The Court of Justice of the European Union (CJEU) was requested by the French Conseil d’État to determine, in essence, whether organisms obtained by mutagenesis (i.e. gene editing) are genetically modified organisms (GMOs) and whether they are subject to the obligations laid down by Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. Contrary to the Advocate-General’s opinion of 18 January 2018, the Court of Justice ruled, on 25 July 2018, in case C-528/16 that Directive 2001/18/EC also applies to organisms obtained by mutagenesis techniques that have emerged since its adoption. The article analyses the grounds and implications of the CJEU’s decision.
Unlike transgenesis, mutagenesis is a set of techniques, which make it possible to alter the genome of a living species without the insertion of foreign DNA. Indeed, it is virtually impossible to detect whether the DNA of a plant or animal has been edited or not, because the changes involved are indistinguishable from naturally occurring mutations. Mutagenesis techniques have made it possible to develop, inter alia, seed varieties that are resistant to selective herbicides.
In response to the CJEU’s judgment, the US Secretary of Agriculture issued a statement criticizing the ruling. The statement reads, in part, that ‘[g]overnment policies should encourage scientific innovation without creating unnecessary barriers or unjustifiably stigmatizing new technologies. Unfortunately, this [...] ruling is a setback in this regard in that it narrowly considers newer genome editing methods to be within the scope of the European Union’s regressive and outdated regulations governing genetically modified organisms’.
The article also analyses the possible international trade implications of this decision and of its effects, in light of the applicable WTO law and of the relevant case law, such as the EU – Biotech Products dispute by Argentina, Canada and the US, where the WTO had ultimately condemned a de facto moratorium on the approval of GM products in the EU and in its Member States.Global Trade and Customs Journal