Safety evaluation of the food enzyme cellulase from the genetically modified Aspergillus niger strain NZYM‐EN

TL;DR

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

Contribution

A safety assessment of a genetically modified cellulase enzyme produced by Aspergillus niger strain NZYM-EN for food use.

Findings

Genetic modifications in the enzyme do not raise safety concerns.

Dietary exposure was estimated at up to 0.018 mg TOS/kg body weight per day.

No observed adverse effects were found in toxicity studies, with a high margin of safety.

Abstract

The food enzyme cellulase (4‐(1,3;1,4)‐β‐d‐glucan 4‐glucanohydrolase, EC 3.2.1.4) is produced with the genetically modified Aspergillus niger strain NZYM‐EN 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 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 0.018 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 1233 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 68,500. 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 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.