On 5 July 2023, the European Commission adopted a proposal for a new Regulation on plants produced by certain new genomic techniques.
The proposal covers plants that contain genetic material from the same plant (targeted mutagenesis) or from crossable plants (cisgenesis, including intragenesis); transgenic plants (which contain genetic material from non-crossable species) will remain subject to the GMO legislation as it stands today. The placing on the market and cultivation of NGT plant and forest reproductive material will also have to comply with Union legislation on the marketing of seeds and other Plant and Forest Reproductive Material (‘PRM’, ‘FRM’) which is also undergoing a revision.
The main objectives of the proposal are:
- maintain a high level of protection of human and animal health and of the environment, in accordance with the precautionary principle.
- enable the development and placing on the market of plants and plant products contributing to the innovation and sustainability objectives of the European Green Deal and of the Farm to Fork and Biodiversity strategies.
- ensure the effective functioning of the internal market in NGT plants and products and food and feed containing, consisting, or produced from NGT plants, and enhance the competitiveness of the Union agri-food sector at the Union and global levels, including a level-playing field for operators.
- procedures for the deliberate release and placing on the market ensure that NGT plants and their food and feed are as safe as their conventional counterparts, while not entailing unnecessary regulatory burden.
- deliberate release and placing on the market of NGT plants and their food and feed that feature a wide range of plant species and traits by various developers.
- NGT plants released or placed on the market feature traits that can contribute to a sustainable agri-food system.
The proposal creates two distinct pathways for NGT plants to be placed on the market:
Category 1 NGT Plants
NGT plants that could also occur naturally or by conventional breeding (‘category 1 NGT plants’) would be subject to a verification procedure, based on criteria set in the proposal. NGT plants that meet these criteria would be treated like conventional plants and exempted from the requirements of the GMO legislation. Information on category 1 NGT plants would be provided through the labelling of seeds, in a public database and through the relevant catalogues on plant varieties.
- Criteria of equivalence of NGT plants to conventional plants A NGT plant is considered equivalent to conventional plants when it differs from the recipient/parental plant by no more than 20 genetic modifications of the types referred to in points 1 to 5, in any DNA sequence sharing sequence similarity with the targeted site that can be predicted by bioinformatic tools.
(1) substitution or insertion of no more than 20 nucleotides;
(2) deletion of any number of nucleotides;
(3) on the condition that the genetic modification does not interrupt an endogenous gene:
- targeted insertion of a contiguous DNA sequence existing in the breeder’s gene pool;
- targeted substitution of an endogenous DNA sequence with a contiguous DNA sequence existing in the breeder’s gene pool;
(4) targeted inversion of a sequence of any number of nucleotides;
(5) any other targeted modification of any size, on the condition that the resulting DNA sequences already occur (possibly with modifications as accepted under points (1) and/or (2)) in a species from the breeders’ gene pool.
Category 2 NGT Plants
For all other NGT plants (‘category 2 NGT plants’), the requirements of the current GMO legislation would apply. They would be subject to risk assessment and authorisation before could be put on the market. They would be traced and labelled as GMOs, with the possibility of a voluntary label to indicate the purpose of the genetic modification. The risk assessment, detection method and monitoring requirements would be adapted to different risk profiles and regulatory incentives would be available for NGT plants featuring traits that can contribute to sustainability goals.
To ensure transparency and freedom of choice for farmers:
- all NGT plants will be listed in a public database.
- NGT seeds and other plant reproductive material will be labelled
- information on NGT plant reproductive material will be listed in the common catalogues of plant varieties so that farmers can freely choose to use such plants or not.
Patents and intellectual property rights
The legislative proposal concerns the release and placing on the market of NGT plants but does not regulate issues of intellectual property.
The Commission will assess, as part of a broader market analysis, the impact that the patenting of plants and related licensing and transparency practices may have on innovation in plant breeding. It will also assess their impact on breeders' access to genetic material and techniques, on availability of seeds to farmers and on the overall competitiveness of the EU biotech industry. The Commission will report on its findings by 2026. It will identify possible challenges in the sector and serve as basis to decide on any possible follow-up actions.
Organic
NGT plants will be prohibited in organic production. For NGT plants subject to authorisation, the legislative proposal maintains the traceability and labelling requirements of the GMO legislation. Today, GMOs are banned in organic production by the EU Organic Production Regulation. In addition, the proposal makes the adoption of coexistence measures at national level mandatory. Member States must adopt measures so that different types of cultivation can exist side by side, e.g., distances between the fields.
To exclude NGT plants from organic production, even those that have been verified to be comparable to conventional plants, organic and GM-free farmers can consult a public register of all NGT products and seed labelling in common catalogues of varieties.