RT Journal Article
T1 Safety evaluation of the food enzyme endo-1,4-β-xylanase and β-glucanase from Disporotrichum dimorphosporum strain DXL.
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 Lampi, Evgenia
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 Marcon, Francesca
A1 Penninks, André
A1 Smith, Andrew
A1 Aguilera-Gomez, Margarita
A1 Andryszkiewicz, Magdalena
A1 Arcella, Davide
A1 Gomes, Ana
A1 Kovalkovičová, Natália
A1 Liu, Yi
A1 Maia, Joaquim
A1 Roncancio Peña, Claudia
A1 Chesson, Andrew
K1 4‐β‐d‐xylan xylanohydrolase
K1 Disporotrichum dimorphosporum
K1 EC 3.2.1.8
K1 food enzyme
K1 β‐glucanases
AB The food enzyme with xylanases (4-β-d-xylan xylanohydrolase, EC 3.2.1.8) and glucanases active against β-1,4 linkages is produced with the non-genetically modified fungus Disporotrichum dimorphosporum strain DXL by DSM Food Specialities B.V. The food enzyme is intended to be used in brewing processes. Based on the maximum use level and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme-Total Organic Solids (TOS) was estimated to be up to 0.167 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise 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 (NOAEL) at the highest dose of 199 mg TOS/kg bw per day that, compared with the estimated dietary exposure, results in a high Margin of Exposure of at least 1,100. Similarity of amino acid sequences of the identified xylanases and β-glucanases to those of known allergens was searched. No matches were found for two endo-1,4-β-glucanases and two endo-1,4-β-xylanases. However, for a third endo-β-1,4-glucanase the search resulted in matches with three mite protein sequences. While incidental cases of allergic reactions to endo-1,4-β-xylanases and β-glucanases have been reported after inhalation in respiratory sensitised individuals in the workplace, no allergic reactions to xylanases or β-glucanases have been reported in the literature after oral exposure. The Panel considered that, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be 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.
YR 2020
FD 2020-01-10
LK https://hdl.handle.net/10668/26726
UL https://hdl.handle.net/10668/26726
LA en
DS RISalud
RD Apr 19, 2025