Announcement of the State Food and Drug Administration on Issues concerning Further Optimizing the Safety Information Management Measures for Cosmetic Raw Materials (No.34, 2023)

Release time:

2023-03-29 09:16

In order to standardize the management of cosmetics registration and filing, implement the main responsibility of enterprise quality and safety, and ensure product quality and safety, in accordance with 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), the relevant matters concerning the further optimization of the safety information management measures of cosmetic raw materials are hereby announced as follows:
1. content 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 material control, raw material safety risk assessment conclusions and other information related to raw material safety. The "Catalogue of Used Cosmetic Ingredients" (hereinafter referred to as the "Catalogue") issued by the State Food and Drug Administration contains information such as the Chinese names of cosmetic raw materials used in products already on the market in my country and the highest historical usage of some raw materials. As the main body responsible for the quality and safety of products, the registrant and the filing person of cosmetics shall collect and obtain detailed information on the safety of raw materials by asking for raw material manufacturers, consulting literature, conducting research and testing, etc., and collate and form the safety information of cosmetic raw materials.
In order to facilitate enterprises to fill in cosmetic safety information, the State Food and Drug 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 the relevant safety information of the 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 shall be responsible for the authenticity and integrity of the content 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. Cosmetics registrants and filers can associate with each other through the submission code during product registration and filing. There is no need to fill in detailed raw material safety information repeatedly, thus improving the efficiency of cosmetics registration and filing.
Submission of Safety Information Materials of Cosmetic Raw Materials by 2.
From the date of this announcement, when registering and filing products, cosmetics registrants and filers can choose the following methods to submit the safety information of cosmetic raw materials according to the actual situation of the raw materials used in the product formula:
If the manufacturer of (I) raw materials has registered with the raw material platform and obtained the raw material safety information submission code, the cosmetic registrant and the filing person shall directly fill in the submission code of the raw material. Cosmetic registrants and filers shall also request the raw material manufacturer for the corresponding raw material safety information for archiving for future reference;
If the manufacturer of (II) raw materials has not registered on the raw material platform and obtained the raw material safety information submission code, the cosmetic registrant and the filer can fill in the raw material safety related information of the raw material through the cosmetic registration and filing information service platform, and upload the scanned paper data stamped with the seal of the registrant and the filer. The relevant supporting materials of the raw material safety information materials filled in by the enterprise itself, such as the raw material quality specification certification documents provided by the raw material manufacturer, the literature consulted, the relevant research and test data, etc., shall be filed by the registrant and the filing person for future reference;
If only some of the raw materials used in the (III) product formula have safety information submission codes, the cosmetic registrant and the filing person may submit the materials by filling in the submission codes and filling in the safety information of the raw materials themselves in accordance with the above requirements respectively.
Cosmetic registrants and filers shall review and evaluate the authenticity and completeness of the submission codes provided by the raw material manufacturers and the corresponding raw material safety information. 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 cosmetic registrant and the filing person may supplement and collect the corresponding raw material safety information, and submit the raw material safety information by filling in the information by themselves. At the same time, explain the problems existing in the raw material submission code.
3. Adjustment on the Transitional Period of Policy Implementation
Taking into account the impact of the early new crown epidemic and other factors, some enterprises in the collection, access to cosmetic raw material safety information and data really have difficulties, in order to effectively help enterprises to bail out, deepen the implementation of the "release of management and service" requirements, the cosmetic raw material safety information and data submitted to the relevant policies for the implementation of the transition period for the following adjustments:
(I) From January 1, 2024, when applying for registration of special cosmetics or filing of ordinary cosmetics, cosmetics registrants and filers shall, in accordance with relevant regulations, technical specifications and the requirements of this announcement, fill in the raw material safety information of all raw materials used in the product formula;
(II) cosmetics that have been registered or filed before May 1, 2021, if raw materials with quality specifications required by the Cosmetic Safety Technical Specification are used in the product formula, the registrant and the filer shall supplement the quality specification certification documents or raw material safety information materials of the 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 filing person for future reference;
(III) cosmetics that have been registered or filed between May 1, 2021 and December 31, 2023, if raw materials with anti-corrosion, sun protection, coloring, hair dyeing, freckle removing and whitening functions are used in the product formula, the registrant and the filer shall fill in the quality specification documents or raw material safety information materials of the 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 filing person for future reference.
When the drug regulatory department needs to consult the raw material safety information that has been filed by the cosmetics registrant and the filing person for future reference in the technical review of cosmetics registration, technical verification of data after filing or on-site verification, the registrant and the filing person shall cooperate and provide the corresponding information as required.
Since the date of this announcement, if the contents of the relevant documents previously issued by the State Food and Drug Administration are inconsistent with this announcement, this announcement shall prevail. The drug regulatory department will further strengthen the management of cosmetic raw material safety information, and provide timely guidance on the relevant technical issues involved in the filling of cosmetic raw material safety information by issuing technical guidelines.
It is hereby announced.
State Food and Drug Administration
22 March 2023
Original Link: Announcement of the State Food and Drug Administration on Matters Related to Further Optimizing Safety Information Management Measures for Cosmetic Raw Materials (No. 34, 2023) (nmpa.gov.cn)