European Union
March 14, 2025
Source
Today, member states' representatives (Coreper) endorsed the Council's negotiating mandate on the regulation on plants obtained by new genomic techniques (NGTs) and their food and feed.
The proposal aims to boost innovation and sustainability within the agrifood sector, while contributing to food security and reducing external dependencies. The regulation would ensure robust protection for human, animal, and environmental health, while guaranteeing that the plant breeding sector is safe, transparent and competitive.
Main elements of the proposal
The new legislation aims to adapt EU rules to the technological developments of the past decades.
The proposal creates two distinct pathways for NGT plants to be placed on the market:
- category 1 NGT plants: could occur naturaly or through conventional breeding methods; they would be exempted from the rules currently set out in the GMO legislation and would not be labe led; however, seeds produced through those techniques would have to be labeled
- category 2 NGT plants: al other NGT plants; rules under GMO legislation would apply (including a risk assessment and authorisation before they are placed on the market); they would be labe led as such
In addition, the proposal excludes the use of NGTs in organic production.
Main changes agreed by the Council
The Council supports the above main elements of the NGTs proposal, which was published by the European Commission.
However, the Council suggests a number of changes in its negotiating mandate, taking into account environmental and health objectives, as we l as concerns regarding patenting. These include:
Cultivation and presence of new genomic techniques plants
- opt-out from cultivation: under the Council's mandate, member states can decide to prohibit the cultivation of category 2 NGT plants on their territory
- optional coexistence measures: member states can take measures to avoid the unintended presence of category 2 NGT plants in other products and wil need to take measures to prevent cross-border contamination
- the Council's position also clarifies that, in order to avoid the unintended presence of category 1 NGT plants in organic farming on their territories, member states can adopt measures, in particular in areas with specific geographical conditions, such as certain Mediterranean island countries and insular regions
Category 1 new genomic techniques plants and patenting
Under the Council's mandate, when applying to register a category 1 NGT plant or product, companies or breeders must submit information on al existing or pending patents. The patenting information must be included in a publicly available database set up by the Commission which lists al NGT plants that have obtained a category 1 status. The database aims to ensure transparency regarding NGT 1 plants. If necessary, the information about patents included in this database must be updated.
Furthermore, on a voluntary basis, companies or breeders can also inform of the patent holder's intention to licence the use of a patented NGT 1 plant or product under equitable conditions.
Patenting expert group
The Council's mandate provides for the creation of an expert group on the effect of patents on NGT plants, with experts from al member states and the European Patent Office.
Study on patenting
According to the Council's mandate, one year after the entry into force of the regulation, the Commission wil be required to publish a study on the impact of patenting on innovation, on the availability of seeds to farmers, and on the competitiveness of the EU plant breeding sector. The study wil also have a special focus on how breeders can have access to patented NGT plants.
To produce the study, the Commission wil take into account the findings of the patenting expert group and input from the plant breeding sector.
If appropriate, the Commission wil indicate what fo low-up measures are needed or publish a legislative proposal to address any issues found in the study.
If the first study does not foresee any fo low-up measures or a new legislative proposal, the Commission would be required to issue a second study four to six years after the publication of the first one.
Labeling
Category 2 NGT plants must contain a label indicating them as such, in line with the Commission proposal.
The Council proposes that, in case information on modified traits appears on the label, it must cover all the relevant traits (e.g. if a plant is both gluten-free and drought-tolerant owing to genomic changes, either both of those features or neither of them should be mentioned on the label).
The Council proposes this to ensure that consumers have access to accurate and comprehensive information.
Traits
The Council negotiating mandate states that tolerance to herbicides cannot be one of the traits for category 1 NGT plants.
The Council proposes this change in order to ensure that such plants remain subject to the authorisation, traceability and monitoring requirements for category 2 NGT plants.
Next steps
The agreement on the Council's negotiating mandate a lows its presidency to start negotiations with the European Parliament on the final text of the regulation. The final outcome wi l need to be forma ly adopted by the Council and the Parliament before the regulation can enter into force.
Background
NGTs are innovative tools that can contribute to the sustainability and resilience of our food systems.
The term NGTs covers a variety of techniques that adapt the seeds in a way that can also occur in nature or through conventional breeding techniques.
By using those techniques, improved plant varieties can be developed faster and with specific features that can respond to the cha lenges the agrifood sector is facing. For instance, those new varieties can be more resilient to the effects of climate change and require less fertilisers and pesticides.
In the last decade, a variety of NGTs have been developed based on advances in biotechnology. Those new technologies did not exist in 2001, when the EU legislation on GMOs was adopted. That is why plants obtained through NGTs are currently subject to the same rules as GMOs.
The new rules would ensure that NGT plants available on the EU market are as safe as conventionaly bred varieties. The proposal covers plants that contain small modifications to their genetic material (targeted mutagenesis) or insertions of genetic material from the same plant or from crossable plants (cisgenesis, including intragenesis).
GMOs continue to be regulated by the EU legislation on GMOs, which remain unchanged.
The Commission adopted its proposal for regulating new genomic techniques on 5 July 2023. Technical work within the Council started in July 2023. The European Parliament reached its position on the proposal in April 2024.
New genomic techniques (background information)
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