Safety evaluation of the food enzyme non-reducing end alpha-L-arabinofuranosidase from the genetically modified Trichoderma reesei strain NZYM-GV

Abstract

[EN] The food enzyme non-reducing end alpha-L-arabinofuranosidase (alpha-L-arabinofuranoside non-reducing end alpha-L-arabinofuranosidase; EC 3.2.1.55) is produced with the genetically modified Trichoderma reesei strain NZYM-GV by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in grain treatment for the production of starch and gluten fractions. Since residual amounts of total organic solids (TOS) are removed by washing and purification steps applied during grain treatment, the estimation of a dietary exposure is considered not necessary. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1,116 mg TOS/kg body weight per day, the highest dose tested. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. Based on the data provided and the removal of TOS during the grain treatment, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.