Safety evaluation of the food enzyme β‐fructofuranosidase from the genetically modified Trichoderma reesei strain AR‐996

The food enzyme β-fructofuranosidase (β-d-fructofuranoside fructohydrolase; EC 3.2.1.26) is produced with the genetically modified <i>Trichoderma reesei</i> strain AR-996 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in three food manufacturing processes. Dietary exposure was estimated to be up to 0.605 mg total organic solids (TOS)/kg body weight 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 1000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 1653. A search for the homology of the amino acid sequence of the β-fructofuranosidase 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 the likelihood is low. Based on the data provided and the derived margin of exposure, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

Authors

Publication Details

Journal
EFSA Journal
Published
2025-03-01
DOI
https://doi.org/10.2903/j.efsa.2025.9287
Primary Topic
Occupational exposure and asthma
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 the food enzyme β‐fructofuranosidase from the genetically modified Trichoderma reesei strain AR‐996

José Manuel Barat Baviera, Jaime Aguilera, Ana Criado, Yrjö H. Roos et al.
EFSA Journal
Occupational exposure and asthma
article

Safety evaluation of the food enzyme β‐fructofuranosidase from the genetically modified Trichoderma reesei strain AR‐996

José Manuel Barat Baviera, Jaime Aguilera, Ana Criado, Yrjö H. Roos, Cristina Fernández‐Fraguas, Francesco Catania, Giulio di Piazza, Gabriele Gadermaier, Henk Van Loveren, Laurence Vernis, Baltasar Mayo, Alicja Mortensen, Daniele Cavanna, Ralf Greiner, Monika Šrámková, Yi Liu, Eleonora Marini, Marize L. M. Solano, Magdalena Andryszkiewicz, Claudia Bolognesi, Holger Zorn
article en

Abstract

The food enzyme β-fructofuranosidase (β-d-fructofuranoside fructohydrolase; EC 3.2.1.26) is produced with the genetically modified <i>Trichoderma reesei</i> strain AR-996 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in three food manufacturing processes. Dietary exposure was estimated to be up to 0.605 mg total organic solids (TOS)/kg body weight 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 1000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 1653. A search for the homology of the amino acid sequence of the β-fructofuranosidase 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 the likelihood is low. Based on the data provided and the derived margin of exposure, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

EFSA JournalVol. 23(3)
Openalex Percentile: Top 93%
Occupational exposure and asthma
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.