Inside Scoop: China to Optimize Cosmetic Safety Assessment Management

According to an unofficial draft document currently circulating in the industry, the proposed optimization measures for safety assessment encompass the following key points: 1) Introduction of a six-month transition period; 2) Enhancement of technical guidance; 3) Integration of ingredient data resources; 4) Implementation of a classified management system for assessment reports.

Background

As per the Technical Guidelines for Cosmetic Safety Assessment, until May 1, 2024, registrants and notifiers of cosmetics have the option to submit a simplified version of the product safety assessment report during product registration or notification process. However, starting from May 1, 2024, registrants and notifiers should submit the full version of safety assessment report. Due to difficulties such as the lack of toxicological data for various ingredients and the shortage of safety assessment personnel, the shift to the full version of the safety assessment report presents a challenge for the industry.

According to the official industry newspaper of National Medical Products Administration (NMPA) on March 15, 2024, NMPA is organizing research and formulating multiple measures to optimize the management of cosmetics safety assessment.

Recently, an unofficial draft document titled "Several Measures to Optimize Cosmetic Safety Assessment Management" is widely circulating and sparking extensive discussion in the industry. Key information of the document includes the proposal of a six-month transition period, as well as various optimization measures concerning the ingredient safety database and the submission system for safety assessment reports. It is crucial to note that this document is not the official version. The final document to be issued by NMPA will take precedence.

1. Setting a Six-month Transition Period

1) Starting from May 1, 2024, cosmetics registrants and notifiers shall conduct safety assessment in accordance with Technical Guidelines for Cosmetics Safety Assessment. Registrants and notifiers that have started safety assessment before May 1, 2024, and apply for registration and notification before November 1, 2024, are allowed to submit a simplified version of the report;

2) Starting from November 1, 2024, ingredients’ highest historical use concentration listed in the Inventory of Existing Cosmetic Ingredients cannot be utilized as evidence to demonstrate ingredient safety.

2. Strengthening Technical Guidance

1) Improving the applicability of technical methods such as read-across, threshold of toxicological concern (TTC), and integration strategy. On March 19, 2024, the draft guidelines for the application of TTC method and read-across method were published;

2) Guidelines for physical and chemical stability, preservative challenges, and packaging material compatibility testing are under formulation. Enterprises can conduct relevant research in accordance with national standards, technical specifications, industry standards, or internationally recognized standards, technical guidelines, and validated methods endorsed by the enterprise, and include the testing conclusions in their safety assessment report.

3. Integrating Ingredient Data Resources

1) Recognizing ingredient usage history of marketed products as a source of ingredient safety data;

2) Compiling an index of cosmetics safety assessment data from international authoritative organizations;

3) Collecting information on ingredient usage in marketed products to establish a cosmetic ingredient safety database. Additionally, a data sharing platform will be developed to facilitate the exchange of information.

4. Classified Management for Safety Assessment Report

1) Depending on the product situation and the enterprise's quality management and safety assessment system, enterprises are permitted to archive safety assessment reports for certain general cosmetics for future reference. Authorities retain the right to conduct reasoned inspection;

2) Guidelines for self-examination of safety assessment reports will be published to provide guidance to enterprises.

With extensive experience in cosmetic registration and notification, ChemLinked’s parent company REACH24H Consulting Group offers compliance solutions to assist overseas cosmetic enterprises entering into China market. Welcome to contact us at [email protected] for more advice.