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EU Court Offers Preview of Potential Regulatory Approach for Gene Edited Plants

Late last month, an advisor to the Court of Justice of the European Union issued an opinion recommending that plants produced using innovative breeding techniques, like gene editing, be regulated like conventionally-bred plants rather than under the EU’s genetically modified organism Directive, the principal EU law governing the regulation of GMOs. 

Advocate General reports are non-binding and advisory for the judges who will ultimately decide the case, but are given considerable weight and followed by the court in whole or in part in many cases. Here, the AG’s opinion[1] offers an important preview of the key issue to be decided by the full ECJ later this year. 
The case currently before the ECJ will decide whether mutagenesis, a plant breeding technique, should be regulated under European Union law in the same way as transgenic plants, which are regulated under the EU law as GMOs. The case was brought to the ECJ by France, where French agricultural organizations had filed a legal complaint claiming that plants derived from all forms of mutagenesis—including both conventional forms, which had been excluded from the EU’s GMO law, and new breeding techniques, like gene editing—are subject to regulation under the EU’s GMO Directive. 
In his advisory opinion, AG Michael Bobek determined that plant seeds derived from all forms of mutagenesis that meet the GMO Directive’s exemption criteria should be exempt from regulation under the GMO Directive. He reasoned that modern mutagenesis techniques, like those aimed at inducing precise genetic mutations, are no different from conventional mutagenesis methods, which the GMO Directive expressly exempts. Thus, seeds resulting from mutagenesis should not be subject to the GMO law’s onerous regulatory requirements, including a pre-market environmental risk assessment or post-market traceability, labeling, and monitoring requirements. Importantly, in reaching his opinion, the AG rejected an argument that the mutagenesis exemption should be limited to only those techniques routinely used when the GMO Directive was adopted in 2001.
AG Bobek observed that the GMO Directive’s mutagenesis exemption does not have preemptive effect and that EU Member States are free under EU law to enact their own laws regulating mutagenesis. Importantly, however, the AG clarified that he sees no grounds for such legislation under the EU’s precautionary principle, which requires regulatory action unless there is an absolute certainty of no harm to human health or the environment.
The ECJ will review the AG’s opinion and is expected to issue a decision this summer. The ECJ’s opinion is likely to significantly impact the regulatory landscape for companies seeking approval of products derived from innovative plant breeding techniques in Europe.

[1] See: here.


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