The top court in the European Union recently ruled that gene editing techniques such as CRISPR-Cas9 are subject to the EU GMO Directive, bringing researchers extensive obligations that will likely slow research in innovative crop breeding.
In January 2018, in response to a case brought forward by the French Agricultural Union and others to contest the exemption of organisms obtained by mutagenesis from the obligations of the GMO Directive, an advocate general from the European Court of Justice (ECJ) published an opinion stating that species modified with technologies discovered since 2001 (such as CRISPR-Cas9), could still be considered ‘mutagenesis’ and be exempted, as long as they did not contain DNA from other species or other artificial DNA.
However, the ECJ (EU’s top court) ruled on July 25th 2018 that only mutagenesis techniques that have “conventionally been used in a number of applications and have a long safety record are exempt from those obligations”. Therefore, organisms made using mutagenesis techniques developed after 2001 — including gene editing — are not exempt from the Directive. Therefore, gene-edited crops that are released to the environment (e.g. for field trials or commercialization) must undergo extensive risk evaluations, which can be particularly difficult for research institutes and small companies with limited resources.
Several groups have already been negatively affected, and plant and agricultural research is suffering, the journal 'Nature' reports. Field trials that were already in progress are now subject to extra precautionary measures and documentation, projects are now more expensive, and innovative agricultural and biotech companies have lost financing. Many scientists assert that there is no scientific basis for this ruling, and are concerned that it could effectively lead to a ban of innovative crop breeding.