EU court exempts gene modification technique from stricter rules

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.

But while clarifying that the latter should, in principle, fall under the 2001 directive, a question mark was still left over another gene modification technique known as random mutagenesis.

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A new study from the European Commission has concluded that the current legal framework governing new genomic techniques (NGTs) is insufficient and indicated that new policy instruments should be considered to reap the benefits of this technology.

Random mutagenesis involves inducing spontaneous genetic mutations in living organisms, such as via the use of certain chemicals that have the ability to alter the genetic makeup of plant cells.

The idea behind the technique is that these changes may then result in a plant with a desirable trait, such as a higher tolerance to drought or resistance to pests, which can then be selected for. 

Random mutagenesis can be applied in-vitro – when mutagenic agents are applied to plant cells and the whole plant is then artificially reconstituted –  or in-vivo  – when mutagenic agents are applied to the whole plant or plant parts. 

While in-vivo random mutagenesis is a common plant breeding practice in the EU and was declared exempt in the 2018 ruling, as the technology has been in use since before 2001, in-vitro random mutagenesis has been a point of contention.

However, given that random mutagenesis has “conventionally been used in a number of in-vivo applications and has a long safety record with regard to those applications”, the Court found that those organisms obtained by in-vitro random mutagenesis should also qualify for an exemption from the EU’s GMO directive, and thus greenlighting their use in the EU.

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.

For agrochemical giant Bayer, 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”. 

“It makes no sense to regulate both breeding practices differently,” the company’s senior vice president of public affairs, science and sustainability, Matthias Berninger, wrote on Twitter following the decision.

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,” the association said in a statement.

But green groups and small farming associations warned the ruling risks opening the door to a “massive flood of unlabelled and un-assessed GMOs in farmers’ fields and on European citizens’ plates”.

Lambasting the court for “capitulating in favour of seed multinationals”, the small farmers’ association European Coordination Via Campesina (ECVC) maintained that the technology generates the “same health and environmental risks that justify the current regulatory obligations of risk assessment, labelling and traceability”.

The association warned that it will now become impossible for farmers and consumers to distinguish these crops produced via in-vitro random mutagenesis from any other non-GMO conventionally bred plant. 

German Green ministers not aligned on EU gene editing deregulation

With the Greens leading both the German agriculture and environment ministries, many expect the country to stand against the Commission’s expected push to deregulate new genomic techniques (NGTs). But agriculture minister Cem Özdemir has so far refused to take sides.

[Edited by Gerardo Fortuna/Zoran Radosavljevic]

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