On 9 June 2026, the European Food Safety Authority (EFSA) published a scientific opinion evaluating the safety of an extension of use of the food enzyme glucan 1,4-α-maltohydrolase produced from the genetically modified Bacillus licheniformis strain NZYM-FR. The opinion, which updates a previous 2024 assessment, concludes that the proposed extension of use does not raise safety concerns under the intended conditions of use, impacting food manufacturers and consumers.
The document, prepared by EFSA's Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), assesses the enzyme's safety for use in additional food processing applications beyond those previously authorised. The enzyme is used to hydrolyse starch into maltose and other sugars, and the extension covers its use in the production of glucose syrups and other starch-derived products.
EFSA's evaluation follows the European Commission's request for a safety assessment of the extended use, submitted under Regulation (EC) No 1332/2008 on food enzymes. The opinion is based on a comprehensive review of toxicological data, including a 90-day oral toxicity study in rats, genotoxicity tests, and allergenicity assessment. The panel concluded that the enzyme does not raise safety concerns at the proposed use levels, and that the genetic modification of the production strain does not introduce additional risks.
Policy orientations and trade-offs
The opinion balances the need for innovation in food processing with consumer safety. The extension allows manufacturers to use a more efficient enzyme in a wider range of applications, potentially reducing production costs and energy use. However, the use of a genetically modified organism (GMO) as the production strain may raise consumer concerns about GMOs in the food chain, despite EFSA's conclusion that the enzyme itself is safe and free of viable GMO cells.
Impact on stakeholders
- Food manufacturers: Benefit from increased flexibility and potential cost savings in starch processing, but must ensure compliance with labelling requirements for enzymes derived from GMOs.
- Consumers: No direct safety risk according to EFSA, but may face products containing an enzyme from a GM source, which could affect purchasing decisions.
- EU regulatory bodies: The opinion provides the scientific basis for the European Commission to update the Union list of authorised food enzymes.
- NGOs and consumer groups: May criticise the reliance on GMO-derived enzymes and call for stricter labelling or alternative non-GM sources.
Expected institutional follow-up
Following EFSA's opinion, the European Commission will propose an amendment to the Union list of authorised food enzymes to include the extended use. The proposal will be examined by the Standing Committee on Plants, Animals, Food and Feed, and then adopted via a comitology procedure. Member states and stakeholders will have the opportunity to comment during the process.