RT Journal Article
T1 Safety evaluation of the food enzyme endo-1,4-β-xylanase from the genetically modified Trichoderma reesei strain RF5427.
A1 EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)
A1 Silano, Vittorio
A1 Barat Baviera, José Manuel
A1 Bolognesi, Claudia
A1 Cocconcelli, Pier Sandro
A1 Crebelli, Riccardo
A1 Gott, David Michael
A1 Grob, Konrad
A1 Lambré, Claude
A1 Lampi, Evgenia
A1 Mengelers, Marcel
A1 Mortensen, Alicja
A1 Rivière, Gilles
A1 Steffensen, Inger-Lise
A1 Tlustos, Christina
A1 Van Loveren, Henk
A1 Vernis, Laurence
A1 Zorn, Holger
A1 Glandorf, Boet
A1 Herman, Lieve
A1 Engel, Karl-Heinz
A1 Aguilera, Jaime
A1 Aguilera-Gomez, Margarita
A1 Arcella, Davide
A1 Maia, Joaquim
A1 Liu, Yi
A1 Chesson, Andrew
K1 4‐β‐D‐xylan xylanohydrolase
K1 4‐β‐xylanase
K1 EC 3.2.1.8
K1 Trichoderma reesei
K1 endo‐1
K1 food enzyme
K1 genetically modified microorganism
AB The food enzyme endo-1,4-β-xylanase (4-β-D-xylan xylanohydrolase; EC 3.2.1.8) is produced with the genetically modified Trichoderma reesei strain RF5427 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 recombinant DNA. It is intended to be used in baking, brewing and cereal-based processes, distilled alcohol production and grain treatment for the production of starch and gluten fractions. Since residual amounts of the food enzyme are removed by distillation and during grain treatment, dietary exposure was only calculated for baking, brewing and cereal-based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme-Total Organic Solids (TOS) was estimated to be up to 0.119 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. The Panel identified a no observed adverse effect level at the highest dose tested of 939 mg TOS/kg bw per day in a repeated dose 90-day oral toxicity study in rats, resulting in a margin of exposure of at least 7,890. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and no matches were found. The Panel considered that allergenicity can be excluded for distilled alcohol production. The risk of allergic sensitisation and elicitation reactions cannot be excluded for baking, brewing and cereal-based processes, and for grain treatment for the production of starch and gluten fractions, but the likelihood of such reactions to occur is considered to be low. Based on the data provided, the removal of TOS during the production of distilled alcohol and grain treatment, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.
YR 2020
FD 2020-06-03
LK https://hdl.handle.net/10668/26731
UL https://hdl.handle.net/10668/26731
LA en
DS RISalud
RD Apr 7, 2025