To be or not to be GMO? Application of European GMO Regulation in Times of Genome Editing

Discussion is ongoing throughout the EU as to whether organisms developed with the help of so-called “new plant breeding technologies” fall under the scope of the current regulation of GMO and products thereof. In particular the techniques of oligonucleotide-directed mutagenesis (ODM) and CRISPR-Cas9 are discussed in this context.

A common feature of these technologies is, that they can be used to induce point mutations. These types of genetic modifications could also result from conventional breeding techniques or natural processes.

The decision for an organism to be regarded as GMO requires detailed knowledge of the process used for its development and the molecular genetics of the final product.

Equally important is a careful interpretation of the legal basis, Directive 2001/18/EC. In this context the wording of the definition of GMO needs to be scrutinized. In addition the intention of the law need to be identified, as the technologies under discussion were not known or anticipated at the time of law-making.

The term GMO presupposes that the organism’s genetic material has been altered in a way that does not occur naturally, and that this modification cannot be achieved by mating and/or natural recombination.

For this reason, at least some products resulting from new plant breeding technologies should not fall under the scope of the current regulation of GMO in the EU.

An overview over decisive points within the ongoing discussion will be presented.