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On January 7, 2021, the European Food Safety Agency issued opinions on the safety evaluation of a food enzyme, triacylglycerol lipase.
It is understood that this food enzyme is produced by the genetically modified Aspergillus niger strain NZYM-DB and is intended to be used in the process of producing modified fats through transesterification.
After evaluation, the expert panel believes that under the expected use conditions, the risk of allergic sensitization and induced reactions caused by dietary exposure cannot be ruled out, but the possibility of this occurrence is very low. Based on the data provided, the immobilization of food enzymes and the removal of total organic solids during oil processing, the team concluded that the food enzymes will not cause safety issues under the expected use conditions. Part of the original report is as follows:
The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase EC 184.108.40.206) is produced with a genetically modified Aspergillus niger strain NZYM-DB 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 recombinant DNA. The food enzyme is intended to be used in an immobilised form in the production of modified fats and oils by interesterification. based on the estimated use levels recommended for interesterification of fats and oils and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.75 mg TOS/kg body weight (bw) per day in European populations. 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 at the h ighest dose of 1,132 mg TOS/kg bw per day, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 1,500. 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 of such reactions to occur is likely to be low. based on the data provided, the immobilisation of the food enzyme and the removal of total organic solids during fats and oils processing, the Panel concluded that the food enzyme does not give rise to safety concerns under the intended conditions of use.
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