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 β-galactosidase produced from the genetically modified Bacillus licheniformis strain NZYM-BT. The opinion, prepared by EFSA's Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), concludes that the proposed extension of use does not raise safety concerns under the intended conditions of use. The assessment covers the enzyme's use in dairy processing for the production of lactose-reduced milk and whey, as well as in the manufacture of lactulose, a prebiotic ingredient. The opinion is part of the EU's regulatory framework for food enzymes, which requires pre-market safety evaluation by EFSA before authorisation by the European Commission.
Document background and type
The document is a scientific opinion, which is a non-binding technical assessment that EFSA provides to the European Commission to inform risk management decisions. It was adopted by the CEP Panel on 28 April 2026 and published on EFSA's website on 9 June 2026. The opinion is based on data submitted by the applicant, including toxicological studies, genetic modification analysis, and production process details. EFSA's role is to evaluate whether the enzyme is safe for consumers under the requested conditions of use, not to assess its efficacy or economic impact.
Policy orientations and trade-offs
The opinion supports a moderate expansion of the authorised uses of this food enzyme, which could facilitate innovation in dairy processing and the production of lactose-free products and prebiotics. This aligns with EU consumer demand for specialised dietary products. However, the extension also raises considerations about consumer acceptance of genetically modified organisms (GMOs) in food production, as the enzyme is produced from a GM strain. EFSA's assessment concluded that the genetic modification does not pose additional safety risks, but the use of GM-derived enzymes remains a point of contention among some consumer groups and member states. The trade-off is between enabling technological innovation and addressing consumer concerns about GMOs, though EFSA's opinion focuses solely on scientific safety.
Impact on stakeholders
EU dairy processors and food manufacturers stand to benefit from the extended use, as it allows them to produce lactose-reduced products and lactulose more efficiently, potentially reducing costs and expanding product lines. EU consumers with lactose intolerance may gain access to a wider range of safe, enzyme-treated products. Conversely, anti-GMO advocacy groups and some organic food producers may oppose the use of GM-derived enzymes, arguing it undermines consumer choice and the non-GM food chain. EU regulatory bodies, including the European Commission and member state authorities, will use the opinion to decide on authorisation, balancing scientific evidence with broader policy considerations.
Expected institutional follow-up
The European Commission will now consider EFSA's opinion in drafting a proposal to amend the Union list of authorised food enzymes. The proposal will be submitted to the Standing Committee on Plants, Animals, Food and Feed (PAFF Committee) for a vote by member state representatives. If adopted, the extension of use will be formally authorised via an implementing regulation. The process typically takes several months.
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