# Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from the genetically modified Aspergillus niger strain NZYM‐DM

## TL;DR

This study evaluates the safety of a genetically modified enzyme used in food manufacturing and concludes it is safe under intended conditions.

## Contribution

The novelty lies in the safety evaluation of a specific food enzyme produced by a genetically modified organism.

## Key findings

- Genotoxicity tests showed no safety concerns.
- The enzyme's dietary exposure was estimated to be up to 3.430 mg TOS/kg body weight per day.
- A potential risk of allergic reactions was identified but considered to have low likelihood.

## Abstract

The food enzyme glucan 1,4‐α‐glucosidase (4‐α‐d‐glucan glucohydrolase; EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐DM by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme was considered 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 two processes, dietary exposure was calculated only for the remaining three food manufacturing processes. It was estimated to be up to 3.430 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 1070 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 312. A search for the homology of the amino acid sequence of the glucan 1,4‐α‐glucosidase to known allergens was made and a match with one respiratory allergen 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.