China NIFDC Issued Latest Supporting Files for Full Version of Safety Assessment of Cosmetics

On April 30, 2024, the National Institutes for Food and Drug Control released seven documents and twelve Q&A sessions, all related to cosmetic safety assessment.

These documents are:

1. Guidelines for Submission of Cosmetic Safety Assessment Data

2. Technical Guidelines for Identification and Assessment of Risk Substances in Cosmetics

3. International Authoritative Cosmetic Safety Assessment Data Index and its Q&A

4. Usage Information for Ingredients in Marketed Products and its Q&A

5. Technical Guidelines for the Application of the Threshold of Toxicological Concern (TTC) Method and its Q&A

6. Technical Guidelines for the Application of the Read-Across Method and its Q&A

7. Guidelines for the Use of Cosmetic Ingredient Data and its Q&A.

These publications aim to enhance the safety standards of the cosmetic industry and provide clearer guidance and references for cosmetic companies.

Guidelines for Submission of Cosmetic Safety Assessment Data

This guide combines the risk levels of various types of cosmetics and the key focus areas in the safety assessment data to refine the classification of cosmetics; based on risk management principles and considering the operation of product and corporate quality management systems, it categorizes the circumstances under which cosmetic safety assessment data is submitted; and it establishes key points for self-inspection of cosmetic safety assessment reports to provide guidance for enterprises to accurately and standardly submit safety assessment data.

Technical Guidelines for Identification and Assessment of Risk Substances in Cosmetics

The safety risk substances in cosmetics may originate from or be introduced during the production, transportation, and storage processes of cosmetic ingredients and packaging materials. Exposure to these substances could potentially pose health risks to humans. Conducting a comprehensive hazard identification and assessment of potential safety risk substances in cosmetics can effectively evaluate the potential risks of the products.

International Authoritative Cosmetic Safety Assessment Data Index

This index is an objective collection of ingredients used in cosmetics in China that are not included in the "Technical Guidelines for Cosmetics Safety Assessment", but for which the European Union’s Scientific Committee on Consumer Safety (SCCS) and the United States Cosmetic Ingredient Review (CIR) have published safety assessment reports. It serves as a reference for cosmetic safety assessments.

Usage Information for Ingredients in Marketed Products

This information on ingredient usage is an objective record of the amounts used in special cosmetics within the validity period of their approvals in China, which are not included in the "Safety and Technical Standards for Cosmetics" and for which there are no authoritative assessment reports.

Technical Guidelines for the Application of the Threshold of Toxicological Concern (TTC) Method

This guide describes the application of the Threshold of Toxicological Concern (TTC) in cosmetic safety assessments, specifying the scope of application, terminology and definitions, substance classification, assessment procedures, and the requirements for the use of mixtures in the TTC method.

Guidelines for the Use of Cosmetic Ingredient Data

This guide introduces the application of the cross-reference method in cosmetic safety assessments, clarifies the scope of application, assessment procedures, and steps of the cross-reference method, and provides an example report.

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