China Simplifies Safety Assessment Requirements for NCIs and Accelerates Product Launches Using NCIs

Background

Since the implementation of the Cosmetic Supervision and Administration Provisions (CSAR) in 2021, the China National Medical Product Administration (NMPA) has introduced a risk-based classification system for cosmetic products and NCIs. High-risk NCIs must undergo registration with the NMPA, while low-risk NCIs only need to be notified and can subsequently be manufactured and imported once enterprises complete the online dossier submission. This streamlined process reduces the market entry threshold for NCIs in China.

However, the cosmetics industry still faces several challenges and constraints in areas such as technical requirements for NCIs, guidance services, standard setting, and enhancing innovation capabilities.

On February 6, 2025, China’s National Medical Products Administration (NMPA) released and implemented Several Provisions on Supporting Innovation of Cosmetic Ingredients. ¹ The Provisions outlines nine specific measures from multiple dimensions, including classification management, review and approval, and standard setting, with the aim of systematically supporting innovation in cosmetic ingredients and promoting high-quality development in the industry.

To ensure effective implementation of the Provisions, the NMPA also released an official policy interpretation, detailing the drafting purpose, formulation principles, key points, and technical requirements. ²

The Provisions can be summarized into the following three key points:

1. Simplifying Safety Assessment Requirements for NCIs

Based on the characteristics, functions, and innovation levels of ingredients, the Provisions classifies NCIs into three categories: "NCI used for the first time at home and abroad," "NCIs with a substantial safety history," and "NCIs Innovated from existing ingredients," each with differentiated safety assessment requirements.

NCI Type	Safety Assessment Related Requirements
NCIs used for the first time at home and abroad	Safety assessment requirements to be optimized based on actual risk levels, allowing for the reduction or exemption of some toxicological testing and long-term human trial safety testing
NCIs with a substantial safe use history	To clarify the standards for determining and researching safe usage and consumption history, to strengthen the utilization of existing data, and to simplify the requirements for safety assessment
NCIs Innovated from existing ingredients	To establish technical requirements based on a thorough review of the ingredient’s safe use history. To clarify pathways for changes to marketed NCIs, and develop technical guidance for the changes.

2. Establishing a Concurrent Application Mechanism for NCIs and Related Products

1) Establishing a concurrent application mechanism for NCIs and related products

During the NCI registration and notification, registration applications for special cosmetics using these NCIs are allowed to be submitted simultaneously.

This initiative will enhance the efficiency of the review and approval process for NCIs and cosmetic products using them, as well as accelerate the market launch of products using NCIs.

2) Establishing dedicated review channel

For NCIs that meet specific conditions and are intended for initial marketing in China, and that are developed using modern science and technology alongside traditional Chinese projects and characteristic plant resources, the NMPA will provide early engagement and comprehensive guidance throughout the entire process. This aims to enhance the quality of NCI research and development and expedite the application process.

For NCIs that meet the above conditions and are submitted for registration, as well as special cosmetics utilizing these NCIs, a dedicated review channel will be established to prioritize reviews and expedite the launch of NCIs and products.

3. Improving Safety Monitoring Period Management

The Provisions allows companies to update production processes without altering the monitoring period, ensuring that the sales of already marketed products remain unaffected. This flexibility reduces the market risks caused by technical adjustments.

In addition, the Provisions includes measures to strengthen technical guidance and communication for NCIs, enhance guidance on ingredient standards research, promote the formulation and revision of these standards, reinforce foundational research related to ingredients, improve the information infrastructure for cosmetic ingredients, and deepen the application of alternative methods in NCI safety assessments.

Industry Comments

Chen Laicheng, founder of Guangzhou Mashanghui Biotechnology Co., Ltd. and a senior R&D engineer in cosmetics, believes the Provisions facilitates the incorporation of registered and notified NCIs into cosmetic products. It significantly benefits companies and brands that have invested heavily in cosmetics research and innovation. Regulatory authorities have streamlined the registration and notification processes for cosmetics using NCIs, enabling quicker product launches and shortening the new product development cycle.