ZMUni Compliance Centre

On April 22, 2024, the China National Medical Products Administration released an Announcement on Implementing Several Measures to Optimize Cosmetic Safety Assessment Management (hereinafter referred to as the Announcement). The Announcement takes effect from May l, 2024.

The critical points of the Announcement and its associated attachment, Several Measures to Optimize Cosmetic Safety Assessment Management (referred to as the Measures), which include 12 specific measures, are summarized as follows:

1. Extended Use of Simplified Version of Cosmetic Safety Assessment Reports (or CPSR)

 Until May 1, 2025, when applying for registration or filing, cosmetics registrants and filers can still submit simplified safety assessment reports that comply with the Technical Guidelines for Cosmetic Safety Assessment (2021 Edition).

This means that during the upcoming one-year transition period, companies can either submit the full version of the cosmetic safety assessment reports or the simplified version (if companies haven't had enough time to prepare fully).

2. Implementation of Classified Management for Safety Assessment Reports

The government intends to develop and release guidelines for the submission of cosmetic safety assessment reports based on international best practices. Under this framework, the submission of safety assessment reports will be categorized. Certain general cosmetics are only required to submit basic safety assessment conclusions, while the safety assessment reports will be archived by relevant cosmetic companies for future reference. However, high-risk products such as children's cosmetics and whitening products will necessitate the submission of full-version safety assessment reports. The implementation of classified management aims to enhance the efficiency of safety assessment report submissions and prevent resource wastage.

3. Formulation and Release of Ingredient Lists

Currently, the Inventory of Existing Cosmetic Ingredients in China includes nearly 9,000 ingredients, of which only 3,500 have supporting evaluation data. The absence of data for over 5,000 ingredients severely hampers the implementation of comprehensive safety assessment management.

Therefore, the Measures propose the integration and release of data pertaining to cosmetic ingredient safety assessments. Furthermore, efforts will be made to establish and enhance a platform for sharing ingredient data. By collecting, organizing, and publishing authoritative international indices of cosmetic safety assessment data and information regarding ingredient usage in marketed products, the cosmetic ingredient information database will gradually improve. This database will serve as a valuable reference for cosmetic companies in conducting safety assessments.