From January 1, 2024, all cosmetic raw material safety information must be submitted

Release time:

2023-10-13 09:27

According to Announcement No. 34 of 2023 of the State Food and Drug Administration, starting from January 1, 2024, safety information of all raw materials shall be provided when applying for registration/filing of cosmetics. For products that have been registered or filed, the cosmetic registrant/filer shall collect all raw materials, and some of the raw material information shall be submitted on the platform.

At present, it is less than 2 months before January 1, 2024. Xiaobian hereby summarizes the contents of the relevant laws and regulations on the submission of raw material quality and safety information for your reference.

Why is it necessary to submit raw material safety information?

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.

-Announcement No. 34 of 2023 of the State Food and Drug Administration

The safety of raw materials is a prerequisite for the safety of cosmetic products. The risk assessment of cosmetic raw materials includes the raw materials themselves and the risk substances that may be brought in. Cosmetic products can generally be regarded as a combination of various raw materials and should be evaluated based on all raw materials and risk substances. If it is confirmed that there are chemical and/or biological interactions between certain raw materials, the risk substances and/or potential safety risks caused by the interactions should be evaluated.

-2.1 of Technical Guidelines for Safety Assessment of Cosmetics

What raw materials need to be submitted for safety information?

The (II) registrant, the filing person or the domestic responsible person shall fill in the manufacturer information of the raw materials used in the product and upload the raw material safety information file issued by the raw material manufacturer. If the raw material manufacturer has submitted the raw material safety-related information (Annex 14) in accordance with the Guidelines for Submitting Cosmetic Raw Material Safety-related Information (Annex 12 and Annex 13), the registrant, the filing person or the domestic responsible person may fill in the raw material safety information file associated with the raw material submission code.

-Article 29 of the Provisions on the Administration of Registration and Filing Materials for Cosmetics

(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.

-Announcement No. 34 of 2023 of the State Food and Drug Administration

Who will submit it?

-Article 29 of the Provisions on the Administration of Registration and Filing Materials for Cosmetics

Cosmetic 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 when registering and filing products:

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.

-Announcement No. 34 of 2023 of the State Food and Drug Administration

Who is the responsible subject?

Cosmetic registrants and filers claim responsibility for the quality, safety and efficacy of cosmetics.

-Article 6 of the Regulation on the Supervision and Administration of Cosmetics

Article 7 The registrant and the archivist of new raw materials for cosmetics and cosmetics shall perform the obligations of product registration and archival filing in accordance with the law, and shall be responsible for the quality and safety of new raw materials for cosmetics and cosmetics.

......

Article 30 The registrant and recordal person of cosmetics shall select raw materials that meet the requirements of laws, administrative regulations, mandatory national standards and technical specifications for the production of cosmetics, and shall be responsible for the safety of the cosmetic raw materials used. When applying for registration and filing, the registrant and the filing person of cosmetics shall clarify the source of raw materials and information related to the safety of raw materials through the information service platform.

-Measures for the Administration of Registration and Filing of Cosmetics

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.

-Announcement No. 34 of 2023 of the State Food and Drug Administration

What is the content of raw material safety information?

-Announcement No. 34 of 2023 of the State Food and Drug Administration

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