The European Food Safety Authority (EFSA) has issued a revised safety evaluation of the food enzyme triacylglycerol lipase from the non-genetically modified Burkholderia stagnalis strain PL266-QLM, concluding that its use cannot be considered safe due to the risk of promoting the spread of antimicrobial resistance (AMR) genes. The opinion, adopted on 17 June 2026 and published on 7 July 2026, reiterates the Panel's previous conclusion from 2023, despite new data submitted by the applicant, Meito Sangyo Co., Ltd.
In the earlier evaluation (EFSA-Q-2019-00056), EFSA had already identified a safety concern because the production strain's genome contained several genes conferring resistance to clinically important antibiotics, and DNA from the strain was present in the food enzyme. The applicant subsequently submitted a new application (EFSA-Q-2024-00084) on 2 February 2024, providing additional data including PCR analysis confirming the presence of production strain DNA in the food enzyme, and an in vivo micronucleus test. However, EFSA deemed the micronucleus test inconclusive as bone marrow exposure was not demonstrated, and the PCR results confirmed the earlier risk. The applicant also withdrew one intended use (cheese production) and added another (flavour compounds by esterification), but since residual amounts of food enzyme–total organic solids (TOS) are removed in all three intended processes (modified fats and oils, free fatty acids, and flavour compounds), dietary exposure was not calculated. The Panel concluded that the new data do not alter the previous conclusion that the food enzyme poses a risk of promoting the spread of AMR genes in the environment, and therefore its use is not safe.
The opinion impacts several stakeholders. For the applicant, Meito Sangyo Co., Ltd., the negative opinion blocks EU market access for this enzyme, potentially affecting its product portfolio and investment in alternative production strains. For EU food manufacturers, the inability to use this lipase may require sourcing alternative enzymes or adjusting processes, potentially increasing costs or limiting technological options. For EU consumers, the opinion maintains protection from potential AMR risks, though the direct health impact is minimal as the enzyme is removed during processing. For EU regulatory bodies, the opinion reinforces the precautionary approach to AMR risks from food enzymes, setting a precedent for future evaluations of similar products. The opinion will now inform the European Commission's decision on whether to include the enzyme in the Union list of authorised food enzymes.