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CSAR Subsidiary Regulations: China Consults on the Draft Technical Guidelines for Cosmetic Safety Assessment

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 to ensure a smooth transition.

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 huazhuangpinchu@163.com.

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.

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