1、 What are the requirements for selecting toxicology methods?

 

According to the "Regulations on the Management of Registration and Filing Materials for New Cosmetics Raw Materials", toxicology testing projects for new raw materials should be conducted in accordance with the testing methods specified in the "Technical Safety Standards for Cosmetics". Items that are not specified in the "Technical Specification for Safety of Cosmetics" shall be inspected in accordance with national standards or internationally recognized methods.

 

When using animal substitution methods for toxicological safety evaluation, appropriate integrated testing and evaluation methods (IATA) should be selected based on the structural characteristics of the raw materials and specific toxicological endpoints to evaluate the toxicity of the new raw materials. If the animal substitution test method used has not been included in China's "Technical Specification for Safety of Cosmetics", the substitution test method should be a method that has been included by an internationally authoritative substitution method verification institution, and proof that the method can accurately predict the toxicological endpoint should be submitted at the same time. The supporting documents should include a brief description of the research process of the alternative test method, as well as research data, result analysis, and research conclusions of no less than 10 known toxic test substances.

 

2、 What are the requirements for the test substance when conducting toxicology experiments?

 

To fully alert the potential safety risks of new raw materials, corresponding toxicological tests should be conducted on newly registered raw materials as research subjects. If the actual commercial sales form of a new raw material is its diluted solution, the new raw material should also be the research object, and toxicological tests should not be directly conducted using the commercial diluted solution as the research object. When conducting toxicology experiments, the form and dosage level of the test substance should comply with relevant method requirements and fully reflect the toxicity of the new raw material substance itself.

 

3、 How to conduct exposure assessment based on the "applicability and scope of use" of raw materials?

 

According to the Technical Guidelines for Safety Assessment of Cosmetics, when conducting exposure assessment, factors such as the location, dosage, concentration, frequency, and duration of use of products containing the raw material or hazardous substance should be considered. Therefore, exposure assessment and risk assessment of new raw materials should be conducted in conjunction with their "applicability and scope of use". For example, for new raw materials with "applicability and scope of use" as "various types of skin cosmetics", analysis and evaluation should be based on the total exposure of each type of product, taking into account inhalation risks, rather than evaluating each type of product separately.

 

4、 How to conduct a safety assessment of the inhalation toxicity related risks of raw materials?

 

According to the Technical Guidelines for Safety Assessment of Cosmetics, when there is a possibility of inhalation exposure, the health hazards caused by inhalation exposure should be considered; According to the "Regulations on the Management of Registration and Filing Materials for New Cosmetics Raw Materials", when raw materials may be exposed to inhalation, inhalation toxicity tests should be conducted. Inhalation exposure risk assessment should consider both the physical and chemical properties of the raw materials themselves, as well as factors such as product formulation and usage methods when the raw materials are used in cosmetics. For new raw materials that are not expected to be used in products that may have inhalation exposure risks, the registrant and filer of the new raw materials should specify in the "Scope of Application and Use" of the new raw materials (such as stating "not to be used in products that may have inhalation exposure risks").

 

5、 How to identify and evaluate potential risk substances in new raw materials?

 

The risk substances in new raw materials may come from starting materials, production processes, storage, and use processes, etc., and should be fully analyzed in conjunction with relevant information and research data. In the production process of new raw material registration and filing materials, specific starting materials, solvents or additives used, intermediate products and by-products of the reaction process should be listed based on reaction principles, preparation processes, actual production processes, etc. Based on the characteristics of new raw materials and stability test data, a comprehensive analysis should be conducted on the degradation products that may occur during storage and use. On this basis, identify potential safety risk substances in the new raw materials, explain control measures, and analyze and evaluate them in the safety assessment report.