Safety evaluation of the food enzyme phospholipase A1 from the genetically modified Aspergillus niger strain NZYM‐FP
Note: The full opinion will be published in accordance with Article 12 of Regulation (EC) No 1331/2008 once the decision on confidentiality will be received from the European Commission.
The food enzyme phospholipase A1 (phosphatidycholine 1‐acylhydrolase EC 184.108.40.206) is produced with the genetically modified Aspergillus niger strain NZYM‐FP 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. The phospholipase A1 food enzyme is intended to be used for degumming of fats and oils. Since residual amounts of Total Organic Solids (TOS) are removed by the purification steps applied during degumming, dietary exposure estimation was not considered necessary. Genotoxicity tests did not raise safety concerns. The repeated dose 90‐day oral 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) of 1,356 mg TOS/kg body weight (bw) 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 upon 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 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.