From January 1, 2023, all cosmetic raw material safety information shall be provided-the latest interpretation of cosmetic raw material quality and safety information shall be submitted.

Release time:

2022-11-25 09:12

Background of quality and safety information submission of cosmetic raw materials
According to regulations and technical specifications such as the Regulations on the Supervision and Administration of Cosmetics, the Measures for the Administration of Cosmetics Registration and Filing, and the Technical Specifications for Cosmetic Safety, cosmetics registrants and filers shall conduct safety risk assessments on cosmetic raw materials and fill in the product during the registration and filing process. Safety information of raw materials used in formula.
Cosmetic raw material safety information reporting platform has been opened, cosmetic raw material enterprises can uniformly fill in the raw material safety information, generate raw material submission code. Cosmetics registrants and filers can only fill in the raw material submission code provided by the raw material manufacturer and be related by the platform. There is no need to fill in detailed raw material safety information repeatedly, thus improving the efficiency of cosmetics registration and filing.
According to document No. 35 of 2021 of the State Food and Drug Administration-the announcement of the State Food and Drug Administration on matters related to the implementation of the regulations on the Administration of Cosmetics Registration and filing materials, starting from January 1, 2023, when the registrant filing person applies for registration or filing, it shall provide safety-related information of all raw materials in accordance with the requirements of the regulations. 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.
Who carries out the quality and safety information of cosmetic raw materials?
Cosmetic raw material manufacturers can submit their own cosmetic raw material safety information, can also authorize overseas or domestic legal person enterprises to submit and daily maintenance of raw material safety information, the same quality specifications of raw material safety-related information can only be authorized by one enterprise.
Cosmetic raw material manufacturer refers to the enterprise that is responsible for the safety of raw materials, which can be the actual production enterprise of raw materials, the affiliated enterprise belonging to the same group company as the actual production enterprise of raw materials, or the entrusted enterprise in the entrusted production of raw materials. The raw material distributor shall judge whether it meets the definition of raw material manufacturer according to the actual situation.
The reporting platform is divided into domestic users and overseas users. Domestic users log in directly through the "Cosmetic Raw Material Safety Information Registration Platform" module in the online service hall of the State Food and Drug Administration. Overseas users log in after opening the account number of the "Cosmetic Raw Material Safety Information Registration Platform.
Among them, if the overseas raw material manufacturer submits it by itself or authorizes the overseas enterprise to submit it, the main body certification document of the raw material manufacturer shall be notarized by the Chinese notary office or certified by the Chinese embassy (consulate), and the relevant documents shall be uploaded together with the main body certification document. If the overseas raw material manufacturer authorizes the domestic enterprise to submit the report, the domestic authorized enterprise shall verify the main body and relevant information of the overseas raw material manufacturer, and after the authorized enterprise opens the account, it shall submit the main body certification document of the cosmetic raw material manufacturer and the power of attorney issued by the raw material manufacturer at the same time. The authorization letter shall specify the authorization relationship and scope of authorization, and only one enterprise can be authorized with the raw material safety-related information of the same quality specification.
Authorized enterprise: when the authorized enterprise opens the user right, it shall submit the authorization letter issued by the manufacturer of cosmetic raw materials at the same time. The authorized enterprise may be a third-party advisory body and will not have a significant impact on the actual trade of raw materials of the authorized enterprise.
If the raw material manufacturer has not yet obtained the raw material submission code, there are two ways to provide it to the cosmetics registrant, the filing person or the domestic responsible person: 1. Provide the raw material quality specification document stamped with the official seal of the raw material manufacturer or the raw material safety related information (Annex 14 of the Regulations on the Administration of Cosmetic Registration and Filing Materials). 2. If the raw material manufacturer authorizes the registrant, the filing person or the domestic responsible person to fill in the raw material safety-related information (Annex 14), it shall provide the raw material safety-related information stamped with the official seal of the registrant, the filing person or the domestic responsible person (Annex 14). Among them, the following contents are noted in "other issues that need to be explained: the registrant, filer or domestic responsible person (specific enterprise name) is authorized by the raw material manufacturer (specific enterprise name) to fill in the relevant contents in Annex 14, which are true, complete and accurate.
Cosmetic raw material quality and safety information publicity style
The publicity of raw material safety information will not show the composition ratio of raw materials or the information of raw material manufacturers. It will only publicize some numbers of raw material submission codes (e.g. 100003 * * * * * * * * * * * * * *) and some raw material compositions (e.g. aloe vera (ALOE BARBADENSIS) leaf juice, glycerin...) as shown in the following figure.
When the cosmetics are filed, the related raw material submission code does not display the cosmetic raw material safety information file, but only the raw material submission code. Therefore, the raw material submission application enterprise does not need to worry about the raw material publicity or cosmetics filing related raw material submission code will disclose their own raw material information.

