Dataset Information

Safety evaluation of the food enzyme endo-1,4-?-xylanase from the genetically modified Trichoderma reesei strain RF5427.

ABSTRACT: The food enzyme endo-1,4-?-xylanase (4-?-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.

SUBMITTER: EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP)

PROVIDER: S-EPMC7448032 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Publications

Safety evaluation of the food enzyme endo-1,4-β-xylanase from the genetically modified <i>Trichoderma reesei</i> strain RF5427.

Silano Vittorio V Barat Baviera José Manuel JM Bolognesi Claudia C Cocconcelli Pier Sandro PS Crebelli Riccardo R Gott David Michael DM Grob Konrad K Lambré Claude C Lampi Evgenia E Mengelers Marcel M Mortensen Alicja A Rivière Gilles G Steffensen Inger-Lise IL Tlustos Christina C Van Loveren Henk H Vernis Laurence L Zorn Holger H Glandorf Boet B Herman Lieve L Engel Karl-Heinz KH Aguilera Jaime J Aguilera-Gomez Margarita M Arcella Davide D Maia Joaquim J Liu Yi Y Chesson Andrew A

EFSA journal. European Food Safety Authority 20200603 6

The food enzyme endo-1,4-β-xylanase (4-β-D-xylan xylanohydrolase; EC 3.2.1.8) is produced with the genetically modified <i>Trichoderma reesei</i> 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 fract ...[more]

PMID: 32874316

Similar Datasets

Project description: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) is produced with the non-genetically modified Trichoderma reesei strain AR-256 by AB-Enzymes GmbH. The food enzyme is considered free from viable cells of the production organism. It is intended to be used in seven food manufacturing processes: baking processes, cereal-based processes, brewing processes, fruit and vegetable processing for juice production, wine and wine vinegar production, distilled alcohol production and grain treatment for production of starch and gluten fractions. Since the residual amounts of total organic solids (TOS) are removed during grain treatment and distilled alcohol production, dietary exposure was estimated for the remaining five processes and amounted up to 3.92 mg TOS/kg body weight (bw) per day. The toxicity studies were carried out with an endo-1,4-β-xylanase from T. reesei ■■■■■, considered by the Panel as a suitable substitute, because the genetic differences between the strains are well characterised and of no concern. Additionally, several strains derived from the production strain are considered safe by EFSA and the manufacturing of both food enzymes is similar. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by a repeated dose 90-day oral toxicity rat study. The no observed adverse effect level of 939 mg TOS/kg bw per day, the highest dose tested, compared with the estimated dietary exposure, resulted in a margin of exposure above 239. In the search for the similarity of the amino acid sequences to known allergens, one match (salmon) was found. The Panel considered that, under the intended conditions of use (except distilled alcohol production), the risk of allergic reactions by dietary exposure cannot be excluded, in particular for individuals sensitised to salmon. The Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

Dataset Information

Safety evaluation of the food enzyme endo-1,4-?-xylanase from the genetically modified Trichoderma reesei strain RF5427.

Publications

Safety evaluation of the food enzyme endo-1,4-β-xylanase from the genetically modified <i>Trichoderma reesei</i> strain RF5427.

Similar Datasets

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