Safety evaluation of the food enzyme asparaginase from the genetically modified Aspergillus oryzae strain NZYM-SP

The food enzyme asparaginase (l-asparagine amidohydrolase, EC 3.5.1.1) is produced with the genetically modified Aspergillus oryzae strain NZYM-SP by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. It is intended to be used to prevent acrylamide formation in food processing. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.101 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 880 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 8,713. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions by dietary exposure 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.