After years of political and regulatory debate, the European Parliament has adopted a new regulatory framework for New Genomic Techniques (NGTs), establishing a specific legal framework for plants developed using these technologies.
The approval marks a significant shift in the European regulatory approach. Under the new legislation, plants will be assessed according to their final characteristics rather than solely on the technique used to develop them—an issue that has been at the centre of scientific and political discussions for many years.
Two categories of NGT plants
The new regulation establishes two distinct categories of plants obtained through NGTs.
Category 1 NGT plants are those that could also have been obtained through conventional breeding methods. These plants are subject to a limited number of genetic modifications:
- A maximum of 20 genetic modifications per monoploid genome.
- Insertions or substitutions of up to 20 nucleotides per modification.
The regulation also introduces a specific limitation: plants developed to tolerate herbicides or produce insecticidal substances cannot qualify as Category 1 NGT plants.
Once verified as meeting the established criteria, these plants will be treated similarly to conventionally bred varieties.
Category 2 NGT plants are those carrying more extensive or complex genetic modifications. These plants will continue to be regulated under the existing EU legislation for genetically modified organisms (GMOs), including risk assessment, labelling requirements and the authorisation procedures necessary for their commercialisation within the EU.
Traceability and transparency
The new regulation maintains traceability and information requirements for farmers, operators and consumers.
Plant varieties that contain or are derived from a Category 1 NGT plant will be included in a public European Union database. In addition, seeds and plant reproductive material must be identified as “Category 1 NGT”. However, the resulting plants will not carry specific consumer labels, as their characteristics cannot be distinguished from those of products obtained through conventional breeding methods.
For Category 2 NGT plants, the existing traceability and labelling requirements applicable to GMOs will continue to apply. The regulation also allows Member States to restrict or prohibit the cultivation of Category 2 NGT plants within their territory, even if they have been authorised at EU level.
Organic production
NGTs may not be used in organic production.
However, the approved text establishes that the technically unavoidable and accidental presence of Category 1 NGT plants will not constitute non-compliance with the rules governing organic production.
Patents and access to innovation
Intellectual property was one of the most debated aspects during the legislative process, particularly regarding the potential impact of patents on access to innovations developed through NGTs.
The new regulation does not modify the existing European rules governing intellectual property for biotechnological inventions. Certain innovations developed using NGTs may continue to be protected by patents, provided they meet the requirements established under current legislation. However, naturally occurring genetic characteristics or those resulting from natural biological processes cannot be patented.
To increase transparency and facilitate access to innovation, developers of Category 1 NGT plants will be required to declare relevant patents associated with their varieties in a public European Union database. They may also voluntarily indicate their willingness to license those patents under fair and reasonable terms.
The regulation also preserves traditional farming practices such as the saving and reuse of seeds by farmers, while establishing monitoring mechanisms to assess the impact of patents on innovation, seed availability and the competitiveness of the European agricultural sector.
Benefits of NGTs for farmers and consumers
For European farmers, these technologies will provide faster access to crop varieties with improved traits, including greater resistance to pests and diseases, better adaptation to adverse climate conditions and more efficient use of natural resources. They also have the potential to reduce the need for fertilisers and crop protection products, improving the sustainability of agricultural production while strengthening the competitiveness of European agriculture.
The development of varieties adapted to local growing conditions may also help reduce dependence on imports and increase the resilience of agricultural supply chains.
Consumers, in turn, stand to benefit from a more sustainable and resilient food system. NGTs can enable the development of products with improved nutritional value, longer shelf life and reduced food waste, contributing to a lower environmental footprint across the food chain.
Why was a new regulatory framework needed?
Until now, plants obtained through NGTs were regulated under the same legislation as genetically modified organisms (GMOs), rules that were developed before modern gene-editing technologies existed.
As a result, highly precise modifications—such as changing a single DNA base, something that can also occur naturally—were subject to the same regulatory requirements as much more complex genetic modifications, such as introducing genes from another species.
For many years, scientific organisations, research institutions and stakeholders across the agricultural sector argued that this approach did not adequately reflect the level of risk associated with different types of genetic modifications.
According to the European Parliament, maintaining the previous framework would have significantly limited the introduction of innovation into the European market. It would also have left Europe in a position of technological dependence, importing products developed elsewhere without actively participating in their research, development and economic value creation.
The new regulation seeks to strike a balance between encouraging innovation and maintaining high safety standards. It introduces a proportionate regulatory system based on the nature of the genetic modification: simplified procedures for plants equivalent to those obtained through conventional breeding, while maintaining the full GMO regulatory framework for more complex modifications, including Category 2 NGT plants.
Next steps
Although the new Regulation already establishes the legal basis for the regulation of New Genomic Techniques within the European Union, its effective implementation will require a 24-month transitional period during which implementing rules, verification procedures for Category 1 NGT plants, transparency systems and oversight mechanisms will be developed.
If the expected timeline is maintained, the new regulatory framework is expected to become fully applicable from mid-2028, marking the beginning of a new era for plant innovation in Europe.
The sector’s perspective
The adoption of the new regulatory framework represents a major milestone for those of us who have spent years developing and applying New Genomic Techniques in plant breeding.
As Diego Orzáez, CSIC research scientist and co-founder of Madeinplant, explains, the new regulation will allow technologies that have been available for years to finally reach the field:
“For many years, we have developed technologies capable of improving plant performance, functionality and adaptation to climate change. We now have the opportunity to apply these technologies to develop new crop varieties that are better suited to today’s agricultural challenges.”
Mercedes Diez, Director of Development at Madeinplant, also believes the new regulation recognises the scientific progress achieved in recent years and the precision of these breeding technologies.
“At last, plants are being regulated according to their characteristics rather than the way they were developed.”
She also points out that parliamentary approval represents an important milestone, but not the end of the process:
“Now comes the implementation phase. We need to see how these provisions are translated into detailed regulations and how they are applied in each Member State.”
The entry into force of the new regulation marks the beginning of a new chapter for NGTs in Europe. After years of political and regulatory debate, the scientific advances achieved over the past decade can now begin to be translated into practical applications for agriculture.
