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ECJ decision: Organisms obtained by mutagenesis are genetically modified organisms and are subject to the GMO Directive – industry fears negative “blow to innovation”

  • Germany
  • Health and life sciences


The European Court of Justice (ECJ) ruled yesterday (25 July) that organisms obtained by mutagenesis plant breeding technique including gene editing are genetically modified organisms (GMOs) and should, in principle, fall under the GMO Directive 2001/18/EC.

The industry is rather shocked by this decision and describes it as a severe “blow to innovation in EU agriculture” and a “bad day” for the EU agri-food sector and warns about economic and environmental consequences. Subjecting plants obtained through using the latest plant breeding methods to the EU GMO legislation would prohibit consumers, producers, researchers and entrepreneurs from accessing the benefits of these innovations.


New plant breeding techniques (NPBTs) focus on developing new seed attributes within a given species. The term NPBTs describes a number of scientific methods for the genetic engineering of plants to enhance attributes like drought tolerance and pest resistance.

In 2016, France asked the ECJ to clarify whether a variety of herbicide-resistant rapeseed obtained through NPBTs should follow the EU GMO approval process.

The industry’s argument is that the plants obtained through these techniques could also be a product of conventional cross-breeding techniques that mimic natural processes and hence cannot be considered GMOs. Opponents of NPBT state that NPBT should fall under the strict GMO approval process as these are an attempt by the industry at selling hidden GMOs to farmers, who would simultaneously lose their right to use their own seeds.


The ECJ ruled that organisms obtained by mutagenesis are GMOs within the meaning of the GMO Directive, in so far as the techniques and methods of mutagenesis alter the genetic material of an organism in a way that does not occur naturally. It follows that those organisms, in principle, fall within the scope of the GMO Directive and are subject to the obligations laid down by that directive.

This ruling was rather surprising as Advocate General Michal Bobek issuing his opinion in January stated that organisms obtained by mutagenesis are, in principle, exempt from the obligations in the GMO directive. In practice, the ECJ usually follows the Advocate’s opinion. Not this time however.

The Court at the same time pointed out that the GMO Directive does not apply to “organisms obtained by means of certain mutagenesis techniques, namely those which have conventionally been used in a number of applications and have a long safety record”. The Member States are thus free to legislate in this area in compliance with EU law.

The second part of the ruling refers to new mutagenesis techniques, meaning those that emerged since the adoption of the GM Directive: “The Court considers that the risks linked to the use of these new mutagenesis techniques might prove to be similar to those that result from the production and release of a GMO through transgenesis.” It follows that the GMO Directive is also applicable to organisms obtained by mutagenesis techniques that have emerged since its adoption.

Victory or setback?

While the ruling was welcomed by environmental NGOs calling it a victory for consumers, farmers and the environment, industry and research organisations describe it as a setback for cutting-edge science and innovation in the EU. Breakthroughs in plant breeding technologies, such as genome editing, would remain crucial for food and nutrition security globally. The ruling would thus also have implications outside the EU, particularly in developing countries who would benefit most from crops that better withstand the devastating effects of climate change. It is now however likely that much of the potential of these innovative methods will be lost for Europe – with significant negative economic and environmental consequences. Europe once more would thus miss out on significant benefits of certain applications of genome editing.

Consequences for the industry

Whether victory or setback, the ECJ’s ruling is binding. The industry will have to adhere to the GMO Directive and plants obtained through respective techniques are subject to the obligations laid down by the directive (such as an approval process) and the local laws implementing the directive.