EU court exempts gene modification technique from stricter rules

7 February 2023. The EU’s highest court has concluded that organisms obtained by in-vitro random mutagenesis, a genetic modification technique, are excluded from the bloc’s rules governing genetically modified organisms (GMOs), a move welcomed by industry players but lambasted by green groups.

The European Court of Justice ruling, published on Tuesday (7 February), closes a 2015 case brought by the French small farmers’ association Confédération Paysanne, together with eight other green campaign groups, who called for clarification over the status of certain methods of mutagenesis under the EU’s 2001 GMO directive.

The directive includes an exemption whereby certain genetic modification techniques fall outside its very strict scope.

The reach of this directive was up for debate until another EU court judgement in 2018, which placed on an equal footing traditional GMOs and gene editing – a targeted modification achieved via a genetic technique called CRISPR/Cas9.

The ruling comes at a critical juncture in the EU, just ahead of a crucial proposal from the European Commission on whether to loosen EU rules on new genetic techniques (NGTs), expected in early June 2023.

"The ruling on in-vitro random mutagenesis – which it points out is less targeted and more risk-prone than gene-editing – should pave the way for Europe to unlock the opportunities of the bio-revolution in plant- and soil sciences”. Agrochemical giant Bayer, 

Likewise, the EU farmers’ association welcomed the ruling, stressing that farmers need to “access the benefits of innovation to be more sustainable and achieve the ambition as set out in the European Green Deal”.

“Plant breeders should be able to consider certain mutagenesis techniques in their breeding programs, reducing by some 10 years the time to market”.