EU lawyer: Genome Editing can be exempted from GMO directive

According to Advocate General Bobek, organisms obtained by mutagenesis are, in principle, exempted from
the obligations in the Genetically Modified Organisms Directive. Member States are free to adopt measures regulating such organisms provided they respect overarching principles of EU law.

The ‘GMO Directive’1 regulates the deliberate release into the environment of genetically modified organisms (GMOs) and their placing on the market within the EU. In particular, the organisms covered by that Directive must be authorised after an environmental risk assessment. They are also subject to traceability, labelling and monitoring obligations. The Directive does not, however, apply to organisms obtained through certain techniques of genetic modification, such as mutagenesis (‘the mutagenesis exemption’). Unlike transgenesis, mutagenesis does not, in principle, entail the insertion of foreign DNA into a living organism. It does, however, involve an alteration of the genome of a living species. The mutagenesis techniques have made it possible to develop seed varieties with elements resistant to a selective herbicide.

Confédération paysanne is a French agricultural union defending 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 regulation transposing the GMO Directive2. They argue that mutagenesis techniques have evolved over time. Prior to the adoption of the GMO Directive in 2001, only conventional or random methods of mutagenesis were applied in vivo to entire plants. Subsequently, technical progress has led to the emergence of mutagenesis techniques like targeted mutagenesis methods which enable a precise mutation in a gene in order to obtain, for example, a product resistant to certain herbicides only. For Confédération paysanne and the other associations, the use of herbicide resistant seed varieties obtained by mutagenesis carries a risk of significant harm to the environment and to human and animal health.

In this context, the Court of Justice is invited by the French Conseil d’État to clarify the exact scope of the GMO Directive, specifically the ambit, rationale and effects of the mutagenesis exemption, and to assess its validity. Advocate General Michal Bobek first considers that an organism obtained by mutagenesis can be a GMO if it fulfils the substantive criteria laid down in the GMO Directive3. He observes that that Directive does not require the insertion of foreign DNA in an organism in order for the latter to be characterised as a GMO, but merely says that the genetic material has been altered in such a way that does not occur naturally. The open-ended character of that definition allows organisms obtained by methods other than transgenesis to fall under the notion of a GMO. Further, it would be illogical to exempt certain organisms obtained by mutagenesis from the application of the Directive if those organisms could not be characterised as GMOs in the first place.

Only only relevant distinction

The Advocate General then examines whether the mutagenesis exemption foreseen in the GMO Directive ought to mean all techniques of mutagenesis or only some techniques. According to him, the only relevant distinction that should be made in order to clarify the scope of the mutagenesis exemption is the caveat set out in Annex I B of the GMO Directive, namely whether the technique ‘involves the use of recombinant nucleic acid molecules or GMOs other than those produced by mutagenesis or cell fusion of plant cells of organisms which can exchange genetic material through traditional breeding methods’. It follows that mutagenesis techniques are exempt from the obligations of the GMO Directive provided that they do not involve the use of recombinant nucleic acid molecules or GMOs other than those produced by one or more of the methods listed in Annex I B.

Next, the Advocate General examines whether Member States could actually go further than the GMO Directive and decide to subject organisms obtained by mutagenesis either to the obligations laid down by the Directive or to purely national rules. He is of the opinion that by inserting the mutagenesis exemption, the EU legislature did not wish to regulate that matter on the EU level. Accordingly, that space remains unoccupied and, provided that the Member States respect their overall EU law obligations, they can legislate with regard to organisms obtained by mutagenesis.