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

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:

1) Advancing the development of safety assessment systems;

2) Strengthening technical guidance;

3) Integrating ingredient data resources;

4) Innovating assessment report management mechanisms.

Significantly, China Pharmaceutical News' article disclosed that NMPA intends to introduce a transition period for the submission of the full version of safety assessment reports. Registrants and notifiers of cosmetic products that have commenced safety assessments prior to May 1, 2024, will be permitted to submit a simplified version of the report within a specified timeframe. The exact duration of the transition period, expected to be around six months, is subject to industry's feedback and expert's input, with the final measures to be issued by NMPA prevailing.

Relevant regulatory technical support departments are also actively developing and aiming to promptly publish technical guidance documents pertaining to cosmetic safety assessment. NMPA is committed to adopting assessment concepts and approaches that align with internationally accepted rules, to facilitate the market entry of imported cosmetics while standardizing safety assessment for Chinese domestic enterprises and reducing animal testing.

Compliance Suggestions for the Industry

Although the submission of the full version of safety assessment reports may experience a delay, it is crucial for companies to recognize that the implementation of the full version is inevitable. Therefore, it is essential to proactively prepare for this transition.

1) Accurate Planning: Enterprises should stay informed about the implementation date of the full version of the safety assessment, and proactively adjust their new product development and registration/notification plans accordingly;

2) Building a Qualified Team: Enterprises need to assemble a team of qualified safety assessment personnel who meet the requirements outlined in the Technical Guidelines. This may involve recruiting professionals or providing training to existing personnel to enhance their expertise;

3) Data Consolidation and Gap Filling: Enterprises should systematically review the ingredients used in their products, gather assessment conclusions and/or ingredient safety data from authoritative institutions, and address data gaps. Besides, it is important to stay updated on new safety assessment approaches and tools;

4) Collaboration and Resource Sharing: When necessary, companies can seek external expert consultants and/or establish partnerships with professional research institutions to initiate research projects on cosmetic ingredients and formulas, create data sharing platforms, and foster resource sharing.

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.

Further Reading

• China Details Cosmetic Safety Assessment Requirements

• China NMPA Consults on the Key Points for Reviewing of Cosmetic Safety Assessment Report