CJEU: Organisms obtained by mutagenesis are GMOs

Luxembourg: The CJEU has decided that organisms obtained by mutagenesis are GMOs and are, in principle, subject to the obligations laid down by the GMO Directive.

The Court of Justice of the European Union (CJEU) has today released its judgement in a case involving a scientific process called mutagenesis, a set of techniques which make it possible to alter the genome of a living species without the insertion of foreign DNA.

In Confédération paysanne and Others v Premier ministre and Ministre de l’Agriculture, de l’Agroalimentaire et de la Forêt (Case C-528/16), the CJEU ruled that:

– organisms obtained by mutagenesis are GMOs within the meaning of the GMO Directive;
– such organisms are subject to the obligations and restrictions laid down by that Directive.

The only exemption specified by the CJEU applies 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-standing safety record. 

Nevertheless, the Court specified that the EU Member States were free to subject such organisms to the obligations laid down by the GMO Directive or other obligations, hence opening the door to further legislation and restrictions on the use and trade of such organisms on the Member State level, for instance in regard to the free movement of goods. 

The Court also elaborated that risks linked to new mutagenesis techniques might prove to may prove to be similar to those that result from the production and release of a GMO obtained through transgenesis since the direct modification on the genetic material of an organism through mutagenesis makes it possible to obtain the same effects as the introduction of a foreign gene into the organism.

The action in the case was originally brought forward by Confédération paysanne, a major player in French agricultural unionism, together with eight other associations before the Counseil d’Ètat in France in order to contest the French legislation which exempted organisms obtained by in vitro mutagenesis techniques from the obligations imposed by the GMO Directive.

The full text of the CJEU judgement can be found here.