{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T19:56:51Z","timestamp":1783367811648,"version":"3.54.6"},"reference-count":13,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2014,5,1]],"date-time":"2014-05-01T00:00:00Z","timestamp":1398902400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1"},{"start":{"date-parts":[[2014,5,14]],"date-time":"2014-05-14T00:00:00Z","timestamp":1400025600000},"content-version":"vor","delay-in-days":13,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["EFS2","EFSA Journal"],"published-print":{"date-parts":[[2014,5]]},"abstract":"<jats:p>Abstract The food enzyme considered in this opinion is a xylanase (endo\u20101, 4\u2010\u03b2\u2010xylanase; EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae. The genetic modifications do not raise safety concern. The food enzyme contains neither the production organism nor recombinant DNA. The xylanase is intended to be used in a number of food manufacturing processes, such as starch processing, beverage alcohol (distilling), brewing, baking and other cereal based processes. The dietary exposure was assessed according to the Budget method. The food enzyme did not induce gene mutations in bacteria nor chromosome aberrations in human peripheral blood lymphocytes. Therefore, there is no concern with respect to genotoxicity. The systemic toxicity was assessed by means of a 90\u2010day subchronic oral toxicity study in rodents. A No Observed Adverse Effect Level was derived, 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. The Panel considered that the likelihood of food allergic reactions to the enzyme is low and therefore does not raise safety concern. Based on the genetic modifications performed, the manufacturing process, the compositional and biochemical data provided and the toxicological studies, this food enzyme does not raise safety concern under the intended conditions of use.<\/jats:p>","DOI":"10.2903\/j.efsa.2014.3645","type":"journal-article","created":{"date-parts":[[2016,5,23]],"date-time":"2016-05-23T18:39:38Z","timestamp":1464028778000},"source":"Crossref","is-referenced-by-count":2,"title":["Scientific Opinion on Xylanase from a Genetically Modified Strain of Aspergillus oryzae (strain NZYM\u2010FB)"],"prefix":"10.2903","volume":"12","author":[{"name":"EFSA Panel on Food Contact Material, Enzymes, Flavourings and Processing Aids (CEF)","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","reference":[{"key":"10.2903\/j.efsa.2014.3645_ref1","doi-asserted-by":"crossref","first-page":"214","DOI":"10.1016\/j.yrtph.2003.09.002","article-title":"Production of toxic metabolites in Aspergillus niger, Aspergillus oryzae, and Trichoderma reesei: justification of mycotoxin testing in food grade enzyme preparations derived from the three fungi","volume":"39","author":"Blumenthal","year":"2004","journal-title":"Regulatory Toxicology and Pharmacology"},{"key":"10.2903\/j.efsa.2014.3645_ref2","volume-title":"Report on methodologies for the monitoring of food additive intake across the European Union","author":"EC (European Commisssion)","year":"1998"},{"key":"10.2903\/j.efsa.2014.3645_ref3","first-page":"1","article-title":"Guidance of the Scientific Panel of Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) on the Submission of a Dossier on Food Enzymes for Safety Evaluation by the Scientific Panel of Food Contact Material, Enzymes, Flavourings and Processing Aids","volume":"1305","author":"EFSA (European Food Safety Authority)","year":"2009","journal-title":"The EFSA Journal"},{"issue":"7","key":"10.2903\/j.efsa.2014.3645_ref4","doi-asserted-by":"crossref","first-page":"168","DOI":"10.2903\/j.efsa.2010.1700","article-title":"Scientific opinion on the assessment of allergenicity of GM plants and microorganisms and derived food and feed","volume":"8","author":"EFSA Panel on Genetically Modified Organisms (GMO)","year":"2010","journal-title":"EFSA Journal"},{"issue":"6","key":"10.2903\/j.efsa.2014.3645_ref5","doi-asserted-by":"crossref","first-page":"54","DOI":"10.2903\/j.efsa.2011.2193","article-title":"Guidance on the risk assessment of genetically modified microorganisms and their products intended for food and feed use","volume":"9","author":"EFSA Panel on Genetically Modified Organisms (GMO)","year":"2011","journal-title":"EFSA Journal"},{"issue":"12","key":"10.2903\/j.efsa.2014.3645_ref6","doi-asserted-by":"crossref","first-page":"84","DOI":"10.2903\/j.efsa.2012.3020","article-title":"Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2012 update)","volume":"10","author":"EFSA Panel on Biological Hazards (BIOHAZ)","year":"2012","journal-title":"EFSA Journal"},{"key":"10.2903\/j.efsa.2014.3645_ref7","unstructured":"FAO\/WHO (Food and Agriculture Organization of the United States\/World Health Organization) , 2001. 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