58  I  SEED WORLD EUROPE  I  SEEDWORLD.COM/EUROPE | OCTOBER 2026
THE RISK CORNER 
BY: DAVID ZARUK
AFTER THE NGT REGULATION, TIME TO 
RATIONALISE THE GMO DIRECTIVE
T
he sante-eNews Newsletter from 
2 June 2026 announced another 
GMO decision. The title claims 
that the European “Commission author­
ises use of safe genetically modified crop 
as food and animal feed”. The reader was 
reassured that the decision was based on “a 
scientific assessment by the European Food 
Safety Authority, which concluded that 
the GM soybean is as safe as its non-GM 
counterpart.”
I did not get excited because, like Lucy 
pulling the football away at the last minute, 
I had been conditioned to expect what came 
next. “The Commission’s decision only 
allows this GM crop to be imported for 
use in food and animal feed, but not to be 
cultivated in the EU.”
Since 2001, this pantomime has been 
played out on a regular basis. Companies 
comply with all stringent EU regulatory 
requirements. EFSA declares that the 
GM seed is safe. Approval is then sent 
to the European Council where the inev­
itable statement is then copy-pasted into 
Commission press releases, as was the case 
in June:
“The authorisation is valid for 10 years, 
and any product produced from this GM 
crop will be subject to the EU's labelling 
and traceability rules. The Commission had 
a legal obligation to decide on this authori­
sation after Member States did not reach a 
qualified majority either in favour or against 
this decision.”
As the European Commission will 
be sued for failure to comply with global 
trade obligations, we get the ridiculous sit­
uation where EU farmers can’t enjoy the 
sustainability and yield benefits of grow­
ing GM plants that are then imported into 
the EU. For 25 years, the madness of this 
poisoned process has been allowed to con­
tinue, tainting the European Union’s claim 
to regulatory legitimacy. Twenty-five years 
is long enough. The old generation of anti-
GMO fearmongers have moved on and it is 
time for the European Commission to take 
responsibility for this broken legislation and 
revise the 2001 GMO Directive.
HARMONISE THE REGULATORY 
PROCESS
The recent passing of the New Genomic 
Techniques (NGT) regulation has finally 
aligned the European rules with the global 
seed research regulatory approach. The 
NGT regulation evaluates the product (the 
seed traits) rather than the process (how the 
seed was developed). The European GMO 
Directive only examines the research pro­
cess without consideration of the product.
It may be argued that the two-tiered 
approach of the NGT regulation was a fair 
compromise between long-warring stake­
holders. If it can be shown that a seed inno­
vation has no modification with any foreign 
material — if the seed could have been bred 
naturally or through conventional breeding 
— then it falls under the NGT-1 classifi­
cation and requires no stringent regulatory 
process or labelling. If, however, there is a 
genetic modification, then, as NGT-2, the 
seed falls under the requirements of the 
existing GMO Directive.
But can these two regulatory frame­
works coexist, or will the European seed 
approval process fall back into the relentless 
gamesmanship that has marred Europe’s 
ability, for decades, to enable farmers to ben­
efit from the best agricultural technologies?
The most important question has yet 
to be tested. How will the European Union 
determine if a seed innovation can be clas­
sified as an NGT-1 and avoid falling under 
the more restrictive GMO Directive? 
The seed research institution will file 
a dossier with one Member State compe­
tent authority for an NGT-1 classification. 
The Member State will then submit the 
request to EFSA for scientific analysis and 
approval. The dossier will then proceed to 
the Council for a vote on whether the seed 
can be excluded from the GMO Directive. 
In other words, little will likely change.
OLD CONFLICTS IN NEW 
BOTTLES
The NGO community was quiet during the 
final approval process of the NGT regula­
tion. Only several die-hard activist MEPs 
submitted amendments and there was no 
real fight to integrate them into the final 
legislation. Did they give up or just move 
camp to the next battlefield? It appears 
these battles will be fought on an ad hoc 
basis with greater focus and intensity on the 
hot-button biotech issues.
Many of the gene-edited solutions will 
provide enormous benefits with no risks (eg, 
leading to reduced pesticide or fertiliser use, 
drought resistance or reduced spoilage). 
Rather than risk negative public reaction 
or regulator frustration, the anti-GMO 
NGOs would just stand to the side as the 
innovations would be “fast-tracked” to the 
farm. But where NGT innovations would 
challenge organic farming (eg, providing 
pesticide resistance or increasing yields), 
that would mark a line in the sand where 
the campaigns to block these seeds from the 
simpler regulatory system would intensify at 
the Member State level to block any quali­
fied majority. In reality, I fear only the most 
clear-cut innovations will pass through the 
NGT-1 regulatory structure.
It is imperative then that the 2001 
GMO Directive be revised to provide a 
more cohesive regulatory framework for 
seed innovations. The out-dated directive 
should not be used as some purgatory for 
approvals held up by ad hoc activist cam­
paigns. The revision needs to harmonise the 
regulations on a product focus and aban­
don the failed process-oriented distraction. 
Only then can European farmers and con­
sumers enjoy the same benefits as most of 
the rest of the world.
How many more times will research­
ers, regulators and industry try to kick the 
ball knowing that Lucy is still up to her 
old tricks? 
David Zaruk is a professor based in Brussels 
writing on environmental-health risk policy 
within the EU Bubble.

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