In April 2021, the China National Medical Products Administration (NMPA) issued the "Technical Guidelines for Cosmetic Safety Assessment (2021 Edition)" (referred to as the "Guidelines" below), which officially came into effect on May 1, 2021. The requirements are as follows:
According to the "Guidelines", ZMUni Compliance Centre has summarized the requirement differences between the simplified and the complete version of the CPSR as follows:
|
Item |
CPSR - Simplified Version |
CPSR - Complete Version |
|
Safety assessment of the ingredients in the formulation |
Acceptable evidence includes: 《Technical Specifications for Cosmetic Safety》 Evaluation conclusions from authoritative institutions at home and abroad Historical usage data of the company Maximum historical usage data of the raw materials (IECIC). |
Toxicological information of the raw material (hazard identification) Risk characterization of the raw material calculating margin of safety (MoS), etc.) |
|
Safety assessment conclusion |
√ |
Preservative challenge testing results Physical and chemical characteristics, stability testing results of the product Compatibility evaluation results of products and packaging |
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Abstract |
√ |
√ |
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Product introduction |
√ |
√ |
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Product formulation |
√ |
Table of actual ingredient content in the product |
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Formulation design principles (for children's cosmetics only) |
√ |
√ |
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Safety assessment of possible risk substances |
√ |
√ |
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Risk control measures or recommendations |
√ |
√ |
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Signature of safety assessment personnel |
√ |
√ |
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Resume of safety assessment personnel |
√ |
√ |
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References |
√ |
√ |
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Appendices/Annexes |
√ |
√ |
Current Challenges
Overall, many cosmetic companies are currently facing various difficulties in submitting the CPSR, such as a lack of toxicological data for raw materials, a shortage of personnel skilled in safety assessment, differences in domestic raw material standards, and inadequate safety assessment capabilities.
Possibility of Policy Extension
Currently, China NMPA has not indicated whether the implementation of this policy will be extended. Cosmetic evaluation departments in various regions, including Beijing, Zhejiang, Hainan, and Liaoning, have also stated that there is no news of a delay in implementation.
Recommendations from ZMUni Compliance Center
For general cosmetics, companies can proactively plan their product launch schedule and complete the filing process before May 1st of next year. For special cosmetics, as the implementation date for the complete version of CPSR approaches, companies can first evaluate whether their products can meet the requirements of the complete version, ensuring a smooth market launch.
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