Safety evaluation of the food enzyme cellulase from the genetically modified Trichoderma reesei strain NZYM‐FS
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 Trichoderma reesei strain NZYM‐FS by Novozymes A/S. The genetic modifications did 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 four 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 two food manufacturing processes. It was estimated to be up to 0.140 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 1292 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 9229. 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.
Related
- Safety evaluation of an extension of use of the food enzyme lysophospholipase from the genetically modified Aspergillus niger strain NZYM‐LP
- In Vivo Antioxidant Effects Evaluation of Genetically Modified Astaxanthin-Rich Maize.
- Developing a consensus patient safety curriculum for junior doctors in Taiwan: a modified Delphi protocol
- Durability of a physician-modified endograft constructed using the Terumo Aortic TREO device: A postmortem evaluation
- Experimental Evaluation of a Large Fenestrated Physician-Modified Endo-wheat Using a Cadaveric Model
BibTeX
@article{fez2026safety,
title = {{Safety evaluation of the food enzyme cellulase from the genetically modified Trichoderma reesei strain NZYM‐FS}},
author = {EFSA Panel on Food Enzymes (FEZ) and Holger Zorn and José Manuel Barat Baviera and Claudia Bolognesi and Francesco Catania and Gabriele Gadermaier and Ralf Greiner and Baltasar Mayo and Alicja Mortensen and Yrjö Henrik Roos and Marize L. M. Solano and Henk Van Loveren and Laurence Vernis and Cristina Andreoli and Andrea Terron and Andrey Yurkov and Ana Gomes and Daniele Cavanna and Cristina Fernández‐Fraguas and Natália Kovalkovičová and Yi Liu},
journal = {EFSA Journal},
year = {2026},
month = oct,
doi = {10.2903/j.efsa.2026.10331},
url = {https://doi.org/10.2903/j.efsa.2026.10331},
note = {CC BY-ND},
}
RIS
TY - JOUR
TI - Safety evaluation of the food enzyme cellulase from the genetically modified Trichoderma reesei strain NZYM‐FS
AU - EFSA Panel on Food Enzymes (FEZ)
AU - Holger Zorn
AU - José Manuel Barat Baviera
AU - Claudia Bolognesi
AU - Francesco Catania
AU - Gabriele Gadermaier
AU - Ralf Greiner
AU - Baltasar Mayo
AU - Alicja Mortensen
AU - Yrjö Henrik Roos
AU - Marize L. M. Solano
AU - Henk Van Loveren
AU - Laurence Vernis
AU - Cristina Andreoli
AU - Andrea Terron
AU - Andrey Yurkov
AU - Ana Gomes
AU - Daniele Cavanna
AU - Cristina Fernández‐Fraguas
AU - Natália Kovalkovičová
AU - Yi Liu
PY - 2026
DA - 2026/10/31
JO - EFSA Journal
DO - 10.2903/j.efsa.2026.10331
UR - https://doi.org/10.2903/j.efsa.2026.10331
AB - 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 Trichoderma reesei strain NZYM‐FS by Novozymes A/S. The genetic modifications did 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 four 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 two food manufacturing processes. It was estimated to be up to 0.140 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 1292 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 9229. 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.
SN - 1831-4732
ER -