# Safety evaluation of a food enzyme containing cellulase, endo‐1,3(4)‐β‐glucanase and endo‐1,4‐β‐xylanase activities from the non‐genetically modified Trichoderma reesei strain AR‐999

## TL;DR

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

## Contribution

The novelty lies in the safety evaluation of a specific food enzyme derived from Trichoderma reesei strain AR-999 for use in food processes.

## Key findings

- The enzyme is free from viable cells of the production organism and dietary exposure is estimated up to 4.031 mg TOS/kg body weight per day.
- Genotoxicity tests showed no safety concerns, and a margin of exposure of at least 248 was calculated.
- A potential risk of allergic reactions cannot be excluded due to a match with a food allergen.

## Abstract

The food enzyme containing cellulase (EC 3.2.1.4), endo‐1,3(4)‐β‐glucanase (EC 3.2.1.6) and endo‐1,4‐β‐xylanase (EC 3.2.1.8) activities is produced with the non‐genetically modified Trichoderma reesei strain AR‐999 by AB‐Enzymes GmbH. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in 11 food manufacturing processes. Since residual amounts of food enzyme–total organic solids (TOS) are removed in three processes, dietary exposure was calculated for the remaining eight food manufacturing processes. It was estimated to be up to 4.031 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 248. A search for the homology of the amino acid sequence of the cellulase, endo‐1,3(4)‐β‐glucanase and endo‐1,4‐β‐xylanase to known allergens was made and a match with one food allergen was found. The panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded. 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.