Found to be in principle, subject to the obligations laid down by the GMO Directive
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. Mutagenesis techniques have made it possible to develop seed varieties which are resistant to selective herbicides.
Confédération paysanne is a French agricultural union which defends the interests of small-scale farming. Together with eight other associations, it has brought an action before the Conseil d’État (Council of State, France) in order to contest the French legislation which exempts organisms obtained by mutagenesis from the obligations imposed by the directive on genetically modified organisms (GMOs).1 In particular, that directive provides that GMOs must be authorised following an assessment of the risks which they present for human health and the environment and also makes them subject to traceability, labelling and monitoring obligations.
Confédération paysanne and the other associations argue that mutagenesis techniques have evolved over time. Prior to the adoption of the GMO Directive, only conventional or random methods of mutagenesis were applied in vivo to entire plants. Subsequently, technical progress has led to the emergence of in vitro mutagenesis techniques which make it possible to target the mutations in order to obtain an organism resistant to certain herbicides. Confédération paysanne and the other associations take the view that the use of herbicide-resistant seed varieties carries a risk of significant harm to the environment and to human and animal health, in the same way as GMOs obtained by transgenesis.
It is in this context that the Court of Justice has been requested by the Conseil d’État to determine, in essence, whether organisms obtained by mutagenesis are GMOs and whether they are subject to the obligations laid down by the GMO Directive.
In today’s judgment, the Court of Justice takes the view, first of all, that organisms obtained by mutagenesis are GMOs within the meaning of the GMO Directive, in so far as the techniques and methods of mutagenesis alter the genetic material of an organism in a way that does not occur naturally. It follows that those organisms come, in principle, within the scope of the GMO Directive and are subject to the obligations laid down by that directive.
The Court states, however, that it is apparent from the GMO Directive that it does not apply to organisms obtained by means of certain mutagenesis techniques, namely those which have conventionally been used in a number of applications and have a long safety record. The Court nevertheless specifies that the Member States are free to subject such organisms, in compliance with EU law (in particular the rules on the free movement of goods), to the obligations laid down by the GMO Directive or to other obligations. The fact that those organisms are excluded from the scope of the directive does not mean that the persons concerned may proceed freely with their deliberate release into the environment or with their placement on the market within the EU. The Member States are thus free to legislate in this area in compliance with EU law, in particular with the rules on the free movement of goods.
NOTE: A reference for a preliminary ruling allows the courts and tribunals of the Member States, in disputes which have been brought before them, to refer questions to the Court of Justice about the interpretation of EU law or the validity of a European Union act. The Court of Justice does not decide the dispute itself. It is for the national court or tribunal to dispose of the case in accordance with the Court’s decision, which is similarly binding on other national courts or tribunals before which a similar issue is raised.
1 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 (OJ 2001 L 106, p. 1).