On August 19, 2024, the Beijing Municipal MPA issued the “FAQs on Notification of General Cosmetics (Vol. 36),” providing a entry-level guide on conducting full-version safety assessment report of cosmetics. This practical resource involves main regulations, main content of the full version of CPSR and reference for commonly used toxicology databases.
Q1:What are the main regulations and technical guidelines related to cosmetic safety assessment in China?
A: Main regulations include:
Cosmetic Supervision and Administration Regulation
Administrative Measures on Cosmetics Registration and Notification
Provisions for Management of Cosmetic Registration and Notification Dossiers
Technical Guidelines for Cosmetic Safety Assessment
Safety and Technical Standards for Cosmetics
Cosmetic Classification Rules and Catalogs
Administrative Measures on Cosmetics Labeling
Technical documents include:
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Document |
Remark |
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Guidelines for Use of Cosmetic Ingredient Data |
The document clearly defines the seven main types of ingredient data required for safety assessments, including their usage requirements and necessary supporting documentation. |
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Index of International Authoritative Institution Cosmetic Safety Assessment Data |
It includes an objective collection of data for cosmetic ingredients used in China that are not listed in the Safety and Technical Standards for Cosmetics but have safety assessment reports from the EU SCCS (Scientific Committee on Consumer Safety) and the U.S. CIR (Cosmetic Ingredient Review). |
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Ingredient Usage Information of Marketed Products |
It provides an objective collection of usage data for ingredients in special cosmetics with valid licenses that are used in China but are not listed in the Safety and Technical Standards for Cosmetics and lack safety assessment reports from authoritative institutions. |
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Technical Guidelines for Application of Threshold of Toxicological Concern (TTC) Method |
This method is applicable for ingredients or hazardous substances with well-defined chemical structures that do not contain severe mutagenic warning structures. It can be referenced when the content is low and there is a lack of systematic toxicological research data. |
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Technical Guidelines for Application of Read-across Method |
This method is applicable for non-functional ingredients or hazardous substances that lack systematic toxicological research data and can be used as a reference. |
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Technical Guidelines for Integrated Approaches to Testing and Assessment (IATA) of Skin Sensitization |
This method is suitable for evaluating skin sensitization of cosmetic ingredients. |
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Technical Guidelines for Stability Testing and Assessment of Cosmetics |
These methods are suitable for: evaluating cosmetic stability, assessing the efficacy of cosmetic preservative systems and evaluating compatibility between the product and containers or carriers that come into direct contact with the cosmetic contents. |
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Technical Guidelines for Preservative Challenge Testing and Assessment of Cosmetics |
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Technical Guidelines for Compatibility Testing and Assessment of Cosmetics with Packaging Materials |
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Technical Guidelines for Identification and Assessment of Cosmetic Risk Substances |
To identify and assess potential risk substances in cosmetics, refer to risk assessment conclusions from authoritative domestic and international agencies. |
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Guidelines for Submission of Cosmetics Safety Assessment Dossiers |
This document specifies the classification and submission requirements for cosmetic safety assessment dossiers, guiding registrants/notifier to submit safety assessment dossiers accurately and in accordance with regulations. |
Q2: How to fully understand the Technical Guidelines for Cosmetic Safety Assessment (referred to as the Guidelines)?
A: The main body of the Guidelines is divided into ten sections, which include:
● Scope of Application
● Basic Principles and Requirements
● Qualifications for Safety Assessors
● Risk Assessment Process
● Toxicological Testing
● Safety Assessment of Ingredients
● Safety Assessment of Cosmetic Products
● Safety Assessment Reports
● Explanations
● Interpretations
These sections provide detailed guidance on the principles of safety assessment, personnel qualifications, the assessment process, and the requirements for evaluating the safety of ingredients and products, as well as the content for both full and simplified safety assessment reports.
Additionally, the Guidelines feature four appendices:
● Appendix 1: Details the required content for ingredient safety assessment reports.
● Appendix 2: Outlines the required content for cosmetic product safety assessment reports.
● Appendix 3: Provides an example of a full version of a product safety assessment report.
● Appendix 4: Offers an example of a simplified version of a product safety assessment report.
Q3: What does a full version of safety assessment report include?
A: According to the Guidelines, a full cosmetic safety assessment report should include the following:
● Summary
● Product overview
● Product formula
● Formulation design principles (only for children's cosmetics)
● Safety assessment of each ingredient in the formula
● Evaluation of potential risk substances
● Risk control measures or recommendations
● Safety assessment conclusion
● Signature of the safety assessor
● Safety assessor's resume
● References
● Appendices
In comparison to a simplified safety assessment report, the full report should also include the results of preservative efficacy testing, stability testing results, compatibility assessment between the product and packaging materials, and the corresponding test reports.
Q4: What is the four-step method for risk assessment?
A: The four-step method for assessing the risks of cosmetic ingredients and hazardous substances includes: hazard identification, dose-response assessment, exposure assessment and risk characterization.
Q5: What are the commonly used toxicology databases?
A:
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Database |
Official Website |
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U.S. CIR Cosmetic Ingredient Database |
http://www.cir-safety.org/ |
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EU CosIng Database |
https://ec.europa.eu/growth/tools-databases/cosing/ |
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OECD eChemPortal |
http://www.echemportal.org/echemportal/ |
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EU ECHA Database |
http://echa.europa.eu/home |
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Looking forward to your participation! Click the picture below to register for free.
https://yjj.beijing.gov.cn/yjj/xxcx/kpxc/hzp36/543387815/index.html
