NGTs: when the biotech revolution meets EU legislative caution
Several articles have informed readers of this journal about the long process concerning the possible relief of European regulations for genetic modifications resulting from new biotechnological techniques or NGTs (New Genomic Techniques): a development that has become necessary not only for scientific and economic reasons, but also, in these troubled geopolitical times, for reasons of agri-food sovereignty.
This regulatory review, which has taken six years, has given rise to multiple episodes worthy of a soap opera full of twists and turns. But in December 2025, final negotiations between supporters of technological progress and those advocating the degrowth of the Western economy led to an agreement being reached at the European Union trilogue on the night of December 3 to 4, 2025.
It should be noted that the trilogue is a meeting of the three European institutions involved in the legislative process. It is composed of representatives of the European Parliament, the Council of the European Union, and the European Commission for a final interinstitutional negotiation before the final texts are submitted for ratification by the Member States and the European Parliament.
The compromise reached in early December was strongly encouraged by Swedish MEP Jessica Polfjärd (European People’s Party), who is responsible for reporting on this issue, and by Denmark, which holds the rotating presidency of the European Union (EU) until the end of December. Will it meet the requirements of the new global geopolitical balance that is currently taking shape? Will it give the EU the means to ensure its agri-food independence?
NGTs, 21st century biotechnologies: a technological breakthrough adopted by many countries across all continents.
20th century biotechnologies were developed to modify the genome of living organisms to find solutions to several diseases affecting humans, animals and plants, or to improve food technology processes, particularly those related to fermentation. Based on advances in scientific knowledge, these biotechnologies made it possible to overcome the randomness of natural genetic mutations and modify the genome in the laboratory in order to provide solutions to the problems raised. Two techniques have been used primarily for this purpose: mutagenesis and transgenesis. One example is the synthesis of human insulin produced by transgenesis in a reactor to treat diabetes.
In the 2000s, new techniques were developed that were more precise and less expensive. The flagship technique of this biotechnological revolution is CRISPR-Cas, described in 2012 by European Emmanuelle Charpentier and American Jennifer Doudna, who received the 2020 Nobel Prize in Chemistry for this major scientific breakthrough. It has been described as “molecular scissors,” but Jennifer Doudna, in an evocative image, compares it to a “surgical scalpel,” contrasting it with 20th-century transgenesis, which she calls to be a “blacksmith’s hammer.” Other techniques, now referred to as genome editing, have since been developed, such as “base editing” in 2017 and “primary editing” in 2019. These techniques modify the genome without cutting the DNA. David Liu from Harvard University, whose team developed these new techniques, points out that they are more like a pencil redrawing the genome because the genetic modifications made could be minimal: small modifications but with major advances in the fields of plant and animal health and human medicine, as I have discussed in two recent books (1) (2).
Considering scientific advances and understanding the economic challenges associated with climate change in feeding an ever-growing global population, many countries have decided to adopt more flexible rules for bringing new genome-edited products to market, especially when they cannot be biologically distinguished from products found in nature or obtained through more traditional plant breeding techniques. Vegetable oils with improved nutritional profiles and genetically edited nutraceutical tomatoes are already being marketed in the United States and Japan! In fact, all continents are involved: North and South America, Asia and the Pacific region, Africa, and even Europe, with the United Kingdom leaving the European Union in 2020 and abandoning its restrictive and inappropriate regulations!
A necessary revision of European regulations
Scientific protocols and marketing authorization procedures are specific to the medical field, and societal debates surrounding therapeutic technological advances are generally less heated (except for mRNA vaccines during the global COVID pandemic). However, in the agri-food sector, controversy remains fierce, particularly at the European level.
In July 2018, the Court of Justice of the European Union (CJEU) ruled that any new product derived from NGT biotechnology should be considered a GMO and subject to current European regulations, Directive 2001/18, which is based on the precautionary principle and scientific knowledge that is less advanced than today. And indeed, apart from a few hundred hectares of transgenic corn resistant to major lepidopteran pests (the corn borer and the corn earworm) grown in Spain and Portugal, no transgenic plants regulated as GMOs are currently grown in the European Union. Applying these regulations to NGTs would be tantamount to replicating the same barriers that discouraged the cultivation of GMO plants in Europe.