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Specific contents of quality and safety information submission of cosmetic raw materials
The contents required to be filled in in the submission platform have changed from those required in Annex 14 of the original Regulations on the Administration of Cosmetics Registration and Filing Materials, mainly focusing on the requirements of raw material production process and attribute information. The following are the issues that need to be focused on.
1. What does raw material attribute information refer?
The properties of raw materials include the basic characteristics of the main components, the source of raw materials, the production process and other information, mainly based on the raw material production process, starting materials, etc. to judge, which can be seen in the raw material quality and safety information submission data, the process is one of the key requirements.
2. Component content
The "raw material composition" information should be determined by the raw material manufacturer according to the production process of the raw material and the target product, especially the components and impurities should be clearly defined. Raw materials from different sources should be analyzed on a case-by-case basis. For example, the water of crystallization contained in the compound, or the water contained in the plant extract, is not a component of the raw material composition; whereas, if used as a solvent in an aqueous solution, water is a component of the raw material composition. In addition, the different raw material components in the compound raw materials, stabilizers, preservatives, antioxidants, etc. added to protect the raw materials, should all belong to the components of the raw material composition.
The mixture produced by the synthesis process can only fill in the content range, fill in the content range can not be too broad, should reflect the actual quality control of raw materials. It is encouraged to fill in the "typical value/target value" at the same time. This value can be a theoretical value, or an average value or representative data obtained by testing over a long period of time.
For compounding/mixing raw materials caused by other reasons, typical values/target values should be filled in, for example, mixing and extraction, adding necessary solvents or stabilizers, preservatives, antioxidants, homemade or purchased main components for compounding, etc.
3. How to fill in the "Description of Production Process Type?
The description of the type of production process should specify the type of production process (e. g. physical crushing, physical pressing, water or other solvent extraction, chemical synthesis, biological fermentation, etc.). A brief overview of the mixing, heating, distillation, filtration, drying, packaging and other processes without involving trade secrets. For natural raw materials directly derived from animals and plants, species information, Latin names, and parts of use should be clarified. For algae and macrofungi raw materials, species information, Latin names, etc. should also be clarified.
4. What do the characteristic indicators need to be filled in?
In the characteristic index of raw materials, the specific structure of single compound, polymer raw material, plant raw material (direct source), peptide, protein, nano material, other and other options are listed respectively. The submiter should describe the characteristic index according to the specific product category.
5. How to fill in risk information and control indicators?
In accordance with the instructions for completion, this item is filled in "if necessary. The submitter shall comprehensively judge whether the raw materials carry risk substances such as heavy metals and microorganisms according to the source of raw materials and the characteristics of the production process, and fill in the form according to the actual situation.
6. The operational level needs to focus
The data cannot be changed after the raw material quality and safety information is submitted. After the raw material quality and safety information submission code is generated, if you need to modify any information, you need to apply for a new raw material submission code. Raw material safety information is a link in the registration of cosmetics. As a manufacturer of cosmetic raw materials, it is necessary to understand the raw material-related matters involved in the daily compliance response of cosmetic enterprises and prepare in advance, such as pesticide residue analysis for plant extracts, impurity detection report or TDS for raw materials with quality specifications in the Code, etc. Raw material enterprises have any needs and problems, can also directly contact the new Anrun consulting.