European Court of Justice (ECJ): Confédération paysanne, a French agricultural union which defends the interests of small-scale farming, together with eight other associations, 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). [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)].

In particular, the 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 was of 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, ECJ was requested by the Conseil d’État to determine, whether organisms obtained by mutagenesis are GMOs and whether they are subject to the obligations laid down by the GMO Directive.

ECJ held 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 and 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, however, made clear that the GMO Directive 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. It nevertheless specified 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.

Court also held that the GMO Directive is applicable to organisms obtained by mutagenesis techniques that have emerged since its adoption, as risks linked to the use of these new mutagenesis techniques might prove to be similar to those that result from the production and release of a GMO through transgenesis and new techniques make it possible to produce genetically modified varieties at a rate out of all proportion to those resulting from the application of conventional methods of mutagenesis.

The Court considered that the concept of ‘genetically modified variety’ must be construed as referring to the concept of a GMO in the GMO Directive, with the result that varieties obtained by mutagenesis which come under that directive must fulfil the condition for inclusion in the ‘common catalogue of varieties of agricultural plant species the seed of which may be marketed’ only if all appropriate measures have been taken to avoid risks to human health and the environment. [Confédération paysanne v. Premier ministre and Ministre de I’Agriculture, de I’Agroalimentaire et de la Forêt, Case C-528/16, judgment dated 25-07-2018]

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