Safety evaluation of the food enzyme cellulase from the genetically modified <i>Aspergillus niger</i> strain NZYM-EN.

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

SUBMITTER: EFSA Panel on Food Enzymes (FEZ) 

PROVIDER: S-EPMC12572824 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature