (VI) registrant or filer has produced on its own 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 certificate of overseas production specifications.

At the same time, the product inspection report of the registered or filed product, issued by the cosmetics registration and filing inspection agency, shall comply with the "Cosmetic Safety Technical Specifications", "Cosmetic Registration and Filing Inspection Work Specifications" and other relevant regulations.

It is worth noting that cosmetics that claim new effects are inspected in accordance with the "Cosmetics Registration and Filing Inspection Work Regulations" and relevant technical regulations.

If the manufacturer of ordinary cosmetics has obtained the relevant qualification certification of the 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 toxicology test report of the product, except in the following circumstances:

1. The product claims to be used by infants and children;

2. The product uses new raw materials for cosmetics that are still under safety monitoring;

3. According to the results of quantitative grading, the filing person, the domestic responsible person and the production enterprise are listed as the key supervision objects.

03 Special Cosmetic Efficacy Test Report Submitted

Starting from January 1, 2022, when applying for registration of freckle whitening and hair loss prevention cosmetics, the registration applicant shall submit a human efficacy test report that meets the requirements in accordance with the regulations.

For cosmetics that apply for and obtain registration before May 1, 2021, the registrant shall submit a supplementary human efficacy test report before May 1, 2023.
For cosmetics that apply for and obtain registration from May 1 to December 31, 2021, the registrant shall submit a supplementary human efficacy test report that meets the requirements before May 1, 2022.

04 General Cosmetics Annual Report Management

From January 1, 2022, the annual report system will be 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 new registration and filing platform during the period from January 1 to March 31 of each year.

As the first supporting regulation of the new regulations, the measures for the administration of cosmetics registration and filing further refines the rules for the management of cosmetics and their raw materials, which is a new innovation in the supervision of cosmetics. With the implementation of the "Regulations on the Management of New Cosmetic Raw Materials Registration and Filing Materials" and "Regulations on the Management of Cosmetic Registration and Filing Materials", it will further provide guidance for the practical operation process and enable the cosmetics market to be further regulated. This will promote the positive guidance of industry competition, improve the development of the industry, and promote the win-win situation of enterprises and consumers.

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