EFSA Confirms 83000 Fold Safety Margin for Enzyme from GM Bacteria in Starch Processing

On May 19, 2025, the European Food Safety Authority (EFSA) released its latest opinion on the safety of the food enzyme 4-α-glucanotransferase, which is produced using a genetically modified strain of Bacillus amyloliquefaciens (MAS).

The enzyme is intended for use in the manufacturing of enzymatically treated starch. While the production strain carries multiple antimicrobial resistance genes, EFSA noted that no viable cells or DNA remain in the final product, thereby eliminating the risk associated with gene transfer.

Dietary exposure estimates in Europe reached a maximum of 0.012 mg/kg body weight per day, while animal testing showed no adverse effects at doses over 83,000 times higher. No genotoxic effects were detected, and allergenicity testing found no matches to known allergenic proteins. Although the panel did not fully rule out allergic responses, they emphasized the low likelihood of such reactions occurring.

EFSA ultimately concluded that the enzyme is safe under its intended conditions of use, reinforcing consumer protection while allowing innovation in food processing.