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REPORT (COM(2023)0411 – C90238/2023 – 2023/0226(COD))

On the proposal for a regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625

A-9-2024-0014

Committee on the Environment, Public Health and Food Safety · Rapporteur: Jessica Polfjärd

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Parliament's amended version of the proposed regulation on plants obtained by certain new genomic techniques (NGTs) and their food and feed, and amending Regulation (EU) 2017/625. It lays down specific rules for the deliberate release and placing on the market of NGT plants and products, ensuring a high level of protection of human and animal health and the environment, in accordance with the precautionary principle. It establishes two categories: category 1 NGT plants equivalent to conventional plants, exempt from GMO legislation, and category 2 NGT plants subject to authorisation. It sets criteria for equivalence, verification procedures, labelling, traceability, and incentives for certain traits, and excludes NGT plants from patentability.

Committee position. The Committee on the Environment, Public Health and Food Safety proposes to amend the Commission proposal to clarify criteria for category 1 NGT plants, allow NGTs in organic farming, ensure science-based verification, and exclude NGT plants from patentability.

Key points

  1. Category 1 NGT plants and products should not be subject to Union GMO legislation and should be exempted from Annex 1 B to Directive 2001/18/EC.
  2. The regulation should only cover plants obtained by targeted mutagenesis and cisgenesis (including intragenesis), not transgenesis.
  3. NGT plants with potential to persist, reproduce or spread in the environment should be evaluated with the highest level of scrutiny.
  4. Criteria for equivalence should include thresholds for size and number of genetic modifications, reflecting ploidy.
  5. Verification of category 1 status before field trials should be done by national competent authorities; reasoned objections from other Member States trigger Union-level consultation.
  6. Category 1 NGT plants should be prohibited in organic production until further consideration, and their adventitious presence in organic products should not constitute non-compliance.
  7. Plant reproductive material of category 1 NGT plants must be labelled 'cat 1 NGT' with identification number.
  8. Member States may not restrict or prohibit cultivation of category 2 NGT plants.
  9. NGT plants, plant material, parts thereof, genetic information and process features they contain shall not be patentable.
  10. The Commission shall report on the role and impact of patents on breeders' and farmers' access by June 2025.
  11. The Commission shall evaluate specificities of other sectors, such as microorganisms, by 2024.

Who is affected

  • Breeders and farmers: gain access to NGT plants without patent restrictions, but must label category 1 NGT reproductive material.
  • Organic producers: category 1 NGT plants prohibited in organic production until further consideration.
  • Member States: cannot ban cultivation of category 2 NGT plants; must conduct verification procedures.
  • Importers: imports from third countries meeting same standards shall not be impeded.

Figures and deadlines

  • 20 genetic modifications threshold for equivalence, but limited to 3 per protein-coding sequence.
  • 30 working days for competent authority to prepare verification report.
  • 20 days for other Member States and Commission to make reasoned objections.
  • 10 working days for decision in absence of objections.
  • 45 working days for Commission draft decision after objections.
  • 5 years for delegation of power, with report 9 months before end.
  • 24 months after entry into force for application, except Articles 4a and 33a apply from entry into force.
  • June 2025 for Commission report on patents.

Legal basis: Article 294(2), Article 43(2), Article 114 and Article 168(4)(b) of the Treaty on the Functioning of the European Union