CCTV News:On March 27th, National Medical Products Administration website released the announcement of National Medical Products Administration on matters related to further optimizing the safety information management measures for cosmetic raw materials (No.34, 2023).
In order to standardize the management of cosmetics registration and filing, implement the main responsibility of quality and safety of enterprises, and ensure the quality and safety of products, according to the Regulations on the Supervision and Administration of Cosmetics (hereinafter referred to as the Regulations) and the Measures for the Administration of Cosmetics Registration and Filing (hereinafter referred to as the Measures) and other laws and regulations, matters related to further optimizing the measures for the safety information management of cosmetics raw materials are hereby announced as follows:
I. Contents of safety information about 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 issued by National Medical Products Administration (hereinafter referred to as the Catalogue) contains the Chinese names of used cosmetic raw materials in China’s listed products, the highest historical usage of some raw materials and other information. Cosmetic registrants and filers, who are responsible for product quality and safety, should collect and obtain detailed information about raw material safety by asking raw material manufacturers, consulting literature, conducting research and experiments, etc. when selecting raw materials included in the Catalogue, and sort out and form information about raw material safety of cosmetics.
In order to facilitate enterprises to fill in cosmetic safety information, National Medical Products Administration has set up 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 shall register raw material safety information in accordance with the requirements of relevant laws and regulations and technical specifications, and be responsible for the authenticity and integrity of raw material safety information. After the registration of raw material safety information is completed, the raw material platform will automatically generate the corresponding submission code. Cosmetic registrants and filers can associate with each other through the submission code when registering and filing products, and there is no need to fill in detailed raw material safety information repeatedly, thus improving the efficiency of cosmetic registration and filing.
II. Submission of safety information on cosmetic raw materials
From the date of this announcement, the registrants and filers of cosmetics can choose the following ways to submit the safety information of cosmetic raw materials according to the actual situation of the raw materials used in the product formula when registering and filing products:
(1) If the raw material manufacturer has registered on the raw material platform and obtained the submission code of raw material safety information, the cosmetics registrant and filing person shall directly fill in the submission code of the raw material. Cosmetic registrants and filers should also ask the raw material manufacturers for the corresponding raw material safety information for archiving for future reference;
(II) If the raw material manufacturer has not registered on the raw material platform and obtained the raw material safety information reporting code, the cosmetic registrant and the filing person can fill in the raw material safety related information of the raw material by themselves through the cosmetic registration and filing information service platform, and upload the scanned paper materials stamped with the registrant and filing person’s seals. Relevant evidential materials of raw material safety information provided by enterprises themselves, such as raw material quality specification documents provided by raw material manufacturers, documents consulted, relevant research and test data, etc., shall be filed by registrants and filers for future reference;
(3) If only a part of the raw materials used in the product formula have safety information submission codes, the cosmetics registrant and the filer may submit the codes and the raw material safety information by themselves according to the above requirements.
Cosmetic registrants and filers shall review and evaluate the authenticity and completeness of the submission code provided by raw material manufacturers and the corresponding raw material safety information. If there is a problem with the authenticity, the raw material shall not be used; If there is a problem with the integrity, the cosmetics registrant and filer can supplement and collect the corresponding raw material safety information, and submit the raw material safety information by self-reporting, and at the same time explain the problems existing in the raw material submission code.
Iii. Adjustment during the transition period of policy implementation
Considering that some enterprises have difficulties in collecting and obtaining safety information of cosmetic raw materials due to factors such as the epidemic situation in COVID-19 in the early stage, in order to effectively help enterprises out of difficulties and deepen the implementation of the "streamline administration, delegate power, strengthen regulation and improve services" requirements, the following adjustments are made to the implementation transition period of the relevant policies for submitting safety information of cosmetic raw materials:
(1) Since January 1, 2024, when applying for registration of special cosmetics or filing of ordinary cosmetics, cosmetics registrants and filers shall fill in the raw material safety information of all raw materials used in product formulas in accordance with relevant laws and regulations, technical specifications and the requirements of this announcement;
(2) For cosmetics that have been registered or put on record before May 1, 2021, if raw materials with quality specifications required by the Technical Specifications for Cosmetic Safety are used in the product formula, the registrant and the filer shall supplement the quality specification documents of relevant raw materials or raw material safety information before January 1, 2024. The raw material safety information of other raw materials in the product formula shall be filed by the registrant and the filer for future reference;
(3) For cosmetics registered or filed during the period from May 1, 2021 to December 31, 2023, if raw materials with antiseptic, sunscreen, coloring, freckle-removing and whitening functions are used in the product formula, the registrant and filing person shall supplement the quality specification 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 filed by the registrant and the filer for future reference.
When the drug regulatory authorities need to consult the raw material safety information that has been filed for future reference by cosmetic registrants and filers in the technical review of cosmetic registration, technical verification of data after filing or on-site verification, the registrants and filers shall cooperate with them and provide corresponding information as required.
Since the date of this announcement, if the contents of relevant documents previously released by National Medical Products Administration are inconsistent with this announcement, this announcement shall prevail. The drug regulatory authorities will further strengthen the management of safety information of cosmetic raw materials, and provide timely guidance on the relevant technical issues involved in the reporting of safety information of cosmetic raw materials by issuing technical guiding principles.
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