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The status under EU Law of Organisms developed through novel genomic techniques

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Abstract
In 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.
Keywords
Safety Research, HORIZONTAL TRANSFER, GENE

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MLA
Van der Meer, Pieter, et al. “The Status under EU Law of Organisms Developed through Novel Genomic Techniques.” EUROPEAN JOURNAL OF RISK REGULATION, 2022, doi:10.1017/err.2020.105.
APA
Van der Meer, P., Angenon, G., Bergmans, H., Buhk, H. J., Callebaut, S., Chamon, M., … Zimny, T. (2022). The status under EU Law of Organisms developed through novel genomic techniques. EUROPEAN JOURNAL OF RISK REGULATION. https://doi.org/10.1017/err.2020.105
Chicago author-date
Van der Meer, Pieter, Geert Angenon, Hans Bergmans, Hans Jörg Buhk, Sam Callebaut, Merijn Chamon, Dennis Eriksson, et al. 2022. “The Status under EU Law of Organisms Developed through Novel Genomic Techniques.” EUROPEAN JOURNAL OF RISK REGULATION. https://doi.org/10.1017/err.2020.105.
Chicago author-date (all authors)
Van der Meer, Pieter, Geert Angenon, Hans Bergmans, Hans Jörg Buhk, Sam Callebaut, Merijn Chamon, Dennis Eriksson, Godelieve Gheysen, Wendy Harwood, Penny Hundleby, Peter Kearns, Thomas Mcloughlin, and Tomasz Zimny. 2022. “The Status under EU Law of Organisms Developed through Novel Genomic Techniques.” EUROPEAN JOURNAL OF RISK REGULATION. doi:10.1017/err.2020.105.
Vancouver
1.
Van der Meer P, Angenon G, Bergmans H, Buhk HJ, Callebaut S, Chamon M, et al. The status under EU Law of Organisms developed through novel genomic techniques. EUROPEAN JOURNAL OF RISK REGULATION. 2022;
IEEE
[1]
P. Van der Meer et al., “The status under EU Law of Organisms developed through novel genomic techniques,” EUROPEAN JOURNAL OF RISK REGULATION, 2022.
@article{8686056,
  abstract     = {{In 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.}},
  author       = {{Van der Meer, Pieter and Angenon, Geert and Bergmans, Hans and Buhk, Hans Jörg and Callebaut, Sam and Chamon, Merijn and Eriksson, Dennis and Gheysen, Godelieve and Harwood, Wendy and Hundleby, Penny and Kearns, Peter and Mcloughlin, Thomas and Zimny, Tomasz}},
  issn         = {{1867-299X}},
  journal      = {{EUROPEAN JOURNAL OF RISK REGULATION}},
  keywords     = {{Safety Research,HORIZONTAL TRANSFER,GENE}},
  language     = {{eng}},
  pages        = {{20}},
  title        = {{The status under EU Law of Organisms developed through novel genomic techniques}},
  url          = {{http://dx.doi.org/10.1017/err.2020.105}},
  year         = {{2022}},
}

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