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Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM-SM)

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
dc.date.accessioned2021-05-26T20:12:53Z
dc.date.available2021-05-26T20:12:53Z
dc.date.issued2018-05
dc.description.abstractThe food enzyme considered is a maltogenic amylase (glucan 1,4-α-maltohydrolase; EC 3.2.1.133) produced with the genetically modified Bacillus subtilis strain NZYM-SM by Novozymes A/S. The food enzyme contains neither the production organism nor recombinant DNA. The maltogenic amylase is intended for use in baking processes and starch processing for glucose syrups production. Based on the 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 0.168 mg TOS/kg body weight (bw) per day in European populations. The food enzyme did not induce gene mutations in bacteria or chromosomal aberrations in human lymphocytes. The subchronic 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 (320 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 searching for similarity of the amino acid sequence to those of known allergens. Three matches to occupational respiratory allergens were found, however, the Panel considered that there are no indications for food allergic reactions to the food enzyme. Based on the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided, the dietary exposure assessment, the findings in the toxicological studies and allergenicity assessment, the Panel concluded that the food enzyme maltogenic amylase from Bacillus subtilis strain NZYM-SM 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.2018.5171pt_PT
dc.identifier.eid85062063760
dc.identifier.issn1831-4732
dc.identifier.pmid32625893
dc.identifier.urihttp://hdl.handle.net/10400.14/33296
dc.identifier.wos000434095800005
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.rights.urihttp://creativecommons.org/licenses/by-nd/4.0/pt_PT
dc.subject4-α-maltohydrolasept_PT
dc.subjectBacillus subtilispt_PT
dc.subjectEC 3.2.1.133pt_PT
dc.subjectFood enzymept_PT
dc.subjectGenetically modified microorganismpt_PT
dc.subjectGlucan 1pt_PT
dc.subjectMaltogenic amylasept_PT
dc.titleSafety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM-SM)pt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue5pt_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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