Regulatory Update on New Breeding Techniques
On 25 July 2018, the Court of Justice of the European Union delivered its judgment in response to a preliminary ruling request made by the French Conseil d’Etat. According to the CJEU, organisms obtained by mutagenesis are indeed GMOs and are, in principle, subject to the obligations laid down in Directive 2001/18/EC on GMOs. Nevertheless, organisms obtained by mutagenesis techniques that have been traditionally used for various applications and whose safety has been proven for a long time are exempt from these obligations. The Conseil d’Etat must consequently decide on the legality of Article D. 531-2 of the French Environmental Code, one of the elements of the transposition of Directive 2001/18/EC into French law. Nine associations and unions challenge the legality of this article, which excludes organisms obtained by mutagenesis from the scope of GMO regulation, and have requested the repeal of this article from the Prime Minister.