# Safety evaluation of the food enzyme cellulase from the non‐genetically modified Aspergillus niger strain AC 4‐984

## TL;DR

This study evaluates the safety of a cellulase enzyme produced by a non-genetically modified Aspergillus niger strain for use in food manufacturing.

## Contribution

The novelty lies in the safety assessment of a specific cellulase enzyme from a non-GM fungal strain for multiple food processes.

## Key findings

- Genotoxicity tests showed no safety concerns with the enzyme.
- The no observed adverse effect level was 1701 mg TOS/kg bw per day, resulting in a high margin of safety.
- No homology was found between the enzyme and known allergens, though a low risk of allergic reactions cannot be ruled out.

## Abstract

The food enzyme cellulase (4‐(1,3;1,4)‐β‐d‐glucan 4‐glucanohydrolase; EC 3.2.1.4) is produced with the non‐genetically modified Aspergillus niger strain AC 4‐984 by Shin Nihon Chemical Co., Ltd. The food enzyme was considered free from viable cells of the production organism. The food enzyme is intended to be used in ten food manufacturing processes. Since residual amounts of food enzyme‐total organic solids (TOS) are removed in two processes, dietary exposure was calculated for the remaining eight food manufacturing processes. It was estimated to be up to 0.993 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 1701 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 1713. A search for the homology of the amino acid sequence of the cellulase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to this 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.