In a victory for environmental activists, Europe’s highest court said today that crops created by gene editing should fall under laws restricting the use of genetically modified organisms (GMOs).

“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 said it takes the view 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.”

However, the court, which sits in Luxembourg, said the decision of adding gene-edited plants under the GMO Directive does not apply to gene-editing techniques which have already been used and have a long safety record.

The biotech industry has argued that gene-editing should not be considered genetically modified because when the technique is used, no foreign DNA is added to the plant, unlike traditional plant breeding methods.

The EU court, however, said 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 (standard genetic modification).”

In January, the biotech industry’s position received support from ECJ Advocate General Michal Bobek who released a statement saying crops and drugs created with gene-editing techniques such as CRISPR–Cas9 might not need to be regulated by the European Union’s GMO rules.

According to that statement, “the only relevant distinction that should be made in order to clarify the scope of the mutagenesis exemption is … whether the technique ‘involves the use of recombinant nucleic acid (RNA) molecules or GMOs other than those produced by…traditional breeding methods.’”  

The statement concluded: “Mutagenesis techniques are exempt from the obligations of the GMO Directive, provided that they do not involve the use of recombinant nucleic acid molecules or GMOs other than those produced by (traditional breeding methods).”

Environmentalists and anti-GMO groups welcomed the EU court’s decision.

“These genetic engineering techniques could radically change our food system, threatening non-GMO and organic agriculture and the livelihoods that depend on it,” Dana Perls, senior food and agriculture campaigner for Friends of the Earth U.S., said in a statement. “We applaud the European Court of Justice for this forward-thinking decision and encourage the USDA to follow its lead. All products made with genetic engineering, including ones made with gene-editing tools like CRISPR, should be regulated, assessed for health and environmental impacts, and labeled.”

Genus Plc, a Britain-based global animal genetics company, said it was disappointed in the ruling.

“Genus believes that gene editing is an acceleration of breeding techniques that have been performed since the dawn of agriculture and therefore should be regulated under a set of laws that acknowledges the different science and risk profile compared to GMOs,” the company said in a statement. It said gene editing has the potential to improve food safety and animal welfare, to eliminate deadly animal diseases and to help feed a growing world population.

“While Genus is disappointed by today’s ruling, we are hopeful that today’s decision will bring to the forefront the debate about how to best manage the risks and harness the undeniable benefits of this technology. Genus is committed to continued engagement with regulators in Europe and other geographies as well as with consumers as we realize the benefits of this technology in a responsible manner.”

In the U.S., Karen Batra, a spokeswoman for Biotechnology Innovation Organization, said the decision sets a "dangerous precedent that could impede trade" and "stifle innovation on a global scale."

“At first glance, it  goes against everything we know about science."

Batra said she's not sure what the organization's next steps might be, adding that BIO is discussing the matter with its members and federal government contacts.

(This story was updated at 1:30 p.m. to include comments from BIO.)


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