Dataset Information

Safety evaluation of the food enzyme endo-1,4-?-xylanase from a genetically modified Trichoderma reesei (strain DP-Nzd22).

ABSTRACT: The food enzyme endo-1,4-?-xylanase (EC 3.2.1.8) is produced with a genetically modified Trichoderma reesei (strain DP-Nzd22) by DuPont. 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 endo-1,4-?-xylanase is intended to be used in distilled alcohol production, bakery and brewery. Residual amounts of total organic solids (TOS) are removed during the production of distilled alcohol, consequently dietary exposure was not calculated. For baking and brewing processes, based on the proposed maximum use levels, dietary exposure to the food enzyme-TOS was estimated to be up to 0.416 mg TOS/kg body weight (bw) per day in European populations. 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 rodents. The Panel identified a No Observed Adverse Effect Level of 1,000 mg TOS/kg bw per day. A comparison of the no observed adverse effect level with the dietary exposure results in a sufficiently high margin of exposure (at least 2,400). Similarity of the amino acid sequence to those of known allergens was searched and no matches were found. The Panel considered that, under the intended conditions 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, the removal of TOS during the production of distilled alcohol and the derived margin of exposure for baking and brewing processes, the Panel concluded that this food enzyme does not raise safety concerns under the intended conditions of use.

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

PROVIDER: S-EPMC7009703 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

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Publications

Safety evaluation of the food enzyme endo-1,4-β-xylanase from a genetically modified <i>Trichoderma reesei</i> (strain DP-Nzd22).

Silano Vittorio V Barat Baviera José Manuel JM Bolognesi Claudia C Brüschweiler Beat Johannes BJ Cocconcelli Pier Sandro PS Crebelli Riccardo R Gott David Michael DM Grob Konrad K Lampi Evgenia E Mortensen Alicja A Riviere Gilles G Steffensen Inger-Lise IL Tlustos Christina C Van Loveren Henk H Vernis Laurence L Zorn Holger H Glandorf Boet B Marcon Francesca F Penninks André A Aguilera Jaime J Aguilera-Gómez Margarita M Andryszkiewicz Magdalena M Arcella Davide D Gomes Ana A Kovalkovičová Natália N Liu Yi Y Chesson Andrew A

EFSA journal. European Food Safety Authority 20181130 11

The food enzyme endo-1,4-β-xylanase (EC 3.2.1.8) is produced with a genetically modified <i>Trichoderma reesei</i> (strain DP-Nzd22) by DuPont. 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 endo-1,4-β-xylanase is intended to be used in distilled alcohol production, bakery and brewery. Residual amounts of total organic solids (TOS) are removed during the production of distilled alcohol, ...[more]

PMID: 32625761

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 a genetically modified Trichoderma reesei (strain DP-Nzd22).

Publications

Safety evaluation of the food enzyme endo-1,4-β-xylanase from a genetically modified <i>Trichoderma reesei</i> (strain DP-Nzd22).

Similar Datasets

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