European Court of Justice decision for genome editing: Consequences on food/feed risk assessment and detection

Abstract

On 25 July 2018 the European Court of Justice (ECJ) clarified that organisms obtained by mutagenesis are genetically modified organisms (GMOs) as defined in the European Directive 18/2001/EC. However, the GMO directive shouldn't apply to organisms obtained by mutagenesis using techniques developed and applied before the respective Directive came into force (i.e. the application of chemical or physical mutageneous agents) and that have a long ‘history of safe’ use. Accordingly a safety assessment and labelling of products containing or consisting of GMOs obtained by mutagenesis developed after the Directive came into force will be needed. From a scientific point of view a similar basis for the risk assessment can be assumed when comparing ‘classical’ GMOs and GMOs obtained by mutagenesis using new plant breeding techniques (NPBTs). In both cases a conventional organism has been modified. Therefore the classical approach of comparing the GMO with the non-GM variety is the straight way to conduct the safety assessment. In contrast, for the identification of GMOs obtained by mutagenesis using NPBTs the development and validation of new tools are needed. However, scientifically it will not be possible to distinguish between GMOs bearing a single mutation, if it is either the result of the intended use of NPBTs, the application of chemical or physical mutageneous agents or the natural process of spontaneously occurring mutations.