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Safety evaluation of the food enzyme endo-1,4-β-xylanase from a genetically modified Aspergillus niger (strain XEA)

2018-04Journal article Open access
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dc.contributor.authorEFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)
dc.contributor.authorPoças, Maria de Fátima Tavares
dc.date.accessioned2021-05-27T14:13:13Z
dc.date.available2021-05-27T14:13:13Z
dc.date.issued2018-04
dc.description.abstractThe food enzyme is an endo-1,4-β-xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus niger (strain XEA), by DSM Food Specialities B.V. The food enzyme is intended to be used in baking and brewing processes. Based on maximum use levels recommended for the food processes and individual consumption data from the EFSA Comprehensive European Food Consumption Database, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.310 mg TOS/kg body weight per day in European populations. Genotoxicity tests with the food enzyme did not indicate a genotoxic concern. A repeated dose 90-day oral toxicity study in rodents, carried out with this endo-1,4-β-xylanase, showed no concern with respect to systemic toxicity. The allergenicity was evaluated by searching for similarity of the amino acid sequence to those of known allergens; no match was found. The Panel considers that there are no indications for allergic sensitisation and elicitation reactions by dietary exposure to the food enzyme endo-1,4-β-xylanase. Based on the microbial source, the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the dietary exposure assessment, the findings in the toxicological studies and the allergenicity assessment, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.doi10.2903/j.efsa.2018.5228pt_PT
dc.identifier.eid85062070126
dc.identifier.issn1831-4732
dc.identifier.pmid32625867
dc.identifier.urihttp://hdl.handle.net/10400.14/33335
dc.identifier.wos000431987900010
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.rights.urihttp://creativecommons.org/licenses/by-nd/4.0/pt_PT
dc.subject4-β-xylanasept_PT
dc.subjectAspergillus nigerpt_PT
dc.subjectEC 3.2.1.8pt_PT
dc.subjectEndo-1pt_PT
dc.subjectFood enzymept_PT
dc.subjectGenetically modified microorganismpt_PT
dc.titleSafety evaluation of the food enzyme endo-1,4-β-xylanase from a genetically modified Aspergillus niger (strain XEA)pt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue4pt_PT
oaire.citation.titleEFSA Journalpt_PT
oaire.citation.volume16pt_PT
person.familyNamePoças
person.givenNameMaria de Fátima
person.identifier.ciencia-id1513-5F90-0B67
person.identifier.orcid0000-0002-6598-6515
person.identifier.scopus-author-id15127714500
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT
relation.isAuthorOfPublicationdca9a545-c7be-41fd-802b-b608d9d240eb
relation.isAuthorOfPublication.latestForDiscoverydca9a545-c7be-41fd-802b-b608d9d240eb

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