TY - JOUR
T1 - The Status under EU Law of Organisms Developed through Novel Genomic Techniques
AU - Van der Meer, Piet
AU - Angenon, Geert
AU - Bergmans, Hans
AU - Buhk, Hans Jörg
AU - Callebaut, Sam
AU - Chamon, Merijn
AU - Eriksson, Dennis
AU - Gheysen, Godelieve
AU - Harwood, Wendy
AU - Hundleby, Penny
AU - Kearns, Peter
AU - McLoughlin, Thomas
AU - Zimny, Tomasz
N1 - Funding Information:
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. This work was supported by Ghent University, Belgium, Vrije Universiteit Brussels, Belgium, the Swedish Foundation for Strategic Environmental Research (Mistra) through the Mistra Biotech public research programme, and the Biotechnology and Biological Sciences Research Council (BBSRC) via grant BB/P013511/1 to the John Innes Centre. The authors warmly thank the following colleagues for their very valuable comments and suggestions on an early draft of this article: Hans-Georg Dederer, David Hamburger, Soeren Mark Jensen, Helen Marquard and Eva Stöger. The usual disclaimer applies.
Publisher Copyright:
© 2021 The Author(s).
PY - 2023/3/6
Y1 - 2023/3/6
N2 - 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.
AB - 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.
KW - GENE
KW - HORIZONTAL TRANSFER
U2 - 10.1017/err.2020.105
DO - 10.1017/err.2020.105
M3 - Article
SN - 1867-299X
VL - 14
SP - 93
EP - 112
JO - European Journal of Risk Regulation
JF - European Journal of Risk Regulation
IS - 1
ER -