Abstract
The Judgment of 25 July 2018 of the Court of Justice of the European Union (CJEU) 1 was optimistically awaited by breeders and supporters of agricultural biotechnology, but shortly after the press release advancing the Judgment, hope turned into frustration. Opinions on how to frame the New Breeding Techniques (NBT) in the context of Directive 2001/18/EC were issued before the Judgment, while proposals to assist the EU legislator to amend the regime driven by the Directive have been also provided afterwards by scientists and institutional bodies around the EU. However, they do not seem to have paid so much attention to the Judgment itself. This paper focuses on the Judgment. It finds out that while the impacts of the Judgment on the NBT might have been slightly overvalued, its potential negative effects on techniques of random mutagenesis and varieties breed through them have been generally underestimated if not absolutely overlooked. The analysis also shows that the Judgment does not preempt the possibility to exempt certain applications of some NBT from the scope of Directive 2001/18/EC, 2 and, in fact, ODM, SDN1, and SDN2 might be, under certain conditions, easily exempted from its scope without the need of a deep legislative revolution nor even the amendment of Directive 2001/18/EC. As regards techniques of random mutagenesis and mutant varieties bred by means of those techniques, until action is taken by Member States (if finally taken), no real limitations upon them are to be feared. However, if Member States start to consider the path opened by the CJEU, then their regulation at an EU level should be readily explored in order to avoid further negative effects on plant breeding as well as on the free movement inside the EU of those varieties and the products thereof.
Highlights
IntroductionAfter a fairly pro-biotech Opinion of Advocate General Bobek3 [see, e.g., Purnhagen et al (2018a; 2018b) and Callaway (2018)], the Judgment of 25 July 2018, Confédération paysanne and Others, C-528/16, EU:C:2018:583 of the Court of Justice of the European Union (CJEU) ( on “the Judgment” or “Confédération paysanne and Others”) deeply disappointed the scientific community [see, e.g., Callaway (2018) or Urnov et al (2018)], because it “classifies genome-edited plants as genetically modified organisms (GMOs) and subjects them to prohibitive premarket risk evaluations” (Urnov et al, 2018: 800)
The interpretation of Directive 2001/18/ EC provided by the Court is coherent with the principles governing the EU legal regime on genetically modified organisms (GMOs) [see, e.g., Purnhagen et al (2018a) and Eriksson (2018)], as shown by the Advocate General in its Opinion, it was not the only possible interpretation of Annex I B Directive 2001/18/EC
It is clear that the Court does not dispute the classification of certain applications of NBT as a variant or species of “mutagenesis,” i.e., targeted mutagenesis; and that the reason leading to consider them as not exempted is the nonfulfilment of the requirements stemming from recital 17 Directive 2001/18/EC
Summary
After a fairly pro-biotech Opinion of Advocate General Bobek3 [see, e.g., Purnhagen et al (2018a; 2018b) and Callaway (2018)], the Judgment of 25 July 2018, Confédération paysanne and Others, C-528/16, EU:C:2018:583 of the Court of Justice of the European Union (CJEU) ( on “the Judgment” or “Confédération paysanne and Others”) deeply disappointed the scientific community [see, e.g., Callaway (2018) or Urnov et al (2018)], because it “classifies genome-edited plants as genetically modified organisms (GMOs) and subjects them to prohibitive premarket risk evaluations” (Urnov et al, 2018: 800). A deeper analysis of the Judgment and its impact on the EU legal regime on GMO seems to be needed. This paper focuses on the Judgment, aiming to debunk some myths around it and clarify its meaning, and to present a proposal addressed to mitigate its potential negative effects on plant breeding, the EU legal regime on GMO and the internal market
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