Safety evaluation of an extension of use of the food enzyme glucan 1,4‐α‐glucosidase from the genetically modified Aspergillus niger strain NZYM‐BF

strain NZYM-BF by Novozymes A/S. The safety of this food enzyme was evaluated previously and it did not give rise to safety concerns when used in two food manufacturing processes. Subsequently, the applicant has requested to extend its use to include one additional process. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of three food manufacturing processes. As the food enzyme-Total Organic Solids (TOS) are removed from the final foods in one process, the dietary exposure to the food enzyme-TOS was estimated for the remaining two food manufacturing processes. It was calculated to be up to 4.431 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (1306 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 307. Based on the new data, the revised margin of exposure and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.

Authors

Publication Details

Journal
EFSA Journal
Published
2026-05-01
DOI
https://doi.org/10.2903/j.efsa.2026.10080
Primary Topic
Agricultural safety and regulations
Type
article
Field-Weighted Citation Impact
0.00
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

Safety evaluation of an extension of use of the food enzyme glucan 1,4‐α‐glucosidase from the genetically modified Aspergillus niger strain NZYM‐BF

Francesco Catania, José Manuel Barat Baviera, Laurence Vernis, Daniele Cavanna et al.
EFSA Journal
Agricultural safety and regulations
article

Safety evaluation of an extension of use of the food enzyme glucan 1,4‐α‐glucosidase from the genetically modified Aspergillus niger strain NZYM‐BF

Francesco Catania, José Manuel Barat Baviera, Laurence Vernis, Daniele Cavanna, Baltasar Mayo, Henk Van Loveren, Alessandro Manghi, Claudia Bolognesi, Holger Zorn, Alicja Mortensen, Ralf Greiner, Gabriele Gadermaier, Yi Liu, Marize L. M. Solano, Yrjö Henrik Roos, EFSA Panel on Food Enzymes (FEZ)
article en

Abstract

strain NZYM-BF by Novozymes A/S. The safety of this food enzyme was evaluated previously and it did not give rise to safety concerns when used in two food manufacturing processes. Subsequently, the applicant has requested to extend its use to include one additional process. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of three food manufacturing processes. As the food enzyme-Total Organic Solids (TOS) are removed from the final foods in one process, the dietary exposure to the food enzyme-TOS was estimated for the remaining two food manufacturing processes. It was calculated to be up to 4.431 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (1306 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 307. Based on the new data, the revised margin of exposure and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.

EFSA JournalVol. 24(5)
Openalex Percentile: Top 8%
Agricultural safety and regulations
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.