Safety evaluation of the food enzyme phospholipase A2 from the genetically modified Aspergillus niger strain PLA.

Abstract

The food enzyme phospholipase A2 (phosphatidylcholine 2-acylhydrolase, EC 3.1.1.4) is produced with the genetically modified Aspergillus niger strain PLA by DSM Food Specialties B.V. 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 the processing of egg and egg products, in the processing of fats and oils by degumming and for the production of modified lecithins (lysolecithin). As residual total organic solids (TOS) are removed in the refined fats and oils during degumming, dietary exposure was calculated only for the remaining two food manufacturing processes. For egg processing, the dietary exposure was estimated to be up to 1.712 mg TOS/kg body weight (bw) per day in European populations. Wet gum can be used to produce lysolecithin with the highest dietary exposure of 1.61 mg TOS/kg bw per day in children at the 95th percentile when used as a food additive. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1350 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated overall dietary exposure, resulted in a margin of exposure of at least 851. A search for the similarity of the amino acid sequence of the food enzyme to those of known allergens was made and no match was found. The Panel considered that the 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.