Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from the non‐genetically modified Trichoderma citrinoviride strain TCLSC

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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
+6 more Laurence Vernis, Jaime Aguilera, Magdalena Andryszkiewicz, Daniele Cavanna, Natália Kovalkovičová, Yi Liu
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References: 16

Abstract

strain TCLSC by Advanced Enzyme Technologies Ltd. It was considered free from viable cells of the production organism. It is intended to be used in four 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 three food manufacturing processes and was estimated to be up to 0.754 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 856 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 1135. A search for the homology of the amino acid sequence of the endo-1,4-β-xylanase 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 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.

Fields of Study & Subjects

Agricultural safety and regulations Carcinogens and Genotoxicity Assessment Genetically Modified Organisms Research

Publication details

Journal / source
EFSA Journal
Volume
24
Issue
2
Pages
e9953–e9953
Publication date
1 February 2026
Language
EN