Safety evaluation of the food enzyme phospholipase C from the genetically modified Bacillus licheniformis strain NZYM-VR

The food enzyme phospholipase C (phosphatidylcholine cholinephosphohydrolase EC 3.1.4.3) is produced with the genetically modified Bacillus licheniformis strain NZYM-VR 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. This phospholipase C is intended for use in degumming of fats and oils. The residual amounts of Total Organic Solids (TOS) are removed during washing and purification steps applied during degumming. Consequently, no dietary exposure was calculated. Genotoxicity tests did not raise 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 (NOAEL) at the highest dose tested of 714 mg TOS/kg body weight (bw) per day. Similarity of the amino acid sequence to those of known allergens was searched for 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 is considered to be low. Based on the data provided and the removal of TOS during the degumming of fats and oils, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.