Today, the European Court of Justice (ECJ) has decided in case C-528/16 that organisms obtained by new mutagenesis plant breeding techniques are genetically modified organisms (GMOs) and subject to the obligations laid down in the GMO-Directive (Directive 2001/18/EC). This decision interprets the GMO-Directive in light of new plant breeding techniques such as CRISPR-Cas9.
Mutagenesis is a technique which can be used to alter the genome of a living species without the insertion of foreign DNA (unlike transgenesis). It has been widely argued in the biotech industry that recently emerged mutagenesis techniques such as CRISPR-Cas9 should fall under the existing mutagenesis exemption in the GMO-Directive. In this case, the French agricultural union brought an action before the Conseil d’État, claiming that organisms obtained by such new mutagenesis techniques do carry the risk of significant harm to the environment and to health and argued they should therefore be regulated as GMOs. The ECJ was then invited by the French Conseil d’État to clarify among other things the exact scope of the mutagenesis exemption under the GMO-Directive.
According to the ECJ, organisms obtained by mutagenesis are GMOs in the meaning of the GMO Directive in so far as the mutagenesis techniques 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. These obligations however do not apply to organisms obtained by means of certain mutagenesis techniques, namely those which have conventionally been used and have a long safety record and as a result fall under the mutagenesis exemption. However, Member States are free to subject such organisms, in compliance with EU law, to the obligations laid down by the directive or to other obligations.
By narrowing the scope of the mutagenesis exemption to techniques which have conventionally been used and have a long safety record, the ECJ excludes mutagenesis techniques that have emerged since the adoption of the GMO-Directive from this mutagenesis exemption. The Court considers that the 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, since the direct modification of 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 (transgenesis). According to the ECJ, it follows from these shared risks and the objectives pursued by the GMO-Directive that the Directive is also applicable to organisms obtained by mutagenesis techniques that have emerged since its adoption (you can read the decision here and a summary in the press release here).
The decision of the ECJ goes against the opinion of Advocate General Bobek, who argued in his opinion of 18 January 2018 that organisms obtained by new mutagenesis techniques should also be exempted from the GMO-Directive.