ZMUni Compliance Centre

On September 13, 2024, China's National Center for Food Safety Risk Assessment, under the National Health Commission, issued a notice regarding the improvement of safety evaluation data requirements for "three new foods (new food additive, food ingredients, and food contact materials)." The release of this new regulation signifies a comprehensive opening for the application of synthetic biology new materials in the food sector!

Table 1. Compliance Pathways for Genetically Modified Microorganisms(GMM) in the Food Sector

In recent years, especially after the pandemic, changes in consumer demand for food ingredients and innovations in biotechnology have jointly driven the rapid development of synthetic biology in the food industry. Globally, food ingredients derived from synthetic biology are gradually receiving approvals, particularly in advanced economies such as the European Union, the United States, and Japan.

ZMUni Compliance Center believes that the "New Regulation" signifies China's gradual acceleration of the approval and regulation of synthetic biological food ingredients. This move grants these materials a "legal status," which will facilitate innovation and development in the synthetic biology economy.

Key Points for Applications/Reviews

1. Application Materials

 Applicants should submit relevant materials in accordance with the "Safety Evaluation Application Materials Requirements for Genetically Modified Microorganisms Used in Food Processing (Trial)," which mainly include:

-Product Information

-Relevant Information on Genetically Modified Microorganisms

-Safety Evaluation of the Recipient Microorganism

-Safety Evaluation of Genetic Modifications

2. Application Notes

-No residual exogenous genes in the final product.

-No residual live cells of genetically modified microorganisms in the final product.

3. Application Timeframe 

Following the "New Regulation," the application for new varieties of food additives involving genetically modified microorganisms will only involve one institution for review. The overall application timeframe is expected to be significantly shortened compared to previous processes.

ZMUni Thoughts

Looking back at the acceptance and approval dynamics of "three new foods" in recent years, particularly regarding new food ingredients and new varieties of additives, we can see the enthusiasm of companies in their applications and the positive market response.

Table 2. Acceptance and Approval Data for New Food Ingredients in China (2021 - First Half of 2024)

Table 3. Acceptance and Approval Data for New Varieties of Food Additives in China (2021 - First Half of 2024)

Although policies have been relaxed, companies should still pay attention to the review of new food ingredients and additive varieties by adhering to principles like safety for consumption and controllable quality. Before application, thorough evaluation and appropriate preparation should be conducted.

ZMUni Compliance Center has extensive experience in the application of new food ingredients and food additives both domestically and internationally. With our professional technical support and attentive service, we are committed to providing comprehensive compliance solutions for food and its ingredients.

Webinar Reminder

ZMUni will host a webinar on September 26 at 14:00 (London Time), focusing on the latest compliance requirements for the application of genetically modified food ingredients in China.

Looking forward to your participation! Click the picture below to register for free.