Decoding the Full Version of Safety Assessment in China: Regulatory Updates and Changes

Jun. 25th, 2024

Inna Fu

Free


Under CSAR framework, cosmetics registrants and notifiers are required to submit product safety assessment documents during registration and notification. Until May 1, 2024, they have the option to submit a simplified safety assessment report. However, from May 1, 2024 onwards, the full version of the assessment report must be submitted.

Considering industry challenges, China’s National Medical Products Administration (NMPA) has extended the transition period. Registrants and notifiers can still submit a simplified safety assessment report before May 1, 2025, as long as the assessment was started before May 1, 2024.

To guide companies, in April 2024, NMPA issued several new regulatory documents related to safety assessment. This includes guidelines that classify submission requirements based on risk management principles and provide self-examination points for the assessment reports.

No. Regulatory Documents
1 Guidelines for Submission of Cosmetics Safety Assessment Dossiers
2 Guidelines for Cosmetic Ingredient Data Usage
3 Technical Guidelines for Identification and Assessment of Cosmetic Risk Substances
4 Index of Cosmetics Safety Assessment Data from Authoritative Organizations
5 Ingredient Usage Information of Marketed Cosmetic Products
6 Technical Guidelines for Application of Threshold of Toxicological Concern (TTC) Method
7 Technical Guidelines for Application of Read-across
8 Technical Guidelines for Stability Evaluation of Cosmetics (Draft)
9 Technical Guidelines for Cosmetic Preservative Challenge Testing (Draft)
10 Technical Guidelines for Compatibility Evaluation of Cosmetics with Packaging Materials (Draft)

With these supporting policies and optimization measures, the full safety assessment report system can be effectively implemented in China’s cosmetics industry. ChemLinked invited an experienced regulatory specialist, Inna Fu from REACH24H, to explain the requirements for cosmetic safety assessment in China and highlight important regulatory updates and changes.

Notes:

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Contents


1. Brief Introduction of Cosmetic Safety Assessment Requirements in China

2. Optimized Cosmetic Product Safety Report (CPSR): Important Regulatory Updates and Changes

3. Q&A

Schedule


Date Time (GMT+8) World Clock Language
2024-06-25 22:00 ~ 23:00 London: 15:00-16:00 New York: 10:00-11:00 English

Speaker


Inna Fu

Cosmetic Regulatory Specialist

Inna Fu is an EU certified cosmetic safety assessor and accumulated a lot of experience on the safety assessment both for cosmetic products and ingredients from her daily work, she is also sophisticated in providing professional consulting services on cosmetic regulations, especially for China and EU.

Contact REACH24H


If you have any questions regarding this webinar, please feel free to contact us.

Tel: +86 400 809 5809

Email: customer@reach24h.com