About the rules
On 5 July 2023, the Commission adopted a legislative proposal on the production and marketing of plant reproductive material in the Union ('Regulation on plant reproductive material') and a legislative proposal on the production and marketing of forest reproductive material in the Union ('Regulation on forest reproductive material').
Plant reproductive material (PRM) is plant material (for example seeds, cuttings, trees, roots, tubers, etc.) used for the reproduction of other plants. Forest reproductive material (FRM) refers to seeds, plants and parts of plants of tree species, that are used for the of new forests and for other types of tree planting.
The current EU legislation on plant and forest reproductive material has proven its success in guaranteeing the identity, performance, quality and health of all PRM and FRM. Moreover, it has contributed to fostering an internationally competitive PRM and FRM industry.
However, as it partly dates back to the '60s, the Commission has revised the legislation, with the aim to ensure a level playing field for operators across the EU, support innovation and competitiveness of the EU PRM/FRM industry and contribute to addressing sustainability, biodiversity and climate-related challenges.
The revision seeks to:
- increase clarity and coherence of the legal framework;
- enable the uptake of new scientific and technical developments and in particular, innovative production processes, bio-molecular techniques and digital solutions;
- ensure availability of PRM/FRM suitable for future challenges;
- support the conservation and sustainable use of plant and forest genetic resources;
- harmonise the framework for official controls on PRM/FRM;
- improve coherence of the PRM/FRM legislation with the plant health legislation.
Proposed Regulation on plant reproductive material
The proposed Regulation revises the legislation which applies to production and marketing of plant reproductive material (PRM) by replacing 10 marketing Directives with a single Regulation. The proposed Regulation maintains the basic principles of the current legislation that varieties have to be registered and PRM certified before that PRM can be placed on the market.
Registration refers to the listing of a plant variety in a national catalogue after confirmation of its characteristics (i.e. that it is distinct from other varieties on the market, uniform and stable). Registration also includes testing of varieties for characteristics that can contribute to a more sustainable agri-food production (value for sustainable cultivation and use). The registered varieties in any national catalogue can be accessed on the EU Plant Variety Portal.
Certification refers to inspection in the field where PRM is produced and sampling and testing of the PRM harvested from those fields to confirm that PRM can be marketed.
Furthermore, the proposed Regulation:
- increases the diversity of PRM on the market and of cultivated crops in the fields by offering a larger choice to all types of farmers and other users (e.g. amateur gardeners) and facilitates the conservation of this diverse PRM. This increase in cultivated agro-biodiversity is achieved through simplified rules for conservation varieties see note 1 and heterogeneous material see note 2 and specific derogations for seed conservation networks and exchange in kind of seed between farmers;
- supports organic production by adapted rules for testing of organic varieties see note 3.
- provides more choice for amateur gardeners by lighter rules on market access.
Notes:
- Conservation varieties have been grown under local agro-ecological conditions and have thus become well-adapted to those conditions.
- Heterogeneous material has very diverse characteristics that allow it to evolve and adapt to variable growing conditions. It is not a variety.
- Organic varieties are varieties that are tailored to the needs of production under organic conditions (i.e. restricted use of fertilisers and pesticides).
Proposed Regulation on forest reproductive material
The proposed Regulation revises the legislation which applies to production and marketing of forest reproductive material (FRM) by replacing a marketing Directive with a Regulation. The proposed Regulation also maintains the principles of registration of 'parent trees' ('basic material') and certification before that FRM can be placed on the market.
It is based on two pillars: (i) the harvesting of forest reproductive material from registered parent trees (i.e. basic material) to ensure traceability and (ii) the certification of FRM to ensure high quality of seeds.
Under the proposed Regulation, the assessment of sustainability characteristics of parent trees is strengthened. Those trees are checked for characteristics that contribute to more resilient forests, e.g. tolerance to diseases, better adaptation to the local climatic and ecological conditions.
Better adaptation means that trees grow well and do not display symptoms of stress. The information about the adaptation of parent trees provides users information about the suitability of FRM harvested from those parent trees for current and future projected climatic and ecological conditions in a certain area.
In other words information about the suitability of FRM lets foresters know where that FRM should best be planted. This will ensure that the right tree is planted in the right place and will allow speeding up climate change adaptation of forests, thus ensuring their continued productivity in the future.
