On 14th March, EU member states' representatives 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. Discussions continue at EU level.
Key points in the proposal (attached):
The proposal creates two distinct pathways for NGT plants to be placed on the market:
- category 1 NGT plants: could occur naturally or through conventional breeding methods; they would be exempted from the rules currently set out in the GMO legislation and would not be labelled; however, seeds produced through those techniques would have to be labelled
- category 2 NGT plants: all 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 labelled as such
- the proposal excludes the use of NGTs in organic production.
Main changes agreed by the Council
The Council supports:
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 will 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 NGTs 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 all existing or pending or no patents which is expected to be included in a publicly available database.
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 all 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 will 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 will also have a special focus on how breeders can have access to patented NGT plants.
To produce the study, the Commission will take into account the findings of the patenting expert group and input from the plant breeding sector.
If appropriate, the Commission will indicate what follow-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 follow-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.
Labelling
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.
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 allows its presidency to start negotiations with the European Parliament on the final text of the regulation. The final outcome will need to be formally adopted by the Council and the Parliament before the regulation can enter into force.
Action: Gafta will share further information on negotiations in due course.
Please refer to the official text attached and press release below for full details on EU’s NGT policy.
New genomic techniques: Council agrees negotiating mandate - Consilium
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