Authors
EFSA Panel on Food Enzymes (FEZ), Holger Zorn, José Manuel Barat Baviera, Claudia Bolognesi, Francesco Catania, Gabriele Gadermaier, Ralf Greiner, Baltasar Mayo, Alicja Mortensen, Yrjö Henrik Roos, Marize L M Solano, Henk Van Loveren, Laurence Vernis, Daniele Cavanna, Yi Liu
Published in
EFSA journal. European Food Safety Authority. Volume 24. Issue 7. Pages e10208. Epub Jul 09, 2026.
Abstract
The food enzyme containing cellulase (EC 3.2.1.4), endo-1,3(4)-β-glucanase (EC 3.2.1.6) and endo-1,4-β-xylanase (EC 3.2.1.8) activities is produced with the non-genetically modified Trichoderma reesei strain AR-256 by AB-Enzymes GmbH. The safety of this food enzyme was evaluated previously, and it did not give rise to safety concerns when used in nine food manufacturing processes. Subsequently, the applicant has requested to extend the range of raw materials in one process. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of nine food manufacturing processes. As the food enzyme-Total Organic Solids (TOS) are removed in three processes, the dietary exposure to the food enzyme-TOS was estimated for the remaining six food manufacturing processes. It was estimated to be up to 4.026 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (939 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 233. Based on the revised exposure estimation, the newly derived 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.
PMID:
42428971
Bibliographic data and abstract were imported from PubMed on 10 Jul 2026.
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