Rules to facilitate the conservation of endangered forest genetic resources will enhance the genetic diversity of trees and contribute to biodiversity conservation.
National contingency plans will help ensure sufficient supply of forest reproductive material to reforest areas affected by extreme weather events, fires, pest outbreaks and other disasters.
Relevant documents
- Communication on Sustainable Use of Natural Resources
- Press release
- PRM/FRM factsheet
- Questions and answers
- Proposal for a Regulation on plant reproductive material
- Impact Assessment
- Executive summary of the Impact Assessment
- Opinion of the Regulatory Scrutiny Board
- Study supporting the impact assessment - Report - Summary
- Proposal for a Regulation on forest reproductive material
- Impact Assessment
- Executive summary of the Impact Assessment
- Opinion of the Regulatory Scrutiny Board
- Study supporting the impact assessment - Report - Summary
- Consultation on the review
- Inception impact assessment
- PRM study
Impact assessment
To support the preparation of the revision of the PRM and FRM legislation, an impact assessment was carried out.
The impact assessment refined and detailed the policy options identified in the inception impact assessment to deal with the problems identified by the PRM study and meet the objectives set.
The Commission was supported by the external contractor ICF, who worked on gathering and assessing data on the impacts of different policy options.
Consultation activities and adoption proposals
Evidence to inform the proposal for the revision of the PRM and FRM legislation was collected by means of a public consultation as well as several other consultation activities that ICF carried out.
These included a mix of open consultations and targeted interviews with key stakeholders in order to engage with them and seek their opinion on main policy approaches and how they would be impacted by them (Table 1).
Table 1: Envisaged timeline
|
Dates |
Activity |
Description of activities |
|
November 2021 |
Interviews with key stakeholders |
The external contractor conducted 6 exploratory interviews with key stakeholders; competent authorities, industry associations, farmers’ associations, civil society organisations and an EU level organisation representing non-forestry uses of FRM. |
|
January – March 2022 |
Deadline 27 March |
The Commission will gather feedback from the public and stakeholders on the proposed revisions to the PRM legislation. The feedback received is available on Have your say |
|
March - April 2022 |
Targeted surveys, interviews and focus groups |
The external contractor will gather expert feedback through consultation of stakeholders. The targeted survey was launched on 3 March and closed on 1 April. A validation survey by the contractor to assess the validity of key findings was initially planned for May 2022 but it has been cancelled. |
|
5 July 2023 |
Legal proposals |
Commission has adopted its proposals for the revision of the PRM and FRM legislation. The proposals are accompanied by an impact assessment. |
Inception impact assessment
The Commission informed stakeholders and the public about its plans to revise the legislation on plant and forest reproductive material through the publication of an inception impact assessment on Have your say.
The inception impact assessment identifies possible options for this revision. It was available for public feedback from 15 June until 13 July 2021 and 66 comments were received (Fig. 1).
Figure 1: Overview of replies received Sixty-six stakeholders from 13 Member States and one third country provided comments.
Comments received outside of "Have your say":
PRM study
The PRM study concluded that the current PRM legislation functions very well but that it is outdated. It confirmed the continued relevance of certain key problems identified in the previous evaluation of the PRM legislation that was carried out in 2007 – 2008.
The PRM study also identified new challenges. In the past decade, there have been numerous new technical developments in the breeding and seed production sector and the forest reproductive material sector, which can only be partially addressed or not addressed at all, with the tools of the existing PRM legislation.
This development has been accompanied by a growing demand for sustainability in agriculture and the increasing need to support conservation of agro-biodiversity and adaptation to climate change. It was concluded that the PRM legislation had to be aligned with the objectives of the European Green Deal and the Farm to Fork Strategy to ensure sustainable agri-food production, long-term food security and adaptation to changing climatic and environmental conditions.
The PRM study was published as a Staff Working Document. An Executive Summary is also available. The study was supported by an analysis carried out by an external contractor. EU Member States and EEA competent authorities, industry representatives and Farmers' organisations, civil society organisations, PRM experts, and the wider public were consulted for the preparation of the PRM study.
Based on the findings of the PRM study, the Commission decided to present legislative proposals for the revision of the PRM legislation by the end of 2022.
