Updated safety evaluation of the food enzyme phospholipase A2 from the genetically modified Trichoderma reesei strain RF8793

TL;DR

This study completes the safety evaluation of a food enzyme produced from a genetically modified fungus, confirming it is safe for use in food manufacturing.

Contribution

The study provides a completed safety evaluation of phospholipase A2 from a genetically modified Trichoderma reesei strain, addressing prior data gaps.

Findings

Dietary exposure to the food enzyme was estimated at up to 0.008 mg TOS/kg body weight per day.

Genotoxicity tests showed no safety concerns.

A margin of exposure of at least 125,000 was calculated, indicating no safety concerns under intended use.

Abstract

The food enzyme phospholipase A2 (phosphatidylcholine 2‐acylhydrolase; EC 3.1.1.4) is produced with the genetically modified Trichoderma reesei strain RF8793 by AB Enzymes GmbH. In a previous opinion, the total organic solids (TOS) values could not be calculated, which led to the inability to establish the representativeness of the batch used for toxicological examination and to calculate the dietary exposure. In this assessment, EFSA completes the safety evaluation of this food enzyme by taking into account the chemical compositional data from new food enzyme batches. The food enzyme is intended to be used in three food manufacturing processes. Dietary exposure to the food enzyme–TOS was estimated to be up to 0.008 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, results in a margin of exposure of at least 125,000. Based on the new data and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.