China Officially Grants One-Year Buffer Period for Submission of Cosmetic Safety Assessment Report (Full Version)

On April 22, 2024, China National Medical Products Administration (NMPA) unveiled the "Announcement on Issuing Several Measures to Optimize Cosmetic Safety Assessment Management", pointing out that before May 1, 2025, cosmetics registrants and notifiers can still submit a simplified version of the safety assessment report that meets the requirements of the Technical Guidelines when applying for registration or notification. This move recognizes the time required for cosmetics research and development and aims to alleviate the burden on enterprises and facilitate a smooth transition to the full version of the safety assessment.

The announcement also clarifies the implementation of classified management of safety assessment dossiers, allowing notifiers of qualified general cosmetics to submit safety assessment conclusions, and archive the safety assessment report for future reference.

Notably, the announcement indicates a one-year delay in enforcing the full version of the safety assessment report, now extending until May 1, 2025. During this buffer period, both full and simplified versions of the safety assessment will run in parallel, providing flexibility for cosmetics registrants and notifiers to choose the most suitable approach based on their specific circumstances.

Specific Measures

Accompanying the announcement, the NMPA has attached a document titled "Several Measures to Optimize Cosmetic Safety Assessment Management (the Optimization Measures)," which provides further detailed guidelines to help enterprises conduct safety assessments in a standardized manner. Effective from May 1, 2024, the Optimization Measures consist of four parts and twelve articles, with the following key contents:

1. Strengthening Technical Guidance

• Formulating and publishing technical guidelines concerning assessment methods such as read-across, threshold of toxicological concern (TTC) as well as integration strategy, to enhance the assessment methods' applicability, particularly in addressing safety assessment challenges for ingredients with large safety data gaps like plant extracts and fermentation ingredients;

• Formulating and publishing the Technical Guidelines for Identification and Assessment of Cosmetic Risk Substances to improve the effective identification and control of risk substances;

• Formulating and publishing technical guidelines for cosmetic’s physical and chemical stability testing, preservative challenge testing, packaging compatibility testing, etc., to strengthen research on product quality stability. Additionally, enterprises are allowed to conduct research using self-built methods and submit relevant tests or assessment conclusions, which provide them with operational flexibility.

2. Integrating Ingredient Data Resources

• Formulating and publishing guidelines for the use of cosmetic ingredient data to standardize the use of ingredient safety assessment data;

• Establishing a cosmetic ingredient safety database by integrating and publishing data information related to ingredient safety assessment. This will involve collecting, collating, and compiling an index of cosmetics safety assessment data from international authoritative organizations, as well as collecting information on ingredient usage in marketed products.

• Building an industry-wide cosmetic ingredient data sharing platform to facilitate the exchange of information.

3. Implementing Classified Management for Safety Assessment Report

• Formulating and publishing the Guidelines for Submission of Cosmetics Safety Assessment Dossiers. Based on risk management principles and considering product specifics, enterprise quality management, etc. the Guidelines is designed to classify the situations where safety assessment reports are submitted. Products with higher risks, such as children's cosmetics, freckle-removing and whitening cosmetics, etc., still require the submission of complete safety assessment reports. While for products with lower risks, companies are only mandated to provide safety assessment conclusions, with the safety assessment report be archived for future reference.

• Allowing companies to conduct final product safety testing (including animal testing and in vitro testing) as a supplement for safety assessment in the absence of individual ingredient safety data. The conclusions and safety assessment reports from these tests can be used as a basis for product safety evaluation.

4. Promoting the construction of safety assessment system

• Strengthening safety assessment-related infrastructure.

• Implementing the management responsibilities of cosmetics companies for the entire product life cycle.

• Supporting the development of safety assessment disciplines and training for professional talents.

• Enhancing exchanges and technical cooperation in cosmetics safety assessment.

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.