China May Provide Six-month Transition Period for Submission of Cosmetic Safety Assessment Report (Full Version)

1) The regulatory authorities are developing and aiming to promptly publish optimization measures and technical guidance documents pertaining to cosmetic safety assessment; 2) Regarding the submission of full version of safety assessment reports, a six-month transition period is under consideration. Registrants and notifiers of cosmetic products that have already started safety assessments before May 1, 2024, will be allowed to submit a simplified version of the report within a specified timeframe.

Background

As per the Technical Guidelines for Cosmetic Safety Assessment (hereinafter referred to as “Technical Guidelines”), 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.

On March 15, 2024, China Pharmaceutical News, the official industry newspaper of National Medical Products Administration (NMPA), published an article titled "NMPA to Optimize Cosmetic Safety Assessment Management" on their WeChat public account. ¹ The article disclosed that NMPA, after conducting extensive preliminary research, is organizing research and formulating multiple measures to optimize the management of cosmetics safety assessment. According to QingYan, a Chinese media focusing on cosmetic industry, an official from a provincial MPA revealed that specific details pertaining to the optimization measures were anticipated to be released by the end of March or early April. ²

The optimization measures encompass 4 key areas with a total of 12 measures, aiming to provide further detailed guidelines for the implementation of cosmetic safety assessment: