The European Food Safety Authority has delivered a scientific opinion on the safety evaluation of the food enzyme glucan 1,4-?-glucosidase (EC 3.2.1.3), produced using a genetically modified strain of Trichoderma reesei (DP-Nzh109) by Genencor International B.V.
According to the assessment, the genetic modifications introduced into the production strain do not raise safety concerns, and the manufacturing process ensures that the final enzyme preparation is free from viable production organisms and recombinant DNA. This is a critical safety requirement under EU food enzyme regulations.
The enzyme is intended for use in two food manufacturing processes production of - Starch and Production of distilled alcohol, , where it functions as a processing aid. EFSA noted that during these processes, residual amounts of total organic solids (TOS) from the enzyme are effectively removed. As a result, dietary exposure estimation was deemed unnecessary, and no toxicological studies were required to support the safety assessment.
A detailed allergenicity assessment was conducted by comparing the amino acid sequence of the enzyme with known allergens. The analysis identified a match with one known respiratory allergen. However, EFSA clarified that while the risk of allergic reactions via dietary exposure cannot be completely excluded, the probability of occurrence is considered low under the intended conditions of use.
Taking all evidence into accountincluding production methodology, absence of residual DNA and cells, lack of consumer exposure, and low allergenic potentialthe EFSA Panel concluded that the enzyme does not pose safety concerns for consumers when used as intended.
This evaluation aligns with EFSAs risk-based approach for food enzymes, particularly those used as processing aids with negligible residual presence in final food products, reinforcing regulatory confidence in enzyme technologies derived from genetically modified microorganisms.
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