# Safety evaluation of the food enzyme cellulase from the non‐genetically modified Aspergillus niger strain HBI‐AC01

## TL;DR

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

## Contribution

The novel contribution is the safety assessment of a specific cellulase enzyme from a non-genetically modified Aspergillus niger strain.

## Key findings

- Genotoxicity tests showed no safety concerns for the food enzyme.
- The no observed adverse effect level was 349 mg TOS/kg body weight per day.
- Allergen homology search found no matches, but a low likelihood of allergic reactions was noted.

## 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 microorganism Aspergillus niger strain HBI‐AC01 by HBI Enzymes Inc. The food enzyme was considered free from viable cells of the production strain. It is intended to be used in three 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 two food manufacturing processes. It was estimated to be up to 0.475 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 349 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 735. 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 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.