The management regulations for the registration and filing of cosmetics and new raw materials are here!

Today (March 4), the State Food and Drug Administration successively issued the "Announcement on Issuing the "Regulations on the Administration of the Registration and Filing of New Cosmetic Materials" (No. 31 of 2021)" and "Regarding the Administration of the "Regulations on the Administration of the Registration and Filing of Cosmetics" Announcement (No. 32 of 2021)” to further regulate and guide the registration and filing of new cosmetic raw materials and cosmetics. The two major management regulations will be officially implemented on May 1, 2021.

On January 12, the "Administrative Measures for the Registration and Filing of Cosmetics" was released as the first supporting regulation after the implementation of the "New Regulations" and will be formally implemented on May 1. On the basis of the Regulations, the "Administrative Measures" further specify the dual-track management system of cosmetics "registration system" and "filing system", implement classified management of cosmetics and cosmetic raw materials according to the degree of risk, simplify and clarify the two systems Management requirements.

The "Regulations on the Administration of the Registration and Filing of New Cosmetic Materials" and the "Regulations on the Administration of the Administration of the Registration and Filing of Cosmetics" released today further clarify the details of the "Administrative Measures for the Registration and Filing of Cosmetics", refine the regulatory responsibilities of the regulatory authorities, and promote new developments in the cosmetics industry. change.

01

Further clarify the safety monitoring system, continuous monitoring and evaluation system for new raw materials

Cosmetic raw materials are not only the core of safety, but also the core of technological innovation. At present, the state encourages and supports the use of modern science and technology, combined with my country's traditional superior projects and characteristic plant resources to research and develop cosmetics.

There are 20 articles in the "Regulations on the Administration of Registration and Filing of New Cosmetic Ingredients", together with: an overview of the safety risk monitoring and evaluation system for the registrant/filer of new cosmetics raw materials (sample), and an update form for the registrant/filer of new cosmetics raw materials ( Sample), new cosmetic raw material registration filing requirements, new cosmetic raw material technical requirements (sample), new cosmetic raw material development report preparation requirements, new cosmetic raw material quality control standards preparation requirements, new cosmetic raw material safety monitoring annual report preparation requirements, cosmetics The preparation of the new raw material safety risk control report requires 8 attachments.

The regulations require that the registrant and recorder of new cosmetic raw materials who apply for the registration of new cosmetic raw materials or apply for the record of new raw materials shall submit the following materials:

1. The name, address and contact information of the registrant, the filing person and the responsible person in China;
2. New raw material research and development report;
3. Research materials such as the preparation process, stability and quality control standards of the new raw materials;
4. New raw material safety assessment data.

The registrant, recorder or domestic responsible person of new cosmetic raw materials shall be classified according to the specific circumstances of the new raw materials declared for registration or filing, sorted out and submitted corresponding registration and record materials in accordance with the requirements of new cosmetic raw material registration and record materials.

The registrant, recorder or domestic responsible person of cosmetic new raw materials shall, in combination with the relevant technical information of the new raw material registration and record data, compile and provide the new cosmetic raw material technical requirements data for registration and record information disclosure, and obtain approval or complete the record after the new raw material is approved Later, it will be published as an attachment to the approval certificate or filing voucher for public inquiry and reference.

According to regulations, the research report of new cosmetic raw materials should be prepared in accordance with the requirements, and generally should include the following content:

(1) The background of raw material research and development, including research and development background, research purpose, research and development process and research results, etc.;
(2) Basic information of raw materials, including raw material name, source, composition, relative molecular weight, molecular formula, chemical structure, physical and chemical properties, etc.;
(3) Information on the use of raw materials, including the use specifications, purpose of use, scope of application or use, safe use, use period, precautions, warning words, etc. of the raw materials in cosmetics; the status of the raw materials used in cosmetics abroad and their approval status;
(4) Functional basis data. The functional basis of new cosmetic raw materials refers to relevant data that can prove that the raw materials have consistent with the purpose of use, generally including scientific literature, regulatory data, laboratory research data, human efficacy evaluation test data, etc.;
(5) Other materials related to the development of new raw materials.

