China’s novel food regulatory framework has been evolving rapidly in recent years, reflecting the country’s commitment to food safety and innovation. The National Health Commission (NHC) and the State Administration for Market Regulation (SAMR) have been at the forefront of these changes, introducing new regulations and updating existing ones to keep pace with the burgeoning novel food market.

In 2021, China saw a significant increase in novel food registrations, with over 100 applications submitted and several approvals granted. This surge in activity underscores the growing interest in novel foods among both domestic and international companies seeking to tap into the world’s largest consumer market.

Recent developments include the approval of cell-cultured meat for human consumption and the ongoing discussions surrounding the regulation of gene-edited crops. These advancements highlight China’s progressive stance on emerging food technologies and its commitment to fostering innovation while maintaining stringent safety standards.

Key Regulations Explained

1. Administrative Measures for Novel Food Registration

The cornerstone of China’s novel food regulatory framework is the “Administrative Measures for Novel Food Registration” (Order No. 4 of the National Health Commission), which came into effect on March 1, 2023. This regulation outlines the comprehensive process for registering novel foods in China, including:

• Definition of novel foods
• Application requirements and procedures
• Safety assessment criteria
• Labeling and marketing regulations

The measures align with international standards while incorporating China-specific requirements, such as the need for extensive toxicological studies and traditional Chinese medicine safety assessments where applicable.

2. Guidelines for Safety Assessment of Novel Foods

Complementing the Administrative Measures is the “Guidelines for Safety Assessment of Novel Foods” (GB 16740-2014), which provides detailed technical guidance for conducting safety evaluations. Key aspects include:

• Toxicological testing protocols
• Nutritional assessment requirements
• Allergenicity evaluations
• Environmental impact considerations

These guidelines reference other relevant standards, such as GB 5009.1-2021 for food safety national standards and GB 28050-2011 for nutrition labeling, ensuring a holistic approach to novel food safety.

3. Catalogue of Novel Foods

The “Catalogue of Novel Foods” is a dynamic document maintained by the NHC, listing all approved novel foods in China. It serves as a crucial reference for both regulators and industry stakeholders. The catalogue is regularly updated to include newly approved novel foods and their specific conditions of use.

4. Food Safety Law of the People’s Republic of China

While not specific to novel foods, the Food Safety Law (2015, amended in 2021) provides the overarching legal framework for all food-related regulations in China. Article 37 of this law specifically addresses novel food ingredients, emphasizing the need for safety assessments and approvals before market entry.

Strategies for Successful Novel Food Applications

Based on industry experience, here are key strategies to enhance the likelihood of a successful novel food application in China:

Comprehensive Pre-Application Planning:

1. Conduct thorough market research and regulatory intelligence gathering.
2. Develop a tailored regulatory strategy that aligns with both Chinese regulations and business objectives.
3. Identify potential gaps in the current regulatory strategy and address them proactively.

Robust Dossier Preparation:

1. Compile comprehensive administrative and technical documents.
2. Ensure all data and documents are accurate, complete, and consistent across the entire dossier.
3. Pay special attention to the quality of translations for technical accuracy and regulatory compliance.

Strategic Risk Management:

1. Conduct thorough risk assessments to identify potential regulatory hurdles.
2. Develop mitigation strategies for identified risks.
3. Continuously monitor and update risk assessments throughout the application process.

Effective Project Management:

1. Establish clear timelines and milestones for the application process.
2. Implement efficient resource allocation and budget utilization strategies.
3. Maintain clear communication channels with all stakeholders involved in the application process.

Quality Assurance and Compliance:

1. Implement rigorous quality control measures for all documentation.
2. Ensure consistent adherence to Chinese regulatory standards.
3. Regularly review compliance audit reports and regulatory intelligence updates.

Post-Submission Strategy:

1. Develop a hypercare post-submission strategy to address any queries promptly.
2. Maintain open lines of communication with regulatory authorities.
3. Be prepared to provide additional information or clarifications swiftly.

Leverage Local Expertise:

1. Collaborate with local regulatory experts who understand the nuances of the Chinese regulatory landscape.
2. Engage with subject-matter experts for additional layers of review and validation.

Continuous Monitoring and Adaptation:

1. Stay informed about regulatory updates and changes in the novel food landscape.
2. Be prepared to adapt the application strategy based on new developments or feedback from regulatory authorities.

By following these strategies and maintaining a proactive, thorough approach throughout the application process, companies can significantly improve their chances of successfully registering novel food ingredients in China.

Conclusion

China’s novel food regulations represent a significant step forward in balancing innovation with consumer safety. As the regulatory framework continues to evolve, it is crucial for all stakeholders to stay informed and engaged with the latest developments. A well-prepared, strategically planned application, coupled with a deep understanding of the regulatory landscape, can pave the way for successful novel food registrations in this dynamic market.

To navigate the complex landscape of China’s novel food regulations successfully, partner with Knudsen&CRC. Our experienced team of regulatory advisors specializes in managing novel food applications in China, providing comprehensive support and guidance throughout the entire registration process. Contact Knudsen&CRC today to ensure your novel food application meets all regulatory requirements and maximizes its chances of approval in the Chinese market.