Q&A on Legal Risks and Compliance of Synthetic Biology Commercialization for Food Manufacturing

On July 28, 2023, we held a Chinese webinar on the commercialization of synthetic biology for food manufacturing. Many questions were raised during the webinar. We have collected the questions and summarized the answers below:

Q: Is it possible to use engineering bacteria to apply for new food raw materials for products such as sialic acid and hyaluronic acid?

A: At present, substances involving genetically modified technology can’t be registered as new food raw materials.

Q: If a product uses genetically modified microorganisms but the final product doesn’t contain genetically modified fragments. Will it be considered a genetically modified product?

A: No, the final product won’t be considered a genetically modified product. However, the application process required is not significantly different from that of genetically modified products.

Q: Are there any legal methods and regulatory approaches for the inspection of genetically modified fermentation and wild strains fermentation?

A: You can make reference to GB/T 19495 Detection of Genetically Modified Organism and Derived Products, and related analysis methods announced by the Ministry of Agriculture and Rural Affairs (MARA). Specific detection methods are determined based on the gene editing modes and the situation of standard substances. Enterprises should take the initiative to reveal their use of genetically modified strains for fermentation. Business activities could not be carried out until they have obtained approval.

Q: We know that MARA normally organizes two review meetings each year. When are the meetings usually held?

A: Usually in July and December each year. The specific time is according to MARA's schedule.

Q: Many enterprises are currently applying for the registration of human milk oligosaccharides (HMOs) as food additives. What are the differences between new food additives and new food raw materials? Can I apply for the registration of sialic acid and hyaluronic acid as food additives?

A: The differences between new food additives and new food raw materials need to be analyzed from multiple perspectives, such as their roles in food products. More details could be found in our previous webinars on New Food Raw Materials or New Food Additives. How Should Enterprises Choose the Direction of Application?

Sialic acid and hyaluronic acid have already been approved as new food raw materials. However, new food raw materials and new additives are not under cross-management in China, thus the two substances cannot register as new food additives.

Q: Is an application required for strains not included in the List of Strains that can be used in food?

A: Strains used for food production and processing are allowed to be used as usual. For those new strains not included in the List, related enterprises shall comply with the registration in accordance with the requirements of Measures on the Safety Review of New Food Raw Materials.

Q: I intend to register one ingredient as a new food raw material. However, one raw material of this ingredient has not finished the compliance process, do I have to apply to register this raw material as a raw material too?

A: Generally speaking, there is no specific requirement on the ingredients of new food raw materials. However, circumstances alter cases, you need to determine whether a safety assessment is also needed for the ingredients of the new food raw materials while applying for new food raw material registration.

Q: The definition of food additives and new food raw materials share some similarities. Is there any criterion for us to clearly distinguish these two ingredients?

A: There are no clear differentiation criteria, but some rules may still help us tell the difference. For example, food additives are substances used to improve food quality and serve the food itself, whereas for food raw materials the emphasis is more on the nutritional properties of the substance. For more information on the differences, please refer to the answer to Question 5.

Q: Do I have to submit the experiment design in the sixth part of the materials for genetically modified microorganism safety evaluation?

A: Yes. All documents required by the regulations must be submitted.

Q: Is it true that all the ingredients used in new food raw materials must be food grade? What are the requirements for this?

A: There is no specific regulatory requirement for the ingredients used in new food raw materials.

Q: In terms of the application of new food-related materials involving engineering bacteria production (genetic modification), what do you know?

A: The application channel for this kind of substance is not available yet, and we estimate that it’s likely to be available in the future along with the application of genetically modified new food raw materials.

We have prepared a series of free webinars throughout the year, to find out more, please visit the CIRS Food - Upcoming Free Webinars in 2023.

If you need any assistance or have any questions, please get in touch with us via service@hfoushi.com.