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hal.structure.identifierUnité de Recherche Génomique Info [URGI]
dc.contributor.authorCASACUBERA, Josep
hal.structure.identifierInstitut Jean-Pierre Bourgin [IJPB]
dc.contributor.authorNOGUÉ, Fabien
dc.contributor.authorNAEGELI, Hanspeter
dc.contributor.authorBIRCH, Andrew Nicholas
dc.contributor.authorDE SCHRIJVER, Adinda
dc.contributor.authorGRALAK, Mikołaj Antoni
dc.contributor.authorGUERCHE, Philippe
dc.contributor.authorMANACHINI, Barbara
hal.structure.identifierUnité Impacts Ecologiques des Innovations en Production Végétale [ECO-INNOV]
dc.contributor.authorMESSÉAN, Antoine
dc.contributor.authorNIELSEN, Elsa Ebbesen
hal.structure.identifierBiologie du fruit et pathologie [BFP]
dc.contributor.authorROBAGLIA, Christophe
dc.contributor.authorROSTOKS, Nils
dc.contributor.authorSWEET, Jeremy
dc.contributor.authorTEBBE, Cristoph
dc.contributor.authorVISIOLI, Francesco
hal.structure.identifierLaboratoire d'Etudes et de Recherches en Immunoanalyses [LERI]
dc.contributor.authorWAL, Jean-Michel
dc.contributor.authorMOXON, Simon
dc.contributor.authorSCHNEEBERGER, Korbinian
dc.contributor.authorFEDERICI, Silvia
dc.contributor.authorRAMON, Matthew
dc.contributor.authorPAPADOPOULOU, Nikoletta
dc.contributor.authorJONES, Huw
dc.date.issued2018
dc.identifier.issn1831-4732
dc.description.abstractEnAs part of the risk assessment (RA) requirements for genetically modified (GM) plants, according to Regulation (EU) No 503/2013 and the EFSA guidance on the RA of food and feed from GM plants (EFSA GMO Panel, 2011), applicants need to perform a molecular characterisation of the DNA sequences inserted in the GM plant genome. The European Commission has mandated EFSA to develop a technical note to the applicants on, and checking of, the quality of the methodology, analysis and reporting covering complete sequencing of the insert and flanking regions, insertion site analysis of the GM event, and generational stability and integrity. This Technical Note puts together requirements and recommendations for when DNA sequencing is part of the molecular characterisation of GM plants, in particular for the characterisation of the inserted genetic material at each insertion site and flanking regions, the determination of the copy number of all detectable inserts, and the analysis of the genetic stability of the inserts, when addressed by Sanger sequencing or NGS. This document reflects the current knowledge in scientific‐technical methods for generating and verifying, in a standardised manner, DNA sequencing data in the context of RA of GM plants. From 1 October 2018, this Technical Note will replace the JRC guideline of 2016 (updated April 2017) related to the verification and quality assessment of the sequencing of the insert(s) and flanking regions. It does not take into consideration the verification and validation of the detection method which remains under the remit of the JRC.
dc.language.isoen
dc.publisherEuropean Food Safety Authority
dc.subject.enDNA sequencing
dc.subject.ennext-generation sequencing
dc.subject.engenetically modified organisms
dc.subject.enmolecularcharacterisation
dc.subject.enrisk assessment
dc.subject.enNGS
dc.subject.engenetic stability
dc.title.enTechnical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plants
dc.typeArticle de revue
dc.identifier.doi10.2903/j.efsa.2018.5345
dc.subject.halSciences du Vivant [q-bio]
bordeaux.journalEFSA Journal
bordeaux.pagenp
bordeaux.volume16
bordeaux.issue7
bordeaux.peerReviewednon
hal.identifierhal-02187464
hal.version1
hal.popularnon
hal.audienceNon spécifiée
hal.origin.linkhttps://hal.archives-ouvertes.fr//hal-02187464v1
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