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DRAFT OPINION (COM(2023)0414 – C90236/2023 – 2023/0227(COD))

On the proposal for a regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union, amending Regulations (EU) 2016/2031, 2017/625 and 2018/848 of the European Parliament and of the Council, and repealing Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 2002/53/EC, 2002/54/EC, 2002/55/EC, 2002/56/EC, 2002/57/EC, 2008/72/EC and 2008/90/EC (Regulation on plant reproductive material)

ENVI-PA-757169

Committee on the Environment, Public Health and Food Safety · Rapporteur: Christophe Clergeau

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The draft opinion concerns the proposed regulation on the production and marketing of plant reproductive material (PRM) in the Union, which replaces 10 Directives with a single framework. The rapporteur proposes amendments to limit the regulation's scope to PRM produced for marketing as PRM, and to add derogations for farmers' own use, exchanges between farmers, gene banks and heterogeneous material. The amendments exclude genetically modified organisms and category 1 or category 2 NGT plants from the derogations, and require the official label to indicate intellectual property rights. The rapporteur proposes that the value for sustainable cultivation and use (VSCU) test be carried out in different production systems, remain voluntary for fruits and vegetables, and not lead to the exclusion of varieties that would reduce biodiversity. The opinion also proposes amending Directive 98/44/EC so that NGT plants and plant material are not patentable, and widening compulsory licensing.

Committee position. The rapporteur proposes amendments to the Commission proposal to limit its scope to PRM produced for marketing as PRM, add derogations for farmers, gene banks and heterogeneous material, exclude GMOs and NGT plants from derogations, adjust VSCU testing, and amend Directive 98/44/EC to exclude NGT plants from patentability.

Key points

  1. The regulation should apply only to PRM produced with a view to marketing as PRM, and not to PRM intended for other purposes such as food or feed.
  2. The regulation should ensure quality and diversity of choice for PRM, appropriate and proportionate competition conditions, and dynamic conservation of plant genetic resources.
  3. Exemptions from the regulation should cover PRM produced for export outside commercial activities and private use, and PRM sold or transferred for official testing, breeding, inspections, exhibitions, scientific purposes, participatory research and gene bank activities.
  4. Farmers should be allowed to produce PRM for their own use and to exchange PRM free of charge or against reimbursement of costs, including as part of a mutual support system.
  5. Heterogeneous material of all species may be marketed without belonging to a variety, after notification to the competent authority three months prior to marketing, and registration free of charge.
  6. Gene banks, organisations and networks may market PRM for conservation to persons contributing to dynamic conservation, with a label 'PRM for conservation', and must notify the competent authority annually.
  7. PRM exchanged between farmers must be limited to quantities defined by competent authorities to meet normal needs per species per year and per farmer, without commercial intermediaries or public offer of marketing.
  8. The Commission is empowered to adopt delegated acts to authorise Member States for up to 1 year to allow marketing of pre-basic, basic or certified material to remove temporary supply difficulties.
  9. Imports of PRM from third countries should be allowed only if they comply with the requirements applicable to PRM produced and marketed in the Union.
  10. The VSCU test should be carried out in different agricultural production systems, including organic, and must not lead to the exclusion of varieties that would reduce the diversity of the species cultivated.
  11. The VSCU examination should remain voluntary for species listed in Parts B and C of Annex I, and registration should be free of charge for applicants.
  12. Directive 98/44/EC should be amended so that NGT plants, plant material and parts thereof, and genetic information they contain, are not patentable, and compulsory licensing should be widened.

Who is affected

  • Farmers, who may produce PRM for their own use and exchange PRM with reimbursement of costs.
  • Professional operators, who must ensure traceability of PRM intended for marketing and report on preservation mixtures.
  • Gene banks and conservation organisations, which may market PRM for conservation under certain conditions.
  • Small and medium-sized seed producers, for whom VSCU testing remains voluntary for fruits and vegetables.
  • Breeders, who are affected by the proposed amendment to Directive 98/44/EC on patentability of NGT plants.

Figures and deadlines

  • Maximum period of 1 year for authorising Member States to allow marketing of certain PRM categories.
  • Notification to competent authority three months prior to marketing of heterogeneous material.
  • If no further information is requested within three months, heterogeneous material may be marketed.
  • Registration period of 30 years for conservation varieties and varieties of fruit plants and vine propagating material.