Exploring the regulatory evolution of New Genomic Techniques and their potential to transform sustainable agriculture
Imagine being able to develop crops that can withstand devastating diseases, thrive in drought-stricken soils, and require fewer pesticides—all through precise genetic adjustments that mimic natural processes.
This isn't science fiction; it's the promise of New Genomic Techniques (NGTs), revolutionary plant breeding methods that are forcing a dramatic rethink of European regulations originally designed for genetically modified organisms (GMOs). At the heart of this scientific and policy debate lies a pivotal legal opinion from the European Union's Court of Justice that suggested these techniques might not fit neatly into existing GMO frameworks. This article explores how this opinion has set the stage for a potential agricultural transformation that could reshape what grows on European farms for generations to come.
Targeted genetic changes without foreign DNA
EU rethinking 20-year-old GMO framework
Potential for climate-resilient crops
New Genomic Techniques (NGTs) are a suite of precision breeding methods that allow scientists to make targeted, specific changes to an organism's DNA. Unlike earlier genetic modification that often introduced DNA from unrelated species, many NGTs work by making subtle adjustments to a plant's existing genetic blueprint or by introducing genes from closely related, sexually compatible plants.
The most famous of these techniques is CRISPR-Cas9, often described as "genetic scissors," which allows researchers to cut DNA at precise locations to delete, replace, or modify specific genes.
What makes NGTs revolutionary is their unprecedented precision, speed, and affordability compared to both conventional breeding (which relies on random genetic combinations) and earlier genetic modification techniques. While conventional breeding might take a decade to develop a new variety, NGTs can achieve more precise results in a fraction of the time 1 .
The regulatory landscape for these new techniques reached a critical juncture in 2018 when Advocate General Michal Bobek of the European Court of Justice delivered a groundbreaking opinion. The case originated from a French legal challenge brought by the agricultural association Confédération Paysanne, which ultimately led France's highest administrative court to seek guidance from the European Court of Justice 7 .
Should plants developed using NGTs be classified as GMOs under the EU's strict 2001 GMO legislation?
The European Commission responded to this legal context with a landmark proposal in July 2023 that aims to create a modernized, two-track regulatory pathway for NGT plants 2 4 . This proposal represents the most significant potential overhaul of EU biotechnology regulations in decades.
Equivalent to conventional breeding methods. To qualify, plants must meet specific criteria:
These plants would be exempt from GMO requirements though their seeds would still require labeling, and they would be listed in a public database 5 .
| Feature | Category 1 NGT Plants | Category 2 NGT Plants |
|---|---|---|
| Definition | Equivalent to conventional plants | All other NGT plants |
| GMO Rules | Exempted | Subject to full GMO legislation |
| Risk Assessment | Not required | Required before authorization |
| Labeling | Not required (except for seeds) | Mandatory |
| Database | Listed in public database | Not applicable |
| Patent Transparency | Must declare existing patents | No additional requirements |
One of the most contentious issues in the NGT discussion has been patent protection. In February 2024, the European Parliament surprised many by calling for a complete ban on patents for all NGT plants, arguing this would prevent "legal uncertainties, increased costs and new dependencies for farmers and breeders" 2 .
The Council of the EU took a different approach in its March 2025 negotiating mandate, rejecting a full patent ban in favor of transparency mechanisms 5 . Under the Council's proposal:
This compromise aims to balance incentives for innovation (through patent protection) with ensuring that breeders and farmers maintain access to improved plant materials 2 .
| Institution | Position on NGT Patenting | Primary Concern |
|---|---|---|
| European Parliament | Complete ban on all NGT plant patents | Protecting farmers from dependencies |
| European Council | Transparency instead of ban | Balancing innovation with access |
| Industry Associations | Opposed to patent ban | Maintaining incentives for R&D investment |
| Seed Industry | Supportive of Council's approach | Ensuring continued innovation |
To understand how NGTs work in practice, let's examine how researchers used CRISPR-Cas9 to develop powdery mildew-resistant wheat—a devastating fungal disease that typically requires frequent fungicide applications.
Researchers identified the MLO gene which, when functional, makes wheat susceptible to powdery mildew.
Scientists designed a specific guide RNA molecule that would lead the CRISPR-Cas9 system precisely to the MLO gene.
The CRISPR-Cas9 system was introduced into wheat cells using established transformation techniques.
Transformed wheat cells were grown into complete plants using tissue culture methods.
Edited plants were screened to identify those with successful MLO gene mutations.
The experiment successfully generated wheat plants with specific mutations in the MLO gene that conferred strong resistance to powdery mildew. Unlike traditional breeding that might introduce hundreds of unknown genetic changes along with the desired trait, the CRISPR approach made precise changes only to the target gene.
| Parameter | Conventional Wheat | CRISPR-Edited Wheat |
|---|---|---|
| Powdery Mildew Susceptibility | High | Resistant |
| Genetic Changes | Unknown thousands from breeding | Precise modification of 3-6 MLO alleles |
| Development Time | 8-10 years | 2-3 years |
| Fungicide Requirements | High | Significantly reduced |
| Yield Impact | Variable under disease pressure | Stable under disease pressure |
This case demonstrates how NGTs can achieve precise outcomes similar to what might occur through natural mutations or conventional breeding, but in a more targeted, efficient, and predictable manner.
Creating plants using New Genomic Techniques requires specialized biological tools and reagents. Here are the key components:
The core gene-editing machinery consisting of the Cas9 enzyme that cuts DNA and guide RNA that directs it to specific sequences 7 .
Short RNA sequences engineered to match and target specific DNA sequences in the plant genome.
DNA constructs used to deliver editing components into plant cells, often using Agrobacterium tumefaciens.
Genes that allow researchers to identify successfully transformed plants, typically providing resistance to specific antibiotics or herbicides.
Specially formulated nutrient mixtures that enable single plant cells to regenerate into whole plants.
Tools to verify precise genetic modifications and check for potential off-target effects.
The journey from the Advocate General's 2018 opinion to the current proposed NGT regulation illustrates how law and science must continually adapt to each other. The European Union stands at a crossroads, balancing the potential benefits of these technologies—climate resilience, reduced pesticide use, food security—with legitimate concerns about safety, corporate control, and consumer choice.
As trilogue negotiations between the Commission, Parliament, and Council continue through 2025, the outcome will significantly influence not just European agriculture but global innovation in plant breeding 2 5 . What's clear is that the conversation has moved beyond simplistic GMO debates to more nuanced discussions about how to responsibly govern a new generation of breeding techniques that offer unprecedented precision and potential.
The future of what we grow and eat in Europe may depend on getting this balance right—fostering innovation while maintaining trust and safety. As these discussions continue, they represent a fascinating case study in how society navigates the challenges and opportunities of technological progress in our most fundamental human endeavor: producing food.