CJEU tightens gene-editing rules with GMO decision
Genome-editing techniques, including CRISPR/Cas9, will be subject to more stringent regulations after a ruling from Europe’s highest court yesterday.
The Court of Justice of the European Union (CJEU) held that genome-editing falls into the genetically modified organisms (GMO) category so it is covered by the GMO directive.
“Organisms obtained by mutagenesis are GMOs and are, in principle, subject to the obligations laid down by the GMO directive,” the court said in a press release.
Mutagenesis techniques make it possible to alter the genome of a living species without the insertion of foreign DNA.
GMOs must be authorised following an assessment of the risks which they present for human health and the environment. They are also subject to traceability, labelling and monitoring obligations.
Penny Gilbert, partner at Powell Gilbert, said that while it is not revelatory that gene editing methods might be considered to be genetic engineering techniques, “it is very surprising that these highly focussed methods of mutagenesis are considered to pose potentially more risk than the use of random genetic change arising from chemical mutagens and ionising radiation.”
The decision is a setback for proponents of gene-edited crops in the EU—Copa-Cogeca, which represents 23 million farmers across the EU, said it regretted the CJEU’s interpretation and that the decision would risk isolating European agriculture from innovative developments.
In a tweet, Copa-Cogeca said: “EU farmers are facing many challenges like extreme weather conditions, price volatility, etc, therefore they need the availability of improved breeds.”
French agricultural union Confédération paysanne had claimed that herbicide-resistant seed varieties posed a significant risk to the environment and human and animal health, in the same way as GMOs obtained by transgenesis (the process of introducing an exogenous gene into a living organisms).
The court concluded that organisms obtained by mutagenesis are GMOs, but added that older techniques of mutagenesis that have a “long safety record” are exempt.
However, the court explained that member states can legislate on such GMOs, provided they do so in a manner that is compliant with EU law.
GM Freeze, a not-for-profit company which campaigns for a moratorium on GM food and farming in the UK, welcomed the decision.
Liz O’Neill, a director, said: “This case was portrayed by industry as an argument about definition but the court has seen sense and made it clear that what actually matters is how we regulate emerging technologies that have the potential to permanently alter the ecosystem."
Did you enjoy reading this story? Sign up to our free daily newsletters and get stories sent like this straight to your inbox.
