Dataset Information

Safety evaluation of the food enzyme endo-1,4-?-xylanase and ?-glucanase from Disporotrichum dimorphosporum strain DXL.

ABSTRACT: The food enzyme with xylanases (4-?-d-xylan xylanohydrolase, EC 3.2.1.8) and glucanases active against ?-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 ?-glucanases to those of known allergens was searched. No matches were found for two endo-1,4-?-glucanases and two endo-1,4-?-xylanases. However, for a third endo-?-1,4-glucanase the search resulted in matches with three mite protein sequences. While incidental cases of allergic reactions to endo-1,4-?-xylanases and ?-glucanases have been reported after inhalation in respiratory sensitised individuals in the workplace, no allergic reactions to xylanases or ?-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.

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

PROVIDER: S-EPMC7008894 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Publications

Safety evaluation of the food enzyme endo-1,4-β-xylanase and β-glucanase from <i>Disporotrichum dimorphosporum</i> strain DXL.

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 Lampi Evgenia E 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 Marcon Francesca F Penninks André A Smith Andrew A Aguilera-Gomez Margarita M Andryszkiewicz Magdalena M Arcella Davide D Gomes Ana A Kovalkovičová Natália N Liu Yi Y Maia Joaquim J Roncancio Peña Claudia C Chesson Andrew A

EFSA journal. European Food Safety Authority 20200110 1

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 <i>Disporotrichum dimorphosporum</i> 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 t ...[more]

PMID: 32626505

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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 and ?-glucanase from Disporotrichum dimorphosporum strain DXL.

Publications

Safety evaluation of the food enzyme endo-1,4-β-xylanase and β-glucanase from <i>Disporotrichum dimorphosporum</i> strain DXL.

Similar Datasets

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