# Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from the non‐genetically modified Trichoderma citrinoviride strain TCLSC

## TL;DR

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

## Contribution

The novel contribution is the safety evaluation of endo-1,4-β-xylanase from Trichoderma citrinoviride for food applications.

## Key findings

- Genotoxicity tests showed no safety concerns for the food enzyme.
- The enzyme's amino acid sequence does not match known allergens, but allergic reactions cannot be completely ruled out.
- The estimated dietary exposure is well below the no observed adverse effect level, ensuring a high margin of safety.

## Abstract

The food enzyme endo‐1,4‐β‐xylanase (4‐β‐D‐xylan xylanohydrolase; EC 3.2.1.8) is produced with the non‐genetically modified Trichoderma citrinoviride strain TCLSC by Advanced Enzyme Technologies Ltd. It was considered free from viable cells of the production organism. It is intended to be used in four 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 three food manufacturing processes and was estimated to be up to 0.754 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 856 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 1135. A search for the homology of the amino acid sequence of the endo‐1,4‐β‐xylanase 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.