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On July 29, 2020, China National Medical Products Administration released the draft Technical Guidelines for Cosmetic Safety Assessment for public consultation [1], which is one of the subsidiary measures of CSAR and the revised version of the previous Guidance for Cosmetic Safety Risk Assessment. The public consultation will last until August 30, 2020. Any suggestions can be mailed to [email protected].
Main Content of the Draft Guideline
1. Safety Assessment Requirements for Cosmetic Ingredients and Products
Scope of application
Basic principles and requirements
Safety assessors’ requirements
Risk assessment procedures
Toxicology research
Ingredient risk assessment
Product safety assessment
Safety assessment report
Instruction
Terms and definition
2. Four Annexes
Cosmetic ingredient risk assessment report
Cosmetic product safety assessment report
Operation procedures of cosmetics anti-corrosion efficacy evaluation method
Guidelines for the implementation of cosmetic safety assessment operations
3. Two Samples
Overall safety analysis of the product formula
Safety assessment report of body lotion
The Content of the Cosmetic Ingredient Risk Assessment Report and Product Safety Assessment Report
Report Contents
The draft guideline clarifies the content of the ingredient risk assessment report and product safety assessment report.
Ingredient Risk Assessment Report | Product Safety Assessment Report |
1. Summary 2. Ingredient physical and chemical properties 3. Risk assessment process: hazard identification, dose-response assessment, exposure assessment, risk characterization 4. Analysis of risk assessment results, including the analysis of the completeness, reliability, and scientificity of the documents in the risk assessment process and data uncertainty analysis. 5. Risk control measures or recommendations 6. Conclusion of risk assessment 7. signature of the risk assessor 8. Resume of the risk assessor 9. References 10. Annexes, including testing reports, proof of involved ingredients specifications. If there is a risk substance, the risk substance assessment conclusion and documents, or the risk substance testing report shall be provided | 1. Summary of safety assessment 2. Product introduction 3. Product formula 4. Formula design principles (only for children cosmetics) 5. Safety assessment of each ingredient in the formula: hazard identification, dose-response assessment, exposure assessment, risk characterization 6. Assessment of possible risk substances 7. Risk control measures or recommendations (such as warning, usage methods) 8. Safety assessment conclusions, generally including product physical and chemical stability assessment conclusions; product microbiological stability assessment conclusions; human safety data, including clinical data, consumer use research, adverse reaction records; testing conclusions, assessment conclusions of each ingredient) 9. Signature of safety assessor 10. Qualification certificate of safety assessor (resume) 11. References 12. Annexes, including testing reports, proof of involved ingredients quality specifications, etc. |
Transitional Measures
Considering that there is a gap between the safety assessment capacity of China's cosmetic industry and that of the developed countries, the draft sets a transitional period, during which the enterprises can provide a relatively simple "Product Formula Overall Safety Analysis” to substitute the cosmetic product safety assessment document.
Product Formula Overall Safety Analysis |
1. Summary 2. Product introduction, including product name, usage method, average daily usage, retention factor, exposure dose, etc. 3. Formula analysis (only for children cosmetics) 4. Safety assessment of each ingredient in the formula, including the standard Chinese names of all ingredients in the formula, ingredient/raw material percentage in the formula, the risk assessment of ingredient/raw material, etc. 5. Safety assessment of possible risk substances. Identify the risk substance that may be contained in the product and assess its safety 6. Safety assessment conclusion 7. Signature of safety assessor 8. Resume of safety assessor 9. References 10. Annexes |
Points for Attention
Cosmetic registrants and notifiers shall conduct cosmetic safety assessments on their own or entrust professional institutions.
The safety assessment documents shall be updated in time as needed, and the storage period should be at least ten years after the shelf life of the last batch of products on the market.
If the cosmetic safety assessment report's conclusion is not sufficient to rule out the risk of the product to human health, the toxicology test method should be used for product safety assessment.
After analyzing the relevant data, the following ingredients' relevant assessment conclusion can be adopted if they meet the requirements of Chinese cosmetic regulations. If the assessment results of different authoritative organizations are inconsistent, the relevant assessment conclusions shall be adopted according to the data's reliability and relevance.
The ingredient in which the international authoritative cosmetic safety assessment institution has announced the assessment conclusion. |
The ingredient which the authoritative organizations such as WHO, FAO, OECD have announced safety limits (such as Acceptable Daily Intake, Tolerable Daily Intake, Reference Dose) or conclusion (such as Generally Recognized As Safe Substances, with a long history of eating). Local toxicity is required risk assessment separately if there is no local toxicity data. |
The fragrance that meets the International Fragrance Association (IFRA) standards. |
Qualification Requirements for Safety Assessors
Cosmetic safety assessors should meet the following requirements:
Have professional knowledge of cosmetics quality and safety such as medicine, pharmacy, chemistry or toxicology, understand the cosmetic production process and quality and safety control requirements, and have more than five years of relevant professional experience.
Be able to consult and analyze chemistry, toxicology, and other related literature information, analyze, assess, and interpret relevant data.
Be able to analyze cosmetics' safety fairly and objectively and conduct safety assessments based on a comprehensive analysis of all available data and exposure conditions.
Be able to regularly receive corresponding professional training, learn relevant knowledge of safety assessment, understand and master new safety assessment theories, techniques and methods, and use them in practice.
The resume of the safety assessor should be attached to the safety assessment report. The resume should include the assessor’s educational experience, cosmetics industry experience, professional training experience, etc.
ChemLinked Comment
The draft guidelines clarify the basic requirements of safety assessors, the requirements and operating guidelines for safety assessment reports, attach corresponding samples and set transitional measures considering China's actual safety assessment capacity. But the duration of the transitional period is unclear.
Whether the safety assessment report issued by foreign institutions can be used or whether the foreign safety assessor is recognized has not been clearly stated. Also, safety assessors are required to have at least five years of relevant professional experience. Currently, such talents in China are relatively in short supply. It is hoped that during the transitional period, there could be relatively loose requirements for safety assessors.
Related Resources:
News 1: China Finalized the Long-Awaited Cosmetic Supervision and Administration Regulation
News 2: Finalization of CSAR: A Milestone on Road to Modernization of China's Cosmetic Sector
News 3: Key Points in China Cosmetic Supervision and Administration Regulation (CSAR)
News 5: Will China Remove Mandatory Animal Testing for Imported General Cosmetics?
News 8: CSAR Subsidiary Regulations: China Releases the Draft Cosmetic Classification Rules and Catalog
Webinar: Understanding China's New Draft Subsidiary Measures of CSAR
Webinar (Live Streaming): Interpretation of China's Cosmetic Supervision and Administration Regulation (Final Version)
English Translation: Supervision and Administration Measures on Cosmetics Manufacture and Operation
English Translation: Administrative Measures on Cosmetic Registration
English Translation: Cosmetic Supervision and Administration Regulation 2020
English Translation: Cosmetic Classification Rules and Catalog
English Translation: Technical Guidelines for Cosmetic Safety Assessment
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