Crop Biotech Update

EU Court of Justice Advocate General Says Gene Edited Crops Should be Exempted from GM Food Laws

January 24, 2018

In his Opinion on Case C-528/16, Advocate General of the European Court of Justice Michal Bobek said that organisms obtained by mutagenesis are, in principle, exempted from the obligations in the Genetically Modified Organisms Directive of the European Parliament (GMO Directive). The GMO Directive regulates the deliberate release into the environment of genetically modified organisms (GMOs) and their placing on the market within the EU.

The Opinion Case said that the Directive does not, however, apply to organisms obtained through certain techniques of genetic modification, such as mutagenesis (‘the mutagenesis exemption'). Unlike transgenesis, mutagenesis does not, in principle, entail the insertion of foreign DNA into a living organism.

The Advocate General first considers that an organism obtained by mutagenesis can be a GMO if it fulfills the substantive criteria laid down in the GMO Directive. He observes that the Directive does not require the insertion of foreign DNA in an organism in order for the latter to be considered as a GMO, but merely says that the genetic material has been altered in such a way that does not occur naturally. The Opinion Case also indicated that Member States can legislate with regard to organisms obtained by mutagenesis.

The first reaction to the Opinion Case came from the European Plant Science Organisation (EPSO), which states that it welcomes the Advocate General's opinion, and that it is an important step in clarifying the European Directive concerning organisms modified by recent mutagenesis techniques that appeared after 2001.

For more details, read the Opinion Case and EPSO's reaction.