Earlier this week the Court of Justice of the European Union, the EU’s highest court, issued a decision clarifying whether the EU would regulate products of innovative breeding techniques, like gene editing, under the EU’s Directive 2001/18, the principal EU law governing the regulation of GMOs.
The court took up the issue of whether organisms developed using mutagenesis, a plant breeding technique that does not require the insertion of DNA from outside organisms, were subject to regulation under the GMO Directive. It held that while traditional forms of mutagenesis were excluded from the Directive, organisms developed using newer applications of mutagenesis, including gene editing, will be regulated as GMOs and therefore subject to restrictive and onerous regulatory requirements, including a pre-market environmental risk assessment or post-market traceability, labeling, and monitoring requirements. The ECJ’s decision is anticipated to have wide-ranging impacts on the regulation of organisms produced using innovative breeding techniques.
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. The court’s decision determined the following:
- An organism developed through mutagenesis is a “genetically modified organism” as defined in the GMO Directive because the specific mutations developed using the technique are “alterations to the genetic material of an organism” and alter an organism’s genetic material in a way that does not occur naturally. Such organisms “are GMOs and are, in principle, subject to the obligations laid down by the GMO Directive.”
- While the GMO Directive excludes organisms produced using mutagenesis techniques routinely used at the time the GMO Directive was adopted in 2001, the exclusion does not extend to organisms developed using newer mutagenesis techniques, like gene editing, because the newer techniques have not been “conventionally used in a number of applications” and do not “have a long safety record.” The court held that finding otherwise “would fail to respect the precautionary principle,” which requires regulatory action unless there is an absolute certainty of no harm to human health or the environment.'
- Because organisms developed using newer mutagenesis techniques are GMOs under the GMO Directive and not subject to the exclusion for mutagenesis, they are also subject to Directive 2002/53, a separate EU Directive governing plant varieties, which requires that such organisms may be accepted “only if all appropriate measures have been taken to avoid risks to human health or the environment,” including a pre-market environmental risk assessment.
- EU member countries are permitted to regulate organisms, like those developed using “old” mutagenesis, that are excluded from the GMO Directive so long as any such regulation complies with EU law pertaining to the free movement of goods.
- The court did not need to reach the question of whether certain provisions of the GMO Directive were valid under the precautionary principle, since the court did not find that all forms of mutagenesis were exempt from the Directive’s obligations.
The ECJ’s decision is contrary to an earlier, non-binding Advocate General opinion that plants produced using innovative breeding techniques, like gene editing, be regulated like conventionally-bred plants rather than under the EU’s GMO Directive. In the earlier decision, the AG 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, and rejected the argument that the mutagenesis exemption should be limited to only those techniques routinely used when the GMO Directive was adopted in 2001.
The decision also runs counter to the approach taken by the United States Department of Agriculture, which announced in March that it “does not regulate or have any plans to regulate plants” created using new breeding techniques, such as gene editing, as long as such plants “are developed without the use of a plant pest as the donor or vector and they are not themselves plant pests.”
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.