Complete interpretation of quality and safety information submission of cosmetic raw materials

Release time:

2022-02-24 18:13

Cosmetic raw material quality and safety information platform has been officially opened. 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 Cosmetic Registration and Filing Materials, "starting from January 1, 2022, when a registrant applies for registration or filing, it shall provide safety-related information with anti-corrosion, sun protection, coloring, hair dyeing, freckle removing and whitening functional materials in accordance with the requirements of the Regulations", "starting from January 1, relevant safety information shall be provided for cosmetic raw materials with quality specifications required in the Safety Technical Specification for Cosmetics and raw materials with anti-corrosion, sun protection, coloring, hair dyeing, freckle removing and whitening functions.

Background of quality and safety information submission of cosmetic raw materials

The production license system of the existing cosmetics regulatory system has carried out an access audit on the quality control ability of cosmetics manufacturers, and irregular supervision and inspection also ensures the quality of cosmetics production process control to a certain extent.

As an important part of cosmetic safety assurance, the submission of cosmetic raw material quality and safety information adopts a new way to connect raw material supplier evaluation, procurement, raw material quality control, etc., which is a new management method and does not change the quality of raw materials. The principle of safety supervision.

Who carries out the quality and safety information of cosmetic raw materials?

According to the Regulations on the Administration of Cosmetic Registration and Filing Materials, cosmetic raw material manufacturers can submit their own cosmetic raw material safety information, and can also authorize overseas or domestic legal person enterprises to submit and maintain raw material safety information. Only one enterprise can be authorized for raw material safety information of the same quality specification.

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.

Responsibility of the 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 responsibility of the authorized enterprise is relatively limited. It can only submit and maintain the safety information of raw materials. It can be a third-party consulting organization, which will not have a great impact on the actual trade of raw materials of the authorized enterprise.

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.

Picture 1

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. raw material attribute information refers to what? how to choose?

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 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. 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.

4. 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.

5. Concerns at the operational level

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.

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Announcement of the State Food and Drug Administration on Issuing the Measures for the Monitoring and Administration of Adverse Reactions of Cosmetics (No. 16 of 2022)

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