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2021-01-06Zeitschriftenartikel
The Status under EU Law of Organisms Developed through Novel Genomic Techniques
dc.contributor.authorvan der Meer, Piet
dc.contributor.authorAngenon, Geert
dc.contributor.authorBergmans, Hans
dc.contributor.authorBuhk, Hans Jörg
dc.contributor.authorCallebaut, Sam
dc.contributor.authorChamon, Merijn
dc.contributor.authorEriksson, Dennis
dc.contributor.authorGheysen, Godelieve
dc.contributor.authorHardwood, Wendy
dc.contributor.authorHundleby, Penny
dc.contributor.authorKearns, Peter
dc.contributor.authorMcloughlin, Thomas
dc.date.accessioned2024-08-26T15:40:21Z
dc.date.available2024-08-26T15:40:21Z
dc.date.issued2021-01-06none
dc.identifier.other10.1017/err.2020.105
dc.identifier.urihttp://edoc.rki.de/176904/11977
dc.description.abstractIn a ruling on 25 July 2018, the Court of Justice of the European Union concluded that organisms obtained by means of techniques/methods of mutagenesis constitute GMOs in the sense of Directive 2001/18, and that organisms obtained by means of techniques/methods of directed mutagenesis are not excluded from the scope of the Directive. Following the ruling, there has been much debate about the possible wider implications of the ruling. In October 2019, the Council of the European Union requested the European Commission to submit, in light of the CJEU ruling, a study regarding the status of novel genomic techniques under Union Law. For the purpose of the study, the Commission initiated stakeholder consultations early in 2020. Those consultations focused on the technical status of novel genomic techniques. This article aims to contribute to the discussion on the legal status of organisms developed through novel genomic techniques, by offering some historical background to the negotiations on the European Union (EU) GMO Directives as well as a technical context to some of the terms in the Directive, and by analysing the ruling. The article advances that (i) the conclusion that organisms obtained by means of techniques/methods of mutagenesis constitute GMOs under the Directive means that the resulting organisms must comply with the GMO definition, ie the genetic material of the resulting organisms has been altered in a way that does not occur naturally by mating and/or natural recombination; (ii) the conclusion that organisms obtained by means of techniques/methods of directed mutagenesis were not intended to be excluded from the scope of the Directive is not inconsistent with the negotiation history of the Directive; (iii) whether an organism falls under the description of “obtained by means of techniques/methods of directed mutagenesis” depends on whether the genetic material of the resulting organisms has been altered in a way that does not occur naturally by mating and/or natural recombination. Finally, the article offers an analysis of the EU GMO definition, concluding that for an organism to be a GMO in the sense of the Directive, the technique used, as well as the genetic alterations of the resulting organism, must be considered.eng
dc.language.isoengnone
dc.publisherRobert Koch-Institut
dc.rights(CC BY 3.0 DE) Namensnennung 3.0 Deutschlandger
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/de/
dc.subject.ddc610 Medizin und Gesundheitnone
dc.titleThe Status under EU Law of Organisms Developed through Novel Genomic Techniquesnone
dc.typearticle
dc.identifier.urnurn:nbn:de:0257-176904/11977-5
dc.type.versionpublishedVersionnone
local.edoc.container-titleEuropean Journal of Risk Regulationnone
local.edoc.container-issn2190-8249none
local.edoc.pages20none
local.edoc.type-nameZeitschriftenartikel
local.edoc.container-typeperiodical
local.edoc.container-type-nameZeitschrift
local.edoc.container-urlhttps://www.cambridge.org/core/journals/european-journal-of-risk-regulationnone
local.edoc.container-publisher-nameCambridge University Pressnone
local.edoc.container-volume14none
local.edoc.container-issue1none
local.edoc.container-reportyear2021none
local.edoc.container-firstpage93none
local.edoc.container-lastpage112none
dc.description.versionPeer Reviewednone

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