The European Court of Justice has ruled that altering living things using the relatively new technique of genome editing counts as genetic engineering.
Until now, gene editing, involving the precise replacement of one DNA sequence with another, has been a grey area.
Traditional genetic engineering involves the less precise insertion of foreign DNA into an organism.
It would mean food developed with gene editing would need to be labelled as GM.
But it would also apply to a range of burgeoning areas, such as the use of genetically altered animals.
The ruling contains a number of exemptions for older techniques that produce mutations in the DNA of living things.
In a statement, the Court of Justice (ECJ) said it “takes the view, first of all, that organisms obtained by mutagenesis are GMOs within the meaning of the GMO Directive”.
In the opinion of ECJ Advocate General Michal Bobek, “mutagenesis” covers any alteration to a genome – effectively the instruction booklet for building a living thing.
The ECJ statement added: “It follows that those organisms come, in principle, within the scope of the GMO Directive and are subject to the obligations laid down by that directive.”
Scientists who work in the areas of gene editing and modification expressed concern about the ruling.
Prof Johnathan Napier, from the crop science institute Rothamsted Research in Harpenden, UK, called the decision “a very disappointing outcome” that would “hinder European innovation, impact and scientific advance”.
He said: “The classification of genome-edited organisms as falling under the GMO Directive could slam the door shut on this revolutionary technology. This is a backward step, not progress.”
Prof Nigel Halford, also from Rothamsted, commented: “This is highly unusual in that the ruling appears to have ignored the opinion of the Advocate General and scientific advice and the pleas of multiple agricultural biotech organisations and taken a decision to keep the NGOs sweet.
“If adopted by the Council and Parliament the decision could set agbiotech in Europe back another 20 years. We are already a generation behind. Young scientists interested in agbiotech are likely to move to places where common sense and scientific evidence prevail.”
But the group GM Freeze, which campaigns in favour of a moratorium on GM food and farming in the UK, welcomed the move.
The group’s director Liz O’Neill 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.”
Gene editing is GM, says European Court