Back to the future. A legal analysis of the EU Court's decision on mutagenesis (C-528/16)

Activity: Talk or presentationInvited talkAcademic


The rapid development of new mutagenesis techniques, commonly referred to as gene editing, have sparked questions about their legal status under the current EU framework for the regulation of plant biotechnology. The GMO Directive 2001/18/EC contains a provision that exempts organisms obtained by mutagenesis techniques from the obligations of the directive. However, in a recent ruling (C-528/16) addressing preliminary questions from the French Conseil d’État, the EU Court of Justice rejects a literal interpretation of the exemption and judges that it should be interpreted as applying only to organisms obtained by mutagenesis techniques ‘which have conventionally been used in a number of applications and have a long safety record’. These criteria seem to restrict the scope of the exemption to mutagenesis techniques already in use before 2001. As ‘modern’ gene editing techniques thus appear to be subject to the authorisation procedure and labelling measures of Directive 2001/18/EC, the EU Court ruling is widely seen as a major blow to the future of gene editing in the EU. In this presentation, we go back to the future and discuss the Court ruling from a legal perspective, examining how the Court arrived at its judgment and attempting to establish what the newly introduced criteria for exempting products of mutagenesis mean for which techniques. In addition, we tentatively explore which legal options for the development of gene editing are left after this ruling.
Period10 Oct 2019
Event titleCOGEM Symposium : Gene Edited Crops: Global Perspectives & Regulation
Event typeConference
LocationDen Haag, NetherlandsShow on map
Degree of RecognitionInternational