he EFSA CEP Panel has issued a favourable scientific opinion on the food enzyme aspergillopepsin I (EC 3.4.23.18), produced by Danisco US Inc. using the genetically modified microorganism Trichoderma reesei strain DP-Nzq40. EFSA concluded that the genetic modifications applied to the production strain do not give rise to safety concerns.
The enzyme is intended for use in the processing of grains and other cereals for the production of distilled alcohol, where it acts as a processing aid.
Manufacturing and Exposure Assessment
EFSA confirmed that the food enzyme preparation is free from viable cells of the production organism and from recombinant DNA. During the production of distilled alcohol, residual amounts of total organic solids (TOS), including the food enzyme, are effectively removed through the distillation process.
As a result:
Dietary exposure was not calculated, and
Toxicological studies were not considered necessary, in line with EFSA guidance for food enzymes used in distilled alcohol production.
Allergenicity Assessment
A bioinformatic comparison of the amino acid sequence of aspergillopepsin I with known allergens identified matches with two respiratory allergens. However, EFSA determined that the risk of allergic reactions can be excluded in this case, as the enzyme is removed during distillation and does not remain in the final distilled alcohol product.
Regulatory Conclusion
Based on:
the safety of the genetic modifications,
the absence of viable production organisms and DNA,
the effective removal of enzyme residues during distillation, and
the negligible risk of allergenicity,
the EFSA CEP Panel concluded that aspergillopepsin I does not pose a safety concern under its intended conditions of use in the production of distilled alcohol.