Cosmetic Product Safety Assessment Report (CPSR) Now Mandatory in China Starting May 1, 2025

Cosmetic Product Safety Assessment Report (CPSR) are now mandatory in China starting May 1, 2025 for cosmetics filings and registrations. Cosmetic registrants and filers must now submit the complete PSAR to the National Medical Products Administration (NMPA) or the relevant provincial Medical Products Administration (MPA), as simplified reports are no longer accepted under the new lifecycle-based oversight framework.

Background and Purpose

Measures to optimize China cosmetic safety assessment management were announced by the National Medical Products Administration (NMPA) on April 22, 2024. The measures are based on the following existing regulations and seek to further improve the safety of cosmetics:

Cosmetic Supervision and Administration Regulations
Measures for the Registration and Filing Management of Cosmetics
Cosmetic Safety Assessment Technical Guidelines (2021 Edition)

Cosmetic safety assessment data will now be managed in categories, permitting some qualified general cosmetics to submit basic conclusions of safety assessment, and the Product Safety Assessment Report must be kept on record by cosmetics companies.

Cosmetic registrants and filers can submit simplified Product Safety Assessment Reports until May 1, 2025. This takes into account the time requirements to obtain documentary evidence.

In addition to the above, welcomed extensions to the PSAR requirements, the NMPA also released information on their plans to introduce various guidelines, principles, systems and indices as well as their desire to open industry communication. Some guidelines may already have been released.

Key Measures in the PSAR Optimization Strategy

1. Strengthening Technical Guidance:
New guidelines clarify safety assessment methods, toxicological thresholds, and ingredient risk analysis. Technical standards now cover stability testing, preservative challenge testing, and packaging compatibility.
2. Enhancing Raw Material Data Access:
Enterprises are encouraged to use indexed data from international sources and domestic products. A shared data platform is under development to support consistent ingredient safety assessment.
3. Improving Assessment Report Mechanisms:
A category-based PSAR submission system is being adopted, allowing simplified conclusions for eligible products. Safety testing guidance is also provided for products lacking raw material data.
4. Advancing Lifecycle Safety Systems:
Enterprises must manage product safety across the full lifecycle. This includes pre-market assessments, post-market monitoring, reassessment, talent training, and inter-industry technical collaboration.

Further Information

To read the original announcement about the measures to optimize China cosmetic safety assessment management released by the National Medical Products Administration (NMPA), please click here.

If you are a cosmetic product manufacturer with questions about how the full PSAR submission requirements affect your product registration in the China market, please contact Cisema.