On 20 May 2026, the European Food Safety Authority (EFSA) published a scientific opinion evaluating the safety of a food enzyme preparation containing metalloendopeptidase and leucyl aminopeptidase activities, derived from the non-genetically modified Aspergillus oryzae strain HBI-POP01. The opinion concludes that the enzyme does not raise safety concerns under the intended conditions of use, clearing a regulatory hurdle for its potential authorisation in the EU food market.
The document, produced by EFSA's Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), assesses the enzyme's production, composition, and toxicological profile. The enzyme is intended for use in the processing of protein-containing foods, such as meat and fish products, to improve texture or flavour. The panel evaluated data on genotoxicity, repeated-dose toxicity, and allergenicity, finding no adverse effects at the proposed use levels.
As a scientific opinion, this document is not legally binding but serves as a risk assessment basis for the European Commission's decision on whether to include the enzyme in the EU list of authorised food enzymes. The opinion is part of EFSA's ongoing work to evaluate food enzymes submitted for market authorisation under Regulation (EC) No 1332/2008.
Stakeholder impact
For food enzyme producers, the positive opinion supports their application for EU market access, potentially opening new business opportunities. Food manufacturers using protein-processing enzymes may benefit from an additional safe option for product development. Consumers are indirectly affected as the opinion contributes to ensuring that only safe enzymes reach the market. Regulatory bodies, including the European Commission and Member State authorities, will use the opinion to inform their authorisation decision, which is expected in the coming months.
Trade-offs
The opinion balances innovation in food processing with consumer safety. While the enzyme offers functional benefits for protein-rich foods, the assessment required extensive data submission and review, which can be costly and time-consuming for applicants. No significant negative impacts were identified, as the safety conclusion is clear and no new regulatory burdens are imposed beyond standard authorisation procedures.
Next steps
The European Commission will now consider EFSA's opinion and draft a regulation to authorise or reject the enzyme. Stakeholders may submit comments during the public consultation phase of the authorisation process.