CIRS FAQ: For Food Additives Listed in GB 2760 involving New Synthetic Biology Processes, Is the Safety Assessment from the Ministry of Agriculture Required Only? Vol. 05, 2024

From our years of regulatory compliance experience, we’ve translated a selection of some frequently asked questions on new food raw material and new food additive to help you gain a clearer understanding of the current requirements in China.

1. How is genetic modification defined? And what constitutes a genetically modified microorganism (GMO)?

According to the Measures for the Administration of the Safety Evaluation of Agricultural Genetically Modified Organisms, agricultural genetically modified organisms refer to animals, plants, microorganisms, and their products whose genetic makeup has been altered using genetic engineering techniques for agricultural production or processing.

Genetic engineering techniques include the use of recombinant DNA technology with vector systems, as well as methods involving physics, chemistry, and biology to introduce recombinant DNA molecules into organisms. In simple terms, any microorganism whose genome has been modified using genetic engineering techniques qualifies as a GMO.

2. When applying for a fermented product involving genetically modified (GM) process as a new food additive, does the Ministry of Agriculture assess the safety of the GM microorganism or the safety of the fermented product?

The Ministry of Agriculture and Rural Affairs (MARA) is responsible only for evaluating the safety of the GM microorganism used in the food additive. The process is rather complex and requires assessment or approval from the following two regulatory departments:

1. MARA: Responsible for assessing the safety of the GM microorganism used in the additive;
2. The National Health Commission (NHC): Responsible for approving the final fermented product (new food additive).
3. For food additives in GB 2760 that involve new synthetic biology processes, is only the safety assessment for GM microorganisms from the Ministry of Agriculture required?

No. The final new food additive application is also required. As mentioned above, MARA is only responsible for evaluating the safety of the GM microorganisms used in the new food additive, which the final additive, which is different from the approved production process, still needs to be reviewed and approved. Click here to learn more about our genetically modified microorganism food additive registration service.

3. When applying for food additives or raw materials, can methodological validation be conducted by the company itself, or is it necessary to commission to a third-party service?

Currently, no regulations provide clear guidance on this matter. Based on our past experience, we recommended that:

(1) When applying for food additives involving new methods, methodological validation should be conducted at a third-party lab;

(2) When applying for new food raw materials involving new methods, methodological validation should be conducted at three third-party labs.

4. When applying for new food raw materials or new food additives, can toxicological testing be exempted if authoritative toxicological data for the same substance can be found?

It’s important to note that a similar substance is not necessarily the same as the specific substance being applied. Applicants must provide toxicological safety assessment data specifically for the substance being applied, which can be reported from foreign GLP labs but must pertain to the substance manufactured or supplied by the applicant. While publicly available toxicological data for a similar substance conducted by others can be considered as a reference, it cannot directly substitute the applicant’s own safety assessment data for the substance being applied for.

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

Further Information

CIRS FAQ: Is It Necessary to Establish Animal Function Evaluation Methods while Applying for New Health Functions? Vol. 01, 2024

CIRS FAQ: Can Approved New Food Raw Materials Be Used in FSMP? Vol. 02, 2024

CIRS FAQ: Can Different Companies Use the Same Formula to Apply for Health Food Filing? Vol. 3, 2024

CIRS FAQ: Which FSMP are Eligible for Inclusion in the Priority Review and Approval Process? Vol. 4, 2024

CIRS FAQ: Can the Registration Certificates of Filing Products Be Transferred? Vol. 06, 2024