Safety evaluation of the food enzyme 6-Phytase from the genetically modified Trichoderma reesei strain AR-766

Abstract

The food enzyme 6-Phytase (myo-inositol-hexakisphosphate 6-phosphohydrolase; EC 3.1.3.26) is produced with the genetically modified Trichoderma reesei strain AR-766 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in four food manufacturing processes. Since residual amounts of food enzyme–total organic solids (TOS) are removed in the production of distilled alcohol, dietary exposure was calculated only for the remaining three food manufacturing processes. It was estimated to be up to 0.071 mg TOS/kg body weight (bw) per day in European populations. 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 947 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 13,338. A search for the homology of the amino acid sequence of the 6-Phytase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but the likelihood is low. 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.