The discussion regarding NGTs remains open in the European Union because the governments of different countries could not reach an agreement on the matter. The Belgian Presidency was hoping to reach a common stance before handing over the rotating Presidency of the Council to Hungary on 1 July 2024 by clarifying that any potential patents must be rendered unenforceable for the new category 1 NGT plants, but the Council of the EU failed to agree on a general approach to New Genomic Techniques (NGTs).
The opposition to the proposal is mainly due to potential issues related to the patentability of seeds produced with NGTs, which could affect access to these products for medium—and small-scale producers.
Hungary's Presidency aims to continue negotiations on the file.
CIOPORA remains active and is closely following this discussion, liaising with other associations to try to find a joint position on the patent questions and labeling/traceability, and continues.
The Discussion Background
On 5 July 2023, the European Commission tabled a proposal for the regulation on plants obtained by 'new genomic techniques' NGTs.
The original proposal aims to differentiate genetically engineered plants into two categories:
'Category 1 NGT plants:' plants considered equivalent to conventional plants ("when it differs from the parent plant by no more than 20 genetic modifications") produced by targeted mutagenesis (a set of techniques, allowing modifications of the genome without the insertion of foreign DNA), including cisgenesis (a modification of the genetic material of an organism with a sequence from the same species or one closely related).
'Category 2 NGT plants' are by default all other varieties obtained through NGTs, including plants obtained by NGTs that introduce genetic material from a non-crossable species (transgenesis). Such techniques will remain subject to the existing GMO legislation.
CIOPORA answered the public consultation on the legislative proposal in 2022 and highlighted the usefulness of allowing more flexibility in regulations concerning plants obtained by NGTs.
The European Parliament on 7 February 2024 agreed to maintain the general structure of the proposal: NGT plants considered equivalent to conventional plants (Category 1), would be exempt from the requirements of GMO legislation, while other NGT plants (Category 2) would have to comply with the rules of Directive 2001/18 on the deliberate release into the environment of GMOs. All NGT plants would remain banned in organic farming.
Furthermore, for NGT 1 plants, Members of the European Parliament (MEPs) amended the rules on the size and number of modifications required for an NGT plant to be considered equivalent to conventional plants, considering that ‘the threshold of genetic modifications must be relative to the ploidy status of the plant, that is, the number of sets of chromosomes that are found within the nucleus.’ And to ensure transparency, they decided to make compulsory a public online list of all NTG 1 plants, as well as mandatory labeling for all NGT products (including those in Category 1). MEPs also added that the Commission should present a report on how consumers and producers perceive the new techniques, seven years after they came into force.
For category 2 NGTs, MEPs chose to maintain most of the requirements of the legislation on GMOs, including the authorization procedure and compulsory product labeling. To encourage their dissemination, MEPs agreed to speed up the risk assessment procedure but stressed the need to respect the precautionary principle.
MEPs are also in favour of a total ban on patents for all NGT plants, plant material, parts thereof, genetic information, and process characteristics contained therein to avoid legal uncertainty, increased costs, and new dependencies for farmers and breeders. They are also calling for a report to be drawn up by June 2025 on the impact of patents on farmers' and breeders' access to plant reproductive material and for a legislative proposal to be presented to update EU rules on intellectual property rights accordingly.
For more information, please check the webinar organized by CIOPORA in 2023 on the NGT situation in Europe and its comparison with other legislation. Click HERE to watch the webinar.
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