Council request
In 2019, the Council (Council Decision (EU) 2019/1905) requested the Commission under Article 241 TFEU to provide a study on the Union's options to update the existing legislation on the production and marketing of plant reproductive material ('PRM study').
Furthermore, the Council called on the Commission to prepare a legal proposal, if deemed appropriate in view of the outcome of the PRM study.
The Commission followed up on the request of the Council with the PRM study and a letter to the Council.
The proposed revision of the PRM legislation fits into other priorities and policies initiated by the Commission, including the European Green Deal, the Farm to Fork and Biodiversity Strategies as well as the EU Strategy on adaptation to climate change.
The goals of the Farm to Fork Strategy, as part of the European Green Deal, include reducing the environmental and climate footprint of the EU food system, strengthening its resilience, ensuring food security in the face of climate change and reducing biodiversity loss. Sustainable food systems also rely on seed security and diversity. Farmers need to have access to a wide range of quality seeds of plant varieties adapted to the pressures of climate change. Updated rules on seeds and new and improved plant varieties can contribute to achieving a more sustainable, productive and diversified EU agriculture. Moreover, they can also help farmers to improve food quality and security. The Biodiversity Strategy states that the decline of genetic diversity must also be reversed; this can be done by facilitating the use of traditional varieties of crops and breeds. This would also bring health benefits through more varied and nutritious diets. The Commission will take measures to facilitate the registration of seed varieties, including for organic farming, and to ensure easier market access for traditional and locally adapted varieties.
The EU Adaptation Strategy emphasises the need to make better use of genetic diversity and plant and forest genetic resources for adaptation to climate change, and to facilitate the broadening of the supply of suitable high-quality plant and forest reproductive material to support adaptation in agriculture, forestry, and land ecosystem management.
The PRM study concludes that there are problems with the legislation concerning a lack of coherence across the Directives, complex and rigid procedures, uneven implementation and obstacles to innovation. The lack of a harmonised and risk-based framework for official controls and IT support systems creates an uneven playing field for official controls within the Union. The current legislation complicates the adoption of measures to contribute to the goals of the European Green Deal, the Farm to Fork and Biodiversity Strategies as well as the EU Strategy on adaptation to climate change.
Action needs to be taken to address the problems with the legislation on the production and marketing of plant and forest reproductive material. The PRM study identifies possible options to address these problems.
There is sufficient evidence and scientific basis for the Commission to take policy action, which will entail carrying out an impact assessment. The Commission intends to adopt a legislative proposal revising the current legal framework taking into consideration the outcome of the impact assessment.
Member States and stakeholders have been and will continue to be consulted during the process of the revision of the PRM legislation. An online public consultation on the key questions will be organised from beginning of January 2022 to 27 March 2022.
The revision of the PRM legislation will not address plant variety rights or patents.
Based on an evaluation in 2007-2008 [Final report – Annexes – Executive summary ], an Action Plan in 2009 and an impact assessment in 2011-2012, in May 2013, the European Commission submitted a proposal for a Regulation on the production and marketing of PRM including forest reproductive material. The proposed Regulation aimed at consolidating, updating and simplifying the existing legal framework regarding all sectors of seed and other PRM by replacing the 12 existing Directives ('2013 PRM proposal').
The 2013 PRM proposal addressed several areas of concern such as the complexity, rigidity, and fragmentation of the legislation, the non-level playing field, and the lack of coherence with other policies. Moreover, the aim was to create links with the new legislation related to plant health and official controls. These two Regulations were revised at the same time and entered into force in 2016 and 2017, respectively.
The main objective was to create a common and simplified framework for all sectors of seed and other plant reproductive material, and in particular to:
- grant more responsibility and flexibility to operators
- cut red tape and costs by making the rules more flexible and efficient across the EU
- create more opportunities for niche markets and for small producers
- make the rules more compatible with policy aims such as sustainable intensification of agriculture and the enhancement and conservation of biodiversity
- streamline administrative procedures to support innovation; and
- establish a level playing field by introducing the principle of cost recovery.
The 2013 PRM proposal was rejected in 2014 by the European Parliament whereas the Council expressed support for the proposal and provided orientations for possible amendments. In 2015, the Commission withdrew the proposal.
For more information, please see the page on the "2013 PRM proposal"