European Court of Justice: new mutagenesis breeding techniques covered by the GMO Directive.
In its landmark judgment of 25 July 2018, the Court of Justice of the European Union ("CJEU") confirmed that crops obtained by new mutagenesis plant-breeding techniques are subject to the strict conditions of the Directive on genetically modified organisms ("GMO Directive").
The new mutagenesis techniques make it possible to alter the genome of organisms without the insertion of foreign DNA in a directed way. These techniques can be used to develop seed varieties that are resistant to herbicides. In addition, the mutagenesis techniques offer new possibilities to pharmaceutical manufacturers for the development of medicinal products. The question of whether the new mutagenesis techniques are covered by the GMO Directive has been the subject of debate between, on the one hand, biotechnology companies and, on the other hand, agricultural and environmental organisations.
Background of the judgment In its judgment, the CJEU examined the preliminary questions of the French Council of State (Conseil d'État), which were raised in proceedings initiated by several agricultural and nature conservation organisations. These organisations are opposed to French legislation exempting organisms obtained by mutagenesis breeding techniques from the requirements applicable to genetically modified organisms ("GMOs"). The introduction of GMOs on the European internal market is subject to strict requirements, which are laid down in the GMO Directive. The GMO Directive provides for explicit authorisation after extensive assessment of the risks for public health and the environment. GMOs are furthermore subject to strict requirements with respect to traceability, labelling and monitoring.
Analysis Firstly, the CJEU confirmed that organisms obtained by mutagenesis qualify as GMOs within the meaning of the GMO Directive, in so far as these techniques alter the genetic material in a way that does not occur naturally by mating and/or natural recombination. It follows that in principle those organisms fall within the scope of the GMO Directive and are, therefore, subject to the obligations arising from that directive. Secondly, the CJEU ruled that the explicit exemption in the GMO Directive for techniques of mutagenesis which have conventionally been used needs to be interpreted restrictively and does not apply to new mutagenesis techniques. According to the CJEU, the exemption is only applicable to organisms obtained by mutagenesis techniques or methods which have conventionally been used in a number of applications and have a long safety record. The CJEU points out to the fact that the Conseil d'État underlined that the risks linked to the use of new mutagenesis techniques might prove to be similar to those which result from transgenesis techniques whereby the genetic material of an organism is altered through the insertion of foreign DNA. The CJEU emphasised the importance of the precautionary principle on which the GMO Directive is based. It considered that this principle requires mutagenesis techniques to be subject to an environmental risk assessment before authorisation. Any other interpretation would compromise the objective of the GMO Directive, which is to protect public health and the environment. With its interpretation the CJEU dissented from the conclusion of Advocate General Bobek, who considered that the derogation should be interpreted in a dynamic way and also apply to new mutagenesis techniques.
Ultimately, the CJEU held that Member States are free to subject crops obtained by traditional mutagenesis techniques to the GMO-regulations or other requirements. However, the stricter national rules need to comply with general EU law and the rules governing the free movement of goods.
Please find the full judgement here.