Judgment Of The Court Of Justice Of The European Union Of July 25, 2018, In Case C-528/16 Confédération Paysanne And Others

On July 25, 2018, the Court of Justice (Court), sitting in a Grand Chamber, issued its judgment in Confédération paysanne and Others, by which it found that (a) organisms obtained by mutagenesis techniques are to be considered genetically modified organisms (GMOs) within the meaning of Directive 2001/181 (Directive), and (b) the express exemption of mutagenesis in Annex 1B of the Directive applies only to organisms obtained by means of techniques of mutagenesis which have conventionally been used in a number of applications and have a long safety record, which may, however, be the subject of national legislation.

1. Legal Context

   The scope of the Directive is determined by Article 2, under which a GMO is defined as "an organism, with the exception of human being, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination." The Directive also provides a conditional exemption for organisms obtained through the techniques of genetic modification listed in Annex 1B of the Directive.2 The excluded techniques include mutagenesis and cell fusion. The reason given for the exclusion of these techniques was the "long safety record" and the fact that these have been conventionally used in a number of applications.

   The law on the deliberate release of GMOs in the EU, as established by the Directive, was thus always considered to be directed to organisms obtained through so-called transgenesis. Such technique involves a process of inserting a gene into a living organism that normally does not have a copy of that particular gene. In contrast, producing mutations in an organism through mutagenesis occurs through the manipulation of that organism's genes, without inserting foreign genes. Until the Court's judgment in case C-528/16, organisms obtained by any mutagenesis technique were generally considered to be exempted from the scope of the Directive as per the express stipulation in Annex 1B.

2. Facts

   In December 2015, nine French associations, including the French agricultural union Confédération paysanne, brought an action before the highest French administrative court - Conseil d'Etat (Council of State) - contesting the French legislation for transposing the Directive.3

   The applicants argued that since the adoption of the Directive, mutagenesis techniques have evolved, allowing new varieties, and in particular those resistant to herbicides, to be obtained through these techniques. They...