The European Court of Justice has issued its much expected ruling regarding the interpretation of Directive 2001/18 concerning New Plant Breeding Technologies. In essence, it has made most New Plant Breeding Technologies that use new mutagenesis techniques subject to conventional GMO regulation.
This decision means that gene-editing techniques such as ODM and site-directed-nuclease-1 (SDN-1)-based techniques (e.g., ZFN, TALENS and also CRISPR–Cas endonucleases) require the same treatment as other GMOs in the EU. The judgment hence did not follow the Opinion of the Advocate General, who had proposed to classy also new mutagenesis techniques as exempted from the Directive, but left it to Member States to adequately regulate these techniques.
The judgment is binding only upon the interpretation of Directive 2001/18, that means only for products that are released into the environment. However, quite a number of other legislation, particularly concerning GM food, make reference to the definition of the Directive, hence this judgment will also concern food and feed. Whether and how it also affects other regulative areas such as animals, remains to be seen.
So in the view of the Court the new mutagenesis techniques are GMOs in principle.
Those techniques which have a safe use are covered by the mutagenesis exemption. These are all those known until 2001. For these techniques Member States can issue own regulation. The new ones are within the scope of the Directive and have hence to be treated as GMOs. There is however an open question: What happens to new techniques that have a safe use after 2001?