IN Brief:
- EFSA’s 16 October opinion for dossier EFSA-Q-2023-00229 concerns cellulase and endo-1,3(4)-β-glucanase from non-genetically modified Trichoderma reesei DP-Nzc104.
- EFSA concluded that the defined preparation does not raise safety concerns under the intended conditions of use; the applicant proposed eight food manufacturing processes.
- Allergic reactions cannot be excluded for the remaining intended uses, particularly for salmon- and egg-allergic people; the scientific opinion is not an authorisation.
The European Food Safety Authority (EFSA) has concluded that a food enzyme preparation containing cellulase and endo-1,3(4)-β-glucanase activities does not raise safety concerns under its intended conditions of use. The finding applies to the preparation produced by Genencor International B.V. using the non-genetically modified fungus Trichoderma reesei strain DP-Nzc104. EFSA published the scientific opinion on 16 October 2026 under dossier EFSA-Q-2023-00229.
The conclusion comes with a specific qualification on food allergy. EFSA found that a risk of allergic reactions upon dietary exposure cannot be excluded for the remaining intended uses, particularly for people with allergies to salmon or eggs. The panel said the likelihood of such reactions would not exceed that associated with consuming salmon and eggs.
The evaluation concerns two enzyme activities within one defined preparation: cellulase, designated EC 3.2.1.4, and endo-1,3(4)-β-glucanase, designated EC 3.2.1.6. Genencor proposed the product for eight food manufacturing processes. These activity classifications identify the chemical reactions catalysed by the enzymes; they do not establish that every enzyme manufactured by T. reesei has the same safety profile, or that the preparation can be used at any dose in any food process.
Cellulase acts on susceptible bonds in cellulose, a major structural component of plant cell walls. Hydrolysis can reduce the length of polysaccharide chains and change how plant material breaks down during processing. Endo-1,3(4)-β-glucanase acts on certain linkages in beta-glucans. Its action is related to, but distinct from, cellulose hydrolysis, and the balance of effects in a food processing stream depends on the plant substrate and the conditions applied.
Changing the structure of these polysaccharides can affect viscosity, separation and the release of material from plant tissues, depending on the manufacturing operation. Industrial application still requires an appropriate treatment time, temperature, pH and enzyme dose. A reduction in viscosity can be useful where liquid is to be filtered or pumped, while more extensive breakdown may be undesirable when the finished food depends on a particular texture.
The enzyme preparation is manufactured by cultivating the DP-Nzc104 fungal strain, then recovering the active enzymes through a controlled industrial process. EFSA’s abstract reports that the preparation was considered free from viable cells of the production organism. This is a dossier-specific characteristic of the assessed material, not a statement that live-cell testing is unnecessary for other enzyme preparations or production strains.
Risk assessment of a food enzyme also considers the preparation’s composition and the amount of enzyme-related material that consumers could encounter. EFSA commonly expresses relevant dietary exposure in terms of food enzyme total organic solids, reflecting organic components of the preparation rather than only its catalytic activity. Exposure depends on intended treatment levels and the extent to which processing removes material before consumption. Neither the proposed input quantity nor a general enzyme activity unit can by itself describe consumer exposure in the final product.
Across the evaluated processes, some manufacturing steps remove enzyme-derived solids, while others leave residues in the finished food. Dietary exposure therefore depends on the process and the amount of enzyme-derived material retained. EFSA’s allergy qualification concerns the remaining intended uses.
Similarity between enzyme protein sequences and known allergens can prompt concern about possible reactions, without indicating that fish or egg is deliberately used as an ingredient in the enzyme preparation. Equally, a positive overall scientific assessment does not prove that individuals with relevant allergies can never react. EFSA retained the possibility of reactions while judging their likelihood not to exceed reactions associated with consumption of salmon and eggs.
Manufacturers using enzyme preparations need to distinguish product identity, process validation and applicable allergen controls. A certificate or specification for one strain does not establish equivalent composition for another. Procurement documentation should identify the actual preparation supplied, its activity specification, recommended operating range and the processes for which its safety evidence applies. Site assessments remain necessary where equipment configuration, heat treatment, separation steps or product formulation differs from the conditions evaluated.
EU law separates EFSA’s scientific advice from legal decisions on authorisation. Under Regulation (EC) No 1332/2008 and the associated common authorisation procedure, the European Commission and Member States carry out the relevant risk-management and legislative steps. The harmonised Union list of authorised food enzymes has not yet been established, and national provisions continue to apply during the transitional period. EFSA’s conclusion for DP-Nzc104 does not itself grant unrestricted permission to market or use the enzyme across the EU. The finding applies to Genencor’s specified DP-Nzc104 preparation under the evaluated conditions of use; other strains or uses require separate consideration under the relevant scientific and regulatory requirements.
EFSA requested further information on the DP-Nzc104 dossier during its 2025 scientific review, before issuing its opinion on 16 October 2026. The completed assessment covers the specified cellulase and endo-1,3(4)-β-glucanase preparation under its intended conditions of use, with the qualified finding on allergic reactions.
