The Council of the European Union (EU) announced on March 14, 2025, that the Committee of the Permanent Representatives of the Governments of the Member States to the EU (Coreper) endorsed the Council's negotiating mandate on the regulation on plants obtained by new genomic techniques (NGT) and their food and feed. The regulation proposed by the European Commission (EC) would create two ways 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 genetically modified organism (GMO) legislation and would not be labeled; seeds produced through those techniques would have to be labeled, however; or
- Category 2 NGT plants: All other NGT plants; rules under GMO legislation would apply (including a risk assessment and authorization before they are placed on the market); they would be labeled as such.
The proposed regulation would exclude the use of NGTs in organic production.
The press release states that the Council suggested the following changes in its negotiating mandate, including:
- Cultivation and presence of new genomic techniques
plants:
- Opt-out from cultivation: Under the Council's mandate, EU
member states can decide to prohibit the cultivation of category 2
NGT plants on their territory;
- Optional coexistence measures: EU 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; and
- The Council's position also clarifies that, to avoid the
unintended presence of category 1 NGT plants in organic farming on
their territories, EU member states can adopt measures, in
particular in areas with specific geographical conditions, such as
certain Mediterranean island countries and insular regions.
- Opt-out from cultivation: Under the Council's mandate, EU
member states can decide to prohibit the cultivation of category 2
NGT plants on their territory;
- Category 1 new genomic techniques plants and patenting:
According to the press release, 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 patents. The patenting information must be included in a
publicly available database created by the EC that lists all NGT
plants that have obtained a category 1 status. The press release
notes that the database would ensure transparency regarding NGT 1
plants and information about patents included in the database would
be updated. The press release states that on a voluntary basis,
companies or breeders could also report the patent holder's
intention to license 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: The press release states that according to
the Council's mandate, one year after the entry into force of
the regulation, the EC would 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 would also have a special focus on how breeders
can have access to patented NGT plants. To produce the study, the
EC would take into account the findings of the patenting expert
group and input from the plant breeding sector. According to the
press release, if appropriate, the EC would indicate what follow-up
measures are needed or publish a legislative proposal to address
any issues found in the study. The press release notes that if the
first study does not foresee any follow-up measures or a new
legislative proposal, the EC 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 EC proposal. The press release
states that 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 intends this proposal 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. According to the press release, the Council proposes this change to ensure that such plants remain subject to the authorization, traceability, and monitoring requirements for category 2 NGT plants.
The agreement on the Council's negotiating mandate allows its presidency to begin negotiations with the European Parliament (EP) on the final text of the regulation. The final text must be formally adopted by the Council and the EP before the regulation can enter into force.
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