Safety evaluation of the food enzyme lysophospholipase from the genetically modified Aspergillus niger strain NZYM‐LP
The food enzyme is a lysophospholipase (2‐lysophosphatidylcholine acylhydrolase; EC 184.108.40.206) produced with a genetically modified Aspergillus niger strain NZYM‐LP 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 lysophospholipase food enzyme is intended to be used in starch processing for glucose syrups production, and for degumming of fats and oils. Residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, and washing and purification steps applied during degumming, consequently, dietary exposure estimation was considered not necessary. Genotoxicity tests did not raise safety concerns. The repeated dose 90‐day oral toxicity study was carried out with a phospholipase A1 from A. niger (strain NZYM‐FP). The Panel considered this enzyme as a suitable substitute to be used in this toxicity study in rats, because they derive from the same recipient strain, the location of the inserts are comparable, no partial inserts were present and the production methods are essentially the same. The Panel identified a no observed adverse effect level (NOAEL) at the highest dose tested of 1,356 mg TOS/kg body weight (bw) per day. 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 by dietary exposure cannot be excluded, but the likelihood for this occurring is considered to be low. Based on the data provided, the removal of TOS during the starch processing for the production of glucose syrups and 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.