In China, Cosmetics Supervision and Administration Regulation (CSAR) requires submission of safety assessment report for cosmetic products and new cosmetic ingredient for notification or registration purpose. In April 2021, China National Medical Products Administration, NMPA, issued Notice No. 51, namely Technical Guideline of Cosmetic Safety Assessment, providing detailed requirements on the scope and format of safety assessment, qualification of safety assessors, testing reports etc, with examples of safety assessment reports.
Safety assessment format of a cosmetic product includes several sections,
• Abstract (summary of assessment)
• Product introduction
• Product formulation
• Safety evaluation of each composition
• Safety evaluation of risk substances
• Risk control measures or recommendations
• Safety conclusion
• Signature of safety assessor
• Resume of safety assessor
CSAR and this Technical Guideline require certain level of qualification of safety assessors to perform the assessment. The cosmetic safety assessors shall
• Possess professional knowledge in areas such as medicine, pharmacy, chemistry or toxicology.
• Well understand the requirement of manufacturing process, as well as, safety and quality control of a cosmetic product
• Have more than 5 years of relevant working experience
This Technical Guideline is implemented since 1st May 2021. Transition period is also given to the cosmetic industry.
• Since 1st January 2021, notifiers or registrants for a general cosmetic product or special cosmetic product shall submit safety assessment report according to this Technical Guideline.
• Before 1st May 2024, notifiers or registrants for a general cosmetic product or special cosmetic product are allowed to submit safety assessment report with simplified version as described in the Technical Guideline.
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