The Status under EU Law of Organisms Developed through Novel Genomic Techniques

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.

New genomic techniques and their European Union reform. Potential policy changes and their implications

“…Exemption (the way products of random mutagenesis are currently exempted) of certain products from legislation (e.g., SDN-1 and 2 -Vives-Vallés and Collonnier, 2020; see also Zimny and Eriksson, 2020) or even an interpretation of the GMO definition in such a way that it would not cover such products (Van Der Meer et al, 2021) has been postulated not only by researchers, but also stakeholders and some organizations. The adoption of such a policy would definitely have the most benefits from the point of view of researchers and developers of products covered by the exemption.…”

“…that it means at least: gene editing techniques either through the application of oligonucleotide mediated mutagenesis (ODM), site directed nucleases (SDN) (Zimny and Sowa, 2021) and RNAdirected DNA methylation (European Commission, 2021, 62-63), although this classification of methods and their products is not uncontroversial (Vives-Vallés and Collonnier, 2020;Van Der Meer et al, 2021).…”

Europe’s Farm to Fork Strategy and Its Commitment to Biotechnology and Organic Farming: Conflicting or Complementary Goals?

“…As to the interpretation by many academics and stakeholders of the judgment Confédération paysanne, the products of most novel breeding technologies, including targeted mutagenesis through genome editing, are subject to the GMO regulations [1,2]. Others argue that certain applications of targeted mutagenesis may still be excluded postjudgment [3,4]. Labeling exemptions apply to the adventitious or technically unavoidable presence of traces of GMOs, as long as they do not exceed the threshold level of 0.9%, as defined under Regulation 1829/2003.…”

GMO Regulation in Crisis – The Experimental Potential of Regulation (EU) 2020/1043 on Covid-19 in Addressing Both a Crisis and a ­Pandemic

“…Several stakeholders hoped beforehand that the CJEU ruling would pave the way for a more innovation-friendly road by exempting new mutagenesis techniques from the obligations of the directive. On the contrary, the CJEU decided that these techniques are techniques of genetic modification and fall within the scope of Directive 2001/18/EC (Bergmans, Poort, Kortleven & Kleinjans, 2020;Van der Meer et al, 2021). As a response to this ruling, the Council of the EU called for a study to offer clarity on the status of new genomic techniques.…”