The European Food Safety Authority (EFSA) has been unable to conclude on the safety of the food enzyme mannan endo-1,4-β-mannosidase produced with the non-genetically modified Aspergillus niger strain HBI-GM01 by HBI Enzymes Inc., due to discrepancies and uncertainties in the data provided. In a scientific opinion published on 7 July 2026, the EFSA Panel on Food Enzymes (FEZ) estimated dietary exposure to the enzyme's total organic solids (TOS) at up to 0.824 mg TOS/kg body weight per day in European populations, but toxicological studies were not evaluated because the test item's representativeness was uncertain. The Panel noted that a risk of allergic reactions cannot be excluded, though the likelihood is low, and no match was found in a search for homology to known allergens.
The opinion, adopted on 18 June 2026, addresses an application submitted by the Association of Manufacturers and Formulators of Enzyme Products (AMFEP) and later assigned to HBI Enzymes Inc. The enzyme is intended for use in three food manufacturing processes: production of baked products from cereals and other grains, coffee extracts, and partially hydrolysed polysaccharides from galactomannans. The production strain, deposited at the National Institute of Technology and Evaluation (NITE) Biological Resource Center in Japan, was identified as Aspergillus niger. The manufacturing process follows the Food Hygiene Regulation (EC) No 852/2004 and Good Manufacturing Practice, with fermentation, extraction, filtration, and ultrafiltration steps. The Panel considered sufficient information was provided on the manufacturing process and quality assurance to exclude issues of concern.
The application was part of a joint dossier initially submitted in 2015 and later split into individual data packages. EFSA requested additional information from the applicant on 23 January 2024 and 18 May 2026, receiving responses on 27 September 2024 and 29 May 2026. A clarification teleconference was held on 27 April 2026, after which further data were provided on 12 May 2026. Despite these efforts, the Panel concluded it could not establish the safety of the food enzyme due to unresolved data gaps.
The inability to conclude on safety blocks the enzyme's inclusion in the EU Community list of authorised food enzymes, preventing HBI Enzymes Inc. from marketing the product in the EU. Food manufacturers that could have used the enzyme to improve processing efficiency or product quality lose access to a potential processing aid. Consumers face no new risk from the enzyme, as it will not be authorised. The EFSA opinion reinforces the regulatory burden on applicants to provide complete and representative toxicological data for food enzyme approvals.