Open AccessSafety evaluation of the food enzyme xylanase from the genetically modified Trichoderma reesei strain RF 5703
Author(s) -
Silano Vittorio,
Barat Baviera José Manuel,
Bolognesi Claudia,
Cocconcelli Pier Sandro,
Crebelli Riccardo,
Gott David Michael,
Grob Konrad,
Lampi Evgenia,
Mortensen Alicja,
Rivière Gilles,
Steffensen IngerLise,
Tlustos Christina,
Van Loveren Henk,
Vernis Laurence,
Zorn Holger,
Glandorf Boet,
Herman Lieve,
Engel Karl Heinz,
Marcon Francesca,
Penninks André,
Smith Andrew,
Aguilera Jaime,
Andryszkiewicz Magdalena,
Liu Yi,
Rainieri, Sandra,
Chesson Andrew
Publication year - 2020
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2020.5974
Subject(s) - genotoxicity , food science , xylanase , trichoderma reesei , brewing , enzyme , enzyme assay , toxicity , animal feed , no observed adverse effect level , biology , microbiology and biotechnology , chemistry , toxicology , biochemistry , cellulase , fermentation , organic chemistry
The food enzyme xylanase ( EC 3.2.1.8) is produced with the genetically modified Trichoderma reesei strain RF 5703 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 . The food enzyme is intended to be used in brewing processes and grain treatment for the production of starch and gluten fractions. Since residual amounts of the food enzyme are removed during grain treatment, dietary exposure was only calculated for brewing processes. Based on the maximum recommended use levels for brewing processes, dietary exposure to the food enzyme–Total Organic Solids ( TOS ) was estimated to be up to 0.023 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 at the highest dose tested of 1,000 mg TOS /kg bw per day, resulting in a high margin of exposure of at least 43,000. Similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that, under the intended condition of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood of such reactions to occur is considered to be low. Based on the data provided and the removal of TOS during the intended food production process, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.