Safety evaluation of the food enzyme triacylglycerol lipase from the genetically modified Trichoderma reseei strain AR‐822

TL;DR

This study evaluates the safety of a food enzyme produced from a genetically modified fungus and concludes it is safe for use in food manufacturing.

Contribution

The novelty lies in the safety evaluation of a genetically modified triacylglycerol lipase enzyme for food use.

Findings

Genetic modifications in the enzyme production do not raise safety concerns.

Dietary exposure was estimated at up to 0.127 mg TOS/kg body weight per day in European populations.

No homology to known allergens was found, though a low likelihood of allergic reactions cannot be fully ruled out.

Abstract

The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with the genetically modified Trichoderma reseei strain AR‐822 by AB Enzymes GmbH. 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 five food manufacturing processes. Since residual amounts of food enzyme–total organic solids (TOS) are removed in one process, dietary exposure was calculated for the remaining four food manufacturing processes. It was estimated to be up to 0.127 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate 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 of 1000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 7874. A search for the homology of the amino acid sequence of the triacylglycerol lipase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that 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.