The European Food Safety Authority (EFSA) has published a scientific opinion on the safety of a food enzyme containing oryzin and leucyl aminopeptidase activities, and a heat-treated version containing only leucyl aminopeptidase activity, both derived from the non-genetically modified Aspergillus sp. strain FL 72-230. The opinion, dated 8 June 2026, concludes that the enzyme does not raise safety concerns under the intended conditions of use, impacting producers of protein hydrolysates and other food processing sectors.
The document, prepared 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 production of protein hydrolysates from animal and plant proteins, as well as in dairy processing and brewing. The panel evaluated data on genotoxicity, repeated-dose toxicity, and allergenicity, and established a margin of exposure that supports its safe use.
Policy orientations and trade-offs
EFSA's opinion is a mandatory step in the EU's food enzyme authorization process under Regulation (EC) No 1332/2008. The assessment balances consumer safety with the need for innovation in food processing. The panel noted that the heat-treated version, which retains only leucyl aminopeptidase activity, may offer a narrower application but reduces potential exposure to the oryzin component.
Impact on stakeholders
- Food enzyme producers: The positive safety opinion clears a regulatory hurdle for the applicant, enabling market access if the European Commission grants authorization. However, the requirement for heat treatment may increase production costs.
- Food manufacturers: Access to a new enzyme for protein hydrolysis could improve efficiency and product quality, but they must ensure compliance with any conditions set in the final authorization.
- Consumers: The opinion provides assurance that the enzyme is safe for use in food processing, with no significant allergenicity concerns identified.
- EU regulatory bodies: EFSA's opinion provides the scientific basis for the Commission's decision on authorization, which will follow the comitology procedure.
Expected institutional follow-up
The European Commission will now consider EFSA's opinion and propose a draft regulation authorizing or rejecting the enzyme. Member States will vote on the proposal in the Standing Committee on Plants, Animals, Food and Feed. If adopted, the enzyme will be added to the EU list of authorized food enzymes.