In an opinion delivered in Thursday 18 January (case C-528/16), Advocate General of the European Court of Justice (ECJ) Michal Bobek takes the view that organisms obtained by mutagenesis are, in principle, exempted from the obligations in the genetically modified organisms (GMO) directive (2001/18/EC).
The GMO directive regulates the deliberate release into the environment of genetically modified organisms and their placing on the market within the EU. The text is limited in scope and techniques of genetic modification, such as mutagenesis (the “mutagenesis exemption”). Mutagenesis involves an alteration of the genome of a living species but, unlike transgenesis, which is governed by the directive, does not entail the insertion of foreign DNA into a living organism.
The Confédération paysanne, a French agricultural union representing the interests of small-scale farming, and eight other associations brought an action before the Conseil d’État (Council of State, France) in order to have acknowledged the serious risks to the environment and human and animal health of mutagenesis techniques. They argue that mutagenesis techniques have evolved over time and now carry a greater risk of harm than at the time of the adoption of the above-mentioned directive.
The French Conseil d’État submitted a question for a preliminary ruling to the ECJ to clarify the exact scope of the GMO directive and to assess its validity. It also asked the Court to indicate what role the passing of time and evolving technical and scientific knowledge should play with regard to both legal interpretation and the assessment of the validity of EU legislation, carried out with the precautionary principle in mind.
In his opinion, Advocate General Bobek first considers that an organism obtained by mutagenesis can be a GMO if it fulfils the substantive criteria laid down in the GMO directive. He observes that the directive does not require the insertion of foreign DNA in an organism for it to be considered a GMO, but merely says that the genetic material has been altered in such a way that does not occur naturally.
He takes the view that these techniques are exempt from the obligations of the directive provided they do not involve “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”, as set out in Annex 1 B of the directive.
The Advocate General considers that both new and older mutagenesis techniques should be exempt from the obligations set out. He further considers that, provided they respect their overall EU law obligations, member states can legislate on mutagenesis techniques and ultimately subject them to the obligations laid down by the directive.
Lastly, while the Advocate General recognises that the precautionary principle requires that EU regulation be kept reasonably up to date, he does not, at present, see any grounds which could affect the validity of the mutagenesis exemption. (Original version in French by Lucas Tripoteau)