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

The ruling was in response to 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.

In its ruling, the European Court of Justice said that organisms obtained by the in vitro application of a technique/method of mutagenesis have a long safety record and are thus excluded from the scope of that directive.

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

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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 EU Commission (EC) is intending to publish a new legislative proposal for NGTs in the second quarter of 2023, and Alexander Döring, secretary general of, the European Feed Manufacturers’ Federation (FEFAC), had earlier said that the industry eagerly anticipates its arrival.

The review of NGTs undertaken by the EC in April 2021 concluded that such plant breeding technology could contribute to a more sustainable food system under the EU Green Deal and the EU Farm to Fork Strategy

However, the decision has spurred up a heated debate in France with many disagreeing on the nature of random in vitro mutagenesis techniques.

The Conseil d’Etat, now wants clarification on whether in vitro random mutagenesis should fall within the scope of the GMO directive or not.

Positively, EU farmer representatives, Copa and Cogeca, welcomed the latest ECJ ruling, saying European agriculture needs to access the benefits of innovation to be more sustainable and achieve the ambition as set out in the EU Green Dea

The French Association of Plant Biotechnology (AFBV) also weighed in on the deliberations at the top EU court sa it understands from the ruling that mutagenesis, whether by in vivo or in vitro techniques, benefits from the exclusion regime set out in the GMO legislation.

Echoing the EU farming body, it said such techniques will support the development of new innovative plant varieties essential to agriculture, to produce food while meeting the challenges of reduced inputs, climate change, and the EU Farm to Fork strategy.

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