According to the NMPA’s announcement on the release of several measures to optimize the safety assessment management of cosmetics, the complete safety assessment of cosmetics has been carried out in an orderly manner. In order to help cosmetic registrants to carry out related work smoothly, this article will guide you step by step into the full version of cosmetic safety assessment.
1.What are the main regulations and technical documents related to cosmetic safety assessment?
■ Main regulations:
The Regulations on Supervision and Administration of Cosmetics
The Provisions for Registration and Filing of Cosmetics
The Provisions for the Registration or Filing Dossier of Cosmetics
The Technical Guidance for the Safety Evaluation of Cosmetics
The Technical Specification for the Safety of Cosmetics
The Classification Rules and Classification Catalogue of Cosmetics
The Measures for the Administration of Cosmetics Labels
■ Technical documents:
The Guidelines for the Use of Cosmetic Raw Material Data: The guidelines clarifies the seven main types of raw material data, usage requirements and certification materials required for safety assessment.
The International Authoritative Cosmetic Safety Assessment Data Index: The document objectively collects the raw materials used in Chinese cosmetics that are not included in the "Technical Specifications for Cosmetic Safety" and for which SCCS and CIR have published cosmetic safety assessment reports.
The Information on the Use of Raw Materials for Marketed Products: The document objective collects the raw materials that have been used in special cosmetics within the validity period of the approval, are not included in the "Safety Technical Specifications for Cosmetics", and do not have an assessment report from an authoritative organization.
The Technical Guidelines for Application of Threshold of Toxicological Concern (TTC) Method: This method is suitable for raw materials or risk substances with clear chemical structures and no serious mutagenic warning structures. It can be used as a reference when the content is low and there is a lack of systematic toxicology research data.
The Technical Guidelines for Application of Read-across Method: This method is suitable for non-functional ingredients or risk substances that lack systematic toxicology research data and can be used as a reference.
The Technical Guidelines for the Application of Integrated Testing and Assessment Strategies for Skin Sensitization: This guideline is suitable for skin sensitization evaluation of cosmetic raw materials.
The Technical Guidelines for Cosmetic Stability Testing and Evaluation；The Technical Guidelines for Cosmetic Preservative Challenge Testing and Evaluation；The Technical Guidelines for Cosmetic and Packaging Material Compatibility Testing and Evaluation：These three guidelines are applicable to the stability evaluation of cosmetics, the effectiveness evaluation of cosmetic preservative systems, and the compatibility evaluation of containers or carriers in direct contact with the contents of cosmetics and products.
The Technical Guidelines for Identification and Assessment of Risky Substances in Cosmetics：According to the Technical Specifications for Safety of Cosmetics, possible risk substances in cosmetics are identified and evaluated with reference to the risk assessment conclusions of domestic and foreign authoritative institutions and other methods.
The Guidelines for Submission of Cosmetics Safety Assessment Data：The guideline details the requirements for submission of cosmetic safety assessment materials by category and guides filers to submit safety assessment materials accurately and standardizedly.
2. How to fully understand the safety assessment of cosmetics - "Technical Guidelines for Safety Assessment of Cosmetics"?
The main body of the Guidelines consists of ten parts, including scope of application, basic principles and requirements, requirements for safety assessment personnel, risk assessment procedures, toxicology tests, safety assessment of raw materials, safety assessment of cosmetic products, safety assessment reports, instructions and interpretations. It mainly clarifies the principles and personnel of safety assessment, stipulates the assessment procedures, safety assessment requirements for raw materials and products, the content of assessment reports, and requirements for simplified safety assessment reports.
The Guidelines consists of four appendices. Appendix 1 and Appendix 2 respectively stipulate the contents that should be included in the safety assessment reports for raw materials and cosmetic products. Appendix 3 and Appendix 4 respectively give examples of complete and simplified product safety assessment reports.
3. What does the complete safety assessment report include?
According to the Technical Guidelines for Cosmetic Safety Assessment, the complete version of the cosmetic safety assessment should include: summary, product introduction, product formula, formula design principles (only for children's cosmetics), safety assessment of each ingredient in the formula, assessment of possible risk substances, risk control measures or suggestions, safety assessment conclusion, signature of the safety assessor, resume of the safety assessor, references, and appendix. Compared with the simplified version of the safety assessment, the complete version of the safety assessment should also reflect the preservative challenge results, stability test results, and compatibility assessment results of the product and packaging materials, as well as the corresponding test report.
4. What is the four-step risk assessment approach?
That is, the four steps for risk assessment of cosmetic raw materials and risk substances: hazard identification, dose-response relationship, exposure assessment, and risk characterization.
5. Commonly used toxicology databases and their login websites
■ US CIR Cosmetic Ingredient Database
■ EU CosIng Database
■ OECD Database
■EU ECHA Database
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