Top EU Court: GMO Rules Cover Plant Gene Editing Technique

Brussels (July 25, 2018) - Crops obtained by plant breeding technique mutagenesis should fall under laws restricting the use of genetically modified organisms (GMOs), Europe’s highest court said on Wednesday, in a victory for environmental campaigners.

In response to the ruling, the American Seed Trade Association (ASTA) issued a statement.

“Today’s EU Court of Justice (ECJ) ruling is a legal interpretation of existing EU law; it is not a policy decision. However, the court’s interpretation contradicts the direction many other governments outside of Europe are going with respect to plant breeding innovation policy, and sets a dangerous precedent that could impede global trade and stifle innovation for the future.

“The ECJ’s decision is based solely on the plant breeding method, without taking into account whether the end-product could have been achieved through more traditional means. Even very small improvements made to a plant would be subject to burdensome regulation under the court’s definition. This would be a huge blow to the continuing evolution of plant breeding innovation and the tremendous promise it holds for a more sustainable and secure global food production system.”

The European Seed Association sees the Court of Justice ruling in Case C-528/16 as a missed opportunity for agricultural innovation in the EU.

The EU Court of Justice ruling on the regulatory status of plants resulting from some of the latest plant breeding methods is widely seen as decisive for their practical take-up by European researchers, breeders and farmers. It is a watershed moment for the EU’s agri-food chain.

Contrary to the Opinion of Advocate General, it now seems that the Court’s decision subjects [almost all] plants obtained with these methods to the EU’s regular GMO legislation with its prohibitive costs and political uncertainty of final market approval.

“It is now likely that much of the potential of these innovative methods will be lost for Europe - with significant negative economic and environmental consequences. That strikes a serious blow to European agriculture and plant science.”, says Garlich von Essen, ESA Secretary General.

Latest breeding innovations such as CRISPR CAS are widely seen as critical tools to help breeders and farmers to do more with less inputs: less water, less fertilizers, less pesticides, as e.g. requested by the post-2020 CAP. They are also used to develop improved varieties that better meet consumer demands by providing more nutritious, tastier, healthier, more convenient and more varied plant-based food.

A more detailed analysis of the ruling still needs to be done; but the initial view of the seed sector is a bleak one:

“While other parts of the world go ahead with these innovations without unnecessary overregulation, Europe’s breeders and farmers will once again loose out, without a chance to explore the huge potential and benefits of these plant breeding innovations in practice.’’

The biotech industry had argued that much of mutagenesis, or gene editing, is effectively little different to the mutagenesis that occurs naturally or is induced by radiation - a standard plant breeding method since the 1950s, but the court disagreed.

“Organisms obtained by mutagenesis are GMOs and are, in principle, subject to the obligations laid down by the GMO Directive,” the Court of Justice of the European Union (ECJ) said in a statement.

“The Court of Justice takes the view, first of all, 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 added.

The ruling by the ECJ goes against the opinion of the court’s advocate general, who argued in January that the new techniques should be allowed.

Gene editing has the potential to make hardier and more nutritious crops - as well as offering drug companies new ways to fight human disease.

German chemical industry association VCI, which represents companies such as Bayer, BASF and Merck KGaA, said the court’s ruling was “backward looking and hostile to progress”.

European biotech association EuropaBio said the ruling failed to provide regulatory clarity.

“Public confidence and science-based decision-making are both important for ensuring that genome editing can deliver needed solutions,” EuropaBio secretary general John Brennan said.

Environmentalists, anti-GM groups and farmers concerned about the potential environmental and health impacts of all genetically engineered products said allowing gene editing would usher in a new era of “GMO 2.0” via the backdoor.

“We welcome this landmark ruling which defeats the biotech industry’s latest attempt to push unwanted genetically-modified products onto our fields and plates,” Mute Schimpf, a campaigner for environmental group Friends of the Earth said in a statement.

The European Union has long restricted the use of GMOs widely adopted around the world, but there was legal uncertainty as to whether modern gene editing of crops should fall under the same rules.

While older GMO technology typically adds new DNA to a crop or animal, gene editing can swiftly cause a mutation by changing a few pieces of DNA code, such as with the CRISPR/Cas9 tool, a type of molecular scissor technology that can be used to edit DNA.

Earlier this month, scientists studying the effects of CRISPR/Cas9 said it could cause unexpected genetic damage which could lead to dangerous changes in some cells.

A group of French agricultural associations brought the case to the ECJ, saying plant varieties obtained via mutagenesis should not be exempt from GMO rules under French law.

The court added that an exception could be made for techniques that have been used conventionally and have a long safety record.