China Approves Three GMM-Derived Enzymes

China's National Health Commission (NHC) approved 11 new food materials and additives under its 2025 No. 3 Announcement, including three products derived from genetically modified microorganisms (GMMs). The approvals mark a continued expansion of China's food innovation framework and include novel ingredients for food processing.

The newly approved enzymes (e.g., peroxidase and xylanase) were developed using Aspergillus niger, with genetic material sourced from Marasmius scorodonius and Rasamsonia emersonii, respectively. These enzymes are commonly used in food processing and are not subject to specific labeling requirements. Additionally, the approval also included lacto-N-neotetraose produced from BL21 (DE3) with genes from Neisseria spp. and Helicobacter spp.

Notably, 2'-fucosyllactose (2'-FL), a purified human milk oligosaccharide (HMO) used as a nutritional fortifier in infant formula, had already received approval under the NHC's 2023 No. 8 Announcement. The latest approval refers to a version of 2'-FL produced using a different combination of host and donor organisms. These approvals reflect China's effort to modernize its regulatory environment in response to advancements in biotechnology, while maintaining detailed usage guidelines and safety standards for food applications.

For more information, read the USDA FAS GAIN report.