An industry researcher told the reporter of "Cosmetics Finance Online" that the publication of the "Regulations on the Administration of Registration and Recording of New Cosmetics Raw Materials" is based on the classification management of new raw materials based on the principles of risk management in the "New Regulations", which further clarifies the management of new raw materials. A series of special supervision measures for raw materials, such as safety monitoring system, continuous monitoring and evaluation system.

"As the source and foundation for the development of the cosmetics industry, the innovation of raw materials will undoubtedly promote industrial upgrading. For example, after long-term development and practice, Japan has established a relatively complete adverse reaction monitoring system and supervision system, which is worth learning from. This time, the issuance of the "Regulations on the Administration of the Registration and Filing of New Cosmetic Raw Materials" has further promoted the safety of raw materials through open and transparent information."

02

When applying for registration of special cosmetics or filing for general cosmetics for the first time

Need to pay attention to these

The "Regulations on the Administration of Cosmetics Registration and Filing Data" are divided into six chapters and sixty articles: "General Provisions", "User Information-related Data Requirements", "Registration and Filing Information Requirements", "Requirements for Changes", "Requirements for Continuation and Cancellation, etc." and "Supplementary Provisions".

The regulations state that when applying for registration of special cosmetics or filing for general cosmetics for the first time, domestic registration applicants, filing persons and domestic responsible persons shall submit the following user information related materials: (1) Registrant filing person information form and responsible for quality and safety (2) Overview of the registrant’s quality management system for the recorder; (3) Overview of the registrant’s recorder’s adverse reaction monitoring and evaluation system; (4) Overseas registrants and recorders should submit a domestic responsible person information form; (5) The original copy of the authorization letter of the domestic responsible person and its original notarized certificate; (6) If the registrant or recorder has self-produced or entrusted overseas production enterprises to produce, they should submit the production enterprise information form and the information of the person in charge of quality and safety, and fill in the existing production at one time Enterprise and its information. If the production enterprise is overseas, the original copy of the overseas production standard certification materials shall be submitted.

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

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

Manufacturers of ordinary cosmetics that have obtained the relevant qualification certification of the production quality management system issued by the competent government department of the country (region), and the product safety risk assessment results can fully confirm the safety of the product, are exempt from submitting the toxicology test report of the product , Except for the following situations:

1. The product claims to be used by infants and children;
2. The product uses new cosmetic raw materials under safety monitoring;
3. According to the quantitative grading and scoring results, the filing person, the domestic responsible person, and the production enterprise are listed as key supervision objects.

Some voices pointed out that the "Administrative Measures for the Registration and Recording of Cosmetics" as a supporting departmental regulation of the "New Regulations" further clarified that the record of ordinary cosmetics is a real informative record. There will be no review link before the listing, and the recorder will complete the record. Products can be put on the market, "but the industry needs to be reminded that informative filing has not reduced the requirements for product safety while optimizing filing procedures and facilitating product launches."

A relevant person in charge of a brand told the reporter of Cosmetic Finance Online that as the key hub between products and consumers, cosmetics registrants and recorders need to establish a complete product quality management system to ensure that cosmetic raw materials are from "born" to All aspects of "growth" supervision.

"In this way, on the one hand, we will improve product quality and crack down on unqualified cosmetics manufacturers; on the one hand, we will deepen the implementation of the reform of decentralization, regulation and service, purify the competitive environment of cosmetics business, and consolidate the main responsibility of the enterprise." To.

The "Administrative Measures for Cosmetics Registration and Filing", as the first supporting regulation of the "New Regulations", further refines the "Administrative Rules for Cosmetics and Their Raw Materials", which is a new initiative in cosmetics supervision. With the implementation of the "Regulations on the Administration of New Cosmetic Raw Material Registration and Recording Materials" and the "Regulations on the Administration of Registration and Recording Materials on Cosmetics", further guidance is provided for the actual operation process and the cosmetics market can be further regulated. This will promote industry competition to be positively guided, improve industry development, and promote a win-win situation for enterprises and consumers.