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Safety evaluation of food enzyme xylanase from a genetically modified Bacillus subtilis (strain LMG S-27588)

2018-05Artigo científico Acesso aberto
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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 Tavares
dc.contributor.authorGomes, Ana
dc.date.accessioned2021-05-26T19:41:14Z
dc.date.available2021-05-26T19:41:14Z
dc.date.issued2018-05
dc.description.abstractThe food enzyme considered in this opinion is an endo-1,4-β-xylanase (4-β-d-xylan xylanohydrolase; EC 3.2.1.8) produced from the genetically modified Bacillus subtilis strain LMG S-27588 by the company Puratos N. V. The production strain was not detected in the food enzyme. The endo-1,4-β-xylanase is intended to be used in baking processes. Based on the maximum use levels recommended 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 0.325 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests with the food enzyme indicated no genotoxic concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. A no observed adverse effect level (NOAEL) was derived (443 mg TOS/kg bw per day), which, compared with the dietary exposure, results in a sufficiently high margin of exposure. The allergenicity was evaluated by comparing the amino acid sequence to those of known allergens; no match was found. The Panel considered that there are no indications for food allergic reactions to this endo-1,4-β-xylanase by dietary exposure. Based on the genetic modifications, the manufacturing process, the compositional and biochemical data, the dietary exposure assessment, the findings in the toxicological studies and allergenicity assessment, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use. The Panel noted that recombinant DNA was present in all batches of the food enzyme tested.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.doi10.2903/j.efsa.2018.5169pt_PT
dc.identifier.eid85062087281
dc.identifier.issn1831-4732
dc.identifier.pmid32625891
dc.identifier.urihttp://hdl.handle.net/10400.14/33294
dc.identifier.wos000434095800003
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.rights.urihttp://creativecommons.org/licenses/by-nd/4.0/pt_PT
dc.subject4-β-d-xylan xylanohydrolasept_PT
dc.subjectBacillus subtilispt_PT
dc.subjectEC 3.2.1.8pt_PT
dc.subjectEndo-1,4-β-xylanasept_PT
dc.subjectFood enzymept_PT
dc.subjectGenetically modified microorganismpt_PT
dc.subjectXylanasept_PT
dc.titleSafety evaluation of food enzyme xylanase from a genetically modified Bacillus subtilis (strain LMG S-27588)pt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue5pt_PT
oaire.citation.titleEFSA Journalpt_PT
oaire.citation.volume16pt_PT
person.familyNamePoças
person.familyNameGomes
person.givenNameMaria de Fátima
person.givenNameAna Maria
person.identifier162628
person.identifier.ciencia-id1513-5F90-0B67
person.identifier.ciencia-idAA12-BFC1-B2E3
person.identifier.orcid0000-0002-6598-6515
person.identifier.orcid0000-0001-7883-2446
person.identifier.ridB-9944-2013
person.identifier.scopus-author-id15127714500
person.identifier.scopus-author-id57190668768
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT
relation.isAuthorOfPublicationdca9a545-c7be-41fd-802b-b608d9d240eb
relation.isAuthorOfPublicationc18c2fb1-f3dc-4274-a646-23d456432798
relation.isAuthorOfPublication.latestForDiscoverydca9a545-c7be-41fd-802b-b608d9d240eb

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