In order to standardize the registration and filing management of cosmetics, implement the main responsibilities of enterprises for quality and safety, and ensure product quality and safety, in accordance with the “Cosmetics Supervision and Administration Regulations” (hereinafter referred to as the “Regulations”), the “Cosmetics Registration and Filing Management Measures” (hereinafter referred to as the “Measures”), and other regulations, matters related to further optimizing safety information management measures for cosmetic raw materials are hereby announced as follows:
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Contents of Safety Information on the Cosmetic Raw Materials
As an important basis for product safety evaluation, cosmetic raw material safety information mainly includes raw material quality specifications, safety risk substance control, raw material safety risk assessment conclusions and other information related to raw material safety. The “Catalogue of Used Cosmetic Raw Materials” (hereinafter referred to as the “Catalog”) issued by the National Medical Products Administration (hereinafter referred to as NMPA) includes the Chinese names of cosmetic raw materials used in products already on the market in my country, the highest historical usage of some raw materials, and other information. As the main responsibility subject of product quality and safety, cosmetic registrants and filers should collect and obtain detailed raw material safety-related information, and organize and form cosmetic raw material safety information materials by requesting literature from raw material manufacturers, reviewing literature, and conducting research and testing when selecting raw materials included in the Catalog.
In order to facilitate enterprises to fill in cosmetic safety information, the NMPA has established a cosmetic raw material safety information registration platform (hereinafter referred to as the raw material platform), which is mainly used for the unified registration of safety information related to used cosmetic raw materials included in the “Catalogue”. Raw material manufacturers should register raw material safety information in accordance with relevant laws and regulations and technical specifications, and be responsible for the authenticity and completeness of the content of raw material safety information. After the raw material safety information registration is completed, the raw material platform will automatically generate the corresponding submission code. Cosmetic registrants and filers can associate through the submission code during product registration and filing. There is no need to repeatedly fill in detailed raw material safety information, which improves the efficiency of cosmetic registration and filing.
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Submission of safety information on cosmetic raw materials
From the date of this announcement, cosmetics registrants and filers may choose the following methods to submit cosmetic raw material safety information based on the actual situation of raw materials used in product formulas when registering and filing products:
(1) If the raw material manufacturer has registered on the raw material platform and obtained the raw material safety information code, the cosmetics registrant and filer should directly fill in the raw material code. Cosmetic registrants and filers should also request raw material safety information corresponding to the raw material from the raw material manufacturer and file it for future reference;
(2) If the raw material manufacturer has not registered on the raw material platform and not obtained the raw material safety information reporting code, the cosmetics registrant and filer can fill in the raw material safety-related information of the raw material through the cosmetics registration and filing information service platform, and upload copies of the paper materials stamped with the seals of the registrant and filer. Relevant supporting materials for raw material safety information filled in by the enterprise, such as raw material quality specification certification documents provided by the raw material manufacturer, literature reviewed, relevant research and test data, etc., shall be archived by the registrant and filer for future reference;
(3) If only some of the raw materials used in the product formula have safety information codes, the cosmetic registrant and filer can submit the submission by simultaneously filling in code and filling in the raw material safety information by themselves in accordance with the above requirements.
Cosmetics registrants and filers should review and evaluate the authenticity and completeness of the codes and corresponding raw material safety information provided by the raw material manufacturers. If it is believed that there is a problem with the authenticity, the raw material shall not be used; if it is believed that there is a problem with the integrity, the cosmetics registrant or filing person can supplement and collect the corresponding raw material safety information and submit the raw material safety information by filling by themselves. At the same time, the problems existing in the raw material code will be explained.
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Adjustments during the transition period for policy implementation
Considering that due to factors such as the early COVID-19 epidemic, some companies have indeed had difficulties in collecting and obtaining safety information of cosmetic raw materials. In order to effectively help enterprises bail out, and deepen the implementation of the requirements of “streamline government administration, delegate power, improve regulation, and upgrade services.”, the following adjustments will be made during the transition period for the implementation of policies related to the submission of cosmetic raw material safety information:
(1) Starting from January 1, 2024, when applying for special cosmetics registration or general cosmetics filing, cosmetics registrants and filers shall fill in the information of all raw materials used in product formulas in accordance with relevant regulations, technical specifications and the requirements of this announcement;
(2) For cosmetics that have been registered or completed filing before May 1, 2021, if the product formula uses raw materials with quality specifications required by the “Safety and Technical Specifications for Cosmetics”, the registrant and filer should supplement to fill in the quality specification certification documents or raw material safety information of relevant raw materials before January 1, 2024. The raw material safety information of other raw materials in the product formula shall be archived by the registrant and filer for future reference;
(3) For cosmetics that have been registered or completed filing between May 1, 2021 and December 31, 2023, if the product formula uses raw materials with functions of antiseptic, sunscreen, coloring, hair dyeing, freckle removal and whitening, the registrant and filer should supplement to fill in the quality specification certification documents or raw material safety information of relevant raw materials before January 1, 2024. The raw material safety information of other raw materials in the product formula shall be archived by the registrant and filer for future reference.
When the drug regulatory department needs to review the raw material safety information that has been archived by the cosmetics registrant or filer for review during the technical review of cosmetics registration, technical verification of materials after filing, or on-site inspection, the registrant and filer shall cooperate and provide corresponding information as required.
From the date of this announcement, if the contents of relevant documents previously issued by the NMPA are inconsistent with this announcement, this announcement shall prevail. The drug regulatory authorities will further strengthen the management of cosmetic raw material safety information and provide timely guidance on relevant technical issues involved in filling in cosmetic raw material safety information through the release of technical guiding principles.
Notice is hereby given.
The National Medical Products Administration
March 22, 2023
