The Status Under EU Law of Organisms Developed Through Novel Genomic Techniques

Abstract

In a ruling on 25th 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 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 early 2020 stakeholder consultations. 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 firstly offering some historical background of the negotiations on the EU GMO Directives as well as technical context of some of the terms in the Directive and secondly an analysis of 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, i.e. 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 consistent 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 he genetic alterations of the resulting organism must be considered.

Keywords: Directive 2001/18/EC, GMO, Genetic Modification, Mutagenesis, Exclusion, CJEU Ruling C-528/16, Genetic Engineering, Genome Editing, Gene Editing, Council Request 12781/19, Novel Genomic Techniques