However, it is imperative to develop new varieties of genetically edited plants that are better able to cope with observed climate change (tolerance to drought or flooding), defend themselves against pests (insects, diseases), or develop new nutritional properties (biofortification). A race for innovation is underway, not only to find solutions to make agriculture more resilient, but also to gain market share in this highly promising but also highly competitive segment.
Therefore, at the end of 2018, due to strong reactions from numerous stakeholders in research and professional circles, a procedure was launched aimed not at drastically changing the obsolete European regulations—even though they are based on scientific concepts that are now outdated due to progress in the field—but at revising them only minimally.
A lengthy review process was launched in 2019, which we detailed in a recent article (3). After commissioning a series of studies by the JRC (Joint Research Center) on the state of the art and developments in R&D, the European Commission (EC) conducted opinion polls to gather the views of European citizens, economic actors, and various organizations. These polls were conducted before and after the new regulation was proposed. It should be noted that one of these public surveys was marked by a cyberattack supported by Green MEPs, which aimed to interrupt the process, but it was thwarted! The process therefore continued as normal, with a set of very restrictive proposals issued by the EC. This is because the proposed relief only concerns certain genetic modifications of plants known as NGT-1 plants, carried out by targeted mutagenesis or cisgenesis and intragenesis, without the addition of foreign DNA, and with a maximum of 20 modified nucleotides. At this stage, genetic modifications of plants known as NGT-2, which involve other techniques and more extensive genomic modifications, are already excluded from the regulatory relief. However, those concerning microorganisms and animals have also been excluded from the outset and will apparently be considered later.
With public opinion in favor of regulatory change, the debate continued in the European Parliament, where a flurry of amendments altered the initial text to further limit the scope of the proposed regulatory relief. The final negotiations focused on the extent of genetic modifications to be authorized under the lighter regulations, traceability and labeling rules for consumers, and the patentability of genetically edited plants (4).
What are the conclusions of the recent compromise?
Limited regulatory relief
A provisional agreement has therefore been reached on a simplified procedure for NGT plants that would be considered equivalent to conventional plants. The term NGT would be reserved solely for techniques “that adapt seeds in a way that can also occur in nature or through conventional breeding techniques” (5). It is therefore not a scientific or technical definition that prevails, but arguments based on familiar reference points.
While the overall objective is to respond to the challenges facing the agri-food sector, the genomic modifications permitted under this simplified framework must relate to resistance to the effects of climate change, such as drought or floods, and reduced use of fertilizers and pesticides.
The following are excluded from regulatory relief: genetic modifications concerning herbicide tolerance (such as glyphosate or glufosinate, which are widely used in weed control before sowing) and the production of a known insecticide (a typical example being the Bt protein, which enables MON 810 transgenic corn grown in Europe to resist its major pests). Such genetic modifications classify these plants ipso facto as NGT-2 plants, which are not exempt from GMO regulations. It should be noted that the European Council has also decided that NGT plants should be banned in organic farming (6).
Two categories of NGT-1 and NGT-2 plants
NGT-1 plants, which benefit from regulatory relief, will be subject to checks by national authorities to determine whether they are equivalent to conventional plants (i.e., cannot be distinguished from them) at the time of being placed on the market, but products of the next generation will be exempt from this control. NGT-1 plants will not be labeled as such on store shelves. However, seeds and any reproductive material will have to be labeled in order to guarantee a NGT-free production chain for operators who so desire.
NGT-2 plants, i.e. all others, will be subject to current GMO legislation. Mandatory labeling of these products must provide information on what has been genetically modified, for all modifications made, in order to fully inform users. Member States may, at their discretion, refuse to allow the cultivation of these plants or take measures to allow optional coexistence on their territory between conventional, organic, and NGT-2 crops (as is the case in Portugal for the only GMO corn grown in the EU).
Patentability of NGT plants
Intellectual property protection has been the subject of heated debate, as amendments voted on in the European Parliament sought to exclude NGT plant variety innovations from patentability. However, the trilogue concluded that patent rules for these new plants obtained through NGT should fall under the EU Biotechnology Directive. Companies or breeders applying for intellectual property registration for an NGT-1 plant will have to provide all information on existing or pending patents in their application. Licenses to use the plant variety innovation may be granted in accordance with current practice. Finally, all information must be available in a publicly accessible database.
