On 4th December, the European Parliament and the Council of the EU reached agreement on new EU rules for plants obtained by using new genomic techniques (NGTs). The agreed measures will enable more innovative plant breeding in the EU, helping farmers to grow plants that are more resilient to climate change and making them more sustainable as producers will require less resources, fertilisers and pesticides to fight pests.
This will allow breeders and farmers to be more competitive by levelling the international playing field with other producers. The news measures will significantly reduce the administrative burden too, while ensuring high safety standards for NGT plants and products.
New genomic techniques are innovative tools that can boost our agricultural and bioeconomy sectors through enabling faster, more targeted and more precise changes to plant varieties than conventional breeding techniques. Thanks to them, improved plant varieties can be developed, such as those that are climate resilient, pest resistant, or provide higher yields.
Once adopted and fully implemented, the measures agreed will create two distinct pathways for NGT plants to be placed on the market:
Category 1 NGT plants:
The provisional agreement maintains the principle that NGT-1 plants are equivalent to conventional plants
- National authorities must verify that NGT plants belong to category 1, but their offspring do not need to be subsequently verified.
- NGT-1 plants and products will not be labelled, keeping in mind the principle of equivalence. The only exception to this are seeds and other plant reproductive material of NGT-1 plants, which should be labelled. This would not entail a disproportionate burden for plant breeders, but it would allow operators to ensure a NGT-free chain, if they wish to do so.
- agreed on an exclusion list of intended traits that shall be excluded from the NGT-1 category.
- tolerance to herbicides and ‘production of a known insecticidal substance’ will be on the exclusion list and cannot be one of the intended traits for category 1 NGT plants. This change to the Commission proposal will ensure that such plants are classed as NGT-2 and therefore remain subject to authorisation, traceability and monitoring.
Category 2 NGT plants
Plants with more complex or less “natural-equivalent” genomic modifications are classified under category 2.
- maintained the existing GMO legislation requirements, including mandatory labelling of products.If the label includes information on the traits that were modified, it must cover all the relevant traits. This was introduced by the Council, to ensure that consumers have access to accurate and comprehensive information.
- agreed to allow member states to opt out from the cultivation of NGT-2 plants on their territory.
- optional coexistence measures to avoid the unintended presence of NGT-2 plants in other products, if they wish to do so.
Protection of intellectual property
Patent rules are governed by the EU's Biotech Directive. Nonetheless, the NGTs regulation addresses concerns voiced by plant breeders and farmers on patenting.
In particular, when applying to register a category 1 NGT plant or product, companies or breeders must submit information on all existing or pending patents. The patenting information must be included in a publicly available database.
Furthermore, on a voluntary basis, companies or breeders can also provide information on the patent holder's intention to licence the use of a patented NGT 1 plant or product, under equitable conditions.
Agreed on the creation of a patenting expert group, focusing on the effect of patents on NGT plants, composed of experts from all member states, the European Patent Office and the Community Plant Variety Office.
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 to farmers and on the competitiveness of the EU plant breeding sector. The Commission will then indicate what follow-up measures are needed or publish a legislative proposal to address any issues found in the study.
Next steps
The agreed Regulation must be formally adopted by the Council and the European Parliament. It will be published in the Official Journal in the course of 2026 and will start applying two years later.
Full details in the Offiical Press release:
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