Safety evaluation of the food enzyme 4-phytase from a genetically modified Trichoderma reesei (strain DP-Nzt55)

Abstract

The food enzyme Myo-inositol-hexakisphosphate 4-phosphohydrolase (4-phytase, EC 3.1.3.26) is produced with a genetically modified Trichoderma reesei DP-Nzt55 by Danisco US Inc. The production strain contains a known antimicrobial resistance gene. However, based on the absence of viable cells and recombinant DNA of the production strain in the food enzyme, this is not considered to be a risk. The 4-phytase is intended to be used in distilled alcohol production. Since residual amounts of total organic solids are removed by distillation (> 99%), toxicological data were not considered necessary and dietary exposure was not calculated. Similarity of the amino acid sequence to those of known allergens was searched and no matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure can be excluded. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.