The provisional agreement specifies that “one year after the entry into force of the regulation, the Commission will publish a study on the impact of patenting on innovation, on the availability of seeds for farmers, and on the competitiveness of the EU plant breeding sector” (5). This monitoring will be carried out as part of a careful follow-up process to remedy any problems that may arise. A group of experts from the European Patent Office, the Community Plant Variety Office, and all Member States will be set up to study the effects of patents on NTG plants within the EU.
Conclusion
The European Council’s press release emphasizes that NGTs did not exist in 2001 when the EU adopted its GMO regulations, which explains why all NGT plants are subject to these regulations. According to the provisional agreement reached in early December, plants that contain minor modifications (emphasis added in the press release) to their genetic material caused by targeted mutagenesis, cisgenesis, or intragenesis, without the addition of foreign DNA to the species, will benefit from lighter regulation. The Council also emphasizes that “GMOs continue to be regulated by EU legislation on GMOs, which remains unchanged.”
Euroseeds, a professional association representing around 70 European seed companies, welcomed the agreement, emphasizing that it was a signal “Europe’s seed sector and farmers urgently needed.” (Garlich von Essen, Secretary General and CEO of Euroseeds). It also noted that there are “numerous additional have been added to the text that require careful analysis of potential impact on practices, costs and administrative burden for both operators and authorities. (7).
How diplomatically these things are said! It is commendable to see the glass as half full, and I understand the feelings of professionals who have been waiting six years for this lightening of the regulations on NGTs. But given the limited nature of the concessions granted, I would rather exclaim that “the mountain has given birth to a mouse”!!! Admittedly, genome editing allows for minimal genetic modifications that can have significant epigenetic consequences. And this is undoubtedly what the European seed sector is betting on. However, maintaining the European regulations on GMOs, which date back to 2001, on NGT-2 plants and does not consider the scientific and agronomic advances of the last 25 years, is a mistake. The Canadian position, based on the concept of “novel foods” (including plants with new characteristics) with a case-by-case assessment of the properties of the products obtained to verify their food and environmental safety, is much more rational (8). I am not sure that the European Union, which has already shown itself to be resistant to GMOs and maintains obsolete regulations with Directive 2001/18, will give itself the means to fully embrace the biotechnological revolution of the 21st century, NGTs, in order to be able to face the new global economic situation.
Bibliographical references
1. Catherine Regnault-Roger (2022), Enjeux biotechnologiques, Presses des Mines, 204 pages
2. Catherine Regnault-Roger (2024), Biotech Challenges, Springer Nature, 157 pages
3. Catherine Regnault-Roger (2023) NGT: The European Commission plays a ” simultaneously” approach The European Scientist, 11.07.2023, https://www.europeanscientist.com/en/features/ngt-the-european-commission-plays-a-simultaneously-approach/
4. Catherine Regnault-Roger (2025) NGT: the New EU Regulations for plant editing in the midst of parlementary turbulences, The European Scientist, July 1, 2025 https://www.europeanscientist.com/en/features/ngt-the-new-eu-regulations-for-plant-editing-in-the-midst-of-parlementary-turbulences/
5. Council of the EU (2025) New genomic techniques: Council and Parliament strike deal to boost the competitiveness and sustainability of our food systems https://www.consilium.europa.eu/fr/press/press-releases/2025/12/04/new-genomic-techniques-council-and-parliament-strike-deal-to-boost-the-competitiveness-and-sustainability-of-our-food-systems/
6. European Council (2025) New genomic techniques in plant breeding, https://www.consilium.europa.eu/fr/policies/new-genomic-techniques-for-plant-breeding/
7. Euroseeds (2025) Europe’s seed sector welcomes the end of trilogue negotiations on New Genomic Techniques https://euroseeds.eu/news/europes-seed-sector-welcomes-the-end-of-trilogue-negotiations-on-new-genomic-techniques/
8. Health Canada (2024). Response to concerns about the new guidance on Novel Food Regulations, products of plant breeding https://www.canada.ca/en/health-canada/services/food-nutrition/legislation-guidelines/guidance-documents/response-concerns.html
Further reading
NGT: the New EU Regulations for plant editing in the midst of parlementary turbulences
“It is time to review the EU’s outdated rules on GMOs” (Interview)
This post is also available in: FR