Key Points of Toxicological Endpoints of China Cosmetics Safety Assessment Report

Release time:

2024-01-24 09:34

This website in 11, 2023 released the "dry! cosmetics safety assessment report full version of the poisoning data how to prepare?", there are many friends to consult the raw material safety assessment of toxicological data provided to what extent the problem.

In fact, there is no clear provision for the toxicological endpoint information required for the safety assessment of raw materials in China. The information on the toxicological endpoints of the raw materials listed in the content guidelines in Table 1, including local toxicity and systemic toxicity data, is generally required to provide local toxicity data, and systemic toxicity data can be provided to repeated dose toxicity.

Table 1 Toxicological endpoints of cosmetic raw materials

Serial Number	Toxicological Endpoints	Remarks
1	local toxicity	Irritant/Corrosive	Eyes, skin
2	skin sensitization
3	skin phototoxicity	When the raw material has ultraviolet absorption, it needs to be provided.
4	skin photoallergy	When the raw material has ultraviolet absorption, it needs to be provided.
5	systemic toxicity	acute toxicity	Peroral/Percutaneous
6	Genotoxicity	Include at least one gene mutation test and one chromosome aberration test
7	repeated dose toxicity	28 days/90 days oral/percutaneous
8	reproductive and developmental toxicity
9	Chronic toxicity/carcinogenicity
10	toxicokinetics
11	Other	Inhalation toxicity test shall be provided when the raw material has inhalation risk

However, the "Guiding Principles for the Definition and Research of New Cosmetic Raw Materials (Draft for Solicitation of Comments)" (hereinafter referred to as the "Draft for Solicitation of Comments") issued by the Central People's Procuratorate on December 1, 2023 provides us with new information points.

Under the condition that the preparation process and quality control standards based on the raw materials remain unchanged, the registrant and the filing person shall re-evaluate the efficacy and safety of the used cosmetic raw materials with clear use purpose and safe use amount, clarify the new functions and safe use amount of the raw materials, and adjust the use purpose of the raw materials to preservatives, sunscreens, colorants, hair dyes, freckle removing and whitening agents. At a minimum, toxicological endpoints such as acute oral or acute transdermal toxicity, skin and eye irritation/corrosivity, skin allergy, skin phototoxicity, skin photoallergy, mutagenicity (which should include at least one gene level and one chromosome level), sub-chronic oral or transdermal toxicity, teratogenicity, chronic toxicity/carcinogenicity, and long-term human use data should be evaluated for safety, carry out long-term human trial safety test research when necessary.

The five major raw materials of preservatives, sunscreens, colorants, hair dyes, and freckle-removing whitening agents are the high-risk raw materials specified in the "Regulations on the Supervision and Administration of Cosmetics. In particular, there is no official list of whitening raw materials in China, so we believe that the safety assessment of such raw materials may be required in the future full version of the safety assessment reference draft of the safety evaluation toxicological endpoint.

The first case after the new regulations landed, the write-off of new raw materials for cosmetics triggered new thinking.

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The first case after the new regulations landed, the write-off of new raw materials for cosmetics triggered new thinking.

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